CFR 2017 Title40 Vol34

Title 40
Protection of Environment
Parts 723 to 789
Revised as of July 1, 2017
Containing a codification of documents

of general applicability and future effect
As of July 1, 2017
Published by the Office of the Federal Register

National Archives and Records Administration
as a Special Edition of the Federal Register
kpayne on DSK54DXVN1OFR with $$_JOB
VerDate Sep<11>2014 12:21 Aug 11, 2017 Jkt 241184 PO 00000 Frm 00001 Fmt 8091 Sfmt 8091 Q:\40\40V34.TXT 31
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Table of Contents
Page
Explanation ................................................................................................ v
Title 40:
Chapter I—Environmental Protection Agency (Continued) ............ 3
Finding Aids:
Table of CFR Titles and Chapters ....................................................... 427
Alphabetical List of Agencies Appearing in the CFR ......................... 447
List of CFR Sections Affected ............................................................. 457

iii
Cite this Code: CFR
To cite the regulations in

this volume use title,
part and section num-
ber. Thus, 40 CFR
723.50 refers to title 40,
part 723, section 50.
iv
Explanation
The Code of Federal Regulations is a codification of the general and permanent
rules published in the Federal Register by the Executive departments and agen-
cies of the Federal Government. The Code is divided into 50 titles which represent
broad areas subject to Federal regulation. Each title is divided into chapters
which usually bear the name of the issuing agency. Each chapter is further sub-
divided into parts covering specific regulatory areas.
Each volume of the Code is revised at least once each calendar year and issued
on a quarterly basis approximately as follows:
Title 1 through Title 16..............................................................as of January 1
Title 17 through Title 27 .................................................................as of April 1
Title 28 through Title 41 ..................................................................as of July 1
Title 42 through Title 50 .............................................................as of October 1
The appropriate revision date is printed on the cover of each volume.
LEGAL STATUS
The contents of the Federal Register are required to be judicially noticed (44
U.S.C. 1507). The Code of Federal Regulations is prima facie evidence of the text
of the original documents (44 U.S.C. 1510).
HOW TO USE THE CODE OF FEDERAL REGULATIONS
The Code of Federal Regulations is kept up to date by the individual issues
of the Federal Register. These two publications must be used together to deter-
mine the latest version of any given rule.
To determine whether a Code volume has been amended since its revision date
(in this case, July 1, 2017), consult the ‘‘List of CFR Sections Affected (LSA),’’
which is issued monthly, and the ‘‘Cumulative List of Parts Affected,’’ which
appears in the Reader Aids section of the daily Federal Register. These two lists
will identify the Federal Register page number of the latest amendment of any
given rule.
EFFECTIVE AND EXPIRATION DATES
Each volume of the Code contains amendments published in the Federal Reg-
ister since the last revision of that volume of the Code. Source citations for
the regulations are referred to by volume number and page number of the Federal
Register and date of publication. Publication dates and effective dates are usu-
ally not the same and care must be exercised by the user in determining the
actual effective date. In instances where the effective date is beyond the cut-
off date for the Code a note has been inserted to reflect the future effective
date. In those instances where a regulation published in the Federal Register
states a date certain for expiration, an appropriate note will be inserted following
the text.
OMB CONTROL NUMBERS
The Paperwork Reduction Act of 1980 (Pub. L. 96–511) requires Federal agencies
to display an OMB control number with their information collection request.
Many agencies have begun publishing numerous OMB control numbers as amend-
ments to existing regulations in the CFR. These OMB numbers are placed as
close as possible to the applicable recordkeeping or reporting requirements.
PAST PROVISIONS OF THE CODE
Provisions of the Code that are no longer in force and effect as of the revision
date stated on the cover of each volume are not carried. Code users may find
the text of provisions in effect on any given date in the past by using the appro-
priate List of CFR Sections Affected (LSA). For the convenience of the reader,
a ‘‘List of CFR Sections Affected’’ is published at the end of each CFR volume.
For changes to the Code prior to the LSA listings at the end of the volume,
consult previous annual editions of the LSA. For changes to the Code prior to
2001, consult the List of CFR Sections Affected compilations, published for 1949-
1963, 1964-1972, 1973-1985, and 1986-2000.
‘‘[RESERVED]’’ TERMINOLOGY
The term ‘‘[Reserved]’’ is used as a place holder within the Code of Federal
Regulations. An agency may add regulatory information at a ‘‘[Reserved]’’ loca-
tion at any time. Occasionally ‘‘[Reserved]’’ is used editorially to indicate that
a portion of the CFR was left vacant and not accidentally dropped due to a print-
ing or computer error.
INCORPORATION BY REFERENCE
What is incorporation by reference? Incorporation by reference was established
by statute and allows Federal agencies to meet the requirement to publish regu-
lations in the Federal Register by referring to materials already published else-
where. For an incorporation to be valid, the Director of the Federal Register
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rial is treated as if it were published in full in the Federal Register (5 U.S.C.
552(a)). This material, like any other properly issued regulation, has the force
of law.
What is a proper incorporation by reference? The Director of the Federal Register
will approve an incorporation by reference only when the requirements of 1 CFR
part 51 are met. Some of the elements on which approval is based are:
(a) The incorporation will substantially reduce the volume of material pub-
lished in the Federal Register.
(b) The matter incorporated is in fact available to the extent necessary to
afford fairness and uniformity in the administrative process.
(c) The incorporating document is drafted and submitted for publication in
accordance with 1 CFR part 51.
What if the material incorporated by reference cannot be found? If you have any
problem locating or obtaining a copy of material listed as an approved incorpora-
tion by reference, please contact the agency that issued the regulation containing
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CFR INDEXES AND TABULAR GUIDES
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volume, revised annually as of January 1, entitled CFR INDEX AND FINDING AIDS.
This volume contains the Parallel Table of Authorities and Rules. A list of CFR
titles, chapters, subchapters, and parts and an alphabetical list of agencies pub-
lishing in the CFR are also included in this volume.
vi
An index to the text of ‘‘Title 3—The President’’ is carried within that volume.
The Federal Register Index is issued monthly in cumulative form. This index
is based on a consolidation of the ‘‘Contents’’ entries in the daily Federal Reg-
ister.
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revision dates of the 50 CFR titles.
REPUBLICATION OF MATERIAL
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Code of Federal Regulations.
INQUIRIES
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to the Director, Office of the Federal Register, National Archives and Records
Administration, 8601 Adelphi Road, College Park, MD 20740-6001 or e-mail
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The e-CFR is a regularly updated, unofficial editorial compilation of CFR ma-
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Register and the Government Publishing Office. It is available at www.ecfr.gov.
OLIVER A. POTTS,
Director,
Office of the Federal Register.
July 1, 2017.
vii
THIS TITLE
Title 40—PROTECTION OF ENVIRONMENT is composed of thirty-seven volumes.

The parts in these volumes are arranged in the following order: Parts 1–49, parts
50–51, part 52 (52.01–52.1018), part 52 (52.1019–52.2019), part 52 (52.2020–end of part
52), parts 53–59, part 60 (60.1–60.499) , part 60 (60.500–end of part 60, sections), part
60 (Appendices), parts 61–62, part 63 (63.1–63.599), part 63 (63.600–63.1199), part 63
(63.1200–63.1439), part 63 (63.1440–63.6175), part 63 (63.6580–63.8830), part 63 (63.8980–
end of part 63), parts 64–71, parts 72–79, part 80, part 81, parts 82–86, parts 87–
95, parts 96–99, parts 100–135, parts 136–149, parts 150–189, parts 190–259, parts 260–
265, parts 266–299, parts 300–399, parts 400–424, parts 425–699, parts 700–722, parts
723–789, parts 790–999, parts 1000–1059, and part 1060 to end. The contents of these
volumes represent all current regulations codified under this title of the CFR
as of July 1, 2017.
Chapter I—Environmental Protection Agency appears in all thirty-seven vol-

umes. Regulations issued by the Council on Environmental Quality, including
an Index to Parts 1500 through 1508, appear in the volume containing parts 1060
to end. The OMB control numbers for title 40 appear in § 9.1 of this chapter.
For this volume, Ann Worley was Chief Editor. The Code of Federal Regula-
tions publication program is under the direction of John Hyrum Martinez, as-
sisted by Stephen J. Frattini.
ix
Title 40—Protection of
Environment
(This book contains parts 723 to 789)
Part
CHAPTER I—Environmental Protection Agency (Continued) 723

CHAPTER I—ENVIRONMENTAL PROTECTION
AGENCY (CONTINUED)
EDITORIAL NOTE: Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2,

2000; 66 FR 34375, 34376, June 28, 2001.
SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT
Part Page
723 Premanufacture notification exemptions ............... 5
725 Reporting requirements and review processes for
microorganisms .................................................... 27
745 Lead-based paint poisoning prevention in certain
residential structures ........................................... 73
747 Metalworking fluids ................................................ 140
749 Water treatment chemicals ..................................... 145
750 Procedures for rulemaking under section 6 of the
Toxic Substances Control Act .............................. 148
761 Polychlorinated biphenyls (PCBs) manufacturing,
processing, distribution in commerce, and use
prohibitions .......................................................... 154
763 Asbestos .................................................................. 285
766 Dibenzo-para-dioxins/dibenzofurans ........................ 380
767–769 [Reserved]
770 Formaldehyde standards for composite wood prod-
ucts ...................................................................... 390
771–789 [Reserved]
SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT
PART 723—PREMANUFACTURE (1) Act means the Toxic Substances

NOTIFICATION EXEMPTIONS Control Act (15 U.S.C. 2601 et seq).
(2) Consumer means a private indi-
Subpart A [Reserved] vidual who uses a chemical substance
or any product containing the chemical
Subpart B—Specific Exemptions substance in or around a permanent or
temporary household or residence, dur-
Sec. ing recreation, or for any personal use
723.50 Chemical substances manufactured in or enjoyment.
quantities of 10,000 kilograms or less per (3) Environment has the same mean-
year, and chemical substances with low ing as in section 3 of the Act (15 U.S.C.
environmental releases and human expo-
sures.
2602).
723.175 Chemical substances used in or for
(4) Environmental transformation prod-
the manufacture or processing of instant uct means any chemical substance re-
photographic and peel-apart film arti- sulting from the action of environ-
cles. mental processes on a parent com-
723.250 Polymers. pound that changes the molecular iden-
AUTHORITY: 15 U.S.C. 2604.
tity of the parent compound.
(5) Metabolite means a chemical enti-
ty produced by one or more enzymatic
Subpart A [Reserved] or nonenzymatic reactions as a result
of exposure of an organism to a chem-
Subpart B—Specific Exemptions ical substance.
(6) Serious acute effects means human
§ 723.50 Chemical substances manufac- disease processes or other adverse ef-
tured in quantities of 10,000 kilo- fects that have short latency periods
grams or less per year, and chem- for development, result from short-
ical substances with low environ-
mental releases and human expo- term exposure, or are a combination of
sures. these factors and that are likely to re-
sult in death, severe or prolonged inca-
(a) Purpose and scope. (1) This section pacitation, disfigurement, or severe or
grants an exemption from the prolonged loss of the ability to use a
premanufacture notice requirements of normal bodily or intellectual function
section 5(a)(1)(A) of the Toxic Sub- with a consequent impairment of nor-
stances Control Act (15 U.S.C. mal activities.
2604(a)(1)(A)) for the manufacture of: (7) Serious chronic effects means
(i) Chemical substances manufac- human disease processes or other ad-
tured in quantities of 10,000 kilograms verse effects that have long latency pe-
or less per year. riods for development, result from
(ii) Chemical substances with low en- long-term exposure, are long-term ill-
vironmental releases and human expo- nesses, or are a combination of these
sures. factors and that are likely to result in
(2) To manufacture a new chemical death, severe or prolonged incapacita-
substance under the terms of this ex- tion, disfigurement, or severe or pro-
emption a manufacturer must: longed loss of the ability to use a nor-
(i) Submit a notice of intent to man- mal bodily or intellectual function
ufacture 30 days before manufacture with a consequent impairment of nor-
begins, as required under paragraph (e) mal activities.
of this section. (8) Significant environmental effects
(ii) Comply with all other provisions means:
of this section. (i) Any irreversible damage to bio-
(3) This section does not apply to logical, commercial, or agricultural re-
microorganisms subject to part 725 of sources of importance to society;
this chapter. (ii) Any reversible damage to biologi-

(b) Definitions. The following defini- cal, commercial, or agricultural re-
tions apply to this subpart. sources of importance to society if the
§ 723.50 40 CFR Ch. I (7–1–17 Edition)
damage persists beyond a single gen- (ii) Workers. For exposure of workers
eration of the damaged resource or be- to the new chemical substance during
yond a single year; or all manufacturing, processing, dis-
(iii) Any known or reasonably antici- tribution in commerce, use and dis-
pated loss of members of an endangered posal of the substance:
or threatened species. Endangered or (A) No dermal exposure (this cri-
threatened species are those species terion is met if adequate dermal expo-
identified as such by the Secretary of sure controls are used in accordance
the Interior in accordance with the En- with applicable EPA guidance).
dangered Species Act, as amended (16 (B) No inhalation exposure (this cri-
U.S.C. 1531). terion is considered to be met if ade-
(9) Site means a contiguous property quate inhalation exposure controls are
unit. Property divided only by a public used in accordance with applicable
right-of-way is one site. There may be EPA guidance).
more than one manufacturing plant on
(iii) Ambient surface water. For ambi-
a single site.
ent surface water releases, no releases
(10) The terms byproduct, EPA, im-
resulting in surface water concentra-
porter, impurity, known to or reasonably
tions above 1 part per billion, cal-
ascertainable, manufacture, manufac-
turer, new chemical substance, person, culated using the methods prescribed
possession or control, and test data have in §§ 721.90 and 721.91, unless EPA has
the same meanings as in § 720.3 of this approved a higher surface water con-
chapter. centration supported by relevant and
(c) Exemption categories. Except as scientifically valid data submitted to
provided in paragraph (d) of this sec- EPA in a notice under paragraph (e) of
tion, this exemption applies to: this section on the substance or a close
(1) Any manufacturer of a new chem- structural analogue of the substance
ical substance manufactured in quan- which demonstrates that the new sub-
tities of 10,000 kilograms or less per stance will not present an unreason-
year under the terms of this exemp- able risk of injury to aquatic species or
tion. human health at the higher concentra-
(2) Any manufacturer of a new chem- tion.
ical substance satisfying all of the fol- (iv) Incineration. For ambient air re-
lowing low environmental release and leases from incineration, no releases of
low human exposure eligibility cri- the new chemical substance above 1
teria: microgram per cubic meter maximum
(i) Consumers and the general popu- annual average concentration, cal-
lation. For exposure of consumers and culated using the formula:
the general population to the new (kg/day of release after treatment) multi-
chemical substance during all manu- plied by (number of release days per year)
facturing, processing, distribution in multiplied by (9.68 × 10¥6) micrograms per
commerce, use, and disposal of the sub- cubic meter.
stance:
(A) No dermal exposure. (v) Land or groundwater. For releases
(B) No inhalation exposure (except as to land or groundwater, no releases to
described in paragraph (c)(2)(iv) of this groundwater, to land, or to a landfill
section. unless the manufacturer has dem-
(C) Exposure in drinking water no onstrated to EPA’s satisfaction in a
greater than a 1 milligram per year (es- notice under paragraph (e) of this sec-
timated average dosage resulting from tion that the new substance has neg-
drinking water exposure in streams ligible groundwater migration poten-
from the maximum allowable con- tial.
centration level from ambient surface (d) Chemical substances that cannot be
water releases established under para- manufactured under this exemption. A
graph (c)(2)(iii) of this section or a new chemical substance cannot be
higher concentration authorized by manufactured under this section, not-

EPA under paragraph (c)(2)(iii) of this withstanding satisfaction of the cri-
section). terion of paragraphs (c)(1) or (c)(2) of
Environmental Protection Agency § 723.50
this section, if EPA determines, in ac- PMN form and marking the adjacent
cordance with paragraph (g) of this sec- binding option box. Manufacturers who
tion, that the substance, any reason- opt to specify annual production levels
ably anticipated metabolites, environ- below 10,000 kilograms and who mark
mental transformation products, or by- the production volume binding option
products of the substance, or any rea- box shall not manufacture more than
sonably anticipated impurities in the the specific annual amount of the ex-
substance may cause, under antici- empted substance unless a new exemp-
pated conditions of manufacture, proc- tion notice for a higher (up to 10,000
essing, distribution in commerce, use, kgs) manufacturing volume is sub-
or disposal of the new chemical submitted and approved pursuant to this
stance: section.
(1) Serious acute (lethal or sublethal) (B) Manufacturers submitting an ex-
effects. emption under paragraph (c)(2) of this
(2) Serious chronic (including car- section shall list the estimated max-
cinogenic and teratogenic) effects. imum amount to be manufactured dur-
(3) Significant environmental effects. ing the first year of production and the
(e) Exemption notice. (1) A manufac- estimated maximum amount to be
turer applying for an exemption under manufactured during any 12–month pe-
either paragraph (c)(1) or (c)(2) of this riod during the first 3 years of produc-
section must submit an exemption no- tion.
tice to EPA at least 30 days before
(vii) Description of intended cat-
manufacture of the new chemical sub-
egories of use (§ 720.45(f)).
stance begins. Exemption notices and
modifications must be submitted to (viii) For manufacturer-controlled
EPA on EPA Form No. 7710–25 via CDX sites, the manufacturer shall supply
using e-PMN software in the manner identity of manufacturing sites, proc-
set forth in this paragraph. See 40 CFR ess descriptions, and worker exposure
720.40(a)(2)(ii) for information on how and environmental release information
to obtain e-PMN software. Notices and (§ 720.45(g)); for sites not controlled by
any related support documents, must the manufacturer, processing and use
be generated and completed (via CDX) operation descriptions, estimated num-
using e-PMN software. See 40 CFR ber of processing and use sites, and
720.40(a)(2)(ii) for information on how worker exposure/environmental release
to obtain e-PMN software. information (§ 720.45(h)). A manufac-
(2) The notice shall contain the infor- turer applying for an exemption under
mation described below, pursuant to paragraph (c)(1) of this section need
the referenced provisions of § 720.45. not provide information on worker ex-
(i) Manufacturer identity. posure and environmental release ref-
(ii) Chemical identity (§ 720.45(a)). erenced in paragraphs (e)(2)(viii) of this
(iii) Impurities (§ 720.45(b)). section if such information is not
(iv) Known synonyms or trade names known or not readily available to the
(§ 720.45(c)). manufacturer. To assist in reporting
(v) Byproducts (§ 720.45(d)). this information, manufacturers may
(vi) Production volume (§ 720.45(e)). obtain a copy of EPA’s Guidance for
(A) Manufacturers submitting an ex- Reporting Occupational Exposure and
emption application under paragraph Environmental Release Information
(c)(1) of this section will be assumed to under 40 CFR 723.50, available from the
be manufacturing at an annual produc- Environmental Assistance Division at
tion volume of 10,000 kilograms. Manu- the address listed in paragraph (e)(1) of
facturers who intend to manufacture this section. Where worker exposure
an exempted substance at annual vol- and environmental release information
umes of less than 10,000 kilograms and is not supplied by the manufacturer,
wish EPA to conduct its risk assess- EPA will generally apply ‘‘bounding es-
ment based upon such lesser annual timates’’ (i.e., exposure estimates high-
production level rather than a 10,000– er than those incurred by persons in
kilograms level, may so specify by the population with the highest expo-
writing the lesser annual production sure) to account for uncertainties in
volume in the appropriate box on the actual exposure and release scenarios.
§ 723.50 40 CFR Ch. I (7–1–17 Edition)
(ix) Type and category of notice. The facturer reapplying for an exemption
manufacturer must clearly indicate on for the new chemical substance must
the first page of the PMN form that the submit a new exemption notice con-
submission is a ‘‘TSCA section 5(h)(4) taining all the information required
exemption notice,’’ and must indicate under this paragraph (e) of this section
whether the notice is being submitted including a certification page con-
under paragraph (c)(1) or (c)(2) of this taining an original dated signature;
section. Manufacturers of chemical partial submissions sent to EPA to
substances that qualify for an exemp- supplement notices declared incom-
tion under both paragraph (c)(1) and plete will not be accepted. Photocopied
(c)(2) of this section may apply for ei- pages from previously submitted ex-
ther exemption, but not both. emption forms will be accepted pro-
(x) Test data (§ 720.50). vided that the certifications page con-
(xi) Certification. In addition to the tains an original dated signature.
certifications required in EPA form (f) Multiple exemption holders. (1) A
7710–25, the following certifications manufacturer who intends to manufac-
shall be included in notices under this ture a substance for which an exemp-
section. The manufacturer must certify tion under this section was previously
that: approved may apply for an exemption
(A) The manufacturer intends to under paragraph (c)(1) or (c)(2) of this
manufacture or import the new chem- section; however, EPA will not approve
ical substance for commercial pur- any subsequent exemption application
poses, other than in small quantities under paragraph (c)(1) of this section
solely for research and development, unless it can determine that the poten-
under the terms of this section. tial human exposure to, and environ-
(B) The manufacturer is familiar mental release of, the new chemical
with the terms of this section and will substance at the higher aggregate pro-
comply with those terms. duction volume will not present an un-
(C) The new chemical substance for reasonable risk of injury to human
which the notice is submitted meets all health or the environment.
applicable exemption conditions. (2)(i) If EPA proposes to deny an ex-
(D) For substances manufactured emption application for a substance for
under paragraph (c)(1) of this section, which another manufacturer currently
the manufacturer intends to commence holds an exemption, and that proposed
manufacture of the exempted sub- denial is based exclusively on the cu-
stance for commercial purposes within mulative human exposure or environ-
1 year of the date of the expiration of mental release of the substance which
the 30–day review period. precludes the EPA from determining
(xii) Sanitized copy of notice. (A) The that the subsequent applicant’s activi-
manufacturer must make all claims of ties will not present an unreasonable
confidentiality in accordance with risk of injury to human health or the
paragraph (l) of this section. If any in- environment, the EPA will notify the
formation is claimed confidential, the first exemption holder that it must,
manufacturer must submit a second within 21 days of its receipt of EPA’s
copy of the notice, with all information notice, either:
claimed as confidential deleted, in ac- (A) Provide a new certification that
cordance with paragraph (l)(3) of this it has commenced, or that it will com-
section. mence, manufacture of the new chem-
(B) If the manufacturer does not pro- ical substance under this section with-
vide the second copy, the submission in 1 year of the expiration of its exemp-
will be considered incomplete. tion review period; or
(3) Incomplete notices. If EPA receives (B) Withdraw its exemption for the
a submission which does not include all new chemical substance.
of the information required under this (ii) If the first exemption holder does
paragraph (e) of this section, the sub- not respond to the EPA’s notice under
mission will be determined to be in- paragraph (f)(2)(i) of this section with-
complete by EPA. When a submission in the prescribed time period, EPA

for a new chemical substance has been shall issue a notice of ineligibility to
determined to be incomplete, a manu- the first exemption holder under the
provisions of paragraph (h)(2) of this (B) The manufacturer may continue

section. to manufacture, process, distribute in
(g) Review period. (1) EPA will review commerce, and use the substance after
the notice submitted under paragraph receiving the notice under paragraph
(e) of this section to determine whether (h)(2)(i)(A) of this section if the manu-
manufacture of the new chemical sub- facturer was manufacturing, proc-
stance is eligible for the exemption. essing, distributing in commerce, or
The review period will end 30 days after using the substance at the time of the
receipt of the notice by the TSCA Doc- notification and if the manufacturer
ument Control Officer. To provide addi- submits objections or an explanation
tional time to address any unresolved under paragraph (h)(2)(ii) of this sec-
issues concerning an exemption appli- tion. Manufacturers not manufac-
cation, the exemption applicant may, turing, processing, distributing in com-
at any time during the review period, merce, or using the substance at the
request a suspension of the review pe- time of the notification may not begin
riod pursuant to the provisions of manufacture until EPA makes its final
§ 720.75(b) of this chapter. determination under paragraph
(2) Upon expiration of the 30–day re- (h)(2)(iii) of this section.
view period, if EPA has taken no ac- (ii) A manufacturer who has received
tion, the manufacturer may consider notice under paragraph (h)(2)(i)(A) of
its exemption approved and begin to this section may submit, within 15
manufacture the new chemical sub- days of receipt of written notification,
stance under the terms described in its detailed objections to the determina-
notice and in this section. tion or an explanation of its diligence
(h) Notice of ineligibility—(1) During and good faith efforts in attempting to
the review period. If the EPA determines comply with the terms of this section.
during the review period that manufac- (iii) The Assistant Administrator will
ture of the new chemical substance consider any objections or explanation
does not meet the terms of this section submitted under paragraph (h)(2)(ii) of
or that there are issues concerning tox- this section and will make a final de-
icity or exposure that require further termination. The Assistant Adminis-
review which cannot be accomplished trator will notify the manufacturer of
within the 30–day review period, EPA the final determination by telephone
will notify the manufacturer by tele- within 15 days of receipt of the objec-
phone that the substance is not eligi- tions or explanation, and subsequently
ble. This telephone notification will by certified letter.
subsequently be confirmed by certified (iv) If the Assistant Administrator
letter that identifies the reasons for determines that manufacture of the
the ineligibility determination. The new chemical substance meets the
manufacturer may not begin manufac- terms of this section, the manufacturer
ture of the new chemical substance may continue or resume manufacture,
without complying with section 5(a)(1) processing, distribution in commerce,
of the Act or submitting a new notice and use in accordance with the terms
under paragraph (e) of this section that of this section.
satisfies EPA’s concerns. (v) If the Assistant Administrator de-
(2) After the review period. (i)(A) If at termines that manufacture of the new
any time after the review period speci- chemical substance does not meet the
fied in paragraph (g) of this section the terms of this section and that the man-
Assistant Administrator for the Office ufacturer did not act with due dili-
of Chemical Safety and Pollution Pre- gence and in good faith to meet the
vention (‘‘the Assistant Adminis- terms of this section, the manufacturer
trator’’) makes a preliminary deter- must cease any continuing manufac-
mination that manufacture of the new ture, processing, distribution in com-
chemical substance does not meet the merce, and use of the new chemical
terms of this section, the Assistant Ad- substance within 7 days of the written
ministrator will notify the manufac- notification under paragraph (h)(2)(iii)
turer by certified letter that EPA be- of this section. The manufacturer may
lieves that the new chemical substance not resume manufacture, processing,
does not meet the terms of the section. distribution in commerce, and use of
§ 723.50 40 CFR Ch. I (7–1–17 Edition)
the new chemical substance until it becomes available during the last 5
submits a notice under section 5(a)(1) days of the notice review period, the
of the Act and part 720 of this chapter submitter must immediately inform its
and the notice review period has ended. EPA contact for that notice by tele-
(vi) If the Assistant Administrator phone.
determines that manufacture of the (j) Changes in manufacturing site, use,
new chemical substance does not meet human exposure and environmental re-
the terms of this section and that the lease controls, and certain manufacturing
manufacturer acted with due diligence volumes. (1) Except as provided in para-
and in good faith to meet the terms of graph (j)(6) of this section, chemical
this section, the manufacturer may
substances manufactured under this
continue manufacture, processing, dis-
section must be manufactured at the
tribution in commerce, and use of the
new chemical substance if: site or sites described, for the uses de-
(A) It was actually manufacturing, scribed, and under the human exposure
processing, distributing in commerce, and environmental release controls de-
or using the chemical substance at the scribed in the exemption notice under
time it received the notification speci- paragraph (e) of this section.
fied in paragraph (h)(2)(i)(A) of this (2) Where the manufacturer lists a
section. specific physical form in which the new
(B) It submits a notice on the new chemical substance will be manufac-
chemical substance under section tured, processed, and/or used, the man-
5(a)(1) of the Act and part 720 of this ufacturer must continue manufac-
chapter within 15 days of receipt of the turing, processing, and/or using the
written notification under paragraph new chemical substance in either the
(h)(2)(iii) of this section. Such manu- same physical form described in the
facture, processing, distribution in notice under paragraph (e), or in a
commerce, and use may continue un- physical form which will not increase
less EPA takes action under section the human exposure to or environ-
5(e) or 5(f) of the Act. mental release of the new chemical
(3) Action under this paragraph does substance over those exposures or re-
not preclude action under sections 7, leases resulting from the specified
15, 16, or 17 of the Act.
physical form (e.g., a manufacturer
(i) Additional information. If the man-
which specifies that the new chemical
ufacturer of a new chemical substance
substance will be produced in a non-
under the terms of this exemption ob-
tains test data or other information in- volatile liquid form generally may not
dicating that the new chemical sub- change to a respirable powder form).
stance may not qualify under terms of (3) The annual production volume of
this section, the manufacturer must chemical substances manufactured
submit these data or information to under paragraph (c)(1) of this section
EPA within 15 working days of receipt for which the manufacturer designated
of the information. If, during the no- a binding annual production volume
tice review period specified in para- pursuant to paragraph (e)(2)(vi) of this
graph (g) of this section, the submitter section must not exceed that des-
obtains possession, control, or knowl- ignated volume.
edge of new information that materi- (4) Any person who manufactures a
ally adds to, changes, or otherwise new chemical substance under para-
makes significantly more complete the graph (c)(1) or (c)(2) of this section
information included in the notice, the must comply with the provisions of
submitter must send that information this section, including submission of a
to the address listed on the notice form new notice under paragraph (e) of this
within 10 days of receiving the new in- section, before:
formation, but no later than 5 days be-
(i) Manufacturing the new chemical
fore the end of the notice review pe-
substance at a site that was not ap-
riod. The new submission must clearly
identify the submitter and the exemp- proved in a previous exemption notice
tion notice to which the new informa- for the substance, except as provided in
tion is related. If the new information paragraph (j)(6) of this section.
10
(ii) Manufacturing the new chemical substance at the manufacturing site

substance for a use that was not ap- for which the EPA performed its origi-
proved in a previous exemption notice nal risk-assessment pursuant to the
for the substance. original exemption notice; and
(iii) Manufacturing the new chemical (B) Either (1) at the new manufac-
substance without employing the turing site, the manufacturer does not
human exposure and environmental re- release to surface waters any of the
lease controls approved in a previous new chemical substance, or any waste
exemption notice for the substance. streams containing the new chemical
(iv) Manufacturing the new chemical substance; or (2) at the new manufac-
substance in a physical form different turing site, the manufacturer main-
than that physical form approved in a tains surface water concentrations of
previous exemption notice for the sub- the chemical substance, resulting from
stance and which form may increase direct or indirect discharges from the
the human exposure to, or environ- manufacturing site, at or below 1 part
mental release of, the new chemical per billion, or at or below an alter-
substance over those exposures or re- native concentration level approved by
leases resulting from the physical form the Agency in writing or under the pro-
approved in the previous notice. cedures described in paragraph
(v) Manufacturing the chemical sub- (c)(2)(iii) of this section, using the
stance in annual production volumes water concentration calculation meth-
above any volume designated by the od described at §§ 721.90 and 721.91.
manufacturer as binding under para- (ii) The manufacturer shall notify
graph (e)(2)(vi) of this section in a pre- EPA of any new manufacturing site no
vious exemption notice for the sub- later than 30 days after the commence-
stance. ment of manufacture of the new chem-
(5) In an exemption notice informing ical substance under the exemption at
EPA of a change in site, use, or worker the new manufacturing site as follows:
protection, or environmental release (A) The notification must contain
controls, the manufacturer is not re- the EPA-designated exemption number
quired to provide all of the same infor- to which the notification applies, man-
mation submitted to EPA in a previous ufacturer identity, the street address
exemption notice for that chemical of the new manufacturing site, the date
substance. The new exemption notice, on which manufacture commenced at
however, must indicate the identity of the new site, the name and telephone
the new chemical substance; the manu- number of a technical contact at the
facturer’s name; the name and tele- new site, any claim of confidentiality,
phone number of a technical contact; and a statement that the notification
and location of the new site, new work- is an amendment to the original ex-
er protection or environmental release emption application under the terms of
controls, and new use information. The this section.
notice must also include the EPA-des- (B) The notification must be sub-
ignated exemption number assigned to mitted electronically to EPA via CDX
the previous notice and a new certifi- as a support document to the original
cation by the manufacturer, as de- notification. Prior to submission to
scribed in paragraph (e)(2)(xi) of this EPA via CDX, such notices must be
section. generated and completed using the e-
(6)(i) A manufacturer may, without PMN software. See 40 CFR
submitting a new notice, manufacture 720.40(a)(2)(ii) for information on how
the new chemical substance at a site to access the e-PMN software.
not listed in its exemption application (k) Customer notification. (1) Manufac-
under the following conditions: turers of new chemical substances de-
(A) the magnitude, frequency, and scribed in paragraphs (c)(1) and (c)(2) of
duration of exposure of individual this section must notify processors and
workers to the new chemical substance industrial users that the substance can
at the new manufacturing site is equal be used only for the uses specified in
to, or less than, the magnitude, fre- the exemption notice at paragraph (e)
quency, and duration of exposure of the of this section. The manufacturer must
individual workers to the new chemical also inform processors and industrial
11
§ 723.50 40 CFR Ch. I (7–1–17 Edition)
users of any controls specified in the under what conditions, distribution of

exemption notice. The manufacturer the chemical substance to the cus-
may notify processors and industrial tomer may resume.
users by means of a container labeling (l) Confidentiality. (1) If the manufac-
system, written notification, or any turer submits information to EPA
other method that adequately informs under this section which the manufac-
them of use restrictions or controls. turer claims to be confidential business
(2) A manufacturer of a new chemical information, the manufacturer must
substance described in paragraph (c)(2) clearly identify the information at the
of this section may distribute the time of submission to EPA by brack-
chemical substance only to other per- eting, circling, or underlining it and
sons who agree in writing to not fur- stamping it with ‘‘CONFIDENTIAL’’ or
ther distribute the substance until it some other appropriate designation.
has been reacted, incorporated into an Any information so identified will be
article, or otherwise rendered into a treated in accordance with the proce-
physical form or state in which envi- dures in part 2 of this chapter. Any in-
ronmental releases and human expo- formation not claimed confidential at
sures above the eligibility criteria in the time of submission may be made
paragraph (c)(2) of this section are not available to the public without further
likely to occur. notice.
(3) If the manufacturer learns that a (2)(i) Any person who asserts a claim
direct or indirect customer is proc- of confidentiality for chemical identity
essing or using the new substance in under this paragraph (l) must provide a
violation of use restrictions or without generic chemical name that is only as
imposing prescribed worker protection generic as necessary to protect the
or environmental release controls, the confidential chemical identity of the
manufacturer must cease distribution particular chemical substance. The
of the substance to the customer or the
name should reveal the specific chem-
customer’s supplier immediately un-
ical identity to the maximum extent
less the manufacturer is able to docu-
possible.
ment each of the following:
(i) That the manufacturer has, within (ii) The generic name provided by the
5 working days, notified the customer manufacturer will be subject to EPA
in writing that the customer has failed review and approval in accordance with
to comply with the conditions specified the procedures specified in § 720.85(b)(6)
in this section and the exemption no- of this chapter. The generic name pro-
tice under paragraph (e) of this section. vided by the submitter or an alter-
(ii) That, within 15 working days of native selected by EPA under these
notifying the customer of the non- procedures will be placed on a public
compliance, the manufacturer received list of substances exempt under this
from the customer, in writing, a state- section.
ment of assurance that the customer is (3) If any information is claimed con-
aware of the terms of this section and fidential, the manufacturer must sub-
the exemption notice and will comply mit a second copy of the notice with all
with those terms. information claimed as confidential de-
(4) If, after receiving a statement of leted. EPA will place the second copy
assurance from a customer under para- in the public file.
graph (k)(3)(ii) of this section, the (m) Exemptions granted under super-
manufacturer obtains knowledge that seded regulations. Manufacturers hold-
the customer has again failed to com- ing exemptions granted under the su-
ply with any of the conditions specified perseded requirements of this section
in this section or the exemption notice, (as in effect on May 26, 1995) shall ei-
the manufacturer shall cease supplying ther continue to comply with those re-
the new chemical substance to that quirements (including the production
customer and shall report the failure volume limit) or apply for a new ex-
to comply to EPA within 15 days of ob- emption pursuant to this section. EPA
taining this knowledge. Within 30 days will not accept requests to amend ex-
of its receipt of the report, EPA will emptions granted under the superseded
notify the manufacturer whether, and requirements; manufacturers wishing
12
to amend such exemptions must sub- under the authority of section 7 of the
mit a new exemption under paragraph Act (15 U.S.C. 2606) or section 17 of the
(e) of this section. If a new exemption Act (15 U.S.C. 1616).
for a new chemical substance is grant-
[60 FR 16346, Mar. 29, 1995, as amended at 60
ed under this exemption to the manu- FR 34465, July 3, 1995; 62 FR 17932, Apr. 11,
facturer holding an exemption under 1997; 64 FR 31989, June 15, 1999; 71 FR 33642,
the superseded requirements, the ex- June 12, 2006; 75 FR 787, Jan. 6, 2010; 77 FR
emption under the superseded require- 46292, Aug. 3, 2012; 78 FR 72828, Dec. 4, 2013; 80
ments for such substance shall be void. FR 42746, July 20, 2015]
(n) Recordkeeping. (1) A manufacturer
of a new chemical substance under § 723.175 Chemical substances used in
paragraph (c) of this section must or for the manufacture or proc-
essing of instant photographic and
maintain the records described in this peel-apart film articles.
paragraph at the manufacturing site or
site of importation for a period of 5 (a) Purpose and scope. (1) This section
years after their preparation. grants an exemption from the
(2) The records must include the fol- premanufacture notice requirements of
lowing to demonstrate compliance with section 5(a)(1)(A) of the Toxic Sub-
this section: stances Control Act (15 U.S.C.
(i) Records of annual production vol- 2604(a)(1)(A)) for the manufacture and
ume and import volume. processing of new chemical substances
(ii) Records documenting compliance used in or for the manufacture or proc-
with the applicable requirements and essing of instant photographic and
restrictions of paragraphs (c), (e), (f), peel-apart film articles. This section
(h), (i), (j), and (k) of this section. does not apply to microorganisms sub-
(3) Any person who manufactures a ject to part 725 of this chapter.
new chemical substance under the (2) To manufacture a new chemical
terms of this section must, upon re- substance under the terms of this ex-
quest of a duly designated representa- emption, a manufacturer of instant
tive of EPA, permit such person at all photographic or peel-apart film arti-
reasonable times to have access to and cles must:
to copy records kept under paragraph (i) Submit an exemption notice when
(n)(2) of this section. manufacture begins under paragraph (i)
(4) The manufacturer must submit of this section.
the records listed in paragraph (n)(2) of (ii) Comply with certain require-
this section to EPA upon request. Man- ments to limit exposure to the new
ufacturers must provide these records chemical substance under paragraphs
within 15 working days of receipt of (e), (f), (g), and (h) of this section.
such request. (iii) Comply with all recordkeeping
(o) Compliance. (1) Failure to comply requirements under paragraph (j) of
with any provision of this section is a this section.
violation of section 15 of the Act (15 (b) Definitions—(1) Act means the
U.S.C. 2614). Toxic Substances Control Act (15
(2) Submitting materially misleading U.S.C. 2601 et seq.).
or false information in connection with (2) An article is a manufactured item
the requirements of any provision of (i) which is formed to a specific shape
this section is a violation of this sec- or design during manufacture, (ii)
tion and therefore a violation of sec- which has end use function(s) depend-
tion 15 of the Act (15 U.S.C. 2614). ent in whole or in part upon its shape
(3) Violators may be subject to the or design during end use, and (iii)
civil and criminal penalties in section which has either no change of chemical
16 of the Act (15 U.S.C. 2615) for each composition during its end use or only
violation. those changes of composition which
(4) EPA may seek to enjoin the man- have no commercial purpose separate
ufacture or processing of a chemical from that of the article and that may
substance in violation of this section, occur as described in § 710.2 of this
or act to seize any chemical substance chapter except that fluids and particles
manufactured or processed in violation are not considered articles regardless
of this section, or take other action of shape or design.
13
§ 723.175 40 CFR Ch. I (7–1–17 Edition)
(3) The terms byproduct, EPA, impuri- of an instant photographic or peel-

ties, person, and site have the same apart film article.
meanings as in § 710.3 of this chapter. (13) Special production area means a
(4) The term category of chemical sub- demarcated area within which all man-
stances has the same meaning as in sec- ufacturing, processing, and use of a
tion 26(c)(2) of the Act (15 U.S.C. 2625). new chemical substance takes place,
(5) The terms chemical substance, dis- except as provided in paragraph (f) of
tribute in commerce, distribution in com- this section, in accordance with the re-
merce, environment, manufacture, new quirements of paragraph (e) of this sec-
chemical substance, and process have the tion.
same meanings as in section 3 of the (14) Test data means:
Act (15 U.S.C. 2602). (i) Data from a formal or informal
(6) Director of the Office of Pollution study, test, experiment, recorded ob-
Prevention and Toxics means the Direc- servation, monitoring, or measure-
tor of the EPA Office of Pollution Pre- ment.
vention and Toxics or any EPA em- (ii) Information concerning the ob-
ployee designated by the Office Direc- jectives, experimental methods and
tor to carry out the Office Director’s materials, protocols, results, data anal-
functions under this section. yses (including risk assessments), and
(7) The term exemption category conclusions from a study, test, experi-
means a category of chemical sub- ment, recorded observation, moni-
stances for which a person(s) has ap- toring, or measurement.
plied for or been granted an exemption (15) Used in or for the manufacturing or
under section 5(h)(4) of the Act (15 processing of an instant photographic or
U.S.C. 2604). peel-apart film article, when used to de-
(8) The term instant photographic film scribe activities involving a new chem-
article means a self-developing photo- ical substance, means the new chem-
graphic film article designed so that ical substance (i) is included in the ar-
all the chemical substances contained ticle, or (ii) is an intermediate to a
in the article, including the chemical chemical substance included in the ar-
substances required to process the film, ticle or is one of a series of intermedi-
remain sealed during distribution and ates used to manufacture a chemical
use. substance included in the article.
(9) Intermediate means any chemical (16) Wet mixture means a water or or-
substance which is consumed in whole ganic solvent-based suspension, solu-
or in part in a chemical reaction(s) tion, dispersion, or emulsion used in
used for the intentional manufacture of the manufacture of an instant photo-
another chemical substance. graphic or peel-apart film article.
(10) Known to or reasonably ascertain- (c) Exemption category. The exemption
able means all information in a per- category includes new chemical sub-
son’s possession or control, plus all instances used in or for the manufacture
formation that a reasonable person or processing of instant photographic
similarly situated might be expected to or peel-apart film articles which are
possess, control, or know, our could ob- manufactured and processed under the
tain without unreasonable burden or terms of this section.
cost. (d) Applicability. This exemption ap-
(11) The term peel-apart film article plies only to manufacturers of instant
means a self-developing photographic photographic or peel-apart film arti-
film article consisting of a positive cles who:
image receiving sheet, a light sensitive (1) Manufacture the new chemical
negative sheet, and a sealed reagent substances used in or for the manufac-
pod containing a developer reagent and ture or processing of the instant photo-
designed so that all the chemical sub- graphic or peel-apart film articles.
stances required to develop or process (2) Limit manufacture and processing
the film will not remain sealed within of a new chemical substance to the
the article during and after the devel- site(s) listed in the exemption notice
opment of the film. for that new chemical substance sub-

(12) Photographic article means any mitted under paragraph (i) of this sec-
article which will become a component tion.
14
(3) Comply with the requirements of excursion of 50 percent above these

paragraphs (e), (f), (g), (h), and (j) of concentrations for a duration of 30
this section. minutes or less.
(4) Do not distribute in commerce or (iii) Quantitative fit test. Each res-
use a peel-apart film article containing pirator must be issued to a specific in-
a new chemical substance until submis- dividual for personal use. A quan-
sion of a premanufacture notice under titative fit test must be performed for
section 5(a)(1)(A) of the Act (15 U.S.C. each respirator before its first use by
2604) and until the review period for the that person in a special production
notice has ended without EPA action area.
to prevent distribution or use. (3) Monitoring—(i) When to monitor.
(e) Conditions of manufacture and proc- (A) When suitable sampling and ana-
essing in the special production area. All lytic methods exist, periodic moni-
manufacturing, processing, and use op- toring in accordance with this para-
erations involving the new chemical graph must be done to ensure compli-
substance must be performed in a spe- ance with the exposure limits of para-
cial production area under the condi- graphs (e)(1) and (2)(ii) of this section.
tions set forth in this paragraph until (B) When suitable sampling and ana-
the new chemical substance has been lytic methods do not exist, compliance
incorporated into a wet mixture, pho-
with the exposure limits of paragraph
tographic article, or instant photo-
(e)(1) and the requirements of para-
graphic or peel-apart film article.
graph (e)(10) of this section must be de-
(1) Exposure limits. In the special pro-
termined by an evaluation of moni-
duction area, the ambient air con-
toring data developed for a surrogate
centration of the new chemical sub-
chemical substance possessing com-
stance during manufacture, processing,
parable physical-chemical properties
and use cannot exceed an 8-hour time
under similar manufacturing and proc-
weighted average (TWA) of 10 ppm for
essing conditions.
gases and vapors and 50 μg/m3 for par-
ticulates, with an allowable TWA ex- (ii) Monitoring methods. A suitable air
cursion of 50 percent above those con- sampling method must permit personal
centrations for a duration of 30 min- or fixed location sampling by conven-
utes or less. tional collection methods. A suitable
(2) Respiratory protection—(i) Res- analytic method must have adequate
pirator requirement. Except as specified sensitivity for the volume of sample
in paragraph (e)(2)(ii) of this section, available and be specific for the new
each person in the special production chemical substance being monitored. If
area must wear an appropriate res- chemical-specific monitoring methods
piratory protection device to protect are not available, nonspecific methods
against dusts, fumes, vapors, and other may be used if the concentration of the
airborne contaminants, as described in new chemical substance is assumed to
29 CFR 1910.134. Selection of an appro- be the total concentration of chemical
priate respirator must be made accord- substances monitored.
ing to the guidance of American Na- (iii) Monitoring frequency. (A) When
tional Standard Practices for Res- suitable air sampling and analytical
piratory Protection Z88.2–1969 and the procedures are available, monitoring
NIOSH Certified Equipment List, U.S. must be done in each special produc-
Department of Health and Human tion area during the first three 8-hour
Services, NIOSH publication No. 80–144. work shifts involving the manufacture
(ii) Waiver of respirator requirement. or processing of each new chemical
Employees are not required to wear substance. Thereafter, monitoring
respirators if monitoring information must be done in each special produc-
collected and analyzed in accordance tion area for at least one 8-hour period
with paragraph (e)(3) of this section per month, during a production run in
demonstrates that the ambient 8-hour which the new chemical substance is
TWA concentration of the new chem- manufactured or processed. Samples
ical substance in the area is less than must be of such frequency and pattern
1 ppm for gases and vapors and 5 μg/m3 as to represent with reasonable accu-
for particulates with an allowable TWA racy the mean level and maximum 30-
15
§ 723.175 40 CFR Ch. I (7–1–17 Edition)
minute level of employee exposure dur- employee changing and wash-up. Food,
ing an 8-hour work shift. In monitoring beverages, tobacco products, and cos-
for an 8-hour work shift or the equiva- metics must not be allowed in special
lent, samples must be collected peri- production areas.
odically or continuously for the dura- (iii) Work practices. Operating proce-
tion of the 8-hour work shift. Samples dures such as those related to chemical
must be taken during a period which is weighing and filtering, or the charging,
likely to represent the maximum em- discharging and clean-up of process
ployee exposure. equipment, must be designed and con-
(B) If the manufacturer demonstrates ducted to ensure compliance with the
compliance with the exposure limits exposure limits prescribed in para-
for 3 consecutive months, further mon- graph (e)(1) or (e)(2)(ii) of this section.
itoring of the identical process must be Written procedures and all materials
performed only every 6 months there- necessary for responding to emergency
after, unless there is a significant situations must be immediately acces-
change in the process, process design, sible to all employees in a special pro-
or equipment. If there is such a change, duction area. Any spill or unantici-
the manufacturer must begin moni- pated emission must be controlled by
toring again according to the schedule specially trained personnel using the
in paragraph (e)(3)(iii)(A) of this sec- equipment and protective clothing de-
tion. scribed in paragraph (e)(6) of this sec-
(iv) Location of monitoring. Air sam- tion.
ples must be taken so as to ensure that
(6) Personal protection devices. All
the samples adequately represent the
workers engaged in the manufacture
ambient air concentration of a new
and processing of a new chemical sub-
chemical substance present in each
stance in the special production area
worker’s breathing zone.
must wear suitable protective clothing
(4) Engineering controls and exposure
or equipment, such as chemical-resist-
safeguards. Engineering controls such
ant coveralls, protective eyewear, and
as, but not limited to, isolation, enclo-
gloves.
sure, local exhaust ventilation, and
dust collection must be used to ensure (7) Caution signs. Each special produc-
compliance with the exposure limits tion area must be clearly posted with
prescribed in paragraphs (e)(1) or signs identifying the area as a special
(e)(2)(ii) of this section. production area where new chemical
(5) Training, hygiene, and work prac- substances are manufactured and proc-
tices—(i) Training. No employee may essed under controlled conditions. Each
enter a special production area before sign must clearly restrict entry into
the completion of a training program. the special production area to qualified
The training program must be adapted personnel who are properly trained and
to the individual circumstances of the equipped with appropriate personal ex-
manufacturer and must address: The posure safeguards.
known physical-chemical and toxi- (8) Removal for storage or transpor-
cological properties of the chemical tation. A new chemical substance that
substances handled in the area; proce- is not incorporated into a wet mixture,
dures for using and maintaining res- photographic article, or instant photo-
pirators and other personal safeguards; graphic or peel-apart film article may
applicable principles of hygiene; spe- be removed from the special production
cial handling procedures designed to area for purposes of storage between
limit personal exposure to, and inad- operational steps or for purposes of
vertent release of, chemical sub- transportation to another special pro-
stances; and procedures for responding duction area. Such storage or transpor-
to emergencies or spills. tation must be conducted in a manner
(ii) Hygiene. Appropriate standards of that limits worker and environmental
hygiene must be observed by all em- exposure through the use of engineer-
ployees handling a new chemical sub- ing controls, training, hygiene, work
stance in manufacturing, processing, or practices, and personal protective de-

transfer operations. The manufacturer vices appropriate to the chemical sub-
must provide appropriate facilities for stance in question.
16
(9) Labeling. (i) Any new chemical (ii) Hygiene. Appropriate standards of
substance removed from a special pro- hygiene that limit exposure must be
duction area or stored or transported observed by all employees handling wet
between operational steps must be mixtures that contain new chemical
clearly labeled. The label must show substances.
the identity of the new chemical sub- (iii) Work practices. Work practices
stance or an appropriate identification and operating procedures must be de-
code, a statement of any known haz- signed to limit exposure to any new
ards associated with it, a list of special chemical substance contained in wet
handling instructions, first aid infor- mixtures. Any spills or unanticipated
mation, spill control directions, and releases of a wet mixture must be con-
where applicable, the appropriate U.S. trolled by trained personnel wearing
Department of Transportation nota- appropriate protective clothing or
tions. equipment such as gloves, eye protec-
(ii) No label is required if the new tion, and, where necessary, respirators
chemical substance has been incor- or chemically imprevious clothing.
porated into a photographic article, or (3) Personal protection devices. All
if it is contained in a sealed reaction workers engaged in the processing of a
vessel or pipeline, or if it has been in- wet mixture containing a new chemical
corporated into an instant photo- substance must wear suitable protec-
graphic or peel-apart film article. tive clothing or equipment such as cov-
(10) Areas immediately adjacent to the eralls, protective eyewear, respirators,
special production area. The ambient air and gloves.
concentration of the new chemical sub- (g) Incorporation of photographic arti-
stance in areas immediately adjacent cles into instant photographic and peel-
to the special production area must not apart film articles. A photographic arti-
exceed the exposure limit established cle may be incorporated into the in-
in paragraph (e)(2)(ii) of this section stant photographic or peel-apart film
for waiver of respirator protection article outside the special production
within the special production area. area. The manufacturer must take
Periodic monitoring in accordance measures to limit worker and environ-
with paragraph (e)(3) of this section mental exposure to new chemcial sub-
must be performed in immediately ad- stances during these operations using
jacent areas where it is reasonable to engineering controls, training, hy-
expect a risk of inhalation exposure. giene, work practices, and personal
(f) Conditions of processing outside the protective devices.
special production area. A wet mixture (h) Environmental release and waste
may be incorporated into a photo- treatment—(1) Release to land. Process
graphic article or an instant photo- waste from manufacturing and proc-
graphic or peel-apart film article out- essing operations in the special produc-
side the special production area under tion area that contain a new chemical
the conditions listed in this paragraph: substance are considered to be haz-
(1) Engineering controls and exposure ardous waste and must be handled in
safeguards. Engineering controls must accordance with the requirements of
limit the exposure to a new chemical parts 262 through 267 and parts 122 and
substance contained in a wet mixture. 124 of this chapter.
(2) Training, hygiene and work prac- (2) Release to water. All wastewater or
tices—(i) Training. Training of employ- discharge which contain the new
ees involved in the handling of wet chemcial subtance must be appro-
mixtures containing a new chemical priately pretreated before release to a
substance must be adapted to the indi- Publicly Owned Treatment Works
vidual circumstances of the employees’ (POTW) or other receiving body of
activities and must address: Proce- water. In the case of release to a
dures for using personal exposure safe- POTW, the pretreatment must prevent
guards, applicable principles of hy- structural damage to, obstruction of,
giene, handling procedures designed to or interference with the operation of
limit personal exposure, and proce- the POTW. The treatment of direct re-
dures for responding to emergencies lease to a receiving body of water must
and spills. be appropriate for the new chemical
17
§ 723.175 40 CFR Ch. I (7–1–17 Edition)
substance’s physical-chemical prop- diagram, if available. The notice must

erties and potential toxicity. indicate the number average molecular
(3) Release to air. All process emis- weight of the polymer and characterize
sions released to the air which contain the anticipated low molecular weight
the new chemical substance must be species. The notice must include this
vented through control devices appro- information for each typical average
priate for the new chemical substance’s molecular weight composition of the
physical-chemical properties and po- polymer to be manufactured.
tential toxicity. (iii) Impurities. The notice must iden-
(i) Exemption notice. An exemption tify the impurities that can be reason-
notices must be submitted to EPA ably anticipated to be present in the
when manufacture of the new chemical new chemcial substance when manu-
substance begins. factured under the exemption by name
(1) Contents of exemption notice. The and CAS Registry Number, by class of
exemption notice must include the fol- substances, or by process or source.
lowing information: The notice also must estimate the
(i) Manufacturer and sites. The notice maximum percent (by weight) of each
must identify the manufacturer and impurity in the new chemical sub-
the sites and locations where the new stance and the percent of unknown im-
chemical substance and the instant purities present.
photographic or peel-apart film arti- (iv) Physical-chemical properties. The
cles will be manufactured and proc- notice must describe the physical-
essed. chemical properties of the new chem-
(ii) Chemical identification. The notice ical substance. Where specific physical-
must identify the new chemical sub- chemical data are not available, rea-
stance as follows: sonable estimates and the techniques
(A) Class 1 substances. For chemical used to develop these estimates must
substances whose composition can be be provided.
represented by a definite structural (v) Byproducts. The notice must iden-
disagram (Class 1 substances), the notify the name, CAS Registry number (if
tice must provide the chemical name available), and the volume of each by-
(preferably CAS or IUPAC nomen- product that would be manufactured
clature), the molecular formula, CAS during manufacture of the new chem-
Registry Number (if available), known ical substance.
synonyms (including trade names), and (vi) Production volume. The notice
a structural diagram. must include an estimate of the antici-
(B) Class 2 substances. For chemical pated maximum annual production vol-
substances that cannot be fully rep- ume.
resented by a structural diagram, (vii) Test data. The notice must in-
(Class 2 substances), the notice must clude all information and test data on
provide the chemical name, the molec- the new chemical substance’s health
ular formula, the CAS Registry Num- and environmental effects that are
ber (if available), and known synonyms known to or reasonably ascertainable
(including trade names). The notice by the manufacturer.
must identify the immediate precur- (viii) Identity of the article. The notice
sors and reactants by name and CAS must identify and describe the instant
Registry Number (if available). The no- photographic film article(s) or peel-
tice must include a partial or incom- apart film article(s) that will contain
plete structural diagram, if available. the new chemical substance.
(C) Polymers. For a polymer, the no- (ix) Release to water. The notice must
tice must indentify monomers and include a description of the methods
other reactants used in the manufac- used to control and treat wastewater
ture of the polymer by chemical name or discharge released to a POTW or
and CAS Registry Number. The notice other receiving body of water. The no-
must indicate the amount of each mon- tice must also identify the POTW or re-
omer used (by weight percent of total ceiving body of water.
monomer); the maximum residual of (x) Certification. The manufacturer

each monomer present in the polymer; must certify in the notice that it is fa-
and a partial or incomplete structural miliar with the terms of the exemption
18
and that the manufacture, processing, with the exposure limits of paragraph
distribution, use, and disposal of the (e)(1) of this section.
new chemical substance will comply (iii) Training and exposure records. For
with those terms. each employee engaged in the manu-
(2) Duplication of information in facture or processing of a new chemical
premanufacture notice. If a manufac- substance, the company must develop
turer who submits an exemption notice and maintain a record of the worker’s
under this paragraph has already sub- participation in required training. This
mitted, or simultaneously submits, a record must also demonstrate the reg-
premanufacture notice under section ular use of personal exposure safe-
5(a)(1)(A) of the Act for the new chem- guards, including the results of any
ical substance, it may, in lieu of sub- personal exposure monitoring, the re-
mitting the information required by sults of the quantitative fit test for the
this paragraph, reference the required worker’s personal respirator, and any
information to the extent it is included additional information related to the
in the premanufacture notice. At a worker’s occupational exposure.
minimum, the exemption notice must (iv) Treatment records. Manufacturers
identify the manufacturer and the new who release treated wastewater or dis-
chemical substance, and contain the charge containing a new chemical sub-
certification required by paragraph stance to a POTW or other receiving
(i)(1)(x) of this section. body of water must maintain records of
(3) Address. The exemption notice the method of treatment.
must be addressed to the Document (2) The manufacturer must make the
Control Office (DCO) (7407M), Office of records listed in paragraph (j)(1) of this
Pollution Prevention and Toxics section available to EPA upon written
(OPPT), Environmental Protection request by the Director of the Office of
Agency, 1200 Pennsylvania Ave., NW., Pollution Prevention and Toxics. The
Washington, DC 20460–0001. manufacturer must provide these
(j) Recordkeeping. (1) Manufacturers records within 15 working days of re-
of a new chemical substance under this ceipt of this request.
exemption must keep the following (k) Confidentiality. If the manufac-
records for 30 years from the final date turer submits information under para-
of manufacture. graph (i) or (j) of this section which it
(i) Production records. Each manufac- claims to be confidential business in-
turer must maintain records of the an- formation, the manufacturer must
nual production volume of each new clearly identify the information at the
chemical substance manufactured time of submission to the Agency by
under the terms of the exemption. This bracketing, circling, or underlining it
record must indicate when manufac- and stamping it with ‘‘CONFIDEN-
ture of the new chemical substance TIAL’’ or some other appropriate des-
began. ignation. Any information so identified
(ii) Exposure monitoring records. Man- will be treated in accordance with the
ufacturers must maintain an accurate procedures in part 2 of this chapter.
record of all monitoring required by Any information not claimed confiden-
this section. Monitoring records may tial at the time of submission will be
be adapted to the individual cir- made available to the public without
cumstances of the manufacturer but, further notice to the submitter.
at a minimum, must contain the fol- (l) Amendment and repeal. (1) EPA
lowing information: The chemical iden- may amend or repeal any term of this
tity of the new chemical substance, exemption if it determines that the
date of the monitoring, the actual manufacture, processing, distribution,
monitoring data for each monitoring use, and disposal of new chemical sub-
location and sampling, and a reference stances under the terms of the exemp-
to or description of the collection and tion may present an unreasonable risk
analytic techniques. If the manufac- of injury to health or the environment.
turer does not monitor, the manufac- EPA also may amend this exemption to
turer must maintain a record of the enlarge the exemption category or to

reasons for not monitoring and the reduce the restrictions or conditions of
methods used to determine compliance the exemption.
19
§ 723.250 40 CFR Ch. I (7–1–17 Edition)
(2) As required by section 5(h)(4) of (i) Determine that the substance

the Act, EPA will amend or repeal the meets the definition of polymer in
substantive terms of an exemption paragraph (b) of this section.
granted under this part only by the for- (ii) Determine that the substance is
mal rulemaking procedures described not specifically excluded by paragraph
in section 6(c)(2) and (3) of the Act (15 (d) of this section.
U.S.C. 2605(c)). (iii) Ensure that the substance meets
(m) Prohibition of use of the exemption. the exemption criteria of paragraph (e)
The Director of the Office of Pollution of this section.
Prevention and Toxics may prohibit (iv) Submit a report as required
the manufacture, processing, distribu- under paragraph (f) of this section.
tion, use, or disposal of any new chem- (v) Comply with the recordkeeping
ical substance under the terms of this requirements of paragraph (j) of this
exemption if he or she determines that section.
the manufacture, processing, distribu- (b) Definitions. In addition to the defi-
tion in commerce, use, or disposal of nitions under section 3 of the Act, 15
the new chemical substance may U.S.C. 2602, the following definitions
present an unreasonable risk of injury apply to this part.
to health or the environment. Act means the Toxic Substances Con-
(n) Enforcement. (1) A failure to com- trol Act (15 U.S.C. 2601 et seq.).
ply with any provision of this part is a Biopolymer means a polymer directly
violation of section 15 of the Act (15 produced by living or once-living cells
U.S.C. 2614). or cellular components.
(2) Submitting materially misleading Category of chemical substances has
or false information in connection with the same meaning as in section 26(c)(2)
the requirements of any provision of of the Act (15 U.S.C. 2625).
this part is a violation of this regula- Cationic polymer means a polymer
tion and therefore a violation of sec- that contains a net positively charged
tion 15 of the Act (15 U.S.C. 2614). atom(s) or associated groups of atoms
(3) Violators may be subject to the covalently linked to its polymer mol-
civil and criminal penalties in section ecule.
16 of the Act (15 U.S.C. 2615) for each Chemical substance, Director, EPA, im-
violation. porter, impurity, Inventory, known to or
reasonably ascertainable, manufacture,
(4) EPA may seek to enjoin the man-
manufacturer, mixture, new chemical,
ufacture of a new chemical substance
person, possession or control, process and
in violation of this exemption or act to
test data have the same meanings as in
seize any chemical substances manu-
§ 720.3 of this chapter.
factured in violation of the exemption
Equivalent weight of a functional group
under the authority of section 17 of the
means the ratio of the molecular
Act (15 U.S.C. 2616).
weight to the number of occurrences of
[47 FR 24317, June 4, 1982, as amended at 53 that functional group in the molecule.
FR 12523, Apr. 15, 1988; 60 FR 34465, July 3, It is the weight of substance that con-
1995; 62 FR 17932, Apr. 11, 1997; 68 FR 906, Jan. tains one formula-weight of the func-
7, 2003; 71 FR 33642, June 12, 2006] tional group.
Fluorotelomers means the products of
§ 723.250 Polymers.
telomerization, which is the reaction of
(a) Purpose and scope. (1) This section a telogen (such as pentafluoroethyl io-
grants an exemption from certain of dide) with an ethylenic compound
the premanufacture notice require- (such as tetrafluoroethylene) to form
ments of section 5(a)(1)(A) of the Toxic low molecular weight polymeric com-
Substances Control Act (15 U.S.C. pounds, which contain an array of satu-
2604(a)(1)(A)) for the manufacture of rated carbon atoms covalently bonded
certain polymers. This section does not to each other (C-C bonds) and to fluo-
apply to microorganisms subject to rine atoms (C-F bonds). This array is
part 725 of this chapter. predominantly a straight chain, and
(2) To manufacture a new chemical depending on the telogen used produces

substance under the terms of this sec- a compound having an even number of
tion, a manufacturer must: carbon atoms. However, the carbon
20
chain length of the fluorotelomer var- hetero atom, typically, but not nec-
ies widely. The perfluoroalkyl groups essarily oxygen (O) or nitrogen (N).
formed by this process are usually, but Polyester means a chemical substance
do not have to be, connected to the that meets the definition of polymer
polymer through a functionalized and whose polymer molecules contain
ethylene group as indicated by the fol- at least two carboxylic acid ester link-
lowing structural diagram: (Rf-CH2CH2- ages, at least one of which links inter-
Anything). nal monomer units together.
Internal monomer unit means a mon- Polymer means a chemical substance
omer unit that is covalently bonded to consisting of molecules characterized
at least two other molecules. Internal by the sequence of one or more types of
monomer units of polymer molecules monomer units and comprising a sim-
are chemically derived from monomer ple weight majority of molecules con-
molecules that have formed covalent taining at least 3 monomer units which
bonds between two or more other mon- are covalently bound to at least one
omer molecules or other reactants. other monomer unit or other reactant
Monomer means a chemical substance and which consists of less than a sim-
that is capable of forming covalent ple weight majority of molecules of the
bonds with two or more like or unlike same molecular weight. Such mol-
molecules under the conditions of the ecules must be distributed over a range
relevant polymer-forming reaction of molecular weights wherein dif-
used for the particular process. ferences in the molecular weight are
Monomer Unit means the reacted form primarily attributable to differences in
of the monomer in a polymer. the number of monomer units. In the
Number-average molecular weight context of this definition, sequence
means the arithmetic average (mean) means that the monomer units under
of the molecular weight of all mol- consideration are covalently bound to
ecules in a polymer. one another and form a continuous
Oligomer means a polymer molecule string within the molecule, uninter-
consisting of only a few monomer units rupted by units other than monomer
(dimer, trimer, tetramer) units.
Other reactant means a molecule Polymer molecule means a molecule
linked to one or more sequences of which contains a sequence of at least 3
monomer units but which, under the
monomer units which are covalently
relevant reaction conditions used for
bound to at least one other monomer
the particular process, cannot become
unit or other reactant.
a repeating unit in the polymer struc-
ture. Reactant means a chemical substance
that is used intentionally in the manu-
Perfluoroalkyl carboxylate (PFAC)
facture of a polymer to become chemi-
means a group of saturated carbon
atoms covalently bonded to each other cally a part of the polymer composi-
in a linear, branched, or cyclic array tion.
and covalently bonded to a carbonyl Reactive functional group means an
moiety and where all carbon-hydrogen atom or associated group of atoms in a
(C-H) bonds have been replaced with chemical substance that is intended or
carbon-fluorine (C-F) bonds. The car- can reasonably be anticipated to under-
bonyl moiety is also covalently bonded go further chemical reaction.
to a hetero atom, typically, but not Reasonably anticipated means that a
necessarily oxygen (O) or nitrogen (N). knowledgeable person would expect a
Perfluoroalkyl sulfonate (PFAS) means given physical or chemical composition
a group of saturated carbon atoms or characteristic to occur based on
covalently bonded to each other in a such factors as the nature of the pre-
linear, branched, or cyclic array and cursors used to manufacture the poly-
covalently bonded to a sulfonyl moiety mer, the type of reaction, the type of
and where all carbon - hydrogen (C-H) manufacturing process, the products
bonds have been replaced with carbon - produced in polymerization, the in-
fluorine (C-F) bonds. The sulfonyl moi- tended uses of the substance, or associ-
ety is also covalently bonded to a ated use conditions.
21
§ 723.250 40 CFR Ch. I (7–1–17 Edition)
(c) Applicability. This section applies polymer is designed or is reasonably

to manufacturers of new chemical sub- anticipated to substantially degrade,
stances that otherwise must submit a decompose, or depolymerize, including
premanufacture notice to EPA under those polymers that could substan-
§ 720.22 of this chapter. New substances tially decompose after manufacture
are eligible for exemption under this and use, even though they are not actu-
section if they meet the definition of ally intended to do so. For the purposes
‘‘polymer’’ in paragraph (b) of this sec- of this section, degradation, decompo-
tion, and the criteria in paragraph (e) sition, or depolymerization mean those
of this section, and if they are not ex- types of chemical change that convert
cluded from the exemption under para- a polymeric substance into simpler,
graph (d) of this section. smaller substances, through processes
(d) Polymers that cannot be manufac- including but not limited to oxidation,
tured under this section—(1) Cationic hydrolysis, attack by solvents, heat,
polymers. A polymer cannot be manu- light, or microbial action.
factured under this section if the poly- (4) Polymers manufactured or imported
mer is a cationic polymer as defined from monomers and reactants not on the
under paragraph (b) of this section or if TSCA Chemical Substance Inventory. A
the polymer is reasonably anticipated polymer cannot be manufactured under
to become a cationic polymer in a nat- this section if the polymer being manu-
ural aquatic environment (e.g., rivers, factured or imported is prepared from
lakes) unless: monomers and/or other reactants (that
(i) The polymer is a solid material are either charged to the reaction ves-
that is not soluble or dispersible in sel or incorporated in the polymer at
water and will be used only in the solid levels of greater than 2 weight percent)
phase (e.g., polymers that will be used that are not already included on the
as ion exchange beads), or TSCA Chemical Substance Inventory
(ii) The combined (total) functional or manufactured under an applicable
group equivalent weight of cationic TSCA section 5 exemption.
groups in the polymer is equal to or (5) Water absorbing polymers with num-
greater than 5,000. ber average molecular weight (MW) 10,000
(2) Elemental limitations. (i) A polymer and greater. A polymer cannot be man-
manufactured under this section must ufactured under this section if the
contain as an integral part of its com- polymer being manufactured or im-
position at least two of the atomic ele- ported is a water absorbing polymer
ments carbon, hydrogen, nitrogen, oxy- and has a number average MW greater
gen, silicon, and sulfur. than or equal to 10,000 daltons. For pur-
(ii) A polymer cannot be manufac- poses of this section, a water-absorbing
tured under this section if it contains polymer is a polymeric substance that
as an integral part of its composition, is capable of absorbing its weight of
except as impurities, any elements water.
other than the following: (6) Polymers which contain certain
(A) The elements listed in paragraph perfluoroalkyl moieties consisting of a
(d)(2)(i) of this section. CF3- or longer chain length. Except as
(B) Sodium, magnesium, aluminum, provided in paragraph (d)(6)(i), after
potassium, calcium, chlorine, bromine, February 26, 2010, a polymer cannot be
and iodine as the monatomic manufactured under this section if the
counterions Na = , Mg = 2, Al = 3, K = , Ca polymer contains as an integral part of
= 2, Cl¥, Br¥, or I¥. its composition, except as impurities,
(C) Fluorine, chlorine, bromine, and one or more of the following
iodine covalently bound to carbon. perfluoroalkyl moieties consisting of a
(D) Less than 0.20 weight percent of CF3- or longer chain length:
any combination of the atomic ele- Perfluoroalkyl sulfonates (PFAS),
ments lithium, boron, phosphorus, tita- perfluoroalkyl carboxylates (PFAC),
nium, manganese, iron, nickel, copper, fluorotelomers, or perfluoroalkyl
zinc, tin, and zirconium. moieties that are covalently bound to
(3) Polymers which degrade, decompose, either a carbon or sulfur atom where
or depolymerize. A polymer cannot be the carbon or sulfur atom is an inte-
manufactured under this section if the gral part of the polymer molecule.
22
(i) Any polymer that has been manu- isocyanates (including ketoxime-
factured previously in full compliance blocked isocyanates), thiols,
with the requirements of this section unconjugated nitrile groups, and
prior to February 26, 2010 may no halogens (except that reactive halogen-
longer be manufactured under this sec- containing groups such as benzylic or
tion after January 27, 2012. allylichalides cannot be included).
(ii) [Reserved] (B) The polymer has a combined
(e) Exemption criteria. To be manufac- (total) reactive group equivalent
tured under this section, the polymer weight greater than or equal to 1,000
must meet one of the following cri- for the following reactive functional
teria: groups: acidhalides; acid anhydrides;
(1) Polymers with number average MW aldehydes, hemiacetals;
greater than or equal to 1,000 and less methylolamides,- amines or,- ureas;
than 10,000 daltons (and oligomer content alkoxysilanes with alkoxy greater than
less than 10 percent below MW 500 and C2-alkoxysilanes; allyl ethers; con-
less than 25 percent below MW 1,000). (i) jugated olefins; cyanates; epoxides;
The polymer must have a number aver- imines; or unsubstituted positions
age MW greater than or equal to 1,000
ortho or para to phenolic hydroxyl; or
and less than 10,000 daltons and contain
less than 10 percent oligomeric mate- (C) If any reactive functional groups
rial below MW 500 and less than 25 per- not included in paragraph (e)(1)(ii)(A)
cent oligomeric material below MW and (B) of this section are present, the
1,000. combined (total) reactive group equiva-
(ii) The polymer cannot contain reac- lent weight, including any groups list-
tive functional groups unless it meets ed in paragraph (e)(1)(ii)(B), is greater
one of the following criteria: than or equal to 5,000.
(A) The polymer contains only the (2) Polymers with number average MW
following reactive functional groups: greater than or equal to 10,000 (and
carboxylic acid groups, aliphatic oligomer content less than 2 percent below
hydroxyl groups, unconjugated olefinic MW 500 and less than 5 percent below
groups that are considered ‘‘ordi- MW 1,000) . The polymer must have a
nary,’’(i.e., not specially activated ei- number average MW greater than or
ther by being part of a larger func- equal to 10,000 daltons and contain less
tional group, such as a vinyl ether, or than 2 percent oligomeric material
by other activating influences, e.g., below MW 500 and less than 5 percent
strongly electron-withdrawing sulfone oligomeric material below MW 1000.
group with which the olefinic groups (3) Polyester polymers. The polymer is
interact), butenedioic acid groups, a polyester as defined in paragraph (b)
those conjugated olefinic groups con- of this section and is manufactured
tained in naturally-occurring fats, oils, solely from one or more of the
and carboxylic acids, blocked reactants in the following table 1:
TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE
Reactant CAS No.
Monobasic Acids and Natural Oils

Benzoic acid ................................................................................................................................................... 65–85–0
Canola oil ....................................................................................................................................................... 120962–03–0
Coconut oil ..................................................................................................................................................... 8001–31–8*
Corn oil ........................................................................................................................................................... 8001–30–7*
Cottonseed oil ................................................................................................................................................ 8001–29–4*
Dodecanoic acid ............................................................................................................................................. 143–07–7
Fats and glyceridic oils, anchovy ................................................................................................................... 128952–11–4*
Fats and glyceridic oils, babassu .................................................................................................................. 91078–92–1*
Fats and glyceridic oils, herring ..................................................................................................................... 68153–06–0*
Fats and glyceridic oils, menhaden ............................................................................................................... 8002–50–4*
Fats and glyceridic oils, sardine .................................................................................................................... 93334–41–9*
Fats and glyceridic oils, oiticica ..................................................................................................................... 8016–35–1*
Fatty acids,C16-18 and C18-unsatd. ................................................................................................................. 67701–08–0*
Fatty acids, castor-oil ..................................................................................................................................... 61789–44–4*
Fatty acids, coco ............................................................................................................................................ 61788–47–4*

Fatty acids, dehydrated castor-oil .................................................................................................................. 61789–45–5*
Fatty acids, linseed oil ................................................................................................................................... 68424–45–3*
Fatty acids, safflower oil.
23
§ 723.250 40 CFR Ch. I (7–1–17 Edition)
TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.
Fatty acids, soya ............................................................................................................................................ 68308–53–2*

Fatty acids, sunflower oil ............................................................................................................................... 84625–38–7*
Fatty acids, sunflower-oil, conjugated ............................................................................................................ 68953–27–5*
Fatty acids, tall-oil .......................................................................................................................................... 61790–12–3*
Fatty acids, tall-oil, conjugated*.
Fatty acids, vegetable oil ............................................................................................................................... 61788–66–7*
Glycerides, C16-18 and C18-unsatd. ................................................................................................................ 67701–30–8*
Heptanoic acid ............................................................................................................................................... 111–14–8
Hexanoic acid ................................................................................................................................................ 142–62–1
Hexanoic acid, 3,3,5-trimethyl- ...................................................................................................................... 3302–10–1
Linseed oil ...................................................................................................................................................... 8001–26–1*
Linseed oil, oxidized ...................................................................................................................................... 68649–95–6*
Nonanoic acid ................................................................................................................................................ 112–05–0
Oils, Cannabis*.
Oils, palm kernel ............................................................................................................................................ 8023–79–8*
Oils, perilla ..................................................................................................................................................... 68132–21–8*
Oils, walnut .................................................................................................................................................... 8024–09–7
Safflower oil ................................................................................................................................................... 8001–23–8*
Soybean oil .................................................................................................................................................... 8001–22–7*
Sunflower oil .................................................................................................................................................. 8001–21–6*
Tung oil .......................................................................................................................................................... 8001–20–5*
Di and Tri Basic Acids:
1,2-Benzenedicarboxylic acid ........................................................................................................................ 88–99–3
1,3-Benzenedicarboxylic acid, dimethyl ester ................................................................................................ 1459–93–4
1,4-Benzenedicarboxylic acid, diethyl ester ................................................................................................... 636–09–9
1,4-Benzenedicarboxylic acid, dimethyl ester ................................................................................................ 120–61–6
1,2,4-Benzenetricarboxylic acid ..................................................................................................................... 528–44–9
Butanedioic acid ............................................................................................................................................. 110–15–6
Butanedioic acid, diethyl ester ....................................................................................................................... 123–25–1
Butanedioic acid, dimethyl ester .................................................................................................................... 106–65–0
2-Butenedioic acid (E)– .................................................................................................................................. 110–17–8
Decanedioic acid ............................................................................................................................................ 111–20–6
Decanedioic acid, diethyl ester ...................................................................................................................... 110–40–7
Decanedioic acid, dimethyl ester ................................................................................................................... 106–79–6
Dodecanedioic acid ........................................................................................................................................ 693–23–2
Fatty acids, C18-unsatd., dimers .................................................................................................................... 61788–89–4*
Heptanedioic acid .......................................................................................................................................... 111–16–0
Heptanedioic acid, dimethyl ester .................................................................................................................. 1732–08–7
Hexanedioic acid ............................................................................................................................................ 124–04–9
Hexanedioic acid, dimethyl ester ................................................................................................................... 627–93–0
Hexanedioic acid, diethyl ester ...................................................................................................................... 141–28–6
Nonanedioic acid ........................................................................................................................................... 123–99–9
Nonanedioic acid, dimethyl ester ................................................................................................................... 1732–10–1
Nonanedioic acid, diethyl ester ...................................................................................................................... 624–17–9
Octanedioic acid ............................................................................................................................................. (505–48–6)
Octanedioic acid, dimethyl ester .................................................................................................................... 1732–09–8
Pentanedioic acid ........................................................................................................................................... (110–94–1)
Pentanedioic acid, dimethyl ester .................................................................................................................. 1119–40–0
Pentanedioic acid, diethyl ester ..................................................................................................................... 818–38–2
Undecanedioic acid ........................................................................................................................................ 1852–04–6
Polyols
1,3-Butanediol ................................................................................................................................................ 107–88–0
1,4-Butanediol ................................................................................................................................................ 110–63–4
1,4-Cyclohexanedimethanol ........................................................................................................................... 105–08–8
1,2-Ethanediol ................................................................................................................................................ 107–21–1
Ethanol, 2,2′-oxybis- ...................................................................................................................................... 111–46–6
1,6-Hexanediol ............................................................................................................................................... 629–11–8
1,3-Pentanediol, 2,2,4-trimethyl- .................................................................................................................... 144–19–4
1,2-Propanediol, ............................................................................................................................................. 57–55–6
1,3-Propanediol, 2,2-bis(hydroxymethyl)- ...................................................................................................... 115–77–5
1,3-Propanediol, 2,2-dimethyl- ....................................................................................................................... 126–30–7
1,3-Propanediol, 2-ethyl-2-(hydroxymethyl)- .................................................................................................. 77–99–6
1,3-Propanediol, 2-(hydroxymethyl)-2-methyl- ............................................................................................... 77–85–0
1,3-propanediol, 2-methyl .............................................................................................................................. 2163–42–0
1,2,3-Propanetriol ........................................................................................................................................... 56–81–5
1,2,3-Propanetriol, homopolymer ................................................................................................................... 25618–55–7

2-Propen-1-ol, polymer with ethenylbenzene ................................................................................................ 25119-62–4
Modifiers
Acetic acid, 2,2′-oxybis- ................................................................................................................................. 110–99–6
24
TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Reactant CAS No.
1-Butanol ........................................................................................................................................................ 71–36–3**

Cyclohexanol .................................................................................................................................................. 108–93–0
Cyclohexanol, 4,4′-(1-methylethylidene)bis- .................................................................................................. 80–04–6
Ethanol, 2-(2-butoxyethoxy)- .......................................................................................................................... 112–34–5
1-Hexanol ....................................................................................................................................................... 111–27–3
Methanol, hydrolysis products with trichlorohexylsilane and trichlorophenylsilane ....................................... 72318–84–4*
1-Phenanthrenemethanol, tetradecahydro-1,4a-dimethyl-7-(1-methylethyl)- ................................................ 13393–93–6
Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′- [(1-methylethylidene)bis(4,1- 25036-25–3
phenyleneoxymethylene)] bis[oxirane].
Siloxanes and Silicones, di-Me, di-Ph, polymers with Ph silsesquioxanes, methoxy-terminated ................. 68440–65–3*
Siloxanes and Silicones, di-Me, methoxy Ph, polymers with Ph silsesquioxanes, methoxy-terminated ...... 68957–04–0*
Siloxanes and Silicones, Me Ph, methoxy Ph, polymers with Ph silsesquioxanes, methoxy- and Ph-ter- 168957–06–2*
minated.
Silsesquioxanes, Ph Pr .................................................................................................................................. 168037–90–1*
* Chemical substance of unknown or variable composition,complex reaction products, and biological materials (UVCB). The
CAS Registry Numbers for UVCB substances are not used in CHEMICAL ABSTRACTS and its indexes.
** These substances may not be used in a substance manufactured from fumaric or maleic acid because of potential risks as-
sociated with esters, which may be formed by reaction of these reactants.
(f) Exemption report for polymers manu- weight of the chemically combined (in-
factured under the terms of this section. corporated) reactant in the polymer.
For substances exempt under para- Manufacturers who choose the ‘‘incor-
graphs (e)(1), (e)(2), and (e)(3) of this porated’’ method must have analytical
section a report of manufacture or im- data, or theoretical calculations (if it
port must be submitted (postmarked) can be documented that an analytical
by January 31 of the year subsequent determination cannot be made or is not
to initial manufacture. The notice necessary), to demonstrate compliance
must include: with this paragraph. Reactants that in-
(1) Manufacturer’s name. This includes troduce into the polymer elements,
the name and address of the manufac- properties, or functional groups that
turer and the name and telephone num- would render the polymer ineligible for
ber of a technical contact. the exemption are not allowed at any
(2) Number of substances manufactured. level.
Number of substances manufactured. (2) A representative structural dia-
The manufacturer must identify the gram, if possible.
number of polymers manufactured (h) Certification. To manufacture a
under terms of the exemption for the substance under the terms of this sec-
first time in the year preceding the no- tion, a manufacturer must as of the
tice. date of first manufacture, make the
(g) Chemical identity information. For following certification statements and
substances exempt under paragraph (e) maintain them in accordance with
of this section the manufacturer must paragraph (j) of this section:
to the extent known to or reasonably (1) The substance is manufactured or
ascertainable by the manufacturer imported for a commercial purpose
identify the following and maintain the other than for research and develop-
records in accordance with paragraph ment.
(j) of this section: (2) All information in the certifi-
(1) A specific chemical name and CAS cation is truthful.
Registry Number (or EPA assigned Ac- (3) The new chemical substance
cession Number) for each ‘‘reactant,’’ meets the definition of a polymer, is
as that term is defined in paragraph (b) not specifically excluded from the ex-
of this section, used at any weight in emption in paragraph (d) of this sec-
the manufacture of the polymer. For tion, and meets the conditions of the
purposes of determining chemical iden- exemption in paragraph (e) of this sec-
tity, the manufacturer may determine tion.
whether a reactant is used at greater (i) Exemptions granted under super-
than two weight percent according to seded regulations. Manufacturers grant-

either the weight of the reactant ed exemptions under the superseded re-
charged to the reaction vessel or the quirements of § 723.250 (as in effect on
25
§ 723.250 40 CFR Ch. I (7–1–17 Edition)
May 26, 1995) shall either continue to content criteria in paragraphs (e)(1) or
comply with those requirements or fol- (e)(2) of this section.
low all procedural and recordkeeping (vii) If applicable, analytical data, or
requirements pursuant to this section. theoretical calculations (if it can be
If an exemption holder continues to documented that an analytical deter-
follow the superseded regulations, the mination cannot be made or is not nec-
Notice of Commencement requirements essary) required in paragraph (g) of
apply and the exempt polymer will this section for determining monomers
continue to be listed on the Inventory or reactants charged to the reaction
with exclusion criteria and exemption vessel at greater than 2 weight percent
category restrictions on residual mon- but incorporated at 2 weight percent or
omer/reactant and low molecular less in the manufactured polymer.
weight species content limitations. (viii) The certification statements as
(j) Recordkeeping. (1) A manufacturer required under paragraph (h) of this
of a new polymer under paragraphs (e) section.
of this section, must retain the records (3) The manufacturer must submit
described in this paragraph at the man- the records listed in paragraph (j)(2) of
ufacturing site for a period of 5 years this section to EPA upon written re-
from the date of commencement of quest by EPA. The manufacturer must
manufacture or import. provide these records within 15 work-
(2) The records must include the fol- ing days of receipt of this request. In
lowing to demonstrate compliance with addition, any person who manufactures
the terms of this section: a new chemical substance under the
terms of this section, upon request of
(i) Chemical identity information as
EPA, must permit such person at all
required in paragraph (g) of this sec-
reasonable times to have access to and
tion.
to copy these records.
(ii) Information to demonstrate that (k) Submission of information. Infor-
the new polymer is not specifically ex- mation submitted to EPA under this
cluded from the exemption. section must be sent in writing to:
(iii) Records of production volume for TSCA Document Control Officer, (7407),
the first 3 years of manufacture and Office of Pollution Prevention and
the date of commencement of manufac- Toxics, Environmental Protection
ture. Agency, 1200 Pennsylvania Ave., NW.,
(iv) Information to demonstrate that Washington, DC 20460.
the new polymer meets the exemption (l) Compliance. (1) A person who man-
criteria in paragraphs (e)(1), (e)(2), or ufactures or imports a new chemical
(e)(3) of this section. substance and fails to comply with any
(v) Analytical data, or theoretical provision of this section is in violation
calculations (if it can be documented of section 15 of the Act (15 U.S.C. 2614).
that an analytical determination can- (2) Using for commercial purposes a
not be made or is not necessary), to chemical substance or mixture which a
demonstrate that the polymer meets person knew or had reason to know was
the number-average MW exemption cri- manufactured, processed, or distrib-
teria in paragraphs (e)(1) or (e)(2) of uted in commerce in violation of sec-
this section. The analytical tests may tion 5 of the Act is a violation of sec-
include gel permeation chroma- tion 15 of the Act (15 U.S.C. 2614).
tography (GPC).vapor pressure osmom- (3) Failure or refusal to establish and
etry (VPO), or other such tests which maintain records or to permit access to
will demonstrate that the polymer or copying of records, as required by
meets the number-average MW cri- this section and section 11 of the Act,
terion. is a violation of section 15 of the Act
(vi) Analytical data, or theoretical (15 U.S.C. 2614).
calculations (if it can be documented (4) Failure or refusal to permit entry
that an analytical determination can- or inspection as required by section 11
not be made or is not necessary), to of the Act is a violation of section 15 of
demonstrate that the polymer meets the Act (15 U.S.C. 2614).
the criteria in paragraphs (e)(1) or (5) Violators may be subject to the
(e)(2) of this section, meets the low MW civil and criminal penalties in section
26
Environmental Protection Agency Pt. 725
16 of the Act (15 U.S.C. 2615) for each Subpart B—Administrative Procedures
violation. Persons who submit materi-
725.20 Scope and purpose.
ally misleading or false information in 725.25 General administrative requirements.
connection with the requirements of 725.27 Submissions.
any provision of this section may be 725.28 Notice that submission is not re-
subject to penalties calculated as if quired.
they never filed their notices. 725.29 EPA acknowledgement of receipt of
(6) EPA may seek to enjoin the man- submission.
ufacture or processing of a chemical 725.32 Errors in the submission.
725.33 Incomplete submissions.
substance in violation of this section 725.36 New information.
or act to seize any chemical substance 725.40 Notice in the Federal Register.
manufactured or processed in violation 725.50 EPA review.
of this section or take other actions 725.54 Suspension of the review period.
under the authority of section 7 of the 725.56 Extension of the review period.
Act (15 U.S.C. 2606) or section 17 of the 725.60 Withdrawal of submission by the sub-
mitter.
Act (15 U.S.C. 2616).
725.65 Recordkeeping.
(m) Inspections. EPA will conduct in- 725.67 Applications to exempt new micro-
spections under section 11 of the Act to organisms from this part.
assure compliance with section 5 and 725.70 Compliance.
this section, to verify that information 725.75 Inspections.
submitted to EPA under this section is
true and correct, and to audit data sub- Subpart C—Confidentiality and Public
mitted to EPA under this section. Access to Information
(n) Confidentiality. If a manufacturer 725.80 General provisions for confidentiality
submits information to EPA under this claims.
section which the manufacturer claims 725.85 Microorganism identity.
to be confidential business informa- 725.88 Uses of a microorganism.
tion, the manufacturer must clearly 725.92 Data from health and safety studies
identify the information at the time of of microorganisms.
725.94 Substantiation requirements.
submission to EPA by bracketing, cir- 725.95 Public file.
cling, or underlining it and stamping it
with ‘‘CONFIDENTIAL’’ or some other Subpart D—Microbial Commercial
appropriate designation. Any informa- Activities Notification Requirements
tion so identified will be treated in ac-
cordance with the procedures in 40 CFR 725.100 Scope and purpose.
725.105 Persons who must report.
part 2. Any information not claimed 725.110 Persons not subject to this subpart.
confidential at the time of submission 725.150 Procedural requirements for this
may be made available to the public subpart.
without further notice. 725.155 Information to be included in the
MCAN.
[60 FR 16332, Mar. 29, 1995, as amended at 62 725.160 Submission of health and environ-
FR 17932, Apr. 11, 1997; 75 FR 4305, Jan. 27, mental effects data.
2010] 725.170 EPA review of the MCAN.
725.190 Notice of commencement of manu-
PART 725—REPORTING REQUIRE- facture or import.
MENTS AND REVIEW PROCESSES Subpart E—Exemptions for Research and
FOR MICROORGANISMS Development Activities
Subpart A—General Provisions and 725.200 Scope and purpose.
Applicability 725.205 Persons who may report under this
subpart.
Sec. 725.232 Activities subject to the jurisdiction
725.1 Scope and purpose. of other Federal programs or agencies.
725.3 Definitions. 725.234 Activities conducted inside a struc-
725.8 Coverage of this part. ture.
725.12 Identification of microorganisms for 725.235 Conditions of exemption for activi-
Inventory and other listing purposes. ties conducted inside a structure.
725.15 Determining applicability when 725.238 Activities conducted outside a struc-

microorganism identity or use is con- ture.
fidential or uncertain. 725.239 Use of specific microorganisms in
725.17 Consultation with EPA. activities conducted outside a structure.
27
§ 725.1 40 CFR Ch. I (7–1–17 Edition)
725.250 Procedural requirements for the 725.1075 Burkholderia cepacia complex.
TERA.
725.255 Information to be included in the AUTHORITY: 15 U.S.C. 2604, 2607, 2613, and
TERA. 2625.
725.260 Submission of health and environ- SOURCE: 62 FR 17932, Apr. 11, 1997, unless
mental effects data. otherwise noted.
725.270 EPA review of the TERA.
725.288 Revocation or modification of TERA
approval. Subpart A—General Provisions
and Applicability
Subpart F—Exemptions for Test Marketing
§ 725.1 Scope and purpose.
725.305 Persons who may apply under this (a) This part establishes all reporting
subpart. requirements under section 5 of TSCA
725.350 Procedural requirements for this
for manufacturers, importers, and
subpart.
725.355 Information to be included in the processors of microorganisms subject
TME application. to TSCA jurisdiction for commercial
725.370 EPA review of the TME application. purposes, including research and devel-
opment for commercial purposes. New
Subpart G—General Exemptions for New microorganisms for which manufactur-
Microorganisms ers and importers are required to re-
725.400 Scope and purpose. port under section 5(a)(1)(A) of TSCA
725.420 Recipient microorganisms. are those that are intergeneric. In ad-
725.421 Introduced genetic material. dition, under section 5(a)(1)(B) of
725.422 Physical containment and control TSCA, manufacturers, importers, and
technologies. processors may be required to report
725.424 Requirements for the Tier I exemp- for any microorganism that EPA deter-
tion. mines by rule is being manufactured,
725.426 Applicability of the Tier I exemp-
tion. imported, or processed for a significant
725.428 Requirements for the Tier II exemp- new use.
tion. (b) Any manufacturer, importer, or
725.450 Procedural requirements for the Tier processor required to report under sec-
II exemption. tion 5 of TSCA (see § 725.100 for new
725.455 Information to be included in the microorganisms and § 725.900 for signifi-
Tier II exemption request.
cant new uses) must file a Microbial
725.470 EPA review of the Tier II exemption
request. Commercial Activity Notice (MCAN)
with EPA, unless the activity is eligi-
Subparts H–K [Reserved] ble for a specific exemption as de-
scribed in this part. The general proce-
Subpart L—Additional Procedures for Re- dures for filing MCANs are described in
porting on Significant New Uses of subpart D of this part. The exemptions
Microorganisms from the requirement to file a MCAN
725.900 Scope and purpose. are for certain kinds of contained ac-
725.910 Persons excluded from reporting sig- tivities (see §§ 725.424 and 725.428), test
nificant new uses. marketing activities (see § 725.300), and
725.912 Exemptions. research and development activities
725.920 Exports and imports. described in paragraph (c) of this sec-
725.950 Additional recordkeeping require- tion.
ments.
(c) Any manufacturer, importer, or
725.975 EPA approval of alternative control
measures. processor required to file a MCAN for
725.980 Expedited procedures for issuing sig- research and development (R&D) ac-
nificant new use rules for microorga- tivities may instead file a TSCA Exper-
nisms subject to section 5(e) orders. imental Release Application (TERA)
725.984 Modification or revocation of cer- for a specific test (see § 725.250). A
tain notification requirements. TERA is not required for certain R&D
activities; however a TERA exemption
Subpart M—Significant New Uses for

does not extend beyond the research
Specific Microorganisms
and development stage, to general
725.1000 Scope. commercial use of the microorganism,
28
for which compliance with MCAN re- Health and safety study of a microorga-
quirements is required. The TERA ex- nism or health and safety study means
emptions are for R&D activities sub- any study of any effect of a microorga-
ject to other Federal agencies or pro- nism or microbial mixture on health or
grams (see § 725.232), certain kinds of the environment or on both, including
contained R&D activities (see § 725.234), underlying data and epidemiological
and R&D activities using certain listed studies, studies of occupational expo-
microorganisms (see § 725.238). sure to a microorganism or microbial
(d) New microorganisms will be mixture, toxicological, clinical, and ec-
added to the Inventory established ological, or other studies of a micro-
under section 8 of TSCA once a MCAN organism or microbial mixture, and
has been received, the MCAN review any test performed under the Act.
period has expired, and EPA receives a Microorganism identity is always part
Notice of Commencement (NOC) indi- of a health and safety study of a micro-
cating that manufacture or importa-
organism.
tion has actually begun. New micro-
(1) It is intended that the term
organisms approved for use under a
TERA will not be added to the Inven- ‘‘health and safety study of a micro-
tory until a MCAN has been received, organism’’ be interpreted broadly. Not
the MCAN review period has expired, only is information which arises as a
and EPA has received an NOC. result of a formal, disciplined study in-
cluded, but other information relating
§ 725.3 Definitions. to the effects of a microorganism or
Definitions in section 3 of the Act (15 microbial mixture on health or the en-
U.S.C. 2602), as well as definitions con- vironment is also included. Any data
tained in §§ 704.3, 720.3, and 721.3 of this that bear on the effects of a microorga-
chapter, apply to this part unless oth- nism on health or the environment
erwise specified in this section. In addi- would be included.
tion, the following definitions apply to (2) Examples include:
this part: (i) Tests for ecological or other envi-
Consolidated microbial commercial ac- ronmental effects on invertebrates,
tivity notice or consolidated MCAN fish, or other animals, and plants, in-
means any MCAN submitted to EPA cluding: Acute toxicity tests, chronic
that covers more than one microorga- toxicity tests, critical life stage tests,
nism (each being assigned a separate behavioral tests, algal growth tests,
MCAN number by EPA) as a result of a seed germination tests, plant growth or
prenotice agreement with EPA. damage tests, microbial function tests,
Containment and/or inactivation con- bioconcentration or bioaccumulation
trols means any combination of engi- tests, and model ecosystem (micro-
neering, mechanical, procedural, or bi- cosm) studies.
ological controls designed and operated (ii) Long- and short-term tests of mu-
to restrict environmental release of tagenicity, carcinogenicity, or
viable microorganisms from a struc- teratogenicity; dermatoxicity; cumu-
ture. lative, additive, and synergistic effects;
Director means the Director of the and acute, subchronic, and chronic ef-
EPA Office of Pollution Prevention and fects.
Toxics.
(iii) Assessments of human and envi-
Exemption request means any applica- ronmental exposure, including work-
tion submitted to EPA under subparts
place exposure, and impacts of a par-
E, F, or G of this part.
ticular microorganism or microbial
General commercial use means use for
mixture on the environment, including
commercial purposes other than re-
surveys, tests, and studies of: Survival
search and development.
and transport in air, water, and soil;
Genome means the sum total of chro-
ability to exchange genetic material
mosomal and extrachromosomal ge-
netic material of an isolate and any de- with other microorganisms, ability to
scendants derived under pure culture colonize human or animal guts, and
conditions from that isolate. ability to colonize plants.
29
§ 725.3 40 CFR Ch. I (7–1–17 Edition)
(iv) Monitoring data, when they have microbial mixture. Byproducts and im-
been aggregated and analyzed to meas- purities without separate commercial
ure the exposure of humans or the en- value are nonetheless produced for the
vironment to a microorganism. purpose of obtaining a commercial ad-
(v) Any assessments of risk to health vantage, since they are part of the
and the environment resulting from manufacture or processing of a micro-
the manufacture, processing, distribu- organism for commercial purposes.
tion in commerce, use, or disposal of Microbial commercial activity notice or
the microorganism. MCAN means a notice for microorga-
Inactivation means that living micro- nisms submitted to EPA pursuant to
organisms are rendered nonviable. section 5(a)(1) of the Act in accordance
Institutional Biosafety Committee with subpart D of this part.
means the committees described in the Microbial mixture means any combina-
NIH Guidelines in section IV.B.2. tion of microorganisms or microorga-
Intergeneric microorganism means a nisms and other chemical substances,
microorganism that is formed by the if the combination does not occur in
deliberate combination of genetic ma- nature and is not an article.
terial originally isolated from orga- Microorganism means an organism
nisms of different taxonomic genera. classified, using the 5-kingdom classi-
(1) The term ‘‘intergeneric micro- fication system of Whittacker, in the
organism’’ includes a microorganism kingdoms Monera (or Procaryotae),
which contains a mobile genetic ele- Protista, Fungi, and the Chlorophyta
ment which was first identified in a and the Rhodophyta of the Plantae,
microorganism in a genus different and a virus or virus-like particle.
from the recipient microorganism. Mobile genetic element or MGE means
(2) The term ‘‘intergeneric micro- an element of genetic material that
organism’’ does not include a micro- has the ability to move genetic mate-
organism which contains introduced rial within and between organisms.
genetic material consisting of only ‘‘Mobile genetic elements’’ include all
well-characterized, non-coding regu- plasmids, viruses, transposons, inser-
latory regions from another genus. tion sequences, and other classes of ele-
Introduced genetic material means ge- ments with these general properties.
netic material that is added to, and re- New microorganism means a micro-
mains as a component of, the genome organism not included on the Inven-
of the recipient. tory.
Manufacture, import, or process for NIH Guidelines means the National
commercial purposes means: Institutes of Health (NIH) ‘‘Guidelines
(1) To import, produce, manufacture, for Research Involving Recombinant
or process with the purpose of obtain- DNA Molecules’’ (July 5, 1994).
ing an immediate or eventual commer- Non-coding regulatory region means a
cial advantage for the manufacturer, segment of introduced genetic material
importer, or processor, and includes, for which:
among other things, ‘‘manufacture’’ or (1) The regulatory region and any in-
‘‘processing’’ of any amount of a micro- serted flanking nucleotides do not code
organism or microbial mixture: for protein, peptide, or functional ribo-
(i) For commercial distribution, in- nucleic acid molecules.
cluding for test marketing. (2) The regulatory region solely con-
(ii) For use by the manufacturer, in- trols the activity of other regions that
cluding use for product research and code for protein or peptide molecules
development or as an intermediate. or act as recognition sites for the initi-
(2) The term also applies to sub- ation of nucleic acid or protein syn-
stances that are produced coinciden- thesis.
tally during the manufacture, proc- Small quantities solely for research and
essing, use, or disposal of another development (or ‘‘small quantities sole-
microorganism or microbial mixture, ly for purposes of scientific experimen-
including byproducts that are sepa- tation or analysis or research on, or
rated from that other microorganism analysis of, such substance or another
or microbial mixture and impurities substance, including such research or
that remain in that microorganism or analysis for development of a product’’)
30
means quantities of a microorganism § 725.8 Coverage of this part.

manufactured, imported, or processed (a) Microorganisms subject to this part.
or proposed to be manufactured, im- Only microorganisms which are manu-
ported, or processed solely for research factured, imported, or processed for
and development that meet the re- commercial purposes, as defined in
quirements of § 725.234. § 725.3, are subject to the requirements
Structure means a building or vessel of this part.
which effectively surrounds and en- (b) Microorganisms automatically in-
closes the microorganism and includes cluded on the Inventory. Microorga-
features designed to restrict the micro- nisms that are not intergeneric are
organism from leaving. automatically included on the Inven-
Submission means any MCAN or ex- tory.
emption request submitted to EPA (c) Microorganisms not subject to this
under this part. part. The following microorganisms are
Technically qualified individual means not subject to this part, either because
a person or persons: they are not subject to jurisdiction
(1) Who, because of education, train- under the Act or are not subject to re-
ing, or experience, or a combination of porting under section 5 of the Act.
these factors, is capable of under- (1) Any microorganism which would
standing the health and environmental be excluded from the definition of
risks associated with the microorga- ‘‘chemical substance’’ in section 3 of
nism which is used under his or her su- the Act and § 720.3(e) of this chapter.
pervision, (2) Any microbial mixture as defined
(2) Who is responsible for enforcing in § 725.3. This exclusion applies only to
appropriate methods of conducting sci- a microbial mixture as a whole and not
entific experimentation, analysis, or to any microorganisms and other
microbiological research to minimize chemical substances which are part of
such risks, and the microbial mixture.
(3) Who is responsible for the safety (3) Any microorganism that is manu-
assessments and clearances related to factured and processed solely for ex-
the procurement, storage, use, and dis- port if the following conditions are
posal of the microorganism as may be met:
appropriate or required within the (i) The microorganism is labeled in
scope of conducting a research and de- accordance with section 12(a)(1)(B) of
velopment activity. the Act, when the microorganism is
distributed in commerce.
TSCA Experimental Release Application
(ii) The manufacturer and processor
or TERA means an exemption request
can document at the commencement of
for a research and development activ-
manufacturing or processing that the
ity, which is not eligible for a full ex-
person to whom the microorganism
emption from reporting under § 725.232,
will be distributed intends to export it
725.234, or 725.238, submitted to EPA in
or process it solely for export as de-
accordance with subpart E of this part.
fined in § 721.3 of this chapter.
Well-characterized for introduced ge-
netic material means that the fol- § 725.12 Identification of microorga-
lowing have been determined: nisms for Inventory and other list-
(1) The function of all of the products ing purposes.
expressed from the structural gene(s). To identify and list microorganisms
(2) The function of sequences that on the Inventory, both taxonomic des-
participate in the regulation of expres- ignations and supplemental informa-
sion of the structural gene(s). tion will be used. The supplemental in-
(3) The presence or absence of associ- formation required in paragraph (b) of
ated nucleotide sequences and their as- this section will be used to specifically
sociated functions, where associated describe an individual microorganism
nucleotide sequences are those se- on the Inventory. Submitters must
quences needed to move genetic mate- provide the supplemental information
rial including linkers, homopolymers, required by paragraph (b) of this sec-

adaptors, transposons, insertion se- tion to the extent necessary to enable
quences, and restriction enzyme sites. a microorganism to be accurately and
31
§ 725.15 40 CFR Ch. I (7–1–17 Edition)
unambiguously identified on the Inven- (1) Confidential identity or use. In

tory. some cases it may not be possible to di-
(a) Taxonomic designation. The taxo- rectly determine if a specific micro-
nomic designation of a microorganism organism is listed, because portions of
must be provided for the donor orga- that entry may contain generic infor-
nism and the recipient microorganism mation to protect confidential business
to the level of strain, as appropriate. information (CBI). If any portion of the
These designations must be substan- microorganism’s identity or use has
tiated by a letter from a culture collec- been claimed as CBI, that portion does
tion, literature references, or the re- not appear on the public version of the
sults of tests conducted for the purpose Inventory, in § 725.239 or in subpart M
of taxonomic classification. Upon of this part. Instead, it is contained in
EPA’s request to the submitter, data a confidential version held in EPA’s
supporting the taxonomic designation Confidential Business Information Cen-
must be provided to EPA. The genetic ter (CBIC). The public versions contain
history of the recipient microorganism generic information which masks the
should be documented back to the iso- confidential business information. A
late from which it was derived. person who intends to conduct an ac-
(b) Supplemental information. The sup- tivity involving a microorganism or
plemental information described in use whose entry is described with ge-
paragraphs (b)(1) and (b)(2) of this sec- neric information will need to inquire
tion is required to the extent that it of EPA whether the unreported micro-
enables a microorganism to be accu- organism or use is on the confidential
rately and unambiguously identified. version.
(1) Phenotypic information. (2) Uncertain microorganism identity.
Phenotypic information means perti- The current state of scientific knowl-
nent traits that result from the inter- edge leads to some imprecision in de-
action of a microorganism’s genotype scribing a microorganism. As the state
and the environment in which it is in- of knowledge increases, EPA will be de-
tended to be used and may include in- veloping policies to determine whether
tentionally added biochemical and one microorganism is equivalent to an-
physiological traits. other. Persons intending to conduct ac-
(2) Genotypic information. Genotypic tivities involving microorganisms may
information means the pertinent and inquire of EPA whether the microorga-
distinguishing genotypic characteris- nisms they intend to manufacture (in-
tics of a microorganism, such as the cluding import) or process are equiva-
identity of the introduced genetic ma- lent to specific microorganisms de-
terial and the methods used to con- scribed on the Inventory, in § 725.239, or
struct the reported microorganism. in subpart M of this part.
This also may include information on (b) Requirement of bona fide intent. (1)
the vector construct, the cellular loca- EPA will answer the inquiries de-
tion, and the number of copies of the scribed in paragraph (a) of this section
introduced genetic material. only if the Agency determines that the
person has a bona fide intent to con-
§ 725.15 Determining applicability duct the activity for which reporting is
when microorganism identity or required or for which any exemption
use is confidential or uncertain. may apply.
(a) Consulting EPA. Persons intending (2) To establish a bona fide intent to
to conduct activities involving micro- manufacture (including import) or
organisms may determine their obliga- process a microorganism, the person
tions under this part by consulting the who proposes to manufacture (includ-
Inventory or the microorganisms and ing import) or process the microorga-
uses specified in § 725.239 or in subpart nism must submit the request to EPA
M of this part. This section establishes via CDX. Prior to submission to EPA
procedures for EPA to assist persons in via CDX, such bona fide intents to man-
determining whether the microorga- ufacture (including import) or process
nism or the use is listed on the Inven- must be generated and completed using
tory, in § 725.239 or in subpart M of this e-PMN software. See 40 CFR
part. 720.40(a)(2)(ii) for information on how
32
to access the e-PMN software. A bona the microorganism is subject to this

fide intent to manufacture (including part and if so, which sections of this
import) or process must contain the part apply.
following information: (f) If the microorganism is found on
(i) Taxonomic designations and sup- the confidential version of the Inven-
plemental information required by tory, in § 725.239 or in subpart M of this
§ 725.12. part, EPA will notify the person(s) who
(ii) A signed statement certifying originally reported the microorganism
that the submitter intends to manufac- that another person (whose identity
ture (including import) or process the will remain confidential, if so re-
microorganism for commercial pur- quested) has demonstrated a bona fide
poses. intent to manufacture (including im-
(iii) A description of research and de- port) or process the microorganism and
velopment activities conducted with therefore was told that the microorga-
the microorganism to date, demonstra- nism is on the Inventory, in § 725.239, or
tion of the submitter’s ability to in subpart M of this part.
produce or obtain the microorganism (g) A disclosure to a person with a
from a foreign manufacturer, and the bona fide intent to manufacture (in-
purpose for which the person will man- cluding import) or process a particular
ufacture (including import) or process microorganism that the microorganism
the microorganism. is on the Inventory, in § 725.239, or in
(iv) An indication of whether a re- subpart M of this part will not be con-
lated microorganism was previously re- sidered a public disclosure of confiden-
viewed by EPA to the extent known by tial business information under section
the submitter. 14 of the Act.
(v) A specific description of the
(h) EPA will answer an inquiry on
major intended application or use of
whether a particular microorganism is
the microorganism.
subject to this part within 30 days after
(c) If an importer or processor cannot
receipt of a complete submission under
provide all the information required by
paragraph (b) of this section.
paragraph (b) of this section, because it
is claimed as confidential business in- [62 FR 17932, Apr. 11, 1997, as amended at 80
formation by its foreign manufacturer FR 42747, July 20, 2015]
or supplier, the foreign manufacturer
or supplier may supply the information § 725.17 Consultation with EPA.
directly to EPA. Persons may consult with EPA, ei-
(d) EPA will review the information ther in writing or by telephone, about
submitted by the manufacturer (in- their obligations under this part. Writ-
cluding importer) or processor under ten consultation is preferred. Written
this paragraph to determine whether inquiries should be sent to the fol-
that person has shown a bona fide in- lowing address: Environmental Assist-
tent to manufacture (including import) ance Division (7408), Office of Pollution
or process the microorganism. If nec- Prevention and Toxics, U.S. Environ-
essary, EPA will compare this informa- mental Protection Agency, 1200 Penn-
tion to the information requested for sylvania Ave., NW., Washington, DC
the confidential microorganism under 20460, ATTN: Biotechnology Notice
§ 725.85(b)(3)(iii). Consultation. Persons wishing to con-
(e) In order for EPA to make a consult with EPA by telephone should call
clusive determination of the micro- (202) 554–1404; hearing impaired TDD
organism’s status, the proposed manu- (202) 554–0551 or e-mail: TSCA-
facturer (including importer) or proc- Hotline@epamail.epa.gov.
essor must show a bona fide intent to
manufacture (including import) or
process the microorganism and must Subpart B—Administrative
provide sufficient information to estab- Procedures
lish identity unambiguously. After suf-
ficient information has been provided, § 725.20 Scope and purpose.

EPA will inform the manufacturer (in- This subpart describes general ad-
cluding importer) or processor whether ministrative procedures applicable to
33
§ 725.25 40 CFR Ch. I (7–1–17 Edition)
all persons who submit MCANs and ex- ments, must be generated, completed,
emption requests to EPA under section and submitted to EPA (via CDX) using
5 of the Act for microorganisms. e-PMN software. See 40 CFR
720.40(a)(2)(ii) for information on how
§ 725.25 General administrative re- to obtain e-PMN software.
quirements. (d) General requirements for submission
(a) General. (1) Each person who is of data. (1) Submissions under this part
subject to the notification provisions must include the information described
of this part must complete, sign, and in § 725.155, § 725.255, § 725.355, or § 725.455,
submit a MCAN or exemption request as appropriate, to the extent such in-
containing the information as required formation is known to or reasonably
for the appropriate submission under ascertainable by the submitter.
this part. Except as otherwise pro- (2) In accordance with § 725.160 or
vided, each submission must include § 725.260, as appropriate, the submission
all referenced attachments. All infor- must also include any test data in the
mation in the submission (unless cer- submitter’s possession or control and
tain attachments appear in the open descriptions of other data which are
scientific literature) must be in known to or reasonably ascertainable
English. All information submitted by the submitter and which concern
must be true and correct. the health and environmental effects of
(2) In addition to specific information the microorganism.
required, the submitter should submit (e) Agency or joint submissions. (1) A
all information known to or reasonably manufacturer or importer may des-
ascertainable by the submitter that ignate an agent to assist in submitting
would permit EPA to make a reasoned the MCAN. If so, only the manufac-
evaluation of the human health and en- turer or importer, and not the agent,
vironmental effects of the microorga- signs the certification on the form.
nism and any microbial mixture or ar- (2) A manufacturer or importer may
ticle that may contain the microorga- authorize another person, (e.g., a sup-
nism. plier or a toll manufacturer) to report
(b) Certification. Persons submitting some of the information required in the
MCANs and exemption requests to EPA MCAN to EPA on its behalf. The manu-
under this part, and material related to facturer or importer should indicate in
their reporting obligations under this a cover letter accompanying the MCAN
part, must attach the following state- which information will be supplied by
ment to any information submitted to another person and identify that other
EPA. This statement must be signed person as a joint submitter where indi-
and dated by an authorized official of cated in their MCAN. The other person
the submitter: supplying information (i.e., the joint
I certify that to the best of my knowledge submitter) may submit the informa-
and belief: The company named in this sub- tion to EPA either in the MCAN or a
mission intends to manufacture, import, or Letter of Support, except that if the
process for a commercial purpose, other than joint submitter is not incorporated, li-
in small quantities solely for research and
censed, or doing business in the United
development, the microorganism identified
in this submission. All information provided States, the joint submitter must sub-
in this submission is complete and truthful mit the information to EPA in a Letter
as of the date of submission. I am including of Support only, rather than the
with this submission all test data in my pos- MCAN. The joint submitter must indi-
session or control and a description of all cate in the MCAN or Letter of Support
other data known to or reasonably ascertain- the identity of the manufacturer or im-
able by me as required by 40 CFR 725.160 or porter. Any person who submits the
725.260.
MCAN or Letter of Support for a joint
(c) Where to submit information under submission must sign and certify the
this part. MCANs and exemption re- MCAN or Letter of Support.
quests, and any support documents re- (3) If EPA receives a submission
lated to these submissions, may only which does not include the information
be submitted in a manner set forth in required, which the submitter indicates

this paragraph. MCANs and exemption that it has authorized another person
requests, and any related support docu- to provide, the review period will not
34
begin until EPA receives all of the re- (2) Data submitted under paragraph
quired information. (g)(1) of this section must be data
(f) Microorganisms subject to a section 4 which the person submitting the notice
test rule. (1) Except as provided in para- believes show that the manufacture,
graph (f)(3) of this section, if a person processing, distribution in commerce,
intends to manufacture or import a use, and disposal of the microorganism,
new microorganism which is subject to or any combination of such activities,
the notification requirements of this will not present an unreasonable risk
part, and the microorganism is subject of injury to health or the environment.
to a test rule promulgated under sec- (h) Data that need not be submitted.
tion 4 of the Act before the notice is Specific data requirements are listed in
submitted, section 5(b)(1) of the Act re- subparts D, E, F, G, and L of this part.
quires the person to submit the test The following is a list of data that need
data required by the testing rule with not be submitted under this part:
the notice. The person must submit the (1) Data previously submitted to
data in the form and manner specified EPA. (i) A person need not submit any
in the test rule and in accordance with data previously submitted to EPA with
§ 725.160. If the person does not submit no claims of confidentiality if the new
the test data, the submission is incom- submission includes: the office or per-
plete and EPA will follow the proce- son to whom the data were submitted;
dures in § 725.33. the date of submission; and, if appro-
priate, a standard literature citation as
(2) If EPA has granted the submitter specified in § 725.160(a)(3)(ii).
an exemption under section 4(c) of the (ii) For data previously submitted to
Act from the requirement to conduct EPA with a claim of confidentiality,
tests and submit data, the person may the person must resubmit the data
not file a MCAN or TERA until EPA with the new submission and any claim
receives the test data. of confidentiality, under § 725.80.
(3) If EPA has granted the submitter (2) Efficacy data. This part does not
an exemption under section 4(c) of the require submission of any data related
Act and if another person previously solely to product efficacy. However, in-
has submitted the test data to EPA, cluding efficacy data will improve
the exempted person may either sub- EPA’s ability to assess the benefits of
mit the test data or provide the fol- the use of the microorganism. This
lowing information as part of the no- does not exempt a person from submit-
tice: ting any of the data specified in
(i) The name, title, and address of the § 725.160 or § 725.260.
person who submitted the test data to (3) Non-U.S. exposure data. This part
EPA. does not require submission of any
(ii) The date the test data were sub- data which relates only to exposure of
mitted to EPA. humans or the environment outside the
(iii) A citation for the test rule. United States. This does not exclude
(iv) A description of the exemption nonexposure data such as data on
and a reference identifying it. health effects (including epidemiolog-
(g) Microorganisms subject to a section ical studies), ecological effects, phys-
5(b)(4) rule. (1) If a person: ical and chemical properties, or envi-
(i) Intends to manufacture or import ronmental fate characteristics.
a microorganism which is subject to [62 FR 17932, Apr. 11, 1997, as amended at 75
the notification requirements of this FR 788, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
part and which is subject to a rule
issued under section 5(b)(4) of the Act; § 725.27 Submissions.
and Each person who is required to sub-
(ii) Is not required by a rule issued mit information under this part must
under section 4 of the Act to submit submit the information in the form and
test data for the microorganism before manner set forth in the appropriate
the filing of a submission, the person subpart.
must submit to EPA data described in (a) Requirements specific to MCANs

paragraph (g)(2) of this section at the are described in §§ 725.150 through
time the submission is filed. 725.160.
35
§ 725.28 40 CFR Ch. I (7–1–17 Edition)
(b) Requirements specific to TERAs (4) Ambiguous statements or infor-

are described in §§ 725.250 through mation.
725.260. (b) In the request to correct the sub-
(c) Requirements specific to test mission, EPA will explain the action
marketing exemptions (TMEs) are de- which the submitter must take to cor-
scribed in §§ 725.350 and 725.355. rect the submission.
(d) Requirements specific to Tier I (c) If the submitter fails to correct
and Tier II exemptions for certain gen- the submission within 15 days of re-
eral commercial uses are described in ceipt of the request, EPA may extend
§§ 725.424 through 725.470. the review period.
(e) Additional requirements specific
to significant new uses for microorga- § 725.33 Incomplete submissions.
nisms are described at § 725.950.
(a) A submission under this part is
§ 725.28 Notice that submission is not not complete, and the review period
required. does not begin, if:
When EPA receives a MCAN or ex- (1) The wrong person files the sub-
emption request, EPA will review it to mission.
determine whether the microorganism (2) The submitter does not attach and
is subject to the requirements of this sign the certification statement as re-
part. If EPA determines that the quired by § 725.25(b).
microorganism is not subject to these (3) Some or all of the information in
requirements, EPA will notify the sub- the submission or any attachments are
mitter that section 5 of the Act does not in English, except for published sci-
not prevent the manufacture, import, entific literature.
or processing of the microorganism and (4) The submitter does not provide in-
that the submission is not needed. formation that is required by sections
5(d)(1)(B) and (C) of the Act and § 725.160
§ 725.29 EPA acknowledgement of re- or 725.260, as appropriate.
ceipt of submission. (5) The submitter does not provide in-
(a) EPA will acknowledge receipt of formation required by § 725.25, § 725.155,
each submission by sending a letter via § 725.255, § 725.355, or § 725.455, as appro-
CDX or U.S. mail to the submitter that priate, or indicate that it is not known
identifies the number assigned to each to or reasonably ascertainable by the
MCAN or exemption request and the submitter.
date on which the review period begins. (6) The submitter has asserted con-
The review period will begin on the fidentiality claims and has failed to:
date the MCAN or exemption request is (i) Submit a second copy of the sub-
received by the Office of Pollution Pre- mission with all confidential informa-
vention and Toxics Document Control tion deleted for the public file, as re-
Officer. quired by § 725.80(b)(2).
(b) The acknowledgement does not (ii) Comply with the substantiation
constitute a finding by EPA that the requirements as described in § 725.94.
submission is in compliance with this (7) The submitter does not include
part. any information required by section
[62 FR 17932, Apr. 11, 1997, as amended at 75 5(b)(1) of the Act and pursuant to a rule
FR 788, Jan. 6, 2010] promulgated under section 4 of the Act,
as required by § 725.25(f).
§ 725.32 Errors in the submission. (8) The submitter does not submit
(a) Within 30 days of receipt of the data which the submitter believes show
submission, EPA may request that the that the microorganism will not
submitter remedy errors in the submis- present an unreasonable risk of injury
sion. The following are examples of to health or the environment, if EPA
such errors: has listed the microorganism under
(1) Failure to date the submission. section 5(b)(4) of the Act, as required in
(2) Typographical errors that cause § 725.25(g).
data to be misleading or answers to (9) For MCANs, the submitter does

any questions to be unclear. not remit the fees required by
(3) Contradictory information. § 700.45(b)(1) or (b)(2)(vi) of this chapter.
36
(10) The submitter does not include the date that the submission is de-
an identifying number and a payment clared complete. The submitter need
identity number as required by not correct the submission as EPA
§ 700.45(e)(3) of this chapter. originally requested. If EPA can com-
(11) The submitter does not submit plete its review within the review pe-
the notice in the manner set forth in riod beginning on the date of the sub-
§ 725.25(c). mission, the Director, or a designee,
(b)(1) If EPA receives an incomplete may inform the submitter that the
submission under this part, the Direc- running of the review period will re-
tor, or a designee, will notify the sub- sume on the date EPA originally de-
mitter within 30 days of receipt that clared it incomplete.
the submission is incomplete and that (3) If the Director, or a designee,
the review period will not begin until modifies the requirements for com-
EPA receives a complete submission. pleting the submission or concurs with
(2) If EPA obtains additional infor- EPA’s original determination, the re-
mation during the review period for view period will begin when EPA re-
any submission that indicates the ceives a complete submission.
original submission was incomplete, (f) If EPA discovers at any time that
the Director, or a designee, may de- a person submitted materially false or
clare the submission incomplete within misleading statements in information
30 days after EPA obtains the addi- submitted under this part, EPA may
tional information and so notify the find that the submission was incom-
submitter. plete from the date it was submitted,
(c) The notification that a submis- and take any other appropriate action.
sion is incomplete under paragraph (b)
of this section will include: [62 FR 17932, Apr. 11, 1997, as amended at 75
(1) A statement of the basis of EPA’s FR 788, Jan. 6, 2010]
determination that the submission is
incomplete. § 725.36 New information.
(2) The requirements for correcting (a) During the review period, if a sub-
the incomplete submission. mitter possesses, controls, or knows of
(3) Information on procedures under new information that materially adds
paragraph (d) of this section for filing to, changes, or otherwise makes sig-
objections to the determination or re- nificantly more complete the informa-
questing modification of the require- tion included in the MCAN or exemp-
ments for completing the submission. tion request, the submitter must send
(d) Within 10 days after receipt of no- that information within 10 days of re-
tification by EPA that a submission is ceiving the new information, but no
incomplete, the submitter may file later than 5 days before the end of the
written objections requesting that EPA review period. The new information
accept the submission as complete or must be sent in the same manner the
modify the requirements necessary to original notice or exemption was sent,
complete the submission. as described in § 725.25(c)(1), (c)(2), and
(e)(1) EPA will consider the objec- (c)(3).
tions filed by the submitter. The Direc- (b) The new submission must clearly
tor, or a designee, will determine identify the submitter, the MCAN or
whether the submission was complete exemption request to which the new in-
or incomplete, or whether to modify formation is related, and the number
the requirements for completing the assigned to that submission by EPA, if
submission. EPA will notify the sub- known to the submitter.
mitter in writing of EPA’s response
(c) If the new information becomes
within 10 days of receiving the objec-
available during the last 5 days of the
tions.
review period, the submitter must im-
(2) If the Director, or a designee, de-
mediately inform the EPA contact for
termines, in response to the objection,
that the submission was complete, the that submission by telephone of the
review period will be deemed suspended new information.

on the date EPA declared the submis- [62 FR 17932, Apr. 11, 1997, as amended at 75
sion incomplete, and will resume on FR 789, Jan. 6, 2010]
37
§ 725.40 40 CFR Ch. I (7–1–17 Edition)
§ 725.40 Notice in the Federal Register. (1) TERAs. The review period for
TERAs is 60 days.
(a) Filing of FEDERAL REGISTER no-
(2) TMEs. The review period for TMEs
tice. After EPA receives a MCAN or an
is 45 days.
exemption request under this part, (3) Tier II exemption requests. The re-
EPA will issue a notice in the FEDERAL view period for Tier II exemption re-
REGISTER including the information quests is 45 days.
specified in paragraph (b) of this sec-
tion. § 725.54 Suspension of the review pe-
(b) Contents of notice. (1) In the public riod.
interest, the specific microorganism (a) A submitter may voluntarily sus-
identity listed in the submission will pend the running of the review period if
be published in the FEDERAL REGISTER the Director, or a designee, agrees. If
unless the submitter has claimed the the Director does not agree, the review
microorganism identity confidential. If period will continue to run, and EPA
the submitter claims confidentiality, a will notify the submitter. A submitter
generic name will be published in ac- may request a suspension at any time
cordance with § 725.85. during the review period. The suspen-
(2) The categories of use of the micro- sion must be for a specified period of
organism will be published as reported time.
in the submission unless this informa- (b)(1) Request for suspension. A re-
tion is claimed confidential. If con- quest for suspension may only be sub-
fidentiality is claimed, the generic in- mitted in a manner set forth in this
formation which is submitted under paragraph. The request for suspension
§ 725.88 will be published. also may be made orally, including by
(3) A list of information submitted in telephone, to the submitter’s EPA con-
accordance with § 725.160(a), § 725.255, tact for that notice, subject to para-
§ 725.260, § 725.355, or § 725.455, as appro- graph (c) of this section.
priate, will be published. (2) Submission of suspension notices.
(4) The submitter’s identity will be EPA will accept requests for suspen-
published, unless the submitter has sion only if submitted in accordance
claimed it confidential. with this paragraph. Requests for sus-
(c) Publication of exemption decisions. pension, must be generated, completed,
Following the expiration of the appro- and submitted to EPA (via CDX) using
priate review period for the exemption e-PMN software. See 40 CFR
request, EPA will issue a notice in the 720.40(a)(2)(ii) for information on how
FEDERAL REGISTER indicating whether to obtain e-PMN software.
the request has been approved or de- (c) An oral request for suspension
nied and the reasons for the decision. may be granted by EPA for a maximum
of 15 days only. Requests for longer
§ 725.50 EPA review. suspension must only be submitted in
(a) MCANs. The review period speci- the manner set forth in this paragraph.
fied in section 5(a) of the Act for (d) If the submitter has not made a
MCANs runs for 90 days from the date previous oral request, the running of
the Document Control Officer receives the notice review period is suspended
a complete submission, or the date as of the date of receipt of the CDX
EPA determines the submission is com- submission by EPA.
plete under § 725.33, unless the Agency [62 FR 17932, Apr. 11, 1997, as amended at 75
extends the review period under section FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
5(c) of the Act and § 725.56.
(b) Exemption requests. The review pe- § 725.56 Extension of the review pe-
riod starts on the date the Document riod.
Control Officer receives a complete ex- (a) At any time during the review pe-
emption request, or the date EPA de- riod, EPA may unilaterally determine
termines the request is complete under that good cause exists to extend the re-
§ 725.33, unless the Agency extends the view period specified for MCANs, or the
review period under § 725.56. The review exemption requests.

periods for exemption requests run as (b) If EPA makes such a determina-
follows: tion, EPA:
38
(1) Will notify the submitter that same microorganism, a new review pe-
EPA is extending the review period for riod begins.
a specified length of time and state the
[62 FR 17932, Apr. 11, 1997, as amended at 75
reasons for the extension. FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
(2) For MCANs, EPA may issue a no-
tice for publication in the FEDERAL § 725.65 Recordkeeping.
REGISTER which states that EPA is ex-
tending the review period and gives the (a) General provisions. (1) Any person
reasons for the extension. who submits a notice under this part
(c) The total period of the extension must retain documentation of informa-
may be for a period of up to the same tion in the submission, including:
length of time as specified for each (i) Any data in the submitter’s pos-
type of submission in § 725.50. If the ini- session or control; and
tial extension is for less than the total (ii) Records of production volume for
time allowed, EPA may make addi- the first 3 years of manufacture, im-
tional extensions. However, the sum of port, or processing.
the extensions may not exceed the (2) Any person who submits a notice
total allowed. under this part must retain docu-
(d) The following are examples of sit- mentation of the date of commence-
uations in which EPA may find that ment of testing, manufacture, import,
good cause exists for extending the re- or processing.
view period: (3) Any person who is exempt from
(1) EPA has reviewed the submission some or all of the reporting require-
and is seeking additional information. ments of this part must retain docu-
(2) EPA has received significant addi- mentation that supports the exemp-
tional information during the review tion.
period. (4) All information required by this
(3) The submitter has failed to cor- section must be retained for 3 years
rect a submission after receiving EPA’s from the date of commencement of
request under § 725.32. each activity for which records are re-
(4) EPA has reviewed the submission quired under this part.
and determined that there is a signifi- (b) Specific requirements. In addition
cant possibility that the microorga- to the requirements of paragraph (a) of
nism will be regulated under section this section, specific recordkeeping re-
5(e) or section 5(f) of the Act, but EPA quirements included in certain sub-
is unable to initiate regulatory action parts must also be followed.
within the initial review period. (1) Additional recordkeeping require-
ments for activities conducted inside a
§ 725.60 Withdrawal of submission by structure are set forth in § 725.235(h).
the submitter. (2) Additional recordkeeping require-
(a)(1) Withdrawal of notice by the sub- ments for TERAs are set forth in
mitter. A submitter may withdraw a no- § 725.250(f).
tice during the notice review period by (3) Additional recordkeeping require-
submitting a statement of withdrawal ments for TMEs are set forth in
in a manner set forth in this para- § 725.350(c).
graph. The withdrawal is effective upon (4) Additional recordkeeping require-
receipt of the CDX submission by EPA. ments for Tier I exemptions under sub-
(2) Submission of withdrawal notices. part G of this part are set forth in
EPA will accept statements of with- § 725.424(a)(5).
drawal only if submitted in accordance (5) Additional recordkeeping require-
with this paragraph. Statements of ments for Tier II exemptions under
withdrawal must be generated, com- subpart G of this part are set forth in
pleted, and submitted to EPA (via § 725.450(d).
CDX) using e-PMN software. See 40 (6) Additional recordkeeping require-
CFR 720.40(a)(2)(ii) for information on ments for significant new uses of
how to obtain e-PMN software. microorganisms reported under subpart
(b) If a manufacturer, importer, or L of this part are set forth in § 725.850.

processor who withdrew a submission Recordkeeping requirements may also
later resubmits a submission for the be included when a microorganism and
39
§ 725.67 40 CFR Ch. I (7–1–17 Edition)
significant new use are added to sub- other closely related microorganisms
part M of this part. which have a potential for adverse ef-
fects on health or the environment;
§ 725.67 Applications to exempt new (C) A history of safe commercial use
microorganisms from this part. for the microorganism;
(a) Submission. (1) Any manufacturer (D) Commercial uses indicating that
or importer of a new microorganism the microorganism products might be
may request, under TSCA section subject to TSCA;
5(h)(4), an exemption, in whole or in (E) Studies which indicate the poten-
part, from this part by sending a Let- tial for the microorganism to cause ad-
ter of Application in the manner set verse effects to health or the environ-
forth in § 725.25(c). ment; and
(2) General provisions. The Letter of (F) Studies which indicate the sur-
Application should provide information vival characteristics of the microorga-
to show that any activities affected by nism in the environment.
the requested exemption will not (b) Processing of the Letter of Applica-
present an unreasonable risk of injury tion by EPA—(1) Grant of the Applica-
to health or the environment. This in- tion. If, after consideration of the Let-
formation should include data deter of Application and any other rel-
scribed in the following paragraphs. evant information available to EPA,
(i) The effects of the new microorga- the Assistant Administrator for Chem-
nism on health and the environment. ical Safety and Pollution Prevention
(ii) The magnitude of exposure of makes a preliminary determination
human beings and the environment to that the new microorganism will not
the new microorganism. present an unreasonable risk of injury
(iii) The benefits of the new micro- to health or the environment, the As-
organism for various uses and the sistant Administrator will propose a
availability of substitutes for such rule to grant the exemption using the
uses. applicable procedures in part 750 of this
(iv) The reasonably ascertainable chapter.
economic consequences of granting or (2) Denial of the application. If the As-
denying the exemption, including ef- sistant Administrator decides that the
fects on the national economy, small preliminary determination described in
business, and technological innovation. paragraph (b)(1) of this section cannot
(3) Specific requirements. In addition be made, the application will be denied
to the requirements of paragraph (a)(2) by sending the applicant a written
of this section, the specific information statement with the Assistant Adminis-
requirements of the relevant subpart trator’s reasons for denial.
under which the exemption is sought (c) Processing of the exemption—(1) Un-
should be met. reasonable risk standard. Granting a sec-
(i) Exemption from MCAN reporting tion 5(h)(4) exemption requires a deter-
under subpart D. Information require- mination that the activities will not
ments are set forth in §§ 725.155 and present an unreasonable risk of injury
725.160. to health or the environment.
(ii) Exemption from TERA reporting (i) An unreasonable risk determina-
under subpart E. Information require- tion under the Act is an administrative
ments are set forth in §§ 725.255 and judgment that requires balancing of
725.260. the harm to health or the environment
(iii) Listing a recipient microorganism that a chemical substance may cause
as eligible for exemption under subpart G. and the magnitude and severity of that
Information regarding the following harm, against the social and economic
criteria should be addressed in an ap- effects on society of EPA action to re-
plication to list a recipient microorga- duce that harm.
nism under § 725.420: (ii) A determination of unreasonable
(A) Identification and classification risk under section 5(h)(4) of the Act
of the microorganism using available will examine the reasonably ascertain-
genotypic and phenotypic information; able economic and social consequences

(B) Information to evaluate the rela- of granting or denying the exemption
tionship of the microorganism to any after consideration of the effect on the
40
national economy, small business, connection with the requirements of

technological innovation, the environ- any provision of this part may be sub-
ment, and public health. ject to penalties calculated as if they
(2) Grant of the exemption. The exemp- never filed their submissions.
tion will be granted if the Assistant (g) EPA may seek to enjoin the man-
Administrator determines, after con- ufacture or processing of a microorga-
sideration of all relevant evidence pre- nism in violation of this part or act to
sented in the rulemaking proceeding seize any microorganism manufactured
described in paragraph (b)(1) of this or processed in violation of this part or
section, that the new microorganism take other actions under the authority
will not present an unreasonable risk of section 7 of the Act (15 U.S.C. 2606)
of injury to health or the environment. or section 17 of the Act (15 U.S.C. 2616).
(3) Denial of the exemption. The ex-
emption will be denied if the Assistant § 725.75 Inspections.
Administrator determines, after con- EPA will conduct inspections under
sideration of all relevant evidence pre- section 11 of the Act to assure compli-
sented in the rulemaking proceeding ance with section 5 of the Act and this
described in paragraph (b)(1) of this part, to verify that information re-
section, that the determination de- quired by EPA under this part is true
scribed in paragraph (c)(2) of this sec- and correct, and to audit data sub-
tion cannot be made. A final decision mitted to EPA under this part.
terminating the rulemaking pro-
ceeding will be published in the FED- Subpart C—Confidentiality and
ERAL REGISTER.
Public Access to Information
FR 789, Jan. 6, 2010; 77 FR 46292, Aug. 3, 2012] § 725.80 General provisions for con-
fidentiality claims.
§ 725.70 Compliance. (a) A person may assert a claim of
(a) Failure to comply with any provi- confidentiality for any information
sion of this part is a violation of sec- submitted to EPA under this part.
tion 15 of the Act (15 U.S.C. 2614). However,
(b) A person who manufactures or im- (1) Any person who asserts a claim of
ports a microorganism before a MCAN confidentiality for portions of the spe-
is submitted and the MCAN review pe- cific microorganism identity must pro-
riod expires is in violation of section 15 vide the information as described in
of the Act even if that person was not § 725.85.
required to submit the MCAN under (2) Any person who asserts a claim of
§ 725.105. confidentiality for a use of a micro-
(c) Using a microorganism which a organism must provide the information
person knew or had reason to know was as described in § 725.88.
manufactured, processed, or distrib- (3) Any person who asserts a claim of
uted in commerce in violation of sec- confidentiality for information con-
tion 5 of the Act or this part is a viola- tained in a health and safety study of a
tion of section 15 of the Act (15 U.S.C. microorganism must provide the infor-
2614). mation described in § 725.92.
(d) Failure or refusal to establish and (b) Any claim of confidentiality must
maintain records or to permit access to accompany the information when it is
or copying of records, as required by submitted to EPA.
the Act, is a violation of section 15 of (1) When a person submits any infor-
the Act (15 U.S.C. 2614). mation under this part, including any
(e) Failure or refusal to permit entry attachments, for which claims of con-
or inspection as required by section 11 fidentiality are made, the claim(s)
of the Act is a violation of section 15 of must be asserted by circling the spe-
the Act (15 U.S.C. 2614). cific information which is claimed and
(f) Violators may be subject to the marking the page on which that infor-
civil and criminal penalties in section mation appears with an appropriate
16 of the Act (15 U.S.C. 2615) for each designation such as ‘‘trade secret,’’
violation. Persons who submit materi- ‘‘TSCA CBI,’’ or ‘‘confidential business
ally misleading or false information in information.’’
41
§ 725.85 40 CFR Ch. I (7–1–17 Edition)
(2) If any information is claimed con- microorganism identity at the time of

fidential, the person must submit two submission of the information. This
copies of the document including the claim will apply only to the period
claimed information. prior to the commencement of manu-
(i) One copy of the document must be facture or import for general commer-
complete. In that copy, the submitter cial use.
must mark the information which is (ii) A person who submits informa-
claimed as confidential in the manner tion to EPA under this part must re-
prescribed in paragraph (b)(1) of this assert a claim of confidentiality and
section. substantiate the claim each time the
(ii) The second copy must be com- information is submitted to EPA. For
plete except that all information example, if a person claims certain in-
claimed as confidential in the first formation confidential in a TERA sub-
copy must be deleted. EPA will place mission and wishes the same informa-
the second copy in the public file. tion to remain confidential in a subse-
(iii) If the submitter does not provide quent TERA or MCAN submission, the
the second copy, the submission is in- person must reassert and resubstan-
complete and the review period does tiate the claim in the subsequent sub-
not begin to run until EPA receives the mission.
second copy, in accordance with (2) Assertion of claim. (i) A submitter
§ 725.33. may assert a claim of confidentiality
(iv) Any information contained with- only if the submitter believes that pub-
in the copy submitted under paragraph lic disclosure prior to commencement
(b)(2)(ii) of this section which has been of manufacture or import for general
in the public file for more than 30 days commercial use of the fact that anyone
will be presumed to be in the public do- is initiating research and development
main, notwithstanding any assertion of activities pertaining to the specific
confidentiality made under this sec- microorganism or intends to manufac-
tion. ture or import the specific microorga-
(3) A person who submits information nism for general commercial use would
to EPA under this part must reassert a reveal confidential business informa-
claim of confidentiality and substan- tion. Claims must be substantiated in
tiate the claim each time the informa- accordance with the requirements of
tion is submitted to EPA. § 725.94(a).
(c) Any person asserting a claim of (ii) If the submission includes a
confidentiality under this part must health and safety study concerning the
substantiate each claim in accordance microorganism and if the claim for
with the requirements in § 725.94. confidentiality with respect to the spe-
(d) EPA will disclose information cific identity is denied in accordance
that is subject to a claim of confiden- with § 725.92(c), EPA will deny a claim
tiality asserted under this section only asserted under paragraph (a) of this
to the extent permitted by the Act, section.
this subpart, and part 2 of this title. (3) Development of generic name. Any
(e) If a submitter does not assert a person who asserts a claim of confiden-
claim of confidentiality for informa- tiality for portions of the specific
tion at the time it is submitted to microorganism identity under this
EPA, EPA may make the information paragraph must provide one of the fol-
public and place it in the public file lowing items at the time the submis-
without further notice to the sub- sion is filed:
mitter. (i) The generic name which was ac-
cepted by EPA in the prenotice con-
§ 725.85 Microorganism identity. sultation conducted under paragraph
(a) Claims applicable to the period prior (a)(4) of this section.
to commencement of manufacture or im- (ii) One generic name that is only as
port for general commercial use—(1) When generic as necessary to protect the
to make a claim. (i) A person who sub- confidential identity of the particular
mits information to EPA under this microorganism. The name should re-
part may assert a claim of confiden- veal the specific identity to the max-
tiality for portions of the specific imum extent possible. The generic
42
name will be subject to EPA review section in the MCAN submitted for the
and approval. microorganism.
(4) Determination by EPA. (i) Any per- (ii) A submitter may claim the
son who intends to assert a claim of microorganism identity confidential
confidentiality for the specific identity for the period after commencement of
of a new microorganism may seek a de- manufacture or import for general
termination by EPA of an appropriate commercial use if the submitter did
generic name for the microorganism not claim the microorganism identity
before filing a submission. For this confidential under paragraph (a) of this
purpose, the person should submit to section in any TERA submitted for the
EPA: microorganism, but subsequently did
(A) The specific identity of the claim microorganism identity con-
microorganism. fidential in the MCAN submitted for
(B) A proposed generic name(s) which
the microorganism.
is only as generic as necessary to pro-
(2) Assertion of claim. (i) A person who
tect the confidential identity of the
new microorganism. The name(s) believes that public disclosure of the
should reveal the specific identity of fact that anyone manufactures or im-
the microorganism to the maximum ports the microorganism for general
extent possible. commercial use would reveal confiden-
(ii) Within 30 days, EPA will inform tial business information may assert a
the submitter either that one of the claim of confidentiality under para-
proposed generic names is adequate or graph (b) of this section.
that none is adequate and further con- (ii) If the notice includes a health
sultation is necessary. and safety study concerning the new
(5) Use of generic name. If a submitter microorganism, and if the claim for
claims microorganism identity as con- confidentiality with respect to the
fidential under paragraph (a) of this microorganism identity is denied in ac-
section, and if the submitter complies cordance with § 725.92(c), EPA will deny
with paragraph (a)(2) of this section, a claim asserted under paragraph (b) of
EPA will issue for publication in the this section.
FEDERAL REGISTER notice described in (3) Requirements for assertion. Any per-
§ 725.40 the generic name proposed by son who asserts a confidentiality claim
the submitter or one agreed upon by for microorganism identity must:
EPA and the submitter. (i) Comply with the requirements of
(b) Claims applicable to the period after paragraph (a)(3) of this section regard-
commencement of manufacture or import ing submission of a generic name.
for general commercial use—(1) Maintain- (ii) Agree that EPA may disclose to a
ing claim. Any claim of confidentiality person with a bona fide intent to manu-
under paragraph (a) of this section is facture or import the microorganism
applicable only until the microorga- the fact that the particular microorga-
nism is manufactured or imported for nism is included on the confidential In-
general commercial use and becomes ventory for purposes of notification
eligible for inclusion on the Inventory. under section 5(a)(1)(A) of the Act.
To maintain the confidential status of
(iii) Have available and agree to fur-
the microorganism identity when the
nish to EPA upon request the taxo-
microorganism is added to the Inven-
tory, a submitter must reassert the nomic designations and supplemental
confidentiality claim and substantiate information required by § 725.12.
the claim in the notice of commence- (iv) Provide a detailed written sub-
ment of manufacture required under stantiation of the claim, in accordance
§ 725.190. with the requirements of § 725.94(b).
(i) A submitter may not claim the (4) Denial of claim. If the submitter
microorganism identity confidential does not meet the requirements of
for the period after commencement of paragraph (b) of this section, EPA will
manufacture or import for general deny the claim of confidentiality.
commercial use unless the submitter (5) Acceptance of claim. (i) EPA will
claimed the microorganism identity publish a generic name on the public
confidential under paragraph (a) of this Inventory if:
43
§ 725.88 40 CFR Ch. I (7–1–17 Edition)
(A) The submitter asserts a claim of (iii) If the generic name proposed by
confidentiality in accordance with this EPA is acceptable to the submitter,
paragraph. EPA will place that generic name on
(B) No claim for confidentiality of the public Inventory.
the microorganism identity as part of a (iv) If the generic name proposed by
health and safety study has been de- EPA is not acceptable to the sub-
nied in accordance with part 2 of this mitter, the submitter must explain in
title or § 725.92. detail why disclosure of that generic
(ii) Publication of a generic name on name would reveal confidential busi-
the public Inventory does not create a ness information and propose another
category for purposes of the Inventory. generic name which is only as generic
Any person who has a bona fide intent as necessary to protect the confidential
to manufacture or import a microorga- identity of the microorganism. If EPA
nism which is described by a generic does not receive a response from the
name on the public Inventory may sub- submitter within 30 days after the sub-
mit an inquiry to EPA under § 725.15(b) mitter receives the proposed name,
to determine whether the particular EPA will place EPA’s chosen generic
microorganism is included on the con- name on the public Inventory. If the
fidential Inventory. submitter does provide the information
requested, EPA will review the re-
(iii) Upon receipt of a request de-
sponse. If the submitter’s proposed ge-
scribed in § 725.15(b), EPA may require
neric name is acceptable, EPA will
the submitter who originally asserted
publish that generic name on the pub-
confidentiality for a microorganism to
lic Inventory. If the submitter’s pro-
submit to EPA the information listed
posed generic name is not acceptable,
in paragraph (b)(3)(iii) of this section.
EPA will notify the submitter of EPA’s
(iv) Failure to submit any of the in- choice of a generic name. Thirty days
formation required under paragraph after this notification, EPA will place
(b)(3)(iii) of this section within 10 cal- the chosen generic name on the public
endar days of receipt of a request by Inventory.
EPA under paragraph (b) of this sec-
tion will constitute a waiver of the § 725.88 Uses of a microorganism.
original submitter’s confidentiality (a) Assertion of claim. A person who
claim. In this event, EPA may place submits information to EPA under this
the specific microorganism identity on part on the categories or proposed cat-
the public Inventory without further egories of use of a microorganism may
notice to the original submitter. assert a claim of confidentiality for
(6) Use of generic name on the public this information.
Inventory. If a submitter asserts a (b) Requirements for claim. A sub-
claim of confidentiality under para- mitter that asserts such a claim must:
graph (b) of this section, EPA will ex- (1) Report the categories or proposed
amine the generic microorganism categories of use of the microorganism.
name proposed by the submitter. (2) Provide, in nonconfidential form,
(i) If EPA determines that the ge- a description of the uses that is only as
neric name proposed by the submitter generic as necessary to protect the
is only as generic as necessary to pro- confidential business information. The
tect the confidential identity of the generic use description will be included
particular microorganism, EPA will in the FEDERAL REGISTER notice de-
place that generic name on the public scribed in § 725.40.
Inventory. (c) Generic use description. The person
(ii) If EPA determines that the ge- must submit the information required
neric name proposed by the submitter by paragraph (b) of this section by de-
is more generic than necessary to pro- scribing the uses as precisely as pos-
tect the confidential identity, EPA will sible, without revealing the informa-
propose in writing, for review by the tion which is claimed confidential, to
submitter, an alternative generic name disclose as much as possible how the
that will reveal the identity of the use may result in human exposure to
microorganism to the maximum extent the microorganism or its release to the
possible. environment.
44
§ 725.92 Data from health and safety (2) The microorganism identity is not
studies of microorganisms. necessary to interpret a health and
(a) Information other than specific safety study.
microorganism identity. Except as pro- (d) Use of generic names. When EPA
vided in paragraph (b) of this section, discloses a health and safety study con-
EPA will deny any claim of confiden- taining a microorganism identity,
tiality with respect to information in- which the submitter has claimed con-
cluded in a health and safety study of fidential, and if the Agency has not de-
a microorganism, unless the informa- nied the claim under paragraph (c) of
tion would disclose confidential busi- this section, EPA will identify the
ness information concerning: microorganism by the generic name se-
(1) Processes used in the manufacture lected under § 725.85.
or processing of a microorganism.
§ 725.94 Substantiation requirements.
(2) Information which is not in any
way related to the effects of a micro- (a) Claims applicable to the period prior
organism on health or the environ- to commencement of manufacture or im-
ment, such as, the name of the submit- port for general commercial use—(1)
ting company, cost or other financial MCAN, TME, Tier I certification, and
data, product development or mar- Tier II exemption request requirements.
keting plans, and advertising plans, for Any person who submits a MCAN,
which the person submits a claim of TME, Tier I certification, or Tier II ex-
confidentiality in accordance with emption request should strictly limit
§ 725.80. confidentiality claims to that informa-
(b) Microorganism identity—(1) Claims tion which is confidential and propri-
applicable to the period prior to com- etary to the business.
mencement of manufacture or import for (i) If any information in the submis-
general commercial use. A claim of con- sion is claimed as confidential business
fidentiality for the period prior to com- information, the submitter must sub-
mencement of manufacture or import stantiate each claim by submitting
for general commercial use for the spe- written answers to the questions in
cific identity of a microorganism for paragraphs (c), (d), and (e) of this sec-
which a health and safety study was tion at the time the person submits the
submitted must be asserted in conjunc- information.
tion with a claim asserted under (ii) If the submitter does not provide
§ 725.85(a). The submitter must substan- written substantiation as required in
tiate each claim in accordance with paragraph (a)(1)(i) of this section, the
the requirements of § 725.94(a). submission will be considered incom-
(2) Claims applicable to the period after plete and the review period will not
commencement of manufacture or import begin in accordance with § 725.33.
for general commercial use. To maintain (2) TERA requirements. Any person
the confidential status of the specific who submits a TERA, should strictly
identity of a microorganism for which limit confidentiality claims to that in-
a health and safety study was sub- formation which is confidential and
mitted after commencement of manu- proprietary to the business. If any in-
facture or import for general commer- formation in such a submission is
cial use, the claim must be reasserted claimed as confidential business infor-
and substantiated in conjunction with mation, the submitter must have avail-
a claim under § 725.85(b). The submitter able for each of those claims, and agree
must substantiate each claim in ac- to furnish to EPA upon request, writ-
cordance with the requirements of ten answers to the questions in para-
§ 725.94(b). graphs (d) and (e) of this section.
(c) Denial of confidentiality claim. EPA (b) Claims applicable to the period after
will deny a claim of confidentiality for commencement of manufacture or import
microorganism identity under para- for general commercial use. (1) If a sub-
graph (b) of this section, unless: mitter claimed portions of the micro-
(1) The information would disclose organism identity confidential in the

processes used in the manufacture or MCAN and wants the identity to be
processing of a microorganism. listed on the confidential Inventory,
45
§ 725.94 40 CFR Ch. I (7–1–17 Edition)
the claim must be reasserted and sub- the answer is yes to any of these ques-
stantiated at the time the Notice of tions, indicate where the information
Commencement (NOC) is submitted appears and explain why it should
under § 725.190. Otherwise, EPA will list nonetheless be treated as confidential.
the specific microorganism identity on (i) Advertising or promotional mate-
the public Inventory. rials for the microorganism or the re-
(2) The submitter must substantiate sulting end product?
the claim for confidentiality of the (ii) Material safety data sheets or
microorganism identity by answering other similar materials for the micro-
all of the questions in paragraphs (c), organism or the resulting end product?
(d), and (e) in this section. In addition, (iii) Professional or trade publica-
the following questions must be an- tions?
swered: (iv) Any other media available to the
(i) What harmful effects to the com- public or to competitors?
pany’s or institution’s competitive po- (v) Patents?
sition, if any, would result if EPA pub-
(vi) Local, State, or Federal agency
lishes on the Inventory the identity of
public files?
the microorganism? How could a com-
petitor use such information given the (5) Has EPA, another Federal agency,
fact that the identity of the microorga- a Federal court, or a State made any
nism otherwise would appear on the confidentiality determination regard-
TSCA Inventory with no link between ing the information claimed as con-
the microorganism and the company or fidential? If so, provide copies of such
institution? How substantial would the determinations.
harmful effects of disclosure be? What (6) For each type of information
is the causal relationship between the claimed confidential, describe the
disclosure and the harmful effects? harm to the company’s or institution’s
(ii) Has the identity of the micro- competitive position that would result
organism been kept confidential to the if this information were disclosed. Why
extent that competitors do not know it would this harm be substantial? How
is being manufactured or imported for could a competitor use such informa-
general commercial use by anyone? tion? What is the causal connection be-
(c) General questions. The following tween the disclosure and harm?
questions must be answered in detail (7) If EPA disclosed to the public the
for each confidentiality claim: information claimed as confidential,
(1) For what period of time is a claim how difficult would it be for the com-
of confidentiality being asserted? If the petitor to enter the market for the re-
claim is to extend until a certain event sulting product? Consider such con-
or point in time, indicate that event or straints as capital and marketing cost,
time period. Explain why the informa- specialized technical expertise, or un-
tion should remain confidential until usual processes.
such point. (d) Microorganism identity and produc-
(2) Briefly describe any physical or tion method. If confidentiality claims
procedural restrictions within the com- are asserted for the identity of the
pany or institution relating to the use microorganism or information on how
and storage of the information claimed the microorganism is produced, the fol-
as confidential. What other steps, if lowing questions must be answered:
any, apply to use or further disclosure (1) Has the microorganism or method
of the information? of production been patented in the U.S.
(3) Has the information claimed as or elsewhere? If so, why is confiden-
confidential been disclosed to individ- tiality necessary?
uals outside of the company or institu- (2) Does the microorganism leave the
tion? Will it be disclosed to such per- site of production or testing in a form
sons in the future? If so, what restric- which is accessible to the public or to
tions, if any, apply to use or further competitors? What is the cost to a
disclosure of the information? competitor, in time and money, to de-
(4) Does the information claimed as velop appropriate use conditions? What
confidential appear, or is it referred to, factors facilitate or impede product
in any of the following questions? If analysis?
46
(3) For each additional type of infor- commercial use. Persons who manufac-
mation claimed as confidential, explain ture, import, or process a microorga-
what harm would result from disclo- nism in small quantities solely for re-
sure of each type of information if the search and development as defined in
identity of the microorganism were to § 725.3 are not required to submit a no-
remain confidential. tice to EPA. Persons who manufacture,
(e) Health and safety studies of micro- import, or process a microorganism for
organisms. If confidentiality claims are research and development activities
asserted for information in a health or that do not fit the definition of small
safety study of a microorganism, the quantities solely for research and de-
following questions must be answered: velopment may nonetheless qualify for
(1) Would the disclosure of the infor- more limited reporting requirements in
mation claimed confidential reveal: subpart E, including the TERA which
confidential process information, or in- can be used for review of research and
formation unrelated to the effects of development involving environmental
the microorganism on health and the release.
environment. Describe the causal con- (b) Persons subject to MCAN submis-
nection between the disclosure and sion are described in § 725.105.
harm. (c) Exclusions and exemptions spe-
(2) Does the company or institution cific to MCAN submissions are de-
assert that disclosure of the microorga- scribed in § 725.110.
nism identity is not necessary to inter- (d) Submission requirements applica-
pret any health and safety studies ble specifically to MCANs are described
which have been submitted? If so, ex- at § 725.150.
plain how a less specific identity would (e) Data requirements for MCANs are
be sufficient to interpret the studies. set forth in §§ 725.155 and 725.160.
(f) EPA review procedures specific to
§ 725.95 Public file. MCANs are set forth in § 725.170.
All information submitted, including (g) Subparts A through C of this part
any health and safety study of a micro- apply to any MCAN submitted under
organism and other supporting docu- this subpart.
mentation, will become part of the
public file for that submission, unless § 725.105 Persons who must report.
such materials are claimed confiden- (a) Manufacturers of new microorga-
tial. In addition, EPA may add mate- nisms. (1) MCAN submission is required
rials to the public file, unless such ma- for any person who intends to manufac-
terials are claimed confidential. Pub- ture for commercial purposes in the
lically available docket materials are United States a new microorganism.
available at the addresses in Exclusions are described in § 725.110.
§ 700.17(b)(1) and (2) of this chapter (2) If a person contracts with a manu-
facturer to produce or process a new
[62 FR 17932, Apr. 11, 1997, 77 FR 46292, Aug.
3, 2012]
microorganism and the manufacturer
produces or processes the microorga-
nism exclusively for that person, and
Subpart D—Microbial Commercial that person specifies the identity of the
Activities Notification Require- microorganism, and controls the total
ments amount produced and the basic tech-
nology for the plant process, then that
§ 725.100 Scope and purpose. person must submit the MCAN. If it is
(a) This subpart establishes proce- unclear who must report, EPA should
dures for submission of a notice to EPA be contacted to determine who must
under section 5(a) of the Act for per- submit the MCAN.
sons who manufacture, import, or proc- (3) Only manufacturers that are in-
ess microorganisms for commercial corporated, licensed, or doing business
purposes. This notice is called a Micro- in the United States may submit a
bial Commercial Activity Notice MCAN.
(MCAN). It is expected that MCANs (b) Importers of new microorganisms. (1)

will in general only be submitted for MCAN submission is required for a per-
microorganisms intended for general son who intends to import into the
47
§ 725.110 40 CFR Ch. I (7–1–17 Edition)
United States for commercial purposes marketing activities which have been
a new microorganism. Exclusions are granted an exemption under subpart F
described in § 725.110. of this part.
(2) When several persons are involved (c) Manufacturing or importing new
in an import transaction, the MCAN microorganisms under the conditions
must be submitted by the principal im- of a Tier I or Tier II exemption under
porter. If no one person fits the prin- subpart G of this part.
cipal importer definition in a par-
ticular transaction, the importer § 725.150 Procedural requirements for
should contact EPA to determine who this subpart.
must submit the MCAN for that trans- General requirements for all MCANs
action. under this part are contained in sub-
(3) Except as otherwise provided in parts A through C of this part. In addi-
paragraph (b)(4) of this section, the tion, the following requirements apply
provisions of this subpart D apply to to MCANs submitted under this sub-
each person who submits a MCAN for a part:
new microorganism which such person (a) When to submit a MCAN. A MCAN
intends to import for a commercial must be submitted at least 90 calendar
purpose. In addition, each importer days prior to manufacturing or import-
must comply with paragraph (b)(4) of ing a new microorganism and at least
this section. 90 calendar days prior to manufac-
(4) EPA will hold the principal im- turing, importing, or processing a
porter, or the importer that EPA deter- microorganism for a significant new
mines must submit the MCAN when use.
there is no principal importer under (b) Section 5(b) of the Act. The sub-
paragraph (b)(2) of this section, liable mitter must comply with any applica-
for complying with this part, for com- ble requirement of section 5(b) of the
pleting the MCAN, and for the com- Act for the submission of test data.
pleteness and truthfulness of all infor- (c) Contents of a MCAN. Each person
mation which it submits. who submits a MCAN under this sub-
(c) Manufacturers, importers, or proc- part must provide the information and
essors of microorganisms for a significant test data described in §§ 725.155 and
new use. MCAN submission is required 725.160.
for any person who intends to manufac- (d) Recordkeeping. Each person who
ture, import, or process for commercial submits a MCAN under this subpart
purposes a microorganism identified as must comply with the recordkeeping
having one or more significant new requirements of § 725.65.
uses in subpart M of this part, and who
intends either to engage in a des- § 725.155 Information to be included in
ignated significant new use of the the MCAN.
microorganism or intends to distribute (a) Each person who is required by
it in commerce. Persons excluded from this part to submit a MCAN must in-
reporting on significant new uses of clude the information specified in para-
microorganisms and additional proce- graphs (c) through (h) of this section,
dures for reporting are described in to the extent it is known to or reason-
subpart L of this part. ably ascertainable by that person.
However, no person is required to in-
§ 725.110 Persons not subject to this clude information which relates solely
subpart. to exposure of humans or ecological
Persons are not subject to the re- populations outside of the United
quirements of this subpart for the fol- States.
lowing activities: (b) Each person should also submit,
(a) Manufacturing, importing, or in writing, all other information
processing solely for research and de- known to or reasonably ascertainable
velopment microorganisms that meet by that person that would permit EPA
the requirements for an exemption to make a reasoned evaluation of the
under subpart E of this part. health and environmental effects of the

(b) Manufacturing, importing, or microorganism, or any microbial mix-
processing microorganisms for test ture or article, including information
48
on its effects on humans, animals, and selection). The description should

plants, and other microorganisms, and include, for example, a description of
in the environment. The information the introduced genetic material, in-
to be submitted under this subpart including any regulatory sequences and
cludes the information listed in para- structural genes and the products of
graphs (c) through (h) of this section those genes; how the introduced ge-
relating to the manufacture, proc- netic material is expected to affect be-
essing, distribution in commerce, use, havior of the recipient; expression, al-
and disposal of the new microorganism. teration, and stability of the intro-
(c) Submitter identification. (1) The duced genetic material; methods for
name and headquarters address of the vector construction and introduction;
submitter. and a description of the regulatory and
(2) The name, address, and office tele- structural genes that are components
phone number (including area code) of of the introduced genetic material, in-
the principal technical contact rep- cluding genetic maps of the introduced
resenting the submitter. sequences.
(d) Microorganism identity information. (3) Phenotypic and ecological character-
Persons must submit sufficient infor- istics. (i) Habitat, geographical dis-
mation to allow the microorganism to tribution, and source of the recipient
be accurately and unambiguously iden- microorganism.
tified for listing purposes as required (ii) Survival and dissemination under
by § 725.12. relevant environmental conditions in-
(1) Description of the recipient micro- cluding a description of methods for
organism and the new microorganism. (i) detecting the new or recipient micro-
Data substantiating the taxonomy of organism(s) in the environment and
the recipient microorganism and the the sensitivity limit of detection for
new microorganism to the level of these techniques.
strain, as appropriate. In lieu of data, (iii) A description of anticipated bio-
EPA will accept a letter from a culture logical interactions with and effects on
collection substantiating taxonomy, target organisms and other organisms
provided EPA, upon request to the sub- such as competitors, prey, hosts,
mitter, may have access to the data symbionts, parasites, and pathogens; a
supporting the taxonomic designation. description of host range; a description
(ii) Information on the morphological of pathogenicity, infectivity, toxicity,
and physiological features of the new virulence, or action as a vector of
microorganism. pathogens; and capacity for genetic
(iii) Other specific data by which the transfer under laboratory and relevant
new microorganism may be uniquely environmental conditions.
identified for Inventory purposes. (iv) A description of anticipated in-
(2) Genetic construction of the new volvement in biogeochemical or bio-
microorganism. (i) Data substantiating logical cycling processes, involvement
the taxonomy of the donor organism(s). in rate limiting steps in mineral or nu-
In lieu of data, EPA will accept a letter trient cycling, or involvement in inor-
from a culture collection substan- ganic compounds cycling (such as pos-
tiating taxonomy, provided EPA, upon sible sequestration or transformation
request to the submitter, may have ac- of heavy metals).
cess to the data supporting the taxo- (e) Byproducts. A description of the
nomic designation. byproducts resulting from the manu-
(ii) Description of the traits for facture, processing, use, and disposal of
which the new microorganism has been the new microorganism.
selected or developed and other traits (f) Total production volume. The esti-
known to have been added or modified. mated maximum amount of the new
(iii) A detailed description of the ge- microorganism intended to be manu-
netic construction of the new micro- factured or imported during the first
organism, including the technique used year of production and the estimated
to modify the microorganism (e.g., fu- maximum amount to be manufactured
sion of cells, injection of DNA, or imported during any consecutive 12–

electroporation or chemical poration, month period during the first 3 years of
or methods used for induced mutation production. This estimate may be by
49
§ 725.160 40 CFR Ch. I (7–1–17 Edition)
weight or volume and should include ing procedures for inactivation of the
an estimation of viability (i.e., viable new microorganism, containment, dis-
cells per unit volume or colony form- infection, and disposal of contaminated
ing units per unit dry weight). items.
(g) Use information. A description of (2) For sites not controlled by the
intended categories of use by function submitter, a description of each type of
and application, the estimated percent processing and use operation involving
of production volume devoted to each the new microorganism, including
category of use, and the percent of the identification of the estimated number
new microorganism in the formulation of processing or use sites, situations in
for each commercial or consumer use. which worker exposure to and/or envi-
(h) Worker exposure and environmental ronmental release of the new micro-
release. (1) For sites controlled by the organism will occur, the number of
submitter: workers exposed and the duration of
(i) The identity of sites where the exposure; procedures for transport of
new microorganism will be manufac- the new microorganism and for dis-
tured, processed, or used. For purposes posal, including procedures for inac-
of this section, the site for a person tivation of the new microorganism; and
who imports a new microorganism is control measures which limit worker
the site of the operating unit within exposure and environmental release.
the person’s organization which is di-
rectly responsible for importing the § 725.160 Submission of health and en-
new microorganism and which controls vironmental effects data.
the import transaction. The import (a) Test data on the new microorganism
site may in some cases be the organiza- in the possession or control of the sub-
tion’s headquarters office in the United mitter. (1) Except as provided in
States. § 725.25(h), and in addition to the infor-
(ii) A process description of each mation required by § 725.155(d)(3), each
manufacture, processing, and use oper- MCAN must contain all test data in
ation, which includes a diagram of the the submitter’s possession or control
major unit operations and conversions, which are related to the effects on
the identity and entry point of all feed- health or the environment of any man-
stocks, and the identity of any possible ufacture, processing, distribution in
points of release of the new microorga- commerce, use, or disposal of the new
nism from the process, including a de- microorganism or any microbial mix-
scription of all controls, including en- ture or article containing the new
gineering controls, used to prevent microorganism, or any combination of
such releases. such activities. This includes test data
(iii) Worker exposure information, concerning the new microorganism in a
including worker activities, physical pure culture or formulated form as
form of process streams which contain used or as intended to be used in one of
the new microorganism to which work- the activities listed above.
ers may be exposed, the number of (2) A full report or standard lit-
workers, and the duration of activities. erature citation must be submitted for
(iv) Information on release of the new the following types of test data:
microorganism to the environment, in- (i) Health effects data.
cluding the quantity and media of re- (ii) Ecological effects data.
lease and type of control technology (iii) Physical and chemical properties
used. data.
(v) A narrative description of the in- (iv) Environmental fate characteris-
tended transport of the new microorga- tics.
nism, including the means of transport, (v) Monitoring data and other test
containment methods to be used during data related to human exposure to or
transport, and emergency containment environmental release of the new
procedures to be followed in case of ac- microorganism.
cidental release. (3)(i) If the data do not appear in the
(vi) Procedures for disposal of any ar- open scientific literature, the sub-
ticles, waste, clothing, or other equip- mitter must provide a full report. A
ment involved in the activity, includ- full report includes the experimental
50
methods and materials, results, discus- ufacture, processing, distribution in

sion and data analysis, conclusions, commerce, use, or disposal of the
references, and the name and address of microorganism, of any microbial mix-
the laboratory that developed the data. ture or article containing the new
(ii) If the data appear in the open sci- microorganism, or of any combination
entific literature, the submitter need of such activities:
only provide a standard literature cita- (i) Any data, other than test data, in
tion. A standard literature citation in- the submitter’s possession or control.
cludes author, title, periodical name, (ii) Any data, including test data,
date of publication, volume, and page which are not in the submitter’s pos-
numbers. session or control, but which are
(4)(i) If a study, report, or test is in- known to or reasonably ascertainable
complete when a person submits a by the submitter. For the purposes of
MCAN, the submitter must identify the this section, data are known to or rea-
nature and purpose of the study; name sonably ascertainable by the submitter
and address of the laboratory devel- if the data are known to any of its em-
oping the data; progress to date; types ployees or other agents who are associ-
of data collected, significant prelimi- ated with the research and develop-
nary results; and anticipated complement, test marketing, or commercial
tion date. marketing of the microorganism.
(ii) If a test or experiment is com- (2) Data that must be described in-
pleted before the MCAN review period clude data concerning the new micro-
ends, the person must submit the organism in a pure culture or formu-
study, report, or test, as specified in lated form as used or as intended to be
paragraph (a)(3)(i) of this section, to used in one of the activities listed in
the address listed in § 725.25(c) within 10 paragraph (b)(1) of this section.
days of receiving it, but no later than (3) The description of data reported
5 days before the end of the review pe- under paragraph (b) of this section
riod. If the test or experiment is com- must include:
pleted during the last 5 days of the re- (i) If the data appear in the open sci-
view period, the submitter must imme- entific literature, a standard literature
diately inform its EPA contact for that citation, which includes the author,
submission by telephone. title, periodical name, date of publica-
(5) For test data in the submitter’s tion, volume, and pages.
possession or control which are not (ii) If the data are not available in
listed in paragraph (a)(2) of this sec- the open scientific literature, a de-
tion, a person is not required to submit scription of the type of data and sum-
a complete report. The person must mary of the results, if available, and
submit a summary of the data. If EPA the names and addresses of persons the
so requests, the person must submit a submitter believes may have possession
full report within 10 days of the re- or control of the data.
quest, but no later than 5 days before (4) All data described in paragraph (b)
the end of the review period. of this section are subject to these re-
(6) All test data described under para- quirements, regardless of their age,
graph (a) of this section are subject to quality, or results; and regardless of
these requirements, regardless of their whether they are complete at the time
age, quality, or results. the MCAN is submitted.
(b) Other data concerning the health
and environmental effects of the new § 725.170 EPA review of the MCAN.
microorganism that are known to or rea- General procedures for review of all
sonably ascertainable by the submitter. (1) submissions under this part are con-
Except as provided in § 725.25(h), and in tained in §§ 725.28 through 725.60. In ad-
addition to the information required by dition, the following procedures apply
§ 725.155(c)(3), any person who submits a to EPA review of MCANs submitted
MCAN must describe the following under this subpart:
data, including any data from a health (a) Length of the review period. The
and safety study of a microorganism, if MCAN review period specified in sec-

the data are related to effects on tion 5(a) of the Act runs for 90 days
health or the environment of any man- from the date the Document Control
51
§ 725.190 40 CFR Ch. I (7–1–17 Edition)
Officer for the Office of Pollution Pre- (3) Submission of an NOC prior to the
vention and Toxics receives a complete commencement of manufacture or im-
MCAN, or the date EPA determines the port is a violation of section 15 of the
MCAN is complete under § 725.33, unless Act.
the Agency extends the period under (c) Information to be reported. The
section 5(c) of the Act and § 725.56. NOC must contain the following infor-
(b) Notice of expiration of MCAN re- mation: Specific microorganism iden-
view period. (1) EPA will notify the tity, MCAN number, and the date when
submitter that the MCAN review pe- manufacture or import commences. If
riod has expired or that EPA has com- the person claimed microorganism
pleted its review of the MCAN. Expira-
identity confidential in the MCAN, and
tion of the review period does not con-
wants the identity to be listed on the
stitute EPA approval or certification
of the new microorganism, and does confidential Inventory, the claim must
not mean that EPA may not take regu- be reasserted and resubstantiated in
latory action against the microorga- accordance with § 725.85(b). Otherwise,
nism in the future. EPA will list the specific microorga-
(2) After expiration of the MCAN re- nism identity on the public Inventory.
view period, in the absence of regu- (d) How to submit. All notices of com-
latory action by EPA under section mencement must be generated, com-
5(e), 5(f), or 6(a) of the Act, the sub- pleted, and submitted to EPA (via
mitter may manufacture or import the CDX) using e-PMN software. See 40
microorganism even if the submitter CFR 720.40(a)(2)(ii) for information on
has not received notice of expiration. how to obtain e-PMN software.
(3) Early notification that EPA has
completed its review does not permit
FR 789, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013]
commencement of manufacture or im-
port prior to the expiration of the 90–
day MCAN review period. Subpart E—Exemptions for Re-
(c) No person submitting a MCAN in search and Development Ac-
response to the requirements of this tivities
subpart may manufacture, import, or
process a microorganism subject to § 725.200 Scope and purpose.
this subpart until the review period, in- (a) This subpart describes exemptions
cluding all extensions and suspensions,
from the reporting requirements under
has expired.
subpart D of this part for research and
§ 725.190 Notice of commencement of development activities involving
manufacture or import. microorganisms.
(a) Applicability. Any person who (b) In lieu of complying with subpart
commences the manufacture or import D of this part, persons described in
of a new microorganism for nonexempt, § 725.205 may submit a TSCA Experi-
commercial purposes for which that mental Release Application (TERA) for
person previously submitted a section research and development activities in-
5(a) notice under this part must submit volving microorganisms or otherwise
a notice of commencement (NOC) of comply with this subpart.
manufacture or import. (c) Exemptions from part 725 are pro-
(b) When to report. (1) If manufacture vided at §§ 725.232, 725.234, and 725.238.
or import for nonexempt, commercial (d) Submission requirements specific
purposes begins on or after May 27, for TERAs are described at § 725.250.
1997, the submitter must submit the (e) Data requirements for TERAs are
NOC to EPA no later than 30 calendar set forth in §§ 725.255 and 725.260.
days after the first day of such manu-
(f) EPA review procedures specific for
facture or import.
TERAs are set forth in §§ 725.270 and
(2) If manufacture or import for non-
725.288.
exempt, commercial purposes began or
will begin before May 27, 1997, the sub- (g) Subparts A through C of this part
mitter must submit the NOC by May apply to any submission under this
27, 1997. subpart.
52
§ 725.205 Persons who may report (iv) Other evidence that the re-
under this subpart. searcher is aware of a commercial ap-
(a) Commercial research and develop- plication for the research and has di-
ment activities involving new micro- rected the research toward developing
organisms or significant new uses of that application.
microorganisms are subject to report- (c) Certain research and development
ing under this part unless they qualify activities involving microorganisms
for an exemption under this part. subject to jurisdiction under the Act
are exempt from reporting under this
(b) Commercial purposes for research
part. A person conducting research and
and development means that the ac-
development activities which meet the
tivities are conducted with the purpose
conditions for the exemptions de-
of obtaining an immediate or eventual
scribed in §§ 725.232, 725.234, or 725.238 is
commercial advantage for the re-
exempt from TERA reporting under
searcher and would include:
this subpart.
(1) All research and development ac-
(d) A microorganism is not exempt
tivities which are funded directly, in
from reporting under subpart D of this
whole or in part, by a commercial enti-
part if any amount of the microorga-
ty regardless of who is actually con-
nism, including as part of a mixture, is
ducting the research. Indications that
processed, distributed in commerce, or
the research and development activi-
used, for any commercial purpose other
ties are funded directly, in whole or in
than research and development.
part, may include, but are not limited
(e) Quantities of the inactivated
to:
microorganism, or mixtures or articles
(i) Situations in which a commercial containing the inactivated microorga-
entity contracts directly with a univer- nism, remaining after completion of re-
sity or researcher; or search and development activities may
(ii) Situations in which a commercial be disposed of as a waste in accordance
entity gives a conditional grant where with applicable Federal, State, and
the commercial entity holds patent local regulations.
rights, or establishes a joint venture (f) A person who manufactures, im-
where the commercial entity holds pat- ports, or processes a microorganism
ent or licensing rights; or solely for research and development is
(iii) Any other situation in which the not required to comply with the re-
commercial entity intends to obtain an quirements of this section if:
immediate or eventual commercial ad- (1) The person is manufacturing a mi-
vantage for the commercial entity and/ crobial pesticide identified in
or the researcher. § 172.45(c), or
(2) Research and development activi- (2) The person is manufacturing a mi-
ties that are not funded directly by a crobial pesticide for which an Experi-
commercial entity, if the researcher mental Use Permit is required, pursu-
intends to obtain an immediate or ant to § 172.3; or
eventual commercial advantage. Indi- (3) The person is manufacturing a mi-
cations that the researcher intends to crobial pesticide for which a notifica-
obtain an immediate or eventual com- tion or an Experimental Use Permit is
mercial advantage may include, but not required to be submitted.
are not limited to:
(i) The research is directed toward § 725.232 Activities subject to the juris-
developing a commercially viable im- diction of other Federal programs
provement of a product already on the or agencies.
market; or This part does not apply to any re-
(ii) The researcher has sought or is search and development activity that
seeking commercial funding for the meets all of the following conditions.
purpose of developing a commercial ap- (a) The microorganism is manufac-
plication; or tured, imported, or processed solely for
(iii) The researcher or university has research and development activities.
sought or is seeking a patent to protect (b) There is no intentional testing of

a commercial application which the re- a microorganism outside of a struc-
search is developing; or ture, as structure is defined in § 725.3.
53
§ 725.234 40 CFR Ch. I (7–1–17 Edition)
(c)(1) The person receives research and use of containment and/or inac-
funds from another Federal agency, tivation controls, as specified in
and the funds are awarded on the con- § 725.235(c). These records, which must
dition that the research will be con- be maintained at the location where
ducted in accordance with the relevant the research and development activity
portions of the NIH Guidelines, or is being conducted, shall be submitted
(2) A Federal agency or program oth- to EPA upon written request and with-
erwise imposes the legally binding rein the time frame specified in EPA’s
quirement that the research is to be request.
conducted in accordance with relevant (4) Subsequent to EPA review of
portions of the NIH Guidelines. records in accordance with paragraph
(d)(3) of this section, changes to the
§ 725.234 Activities conducted inside a containment/inactivation controls se-
structure. lected under paragraph (d)(1) of this
A person who manufactures, imports, section must be made upon EPA order.
or processes a microorganism is not Failure to comply with EPA’s order
subject to the reporting requirements shall result in automatic loss of eligi-
under subpart D of this part if all of bility for an exemption under this sec-
the following conditions are met: tion.
(a) The microorganism is manufac- (e) The manufacturer, importer, or
tured, imported, or processed solely for processor notifies all persons in its em-
research and development activities. ploy or to whom it directly distributes
(b) The microorganism is used by, or the microorganism, who are engaged in
directly under the supervision of, a experimentation, research, or analysis
technically qualified individual, as de- on the microorganism, including the
fined in § 725.3. The technically quali- manufacture, processing, use, trans-
fied individual must maintain docu- port, storage, and disposal of the
mentation of the procedures selected to microorganism associated with re-
comply with paragraph (d) of this sec- search and development activities, of
tion and must ensure that the proce- any risk to health, identified under
dures are used. § 725.235(a), which may be associated
(c) There is no intentional testing of with the microorganism. The notifica-
a microorganism outside of a struction must be made in accordance with
ture, as structure is defined in § 725.3. § 725.235(b).
(d) Containment and/or inactivation
controls. (1) Selection and use of con- § 725.235 Conditions of exemption for
tainment and/or inactivation controls activities conducted inside a struc-
inside a structure for a particular ture.
microorganism shall take into account (a) Determination of risks. To deter-
the following: mine whether notification under
(i) Factors relevant to the organism’s § 725.234(e) is required, the manufac-
ability to survive in the environment. turer, importer, or processor must do
(ii) Potential routes of release in air, one of the following:
solids and liquids; in or on waste mate- (1) For research conducted in accord-
rials and equipment; in or on people, ance with the NIH Guidelines, the man-
including maintenance and custodial ufacturer, importer, or processor must
personnel; and in or on other orga- meet the conditions laid out at IV-B-4-
nisms, such as insects and rodents. d of the NIH Guidelines; or
(iii) Procedures for transfer of mate- (2) For all other research conducted
rials between facilities. in accordance with § 725.234, the manu-
(2) The technically qualified individ- facturer, importer, or processor must
ual’s selection of containment and/or review and evaluate the following in-
inactivation controls shall be approved formation to determine whether there
and certified by an authorized official is reason to believe there is any risk to
(other than the TQI) of the institution health which may be associated with
that is conducting the test prior to the the microorganism:
commencement of the test. (i) Information in its possession or

(3) Records shall be developed and control concerning any significant ad-
maintained describing the selection verse reaction of persons exposed to
54
the microorganism which may reason- (A) For experiments subject to Insti-
ably be associated with such exposure. tutional Biosafety Committee review,
(ii) Information provided to the man- or notification simultaneous with initi-
ufacturer, importer, or processor by a ation of the experiment, the informa-
supplier or any other person con- tion submitted for review or notifica-
cerning a health risk believed to be as- tion, along with standard laboratory
sociated with the microorganism. records, shall satisfy the recordkeeping
(iii) Health and environmental ef- requirements specified in § 725.234(d)(3).
fects data in its possession or control (B) For experiments exempt from In-
concerning the microorganism. stitutional Biosafety Committee re-
(iv) Information on health effects view or notification simultaneous with
which accompanies any EPA rule or initiation of the experiment, docu-
order issued under TSCA section 4, 5, mentation of the exemption, along
or 6 of the Act that applies to the with standard laboratory records, shall
microorganism and of which the manu- satisfy the recordkeeping requirement
facturer, importer, or processor has specified in § 725.234(d)(3).
knowledge. (ii) Documentation of how the fol-
(b) Notification to employees and oth- lowing requirements are satisfied
ers. (1) The manufacturer, importer, or under the NIH Guidelines:
processor must notify the persons iden- (A) Copies or citations to informa-
tified in § 725.234(e) by means of a con- tion reviewed and evaluated to deter-
tainer labeling system, conspicuous mine the need to make any notifica-
placement of notices in areas where ex- tion of risk.
posure may occur, written notification (B) Documentation of the nature and
to each person potentially exposed, or method of notification of risk, includ-
any other method of notification which ing copies of any labels or written no-
adequately informs persons of health tices used.
risks which the manufacturer, im- (C) The names and addresses of any
porter, or processor has reason to be- persons other than the manufacturer,
lieve may be associated with the importer, or processor to whom the
microorganism, as determined under substance is distributed, the identity of
paragraph (a) of this section. the microorganism, the amount dis-
(2) If the manufacturer, importer, or tributed, and copies of the notifica-
processor distributes a microorganism tions required.
manufactured, imported, or processed (2) For all other research conducted
under this section to persons not in its in accordance with § 725.234, a person
employ, the manufacturer, importer, or who manufacturers, imports, or proc-
processor must in written form: esses a microorganism under this sec-
(i) Notify those persons that the tion, must maintain the following
microorganism is to be used only for records:
research and development purposes and (i) Records describing selection and
the requirements of § 725.234 are to be use of containment and/or inactivation
met. controls required by § 725.234(d)(3) and
(ii) Provide the notice of health risks certification by an authorized official
specified in paragraph (b)(1) of this sec- required by § 725.234(d)(2) for each
tion. microorganism.
(3) The adequacy of any notification (ii) Copies or citations to informa-
under this section is the responsibility tion reviewed and evaluated under
of the manufacturer, importer, or proc- paragraph (a) of this section to deter-
essor. mine the need to make any notifica-
(c) Recordkeeping. (1) For research tion of risk.
conducted in accordance with the NIH (iii) Documentation of the nature and
Guidelines, a person who manufac- method of notification under paragraph
tures, imports, or processes a micro- (b)(1) of this section, including copies
organism under this section must re- of any labels or written notices used.
tain the following records: (iv) The names and addresses of any
(i) Documentation that the NIH persons other than the manufacturer,
Guidelines have been adhered to. Such importer, or processor to whom the
documentation shall include: substance is distributed, the identity of
55
§ 725.238 40 CFR Ch. I (7–1–17 Edition)
the microorganism, the amount dis- is limited to strains of Bradyrhizobium

tributed, and copies of the notifica- japonicum.
tions required under paragraph (b)(2) of (2) Modification of traits. (i) The intro-
this section. duced genetic material must meet the
criteria for poorly mobilizable listed in
§ 725.238 Activities conducted outside § 725.421(c).
a structure.
(ii) The introduced genetic material
(a) Exemption. (1) Research and devel- must consist only of the following com-
opment activities involving intentional ponents:
testing in the environment of certain (A) The structural gene(s) of interest,
microorganisms listed in § 725.239 may which have the following limitations:
be conducted without prior review by (1) For structural genes encoding
EPA if all of the conditions of this sec- marker sequences, the gene is limited
tion and § 725.239 are met. to the aadH gene, which confers resist-
(2) The research and development ac- ance to the antibiotics streptomycin
tivity involving a microorganism listed and spectinomycin.
in § 725.239 must be conducted by, or di- (2) For traits other than antibiotic
rectly under the supervision of, a tech- resistance, the structural gene must be
nically qualified individual, as defined limited to the genera Bradyrhizobium
in § 725.3. and Rhizobium.
(b) Certification. To be eligible for the (B) The regulatory sequences permit-
exemption under this section, a manu- ting the expression of solely the gene(s)
facturer or importer must submit to of interest.
EPA prior to initiation of the activity (C) Associated nucleotide sequences
a document signed by an authorized of- needed to move genetic material, in-
ficial containing the following infor- cluding linkers, homopolymers, adap-
mation: tors, transposons, insertion sequences,
(1) Name, address, and telephone and restriction enzyme sites.
number of the manufacturer or im-
(D) The vector nucleotide sequences
porter.
needed for vector transfer.
(2) Location, estimated duration, and
(E) The vector nucleotide sequences
planned start date of the test.
needed for vector maintenance.
(3) Certification of the following:
(3) Limitations on exposure. (i) The
(i) Compliance with the conditions of
test site area must be no more than 10
the exemption specified for the micro-
terrestrial acres.
organism in § 725.239.
(ii) If state and/or local authorities (ii) The technically qualified indi-
have been notified of the activity, evi- vidual must select appropriate methods
dence of notification. to limit the dissemination of modified
Bradyrhizobium japonicum.
(c) Recordkeeping. Persons who con-
duct research and development activi- (b) Rhizobium meliloti. To qualify for
ties under this section must comply an exemption under this section, all of
with the recordkeeping requirements of the following conditions must be met
§ 725.65 and retain documentation that for a test involving Rhizobium meliloti:
supports their compliance with the re- (1) Characteristics of recipient micro-
quirements of this section and the spe- organism. The recipient microorganism
cific requirements for the microorga- is limited to strains of Rhizobium
nism listed in § 725.239. meliloti.
(2) Modification of traits. (i) The intro-
§ 725.239 Use of specific microorga- duced genetic material must meet the
nisms in activities conducted out- criteria for poorly mobilizable listed in
side a structure. § 725.421(c) of this part.
(a) Bradyrhizobium japonicum. To (ii) The introduced genetic material
qualify for an exemption under this must consist only of the following com-
section, all of the following conditions ponents:
must be met for a test involving (A) The structural gene(s) of interest,
Bradyrhizobium japonicum: which have the following limitations:

(1) Characteristics of recipient micro- (1) For structural genes encoding
organism. The recipient microorganism marker sequences, the gene is limited
56
to the aadH gene, which confers resist- (e) The manufacturer, importer, or
ance to the antibiotics streptomycin processor who receives a TERA ap-
and spectinomycin. proval must comply with all terms of
(2) For traits other than antibiotic the approval, as well as conditions de-
resistance, the structural gene must be scribed in the TERA, and remains lia-
limited to the genera Bradyrhizobium ble for compliance with all terms and
and Rhizobium. conditions, regardless of who conducts
(B) The regulatory sequences permit- the research and development activity.
ting the expression of solely the gene(s) Any person conducting the research
of interest. and development activity approved
(C) Associated nucleotide sequences under the TERA must comply with all
needed to move genetic material, in-
terms of the TERA approval, as well as
cluding linkers, homopolymers, adap-
the conditions described in the TERA.
tors, transposons, insertion sequences,
and restriction enzyme sites. (f) Recordkeeping. Persons submit-
(D) The vector nucleotide sequences ting a TERA must comply with the
needed for vector transfer. recordkeeping requirements of § 725.65.
(E) The vector nucleotide sequences In addition, the following requirements
needed for vector maintenance. apply to TERAs:
(3) Limitations on exposure. (i) The (1) Each person submitting a TERA
test site area must be no more than 10 under this part must retain docu-
terrestrial acres. mentation of information contained in
(ii) The technically qualified indi- the TERA for a period of 3 years from
vidual must select appropriate methods the date that the results of the study
to limit the dissemination of modified are submitted to the Agency.
Rhizobium meliloti. (2) Summaries of all data, conclu-
sions, and reports resulting from the
§ 725.250 Procedural requirements for
the TERA. conduct of the research and develop-
ment activity under the TERA must be
General requirements for all submis- submitted to the EPA address identi-
sions under this part are contained in fied in § 725.25(c) within 1 year of the
subparts A through C of this part. In
termination of the activity.
addition, the following requirements
apply to TERAs submitted under this § 725.255 Information to be included in
subpart: the TERA.
(a) When to submit the TERA. Each
person who is eligible to submit a (a) To review a TERA, EPA must
TERA under this subpart must submit have sufficient information to permit a
the TERA at least 60 calendar days be- reasoned evaluation of the health and
fore the person intends to initiate the environmental effects of the planned
proposed research and development ac- test in the environment. The person
tivity. seeking EPA approval must submit all
(b) Contents of the TERA. Each per- information known to or reasonably
son who submits a TERA under this ascertainable by the submitter on the
subpart must provide the information microorganism(s) and the research and
and test data described in §§ 725.255 and development activity, including infor-
725.260. In addition, the submitter must mation not listed in paragraphs (c), (d),
supply sufficient information to enable and (e) of this section that the person
EPA to evaluate the effects of all ac- believes will be useful for EPA’s risk
tivities for which approval is reassessment. The TERA must be in
quested. writing and must include at least the
(c) A person may submit a TERA for information described in the following
one or more microorganisms and one or paragraphs.
more research and development activi-
(b) When specific information is not
ties, including a research program.
submitted, an explanation of why such
(d) EPA will either approve the
TERA, with or without conditions, or information is not available or not ap-

disapprove it under procedures estab- plicable must be included.
lished in this subpart.
57
§ 725.260 40 CFR Ch. I (7–1–17 Edition)
(c) Persons applying for a TERA, the microorganism(s) by people, ma-

must include the submitter identifica- chinery, or equipment.
tion and microorganism identity infor- (vi) Procedures for disposal of any ar-
mation required for MCANs in ticles, waste, clothing, machinery, or
§ 725.155(c), (d)(1), and (d)(2). other equipment involved in the exper-
(d) Persons applying for a TERA imental release, including methods for
must submit phenotypic and ecological inactivation of the microorganism(s),
characteristics information required in containment, disinfection, and disposal
§ 725.155(d)(3) as it relates directly to of contaminated items.
the conditions of the proposed research
and development activity. § 725.260 Submission of health and en-
(e) Persons applying for a TERA vironmental effects data.
must also submit the following infor- Each TERA must contain all avail-
mation about the proposed research able data concerning actual or poten-
and development activity: tial effects on health or the environ-
(1) A detailed description of the pro- ment of the new microorganism that
posed research and development activity. are in the possession or control of the
(i) The objectives and significance of submitter and a description of other
the activity and a rationale for testing data known to or reasonably ascertain-
the microorganisms in the environ- able by the submitter that will permit
ment. a reasoned evaluation of the planned
(ii) Number of microorganisms retest in the environment. The data must
leased (including viability per volume be reported in the manner described in
if applicable) and the method(s) of ap- § 725.160(a)(3) and (b)(3).
plication or release.
(iii) Characteristics of the test § 725.270 EPA review of the TERA.
site(s), including location, geo- General procedures for review of all
graphical, physical, chemical, and bio- submissions under this part are con-
logical features, proximity to human tained in §§ 725.28 through 725.60. In ad-
habitation or activity, and description dition, the following procedures apply
of site characteristics that would influ- to EPA review of applications sub-
ence dispersal or confinement. mitted under this subpart:
(iv) Target organisms (if the micro- (a) Length of the review period. (1) The
organism(s) to be tested has an in- review period for the TERA will be 60
tended target), including identification days from the date the Document Con-
of each target organism and antici- trol Officer for the Office of Pollution
pated mechanism and result of inter- Prevention and Toxics receives a com-
action. plete TERA, or the date EPA deter-
(v) Planned start date and duration mines the TERA is complete under
of each activity. § 725.33, unless EPA finds good cause for
(vi) If State and/or local authorities an extension under § 725.56.
have been notified of the activity, evi- (2) A submitter shall not proceed
dence of notification. with the research and development ac-
(2) Information on monitoring, confine- tivity described in the TERA unless
ment, mitigation, and emergency termi- and until EPA provides written ap-
nation procedures. (i) Confinement pro- proval of the TERA. A submitter may
cedures for the activity, access and se- receive early approval if a review is
curity measures, and procedures for completed in less than 60 days.
routine termination of the activity. (b) EPA decision regarding proposed
(ii) Mitigation and emergency proce- TERA activity. (1) A decision con-
dures. cerning a TERA under this subpart will
(iii) Measures to detect and control be made by the Administrator, or a
potential adverse effects. designee.
(iv) Name of principal investigator (2) If EPA determines that the pro-
and chief of site personnel responsible posed research and development activ-
for emergency procedures. ity for the microorganism does not
(v) Personal protective equipment, present an unreasonable risk of injury

engineering controls, and procedures to to health or the environment, EPA will
be followed to minimize dispersion of notify the submitter that the TERA is
58
approved and that the submitter can cide whether to change its determina-
proceed with the proposed research and tion regarding approval of the TERA.
development activity described in the (i) If EPA determines that the activ-
TERA. ity will not present an unreasonable
(3) EPA may include requirements risk of injury to health or the environ-
and conditions in its approval of the ment, it will notify the submitter in
TERA that would be stated in the writing. To make this finding, EPA
TERA approval under paragraph (c) of may prescribe additional conditions
this section. which must be followed by the sub-
(4) If EPA concludes that it cannot mitter.
determine that the proposed research (ii) If EPA determines that it can no
and development activity described in longer conclude that the activity will
the TERA will not present an unrea- not present an unreasonable risk of in-
sonable risk of injury to health or the jury to health or the environment, it
environment, EPA will deny the TERA will notify the submitter in writing
and will provide reasons for the denial that EPA is revoking its approval and
in writing. state its reasons. In that event, the
(c) TERA approval. (1) A TERA ap- submitter must terminate the research
proval issued by EPA under this sec- and development activity within 48
tion is legally binding on the TERA hours of receipt of the notice in accord-
submitter. ance with directions provided by EPA
(2) When EPA approves a TERA, the in the notice.
submitter must conduct the research (b) Evidence of unreasonable risk. (1) If,
and development activity only as de- after approval of a TERA under this
scribed in the TERA and in accordance subpart, EPA determines that the pro-
with any requirements and conditions posed research and development activ-
prescribed by EPA in its approval of ity will present an unreasonable risk of
the TERA. injury to health or the environment,
(3) Any person who fails to conduct EPA will notify the submitter in writ-
the research and development activity ing and state its reasons.
as described in the TERA and in ac- (2) In the notice, EPA may prescribe
cordance with any requirements and additional safeguards to address or re-
conditions prescribed by EPA in its ap- duce the risk, or may instruct the sub-
proval of the TERA under this section, mitter to suspend the research and de-
shall be in violation of sections 5 and 15 velopment activities.
of the Act and be subject to civil and (3) Within 48 hours, the submitter
criminal penalties under section 16 of must implement the instructions con-
the Act. tained in the notice. The submitter
may then submit additional informa-
§ 725.288 Revocation or modification tion or arguments concerning the mat-
of TERA approval. ters raised by EPA and whether EPA
(a) Significant questions about risk. (1) should modify or revoke the approval
If, after approval of a TERA under this of the TERA in accordance with para-
subpart, EPA receives information graph (a)(2) of this section.
which raises significant questions (4) EPA will consider the information
about EPA’s determination that the and arguments in accordance with
activity does not present an unreason- paragraph (a)(3) of this section.
able risk of injury to health or the en- (5) Following consideration of the in-
vironment, EPA will notify the sub- formation and arguments under para-
mitter in writing of those questions. graph (a)(3) of this section, if EPA noti-
(2) The submitter may, within 10 fies the submitter that the R&D activ-
days of receipt of EPA’s notice, provide ity must be suspended or terminted,
in writing additional information or the submitter may resume the activity
arguments concerning the significance only upon written notice from EPA
of the questions and whether EPA that EPA has approved resumption of
should modify or revoke the approval the activity. In approving resumption
of the TERA. of an activity, EPA may prescribe addi-

(3) After considering any such infor- tional conditions which must be fol-
mation and arguments, EPA will de- lowed by the submitter.
59
§ 725.300 40 CFR Ch. I (7–1–17 Edition)
(c) Modifications. If, after approval of § 725.350 Procedural requirements for

a TERA under this subpart, the sub- this subpart.
mitter concludes that it is necessary to General requirements for all submis-
alter the conduct of the research and sions under this part are contained in
development activity in a manner subparts A through C of this part. In
which would result in the activity addition, the following requirements
being different from that described in apply to applications submitted under
the TERA agreement and any condi- this subpart:
tions EPA prescribed in its approval,
(a) Prenotice consultation. EPA
the submitter must inform the EPA
strongly suggests that for a TME, the
contact for the TERA and may not
applicant contact EPA for a prenotice
modify the activity without the ap-
consultation regarding eligibility for a
proval of EPA.
TME.
(b) When to submit a TME application.
Subpart F—Exemptions for Test Each person who is eligible to apply for
Marketing a TME under this subpart must submit
the application at least 45 calendar
§ 725.300 Scope and purpose. days before the person intends to com-
(a) This subpart describes exemptions mence the test marketing activity.
from the reporting requirements under (c) Recordkeeping. Each person who is
subpart D of this part for test mar- granted a TME must comply with the
keting activities involving microorga- recordkeeping requirements of § 725.65.
nisms. In addition, any person who obtains a
(b) In lieu of complying with subpart TME must retain documentation of
D of this part, persons described in compliance with any restrictions im-
§ 725.305 may submit an application for posed by EPA when it grants the TME.
a test marketing exemption (TME). This information must be retained for 3
(c) Submission requirements specific years from the final date of manufac-
for TME applications are described at ture or import under the exemption.
§ 725.350.
(d) Data requirements for TME appli- § 725.355 Information to be included in
cations are set forth in § 725.355. the TME application.
(e) EPA review procedures specific (a) To review a TME application,
for TMEs are set forth in § 725.370. EPA must have sufficient information
(f) Subparts A through C of this part to permit a reasoned evaluation of the
apply to any submission under this health and environmental effects of the
subpart. planned test marketing activity. The
person seeking EPA approval must sub-
§ 725.305 Persons who may apply mit all information known to or rea-
under this subpart. sonably ascertainable by the person on
A person identified in this section the microorganism and the test mar-
may apply for a test marketing exemp- keting activity, including information
tion. EPA may grant the exemption if not listed in paragraphs (c), (d), and (e)
the person demonstrates that the of this section that the person believes
microorganism will not present an un- will demonstrate that the microorga-
reasonable risk of injury to health or nism will not present an unreasonable
the environment as a result of the test risk of injury to health or the environ-
marketing. A person may apply under ment as a result of the test marketing.
this subpart for the following test mar- The TME application must be in writ-
keting activities: ing and must include at least the infor-
(a) A person who intends to manufac- mation described in paragraphs (b), (c),
ture or import for commercial purposes (d), and (e) of this section.
a new microorganism. (b) When specific information is not
(b) A person who intends to manufac- submitted, an explanation of why such
ture, import, or process for commercial information is not available or not ap-
purposes a microorganism identified in plicable must be included.

subpart M of this part for a significant (c) Persons applying for a TME must
new use. submit the submitter identification
60
and microorganism identity informa- Subpart G—General Exemptions

tion required for MCANs in § 725.155(c), for New Microorganisms
(d)(1), and (d)(2).
(d) Persons applying for a TME must § 725.400 Scope and purpose.
submit phenotypic and ecological char- (a) This subpart describes exemptions
acteristics information required in from reporting under subpart D of this
§ 725.155(d)(3) as it relates directly to part, and from review under this part
the conditions of the proposed test altogether, for manufacturing and im-
marketing activity. porting of certain new microorganisms
(e) Persons applying for a TME must for commercial purposes.
also submit the following information (b) Recipient microorganisms eligible
about the proposed test marketing ac- for the tiered exemption from review
tivity: under this part are listed in § 725.420.
(1) Proposed test marketing activity. (i) (c) Criteria for the introduced ge-
The maximum quantity of the micro- netic material contained in the new
organism which the applicant will microorganisms are described in
manufacture or import for test mar- § 725.421.
keting. (d) Physical containment and control
(ii) The maximum number of persons technologies are described in § 725.422.
who may be provided the microorga- (e) The conditions for the Tier I ex-
nism during test marketing. emption are listed in § 725.424.
(iii) The maximum number of persons (f) In lieu of complying with subpart
who may be exposed to the microorga- D of this part, persons using recipient
nism as a result of test marketing, in- microorganisms eligible for the tiered
cluding information regarding duration exemption may submit a Tier II ex-
and route of such exposures. emption request. The limited reporting
(iv) A description of the test mar- requirements for the Tier II exemption,
keting activity, including its duration including data requirements, are de-
and how it can be distinguished from scribed in §§ 725.450 and 725.455.
full-scale commercial production and (g) EPA review procedures for the
research and development activities. Tier II exemption are set forth in
(2) Health and environmental effects § 725.470.
data. All existing data regarding health (h) Subparts A through C of this part
and environmental effects of the apply to any submission under this
microorganism must be reported in ac- subpart.
cordance with § 725.160.
§ 725.420 Recipient microorganisms.
§ 725.370 EPA review of the TME appli- The following recipient microorga-
cation. nisms are eligible for either exemption
General procedures for review of all under this subpart:
submissions under this part are con- (a) Acetobacter aceti.
tained in §§ 725.28 through 725.60. In ad- (b) Aspergillus niger.
dition, the following procedures apply (c) Aspergillus oryzae.
to EPA review of TME applications (d) Bacillus licheniformis.
submitted under this subpart: (e) Bacillus subtilis.
(a) No later than 45 days after EPA (f) Clostridium acetobutylicum.
receives a TME, the Agency will either (g) Escherichia coli K-12.
approve or deny the application. (h) Penicillium roqueforti.
(b) A submitter may only proceed (i) Saccharomyces cerevisiae.
with test marketing activities after re- (j) Saccharomyces uvarum.
ceipt of EPA approval.
(c) In approving a TME application, § 725.421 Introduced genetic material.
EPA may impose any restrictions nec- For a new microorganism to qualify
essary to ensure that the microorga- for either exemption under this sub-
nism will not present an unreasonable part, introduced genetic material must
risk of injury to health and the envi- meet all of the criteria listed in this
ronment as a result of test marketing. section.
61
§ 725.421 40 CFR Ch. I (7–1–17 Edition)
(a) Limited in size. The introduced ge- section, capable of interacting with
netic material must consist only of the elongation factor 2, leading to inhibi-
following: tion of protein synthesis in target res-
(1) The structural gene(s) of interest. piratory, heart, kidney, and nerve tis-
(2) The regulatory sequences permit- sues. Indirectly contributes to toxic ef-
ting the expression of solely the gene(s) fects in humans means a sequence
of interest. whose encoded polypeptide is not di-
(3) Associated nucleotide sequences rectly toxic to target cells, yet still ad-
needed to move genetic material, in- versely affects humans. An example of
cluding linkers, homopolymers, adap- a sequence which indirectly contrib-
tors, transposons, insertion sequences, utes to toxic effects is the sequence
and restriction enzyme sites. which encodes the portion of the botu-
(4) The nucleotide sequences needed linum toxin, listed in paragraph (d)(3)
for vector transfer. of this section, capable of blocking the
(5) The nucleotide sequences needed release of acetylcholine from
for vector maintenance. gangliosides. Botulinum toxin affects
(b) Well-characterized. For introduced neuromuscular junctions by its block-
genetic material, well-characterized age of acetylcholine release, leading to
means that the following have been de- irreversible relaxation of muscles and
termined: respiratory arrest.
(1) The function of all of the products (B) It binds a toxin or toxin precursor
expressed from the structural gene(s). to target human cells.
(2) The function of sequences that (C) It facilitates intracellular trans-
participate in the regulation of expres- port of a toxin in target human cells.
sion of the structural gene(s). (ii) While these toxins are listed
(3) The presence or absence of associ- (with synonyms in parentheses) in
ated nucleotide sequences and their as- paragraphs (d)(2) through (d)(7) of this
sociated functions, where associated section according to the source orga-
nucleotide sequences are those se- nism, it is use of the nucleotide se-
quences needed to move genetic mate- quences that encode the toxins that is
rial including linkers, homopolymers, being restricted and not the use of the
adaptors, transposons, insertion se- source organisms. The source orga-
quences, and restriction enzyme sites. nisms are listed to provide specificity
(c) Poorly mobilizable. The ability of in identification of sequences whose
the introduced genetic material to be use is restricted. Although similar or
transferred and mobilized is inac- identical sequences may be isolated
tivated, with a resulting frequency of from organisms other than those listed
transfer of less than 10¥8 transfer below in paragraphs (d)(2) through
events per recipient. (d)(7) of this section, these comparable
(d) Free of certain sequences. (1) The toxin sequences, regardless of the orga-
introduced genetic material must not nism from which they are derived,
contain a functional portion of any of must not be included in the introduced
the toxin-encoding sequences described genetic material.
in this paragraph (d). (2) Sequences for protein synthesis in-
(i) For the purposes of this section, a hibitor.
functional portion of a toxin-encoding Sequence Source Toxin Name
sequence means any sequence which
codes for a polypeptide that has one of Corynebacterium diphtheriae Diphtheria toxin
& C. ulcerans
the following effects: Pseudomonas aeruginosa Exotoxin A
(A) It directly or indirectly contrib- Shigella dysenteriae Shigella toxin (Shiga toxin,
utes to toxic effects in humans. Di- Shigella dysenteriae type I
toxin, Vero cell toxin)
rectly contributes to toxic effects in Abrus precatorius, seeds Abrin
humans means those sequences encod- Ricinus communis, seeds Ricin
ing polypeptides that have direct tox-
(3) Sequences for neurotoxins.
icity to target cells. An example of a
sequence which directly contributes to Sequence Source Toxin Name
toxic effects in humans is one which Clostridium botulinum Neurotoxins A, B, C1, D, E,

encodes the portion of diphtheria F, G (Botulinum toxins,
toxin, listed in paragraph (d)(2) of this botulinal toxins)
62
Sequence Source Toxin Name Sequence Source Toxin Name
Clostridium tetani Tetanus toxin Clostridium bifermentans & Lecithinase

(tetanospasmin) other Clostridium spp
Proteus mirabilis Neurotoxin Clostridium perfringens Alpha-toxin (phospholipase
Staphylococcus aureus Alpha toxin (alpha lysin) C, lecithinase); Enterotoxin
Yersinia pestis Murine toxin Corynebacterium pyogenes & Cytolysin (phospholipase C),
other Corynebacterium spp. Ovis toxin
Snake toxins
(sphingomyelinase D)
Bungarus caeruleus Caeruleotoxin
Staphylococcus aureus Beta-lysin (beta toxin)
Bungarus multicinctus Beta-bungarotoxin
(phospholipase) (7) Sequences that are general
Crotalus spp. Crotoxin (phospholipase)
Dendroaspis viridis Neurotoxin
cytotoxins.
Naja naja varieties Neurotoxin Sequence Source Toxin Name
Notechia scutatus Notexin (phospholipase)
Oxyuranus scutellatus Taipoxin Adenia digitata Modeccin
Invertebrate toxins Aeromonas hydrophila Aerolysin (beta-lysin,
Chironex fleckeri Neurotoxin cytotoxic lysin)
Androctnus australis Neurotoxin Clostridium difficile Cytotoxin (toxin B)
Centruroides sculpturatus Neurotoxin Clostridium perfringens Beta-toxin; Epsilon-toxin;
Kappa-toxin
(4) Sequences for oxygen labile Escherichia coli & other Cytotoxin (Shiga-like toxin,
Enterobacteriaceae spp. Vero cell toxin)
cytolysins. Pseudomonas aeruginosa Proteases
Staphylococcus aureus Gamma lysin (Gamma toxin);
Sequence Source Toxin Name Enterotoxins (SEA, SEB,
SEC, SED SEE);
Bacillus alve Alveolysin
Pyrogenic exotoxins A B;
Bacillus cereus Cereolysin
Toxic shock syndrome tox-
Bacillus laterosporus Laterosporolysin
ins (TSST-1)
Bacillus thuringiensis Thuringiolysin Staphylococcus aureus & Leucocidin (leukocidin,
Clostridium bifermentans Lysin Pseudomonas aeruginosa cytotoxin)
Clostridium botulinum Lysin Streptococcus pyogenes Streptolysin S (SLS);
Clostridium caproicum Lysin Erythrogenic toxins (scarlet
Clostridium chauvoei Delta-toxin fever toxins, pyrogenic
Clostridium histolyticum Epsilon-toxin exotoxins)
Clostridium novyi Gamma-toxin Yersinia enterocolitica Heat-stable enterotoxins (ST)
Clostridium oedematiens Delta-toxin
Clostridium perfringens Theta-toxin (Perfringolysin) § 725.422 Physical containment and
Clostridium septicum Delta-toxin
Clostridium sordellii Lysin
control technologies.
Clostridium tetani Tetanolysin The manufacturer must meet all of
Listeria monocytogenes Listeriolysin (A B) the following criteria for physical con-
Streptococcus pneumoniae Pneumolysin
Streptococcus pyogene Streptolysin O (SLO) tainment and control technologies for
any facility in which the new micro-
(5) Sequences for toxins affecting mem- organism will be used for a Tier I ex-
brane function. emption; these criteria also serve as
Sequence Source Toxin Name guidance for a Tier II exemption.
(a) Use a structure that is designed
Bacillus anthracis Edema factor (Factors I II); and operated to contain the new micro-
Lethal factor (Factors II III)
Bacillus cereus Enterotoxin (diarrheagenic
organism.
toxin, mouse lethal factor) (b) Control access to the structure.
Bordetella pertussis Adenylate cyclase (Heat-la- (c) Provide written, published, and
bile factor); Pertussigen implemented procedures for the safety
(pertussis toxin, islet acti-
vating factor, histamine of personnel and control of hygiene.
sensitizing factor, (d) Use inactivation procedures dem-
lymphocytosis promoting onstrated and documented to be effec-
factor) tive against the new microorganism
Clostridium botulinum C2 toxin
Clostridium difficile Enterotoxin (toxin A) contained in liquid and solid wastes
Clostridium perfringens Beta-toxin; Delta-toxin prior to disposal of the wastes. The in-
Escherichia coli & other Heat-labile enterotoxins (LT); activation procedures must reduce via-
Enterobacteriaceae spp. Heat-stable enterotoxins
(STa, ST1 subtypes ST1a
ble microbial populations by at least 6
ST1b; also STb, STII) logs in liquid and solid wastes.
Legionella pneumophila Cytolysin (e) Use features known to be effective
Vibrio cholerae & Vibrio Cholera toxin (choleragen) in minimizing viable microbial popu-
mimicus
lations in aerosols and exhaust gases
(6) Sequences that affect membrane released from the structure, and docu-
integrity. ment use of such features.
63
§ 725.424 40 CFR Ch. I (7–1–17 Edition)
(f) Use systems for controlling dis- (3) The identification (genus, species)
semination of the new microorganism of the recipient microorganism listed
through other routes, and document in § 725.420 which is being used to create
use of such features. the new microorganism which will be
(g) Have in place emergency clean-up used under the conditions of the Tier I
procedures. exemption.
(4) Certification of the following:
§ 725.424 Requirements for the Tier I
exemption. (i) Compliance with the introduced
genetic material criteria described in
(a) Conditions of exemption. The manu- § 725.421.
facture or import of a new microorga- (ii) Compliance with the containment
nism for commercial purposes is not requirements described in § 725.422, in-
subject to review under this part if all cluding the provision in paragraph
of the following conditions are met for
(a)(3) of this section.
all activities involving the new micro-
organism: (5) The site of waste disposal and the
type of permits for disposal, the permit
(1) The recipient microorganism is
listed in and meets any requirements numbers and the institutions issuing
specified in § 725.420. the permits.
(2) The introduced genetic material (6) The certification statement re-
meets the criteria under § 725.421. quired in § 725.25(b). Certification of
(3) The physical containment and submission of test data is not required
control technologies of any facility in for the Tier I exemption.
which the microorganism will be man-
§ 725.426 Applicability of the Tier I ex-
ufactured, processed, or used meet the
emption.
criteria under § 725.422.
(4) The manufacturer or importer The Tier I exemption under § 725.424
submits a certification described in applies only to a manufacturer or im-
paragraph (b) of this section to EPA at porter of a new microorganism that
least 10 days before commencing initial certifies that the microorganism will
manufacture or import of a new micro- be used in all cases in compliance with
organism derived from a recipient §§ 725.420, 725.421, and 725.422.
microorganism listed in § 725.420.
(5) The manufacturer or importer § 725.428 Requirements for the Tier II
complies with the recordkeeping re- exemption.
quirements of § 725.65 and maintains The manufacturer or importer of a
records for the initial and subsequent new microorganism for commercial
uses of the new microorganism that purposes may submit to EPA a Tier II
verify compliance with the following: exemption request in lieu of a MCAN
(i) The certifications made in para- under subpart D of this part if all of
graph (b) of this section. the following conditions are met:
(ii) All the eligibility criteria for the (a) The recipient microorganism is
Tier I exemption including the criteria listed in and meets any requirements
for the recipient microorganism, the specified in § 725.420.
introduced genetic material, the phys-
(b) The introduced genetic material
ical containment and control tech-
nologies. meets the criteria under § 725.421.
(b) Certification. To be eligible for the (c) Adequate physical containment
Tier I exemption under this subpart, and control technologies are used. The
the manufacturer or importer must criteria listed under § 725.422 for phys-
submit to EPA a document signed by a ical containment and control tech-
responsible company official con- nologies of facilities should be used as
taining the information listed in this guidance to satisfy the Tier II exemp-
paragraph. tion request data requirements listed
(1) Name and address of manufac- at § 725.455(d). EPA will review proposed
turer or importer. process and containment procedures as

(2) Date when manufacture or import part of the submission for a Tier II ex-
is expected to begin. emption under this section.
64
§ 725.450 Procedural requirements for (2) The name, address, and office tele-
the Tier II exemption. phone number (including area code) of
General requirements for all submis- the principal technical contact rep-
sions under this part are contained in resenting the submitter.
§ 725.25. In addition, the following re- (b) Microorganism identity information.
quirements apply to requests sub- (1) Identification (genus, species, and
mitted under this subpart: strain) of the recipient microorganism.
Genus, species designation should be
(a) Prenotice consultation. EPA
substantiated by a letter from a cul-
strongly suggests that for a Tier II ex-
ture collection or a brief summary of
emption, the submitter contact the
the results of tests conducted for taxo-
Agency for a prenotice consultation re-
nomic identification.
garding eligibility for the exemption.
(2) Type of genetic modification and
(b) When to submit the Tier II exemp-
the function of the introduced genetic
tion request. Each person who is eligible
material.
to submit a Tier II exemption request
(3) Site of insertion.
under this subpart must submit the re-
(4) Certification of compliance with
quest at least 45 calendar days before
the introduced genetic material cri-
the person intends to commence manu-
teria described in § 725.421.
facture or import.
(c) Production volume. Production vol-
(c) Contents of the Tier II exemption re- ume, including total liters per year,
quest. Each person who submits a re- and the maximum cell concentration
quest under this subpart must provide achieved during the production proc-
the information described in §§ 725.428 ess.
and 725.455, as well as information (d) Process and containment informa-
known to or reasonably ascertainable tion. (1) A description of the process in-
by the person that would permit EPA cluding the following:
to determine that use of the micro- (i) Identity and location of the manu-
organism, under the conditions speci- facturing site(s).
fied in the request, will not present an (ii) Process flow diagram illustrating
unreasonable risk of injury to health the production process, including
or the environment. downstream separations, and indi-
(d) Recordkeeping. Each person who cating the containment envelope
submits a request under this subpart around the appropriate equipment.
must comply with the recordkeeping (iii) Identities and quantities of feed-
requirements of § 725.65. In addition, stocks.
the submitter should maintain records (iv) Sources and quantities of poten-
which contain information that tial releases to both the workplace and
verifies compliance with the following: environment, and a description of engi-
(1) The certifications made in the re- neering controls, inactivation proce-
quest. dures, and other measures which will
(2) All the eligibility criteria for the reduce worker exposure and environ-
Tier II exemption request including the mental releases.
criteria for the recipient microorga- (v) A description of procedures which
nism, the introduced genetic material, will be undertaken to prevent fugitive
the physical containment and control emissions, i.e. leak detection and re-
technologies. pair program.
(vi) A description of procedures/safe-
§ 725.455 Information to be included in guards to prevent and mitigate acci-
the Tier II exemption request.
dental releases to the workplace and
The submitter must indicate clearly the environment.
that the submission is a Tier II exemp- (2) Certification of those elements of
tion request for a microorganism in- the containment criteria described in
stead of the MCAN under subpart D of § 725.422 with which the manufacturer
this part and must submit the fol- is in compliance, including stating by
lowing information: number the elements with which the
(a) Submitter identification. (1) The manufacturer is in full compliance.

name and headquarters address of the (e) The site of waste disposal and the
submitter. type of permits for disposal, the permit
65
§ 725.470 40 CFR Ch. I (7–1–17 Edition)
numbers and the institutions issuing (3) If the request is denied, the manu-
the permits. facturer or importer may submit the
(f) The certification statement re- information necessary to constitute a
quired in § 725.25(b). Certification of MCAN under subpart D of this part.
submission of test data is not required (e) Approval or denial of the Tier II ex-
for the Tier II exemption. emption request. (1) No later than 45
days after EPA receives a request, the
§ 725.470 EPA review of the Tier II ex-
emption request. Agency will either approve or deny the
request.
General procedures for review of all (2) In approving a request, EPA may
submissions under this part are con- impose any restrictions necessary to
tained in §§ 725.28 through 725.60. In ad-
ensure that the microorganism will not
dition, the following procedures apply
present an unreasonable risk of injury
to EPA review of Tier II exemption re-
to health and the environment as a re-
quests submitted under this subpart:
(a) Length of the review period. The result of general commercial use.
view period for the request will be 45 (f) EPA may seek to enjoin the man-
days from the date the Document Con- ufacture or import of a microorganism
trol Officer for the Office of Pollution in violation of this subpart, or act to
Prevention and Toxics receives a com- seize any microorganism manufactured
plete request, or the date EPA deter- or imported in violation of this section
mines the request is complete under or take other actions under the author-
§ 725.33, unless the Agency extends the ity of sections 7 or 17 of the Act.
review period for good cause under (g) A manufacturer or importer may
§ 725.56. only proceed after receipt of EPA ap-
(b) Criteria for review. EPA will review proval.
the request to determine that the new
microorganism complies with § 725.428 Subparts H–K [Reserved]
and that its manufacture, processing,
use, and disposal as described in the re-
quest will not present an unreasonable Subpart L—Additional Procedures
risk of injury to health or the environ- for Reporting on Significant
ment. New Uses of Microorganisms
(c) EPA decision regarding the Tier II
exemption request. A decision con- § 725.900 Scope and purpose.
cerning a request under this subpart (a) This subpart describes additional
will be made by the Administrator, or provisions governing submission of
a designee. MCANs for microorganisms subject to
(d) Determination that the microorga- significant new use rules identified in
nism is ineligible for a Tier II review. (1) subpart M of this part.
EPA may determine that the manufac- (b) Manufacturers, importers, and
turer or importer is not eligible for processors described in § 725.105(c) must
Tier II review, because the microorga-
submit a MCAN under subpart D of this
nism does not meet the criteria under
part for significant new uses of micro-
§ 725.428 or the Administrator, or a des-
organisms described in subpart M of
ignee, decides that there is insufficient
this part, unless they are excluded
information to determine that the con-
under § 725.910 or § 725.912.
ditions of manufacture, processing,
use, or disposal of the microorganism (c) Section 725.920 discusses exports
as described in the request will not and imports.
present an unreasonable risk to health (d) Additional recordkeeping require-
or the environment. ments specific to significant new uses
(2) If the Agency makes this deter- of microorganisms are described in
mination, the Administrator, or a des- § 725.950.
ignee will notify the manufacturer or (e) Section 725.975 describes how EPA
importer by telephone, followed by a will approve alternative means of com-
letter, that the request has been de- plying with significant new use re-
nied. The letter will explain reasons for quirements designated in subpart M of
the denial. this part.
66
(f) Expedited procedures for promul- (3) That the recipient cannot under-
gating significant new use require- take any significant new use described
ments under subpart M of this part for in the specific section in subpart M of
microorganisms subject to section 5(e) this part.
orders are discussed in §§ 725.980 and (b) The manufacturer, importer, or
725.984. processor described in paragraph (a) of
(g) This subpart L contains provi- this section must submit a MCAN
sions governing submission and review under subpart D of this part, if such
of notices for the microorganisms and person has knowledge at the time of
significant new uses identified in sub- commercial distribution of the micro-
part M of this part. The provisions of organism identified in the specific sec-
this subpart L apply to the microorga- tion in subpart M of this part that a re-
nisms and significant new uses identi- cipient intends to engage in a des-
fied in subpart M of this part, except to ignated significant new use of that
the extent that they are specifically microorganism without submitting a
modified or supplanted by specific re- MCAN under this part.
quirements in subpart M of this part. (c) A person who processes a micro-
In the event of a conflict between the organism identified in a specific sec-
provisions of this subpart L and the tion in subpart M of this part for a sig-
provisions of subpart M of this part, nificant new use of that microorganism
the provisions of subpart M of this part is not required to submit a MCAN if
shall govern. that person can document each of the
(h) The provisions of subparts A following:
through F of this part also apply to (1) That the person does not know the
subparts L and M of this part. For pur- specific microorganism identity of the
poses of subparts L and M of this part, microorganism being processed, and
wherever the words ‘‘microorganism’’ (2) That the person is processing the
or ‘‘new microorganism’’ appear in sub- microorganism without knowledge
parts A through F of this part, it shall that the microorganism is identified in
mean the microorganism subject to subpart M of this part.
subparts L and M of this part. In the (d)(1) If at any time after com-
event of a conflict between the provi- mencing distribution in commerce of a
sions of subparts A through F and the microorganism identified in a specific
provisions of subparts L and M of this section in subpart M of this part, a per-
part, the provisions of subparts L and son who manufactures, imports, or
M of this part shall govern. processes a microorganism described in
subpart M of this part and distributes
§ 725.910 Persons excluded from re- it in commerce has knowledge that a
porting significant new uses.
recipient of the microorganism is en-
(a) A person who intends to manufac- gaging in a significant new use of that
ture, import, or process a microorga- microorganism designated in that sec-
nism identified in subpart M of this tion without submitting a MCAN under
part and who intends to distribute it in this part, the person is required to
commerce is not required to submit a cease supplying the microorganism to
MCAN under subpart D of this part, if that recipient and to submit a MCAN
that person can document one or more for that microorganism and significant
of the following as to each recipient of new use, unless the person is able to
the microorganism from that person: document each of the following:
(1) That the person has notified the (i) That the person has notified the
recipient, in writing, of the specific recipient and EPA enforcement au-
section in subpart M of this part which thorities (at the address in paragraph
identifies the microorganism and its (d)(1)(iii) of this section), in writing
designated significant new uses, or within 15 working days of the time the
(2) That the recipient has knowledge person develops knowledge that the re-
of the specific section in subpart M of cipient is engaging in a significant new
this part which identifies the micro- use, that the recipient is engaging in a
organism and its designated significant significant new use without submitting
new uses, or a MCAN.
67
§ 725.912 40 CFR Ch. I (7–1–17 Edition)
(ii) That, within 15 working days of § 725.912 Exemptions.

notifying the recipient as described in
Persons identified in § 725.105(c) are
paragraph (d)(1)(i) of this section, the
person received from the recipient, in not required to submit a MCAN under
writing, a statement of assurance that subpart D of this part for a microorga-
the recipient is aware of the terms of nism identified in subpart M of this
the applicable section in subpart M of part, unless otherwise specified in a
this part and will not engage in the sig- specific section in subpart M, if:
nificant new use. (a) The person submits a MCAN for
(iii) That the person has promptly the microorganism prior to the pro-
provided EPA enforcement authorities mulgation date of the section in sub-
with a copy of the recipient’s state- part M of this part which identifies the
ment of assurance described in para- microorganism, and the person re-
graph (d)(1)(ii) of this section. The copy ceives written notification of compli-
must be sent to the Director, Office of ance from EPA prior to the effective
Compliance (2221A), Environmental date of such section. The MCAN sub-
Protection Agency, 1200 Pennsylvania mitter must comply with any applica-
Ave., NW., Washington, DC 20460. ble requirement of section 5(b) of the
(2) If EPA notifies the manufacturer, Act. The MCAN must include the infor-
importer, or processor that the recipi- mation and test data specified in sec-
ent is engaging in a significant new use tion 5(d)(1) of the Act. For purposes of
after providing the statement of assur- this exemption, the specific section in
ance described in paragraph (d)(1)(ii) of
subpart M of this part which identifies
this section and without submitting a
the microorganism and §§ 725.3, 725.15,
MCAN under this part, the manufac-
turer, importer, or processor shall im- 725.65, 725.70, 725.75, 725.100, and 725.900
mediately cease distribution to that reapply; after the effective date of the
cipient until the manufacturer, im- section in subpart M of this part which
porter, or processor or the recipient identifies the microorganism, §§ 725.105
has submitted a MCAN under this part and 725.910 apply and § 725.920 continues
and the MCAN review period has ended. to apply. EPA will provide the MCAN
(3) If, after receiving a statement of submitter with written notification of
assurance from a recipient under para- compliance only if one of the following
graph (d)(1)(ii) of this section, a manu- occurs:
facturer, importer, or processor has (1) EPA is unable to make the finding
knowledge that the recipient is engag- that the activities described in the
ing in a significant new use without MCAN will or may present an unrea-
submitting a MCAN under this part, sonable risk of injury to health or the
the manufacturer, importer, or proc- environment under reasonably foresee-
essor must immediately cease distrib- able circumstances, or
uting the microorganism to that re- (2) EPA and the person negotiate a
cipient and notify EPA enforcement consent order under section 5(e) of the
authorities at the address identified in Act, such order to take effect on the ef-
paragraph (d)(1)(iii) of this section. The fective date of the section in subpart M
manufacturer, importer, or processor
of this part which identifies the micro-
may not resume distribution to that
organism.
recipient until any one of the following
has occurred: (b) The person is operating under the
(i) The manufacturer, importer, or terms of a consent order issued under
processor has submitted a MCAN under section 5(e) of the Act applicable to
this part and the MCAN review period that person. If a provision of such sec-
has ended. tion 5(e) order is inconsistent with a
(ii) The recipient has submitted a specific significant new use identified
MCAN under this part and the MCAN in subpart M of this part, abiding by
review period has ended. the provision of the section 5(e) order
(iii) The manufacturer, importer, or exempts the person from submitting a
processor has received notice from EPA MCAN for that specific significant new
enforcement authorities that it may use.
resume distribution to that recipient.
68
§ 725.920 Exports and imports. tity of the microorganism sold or

(a) Exports. Persons who intend to ex- transferred on such date.
port a microorganism identified in sub- § 725.975 EPA approval of alternative
part M of this part, or in any proposed control measures.
rule which would amend subpart M of
this part, are subject to the export no- (a) In certain sections of subpart M of
tification provisions of section 12(b) of this part, significant new uses for the
the Act. The regulations that interpret identified microorganisms are de-
section 12(b) appear at part 707 of this scribed as the failure to establish and
chapter. implement programs providing for the
(b) Imports. Persons who import a use of either: specific measures to con-
substance identified in a specific sec- trol worker exposure to or release of
tion in subpart M of this part are sub- microorganisms which are identified in
ject to the import certification re- such sections, or alternative measures
quirements under section 13 of the Act, to control worker exposure or environ-
which are codified at 19 CFR §§ 12.118 mental release which EPA has deter-
through 12.127 and 127.28(i). The EPA mined provide substantially the same
policy in support of the import certifi- degree of protection as the specified
cation requirements appears at part 707 control measures. Persons who manu-
of this chapter. facture, import, or process a micro-
organism identified in such sections
§ 725.950 Additional recordkeeping re- and who intend to employ alternative
quirements. measures to control worker exposure
Persons submitting a MCAN for a or environmental release must submit
significant new use of a microorganism a request to EPA for a determination
must comply with the recordkeeping of equivalency before commencing
requirements of § 725.65. In addition, manufacture, import, or processing in-
the following requirements apply: volving the alternative control meas-
(a) At the time EPA adds a micro- ures.
organism to subpart M of this part, (b) Persons submitting a request for
EPA may specify appropriate record- a determination of equivalency to EPA
keeping requirements. Each manufac- under this part must submit the re-
turer, importer, and processor of the quest to EPA (via CDX) using e-PMN
microorganism shall maintain the software. See 40 CFR 720.40(a)(2)(ii) for
records for 3 years from the date of information on how to obtain e-PMN
their creation. software. Support documents related to
(b) The records required to be main- these requests must also be submitted
tained under this section may include to EPA via CDX using e-PMN software.
the following: A request for a determination of
(1) Records documenting the informa- equivalency must contain:
tion contained in the MCAN submitted (1) The name of the submitter.
to EPA. (2) The specific identity of the micro-
(2) Records documenting the manu- organism.
facture and importation volume of the (3) The citation for the specific sec-
microorganism and the corresponding tion in subpart M of this part which
dates of manufacture and import. pertains to the microorganism for
(3) Records documenting volumes of which the request is being submitted.
the microorganism purchased domesti- (4) A detailed description of the ac-
cally by processors of the microorga- tivities involved.
nism, names and addresses of suppliers (5) The specifications of the alter-
and corresponding dates of purchase. native worker exposure control meas-
(4) Records documenting the names ures or environmental release control
and addresses (including shipment des- measures.
tination address, if different) of all per- (6) A detailed analysis explaining
sons outside the site of manufacture or why such alternative control measures
import to whom the manufacturer, im- provide substantially the same degree
porter, or processor directly sells or of protection as the specific control

transfers the microorganism, the date measures identified in the specific sec-
of each sale or transfer, and the quan- tion in subpart M of this part which
69
§ 725.980 40 CFR Ch. I (7–1–17 Edition)
pertains to the microorganism for cation requirements are not needed for
which the request is being submitted. the microorganism.
(7) The data and information de- (2) If EPA determines that signifi-
scribed in §§ 725.155 and 725.160. If such cant new use notifications require-
data and information have already ments are not needed for a microorga-
been submitted to EPA’s Office of Pol- nism that is subject to a final order
lution Prevention and Toxics, the sub- issued under section 5(e) of the Act,
mitter need only document that it was EPA will issue a notice in the FEDERAL
previously submitted, to whom, and REGISTER explaining why the signifi-
the date it was submitted. cant new use requirements are not
(c) Requests for determinations of needed.
equivalency will be reviewed by EPA (b) Designation of requirements. (1) The
within 45 days. Determinations under significant new use notification and
this paragraph will be made by the Di- other specific requirements will be
rector, or a designee. Notice of the re- based on and be consistent with the
sults of such determinations will be provisions included in the final order
mailed to the submitter. issued for the microorganism under
(d) If EPA notifies the submitter section 5(e) of the Act. EPA may also
under paragraph (c) of this section that designate additional activities as sig-
EPA has determined that the alter- nificant new uses which will be subject
native control measures provide sub- to notification.
stantially the same degree of protec- (2) Significant new use requirements
tion as the specified control measures and other specific requirements des-
identified in the specific section of sub- ignated under this section will be listed
part M of this part which pertains to in subpart M of this part. For each
the microorganism for which the re- microorganism, subpart M of this part
quest is being submitted, the submitter will identify:
may commence manufacture, import, (i) The microorganism name.
or processing in accordance with the (ii) The activities designated as sig-
specifications for alternative worker nificant new uses.
exposure control measures or environ- (iii) Other specific requirements ap-
mental release control measures iden- plicable to the microorganism, includ-
tified in the submitter’s request, and ing recordkeeping requirements or any
may alter any corresponding notifica- other requirements included in the
tion to workers to reflect such alter- final section 5(e) order.
native controls. Deviations from the (c) Procedures for issuing significant
activities described in the EPA notifi- new use rules—(1) Possible processes.
cation constitute a significant new use EPA will issue significant new use
and are subject to the requirements of rules (SNURs) under this section by
this part. one of the following three processes: di-
[62 FR 17932, Apr. 11, 1997, as amended at 75 rect final rulemaking, interim final
FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013] rulemaking, or notice and comment
rulemaking. EPA will use the direct
§ 725.980 Expedited procedures for final rulemaking process to issue sig-
issuing significant new use rules for nificant new use rules unless it deter-
microorganisms subject to section mines that, in a particular case, one of
5(e) orders. the other processes is more appro-
(a) Selection of microorganisms. (1) In priate.
accordance with the expedited process (2) Notice in the Federal Register. FED-
specified in this section, EPA will issue ERAL REGISTER documents issued to
significant new use notification re- propose or establish significant new
quirements for each new microorga- uses under this section will contain the
nism that, after MCAN review under following:
subpart D of this part, becomes subject (i) The microorganism identity or, if
to a final order issued under section its specific identity is claimed con-
5(e) of the Act, except for an order that fidential, an appropriate generic micro-
prohibits manufacture and import of organism name and an accession num-

the microorganism, unless EPA deter- ber assigned by EPA.
mines that significant new use notifi- (ii) The MCAN number.
70
(iii) A summary of EPA’s findings tablish notification requirements

under section 5(e)(1)(A) of the Act for under this section, EPA will issue a
the final order issued under section final rule adding the microorganism to
5(e). subpart M of this part and designating
(iv) Designation of the significant the significant new uses subject to no-
new uses subject to, or proposed to be tification.
subject to, notification and any other (4) Interim final rulemaking. (i) EPA
applicable requirements. will use the interim final rulemaking
(v) Any modification of subpart L of procedure to issue a significant new
this part applicable to the specific use rule, when specific requirements
microorganism and significant new will be based on and be consistent with
uses. the provisions included in the final
(vi) If the FEDERAL REGISTER docu- order issued for the microorganism
ment establishes a final rule, or noti- under section 5(e) of the Act. The
fies the public that a final rule will not Agency will issue an interim final rule
be issued after public comment has in the FEDERAL REGISTER following its
been received, the document will de- decision to develop a significant new
scribe comments received and EPA’s use rule for a specific new microorga-
response. nism. The document will state EPA’s
(3) Direct final rulemaking. (i) EPA reasons for using the interim final
will use direct final rulemaking to rulemaking procedure.
issue a significant new use rule, when (A) The significant new use rule will
specific requirements will be based on take effect on the date of publication.
and be consistent with the provisions (B) Persons will be given 30 days from
included in the final order issued for the date of publication to submit com-
the microorganism under section 5(e) ments.
of the Act. EPA will issue a final rule (ii) Interim final rules issued under
in the FEDERAL REGISTER following its this section shall cease to be in effect
decision to develop a significant new 180 days after publication unless, with-
use rule under this section for a spe- in the 180–day period, EPA issues a
cific new microorganism. final rule in the FEDERAL REGISTER re-
(ii) The FEDERAL REGISTER document sponding to any written comments re-
will state that, unless written notice is ceived during the 30–day comment pe-
received by EPA within 30 days of pub- riod specified in paragraph (c)(4)(i)(B)
lication that someone wishes to submit of this section and promulgating final
adverse or critical comments, the rule significant new use notification re-
will be effective 60 days from the date quirements and other requirements for
of publication. The written notice of the microorganism.
intent to submit adverse or critical (5) Notice and comment rulemaking. (i)
comments should state which SNUR(s) EPA will use a notice and comment
will be the subject of the adverse or procedure to issue a significant new
critical comments, if several SNURs use rule, when EPA is designating addi-
are established through the direct final tional activities which are not provi-
rule. If notice is received within 30 sions included in the final order issued
days that someone wishes to submit for the microorganism under section
adverse or critical comments, the sec- 5(e) of the Act as significant new uses
tion(s) of the direct final rule con- which will be subject to notification.
taining the SNUR(s) for which a notice EPA will issue a proposal in the FED-
of intent to comment was received will ERAL REGISTER following its decision to
be withdrawn by EPA issuing a docu- develop a significant new use rule
ment in the final rule section of the under this section for a specific new
FEDERAL REGISTER, and a proposal will microorganism. Persons will be given
be published in the proposed rule sec- 30 days to comment on whether EPA
tion of the FEDERAL REGISTER. The pro- should establish notification require-
posal will establish a 30–day comment ments for the microorganism under
period. this part.
(iii) If EPA, having considered any (ii) If EPA, having considered any
timely comments submitted in re- timely comments, decides to establish
sponse to the proposal, decides to es- notification requirements under this
71
§ 725.984 40 CFR Ch. I (7–1–17 Edition)
section, EPA will issue a final rule add- tional basis no longer exists for the
ing the microorganism to subpart M of findings that activities involving the
this part and designating the signifi- microorganism may present an unrea-
cant new uses subject to notification. sonable risk of injury to health or the
(d) Schedule for issuing significant new environment required under section
use rules. (1) Unless EPA determines 5(e)(1)(A) of the Act.
that a significant new use rule should (5) Certain activities involving the
not be issued under this section, EPA microorganism have been designated as
will issue a proposed rule, a direct final significant new uses pending the com-
rule, or an interim final rule within 180 pletion of testing, and adequate test
days of receipt of a valid notice of com-
data developed in accordance with ap-
mencement under § 725.190.
plicable procedures and criteria have
(2) If EPA receives adverse or critical
significant comments following publi- been submitted to EPA.
cation of a proposed or interim final (b) Procedures for limitation or revoca-
rule, EPA will either withdraw the rule tion. Modification or revocation of sig-
or issue a final rule addressing the nificant new use notification require-
comments received. ments for a microorganism that has
been added to subpart M of this part
§ 725.984 Modification or revocation of using the procedures described in
certain notification requirements. § 725.980 may occur either at EPA’s ini-
(a) Criteria for modification or revoca- tiative or in response to a written re-
tion. EPA may at any time modify or quest.
revoke significant new use notification (1) Any affected person may request
requirements for a microorganism modification or revocation of signifi-
which has been added to subpart M of cant new use notification requirements
this part using the procedures of for a microorganism that has been
§ 725.980. Such action may be taken added to subpart M of this part using
under this section if EPA makes one of the procedures described in § 725.980.
the following determinations, unless The request must be accompanied by
other information shows that the re- information sufficient to support the
quirements should be retained:
request. Persons submitting a request
(1) Test data or other information ob-
to EPA under this part must submit
tained by EPA provide a reasonable
the request to EPA (via CDX) using e-
basis for concluding that activities des-
ignated as significant new uses of the PMN software. See 40 CFR
microorganism will not present an un- 720.40(a)(2)(ii) for information on how
reasonable risk of injury to health or to obtain e-PMN software. Support
the environment. documents related to these requests
(2) EPA has promulgated a rule under must also be submitted to EPA via
section 4 or 6 of the Act, or EPA or an- CDX using e-PMN software.
other agency has taken action under (2) The Director, or a designee, will
another law, for the microorganism consider the request, make a deter-
that eliminates the need for significant mination whether to initiate rule-
new use notification under section making to modify the requirements,
5(a)(2) of the Act. and notify the requester of that deter-
(3) EPA has received MCANs for some mination by certified letter. If the re-
or all of the activities designated as quest is denied, the letter will explain
significant new uses of the microorga- why EPA has concluded that the sig-
nism and, after reviewing such MCANs, nificant new use notification require-
concluded that there is no need to re- ments for that microorganism should
quire additional notice from persons remain in effect.
who propose to engage in identical or (3) If EPA concludes that significant
similar activities.
new use notification requirements for a
(4) EPA has examined new informa-
microorganism should be limited or re-
tion, or has reexamined the test data
or other information supporting its voked, EPA will propose the changes in
finding under section 5(e)(1)(A)(ii)(I) of a notice in the FEDERAL REGISTER,
the Act and has concluded that a ra-
72
briefly describe the grounds for the ac- 745.84 Information distribution require-
tion, and provide interested parties an ments.
opportunity to comment. 745.85 Work practice standards.
745.86 Recordkeeping and reporting require-
[62 FR 17932, Apr. 11, 1997, as amended at 75 ments.
FR 790, Jan. 6, 2010; 78 FR 72828, Dec. 4, 2013] 745.87 Enforcement and inspections.
745.88 Recognized test kits.
745.89 Firm certification.
Subpart M—Significant New Uses 745.90 Renovator certification and dust
for Specific Microorganisms sampling technician certification.
745.91 Suspending, revoking, or modifying
§ 725.1000 Scope. an individual’s or firm’s certification.
This subpart identifies uses of micro- 745.92 Fees for the accreditation of renova-
organisms which EPA has determined tion and dust sampling technician train-
ing and the certification of renovation
to be significant new uses under the firms.
authority of section 5(a)(2) of the Toxic
Substances Control Act. Subpart F—Disclosure of Known Lead-
Based Paint and/or Lead-Based Paint
§ 725.1075 Burkholderia cepacia com-
plex. Hazards Upon Sale or Lease of Resi-
dential Property
(a) Microorganism and significant new
uses subject to reporting. (1) The micro- 745.100 Purpose.
organisms identified as the 745.101 Scope and applicability.
745.102 Effective dates.
Burkholderia cepacia complex defined as
745.103 Definitions.
containing the following nine species, 745.107 Disclosure requirements for sellers
Burkholderia cepacia, Burkholderia and lessors.
multivorans, Burkholderia stabilis, 745.110 Opportunity to conduct an evalua-
Burkholderia vietnamiensis, Burkholderia tion.
ambifaria, Burkholderia pyrrocinia, 745.113 Certification and acknowledgment
Burkholderia cepacia genomovar VIII of disclosure.
(Burkholderia anthina), and 745.115 Agent responsibilities.
745.118 Enforcement.
Burkholderia cepacia genomovars III
745.119 Impact on State and local require-
and VI are subject to reporting under ments.
this section for the significant new
uses described in paragraph (a)(2) of Subparts G–K [Reserved]
this section.
(2) The significant new use is any use Subpart L—Lead-Based Paint Activities
other than research and development
745.220 Scope and applicability.
in the degradation of chemicals via in- 745.223 Definitions.
jection into subsurface groundwater. 745.225 Accreditation of training programs:
(b) [Reserved] target housing and child-occupied facili-
ties.
[68 FR 35320, June 13, 2003]
745.226 Certification of individuals and
firms engaged in lead-based paint activi-
PART 745—LEAD-BASED PAINT POI- ties: target housing and child-occupied
SONING PREVENTION IN CER- facilities.
745.227 Work practice standards for con-
TAIN RESIDENTIAL STRUCTURES ducting lead-based paint activities: tar-
get housing and child-occupied facilities.
Subparts A–C [Reserved] 745.228 Accreditation of training programs:
public and commercial buildings, bridges
Subpart D—Lead-Based Paint Hazards and superstructures. [Reserved]
Sec. 745.229 Certification of individuals and
745.61 Scope and applicability. firms engaged in lead-based paint activi-
745.63 Definitions. ties: public and commercial buildings,
745.65 Lead-based paint hazards. bridges and superstructures. [Reserved]
745.230 Work practice standards for con-
Subpart E—Residential Property Renovation ducting lead-based paint activities: pub-
lic and commercial buildings, bridges
745.80 Purpose. and superstructures. [Reserved]

745.81 Effective dates. 745.233 Lead-based paint activities require-
745.82 Applicability. ments.
745.83 Definitions. 745.235 Enforcement.
73
§ 745.61 40 CFR Ch. I (7–1–17 Edition)
745.237 Inspections. mouth or chew. A chewable surface is
745.238 Fees for accreditation and certifi- the same as an ‘‘accessible surface’’ as
cation of lead-based paint activities. defined in 42 U.S.C. 4851b(2)). Hard
745.239 Effective dates.
metal substrates and other materials
Subparts M–P [Reserved] that cannot be dented by the bite of a
young child are not considered
Subpart Q—State and Indian Tribal chewable.
Programs Common area group means a group of
common areas that are similar in de-
745.323 Definitions.
sign, construction, and function. Com-
745.324 Authorization of State or Tribal pro- mon area groups include, but are not
grams. limited to hallways, stairwells, and
745.325 Lead-based paint activities: State laundry rooms.
and Tribal program requirements. Concentration means the relative con-
745.326 Renovation: State and Tribal pro- tent of a specific substance contained
gram requirements. within a larger mass, such as the
745.327 State or Indian Tribal lead-based
paint compliance and enforcement pro-
amount of lead (in micrograms per
grams. gram or parts per million by weight) in
745.339 Effective date. a sample of dust or soil.
Deteriorated paint means any interior
AUTHORITY: 15 U.S.C. 2605, 2607, 2681–2692
and 42 U.S.C. 4852d. or exterior paint or other coating that
is peeling, chipping, chalking or crack-
SOURCE: 61 FR 9085, Mar. 6, 1996, unless oth- ing, or any paint or coating located on
erwise noted.
an interior or exterior surface or fix-
ture that is otherwise damaged or sepa-
Subparts A–C [Reserved] rated from the substrate.
Dripline means the area within 3 feet
Subpart D—Lead-Based Paint surrounding the perimeter of a build-
Hazards ing.
Friction surface means an interior or
SOURCE: 66 FR 1237, Jan. 5, 2001, unless oth- exterior surface that is subject to abra-
erwise noted. sion or friction, including, but not lim-
ited to, certain window, floor, and stair
§ 745.61 Scope and applicability. surfaces.
(a) This subpart identifies lead-based Impact surface means an interior or
paint hazards. exterior surface that is subject to dam-
(b) The standards for lead-based paint age by repeated sudden force such as
hazards apply to target housing and certain parts of door frames.
child-occupied facilities. Interior window sill means the portion
(c) Nothing in this subpart requires of the horizontal window ledge that
the owner of property(ies) subject to protrudes into the interior of the room.
these standards to evaluate the prop- Lead-based paint hazard means haz-
erty(ies) for the presence of lead-based ardous lead-based paint, dust-lead haz-
paint hazards or take any action to ard or soil-lead hazard as identified in
control these conditions if one or more § 745.65.
of them is identified. Loading means the quantity of a spe-
cific substance present per unit of sur-
§ 745.63 Definitions. face area, such as the amount of lead in
The following definitions apply to micrograms contained in the dust col-
part 745. lected from a certain surface area di-
Arithmetic mean means the algebraic vided by the surface area in square feet
sum of data values divided by the num- or square meters.
ber of data values (e.g., the sum of the Mid-yard means an area of a residen-
concentration of lead in several soil tial yard approximately midway be-
samples divided by the number of sam- tween the dripline of a residential
ples). building and the nearest property
Chewable surface means an interior or boundary or between the driplines of a

exterior surface painted with lead- residential building and another build-
based paint that a young child can ing on the same property.
74
Play area means an area of frequent μg/ft2 is 100 μg/ft2. This result is based
soil contact by children of less than 6 on the equation [60 + (3*100) + (4*110)]/
years of age as indicated by, but not (1 + 3 + 4).
limited to, such factors including the Window trough means, for a typical
following: the presence of play equip- double-hung window, the portion of the
ment (e.g., sandboxes, swing sets, and exterior window sill between the inte-
sliding boards), toys, or other chil- rior window sill (or stool) and the
dren’s possessions, observations of play frame of the storm window. If there is
patterns, or information provided by no storm window, the window trough is
parents, residents, care givers, or prop- the area that receives both the upper
erty owners. and lower window sashes when they are
Residential building means a building both lowered. The window trough is
containing one or more residential sometimes referred to as the window
dwellings. ‘‘well.’’
Room means a separate part of the in- Wipe sample means a sample collected
side of a building, such as a bedroom, by wiping a representative surface of
living room, dining room, kitchen, known area, as determined by ASTM
bathroom, laundry room, or utility E1728, ‘‘Standard Practice for Field
room. To be considered a separate Collection of Settled Dust Samples
room, the room must be separated from Using Wipe Sampling Methods for Lead
adjoining rooms by built-in walls or Determination by Atomic Spectrom-
archways that extend at least 6 inches etry Techniques, or equivalent method,
from an intersecting wall. Half walls or with an acceptable wipe material as de-
bookcases count as room separators if fined in ASTM E 1792, ‘‘Standard Speci-
built-in. Movable or collapsible parti- fication for Wipe Sampling Materials
tions or partitions consisting solely of for Lead in Surface Dust.’’
shelves or cabinets are not considered
built-in walls. A screened in porch that § 745.65 Lead-based paint hazards.
is used as a living area is a room.
(a) Paint-lead hazard. A paint-lead
Soil sample means a sample collected
hazard is any of the following:
in a representative location using
ASTM E1727, ‘‘Standard Practice for (1) Any lead-based paint on a friction
Field Collection of Soil Samples for surface that is subject to abrasion and
Lead Determination by Atomic Spec- where the lead dust levels on the near-
trometry Techniques,’’ or equivalent est horizontal surface underneath the
method. friction surface (e.g., the window sill,
Weighted arithmetic mean means the or floor) are equal to or greater than
arithmetic mean of sample results the dust-lead hazard levels identified in
weighted by the number of subsamples paragraph (b) of this section.
in each sample. Its purpose is to give (2) Any damaged or otherwise dete-
influence to a sample relative to the riorated lead-based paint on an impact
surface area it represents. A single sur- surface that is caused by impact from a
face sample is comprised of a single related building component (such as a
subsample. A composite sample may door knob that knocks into a wall or a
contain from two to four subsamples of door that knocks against its door
the same area as each other and of frame.
each single surface sample in the com- (3) Any chewable lead-based painted
posite. The weighted arithmetic mean surface on which there is evidence of
is obtained by summing, for all sam- teeth marks.
ples, the product of the sample’s result (4) Any other deteriorated lead-based
multiplied by the number of subsam- paint in any residential building or
ples in the sample, and dividing the child-occupied facility or on the exte-
sum by the total number of subsamples rior of any residential building or
contained in all samples. For example, child-occupied facility.
the weighted arithmetic mean of a sin- (b) Dust-lead hazard. A dust-lead haz-
gle surface sample containing 60 μg/ft2, ard is surface dust in a residential
a composite sample (three subsamples) dwelling or child-occupied facility that

containing 100 μg/ft2, and a composite contains a mass-per-area concentration
sample (4 subsamples) containing 110 of lead equal to or exceeding 40 μg/ft2
75
§ 745.80 40 CFR Ch. I (7–1–17 Edition)
on floors or 250 μg/ft2 on interior win- § 745.85 are followed during these ren-
dow sills based on wipe samples. ovations.
(c) Soil-lead hazard. A soil-lead hazard [73 FR 21758, Apr. 22, 2008]
is bare soil on residential real property
or on the property of a child-occupied § 745.81 Effective dates.
facility that contains total lead equal (a) Training, certification and accredi-
to or exceeding 400 parts per million tation requirements and work practice
(μg/g) in a play area or average of 1,200 standards. The training, certification
parts per million of bare soil in the rest and accreditation requirements and
of the yard based on soil samples. work practice standards in this subpart
(d) Work practice requirements. Appli- are applicable in any State or Indian
cable certification, occupant protec- Tribal area that does not have a ren-
tion, and clearance requirements and ovation program that is authorized
work practice standards are found in under subpart Q of this part. The train-
regulations issued by EPA at 40 CFR ing, certification and accreditation re-
part 745, subpart L and in regulations quirements and work practice stand-
issued by the Department of Housing ards in this subpart will become effec-
and Urban Development (HUD) at 24 tive as follows:
CFR part 35, subpart R. The work prac- (1) Training programs. Effective June
tice standards in those regulations do 23, 2008, no training program may pro-
not apply when treating paint-lead haz- vide, offer, or claim to provide training
ards of less than: or refresher training for EPA certifi-
(1) Two square feet of deteriorated cation as a renovator or a dust sam-
lead-based paint per room or equiva- pling technician without accreditation
lent, from EPA under § 745.225. Training pro-
(2) Twenty square feet of deteriorated grams may apply for accreditation
paint on the exterior building, or under § 745.225 beginning April 22, 2009.
(2) Firms. (i) Firms may apply for cer-
(3) Ten percent of the total surface
tification under § 745.89 beginning Octo-
area of deteriorated paint on an inte-
ber 22, 2009.
rior or exterior type of component with
(ii) On or after April 22, 2010, no firm
a small surface area. may perform, offer, or claim to per-
form renovations without certification
Subpart E—Residential Property from EPA under § 745.89 in target hous-
Renovation ing or child-occupied facilities, unless
the renovation qualifies for one of the
SOURCE: 63 FR 29919, June 1, 1998, unless exceptions identified in § 745.82(a) or
otherwise noted. (c).
(3) Individuals. On or after April 22,
§ 745.80 Purpose. 2010, all renovations must be directed
by renovators certified in accordance
This subpart contains regulations de- with § 745.90(a) and performed by cer-
veloped under sections 402 and 406 of tified renovators or individuals trained
the Toxic Substances Control Act (15 in accordance with § 745.90(b)(2) in tar-
U.S.C. 2682 and 2686) and applies to all get housing or child-occupied facilities,
renovations performed for compensa- unless the renovation qualifies for one
tion in target housing and child-occu- of the exceptions identified in
pied facilities. The purpose of this sub- § 745.82(a) or (c).
part is to ensure the following: (4) Work practices. (i) On or after April
(a) Owners and occupants of target 22, 2010 and before July 6, 2010 all ren-
housing and child-occupied facilities ovations must be performed in accord-
receive information on lead-based ance with the work practice standards
paint hazards before these renovations in § 745.85 and the associated record-
begin; and keeping requirements in § 745.86 (b)(6)
(b) Individuals performing renova- in target housing or child-occupied fa-
tions regulated in accordance with cilities, unless the renovation qualifies
§ 745.82 are properly trained; renovators for one of the exceptions identified in
and firms performing these renovations § 745.82(a). This does not apply to ren-
are certified; and the work practices in ovations in target housing for which
76
the firm performing the renovation has § 745.82 Applicability.

obtained a statement signed by the
(a) This subpart applies to all renova-
owner that the renovation will occur in
tions performed for compensation in
the owner’s residence, no child under
target housing and child-occupied fa-
age 6 resides there, the housing is not cilities, except for the following:
a child-occupied facility, and the owner
(1) Renovations in target housing or
acknowledges that the work practices
child-occupied facilities in which a
to be used during the renovation will written determination has been made
not necessarily include all of the lead- by an inspector or risk assessor (cer-
safe work practices contained in EPA’s tified pursuant to either Federal regu-
renovation, repair, and painting rule. lations at § 745.226 or a State or Tribal
For the purposes of this section, a child certification program authorized pur-
resides in the primary residence of his suant to § 745.324) that the components
or her custodial parents, legal guard- affected by the renovation are free of
ians, and foster parents. A child also paint or other surface coatings that
resides in the primary residence of an contain lead equal to or in excess of 1.0
informal caretaker if the child lives milligrams/per square centimeter (mg/
and sleeps most of the time at the care- cm2) or 0.5% by weight, where the firm
taker’s residence. performing the renovation has ob-
(ii) On or after July 6, 2010, all ren- tained a copy of the determination.
ovations must be performed in accord- (2) Renovations in target housing or
ance with the work practice standards child-occupied facilities in which a cer-
in § 745.85 and the associated record- tified renovator, using an EPA recog-
keeping requirements in § 745.86(b)(1) nized test kit as defined in § 745.83 and
and (b)(6) in target housing or child-oc- following the kit manufacturer’s in-
cupied facilities, unless the renovation structions, has tested each component
qualifies for the exception identified in affected by the renovation and deter-
§ 745.82(a). mined that the components are free of
(5) The suspension and revocation paint or other surface coatings that
provisions in § 745.91 are effective April contain lead equal to or in excess of 1.0
22, 2010. mg/cm2 or 0.5% by weight. If the com-
(b) Renovation-specific pamphlet. Be- ponents make up an integrated whole,
fore December 22, 2008, renovators or such as the individual stair treads and
firms performing renovations in States risers of a single staircase, the ren-
and Indian Tribal areas without an au- ovator is required to test only one of
thorized program may provide owners the individual components, unless the
and occupants with either of the fol- individual components appear to have
lowing EPA pamphlets: Protect Your been repainted or refinished sepa-
Family From Lead in Your Home or Ren- rately.
ovate Right: Important Lead Hazard In- (3) Renovations in target housing or
formation for Families, Child Care Pro- child-occupied facilities in which a cer-
viders and Schools. After that date, Ren- tified renovator has collected a paint
ovate Right: Important Lead Hazard In- chip sample from each painted compo-
formation for Families, Child Care Pro- nent affected by the renovation and a
viders and Schools must be used exclu- laboratory recognized by EPA pursuant
sively. to section 405(b) of TSCA as being capa-
(c) Pre-Renovation Education Rule. ble of performing analyses for lead
With the exception of the requirement compounds in paint chip samples has
to use the pamphlet entitled Renovate determined that the samples are free of
Right: Important Lead Hazard Informa- paint or other surface coatings that
contain lead equal to or in excess of 1.0
tion for Families, Child Care Providers
mg/cm2 or 0.5% by weight. If the com-
and Schools, the provisions of the Pre-
ponents make up an integrated whole,
Renovation Education Rule in this sub-
such as the individual stair treads and
part have been in effect since June
risers of a single staircase, the ren-
1999.
ovator is required to test only one of
[73 FR 21758, Apr. 22, 2008, as amended at 75 the individual components, unless the
FR 24818, May 6, 2010] individual components appear to have
77
§ 745.83 40 CFR Ch. I (7–1–17 Edition)
been repainted or refinished sepa- ings. With respect to common areas in

rately. public or commercial buildings that
(b) The information distribution re- contain child-occupied facilities, the
quirements in § 745.84 do not apply to child-occupied facility encompasses
emergency renovations, which are ren- only those common areas that are rou-
ovation activities that were not tinely used by children under age 6,
planned but result from a sudden, un- such as restrooms and cafeterias. Com-
expected event (such as non-routine mon areas that children under age 6
failures of equipment) that, if not im- only pass through, such as hallways,
mediately attended to, presents a safe- stairways, and garages are not in-
ty or public health hazard, or threatens cluded. In addition, with respect to ex-
equipment and/or property with signifi- teriors of public or commercial build-
cant damage. Interim controls per- ings that contain child-occupied facili-
formed in response to an elevated blood ties, the child-occupied facility encom-
lead level in a resident child are also passes only the exterior sides of the
emergency renovations. Emergency building that are immediately adjacent
renovations other than interim con- to the child-occupied facility or the
trols are also exempt from the warning common areas routinely used by chil-
sign, containment, waste handling, dren under age 6.
training, and certification require- Cleaning verification card means a
ments in §§ 745.85, 745.89, and 745.90 to card developed and distributed, or oth-
the extent necessary to respond to the erwise approved, by EPA for the pur-
emergency. Emergency renovations are pose of determining, through compari-
not exempt from the cleaning require- son of wet and dry disposable cleaning
ments of § 745.85(a)(5), which must be cloths with the card, whether post-ren-
performed by certified renovators or ovation cleaning has been properly
individuals trained in accordance with completed.
§ 745.90(b)(2), the cleaning verification Component or building component
requirements of § 745.85(b), which must means specific design or structural ele-
be performed by certified renovators, ments or fixtures of a building or resi-
and the recordkeeping requirements of dential dwelling that are distinguished
§ 745.86(b)(6) and (b)(7). from each other by form, function, and
[73 FR 21758, Apr. 22, 2008, as amended at 75 location. These include, but are not
FR 24818, May 6, 2010; 76 FR 47938, Aug. 5, limited to, interior components such
2011] as: Ceilings, crown molding, walls,
chair rails, doors, door trim, floors,
§ 745.83 Definitions. fireplaces, radiators and other heating
For purposes of this part, the defini- units, shelves, shelf supports, stair
tions in § 745.103 as well as the fol- treads, stair risers, stair stringers,
lowing definitions apply: newel posts, railing caps, balustrades,
Administrator means the Adminis- windows and trim (including sashes,
trator of the Environmental Protection window heads, jambs, sills or stools
Agency. and troughs), built in cabinets, col-
Child-occupied facility means a build- umns, beams, bathroom vanities,
ing, or portion of a building, con- counter tops, and air conditioners; and
structed prior to 1978, visited regularly exterior components such as: Painted
by the same child, under 6 years of age, roofing, chimneys, flashing, gutters
on at least two different days within and downspouts, ceilings, soffits, fas-
any week (Sunday through Saturday cias, rake boards, cornerboards, bulk-
period), provided that each day’s visit heads, doors and door trim, fences,
lasts at least 3 hours and the combined floors, joists, lattice work, railings and
weekly visits last at least 6 hours, and railing caps, siding, handrails, stair ris-
the combined annual visits last at least ers and treads, stair stringers, col-
60 hours. Child-occupied facilities may umns, balustrades, windowsills or
include, but are not limited to, day stools and troughs, casings, sashes and
care centers, preschools and kinder- wells, and air conditioners.
garten classrooms. Child-occupied fa- Dry disposable cleaning cloth means a

cilities may be located in target hous- commercially available dry, electro-
ing or in public or commercial build- statically charged, white disposable
78
cloth designed to be used for cleaning Painted surface means a component

hard surfaces such as uncarpeted floors surface covered in whole or in part
or counter tops. with paint or other surface coatings.
Firm means a company, partnership, Pamphlet means the EPA pamphlet
corporation, sole proprietorship or in- titled Renovate Right: Important Lead
dividual doing business, association, or Hazard Information for Families, Child
other business entity; a Federal, State, Care Providers and Schools developed
Tribal, or local government agency; or under section 406(a) of TSCA for use in
a nonprofit organization. complying with section 406(b) of TSCA,
HEPA vacuum means a vacuum clean- or any State or Tribal pamphlet ap-
er which has been designed with a high- proved by EPA pursuant to 40 CFR
efficiency particulate air (HEPA) filter 745.326 that is developed for the same
as the last filtration stage. A HEPA fil- purpose. This includes reproductions of
ter is a filter that is capable of cap- the pamphlet when copied in full and
turing particulates of 0.3 microns with without revision or deletion of mate-
99.97% efficiency. The vacuum cleaner rial from the pamphlet (except for the
must be designed so that all the air addition or revision of State or local
drawn into the machine is expelled sources of information). Before Decem-
through the HEPA filter with none of ber 22, 2008, the term ‘‘pamphlet’’ also
the air leaking past it. HEPA vacuums means any pamphlet developed by EPA
must be operated and maintained in ac- under section 406(a) of TSCA or any
cordance with the manufacturer’s in- State or Tribal pamphlet approved by
EPA pursuant to § 745.326.
structions.
Person means any natural or judicial
Interim controls means a set of meas-
person including any individual, cor-
ures designed to temporarily reduce
poration, partnership, or association;
human exposure or likely exposure to
any Indian Tribe, State, or political
lead-based paint hazards, including
subdivision thereof; any interstate
specialized cleaning, repairs, mainte-
body; and any department, agency, or
nance, painting, temporary contain- instrumentality of the Federal Govern-
ment, ongoing monitoring of lead- ment.
based paint hazards or potential haz-
Recognized test kit means a commer-
ards, and the establishment and oper-
cially available kit recognized by EPA
ation of management and resident edu- under § 745.88 as being capable of allow-
cation programs. ing a user to determine the presence of
Minor repair and maintenance activities lead at levels equal to or in excess of
are activities, including minor heating, 1.0 milligrams per square centimeter,
ventilation or air conditioning work, or more than 0.5% lead by weight, in a
electrical work, and plumbing, that paint chip, paint powder, or painted
disrupt 6 square feet or less of painted surface.
surface per room for interior activities Renovation means the modification of
or 20 square feet or less of painted sur- any existing structure, or portion
face for exterior activities where none thereof, that results in the disturbance
of the work practices prohibited or re- of painted surfaces, unless that activ-
stricted by § 745.85(a)(3) are used and ity is performed as part of an abate-
where the work does not involve win- ment as defined by this part (40 CFR
dow replacement or demolition of 745.223). The term renovation includes
painted surface areas. When removing (but is not limited to): The removal,
painted components, or portions of modification or repair of painted sur-
painted components, the entire surface faces or painted components (e.g.,
area removed is the amount of painted modification of painted doors, surface
surface disturbed. Jobs, other than restoration, window repair, surface
emergency renovations, performed in preparation activity (such as sanding,
the same room within the same 30 days scraping, or other such activities that
must be considered the same job for may generate paint dust)); the removal
the purpose of determining whether the of building components (e.g., walls,

job is a minor repair and maintenance ceilings, plumbing, windows); weather-
activity. ization projects (e.g., cutting holes in
79
§ 745.84 40 CFR Ch. I (7–1–17 Edition)
painted surfaces to install blown-in in- renovation activities in any residential

sulation or to gain access to attics, dwelling unit of target housing, the
planing thresholds to install weather- firm performing the renovation must:
stripping), and interim controls that (1) Provide the owner of the unit with
disturb painted surfaces. A renovation the pamphlet, and comply with one of
performed for the purpose of con- the following:
verting a building, or part of a build- (i) Obtain, from the owner, a written
ing, into target housing or a child-oc- acknowledgment that the owner has
cupied facility is a renovation under received the pamphlet.
this subpart. The term renovation does (ii) Obtain a certificate of mailing at
not include minor repair and mainte- least 7 days prior to the renovation.
nance activities. (2) In addition to the requirements in
Renovator means an individual who paragraph (a)(1) of this section, if the
either performs or directs workers who owner does not occupy the dwelling
perform renovations. A certified ren- unit, provide an adult occupant of the
ovator is a renovator who has success- unit with the pamphlet, and comply
fully completed a renovator course ac- with one of the following:
credited by EPA or an EPA-authorized (i) Obtain, from the adult occupant, a
State or Tribal program. written acknowledgment that the oc-
Training hour means at least 50 min- cupant has received the pamphlet; or
utes of actual learning, including, but certify in writing that a pamphlet has
not limited to, time devoted to lecture, been delivered to the dwelling and that
learning activities, small group activi- the firm performing the renovation has
ties, demonstrations, evaluations, and been unsuccessful in obtaining a writ-
hands-on experience. ten acknowledgment from an adult oc-
Wet disposable cleaning cloth means a cupant. Such certification must in-
commercially available, pre-moistened clude the address of the unit under-
white disposable cloth designed to be going renovation, the date and method
used for cleaning hard surfaces such as of delivery of the pamphlet, names of
uncarpeted floors or counter tops. the persons delivering the pamphlet,
Vertical containment means a vertical reason for lack of acknowledgment
barrier consisting of plastic sheeting or (e.g., occupant refuses to sign, no adult
other impermeable material over scaf- occupant available), the signature of a
folding or a rigid frame, or an equiva- representative of the firm performing
lent system of containing the work the renovation, and the date of signa-
area. Vertical containment is required ture.
for some exterior renovations but it (ii) Obtain a certificate of mailing at
may be used on any renovation. least 7 days prior to the renovation.
Wet mopping system means a device (b) Renovations in common areas. No
with the following characteristics: A more than 60 days before beginning
long handle, a mop head designed to be renovation activities in common areas
used with disposable absorbent clean- of multi-unit target housing, the firm
ing pads, a reservoir for cleaning solu- performing the renovation must:
tion, and a built-in mechanism for dis- (1) Provide the owner with the pam-
tributing or spraying the cleaning solu- phlet, and comply with one of the fol-
tion onto a floor, or a method of equiv- lowing:
alent efficacy. (i) Obtain, from the owner, a written
Work area means the area that the acknowledgment that the owner has
certified renovator establishes to con- received the pamphlet.
tain the dust and debris generated by a (ii) Obtain a certificate of mailing at
renovation. least 7 days prior to the renovation.
[63 FR 29919, June 1, 1998, as amended at 73 (2) Comply with one of the following. (i)
FR 21758, Apr. 22, 2008; 76 FR 47938, Aug. 5, Notify in writing, or ensure written no-
2011] tification of, each affected unit and
make the pamphlet available upon re-
§ 745.84 Information distribution request prior to the start of renovation.
quirements. Such notification shall be accom-

(a) Renovations in dwelling units. No plished by distributing written notice
more than 60 days before beginning to each affected unit. The notice shall
80
describe the general nature and loca- (B) Obtain a certificate of mailing at
tions of the planned renovation activi- least 7 days prior to the renovation.
ties; the expected starting and ending (ii) If the child-occupied facility is
dates; and a statement of how the oc- not the owner of the building, provide
cupant can obtain the pamphlet and a an adult representative of the child-oc-
copy of the records required by cupied facility with the pamphlet, and
§ 745.86(c) and (d), at no cost to the oc- comply with one of the following:
cupants, or (A) Obtain, from the adult represent-
(ii) While the renovation is ongoing, ative, a written acknowledgment that
post informational signs describing the the adult representative has received
general nature and locations of the the pamphlet; or certify in writing that
renovation and the anticipated comple- a pamphlet has been delivered to the
tion date. These signs must be posted facility and that the firm performing
in areas where they are likely to be the renovation has been unsuccessful
seen by the occupants of all of the af- in obtaining a written acknowledgment
fected units. The signs must be accom- from an adult representative. Such cer-
panied by a posted copy of the pam- tification must include the address of
phlet or information on how interested the child-occupied facility undergoing
occupants can review a copy of the renovation, the date and method of de-
pamphlet or obtain a copy from the livery of the pamphlet, names of the
renovation firm at no cost to occu- persons delivering the pamphlet, rea-
pants. The signs must also include in- son for lack of acknowledgment (e.g.,
formation on how interested occupants representative refuses to sign), the sig-
can review a copy of the records re- nature of a representative of the firm
quired by § 745.86(c) and (d) or obtain a performing the renovation, and the
copy from the renovation firm at no date of signature.
cost to the occupants. (B) Obtain a certificate of mailing at
least 7 days prior to the renovation.
(3) Prepare, sign, and date a state-
(2) Provide the parents and guardians
ment describing the steps performed to
of children using the child-occupied fa-
notify all occupants of the intended
cility with the pamphlet, information
renovation activities and to provide
describing the general nature and loca-
the pamphlet.
tions of the renovation and the antici-
(4) If the scope, locations, or expected pated completion date, and informa-
starting and ending dates of the tion on how interested parents or
planned renovation activities change guardians of children frequenting the
after the initial notification, and the child-occupied facility can review a
firm provided written initial notifica- copy of the records required by
tion to each affected unit, the firm per- § 745.86(c) and (d) or obtain a copy from
forming the renovation must provide the renovation firm at no cost to the
further written notification to the occupants by complying with one of
owners and occupants providing revised the following:
information on the ongoing or planned (i) Mail or hand-deliver the pamphlet
activities. This subsequent notification and the renovation information to each
must be provided before the firm per- parent or guardian of a child using the
forming the renovation initiates work child-occupied facility.
beyond that which was described in the (ii) While the renovation is ongoing,
original notice. post informational signs describing the
(c) Renovations in child-occupied facili- general nature and locations of the
ties. No more than 60 days before begin- renovation and the anticipated comple-
ning renovation activities in any child- tion date. These signs must be posted
occupied facility, the firm performing in areas where they can be seen by the
the renovation must: parents or guardians of the children
(1)(i) Provide the owner of the build- frequenting the child-occupied facility.
ing with the pamphlet, and comply The signs must be accompanied by a
with one of the following: posted copy of the pamphlet or infor-
(A) Obtain, from the owner, a written mation on how interested parents or
acknowledgment that the owner has guardians of children frequenting the
received the pamphlet. child-occupied facility can review a
81
§ 745.85 40 CFR Ch. I (7–1–17 Edition)
copy of the pamphlet or obtain a copy posted before beginning the renovation
from the renovation firm at no cost to and must remain in place and readable
the parents or guardians. The signs until the renovation and the post-ren-
must also include information on how ovation cleaning verification have been
interested parents or guardians of chil- completed. If warning signs have been
dren frequenting the child-occupied fa- posted in accordance with 24 CFR
cility can review a copy of the records 35.1345(b)(2) or 29 CFR 1926.62(m), addi-
required by § 745.86(c) and (d) or obtain tional signs are not required by this
a copy from the renovation firm at no section.
cost to the parents or guardians. (2) Containing the work area. Before
(3) The renovation firm must prepare, beginning the renovation, the firm
sign, and date a statement describing must isolate the work area so that no
the steps performed to notify all par- dust or debris leaves the work area
ents and guardians of the intended ren- while the renovation is being per-
ovation activities and to provide the formed. In addition, the firm must
pamphlet. maintain the integrity of the contain-
(d) Written acknowledgment. The writ- ment by ensuring that any plastic or
ten acknowledgments required by para- other impermeable materials are not
graphs (a)(1)(i), (a)(2)(i), (b)(1)(i),
torn or displaced, and taking any other
(c)(1)(i)(A), and (c)(1)(ii)(A) of this sec-
steps necessary to ensure that no dust
tion must:
or debris leaves the work area while
(1) Include a statement recording the
the renovation is being performed. The
owner or occupant’s name and ac-
firm must also ensure that contain-
knowledging receipt of the pamphlet
ment is installed in such a manner that
prior to the start of renovation, the ad-
it does not interfere with occupant and
dress of the unit undergoing renova-
worker egress in an emergency.
tion, the signature of the owner or oc-
cupant as applicable, and the date of (i) Interior renovations. The firm
signature. must:
(2) Be either a separate sheet or part (A) Remove all objects from the work
of any written contract or service area, including furniture, rugs, and
agreement for the renovation. window coverings, or cover them with
(3) Be written in the same language plastic sheeting or other impermeable
as the text of the contract or agree- material with all seams and edges
ment for the renovation or, in the case taped or otherwise sealed.
of non-owner occupied target housing, (B) Close and cover all ducts opening
in the same language as the lease or in the work area with taped-down plas-
rental agreement or the pamphlet. tic sheeting or other impermeable ma-
terial.
[63 FR 29919, June 1, 1998. Redesignated and
amended at 73 FR 21760, Apr. 22, 2008; 75 FR (C) Close windows and doors in the
24818, May 6, 2010] work area. Doors must be covered with
plastic sheeting or other impermeable
§ 745.85 Work practice standards. material. Doors used as an entrance to
(a) Standards for renovation activities. the work area must be covered with
Renovations must be performed by cer- plastic sheeting or other impermeable
tified firms using certified renovators material in a manner that allows work-
as directed in § 745.89. The responsibil- ers to pass through while confining
ities of certified firms are set forth in dust and debris to the work area.
§ 745.89(d) and the responsibilities of (D) Cover the floor surface, including
certified renovators are set forth in installed carpet, with taped-down plas-
§ 745.90(b). tic sheeting or other impermeable ma-
(1) Occupant protection. Firms must terial in the work area 6 feet beyond
post signs clearly defining the work the perimeter of surfaces undergoing
area and warning occupants and other renovation or a sufficient distance to
persons not involved in renovation ac- contain the dust, whichever is greater.
tivities to remain outside of the work Floor containment measures may stop
area. To the extent practicable, these at the edge of the vertical barrier when
signs must be in the primary language using a vertical containment system
of the occupants. These signs must be consisting of impermeable barriers
82
that extend from the floor to the ceil- (i) Open-flame burning or torching of
ing and are tightly sealed at joints painted surfaces is prohibited.
with the floor, ceiling and walls. (ii) The use of machines designed to
(E) Use precautions to ensure that all remove paint or other surface coatings
personnel, tools, and other items, in- through high speed operation such as
cluding the exteriors of containers of sanding, grinding, power planing, nee-
waste, are free of dust and debris before dle gun, abrasive blasting, or sand-
leaving the work area. blasting, is prohibited on painted sur-
(ii) Exterior renovations. The firm faces unless such machines have
must: shrouds or containment systems and
(A) Close all doors and windows with- are equipped with a HEPA vacuum at-
in 20 feet of the renovation. On multi- tachment to collect dust and debris at
story buildings, close all doors and the point of generation. Machines must
windows within 20 feet of the renova- be operated so that no visible dust or
tion on the same floor as the renova- release of air occurs outside the shroud
tion, and close all doors and windows or containment system.
on all floors below that are the same (iii) Operating a heat gun on painted
horizontal distance from the renova- surfaces is permitted only at tempera-
tion. tures below 1,100 degrees Fahrenheit.
(B) Ensure that doors within the (4) Waste from renovations—(i) Waste
work area that will be used while the from renovation activities must be
job is being performed are covered with contained to prevent releases of dust
plastic sheeting or other impermeable and debris before the waste is removed
material in a manner that allows work- from the work area for storage or dis-
ers to pass through while confining posal. If a chute is used to remove
dust and debris to the work area. waste from the work area, it must be
(C) Cover the ground with plastic covered.
sheeting or other disposable imper- (ii) At the conclusion of each work
meable material extending 10 feet be- day and at the conclusion of the ren-
yond the perimeter of surfaces under- ovation, waste that has been collected
going renovation or a sufficient dis- from renovation activities must be
tance to collect falling paint debris, stored under containment, in an enclo-
whichever is greater, unless the prop- sure, or behind a barrier that prevents
erty line prevents 10 feet of such release of dust and debris out of the
ground covering. Ground containment work area and prevents access to dust
measures may stop at the edge of the and debris.
vertical barrier when using a vertical (iii) When the firm transports waste
containment system. from renovation activities, the firm
(D) If the renovation will affect sur- must contain the waste to prevent re-
faces within 10 feet of the property lease of dust and debris.
line, the renovation firm must erect (5) Cleaning the work area. After the
vertical containment or equivalent renovation has been completed, the
extra precautions in containing the firm must clean the work area until no
work area to ensure that dust and de- dust, debris or residue remains.
bris from the renovation does not con- (i) Interior and exterior renovations.
taminate adjacent buildings or migrate The firm must:
to adjacent properties. Vertical con- (A) Collect all paint chips and debris
tainment or equivalent extra pre- and, without dispersing any of it, seal
cautions in containing the work area this material in a heavy-duty bag.
may also be necessary in other situa- (B) Remove the protective sheeting.
tions in order to prevent contamina- Mist the sheeting before folding it, fold
tion of other buildings, other areas of the dirty side inward, and either tape
the property, or adjacent buildings or shut to seal or seal in heavy-duty bags.
properties. Sheeting used to isolate contaminated
(3) Prohibited and restricted practices. rooms from non-contaminated rooms
The work practices listed below are must remain in place until after the
prohibited or restricted during a ren- cleaning and removal of other sheeting.
ovation as follows: Dispose of the sheeting as waste.
83
§ 745.85 40 CFR Ch. I (7–1–17 Edition)
(ii) Additional cleaning for interior ren- (3) If the cloth does not match and is
ovations. The firm must clean all ob- darker than the cleaning verification
jects and surfaces in the work area and card, wait for 1 hour or until the sur-
within 2 feet of the work area in the face has dried completely, whichever is
following manner, cleaning from high- longer.
er to lower: (4)After waiting for the windowsill to
(A) Walls. Clean walls starting at the dry, wipe the windowsill with a dry dis-
ceiling and working down to the floor posable cleaning cloth. After this wipe,
by either vacuuming with a HEPA vac- the windowsill has been adequately
uum or wiping with a damp cloth. cleaned.
(B) Remaining surfaces. Thoroughly (B) Wipe uncarpeted floors and
vacuum all remaining surfaces and ob- countertops within the work area with
jects in the work area, including fur- a wet disposable cleaning cloth. Floors
niture and fixtures, with a HEPA vacu- must be wiped using an application de-
um. The HEPA vacuum must be vice with a long handle and a head to
equipped with a beater bar when which the cloth is attached. The cloth
vacuuming carpets and rugs. must remain damp at all times while it
(C) Wipe all remaining surfaces and is being used to wipe the surface for
objects in the work area, except for post-renovation cleaning verification.
carpeted or upholstered surfaces, with If the surface within the work area is
greater than 40 square feet, the surface
a damp cloth. Mop uncarpeted floors
within the work area must be divided
thoroughly, using a mopping method
into roughly equal sections that are
that keeps the wash water separate
each less than 40 square feet. Wipe each
from the rinse water, such as the 2-
such section separately with a new wet
bucket mopping method, or using a wet
disposable cleaning cloth. If the cloth
mopping system.
used to wipe each section of the surface
(b) Standards for post-renovation clean- within the work area matches the
ing verification—(1) Interiors. (i) A cer- cleaning verification card, the surface
tified renovator must perform a visual has been adequately cleaned.
inspection to determine whether dust, (1) If the cloth used to wipe a par-
debris or residue is still present. If ticular surface section does not match
dust, debris or residue is present, these the cleaning verification card, re-clean
conditions must be removed by re- that section of the surface as directed
cleaning and another visual inspection in paragraphs (a)(5)(ii)(B) and
must be performed. (a)(5)(ii)(C) of this section, then use a
(ii) After a successful visual inspec- new wet disposable cleaning cloth to
tion, a certified renovator must: wipe that section again. If the cloth
(A) Verify that each windowsill in matches the cleaning verification card,
the work area has been adequately that section of the surface has been
cleaned, using the following procedure. adequately cleaned.
(1) Wipe the windowsill with a wet (2) If the cloth used to wipe a par-
disposable cleaning cloth that is damp ticular surface section does not match
to the touch. If the cloth matches or is the cleaning verification card after the
lighter than the cleaning verification surface has been re-cleaned, wait for 1
card, the windowsill has been ade- hour or until the entire surface within
quately cleaned. the work area has dried completely,
(2) If the cloth does not match and is whichever is longer.
darker than the cleaning verification (3) After waiting for the entire sur-
card, re-clean the windowsill as di- face within the work area to dry, wipe
rected in paragraphs (a)(5)(ii)(B) and each section of the surface that has not
(a)(5)(ii)(C) of this section, then either yet achieved post-renovation cleaning
use a new cloth or fold the used cloth verification with a dry disposable
in such a way that an unused surface is cleaning cloth. After this wipe, that
exposed, and wipe the surface again. If section of the surface has been ade-
the cloth matches or is lighter than quately cleaned.
the cleaning verification card, that (iii) When the work area passes the
windowsill has been adequately post-renovation cleaning verification,
cleaned. remove the warning signs.
84
(2) Exteriors. A certified renovator (b) Records that must be retained

must perform a visual inspection to de- pursuant to paragraph (a) of this sec-
termine whether dust, debris or residue tion shall include (where applicable):
is still present on surfaces in and below (1) Records or reports certifying that
the work area, including windowsills a determination had been made that
and the ground. If dust, debris or res- lead-based paint was not present on the
idue is present, these conditions must components affected by the renovation,
be eliminated and another visual in- as described in § 745.82(a). These records
spection must be performed. When the or reports include:
area passes the visual inspection, re- (i) Reports prepared by a certified in-
move the warning signs. spector or certified risk assessor (cer-
(c) Optional dust clearance testing. tified pursuant to either Federal regu-
Cleaning verification need not be per- lations at § 745.226 or an EPA-author-
formed if the contract between the ren- ized State or Tribal certification pro-
ovation firm and the person con- gram).
tracting for the renovation or another (ii) Records prepared by a certified
Federal, State, Territorial, Tribal, or renovator after using EPA-recognized
local law or regulation requires: test kits, including an identification of
(1) The renovation firm to perform the manufacturer and model of any
dust clearance sampling at the conclu- test kits used, a description of the
sion of a renovation covered by this components that were tested including
subpart. their locations, and the result of each
(2) The dust clearance samples are retest kit used.
quired to be collected by a certified in- (iii) Records prepared by a certified
spector, risk assessor or dust sampling renovator after collecting paint chip
technician. samples, including a description of the
(3) The renovation firm is required to components that were tested including
re-clean the work area until the dust their locations, the name and address
clearance sample results are below the of the NLLAP-recognized entity per-
clearance standards in § 745.227(e)(8) or forming the analysis, and the results
any applicable State, Territorial, Trib- for each sample.
al, or local standard. (2) Signed and dated acknowledg-
(d) Activities conducted after post-ren- ments of receipt as described in
ovation cleaning verification. Activities § 745.84(a)(1)(i), (a)(2)(i), (b)(1)(i),
(c)(1)(i)(A), and (c)(1)(ii)(A).
that do not disturb paint, such as ap-
plying paint to walls that have already (3) Certifications of attempted deliv-
been prepared, are not regulated by ery as described in § 745.84(a)(2)(i) and
this subpart if they are conducted after (c)(1)(ii)(A).
post-renovation cleaning verification (4) Certificates of mailing as de-
has been performed. scribed in § 745.84(a)(1)(ii), (a)(2)(ii),
(b)(1)(ii), (c)(1)(i)(B), and (c)(1)(ii)(B).
[73 FR 21761, Apr. 22, 2008, as amended at 76 (5) Records of notification activities
FR 47938, Aug. 5, 2011] performed regarding common area ren-
ovations, as described in § 745.84(b)(3)
§ 745.86 Recordkeeping and reporting and (b)(4), and renovations in child-oc-
requirements.
cupied facilities, as described in
(a) Firms performing renovations § 745.84(c)(2).
must retain and, if requested, make (6) Documentation of compliance
available to EPA all records necessary with the requirements of § 745.85, in-
to demonstrate compliance with this cluding documentation that a certified
subpart for a period of 3 years fol- renovator was assigned to the project,
lowing completion of the renovation. that the certified renovator provided
This 3–year retention requirement does on-the-job training for workers used on
not supersede longer obligations re- the project, that the certified ren-
quired by other provisions for retaining ovator performed or directed workers
the same documentation, including any who performed all of the tasks de-
applicable State or Tribal laws or regu- scribed in § 745.85(a), and that the cer-
lations. tified renovator performed the post-
85
§ 745.86 40 CFR Ch. I (7–1–17 Edition)
renovation cleaning verification de- dust and debris to adjacent property

scribed in § 745.85(b). If the renovation (exteriors).
firm was unable to comply with all of (iv) If paint chip samples were col-
the requirements of this rule due to an lected, that the samples were collected
emergency as defined in § 745.82, the at the specified locations, that the
firm must document the nature of the specified NLLAP-recognized laboratory
emergency and the provisions of the analyzed the samples, and that the re-
rule that were not followed. This docu- sults were as specified.
mentation must include a copy of the (vi) Waste was contained on-site and
certified renovator’s training certifi- while being transported off-site.
cate, and a certification by the cer- (vii) The work area was properly
tified renovator assigned to the project cleaned after the renovation by:
that: (A) Picking up all chips and debris,
(i) Training was provided to workers misting protective sheeting, folding it
(topics must be identified for each dirty side inward, and taping it for re-
worker). moval.
(ii) Warning signs were posted at the (B) Cleaning the work area surfaces
entrances to the work area. and objects using a HEPA vacuum and/
(iii) If test kits were used, that the or wet cloths or mops (interiors).
specified brand of kits was used at the (viii) The certified renovator per-
specified locations and that the results formed the post-renovation cleaning
were as specified. verification (the results of which must
(v) The work area was contained by: be briefly described, including the
number of wet and dry cloths used).
(A) Removing or covering all objects
(c)(1) When the final invoice for the
in the work area (interiors).
renovation is delivered or within 30
(B) Closing and covering all HVAC
days of the completion of the renova-
ducts in the work area (interiors).
tion, whichever is earlier, the renova-
(C) Closing all windows in the work tion firm must provide information
area (interiors) or closing all windows pertaining to compliance with this sub-
in and within 20 feet of the work area part to the following persons:
(exteriors). (i) The owner of the building; and, if
(D) Closing and sealing all doors in different,
the work area (interiors) or closing and (ii) An adult occupant of the residen-
sealing all doors in and within 20 feet tial dwelling, if the renovation took
of the work area (exteriors). place within a residential dwelling, or
(E) Covering doors in the work area an adult representative of the child-oc-
that were being used to allow passage cupied facility, if the renovation took
but prevent spread of dust. place within a child-occupied facility.
(F) Covering the floor surface, in- (2) When performing renovations in
cluding installed carpet, with taped- common areas of multi-unit target
down plastic sheeting or other imper- housing, renovation firms must post
meable material in the work area 6 feet the information required by this sub-
beyond the perimeter of surfaces un- part or instructions on how interested
dergoing renovation or a sufficient dis- occupants can obtain a copy of this in-
tance to contain the dust, whichever is formation. This information must be
greater (interiors) or covering the posted in areas where it is likely to be
ground with plastic sheeting or other seen by the occupants of all of the af-
disposable impermeable material an- fected units.
chored to the building extending 10 feet (3) The information required to be
beyond the perimeter of surfaces un- provided by paragraph (c) of this sec-
dergoing renovation or a sufficient dis- tion may be provided by completing
tance to collect falling paint debris, the sample form titled ‘‘Sample Ren-
whichever is greater, unless the prop- ovation Recordkeeping Checklist’’ or a
erty line prevents 10 feet of such similar form containing the test kit in-
ground covering, weighted down by formation required by § 745.86(b)(1)(ii)
heavy objects (exteriors). and the training and work practice

(G) Installing (if necessary) vertical compliance information required by
containment to prevent migration of § 745.86(b)(6).
86
(d) If dust clearance sampling is per- § 745.88 Recognized test kits.

formed in lieu of cleaning verification
(a) Effective June 23, 2008, EPA rec-
as permitted by § 745.85(c), the renova-
ognizes the test kits that have been de-
tion firm must provide, when the final
termined by National Institute of
invoice for the renovation is delivered
or within 30 days of the completion of Standards and Technology research to
the renovation, whichever is earlier, a meet the negative response criteria de-
copy of the dust sampling report to: scribed in paragraph (c)(1) of this sec-
(1) The owner of the building; and, if tion. This recognition will last until
different, EPA publicizes its recognition of the
(2) An adult occupant of the residen- first test kit that meets both the nega-
tial dwelling, if the renovation took tive response and positive response cri-
place within a residential dwelling, or teria in paragraph (c) of this section.
an adult representative of the child-oc- (b) No other test kits will be recog-
cupied facility, if the renovation took nized until they are tested through
place within a child-occupied facility. EPA’s Environmental Technology
(3) When performing renovations in Verification Program or other equiva-
common areas of multi-unit target lent EPA approved testing program.
housing, renovation firms must post (1) Effective September 1, 2008, to ini-
these dust sampling reports or infor- tiate the testing process, a test kit
mation on how interested occupants of manufacturer must submit a sufficient
the housing being renovated can obtain number of kits, along with the instruc-
a copy of the report. This information tions for using the kits, to EPA. The
must be posted in areas where they are test kit manufacturer should first visit
likely to be seen by the occupants of the following website for information
all of the affected units. on where to apply: http://www.epa.gov/
etv/howtoapply.html.
FR 24819, May 6, 2010; 76 FR 47939, Aug. 5, (2) After the kit has been tested
2011] through the Environmental Tech-
nology Verification Program or other
§ 745.87 Enforcement and inspections. equivalent approved EPA testing pro-
(a) Failure or refusal to comply with gram, EPA will review the report to de-
any provision of this subpart is a viola- termine whether the required criteria
tion of TSCA section 409 (15 U.S.C. have been met.
2689). (3) Before September 1, 2010, test kits
(b) Failure or refusal to establish and must meet only the negative response
maintain records or to make available criteria in paragraph (c)(1) of this sec-
or permit access to or copying of tion. The recognition of kits that meet
records, as required by this subpart, is only this criteria will last until EPA
a violation of TSCA sections 15 and 409 publicizes its recognition of the first
(15 U.S.C. 2614 and 2689). test kits that meets both of the cri-
(c) Failure or refusal to permit entry teria in paragraph (c) of this section.
or inspection as required by 40 CFR (4) After September 1, 2010, test kits
745.87 and TSCA section 11 (15 U.S.C. must meet both of the criteria in para-
2610) is a violation of sections 15 and graph (c) of this section.
409 (15 U.S.C. 2614 and 2689). (5) If the report demonstrates that
(d) Violators may be subject to civil the kit meets the required criteria,
and criminal sanctions pursuant to EPA will issue a notice of recognition
TSCA section 16 (15 U.S.C. 2615) for to the kit manufacturer, provide them
each violation. with the report, and post the informa-
(e) Lead-based paint is assumed to be tion on EPA’s website.
present at renovations covered by this (6) If the report demonstrates that
subpart. EPA may conduct inspections the kit does not meet the required cri-
and issue subpoenas pursuant to the teria, EPA will notify the kit manufac-
provisions of TSCA section 11 (15 U.S.C. turer and provide them with the re-
2610) to ensure compliance with this port.
subpart. (c) Response criteria—(1) Negative re-

[63 FR 29919, June 1, 1998, as amended at 73 sponse criteria. For paint containing
FR 21763, Apr. 22, 2008] lead at or above the regulated level, 1.0
87
§ 745.89 40 CFR Ch. I (7–1–17 Edition)
mg/cm2 or 0.5% by weight, a dem- (iii) EPA will not approve a firm’s ap-
onstrated probability (with 95% con- plication if the firm does not supple-
fidence) of a negative response less ment its application in accordance
than or equal to 5% of the time. with paragraph (a)(2)(ii) of this section
(2) Positive response criteria. For paint or if EPA determines that the environ-
containing lead below the regulated mental compliance history of the firm,
level, 1.0 mg/cm2 or 0.5% by weight, a its principals, or its key employees
demonstrated probability (with 95% demonstrates an unwillingness or in-
confidence) of a positive response less ability to maintain compliance with
than or equal to 10% of the time. environmental statutes or regulations.
[73 FR 21763, Apr. 22, 2008] EPA will send the firm a letter giving
the reason for not approving the appli-
§ 745.89 Firm certification. cation. EPA will not refund the appli-
(a) Initial certification. (1) Firms that cation fees. A firm may reapply for cer-
perform renovations for compensation tification at any time by filing a new,
must apply to EPA for certification to complete application that includes the
perform renovations or dust sampling. correct amount of fees.
To apply, a firm must submit to EPA a (b) Re-certification. To maintain its
completed ‘‘Application for Firms,’’ certification, a firm must be re-cer-
signed by an authorized agent of the tified by EPA every 5 years.
firm, and pay at least the correct (1) Timely and complete application. To
amount of fees. If a firm pays more be re-certified, a firm must submit a
than the correct amount of fees, EPA complete application for re-certifi-
will reimburse the firm for the excess cation. A complete application for re-
amount. certification includes a completed
(2) After EPA receives a firm’s appli- ‘‘Application for Firms’’ which con-
cation, EPA will take one of the fol- tains all of the information requested
lowing actions within 90 days of the by the form and is signed by an author-
date the application is received: ized agent of the firm, noting on the
(i) EPA will approve a firm’s applica- form that it is submitted as a re-cer-
tion if EPA determines that it is com- tification. A complete application
plete and that the environmental com- must also include at least the correct
pliance history of the firm, its prin- amount of fees. If a firm pays more
cipals, or its key employees does not than the correct amount of fees, EPA
show an unwillingness or inability to will reimburse the firm for the excess
maintain compliance with environ- amount.
mental statutes or regulations. An ap- (i) An application for re-certification
plication is complete if it contains all is timely if it is postmarked 90 days or
of the information requested on the more before the date the firm’s current
form and includes at least the correct certification expires. If the firm’s ap-
amount of fees. When EPA approves a plication is complete and timely, the
firm’s application, EPA will issue the firm’s current certification will remain
firm a certificate with an expiration in effect until its expiration date or
date not more than 5 years from the until EPA has made a final decision to
date the application is approved. EPA approve or disapprove the re-certifi-
certification allows the firm to per- cation application, whichever is later.
form renovations covered by this sec- (ii) If the firm submits a complete re-
tion in any State or Indian Tribal area certification application less than 90
that does not have a renovation pro- days before its current certification ex-
gram that is authorized under subpart pires, and EPA does not approve the
Q of this part. application before the expiration date,
(ii) EPA will request a firm to supple- the firm’s current certification will ex-
ment its application if EPA determines pire and the firm will not be able to
that the application is incomplete. If conduct renovations until EPA ap-
EPA requests a firm to supplement its proves its re-certification application.
application, the firm must submit the (iii) If the firm fails to obtain recer-
requested information or pay the addi- tification before the firm’s current cer-
tional fees within 30 days of the date of tification expires, the firm must not
the request. perform renovations or dust sampling
88
until it is certified anew pursuant to for Firms,’’ signed by an authorized

paragraph (a) of this section. agent of the firm, noting on the form
(2) EPA action on an application. After that it is submitted as an amendment
EPA receives a firm’s application for and indicating the information that
re-certification, EPA will review the has changed. The firm must also pay at
application and take one of the fol- least the correct amount of fees.
lowing actions within 90 days of re- (2) If additional information is need-
ceipt: ed to process the amendment, or the
(i) EPA will approve a firm’s applica- firm did not pay the correct amount of
tion if EPA determines that it is time- fees, EPA will request the firm to sub-
ly and complete and that the environ- mit the necessary information or fees.
mental compliance history of the firm, The firm’s certification is not amended
its principals, or its key employees until the firm complies with the re-
does not show an unwillingness or in- quest.
ability to maintain compliance with (3) Amending a certification does not
environmental statutes or regulations. affect the certification expiration date.
When EPA approves a firm’s applica- (d) Firm responsibilities. Firms per-
tion for re-certification, EPA will issue forming renovations must ensure that:
the firm a new certificate with an expi- (1) All individuals performing renova-
ration date 5 years from the date that tion activities on behalf of the firm are
the firm’s current certification expires. either certified renovators or have been
EPA certification allows the firm to trained by a certified renovator in ac-
perform renovations or dust sampling cordance with § 745.90.
covered by this section in any State or (2) A certified renovator is assigned
Indian Tribal area that does not have a to each renovation performed by the
renovation program that is authorized firm and discharges all of the certified
under subpart Q of this part. renovator responsibilities identified in
(ii) EPA will request a firm to supple- § 745.90.
ment its application if EPA determines (3) All renovations performed by the
that the application is incomplete. firm are performed in accordance with
(iii) EPA will not approve a firm’s ap- the work practice standards in § 745.85.
plication if it is not received or is not (4) The pre-renovation education re-
complete as of the date that the firm’s quirements of § 745.84 have been per-
current certification expires, or if EPA formed.
determines that the environmental
(5) The recordkeeping requirements
compliance history of the firm, its
of § 745.86 are met.
principals, or its key employees dem-
onstrates an unwillingness or inability [73 FR 21764, Apr. 22, 2008]
to maintain compliance with environ-
mental statutes or regulations. EPA § 745.90 Renovator certification and
will send the firm a letter giving the dust sampling technician certifi-
reason for not approving the applica- cation.
tion. EPA will not refund the applica- (a) Renovator certification and dust
tion fees. A firm may reapply for cer- sampling technician certification. (1) To
tification at any time by filing a new become a certified renovator or cer-
application and paying the correct tified dust sampling technician, an in-
amount of fees. dividual must successfully complete
(c) Amendment of certification. A firm the appropriate course accredited by
must amend its certification within 90 EPA under § 745.225 or by a State or
days of the date a change occurs to in- Tribal program that is authorized
formation included in the firm’s most under subpart Q of this part. The
recent application. If the firm fails to course completion certificate serves as
amend its certification within 90 days proof of certification. EPA renovator
of the date the change occurs, the firm certification allows the certified indi-
may not perform renovations or dust vidual to perform renovations covered
sampling until its certification is by this section in any State or Indian
amended. Tribal area that does not have a ren-

(1) To amend a certification, a firm ovation program that is authorized
must submit a completed ‘‘Application under subpart Q of this part. EPA dust
89
§ 745.90 40 CFR Ch. I (7–1–17 Edition)
sampling technician certification al- that does not include hands-on training
lows the certified individual to perform will be certified for 3 years from the
dust clearance sampling under date they complete the training. Indi-
§ 745.85(c) in any State or Indian Tribal viduals who take a refresher training
area that does not have a renovation course that includes hands-on training
program that is authorized under sub- will be certified for 5 years. Individuals
part Q of this part. who take the renovator refresher with-
(2) Individuals who have successfully out hands-on training must, for their
completed an accredited abatement next refresher course, take a refresher
worker or supervisor course, or individ- course that includes hands-on training
uals who successfully completed an to maintain renovator certification.
EPA, HUD, or EPA/HUD model renova- (b) Renovator responsibilities. Certified
tion training course before October 4, renovators are responsible for ensuring
2011 may take an accredited refresher compliance with § 745.85 at all renova-
renovator training course that includes tions to which they are assigned. A cer-
hands-on training in lieu of the initial tified renovator:
renovator training course to become a (1) Must perform all of the tasks de-
certified renovator. scribed in § 745.85(b) and must either
(3) Individuals who have successfully perform or direct workers who perform
completed an accredited lead-based all of the tasks described in § 745.85(a).
paint inspector or risk assessor course (2) Must provide training to workers
October 4, 2011 may take an accredited on the work practices required by
refresher dust sampling technician § 745.85(a) that they will be using in
course in lieu of the initial training to performing their assigned tasks.
become a certified dust sampling tech-
(3) Must be physically present at the
nician. Individuals who are currently
work site when the signs required by
certified as lead-based paint inspectors
§ 745.85(a)(1) are posted, while the work
or risk assessors may act as certified
area containment required by
dust sampling technicians without fur-
§ 745.85(a)(2) is being established, and
ther training.
while the work area cleaning required
(4) To maintain renovator certifi-
by § 745.85(a)(5) is performed.
cation or dust sampling technician cer-
tification, an individual must complete (4) Must regularly direct work being
a renovator or dust sampling techni- performed by other individuals to en-
cian refresher course accredited by sure that the work practices required
EPA under § 745.225 or by a State or by § 745.85(a) are being followed, includ-
Tribal program that is authorized ing maintaining the integrity of the
containment barriers and ensuring
under subpart Q of this part within 5
that dust or debris does not spread be-
years of the date the individual com-
yond the work area.
pleted the initial course described in
paragraph (a)(1) of this section. If the (5) Must be available, either on-site
individual does not complete a re- or by telephone, at all times that ren-
fresher course within this time, the in- ovations are being conducted.
dividual must re-take the initial (6) When requested by the party con-
course to become certified again. Indi- tracting for renovation services, must
viduals who complete a renovator use an acceptable test kit to determine
course accredited by EPA or an EPA whether components to be affected by
authorized program on or before March the renovation contain lead-based
31, 2010, must complete a renovator re- paint.
fresher course accredited by EPA or an (7) Must have with them at the work
EPA authorized program on or before site copies of their initial course com-
March 31, 2016, to maintain renovator pletion certificate and their most re-
certification. Individuals who com- cent refresher course completion cer-
pleted a renovator course accredited by tificate.
EPA or an EPA authorized program be- (8) Must prepare the records required
tween April 1, 2010 and March 31, 2011, by § 745.86(b)(1)(ii) and (6).
will have one year added to their origi- (c) Dust sampling technician respon-
nal 5-year certification. Individuals sibilities. When performing optional
who take a renovator refresher course dust clearance sampling under
90
§ 745.85(c), a certified dust sampling (b) Process for suspending, revoking, or

technician: modifying certification. (1) Prior to tak-
(1) Must collect dust samples in ac- ing action to suspend, revoke, or mod-
cordance with § 745.227(e)(8), must send ify an individual’s or firm’s certifi-
the collected samples to a laboratory cation, EPA will notify the affected en-
recognized by EPA under TSCA section tity in writing of the following:
405(b), and must compare the results to (i) The legal and factual basis for the
the clearance levels in accordance with proposed suspension, revocation, or
§ 745.227(e)(8). modification.
(2) Must have with them at the work (ii) The anticipated commencement
site copies of their initial course com- date and duration of the suspension,
pletion certificate and their most re- revocation, or modification.
cent refresher course completion cer-
(iii) Actions, if any, which the af-
tificate.
fected entity may take to avoid sus-
[73 FR 21765, Apr. 22, 2008, as amended at 75 pension, revocation, or modification, or
FR 24819, May 6, 2010; 76 FR 47939, Aug. 5, to receive certification in the future.
2011; 80 FR 20446, Apr. 16, 2015; 81 FR 7995,
(iv) The opportunity and method for
Feb. 17, 2016]
requesting a hearing prior to final sus-
§ 745.91 Suspending, revoking, or pension, revocation, or modification.
modifying an individual’s or firm’s (2) If an individual or firm requests a
certification. hearing, EPA will:
(a)(1) Grounds for suspending, revok- (i) Provide the affected entity an op-
ing, or modifying an individual’s certifi- portunity to offer written statements
cation. EPA may suspend, revoke, or in response to EPA’s assertions of the
modify an individual’s certification if legal and factual basis for its proposed
the individual fails to comply with action.
Federal lead-based paint statutes or (ii) Appoint an impartial official of
regulations. EPA may also suspend, re- EPA as Presiding Officer to conduct
voke, or modify a certified renovator’s the hearing.
certification if the renovator fails to (3) The Presiding Officer will:
ensure that all assigned renovations (i) Conduct a fair, orderly, and impar-
comply with § 745.85. In addition to an tial hearing within 90 days of the re-
administrative or judicial finding of quest for a hearing.
violation, execution of a consent agree- (ii) Consider all relevant evidence,
ment in settlement of an enforcement explanation, comment, and argument
action constitutes, for purposes of this submitted.
section, evidence of a failure to comply
(iii) Notify the affected entity in
with relevant statutes or regulations.
writing within 90 days of completion of
(2) Grounds for suspending, revoking, or
modifying a firm’s certification. EPA may the hearing of his or her decision and
suspend, revoke, or modify a firm’s cer- order. Such an order is a final agency
tification if the firm: action which may be subject to judicial
(i) Submits false or misleading infor- review. The order must contain the
mation to EPA in its application for commencement date and duration of
certification or re-certification. the suspension, revocation, or modi-
(ii) Fails to maintain or falsifies fication.
records required in § 745.86. (4) If EPA determines that the public
(iii) Fails to comply, or an individual health, interest, or welfare warrants
performing a renovation on behalf of immediate action to suspend the cer-
the firm fails to comply, with Federal tification of any individual or firm
lead-based paint statutes or regula- prior to the opportunity for a hearing,
tions. In addition to an administrative it will:
or judicial finding of violation, execu- (i) Notify the affected entity in ac-
tion of a consent agreement in settle- cordance with paragraph (b)(1)(i)
ment of an enforcement action con- through (b)(1)(iii) of this section, ex-
stitutes, for purposes of this section, plaining why it is necessary to suspend

evidence of a failure to comply with the entity’s certification before an op-
relevant statutes or regulations. portunity for a hearing.
91
§ 745.92 40 CFR Ch. I (7–1–17 Edition)
(ii) Notify the affected entity of its (iii) A firm whose certification has
right to request a hearing on the im- been revoked must reapply for certifi-
mediate suspension within 15 days of cation after the revocation ends in
the suspension taking place and the order to become certified again. If the
procedures for the conduct of such a firm’s certification has been suspended
hearing. and the suspension ends less than 5
(5) Any notice, decision, or order years after the firm was initially cer-
issued by EPA under this section, any tified or re-certified, the firm does not
transcript or other verbatim record of need to do anything to re-activate its
oral testimony, and any documents certification.
filed by a certified individual or firm in [73 FR 21765, Apr. 22, 2008]
a hearing under this section will be
available to the public, except as oth- § 745.92 Fees for the accreditation of
erwise provided by section 14 of TSCA renovation and dust sampling tech-
or by part 2 of this title. Any such nician training and the certification
hearing at which oral testimony is pre- of renovation firms.
sented will be open to the public, ex- (a) Persons who must pay fees. Fees in
cept that the Presiding Officer may ex- accordance with paragraph (b) of this
clude the public to the extent nec- section must be paid by:
essary to allow presentation of infor- (1) Training programs—(i) Non-exempt
mation which may be entitled to con- training programs. All non-exempt
fidential treatment under section 14 of training programs applying to EPA for
TSCA or part 2 of this title. the accreditation and re-accreditation
(6) EPA will maintain a publicly of training programs in one or more of
available list of entities whose certifi- the following disciplines: Renovator,
cation has been suspended, revoked, dust sampling technician.
modified, or reinstated. (ii) Exemption. No fee shall be im-
(7) Unless the decision and order posed on any training program oper-
issued under paragraph (b)(3)(iii) of ated by a State, federally recognized
this section specify otherwise: Indian Tribe, local government, or non-
(i) An individual whose certification profit organization. This exemption
has been suspended must take a re- does not apply to the certification of
fresher training course (renovator or firms or individuals.
dust sampling technician) in order to (2) Firms. All firms applying to EPA
make his or her certification current. for certification and re-certification to
(ii) An individual whose certification conduct renovations.
has been revoked must take an initial (b) Fee amounts—(1) Certification and
renovator or dust sampling technician accreditation fees. Initial and renewal
course in order to become certified certification and accreditation fees are
again. specified in the following table:
Re-accreditation (every 4 years, see
Training Program Accreditation 40 CFR 745.225(f)(1) for details)
Initial Renovator or Dust Sampling Technician $560 $340

Course
Refresher Renovator or Dust Sampling Tech- $400 $310

nician Course
Renovation Firm Certification Re-certification (every 5 years see 40

CFR 745.89(b))
Firm $300 $300

Combined Renovation and Lead-based Paint $550 $550
Activities Firm Application
Combined Renovation and Lead-based Paint $20 $20
Activities Tribal Firm Application
Tribal Firm $20 $20
92
(2) Lost certificate. A $15 fee will be contract to purchase or lease target
charged for the replacement of a firm housing.
certificate.
(c) Certificate replacement. Firms seek- § 745.101 Scope and applicability.
ing certificate replacement must: This subpart applies to all trans-
(1) Complete the applicable portions actions to sell or lease target housing,
of the ‘‘Application for Firms’’ in ac- including subleases, with the exception
cordance with the instructions proof the following:
vided. (a) Sales of target housing at fore-
(2) Submit the application and a pay- closure.
ment of $15 in accordance with the in- (b) Leases of target housing that
structions provided with the applica- have been found to be lead-based paint
tion package. free by an inspector certified under the
(3) Accreditation or certification amend- Federal certification program or under
ments. No fee will be charged for ac- a federally accredited State or tribal
creditation or certification amend- certification program. Until a Federal
ments. certification program or federally ac-
credited State certification program is
(d) Failure to remit fees. (1) EPA will
in place within the State, inspectors
not provide certification, re-certifi-
shall be considered qualified to conduct
cation, accreditation, or re-accredita-
an inspection for this purpose if they
tion for any firm or training program
have received certification under any
that does not remit fees described in
existing State or tribal inspector cer-
paragraph (b) of this section in accord-
tification program. The lessor has the
ance with the procedures specified in 40
option of using the results of addi-
CFR 745.89.
tional test(s) by a certified inspector to
(2) EPA will not replace a certificate
confirm or refute a prior finding.
for any firm that does not remit the $15 (c) Short-term leases of 100 days or
fee in accordance with the procedures less, where no lease renewal or exten-
specified in paragraph (c) of this sec- sion can occur.
tion. (d) Renewals of existing leases in tar-
[74 FR 11869, Mar. 20, 2009, as amended at 76 get housing in which the lessor has pre-
FR 47939, Aug. 5, 2011] viously disclosed all information re-
quired under § 745.107 and where no new
Subpart F—Disclosure of Known information described in § 745.107 has
Lead-Based Paint and/or come into the possession of the lessor.
For the purposes of this paragraph, re-
Lead-Based Paint Hazards newal shall include both renegotiation
Upon Sale or Lease of Resi- of existing lease terms and/or ratifica-
dential Property tion of a new lease.
§ 745.100 Purpose. § 745.102 Effective dates.
This subpart implements the provi- The requirements in this subpart
sions of 42 U.S.C. 4852d, which impose take effect in the following manner:
certain requirements on the sale or (a) For owners of more than four resi-
lease of target housing. Under this sub- dential dwellings, the requirements
part, a seller or lessor of target hous- shall take effect on September 6, 1996.
ing shall disclose to the purchaser or (b) For owners of one to four residen-
lessee the presence of any known lead- tial dwellings, the requirements shall
based paint and/or lead-based paint take effect on December 6, 1996.
hazards; provide available records and
reports; provide the purchaser or lessee § 745.103 Definitions.
with a lead hazard information pam- The following definitions apply to
phlet; give purchasers a 10-day oppor- this subpart.
tunity to conduct a risk assessment or The Act means the Residential Lead-
inspection; and attach specific disclo- Based Paint Hazard Reduction Act of
sure and warning language to the sales 1992, 42 U.S.C. 4852d.

or leasing contract before the pur- Agent means any party who enters
chaser or lessee is obligated under a into a contract with a seller or lessor,
93
§ 745.103 40 CFR Ch. I (7–1–17 Edition)
including any party who enters into a be free of paint or other surface coat-
contract with a representative of the ings that contain lead equal to or in
seller or lessor, for the purpose of sell- excess of 1.0 milligram per square cen-
ing or leasing target housing. This timeter or 0.5 percent by weight.
term does not apply to purchasers or Lead-based paint hazard means any
any purchaser’s representative who re- condition that causes exposure to lead
ceives all compensation from the pur- from lead-contaminated dust, lead-con-
chaser. taminated soil, or lead-contaminated
Available means in the possession of paint that is deteriorated or present in
or reasonably obtainable by the seller accessible surfaces, friction surfaces,
or lessor at the time of the disclosure. or impact surfaces that would result in
Common area means a portion of a adverse human health effects as estab-
building generally accessible to all
lished by the appropriate Federal agen-
residents/users including, but not lim-
cy.
ited to, hallways, stairways, laundry
and recreational rooms, playgrounds, Lessee means any entity that enters
community centers, and boundary into an agreement to lease, rent, or
fences. sublease target housing, including but
Contract for the purchase and sale of not limited to individuals, partner-
residential real property means any con- ships, corporations, trusts, government
tract or agreement in which one party agencies, housing agencies, Indian
agrees to purchase an interest in real tribes, and nonprofit organizations.
property on which there is situated one Lessor means any entity that offers
or more residential dwellings used or target housing for lease, rent, or sub-
occupied, or intended to be used or oc- lease, including but not limited to indi-
cupied, in whole or in part, as the home viduals, partnerships, corporations,
or residence of one or more persons. trusts, government agencies, housing
EPA means the Environmental Pro- agencies, Indian tribes, and nonprofit
tection Agency. organizations.
Evaluation means a risk assessment Owner means any entity that has
and/or inspection. legal title to target housing, including
Foreclosure means any of the various but not limited to individuals, partner-
methods, statutory or otherwise, ships, corporations, trusts, government
known in different jurisdictions, of en- agencies, housing agencies, Indian
forcing payment of a debt, by the tak- tribes, and nonprofit organizations, ex-
ing and selling of real property. cept where a mortgagee holds legal
Housing for the elderly means retire- title to property serving as collateral
ment communities or similar types of for a mortgage loan, in which case the
housing reserved for households com- owner would be the mortgagor.
posed of one or more persons 62 years Purchaser means an entity that en-
of age or more at the time of initial oc- ters into an agreement to purchase an
cupancy. interest in target housing, including
HUD means the U.S. Department of but not limited to individuals, partner-
Housing and Urban Development. ships, corporations, trusts, government
Inspection means: agencies, housing agencies, Indian
(1) A surface-by-surface investigation
tribes, and nonprofit organizations.
to determine the presence of lead-based
Reduction means measures designed
paint as provided in section 302(c) of
the Lead-Based Paint Poisoning and to reduce or eliminate human exposure
Prevention Act [42 U.S.C. 4822], and to lead-based paint hazards through
(2) The provision of a report explain- methods including interim controls
ing the results of the investigation. and abatement.
Lead-based paint means paint or other Residential dwelling means:
surface coatings that contain lead (1) A single-family dwelling, includ-
equal to or in excess of 1.0 milligram ing attached structures such as porches
per square centimeter or 0.5 percent by and stoops; or
weight. (2) A single-family dwelling unit in a

Lead-based paint free housing means structure that contains more than one
target housing that has been found to separate residential dwelling unit, and
94
in which each such unit is used or oc- § 745.107 Disclosure requirements for
cupied, or intended to be used or occu- sellers and lessors.
pied, in whole or in part, as the resi- (a) The following activities shall be
dence of one or more persons. completed before the purchaser or les-
Risk assessment means an on-site in- see is obligated under any contract to
vestigation to determine and report purchase or lease target housing that
the existence, nature, severity, and lo- is not otherwise an exempt transaction
cation of lead-based paint hazards in pursuant to § 745.101. Nothing in this
residential dwellings, including: section implies a positive obligation on
(1) Information gathering regarding the seller or lessor to conduct any eval-
the age and history of the housing and uation or reduction activities.
occupancy by children under age 6; (1) The seller or lessor shall provide
the purchaser or lessee with an EPA-
(2) Visual inspection;
approved lead hazard information pam-
(3) Limited wipe sampling or other phlet. Such pamphlets include the EPA
environmental sampling techniques; document entitled Protect Your Family
(4) Other activity as may be appro- From Lead in Your Home (EPA #747-K-
priate; and 94-001) or an equivalent pamphlet that
(5) Provision of a report explaining has been approved for use in that State
the results of the investigation. by EPA.
Secretary means the Secretary of (2) The seller or lessor shall disclose
Housing and Urban Development. to the purchaser or lessee the presence
Seller means any entity that transfers of any known lead-based paint and/or
legal title to target housing, in whole lead-based paint hazards in the target
or in part, in return for consideration, housing being sold or leased. The seller
including but not limited to individ- or lessor shall also disclose any addi-
uals, partnerships, corporations, tional information available con-
cerning the known lead-based paint
trusts, government agencies, housing
and/or lead-based paint hazards, such
agencies, Indian tribes, and nonprofit
as the basis for the determination that
organizations. The term ‘‘seller’’ also lead-based paint and/or lead-based
includes: paint hazards exist, the location of the
(1) An entity that transfers shares in lead-based paint and/or lead-based
a cooperatively owned project, in re- paint hazards, and the condition of the
turn for consideration; and painted surfaces.
(2) An entity that transfers its inter- (3) The seller or lessor shall disclose
est in a leasehold, in jurisdictions or to each agent the presence of any
circumstances where it is legally per- known lead-based paint and/or lead-
missible to separate the fee title from based paint hazards in the target hous-
the title to the improvement, in return ing being sold or leased and the exist-
for consideration. ence of any available records or reports
Target housing means any housing pertaining to lead-based paint and/or
constructed prior to 1978, except hous- lead-based paint hazards. The seller or
ing for the elderly or persons with dis- lessor shall also disclose any additional
abilities (unless any child who is less information available concerning the
than 6 years of age resides or is ex- known lead-based paint and/or lead-
pected to reside in such housing) or based paint hazards, such as the basis
for the determination that lead-based
any 0-bedroom dwelling.
paint and/or lead-based paint hazards
TSCA means the Toxic Substances exist, the location of the lead-based
Control Act, 15 U.S.C. 2601. paint and/or lead-based paint hazards,
0-bedroom dwelling means any residen- and the condition of the painted sur-
tial dwelling in which the living area is faces.
not separated from the sleeping area. (4) The seller or lessor shall provide
The term includes efficiencies, studio the purchaser or lessee with any
apartments, dormitory housing, mili- records or reports available to the sell-
tary barracks, and rentals of individual er or lessor pertaining to lead-based

rooms in residential dwellings. paint and/or lead-based paint hazards
in the target housing being sold or
95
§ 745.110 40 CFR Ch. I (7–1–17 Edition)
leased. This requirement includes The seller of any interest in residential real
records or reports regarding common property is required to provide the buyer
areas. This requirement also includes with any information on lead-based paint
hazards from risk assessments or inspections
records or reports regarding other resi- in the seller’s possession and notify the
dential dwellings in multifamily target buyer of any known lead-based paint haz-
housing, provided that such informa- ards. A risk assessment or inspection for pos-
tion is part of an evaluation or reduc- sible lead-based paint hazards is rec-
tion of lead-based paint and/or lead- ommended prior to purchase.
based paint hazards in the target hous- (2) A statement by the seller dis-
ing as a whole. closing the presence of known lead-
(b) If any of the disclosure activities based paint and/or lead-based paint
identified in paragraph (a) of this sec- hazards in the target housing being
tion occurs after the purchaser or les- sold or indicating no knowledge of the
see has provided an offer to purchase or presence of lead-based paint and/or
lease the housing, the seller or lessor lead-based paint hazards. The seller
shall complete the required disclosure shall also provide any additional infor-
activities prior to accepting the pur- mation available concerning the
chaser’s or lessee’s offer and allow the known lead-based paint and/or lead-
purchaser or lessee an opportunity to based paint hazards, such as the basis
review the information and possibly for the determination that lead-based
amend the offer. paint and/or lead-based paint hazards
exist, the location of the lead-based
§ 745.110 Opportunity to conduct an
evaluation. paint and/or lead-based paint hazards,
and the condition of the painted sur-
(a) Before a purchaser is obligated faces.
under any contract to purchase target (3) A list of any records or reports
housing, the seller shall permit the available to the seller pertaining to
purchaser a 10-day period (unless the lead-based paint and/or lead-based
parties mutually agree, in writing, paint hazards in the housing that have
upon a different period of time) to con- been provided to the purchaser. If no
duct a risk assessment or inspection such records or reports are available,
for the presence of lead-based paint the seller shall so indicate.
and/or lead-based paint hazards. (4) A statement by the purchaser af-
(b) Not withstanding paragraph (a) of firming receipt of the information set
this section, a purchaser may waive out in paragraphs (a)(2) and (a)(3) of
the opportunity to conduct the risk as- this section and the lead hazard infor-
sessment or inspection by so indicating mation pamphlet required under 15
in writing. U.S.C. 2696.
(5) A statement by the purchaser that
§ 745.113 Certification and acknowl-
edgment of disclosure. he/she has either:
(i) Received the opportunity to con-
(a) Seller requirements. Each contract duct the risk assessment or inspection
to sell target housing shall include an required by § 745.110(a); or
attachment containing the following (ii) Waived the opportunity.
elements, in the language of the con- (6) When one or more agents are in-
tract (e.g., English, Spanish): volved in the transaction to sell target
(1) A Lead Warning Statement con- housing on behalf of the seller, a state-
sisting of the following language: ment that:
Every purchaser of any interest in residen- (i) The agent has informed the seller
tial real property on which a residential of the seller’s obligations under 42
dwelling was built prior to 1978 is notified U.S.C. 4852d; and
that such property may present exposure to (ii) The agent is aware of his/her duty
lead from lead-based paint that may place to ensure compliance with the require-
young children at risk of developing lead ments of this subpart.
poisoning. Lead poisoning in young children
(7) The signatures of the sellers,
may produce permanent neurological dam-
agents, and purchasers certifying to
age, including learning disabilities, reduced

intelligence quotient, behavioral problems, the accuracy of their statements to the
and impaired memory. Lead poisoning also best of their knowledge, along with the
poses a particular risk to pregnant women. dates of signature.
96
(b) Lessor requirements. Each contract (6) The signatures of the lessors,
to lease target housing shall include, agents, and lessees, certifying to the
as an attachment or within the con- accuracy of their statements, to the
tract, the following elements, in the best of their knowledge, along with the
language of the contract (e.g., English, dates of signature.
Spanish): (c) Retention of Certification and Ac-
(1) A Lead Warning Statement with knowledgment Information. (1) The sell-
the following language: er, and any agent, shall retain a copy
of the completed attachment required
Housing built before 1978 may contain lead-
based paint. Lead from paint, paint chips,
under paragraph (a) of this section for
and dust can pose health hazards if not man- no less than 3 years from the comple-
aged properly. Lead exposure is especially tion date of the sale. The lessor, and
harmful to young children and pregnant any agent, shall retain a copy of the
women. Before renting pre-1978 housing, les- completed attachment or lease con-
sors must disclose the presence of lead-based tract containing the information re-
paint and/or lead-based paint hazards in the quired under paragraph (b) of this sec-
dwelling. Lessees must also receive a feder- tion for no less than 3 years from the
ally approved pamphlet on lead poisoning
prevention.
commencement of the leasing period.
(2) This recordkeeping requirement is
(2) A statement by the lessor dis- not intended to place any limitations
closing the presence of known lead- on civil suits under the Act, or to oth-
based paint and/or lead-based paint erwise affect a lessee’s or purchaser’s
hazards in the target housing being rights under the civil penalty provi-
leased or indicating no knowledge of sions of 42 U.S.C. 4852d(b)(3).
the presence of lead-based paint and/or (d) The seller, lessor, or agent shall
lead-based paint hazards. The lessor not be responsible for the failure of a
shall also disclose any additional infor- purchaser’s or lessee’s legal representa-
mation available concerning the tive (where such representative re-
known lead-based paint and/or lead- ceives all compensation from the pur-
based paint hazards, such as the basis chaser or lessee) to transmit disclosure
for the determination that lead-based materials to the purchaser or lessee,
paint and/or lead-based paint hazards provided that all required parties have
exist, the location of the lead-based completed and signed the necessary
paint and/or lead-based paint hazards, certification and acknowledgment lan-
and the condition of the painted sur- guage required under paragraphs (a)
faces. and (b) of this section.
(3) A list of any records or reports
available to the lessor pertaining to § 745.115 Agent responsibilities.
lead-based paint and/or lead-based (a) Each agent shall ensure compli-
paint hazards in the housing that have ance with all requirements of this sub-
been provided to the lessee. If no such part. To ensure compliance, the agent
records or reports are available, the shall:
lessor shall so indicate. (1) Inform the seller or lessor of his/
(4) A statement by the lessee affirm- her obligations under §§ 745.107, 745.110,
ing receipt of the information set out and 745.113.
in paragraphs (b)(2) and (b)(3) of this (2) Ensure that the seller or lessor
section and the lead hazard informa- has performed all activities required
tion pamphlet required under 15 U.S.C. under §§ 745.107, 745.110, and 745.113, or
2696. personally ensure compliance with the
(5) When one or more agents are in- requirements of §§ 745.107, 745.110, and
volved in the transaction to lease tar- 745.113.
get housing on behalf of the lessor, a (b) If the agent has complied with
statement that: paragraph (a)(1) of this section, the
(i) The agent has informed the lessor agent shall not be liable for the failure
of the lessor as obligations under 42 to disclose to a purchaser or lessee the
U.S.C. 4852d; and presence of lead-based paint and/or
(ii) The agent is aware of his/her duty lead-based paint hazards known by a
to ensure compliance with the require- seller or lessor but not disclosed to the
ments of this subpart. agent.
97
§ 745.118 40 CFR Ch. I (7–1–17 Edition)
§ 745.118 Enforcement. suring compliance with such State or

local requirements.
(a) Any person who knowingly fails
to comply with any provision of this
subpart shall be subject to civil mone- Subparts G–K [Reserved]
tary penalties in accordance with the
provisions of 42 U.S.C. 3545 and 24 CFR Subpart L—Lead-Based Paint
part 30. Activities
(b) The Secretary is authorized to
take such action as may be necessary SOURCE: 61 FR 45813, Aug. 29, 1996, unless
to enjoin any violation of this subpart otherwise noted.
in the appropriate Federal district
court. § 745.220 Scope and applicability.
(c) Any person who knowingly vio- (a) This subpart contains procedures
lates the provisions of this subpart and requirements for the accreditation
shall be jointly and severally liable to of training programs for lead-based
the purchaser or lessee in an amount paint activities and renovations, proce-
equal to 3 times the amount of dam- dures and requirements for the certifi-
ages incurred by such individual. cation of individuals and firms engaged
(d) In any civil action brought for in lead-based paint activities, and work
damages pursuant to 42 U.S.C. practice standards for performing such
4852d(b)(3), the appropriate court may activities. This subpart also requires
award court costs to the party com- that, except as discussed below, all
mencing such action, together with lead-based paint activities, as defined
reasonable attorney fees and any ex- in this subpart, be performed by cer-
pert witness fees, if that party prevails. tified individuals and firms.
(e) Failure or refusal to comply with (b) This subpart applies to all indi-
§ 745.107 (disclosure requirements for viduals and firms who are engaged in
sellers and lessors), § 745.110 (oppor- lead-based paint activities as defined in
tunity to conduct an evaluation), § 745.223, except persons who perform
§ 745.113 (certification and acknowledg- these activities within residential
ment of disclosure), or § 745.115 (agent dwellings that they own, unless the
responsibilities) is a violation of 42 residential dwelling is occupied by a
U.S.C. 4852d(b)(5) and of TSCA section person or persons other than the owner
409 (15 U.S.C. 2689). or the owner’s immediate family while
(f) Violators may be subject to civil these activities are being performed, or
and criminal sanctions pursuant to a child residing in the building has
TSCA section 16 (15 U.S.C. 2615) for been identified as having an elevated
each violation. For purposes of enforc- blood lead level. This subpart applies
ing this subpart, the penalty for each only in those States or Indian Country
violation applicable under 15 U.S.C. that do not have an authorized State or
2615 shall not be more than $11,000 for Tribal program pursuant to § 745.324 of
all violations occuring after July 28, subpart Q.
1997; all violations occuring on or prior (c) Each department, agency, and in-
to that date are subject to a penalty strumentality of the executive, legisla-
not more than $10,000. tive, and judicial branches of the Fed-
[61 FR 9085, Mar. 6, 1996, as amended at 62 FR eral Government having jurisdiction
35041, June 27, 1997] over any property or facility, or en-
gaged in any activity resulting, or
§ 745.119 Impact on State and local re- which may result, in a lead-based paint
quirements. hazard, and each officer, agent, or em-
Nothing in this subpart shall relieve ployee thereof shall be subject to, and
a seller, lessor, or agent from any re- comply with, all Federal, State, inter-
sponsibility for compliance with State state, and local requirements, both
or local laws, ordinances, codes, or reg- substantive and procedural, including
ulations governing notice or disclosure the requirements of this subpart re-
of known lead-based paint or lead- garding lead-based paint, lead-based

based paint hazards. Neither HUD nor paint activities, and lead-based paint
EPA assumes any responsibility for en- hazards.
98
(d) While this subpart establishes defined by this section, unless such
specific requirements for performing projects are covered by paragraph (4) of
lead-based paint activities should they this definition; or
be undertaken, nothing in this subpart (iv) Projects resulting in the perma-
requires that the owner or occupant nent elimination of lead-based paint
undertake any particular lead-based hazards, that are conducted in response
paint activity. to State or local abatement orders.
[61 FR 45813, Aug. 29, 1996, as amended at 73 (4) Abatement does not include ren-
FR 21766, Apr. 22, 2008] ovation, remodeling, landscaping or
other activities, when such activities
§ 745.223 Definitions. are not designed to permanently elimi-
The definitions in subpart A apply to nate lead-based paint hazards, but, in-
this subpart. In addition, the following stead, are designed to repair, restore,
definitions apply. or remodel a given structure or dwell-
Abatement means any measure or set ing, even though these activities may
of measures designed to permanently incidentally result in a reduction or
eliminate lead-based paint hazards. elimination of lead-based paint haz-
Abatement includes, but is not limited ards. Furthermore, abatement does not
to: include interim controls, operations
(1) The removal of paint and dust, the and maintenance activities, or other
permanent enclosure or encapsulation measures and activities designed to
of lead-based paint, the replacement of temporarily, but not permanently, re-
painted surfaces or fixtures, or the reduce lead-based paint hazards.
moval or permanent covering of soil, Accredited training program means a
when lead-based paint hazards are training program that has been accred-
present in such paint, dust or soil; and ited by EPA pursuant to § 745.225 to
(2) All preparation, cleanup, disposal, provide training for individuals en-
and post-abatement clearance testing gaged in lead-based paint activities.
activities associated with such meas-
Adequate quality control means a plan
ures.
or design which ensures the authen-
(3) Specifically, abatement includes,
ticity, integrity, and accuracy of sam-
but is not limited to:
ples, including dust, soil, and paint
(i) Projects for which there is a writ-
chip or paint film samples. Adequate
ten contract or other documentation,
quality control also includes provisions
which provides that an individual or
for representative sampling.
firm will be conducting activities in or
to a residential dwelling or child-occu- Business day means Monday through
pied facility that: Friday with the exception of Federal
(A) Shall result in the permanent holidays.
elimination of lead-based paint haz- Certified firm means a company, part-
ards; or nership, corporation, sole proprietor-
(B) Are designed to permanently ship, association, or other business en-
eliminate lead-based paint hazards and tity that performs lead-based paint ac-
are described in paragraphs (1) and (2) tivities to which EPA has issued a cer-
of this definition. tificate of approval pursuant to
(ii) Projects resulting in the perma- § 745.226(f).
nent elimination of lead-based paint Certified inspector means an indi-
hazards, conducted by firms or individ- vidual who has been trained by an ac-
uals certified in accordance with credited training program, as defined
§ 745.226, unless such projects are cov- by this section, and certified by EPA
ered by paragraph (4) of this definition; pursuant to § 745.226 to conduct inspec-
(iii) Projects resulting in the perma- tions. A certified inspector also sam-
nent elimination of lead-based paint ples for the presence of lead in dust and
hazards, conducted by firms or individ- soil for the purposes of abatement
uals who, through their company name clearance testing.
or promotional literature, represent, Certified abatement worker means an
advertise, or hold themselves out to be individual who has been trained by an

in the business of performing lead- accredited training program, as defined
based paint activities as identified and by this section, and certified by EPA
99
§ 745.223 40 CFR Ch. I (7–1–17 Edition)
pursuant to § 745.226 to perform abate- molding, walls, chair rails, doors, door
ments. trim, floors, fireplaces, radiators and
Certified project designer means an in- other heating units, shelves, shelf sup-
dividual who has been trained by an ac- ports, stair treads, stair risers, stair
credited training program, as defined stringers, newel posts, railing caps,
by this section, and certified by EPA balustrades, windows and trim (includ-
pursuant to § 745.226 to prepare abate- ing sashes, window heads, jambs, sills
ment project designs, occupant protec- or stools and troughs), built in cabi-
tion plans, and abatement reports. nets, columns, beams, bathroom vani-
Certified risk assessor means an indi- ties, counter tops, and air conditioners;
vidual who has been trained by an ac- and exterior components such as:
credited training program, as defined painted roofing, chimneys, flashing,
by this section, and certified by EPA gutters and downspouts, ceilings, sof-
pursuant to § 745.226 to conduct risk as- fits, fascias, rake boards, cornerboards,
sessments. A risk assessor also samples bulkheads, doors and door trim, fences,
for the presence of lead in dust and soil floors, joists, lattice work, railings and
for the purposes of abatement clear- railing caps, siding, handrails, stair ris-
ance testing. ers and treads, stair stringers, col-
Certified supervisor means an indi- umns, balustrades, window sills or
vidual who has been trained by an ac- stools and troughs, casings, sashes and
credited training program, as defined wells, and air conditioners.
by this section, and certified by EPA Containment means a process to pro-
pursuant to § 745.226 to supervise and tect workers and the environment by
conduct abatements, and to prepare oc- controlling exposures to the lead-con-
cupant protection plans and abatement taminated dust and debris created dur-
reports. ing an abatement.
Child-occupied facility means a build- Course agenda means an outline of
ing, or portion of a building, con- the key topics to be covered during a
structed prior to 1978, visited regularly training course, including the time al-
by the same child, 6 years of age or lotted to teach each topic.
under, on at least two different days Course test means an evaluation of
within any week (Sunday through Sat- the overall effectiveness of the training
urday period), provided that each day’s which shall test the trainees’ knowl-
visit lasts at least 3 hours and the com- edge and retention of the topics cov-
bined weekly visit lasts at least 6 ered during the course.
hours, and the combined annual visits Course test blue print means written
last at least 60 hours. Child-occupied documentation identifying the propor-
facilities may include, but are not lim- tion of course test questions devoted to
ited to, day-care centers, preschools each major topic in the course cur-
and kindergarten classrooms. riculum.
Clearance levels are values that indi- Deteriorated paint means paint that is
cate the maximum amount of lead per- cracking, flaking, chipping, peeling, or
mitted in dust on a surface following otherwise separating from the sub-
completion of an abatement activity. strate of a building component.
Common area means a portion of a Discipline means one of the specific
building that is generally accessible to types or categories of lead-based paint
all occupants. Such an area may in- activities identified in this subpart for
clude, but is not limited to, hallways, which individuals may receive training
stairways, laundry and recreational from accredited programs and become
rooms, playgrounds, community cen- certified by EPA. For example,
ters, garages, and boundary fences. ‘‘abatement worker’’ is a discipline.
Component or building component Distinct painting history means the ap-
means specific design or structural ele- plication history, as indicated by its
ments or fixtures of a building, residen- visual appearance or a record of appli-
tial dwelling, or child-occupied facility cation, over time, of paint or other sur-
that are distinguished from each other face coatings to a component or room.
by form, function, and location. These Documented methodologies are meth-

include, but are not limited to, interior ods or protocols used to sample for the
components such as: ceilings, crown presence of lead in paint, dust, and soil.
100
Elevated blood lead level (EBL) means based paint hazards or potential haz-
an excessive absorption of lead that is ards, and the establishment and oper-
a confirmed concentration of lead in ation of management and resident edu-
whole blood of 20 μg/dl (micrograms of cation programs.
lead per deciliter of whole blood) for a Lead-based paint means paint or other
single venous test or of 15–19 μg/dl in surface coatings that contain lead
two consecutive tests taken 3 to 4 equal to or in excess of 1.0 milligrams
months apart. per square centimeter or more than 0.5
Encapsulant means a substance that percent by weight.
forms a barrier between lead-based Lead-based paint activities means, in
paint and the environment using a liq- the case of target housing and child-oc-
uid-applied coating (with or without cupied facilities, inspection, risk as-
reinforcement materials) or an adhe- sessment, and abatement, as defined in
sively bonded covering material. this subpart.
Encapsulation means the application Lead-based paint activities courses
of an encapsulant. means initial and refresher training
Enclosure means the use of rigid, du- courses (worker, supervisor, inspector,
rable construction materials that are risk assessor, project designer) pro-
mechanically fastened to the substrate vided by accredited training programs.
in order to act as a barrier between Lead-based paint hazard means any
lead-based paint and the environment. condition that causes exposure to lead
Guest instructor means an individual from lead-contaminated dust, lead-con-
designated by the training program taminated soil, or lead-contaminated
manager or principal instructor to pro- paint that is deteriorated or present in
vide instruction specific to the lecture, accessible surfaces, friction surfaces,
hands-on activities, or work practice or impact surfaces that would result in
components of a course. adverse human health effects as identi-
Hands-on skills assessment means an fied by the Administrator pursuant to
evaluation which tests the trainees’ TSCA section 403.
ability to satisfactorily perform the Lead-hazard screen is a limited risk
work practices and procedures identi- assessment activity that involves lim-
fied in § 745.225(d), as well as any other ited paint and dust sampling as de-
skill taught in a training course. scribed in § 745.227(c).
Hazardous waste means any waste as Living area means any area of a resi-
defined in 40 CFR 261.3. dential dwelling used by one or more
Inspection means a surface-by-surface children age 6 and under, including, but
investigation to determine the pres- not limited to, living rooms, kitchen
ence of lead-based paint and the provi- areas, dens, play rooms, and children’s
sion of a report explaining the results bedrooms.
of the investigation. Local government means a county,
Interim certification means the status city, town, borough, parish, district,
of an individual who has successfully association, or other public body (in-
completed the appropriate training cluding an agency comprised of two or
course in a discipline from an accred- more of the foregoing entities) created
ited training program, as defined by under State law.
this section, but has not yet received Multi-family dwelling means a struc-
formal certification in that discipline ture that contains more than one sepa-
from EPA pursuant to § 745.226. Interim rate residential dwelling unit, which is
certifications expire 6 months after the used or occupied, or intended to be
completion of the training course, and used or occupied, in whole or in part,
is equivalent to a certificate for the 6- as the home or residence of one or
month period. more persons.
Interim controls means a set of meas- Nonprofit means an entity which has
ures designed to temporarily reduce demonstrated to any branch of the
human exposure or likely exposure to Federal Government or to a State, mu-
lead-based paint hazards, including nicipal, tribal or territorial govern-
specialized cleaning, repairs, mainte- ment, that no part of its net earnings
nance, painting, temporary contain- inure to the benefit of any private
ment, ongoing monitoring of lead- shareholder or individual.
101
§ 745.223 40 CFR Ch. I (7–1–17 Edition)
Paint in poor condition means more or the firm conducting the risk assess-
than 10 square feet of deteriorated ment, explaining the results of the in-
paint on exterior components with vestigation and options for reducing
large surface areas; or more than 2 lead-based paint hazards.
square feet of deteriorated paint on in- Start date means the first day of any
terior components with large surface lead-based paint activities training
areas (e.g., walls, ceilings, floors, course or lead-based paint abatement
doors); or more than 10 percent of the activity.
total surface area of the component is Start date provided to EPA means the
deteriorated on interior or exterior
start date included in the original noti-
components with small surface areas
fication or the most recent start date
(window sills, baseboards, soffits,
trim). provided to EPA in an updated notifi-
Permanently covered soil means soil cation.
which has been separated from human State means any State of the United
contact by the placement of a barrier States, the District of Columbia, the
consisting of solid, relatively imper- Commonwealth of Puerto Rico, the
meable materials, such as pavement or Virgin Islands, Guam, the Canal Zone,
concrete. Grass, mulch, and other land- American Samoa, the Northern Mar-
scaping materials are not considered iana Islands, or any other territory or
permanent covering. possession of the United States.
Person means any natural or judicial Target housing means any housing
person including any individual, cor- constructed prior to 1978, except hous-
poration, partnership, or association; ing for the elderly or persons with dis-
any Indian Tribe, State, or political abilities (unless any one or more chil-
subdivision thereof; any interstate dren age 6 years or under resides or is
body; and any department, agency, or expected to reside in such housing for
instrumentality of the Federal govern- the elderly or persons with disabilities)
ment. or any 0-bedroom dwelling.
Principal instructor means the indi-
Training curriculum means an estab-
vidual who has the primary responsi-
lished set of course topics for instruc-
bility for organizing and teaching a
particular course. tion in an accredited training program
Recognized laboratory means an envi- for a particular discipline designed to
ronmental laboratory recognized by provide specialized knowledge and
EPA pursuant to TSCA section 405(b) skills.
as being capable of performing an anal- Training hour means at least 50 min-
ysis for lead compounds in paint, soil, utes of actual learning, including, but
and dust. not limited to, time devoted to lecture,
Reduction means measures designed learning activities, small group activi-
to reduce or eliminate human exposure ties, demonstrations, evaluations, and/
to lead-based paint hazards through or hands-on experience.
methods including interim controls Training manager means the indi-
and abatement. vidual responsible for administering a
Residential dwelling means (1) a de- training program and monitoring the
tached single family dwelling unit, in- performance of principal instructors
cluding attached structures such as and guest instructors.
porches and stoops; or (2) a single fam- Training provider means any organiza-
ily dwelling unit in a structure that tion or entity accredited under § 745.225
contains more than one separate resi- to offer lead-based paint activities
dential dwelling unit, which is used or
courses.
occupied, or intended to be used or oc-
cupied, in whole or in part, as the home Visual inspection for clearance testing
or residence of one or more persons. means the visual examination of a resi-
Risk assessment means (1) an on-site dential dwelling or a child-occupied fa-
investigation to determine the exist- cility following an abatement to deter-
ence, nature, severity, and location of mine whether or not the abatement has
lead-based paint hazards, and (2) the been successfully completed.
provision of a report by the individual
102
Visual inspection for risk assessment tion to offer lead-based paint activities
means the visual examination of a resi- courses, renovator courses, or dust
dential dwelling or a child-occupied fa- sampling technician courses:
cility to determine the existence of de- (1) A training program seeking ac-
teriorated lead-based paint or other po- creditation shall submit a written ap-
tential sources of lead-based paint haz- plication to EPA containing the fol-
ards. lowing information:
[61 FR 45813, Aug. 29, 1996, as amended at 64
(i) The training program’s name, ad-
FR 31097, June 9, 1999; 66 FR 1239, Jan. 5, 2001; dress, and telephone number.
69 FR 18495, Apr. 8, 2004] (ii) A list of courses for which it is
applying for accreditation. For the pur-
§ 745.225 Accreditation of training proposes of this section, courses taught in
grams: target housing and child oc- different languages and electronic
cupied facilities. learning courses are considered dif-
(a) Scope. (1) A training program may ferent courses, and each must inde-
seek accreditation to offer courses in pendently meet the accreditation re-
any of the following disciplines: Inspec- quirements.
tor, risk assessor, supervisor, project (iii) The name and documentation of
designer, abatement worker, renovator, the qualifications of the training pro-
and dust sampling technician. A train- gram manager.
ing program may also seek accredita- (iv) The name(s) and documentation
tion to offer refresher courses for each of qualifications of any principal in-
of the above listed disciplines. structor(s).
(2) Training programs may first (v) A statement signed by the train-
apply to EPA for accreditation of their ing program manager certifying that
lead-based paint activities courses or the training program meets the re-
refresher courses pursuant to this sec- quirements established in paragraph
tion on or after August 31, 1998. Train- (c) of this section. If a training pro-
ing programs may first apply to EPA gram uses EPA-recommended model
for accreditation of their renovator or training materials, or training mate-
dust sampling technician courses or re- rials approved by a State or Indian
fresher courses pursuant to this section Tribe that has been authorized by EPA
on or after April 22, 2009. under subpart Q of this part, the train-
(3) A training program must not pro- ing program manager shall include a
vide, offer, or claim to provide EPA- statement certifying that, as well.
accredited lead-based paint activities (vi) If a training program does not
courses without applying for and reuse EPA-recommended model training
ceiving accreditation from EPA as re- materials, its application for accredita-
quired under paragraph (b) of this section shall also include:
tion on or after March 1, 1999. A train- (A) A copy of the student and in-
ing program must not provide, offer, or structor manuals, or other materials to
claim to provide EPA-accredited ren- be used for each course.
ovator or dust sampling technician (B) A copy of the course agenda for
courses without applying for and re- each course.
ceiving accreditation from EPA as re- (C) When applying for accreditation
quired under paragraph (b) of this sec- of a course in a language other than
tion on or after June 23, 2008. English, a signed statement from a
(4) Accredited training programs, qualified, independent translator that
training program managers, and prin- they had compared the course to the
cipal instructors must comply with all English language version and found the
of the requirements of this section in- translation to be accurate.
cluding approved terms of the applica- (vii) All training programs shall in-
tion and all of the requirements and clude in their application for accredita-
limitations specified in any accreditation the following:
tion documents issued to training pro- (A) A description of the facilities and
grams. equipment to be used for lecture and
(b) Application process. The following hands-on training.

are procedures a training program (B) A copy of the course test blue-
must follow to receive EPA accredita- print for each course.
103
§ 745.225 40 CFR Ch. I (7–1–17 Edition)
(C) A description of the activities and (iii) Two years of experience in man-
procedures that will be used for con- aging a training program specializing
ducting the assessment of hands-on in environmental hazards; and
skills for each course. (iv) Demonstrated experience, edu-
(D) A copy of the quality control plan cation, or training in the construction
as described in paragraph (c)(9) of this industry including: Lead or asbestos
section. abatement, painting, carpentry, ren-
(2) If a training program meets the ovation, remodeling, occupational safe-
requirements in paragraph (c) of this ty and health, or industrial hygiene.
section, then EPA shall approve the ap- (2) The training manager shall des-
ignate a qualified principal instructor
plication for accreditation no more
for each course who has:
than 180 days after receiving a com-
(i) Demonstrated experience, edu-
plete application from the training
cation, or training in teaching workers
program. In the case of approval, a cer-
or adults; and
tificate of accreditation shall be sent (ii) Successfully completed at least 16
to the applicant. In the case of dis- hours of any EPA-accredited or EPA-
approval, a letter describing the rea- authorized State or Tribal-accredited
sons for disapproval shall be sent to lead-specific training for instructors of
the applicant. Prior to disapproval, lead-based paint activities courses or 8
EPA may, at its discretion, work with hours of any EPA-accredited or EPA-
the applicant to address inadequacies authorized State or Tribal-accredited
in the application for accreditation. lead-specific training for instructors of
EPA may also request additional mate- renovator or dust sampling technician
rials retained by the training program courses; and
under paragraph (i) of this section. If a (iii) Demonstrated experience, edu-
training program’s application is dis- cation, or training in lead or asbestos
approved, the program may reapply for abatement, painting, carpentry, ren-
accreditation at any time. ovation, remodeling, occupational safe-
(3) A training program may apply for ty and health, or industrial hygiene.
accreditation to offer courses or re- (3) The principal instructor shall be
fresher courses in as many disciplines responsible for the organization of the
as it chooses. A training program may course, course delivery, and oversight
seek accreditation for additional of the teaching of all course material.
courses at any time as long as the pro- The training manager may designate
gram can demonstrate that it meets guest instructors as needed for a por-
the requirements of this section. tion of the course to provide instruc-
(4) A training program applying for tion specific to the lecture, hands-on
accreditation must submit the appro- activities, or work practice compo-
priate fees in accordance with § 745.238. nents of a course. However, the prin-
(c) Requirements for the accreditation cipal instructor is primarily respon-
sible for teaching the course materials
of training programs. A training pro-
and must be present to provide instruc-
gram accredited by EPA to offer lead-
tion (or oversight of portions of the
based paint activities courses, ren-
course taught by guest instructors) for
ovator courses, or dust sampling tech-
the course for which he has been des-
nician courses must meet the following
ignated the principal instructor.
requirements: (4) The following documents shall be
(1) The training program shall em- recognized by EPA as evidence that
ploy a training manager who has: training managers and principal in-
(i) At least 2 years of experience, edu- structors have the education, work ex-
cation, or training in teaching workers perience, training requirements or
or adults; or demonstrated experience, specifically
(ii) A bachelor’s or graduate degree listed in paragraphs (c)(1) and (c)(2) of
in building construction technology, this section. This documentation must
engineering, industrial hygiene, safety, be submitted with the accreditation
public health, education, business ad- application and retained by the train-
ministration or program management ing program as required by the record-
or a related field; or keeping requirements contained in
104
paragraph (i) of this section. Those ments for the abatement worker course
documents include the following: are contained in paragraph (d)(5) of
(i) Official academic transcripts or this section.
diploma as evidence of meeting the (vi) The renovator course must last a
education requirements. minimum of 8 training hours, with a
(ii) Resumes, letters of reference, or minimum of 2 hours devoted to hands-
documentation of work experience, as on training activities. The minimum
evidence of meeting the work experi- curriculum requirements for the ren-
ence requirements. ovator course are contained in para-
(iii) Certificates from train-the-train- graph (d)(6) of this section.
er courses and lead-specific training (vii) The dust sampling technician
courses, as evidence of meeting the course must last a minimum of 8 train-
training requirements. ing hours, with a minimum of 2 hours
(5) The training program shall ensure devoted to hands-on training activities.
the availability of, and provide ade- The minimum curriculum require-
quate facilities for, the delivery of the ments for the dust sampling technician
lecture, course test, hands-on training, course are contained in paragraph
and assessment activities. This in- (d)(7) of this section.
cludes providing training equipment (viii) Electronic learning and other
that reflects current work practices alternative course delivery methods
and maintaining or updating the equip- are permitted for the classroom por-
ment and facilities as needed. tion of renovator, dust sampling tech-
(6) To become accredited in the fol- nician, or lead-based paint activities
lowing disciplines, the training pro- courses but not the hands-on portion of
gram shall provide training courses these courses, or for final course tests
that meet the following training re- or proficiency tests described in para-
quirements: graph (c)(7) of this section. Electronic
(i) The inspector course shall last a learning courses must comply with the
minimum of 24 training hours, with a following requirements:
minimum of 8 hours devoted to hands- (A) A unique identifier must be as-
on training activities. The minimum signed to each student for them to use
curriculum requirements for the in- to launch and re-launch the course.
spector course are contained in para- (B) The training provider must track
graph (d)(1) of this section. each student’s course log-ins, launches,
(ii) The risk assessor course shall last progress, and completion, and maintain
a minimum of 16 training hours, with a these records in accordance with para-
minimum of 4 hours devoted to hands- graph (i) of this section.
on training activities. The minimum (C) The course must include periodic
curriculum requirements for the risk knowledge checks equivalent to the
assessor course are contained in para- number and content of the knowledge
graph (d)(2) of this section. checks contained in EPA’s model
(iii) The supervisor course shall last course, but at least 16 over the entire
a minimum of 32 training hours, with a course. The knowledge checks must be
minimum of 8 hours devoted to hands- successfully completed before the stu-
on activities. The minimum cur- dent can go on to the next module.
riculum requirements for the super- (D) There must be a test of at least 20
visor course are contained in paragraph questions at the end of the electronic
(d)(3) of this section. learning portion of the course, of which
(iv) The project designer course shall 80% must be answered correctly by the
last a minimum of 8 training hours. student for successful completion of
The minimum curriculum require- the electronic learning portion of the
ments for the project designer course course. The test must be designed so
are contained in paragraph (d)(4) of that students to do not receive feed-
this section. back on their test answers until after
(v) The abatement worker course they have completed and submitted the
shall last a minimum of 16 training test.
hours, with a minimum of 8 hours de- (E) Each student must be able to save
voted to hands-on training activities. or print a copy of an electronic learn-
The minimum curriculum require- ing course completion certificate. The
105
§ 745.225 40 CFR Ch. I (7–1–17 Edition)
electronic certificate must not be sus- cate, the photograph must not be
ceptible to easy editing. smaller than 1 square inch.
(7) For each course offered, the train- (viii) For renovator course comple-
ing program shall conduct either a tion certificates, the expiration date of
course test at the completion of the certification.
course, and if applicable, a hands-on (9) The training manager shall de-
skills assessment, or in the alternative, velop and implement a quality control
a proficiency test for that discipline. plan. The plan shall be used to main-
Each student must successfully com- tain and improve the quality of the
plete the hands-on skills assessment training program over time. This plan
and receive a passing score on the shall contain at least the following ele-
course test to pass any course, or suc- ments:
cessfully complete a proficiency test. (i) Procedures for periodic revision of
(i) The training manager is respon- training materials and the course test
sible for maintaining the validity and to reflect innovations in the field.
integrity of the hands-on skills assess-
(ii) Procedures for the training man-
ment or proficiency test to ensure that
ager’s annual review of principal in-
it accurately evaluates the trainees’
structor competency.
performance of the work practices and
(10) Courses offered by the training
procedures associated with the course
program must teach the work practice
topics contained in paragraph (d) of
standards contained in § 745.85 or
this section.
§ 745.227, as applicable, in such a man-
(ii) The training manager is respon-
ner that trainees are provided with the
sible for maintaining the validity and
knowledge needed to perform the ren-
integrity of the course test to ensure
ovations or lead-based paint activities
that it accurately evaluates the train-
they will be responsible for conducting.
ees’ knowledge and retention of the
course topics. (11) The training manager shall be re-
(iii) The course test shall be devel- sponsible for ensuring that the training
oped in accordance with the test blue- program complies at all times with all
print submitted with the training ac- of the requirements in this section.
creditation application. (12) The training manager shall allow
(8) The training program shall issue EPA to audit the training program to
unique course completion certificates verify the contents of the application
to each individual who passes the for accreditation as described in para-
training course. The course completion graph (b) of this section.
certificate shall include: (13) The training manager must pro-
(i) The name, a unique identification vide notification of renovator, dust
number, and address of the individual. sampling technician, or lead-based
(ii) The name of the particular course paint activities courses offered.
that the individual completed. (i) The training manager must pro-
(iii) Dates of course completion/test vide EPA with notification of all ren-
passage. ovator, dust sampling technician, or
(iv) For initial inspector, risk asses- lead-based paint activities courses of-
sor, project designer, supervisor, or fered except for any renovator course
abatement worker course completion without hands-on training delivered
certificates, the expiration date of in- via electronic learning. The original
terim certification, which is 6 months notification must be received by EPA
from the date of course completion. at least 7 business days prior to the
(v) The name, address, and telephone start date of any renovator, dust sam-
number of the training program. pling technician, or lead-based paint
(vi) The language in which the course activities course.
was taught. (ii) The training manager must pro-
(vii) For renovator and dust sampling vide EPA updated notification when
technician course completion certifi- renovator, dust sampling technician, or
cates, a photograph of the individual. lead-based paint activities courses will
The photograph must be an accurate begin on a date other than the start
and recognizable image of the indi- date specified in the original notifica-
vidual. As reproduced on the certifi- tion, as follows:
106
(A) For renovator, dust sampling Postal Service are reminded that they
technician, or lead-based paint activi- should allow 3 additional business days
ties courses beginning prior to the for delivery in order to ensure that
start date provided to EPA, an updated EPA receives the notification by the
notification must be received by EPA required date). Instructions and sample
at least 7 business days before the new forms can be obtained from the NLIC
start date. at 1–800–424–LEAD(5323), or on the
(B) For renovator, dust sampling Internet at http://www.epa.gov/lead.
technician, or lead-based paint activi- Hearing- or speech-impaired persons
ties courses beginning after the start may reach the above telephone number
date provided to EPA, an updated noti- through TTY by calling the toll-free
fication must be received by EPA at Federal Relay Service at 1–800–877–8339.
least 2 business days before the start (vii) Renovator, dust sampling tech-
date provided to EPA. nician, or lead-based paint activities
(iii) The training manager must up- courses must not begin on a date, or at
date EPA of any change in location of a location other than that specified in
renovator, dust sampling technician, or the original notification unless an up-
lead-based paint activities courses at dated notification identifying a new
least 7 business days prior to the start start date or location is submitted, in
date provided to EPA. which case the course must begin on
(iv) The training manager must up- the new start date and/or location spec-
date EPA regarding any course can- ified in the updated notification.
cellations, or any other change to the (viii) No training program shall pro-
original notification. Updated notifica- vide renovator, dust sampling techni-
tions must be received by EPA at least cian, or lead-based paint activities
2 business days prior to the start date courses without first notifying EPA of
provided to EPA. such activities in accordance with the
(v) Each notification, including up- requirements of this paragraph.
dates, must include the following: (14) The training manager must pro-
(A) Notification type (original, up- vide notification following completion
date, cancellation). of renovator, dust sampling technician,
(B) Training program name, EPA ac- or lead-based paint activities courses.
creditation number, address, and tele- (i) The training manager must pro-
phone number. vide EPA notification after the com-
(C) Course discipline, type (initial/re- pletion of any renovator, dust sam-
fresher), and the language in which in- pling, or lead-based paint activities
struction will be given. course. This notification must be re-
(D) Date(s) and time(s) of training. ceived by EPA no later than 10 busi-
(E) Training location(s) telephone ness days following course completion.
number, and address. Notifications for any e-learning ren-
(F) Principal instructor’s name. ovator refresher course that does not
(G) Training manager’s name and sig- include hands-on training must be sub-
nature. mitted via the Central Data Exchange
(vi) Notification must be accom- no later than the 10th day of the month
plished using any of the following and include all students trained in the
methods: Written notification, or elec- previous month.
tronically using the Agency’s Central (ii) The notification must include the
Data Exchange (CDX). Written notifi- following:
cation of lead-based paint activities (A) Training program name, EPA ac-
course schedules can be accomplished creditation number, address, and tele-
by using either the sample form titled phone number.
‘‘Lead-Based Paint Training Notifica- (B) Course discipline and type (ini-
tion’’ or a similar form containing the tial/refresher).
information required in paragraph (C) Date(s) of training.
(c)(13)(v) of this section. All written no- (D) The following information for
tifications must be delivered to EPA by each student who took the course:
U.S. Postal Service, fax, commercial (1) Name.

delivery service, or hand delivery (per- (2) Address.
sons submitting notification by U.S. (3) Date of birth.
107
§ 745.225 40 CFR Ch. I (7–1–17 Edition)
(4) Course completion certificate and components for sampling or test-

number. ing.
(5) Course test score. (v) Paint, dust, and soil sampling
(6) For renovator or dust sampling methodologies.
technician courses, a digital photo- (vi) Clearance standards and testing,
graph of the student. including random sampling.
(7) For renovator refresher courses, (vii) Preparation of the final inspec-
the expiration date of certification. tion report.
(E) Training manager’s name and sig- (viii) Recordkeeping.
nature. (2) Risk assessor. Instruction in the
topics described in paragraphs
(iii) Notification must be accom-
(d)(2)(iv), (vi), and (vii) of this section
plished using any of the following
must be included in the hands-on por-
methods: Written notification, or elec-
tion of the course.
tronically using the Agency’s Central
(i) Role and responsibilities of a risk
Data Exchange (CDX). Written notifi-
assessor.
cation following renovator, dust sam-
(ii) Collection of background infor-
pling technician, or lead-based paint
mation to perform a risk assessment.
activities training courses can be ac-
(iii) Sources of environmental lead
complished by using either the sample
contamination such as paint, surface
form titled ‘‘Lead-Based Paint Train-
dust and soil, water, air, packaging,
ing Course Follow-up’’ or a similar
and food.
form containing the information re-
(iv) Visual inspection for the pur-
quired in paragraph (c)(14)(ii) of this
poses of identifying potential sources
section. All written notifications must
of lead-based paint hazards.
be delivered to EPA by U.S. Postal
(v) Lead hazard screen protocol.
Service, fax, commercial delivery serv-
(vi) Sampling for other sources of
ice, or hand delivery (persons submit-
lead exposure.
ting notification by U.S. Postal Service
(vii) Interpretation of lead-based
are reminded that they should allow 3
paint and other lead sampling results,
additional business days for delivery in
including all applicable Federal or
order to ensure that EPA receives the
State guidance or regulations per-
notification by the required date). In-
taining to lead-based paint hazards.
structions and sample forms can be ob-
(viii) Development of hazard control
tained from the NLIC at 1–800–424–
options, the role of interim controls,
LEAD (5323), or on the Internet at
and operations and maintenance activi-
http://www.epa.gov/lead.
ties to reduce lead-based paint hazards.
(d) Minimum training curriculum re- (ix) Preparation of a final risk assess-
quirements. A training program accred- ment report.
ited by EPA to offer lead-based paint (3) Supervisor. Instruction in the top-
courses in the specific disciplines listed ics described in paragraphs (d)(3)(v),
in this paragraph (d) must ensure that (vii), (viii), (ix), and (x) of this section
its courses of study include, at a min- must be included in the hands-on por-
imum, the following course topics. tion of the course.
(1) Inspector. Instruction in the topics (i) Role and responsibilities of a su-
described in paragraphs (d)(1)(iv), (v), pervisor.
(vi), and (vii) of this section must be (ii) Background information on lead
included in the hands-on portion of the and its adverse health effects.
course. (iii) Background information on Fed-
(i) Role and responsibilities of an in- eral, State, and local regulations and
spector. guidance that pertain to lead-based
(ii) Background information on lead paint abatement.
and its adverse health effects. (iv) Liability and insurance issues re-
(iii) Background information on Fed- lating to lead-based paint abatement.
eral, State, and local regulations and (v) Risk assessment and inspection
guidance that pertains to lead-based report interpretation.
paint and lead- based paint activities. (vi) Development and implementa-
(iv) Lead-based paint inspection tion of an occupant protection plan and
methods, including selection of rooms abatement report.
108
(vii) Lead-based paint hazard rec- (6) Renovator. Instruction in the top-
ognition and control. ics described in paragraphs (d)(6)(iv),
(viii) Lead-based paint abatement (vi), (vii), and (viii) of this section
and lead-based paint hazard reduction must be included in the hands-on por-
methods, including restricted prac- tion of the course.
tices. (i) Role and responsibility of a ren-
(ix) Interior dust abatement/cleanup ovator.
or lead-based paint hazard control and (ii) Background information on lead
reduction methods. and its adverse health effects.
(x) Soil and exterior dust abatement (iii) Background information on
or lead-based paint hazard control and EPA, HUD, OSHA, and other Federal,
reduction methods. State, and local regulations and guid-
(xi) Clearance standards and testing. ance that pertains to lead-based paint
(xii) Cleanup and waste disposal. and renovation activities.
(xiii) Recordkeeping. (iv) Procedures for using acceptable
(4) Project designer. (i) Role and retest kits to determine whether paint is
sponsibilities of a project designer. lead-based paint.
(ii) Development and implementation (v) Procedures for collecting a paint
of an occupant protection plan for chip sample and sending it to a labora-
large-scale abatement projects. tory recognized by EPA under section
(iii) Lead-based paint abatement and 405(b) of TSCA.
lead-based paint hazard reduction (vi) Renovation methods to minimize
methods, including restricted practices the creation of dust and lead-based
for large-scale abatement projects. paint hazards.
(iv) Interior dust abatement/cleanup (vii) Interior and exterior contain-
or lead hazard control and reduction ment and cleanup methods.
methods for large-scale abatement (viii) Methods to ensure that the ren-
projects. ovation has been properly completed,
(v) Clearance standards and testing including cleaning verification and
for large scale abatement projects. clearance testing.
(vi) Integration of lead-based paint (ix) Waste handling and disposal.
abatement methods with moderniza- (x) Providing on-the-job training to
tion and rehabilitation projects for other workers.
large scale abatement projects. (xi) Record preparation.
(5) Abatement worker. Instruction in (7) Dust sampling technician. Instruc-
the topics described in paragraphs tion in the topics described in para-
(d)(5)(iv), (v), (vi), and (vii) of this sec- graphs (d)(6)(iv) and (vi) of this section
tion must be included in the hands-on must be included in the hands-on por-
portion of the course. tion of the course.
(i) Role and responsibilities of an (i) Role and responsibility of a dust
abatement worker. sampling technician.
(ii) Background information on lead (ii) Background information on lead
and its adverse health effects. and its adverse health effects.
(iii) Background information on Fed- (iii) Background information on Fed-
eral, State and local regulations and eral, State, and local regulations and
guidance that pertain to lead-based guidance that pertains to lead-based
paint abatement. paint and renovation activities.
(iv) Lead-based paint hazard recogni- (iv) Dust sampling methodologies.
tion and control. (v) Clearance standards and testing.
(v) Lead-based paint abatement and (vi) Report preparation.
lead-based paint hazard reduction (e) Requirements for the accreditation
methods, including restricted prac- of refresher training programs. A train-
tices. ing program may seek accreditation to
(vi) Interior dust abatement methods/ offer refresher training courses in any
cleanup or lead-based paint hazard re- of the following disciplines: Inspector,
duction. risk assessor, supervisor, project de-
(vii) Soil and exterior dust abate- signer, abatement worker, renovator,
ment methods or lead-based paint haz- and dust sampling technician. A train-
ard reduction. ing program accredited by EPA to offer
109
§ 745.225 40 CFR Ch. I (7–1–17 Edition)
refresher training must meet the fol- (e)(1) through (3) of this section shall
lowing minimum requirements: also apply.
(1) Each refresher course shall review (5) A training program seeking ac-
the curriculum topics of the full-length creditation to offer refresher training
courses listed under paragraph (d) of courses only shall submit a written ap-
this section, as appropriate. In addi- plication to EPA containing the fol-
tion, to become accredited to offer re- lowing information:
fresher training courses, training pro- (i) The refresher training program’s
grams shall ensure that their courses name, address, and telephone number.
of study include, at a minimum, the (ii) A list of courses for which it is
following: applying for accreditation.
(i) An overview of current safety (iii) The name and documentation of
practices relating to lead-based paint the qualifications of the training pro-
in general, as well as specific informa- gram manager.
tion pertaining to the appropriate dis- (iv) The name(s) and documentation
cipline. of the qualifications of the principal
(ii) Current laws and regulations re- instructor(s).
lating to lead-based paint in general, as (v) A statement signed by the train-
well as specific information pertaining ing program manager certifying that
to the appropriate discipline. the refresher training program meets
(iii) Current technologies relating to the minimum requirements established
lead-based paint in general, as well as in paragraph (c) of this section, except
specific information pertaining to the for the requirements in paragraph (c)(6)
appropriate discipline. of this section. If a training program
(2) Refresher courses for inspector, uses EPA-developed model training
risk assessor, supervisor, and abate- materials, or training materials ap-
ment worker must last a minimum of 8 proved by a State or Indian Tribe that
training hours. Refresher courses for has been authorized by EPA under
project designer, renovator, and dust § 745.324 to develop its refresher train-
sampling technician must last a mining course materials, the training man-
imum of 4 training hours. Refresher ager shall include a statement certi-
courses for all disciplines except ren- fying that, as well.
ovator and project designer must in- (vi) If the refresher training course
clude a hands-on component. Ren- materials are not based on EPA-devel-
ovators must take a refresher course oped model training materials, the
that includes hands-on training at training program’s application for ac-
least every other recertification. creditation shall include:
(3) Except for renovator and project (A) A copy of the student and in-
designer courses, for all other courses structor manuals to be used for each
offered, the training program shall con- course.
duct a hands-on assessment. With the (B) A copy of the course agenda for
exception of project designer courses, each course.
the training program shall conduct a (vii) All refresher training programs
course test at the completion of the shall include in their application for
course. Renovators must take a re- accreditation the following:
fresher course that includes hands-on (A) A description of the facilities and
training at least every other recertifi- equipment to be used for lecture and
cation. hands-on training.
(4) A training program may apply for (B) A copy of the course test blue-
accreditation of a refresher course con- print for each course.
currently with its application for ac- (C) A description of the activities and
creditation of the corresponding train- procedures that will be used for con-
ing course as described in paragraph (b) ducting the assessment of hands-on
of this section. If so, EPA shall use the skills for each course (if applicable).
approval procedure described in para- (D) A copy of the quality control plan
graph (b) of this section. In addition, as described in paragraph (c)(9) of this
the minimum requirements contained section.

in paragraphs (c)(1) through (5), (viii) The requirements in paragraphs
(c)(6)(viii) and (c)(7) through (14), and (c)(1) through (5), (c)(6)(viii) and (c)(7)
110
through (14) of this section apply to re- (A) That the training program com-
fresher training providers. plies at all times with all requirements
(ix) If a refresher training program in paragraphs (c) and (e) of this sec-
meets the requirements listed in this tion, as applicable; and
paragraph, then EPA shall approve the (B) The recordkeeping and reporting
application for accreditation no more requirements of paragraph (i) of this
than 180 days after receiving a com- section shall be followed.
plete application from the refresher (vii) A payment of appropriate fees in
training program. In the case of ap- accordance with § 745.238.
proval, a certificate of accreditation (4) Upon request, the training pro-
shall be sent to the applicant. In the gram shall allow EPA to audit the
case of disapproval, a letter describing training program to verify the con-
the reasons for disapproval shall be tents of the application for re-accredi-
sent to the applicant. Prior to dis- tation as described in paragraph (f)(3)
approval, EPA may, at its discretion, of this section.
work with the applicant to address in- (g) Suspension, revocation, and modi-
adequacies in the application for ac- fication of accredited training programs.
creditation. EPA may also request ad- (1) EPA may, after notice and an op-
ditional materials retained by the re- portunity for hearing, suspend, revoke,
fresher training program under para- or modify training program accredita-
graph (i) of this section. If a refresher tion, including refresher training ac-
training program’s application is dis- creditation, if a training program,
approved, the program may reapply for training manager, or other person with
accreditation at any time. supervisory authority over the training
(f) Re-accreditation of training pro- program has:
grams. (1) Unless re-accredited, a train- (i) Misrepresented the contents of a
ing program’s accreditation, including training course to EPA and/or the stu-
refresher training accreditation, shall dent population.
expire 4 years after the date of (ii) Failed to submit required infor-
issuance. If a training program meets mation or notifications in a timely
the requirements of this section, the manner.
training program shall be reaccredited. (iii) Failed to maintain required
(2) A training program seeking re-ac- records.
creditation shall submit an application (iv) Falsified accreditation records,
to EPA no later than 180 days before its instructor qualifications, or other ac-
accreditation expires. If a training pro- creditation-related information or doc-
gram does not submit its application umentation.
for re-accreditation by that date, EPA (v) Failed to comply with the train-
cannot guarantee that the program ing standards and requirements in this
will be re-accredited before the end of section.
the accreditation period. (vi) Failed to comply with Federal,
(3) The training program’s applica- State, or local lead-based paint stat-
tion for re-accreditation shall contain: utes or regulations.
(i) The training program’s name, ad- (vii) Made false or misleading state-
dress, and telephone number. ments to EPA in its application for ac-
(ii) A list of courses for which it is creditation or re-accreditation which
applying for re-accreditation. EPA relied upon in approving the ap-
(iii) The name and qualifications of plication.
the training program manager. (2) In addition to an administrative
(iv) The name(s) and qualifications of or judicial finding of violation, execu-
the principal instructor(s). tion of a consent agreement in settle-
(v) A description of any changes to ment of an enforcement action con-
the training facility, equipment or stitutes, for purposes of this section,
course materials since its last applica- evidence of a failure to comply with
tion was approved that adversely af- relevant statutes or regulations.
fects the students’ ability to learn. (h) Procedures for suspension, revoca-
(vi) A statement signed by the pro- tion or modification of training program
gram manager stating: accreditation. (1) Prior to taking action
111
§ 745.225 40 CFR Ch. I (7–1–17 Edition)
to suspend, revoke, or modify the ac- (i) Notify the affected entity of its in-
creditation of a training program, EPA tent to immediately suspend training
shall notify the affected entity in writ- program accreditation for the reasons
ing of the following: listed in paragraph (g)(1) of this sec-
(i) The legal and factual basis for the tion. If a suspension, revocation, or
suspension, revocation, or modifica- modification notice has not previously
tion. been issued pursuant to paragraph
(ii) The anticipated commencement (g)(1) of this section, it shall be issued
date and duration of the suspension, at the same time the emergency sus-
revocation, or modification. pension notice is issued.
(iii) Actions, if any, which the af- (ii) Notify the affected entity in writ-
fected entity may take to avoid sus- ing of the grounds for the immediate
pension, revocation, or modification, or suspension and why it is necessary to
to receive accreditation in the future. suspend the entity’s accreditation be-
(iv) The opportunity and method for fore an opportunity for a suspension,
requesting a hearing prior to final EPA revocation or modification hearing.
action to suspend, revoke or modify ac- (iii) Notify the affected entity of the
creditation. anticipated commencement date and
(v) Any additional information, as duration of the immediate suspension.
appropriate, which EPA may provide. (iv) Notify the affected entity of its
(2) If a hearing is requested by the ac- right to request a hearing on the im-
credited training program, EPA shall: mediate suspension within 15 days of
(i) Provide the affected entity an op- the suspension taking place and the
portunity to offer written statements procedures for the conduct of such a
in response to EPA’s assertions of the hearing.
legal and factual basis for its proposed (5) Any notice, decision, or order
action, and any other explanations, issued by EPA under this section, any
comments, and arguments it deems rel- transcripts or other verbatim record of
evant to the proposed action. oral testimony, and any documents
(ii) Provide the affected entity such filed by an accredited training program
other procedural opportunities as EPA in a hearing under this section shall be
may deem appropriate to ensure a fair available to the public, except as oth-
and impartial hearing. erwise provided by section 14 of TSCA
(iii) Appoint an official of EPA as or by 40 CFR part 2. Any such hearing
Presiding Officer to conduct the hear- at which oral testimony is presented
ing. No person shall serve as Presiding shall be open to the public, except that
Officer if he or she has had any prior the Presiding Officer may exclude the
connection with the specific matter. public to the extent necessary to allow
(3) The Presiding Officer appointed presentation of information which may
pursuant to paragraph (h)(2) of this be entitled to confidential treatment
section shall: under section 14 of TSCA or 40 CFR
(i) Conduct a fair, orderly, and impar- part 2.
tial hearing within 90 days of the re- (6) The public shall be notified of the
quest for a hearing. suspension, revocation, modification or
(ii) Consider all relevant evidence, reinstatement of a training program’s
explanation, comment, and argument accreditation through appropriate
submitted. mechanisms.
(iii) Notify the affected entity in (7) EPA shall maintain a list of par-
writing within 90 days of completion of ties whose accreditation has been sus-
the hearing of his or her decision and pended, revoked, modified or rein-
order. Such an order is a final agency stated.
action which may be subject to judicial (i) Training program recordkeeping re-
review. quirements. (1) Accredited training pro-
(4) If EPA determines that the public grams shall maintain, and make avail-
health, interest, or welfare warrants able to EPA, upon request, the fol-
immediate action to suspend the ac- lowing records:
creditation of any training program (i) All documents specified in para-

prior to the opportunity for a hearing, graph (c)(4) of this section that dem-
it shall: onstrate the qualifications listed in
112
paragraphs (c)(1) and (c)(2) of this sec- (3) The training program shall notify
tion of the training manager and prin- EPA in writing within 30 days of
cipal instructors. changing the address specified on its
(ii) Current curriculum/course mate- training program accreditation appli-
rials and documents reflecting any cation or transferring the records from
changes made to these materials. that address.
(iii) The course test blueprint. (j) Amendment of accreditation. (1) A
(iv) Information regarding how the training program must amend its ac-
hands-on assessment is conducted in- creditation within 90 days of the date a
cluding, but not limited to: change occurs to information included
(A) Who conducts the assessment. in the program’s most recent applica-
(B) How the skills are graded. tion. If the training program fails to
(C) What facilities are used. amend its accreditation within 90 days
(D) The pass/fail rate. of the date the change occurs, the pro-
(v) The quality control plan as de- gram may not provide renovator, dust
scribed in paragraph (c)(9) of this sec- sampling technician, or lead-based
tion. paint activities training until its ac-
(vi) Results of the students’ hands-on creditation is amended.
skills assessments and course tests, (2) To amend an accreditation, a
and a record of each student’s course training program must submit a com-
completion certificate. pleted ‘‘Accreditation Application for
(vii) Any other material not listed in Training Providers,’’ signed by an au-
paragraphs (i)(1)(i) through (i)(1)(vi) of
thorized agent of the training provider,
this section that was submitted to EPA
noting on the form that it is submitted
as part of the program’s application for
as an amendment and indicating the
accreditation.
information that has changed.
(viii) For renovator refresher and
dust sampling technician refresher (3) Training managers, principal in-
courses, a copy of each trainee’s prior structors, permanent training locations. If
course completion certificate showing the amendment includes a new training
that each trainee was eligible to take program manager, any new or addi-
the refresher course. tional principal instructor(s), or any
(ix) For course modules delivered in new permanent training location(s),
an electronic format, a record of each the training provider is not permitted
student’s log-ins, launches, progress, to provide training under the new
and completion, and a copy of the elec- training manager or offer courses
tronic learning completion certificate taught by any new principal instruc-
for each student. tor(s) or at the new training location(s)
(2) The training program must retain until EPA either approves the amend-
records pertaining to renovator, dust ment or 30 days have elapsed, which-
sampling technician and lead-based ever occurs earlier. Except:
paint activities courses at the address (i) If the amendment includes a new
specified on the training program ac- training program manager or new or
creditation application (or as modified additional principal instructor that
in accordance with paragraph (i)(3) of was identified in a training provider
this section) for the following min- accreditation application that EPA has
imum periods: already approved under this section,
(i) Records pertaining to lead-based the training provider may begin to pro-
paint activities courses must be re- vide training under the new training
tained for a minimum of 3 years and 6 manager or offer courses taught by the
months. new principal instructor on an interim
(ii) Records pertaining to renovator basis as soon as the provider submits
or dust sampling technician courses of- the amendment to EPA. The training
fered before April 22, 2010 must be re- provider may continue to provide
tained until July 1, 2015. training under the new training man-
(iii) Records pertaining to renovator ager or offer courses taught by the new
or dust sampling technician courses of- principal instructor if EPA approves

fered on or after April 22, 2010 must be the amendment or if EPA does not dis-
retained for a minimum of 5 years. approve the amendment within 30 days.
113
§ 745.226 40 CFR Ch. I (7–1–17 Edition)
(ii) If the amendment includes a new (6) Individuals applying for certifi-
permanent training location, the train- cation must submit the appropriate
ing provider may begin to provide fees in accordance with § 745.238.
training at the new permanent training (b) Inspector, risk assessor or super-
location on an interim basis as soon as visor. (1) To become certified by EPA as
the provider submits the amendment an inspector, risk assessor, or super-
to EPA. The training provider may visor, pursuant to paragraph (a)(1)(i) of
continue to provide training at the new this section, an individual must:
permanent training location if EPA ap- (i) Successfully complete an accred-
proves the amendment or if EPA does ited course in the appropriate dis-
not disapprove the amendment within cipline and receive a course completion
30 days. certificate from an accredited training
program.
FR 7995, Feb. 17, 2016] (ii) Pass the certification exam in the
appropriate discipline offered by EPA;
§ 745.226 Certification of individuals and,
and firms engaged in lead-based (iii) Meet or exceed the following ex-
paint activities: target housing and perience and/or education require-
child-occupied facilities. ments:
(a) Certification of individuals. (1) Indi- (A) Inspectors. (1) No additional expe-
viduals seeking certification by EPA to rience and/or education requirements.
engage in lead-based paint activities (2) [Reserved]
must either: (B) Risk assessors. (1) Successful
(i) Submit to EPA an application completion of an accredited training
demonstrating that they meet the re- course for inspectors; and
quirements established in paragraphs (2) Bachelor’s degree and 1 year of ex-
(b) or (c) of this section for the par- perience in a related field (e.g., lead,
ticular discipline for which certifi- asbestos, environmental remediation
cation is sought; or work, or construction), or an Associ-
(ii) Submit to EPA an application ates degree and 2 years experience in a
with a copy of a valid lead-based paint related field (e.g., lead, asbestos, envi-
activities certification (or equivalent) ronmental remediation work, or con-
from a State or Tribal program that struction); or
has been authorized by EPA pursuant (3) Certification as an industrial hy-
to subpart Q of this part. gienist, professional engineer, reg-
(2) Individuals may first apply to istered architect and/or certification in
EPA for certification to engage in lead- a related engineering/health/environ-
based paint activities pursuant to this mental field (e.g., safety professional,
section on or after March 1, 1999. environmental scientist); or
(3) Following the submission of an (4) A high school diploma (or equiva-
application demonstrating that all the lent), and at least 3 years of experience
requirements of this section have been in a related field (e.g., lead, asbestos,
meet, EPA shall certify an applicant as environmental remediation work or
an inspector, risk assessor, supervisor, construction).
project designer, or abatement worker, (C) Supervisor: (1) One year of experi-
as appropriate. ence as a certified lead-based paint
(4) Upon receiving EPA certification, abatement worker; or
individuals conducting lead-based (2) At least 2 years of experience in a
paint activities shall comply with the related field (e.g., lead, asbestos, or en-
work practice standards for performing vironmental remediation work) or in
the appropriate lead-based paint activi- the building trades.
ties as established in § 745.227. (2) The following documents shall be
(5) It shall be a violation of TSCA for recognized by EPA as evidence of meet-
an individual to conduct any of the ing the requirements listed in (b)(2)(iii)
lead-based paint activities described in of this paragraph:
§ 745.227 after March 1, 2000, if that indi- (i) Official academic transcripts or
vidual has not been certified by EPA diploma, as evidence of meeting the
pursuant to this section to do so. education requirements.
114
(ii) Resumes, letters of reference, or (ii) Meet or exceed the following ad-
documentation of work experience, as ditional experience and/or education
evidence of meeting the work experi- requirements:
ence requirements. (A) Abatement workers. (1) No addi-
(iii) Course completion certificates tional experience and/or education re-
from lead-specific or other related quirements.
training courses, issued by accredited (2) [Reserved]
training programs, as evidence of (B) Project designers. (1) Successful
meeting the training requirements. completion of an accredited training
(3) In order to take the certification course for supervisors.
examination for a particular discipline (2) Bachelor’s degree in engineering,
an individual must: architecture, or a related profession,
(i) Successfully complete an accred- and 1 year of experience in building
ited course in the appropriate dis- construction and design or a related
cipline and receive a course completion field; or
certificate from an accredited training (3) Four years of experience in build-
program. ing construction and design or a re-
(ii) Meet or exceed the education and/ lated field.
or experience requirements in para- (2) The following documents shall be
graph (b)(1)(iii) of this section. recognized by EPA as evidence of meet-
(4) The course completion certificate ing the requirements listed in this
shall serve as interim certification for paragraph:
an individual until the next available (i) Official academic transcripts or
opportunity to take the certification diploma, as evidence of meeting the
exam. Such interim certification shall education requirements.
expire 6 months after issuance. (ii) Resumes, letters of reference, or
(5) After passing the appropriate cer- documentation of work experience, as
tification exam and submitting an ap- evidence of meeting the work experi-
plication demonstrating that he/she ence requirements.
meets the appropriate training, edu- (iii) Course completion certificates
cation, and/or experience prerequisites from lead-specific or other related
described in paragraph (b)(1) of this training courses, issued by accredited
section, an individual shall be issued a training programs, as evidence of
certificate by EPA. To maintain cer- meeting the training requirements.
tification, an individual must be re- (3) The course completion certificate
certified as described in paragraph (e) shall serve as an interim certification
of this section. until certification from EPA is re-
(6) An individual may take the cer- ceived, but shall be valid for no more
tification exam no more than three than 6 months from the date of comple-
times within 6 months of receiving a tion.
course completion certificate. (4) After successfully completing the
(7) If an individual does not pass the appropriate training courses and meet-
certification exam and receive a cer- ing any other qualifications described
tificate within 6 months of receiving in paragraph (c)(1) of this section, an
his/her course completion certificate, individual shall be issued a certificate
the individual must retake the appro- from EPA. To maintain certification,
priate course from an accredited train- an individual must be re-certified as
ing program before reapplying for cer- described in paragraph (e) of this sec-
tification from EPA. tion.
(c) Abatement worker and project de- (d) Certification based on prior training.
signer. (1) To become certified by EPA (1) Any individual who received train-
as an abatement worker or project de- ing in a lead-based paint activity be-
signer, pursuant to paragraph (a)(1)(i) tween October 1, 1990, and March 1, 1999
of this section, an individual must: shall be eligible for certification by
(i) Successfully complete an accred- EPA under the alternative procedures
ited course in the appropriate dis- contained in this paragraph. Individ-
cipline and receive a course completion uals who have received lead-based
certificate from an accredited training paint activities training at an EPA-au-
program. thorized State or Tribal accredited
115
§ 745.226 40 CFR Ch. I (7–1–17 Edition)
training program shall also be eligible training course and submits a valid
for certification by EPA under the fol- copy of the appropriate refresher
lowing alternative procedures: course completion certificate.
(i) Applicants for certification as an (3) Individuals applying for re-certifi-
inspector, risk assessor, or supervisor cation must submit the appropriate
shall: fees in accordance with § 745.238.
(A) Demonstrate that the applicant (f) Certification of firms. (1) All firms
has successfully completed training or which perform or offer to perform any
on-the-job training in the conduct of a of the lead-based paint activities de-
lead-based paint activity. scribed in § 745.227 after March 1, 2000,
(B) Demonstrate that the applicant shall be certified by EPA.
meets or exceeds the education and/or (2) A firm seeking certification shall
experience requirements in paragraph submit to EPA a letter attesting that
(b)(1)(iii) of this section. the firm shall only employ appro-
(C) Successfully complete an accred- priately certified employees to conduct
ited refresher training course for the lead-based paint activities, and that
appropriate discipline. the firm and its employees shall follow
(D) Pass a certification exam admin- the work practice standards in § 745.227
istered by EPA for the appropriate dis- for conducting lead-based paint activi-
cipline. ties.
(ii) Applicants for certification as an (3) From the date of receiving the
abatement worker or project designer firm’s letter requesting certification,
shall: EPA shall have 90 days to approve or
(A) Demonstrate that the applicant disapprove the firm’s request for cer-
has successfully completed training or tification. Within that time, EPA shall
on-the-job training in the conduct of a respond with either a certificate of ap-
lead-based paint activity. proval or a letter describing the rea-
(B) Demonstrate that the applicant sons for a disapproval.
meets the education and/or experience (4) The firm shall maintain all
requirements in paragraphs (c)(1) of records pursuant to the requirements
this section; and in § 745.227.
(C) Successfully complete an accred- (5) Firms may first apply to EPA for
ited refresher training course for the certification to engage in lead-based
appropriate discipline. paint activities pursuant to this sec-
(2) Individuals shall have until March tion on or after March 1, 1999.
1, 2000, to apply to EPA for certifi- (6) Firms applying for certification
cation under the above procedures. must submit the appropriate fees in ac-
After that date, all individuals wishing cordance with § 745.238.
to obtain certification must do so (7) To maintain certification a firm
through the procedures described in shall submit appropriate fees in ac-
paragraph (a), and paragraph (b) or (c) cordance with § 745.238 every 3 years.
of this section, according to the dis- (g) Suspension, revocation, and modi-
cipline for which certification is being fication of certifications of individuals en-
sought. gaged in lead-based paint activities. (1)
(e) Re-certification. (1) To maintain EPA may, after notice and opportunity
certification in a particular discipline, for hearing, suspend, revoke, or modify
a certified individual shall apply to and an individual’s certification if an indi-
be re-certified by EPA in that dis- vidual has:
cipline by EPA either: (i) Obtained training documentation
(i) Every 3 years if the individual through fraudulent means.
completed a training course with a (ii) Gained admission to and com-
course test and hands-on assessment; pleted an accredited training program
or through misrepresentation of admis-
(ii) Every 5 years if the individual sion requirements.
completed a training course with a pro- (iii) Obtained certification through
ficiency test. misrepresentation of certification re-
(2) An individual shall be re-certified quirements or related documents deal-

if the individual successfully completes ing with education, training, profes-
the appropriate accredited refresher sional registration, or experience.
116
(iv) Performed work requiring certifi- (i) The legal and factual basis for the
cation at a job site without having suspension, revocation, or modifica-
proof of certification. tion.
(v) Permitted the duplication or use (ii) The commencement date and du-
of the individual’s own certificate by ration of the suspension, revocation, or
another. modification.
(vi) Performed work for which cer- (iii) Actions, if any, which the af-
tification is required, but for which ap- fected entity may take to avoid sus-
propriate certification has not been re- pension, revocation, or modification or
ceived. to receive certification in the future.
(vii) Failed to comply with the ap- (iv) The opportunity and method for
propriate work practice standards for requesting a hearing prior to final EPA
lead-based paint activities at § 745.227. action to suspend, revoke, or modify
(viii) Failed to comply with Federal, certification.
State, or local lead-based paint stat- (v) Any additional information, as
utes or regulations. appropriate, which EPA may provide.
(2) In addition to an administrative (2) If a hearing is requested by the
or judicial finding of violation, for pur- certified individual or firm, EPA shall:
poses of this section only, execution of (i) Provide the affected entity an op-
a consent agreement in settlement of portunity to offer written statements
an enforcement action constitutes evi- in response to EPA’s assertion of the
dence of a failure to comply with rel- legal and factual basis and any other
evant statutes or regulations. explanations, comments, and argu-
(h) Suspension, revocation, and modi- ments it deems relevant to the pro-
posed action.
fication of certifications of firms engaged
in lead-based paint activities. (1) EPA (ii) Provide the affected entity such
may, after notice and opportunity for other procedural opportunities as EPA
may deem appropriate to ensure a fair
hearing, suspend, revoke, or modify a
and impartial hearing.
firm’s certification if a firm has:
(iii) Appoint an official of EPA as
(i) Performed work requiring certifi-
Presiding Officer to conduct the hear-
cation at a job site with individuals
ing. No person shall serve as Presiding
who are not certified.
Officer if he or she has had any prior
(ii) Failed to comply with the work connection with the specific matter.
practice standards established in (3) The Presiding Officer shall:
§ 745.227.
(i) Conduct a fair, orderly, and impar-
(iii) Misrepresented facts in its letter tial hearing within 90 days of the re-
of application for certification to EPA. quest for a hearing;
(iv) Failed to maintain required (ii) Consider all relevant evidence,
records. explanation, comment, and argument
(v) Failed to comply with Federal, submitted; and
State, or local lead-based paint stat- (iii) Notify the affected entity in
utes or regulations. writing within 90 days of completion of
(2) In addition to an administrative the hearing of his or her decision and
or judicial finding of violation, for pur- order. Such an order is a final EPA ac-
poses of this section only, execution of tion subject to judicial review.
a consent agreement in settlement of (4) If EPA determines that the public
an enforcement action constitutes evi- health, interest, or welfare warrants
dence of a failure to comply with rel- immediate action to suspend the cer-
evant statutes or regulations. tification of any individual or firm
(i) Procedures for suspension, revoca- prior to the opportunity for a hearing,
tion, or modification of the certification of it shall:
individuals or firms. (i) Notify the affected entity of its in-
(1) If EPA decides to suspend, revoke, tent to immediately suspend certifi-
or modify the certification of any indication for the reasons listed in para-
vidual or firm, it shall notify the af- graph (h)(1) of this section. If a suspen-
fected entity in writing of the fol- sion, revocation, or modification no-
lowing: tice has not previously been issued, it
117
§ 745.227 40 CFR Ch. I (7–1–17 Edition)
shall be issued at the same time the found in the following: The U.S. De-
immediate suspension notice is issued. partment of Housing and Urban Devel-
(ii) Notify the affected entity in writ- opment (HUD) Guidelines for the Eval-
ing of the grounds upon which the im- uation and Control of Lead-Based
mediate suspension is based and why it Paint Hazards in Housing; the EPA
is necessary to suspend the entity’s ac- Guidance on Residential Lead-Based
creditation before an opportunity for a Paint, Lead-Contaminated Dust, and
hearing to suspend, revoke, or modify Lead-Contaminated Soil; the EPA Res-
the individual’s or firm’s certification. idential Sampling for Lead: Protocols
(iii) Notify the affected entity of the for Dust and Soil Sampling (EPA re-
commencement date and duration of port number 7474–R–95–001); Regula-
the immediate suspension. tions, guidance, methods or protocols
(iv) Notify the affected entity of its issued by States and Indian Tribes that
right to request a hearing on the im- have been authorized by EPA; and
mediate suspension within 15 days of other equivalent methods and
the suspension taking place and the quidelines.
procedures for the conduct of such a (4) Clearance levels are appropriate
hearing. for the purposes of this section may be
(5) Any notice, decision, or order found in the EPA Guidance on Residen-
issued by EPA under this section, tran- tial Lead-Based Paint, Lead-Contami-
script or other verbatim record of oral nated Dust, and Lead Contaminiated
testimony, and any documents filed by Soil or other equivalent guidelines.
a certified individual or firm in a hear- (b) Inspection. (1) An inspection shall
ing under this section shall be avail- be conducted only by a person certified
able to the public, except as otherwise by EPA as an inspector or risk assessor
provided by section 14 of TSCA or by and, if conducted, must be conducted
part 2 of this title. Any such hearing at
according to the procedures in this
which oral testimony is presented shall
paragraph.
be open to the public, except that the
(2) When conducting an inspection,
Presiding Officer may exclude the pub-
lic to the extent necessary to allow the following locations shall be se-
presentation of information which may lected according to documented meth-
be entitled to confidential treatment odologies and tested for the presence of
under section 14 of TSCA or part 2 of lead-based paint:
this title. (i) In a residential dwelling and
child-occupied facility, each compo-
[61 FR 45813, Aug. 29, 1996, as amended at 64 nent with a distinct painting history
FR 31098, June 9, 1999; 64 FR 42851, Aug. 6, and each exterior component with a
1999]
distinct painting history shall be test-
§ 745.227 Work practice standards for ed for lead-based paint, except those
conducting lead-based paint activi- components that the inspector or risk
ties: target housing and child-occu- assessor determines to have been re-
pied facilities. placed after 1978, or to not contain
(a) Effective date, applicability, and lead-based paint; and
terms. (1) Beginning on March 1, 2000, (ii) In a multi-family dwelling or
all lead-based paint activities shall be child-occupied facility, each compo-
performed pursuant to the work prac- nent with a distinct painting history in
tice standards contained in this sec- every common area, except those com-
tion. ponents that the inspector or risk as-
(2) When performing any lead-based sessor determines to have been re-
paint activity described by the cer- placed after 1978, or to not contain
tified individual as an inspection, lead- lead-based paint.
hazard screen, risk assessment or (3) Paint shall be sampled in the fol-
abatement, a certified individual must lowing manner: (i) The analysis of
perform that activity in compliance paint to determine the presence of lead
with the appropriate requirements shall be conducted using documented
below. methodologies which incorporate ade-

(3) Documented methodologies that quate quality control procedures; and/
are appropriate for this section are or
118
(ii) All collected paint chip samples (iii) If deteriorated paint is present,
shall be analyzed according to para- each surface with deteriorated paint,
graph (f) of this section to determine if which is determined, using documented
they contain detectable levels of lead methodologies, to be in poor condition
that can be quantified numerically. and to have a distinct painting history,
(4) The certified inspector or risk as- shall be tested for the presence of lead.
sessor shall prepare an inspection re- (iv) In residential dwellings, two
port which shall include the following composite dust samples shall be col-
information: lected, one from the floors and the
(i) Date of each inspection. other from the windows, in rooms, hall-
(ii) Address of building. ways or stairwells where one or more
(iii) Date of construction. children, age 6 and under, are most
(iv) Apartment numbers (if applica- likely to come in contact with dust.
ble). (v) In multi-family dwellings and
(v) Name, address, and telephone child-occupied facilities, in addition to
number of the owner or owners of each the floor and window samples required
residential dwelling or child-occupied in paragraph (c)(1)(iii) of this section,
facility. the risk assessor shall also collect
composite dust samples from common
(vi) Name, signature, and certifi-
areas where one or more children, age
cation number of each certified inspec-
6 and under, are most likely to come
tor and/or risk assessor conducting
into contact with dust.
testing.
(3) Dust samples shall be collected
(vii) Name, address, and telephone
and analyzed in the following manner:
number of the certified firm employing
(i) All dust samples shall be taken
each inspector and/or risk assessor, if
using documented methodologies that
applicable.
incorporate adequate quality control
(viii) Each testing method and device procedures.
and/or sampling procedure employed (ii) All collected dust samples shall
for paint analysis, including quality be analyzed according to paragraph (f)
control data and, if used, the serial of this section to determine if they
number of any x-ray fluorescence contain detectable levels of lead that
(XRF) device. can be quantified numerically.
(ix) Specific locations of each painted (4) Paint shall be sampled in the fol-
component tested for the presence of lowing manner: (i) The analysis of
lead-based paint. paint to determine the presence of lead
(x) The results of the inspection ex- shall be conducted using documented
pressed in terms appropriate to the methodologies which incorporate ade-
sampling method used. quate quality control procedures; and/
(c) Lead hazard screen. (1) A lead haz- or
ard screen shall be conducted only by a (ii) All collected paint chip samples
person certified by EPA as a risk asses- shall be analyzed according to para-
sor. graph (f) of this section to determine if
(2) If conducted, a lead hazard screen they contain detectable levels of lead
shall be conducted as follows: that can be quantified numerically.
(i) Background information regard- (5) The risk assessor shall prepare a
ing the physical characteristics of the lead hazard screen report, which shall
residential dwelling or child-occupied include the following information:
facility and occupant use patterns that (i) The information required in a risk
may cause lead-based paint exposure to assessment report as specified in para-
one or more children age 6 years and graph (d) of this section, including
under shall be collected. paragraphs (d)(11)(i) through
(ii) A visual inspection of the resi- (d)(11)(xiv), and excluding paragraphs
dential dwelling or child-occupied fa- (d)(11)(xv) through (d)(11)(xviii) of this
cility shall be conducted to: section. Additionally, any background
(A) Determine if any deteriorated information collected pursuant to
paint is present, and paragraph (c)(2)(i) of this section shall

(B) Locate at least two dust sampling be included in the risk assessment re-
locations. port; and
119
§ 745.227 40 CFR Ch. I (7–1–17 Edition)
(ii) Recommendations, if warranted, (7) For child-occupied facilities, inte-

for a follow-up risk assessment, and as rior window sill and floor dust samples
appropriate, any further actions. (either composite or single-surface
(d) Risk assessment. (1) A risk assess- samples) shall be collected and ana-
ment shall be conducted only by a per- lyzed for lead concentration in each
son certified by EPA as a risk assessor room, hallway or stairwell utilized by
and, if conducted, must be conducted one or more children, age 6 and under,
according to the procedures in this and in other common areas in the
paragraph. child-occupied facility where one or
(2) A visual inspection for risk assess- more children, age 6 and under, are
ment of the residential dwelling or likely to come into contact with dust.
child-occupied facility shall be under- (8) Soil samples shall be collected
taken to locate the existence of dete- and analyzed for lead concentrations in
riorated paint, assess the extent and the following locations:
causes of the deterioration, and other (i) Exterior play areas where bare
potential lead-based paint hazards. soil is present; and
(3) Background information regard- (ii) The rest of the yard (i.e., non-
ing the physical characteristics of the play areas) where bare soil is present.
residential dwelling or child-occupied (iii) Dripline/foundation areas where
facility and occupant use patterns that bare soil is present.
may cause lead-based paint exposure to (9) Any paint, dust, or soil sampling
one or more children age 6 years and or testing shall be conducted using doc-
under shall be collected. umented methodologies that incor-
(4) The following surfaces which are porate adequate quality control proce-
determined, using documented meth- dures.
odologies, to have a distinct painting (10) Any collected paint chip, dust, or
history, shall be tested for the presence soil samples shall be analyzed accord-
of lead: ing to paragraph (f) of this section to
(i) Each friction surface or impact determine if they contain detectable
surface with visibly deteriorated paint; levels of lead that can be quantified
and numerically.
(ii) All other surfaces with visibly de- (11) The certified risk assessor shall
teriorated paint. prepare a risk assessment report which
(5) In residential dwellings, dust sam- shall include the following informa-
ples (either composite or single-surface tion:
samples) from the interior window (i) Date of assessment.
sill(s) and floor shall be collected and (ii) Address of each building.
analyzed for lead concentration in all
(iii) Date of construction of build-
living areas where one or more chil-
ings.
dren, age 6 and under, are most likely
to come into contact with dust. (iv) Apartment number (if applica-
ble).
(6) For multi-family dwellings and
child-occupied facilities, the samples (v) Name, address, and telephone
required in paragraph (d)(4) of this sec- number of each owner of each building.
tion shall be taken. In addition, inte- (vi) Name, signature, and certifi-
rior window sill and floor dust samples cation of the certified risk assessor
(either composite or single-surface conducting the assessment.
samples) shall be collected and ana- (vii) Name, address, and telephone
lyzed for lead concentration in the fol- number of the certified firm employing
lowing locations: each certified risk assessor if applica-
(i) Common areas adjacent to the ble.
sampled residential dwelling or child- (viii) Name, address, and telephone
occupied facility; and number of each recognized laboratory
(ii) Other common areas in the build- conducting analysis of collected sam-
ing where the risk assessor determines ples.
that one or more children, age 6 and (ix) Results of the visual inspection.
under, are likely to come into contact (x) Testing method and sampling pro-
with dust. cedure for paint analysis employed.
120
(xi) Specific locations of each painted (4) A certified firm must notify EPA
component tested for the presence of of lead-based paint abatement activi-
lead. ties as follows:
(xii) All data collected from on-site (i) Except as provided in paragraph
testing, including quality control data (e)(4)(ii) of this section, EPA must be
and, if used, the serial number of any notified prior to conducting lead-based
XRF device. paint abatement activities. The origi-
(xiii) All results of laboratory anal- nal notification must be received by
ysis on collected paint, soil, and dust EPA at least 5 business days before the
samples. start date of any lead-based paint
(xiv) Any other sampling results. abatement activities.
(xv) Any background information (ii) Notification for lead-based paint
abatement activities required in re-
collected pursuant to paragraph (d)(3)
sponse to an elevated blood lead level
of this section.
(EBL) determination, or Federal,
(xvi) To the extent that they are used
State, Tribal, or local emergency
as part of the lead-based paint hazard abatement order should be received by
determination, the results of any pre- EPA as early as possible before, but
vious inspections or analyses for the must be received no later than the
presence of lead-based paint, or other start date of the lead-based paint
assessments of lead-based paint-related abatement activities. Should the start
hazards. date and/or location provided to EPA
(xvii) A description of the location, change, an updated notification must
type, and severity of identified lead- be received by EPA on or before the
based paint hazards and any other po- start date provided to EPA. Docu-
tential lead hazards. mentation showing evidence of an EBL
(xviii) A description of interim con- determination or a copy of the Federal/
trols and/or abatement options for each State/Tribal/local emergency abate-
identified lead-based paint hazard and ment order must be included in the
a suggested prioritization for address- written notification to take advantage
ing each hazard. If the use of an of this abbreviated notification period.
encapsulant or enclosure is rec- (iii) Except as provided in paragraph
ommended, the report shall rec- (e)(4)(ii) of this section, updated notifi-
ommend a maintenance and moni- cation must be provided to EPA for
toring schedule for the encapsulant or lead-based paint abatement activities
enclosure. that will begin on a date other than
(e) Abatement. (1) An abatement shall the start date specified in the original
be conducted only by an individual cer- notification, as follows:
tified by EPA, and if conducted, shall (A) For lead-based paint abatement
be conducted according to the proce- activities beginning prior to the start
dures in this paragraph. date provided to EPA an updated noti-
(2) A certified supervisor is required fication must be received by EPA at
for each abatement project and shall be least 5 business days before the new
onsite during all work site preparation start date included in the notification.
and during the post-abatement cleanup (B) For lead-based paint abatement
of work areas. At all other times when activities beginning after the start
abatement activities are being con- date provided to EPA an updated noti-
ducted, the certified supervisor shall be fication must be received by EPA on or
onsite or available by telephone, pager before the start date provided to EPA.
or answering service, and able to be (iv) Except as provided in paragraph
present at the work site in no more (e)(4)(ii) of this section, updated notifi-
than 2 hours. cation must be provided to EPA for
(3) The certified supervisor and the any change in location of lead-based
certified firm employing that super- paint abatement activities at least 5
visor shall ensure that all abatement business days prior to the start date
activities are conducted according to provided to EPA.
the requirements of this section and all (v) Updated notification must be pro-
other Federal, State and local require- vided to EPA when lead-based paint
ments. abatement activities are canceled, or
121
§ 745.227 40 CFR Ch. I (7–1–17 Edition)
when there are other significant Service are reminded that they should
changes including, but not limited to, allow 3 additional business days for de-
when the square footage or acreage to livery in order to ensure that EPA re-
be abated changes by more than 20%. ceives the notification by the required
This updated notification must be re- date). Instructions and sample forms
ceived by EPA on or before the start can be obtained from the NLIC at 1–
date provided to EPA, or if work has 800–424–LEAD(5323), or on the Internet
already begun, within 24 hours of the at http://www.epa.gov/lead.
change. (viii) Lead-based paint abatement ac-
(vi) The following must be included tivities shall not begin on a date, or at
in each notification: a location other than that specified in
(A) Notification type (original, up- either an original or updated notifica-
dated, cancellation). tion, in the event of changes to the
(B) Date when lead-based paint original notification.
abatement activities will start. (ix) No firm or individual shall en-
(C) Date when lead-based paint abate- gage in lead-based paint abatement ac-
ment activities will end (approxima- tivities, as defined in § 745.223, prior to
tion using best professional judge- notifying EPA of such activities ac-
ment). cording to the requirements of this
(D) Firm’s name, EPA certification paragraph.
number, address, telephone number.
(5) A written occupant protection
(E) Type of building (e.g., single fam-
plan shall be developed for all abate-
ily dwelling, multi-family dwelling,
ment projects and shall be prepared ac-
child-occupied facilities) on/in which
cording to the following procedures:
abatement work will be performed.
(i) The occupant protection plan
(F) Property name (if applicable).
shall be unique to each residential
(G) Property address including apart-
dwelling or child-occupied facility and
ment or unit number(s) (if applicable)
be developed prior to the abatement.
for abatement work.
The occupant protection plan shall de-
(H) Documentation showing evidence
scribe the measures and management
of an EBL determination or a copy of
procedures that will be taken during
the Federal/State/Tribal/local emer-
the abatement to protect the building
gency abatement order, if using the ab-
occupants from exposure to any lead-
breviated time period as described in
based paint hazards.
paragraph (e)(4)(ii) of this section.
(I) Name and EPA certification num- (ii) A certified supervisor or project
ber of the project supervisor. designer shall prepare the occupant
(J) Approximate square footage/acre- protection plan.
age to be abated. (6) The work practices listed below
(K) Brief description of abatement shall be restricted during an abatement
activities to be performed. as follows:
(L) Name, title, and signature of the (i) Open-flame burning or torching of
representative of the certified firm who lead-based paint is prohibited;
prepared the notification. (ii) Machine sanding or grinding or
(vii) Notification must be accom- abrasive blasting or sandblasting of
plished using any of the following lead-based paint is prohibited unless
methods: Written notification, or elec- used with High Efficiency Particulate
tronically using the Agency’s Central Air (HEPA) exhaust control which re-
Data Exchange (CDX). Written notifi- moves particles of 0.3 microns or larger
cation can be accomplished using ei- from the air at 99.97 percent or greater
ther the sample form titled ‘‘Notifica- efficiency;
tion of Lead-Based Paint Abatement (iii) Dry scraping of lead-based paint
Activities’’ or similar form containing is permitted only in conjunction with
the information required in paragraph heat guns or around electrical outlets
(e)(4)(vi) of this section. All written no- or when treating defective paint spots
tifications must be delivered by U.S. totaling no more than 2 square feet in
Postal Service, fax, commercial deliv- any one room, hallway or stairwell or
ery service, or hand delivery (persons totaling no more than 20 square feet on
submitting notification by U.S. Postal exterior surfaces; and
122
(iv) Operating a heat gun on lead- present) and one dust sample shall be
based paint is permitted only at tem- taken from the floors of each of no less
peratures below 1100 degrees Fahr- than four rooms, hallways or stairwells
enheit. within the containment area. In addi-
(7) If conducted, soil abatement shall tion, one dust sample shall be taken
be conducted in one of the following from the floor outside the containment
ways: area. If there are less than four rooms,
(i) If the soil is removed: hallways or stairwells within the con-
(A) The soil shall be replaced by soil tainment area, then all rooms, hall-
with a lead concentration as close to ways or stairwells shall be sampled.
local background as practicable, but no (B) After conducting an abatement
greater than 400 ppm. with no containment, two dust samples
(B) The soil that is removed shall not shall be taken from each of no less
be used as top soil at another residen- than four rooms, hallways or stairwells
tial property or child-occupied facility. in the residential dwelling or child-oc-
(ii) If soil is not removed, the soil cupied facility. One dust sample shall
shall be permanently covered, as de- be taken from one interior window sill
fined in § 745.223. and window trough (if present) and one
(8) The following post-abatement dust sample shall be taken from the
clearance procedures shall be per- floor of each room, hallway or stairwell
formed only by a certified inspector or selected. If there are less than four
risk assessor: rooms, hallways or stairwells within
(i) Following an abatement, a visual the residential dwelling or child-occu-
inspection shall be performed to deter- pied facility then all rooms, hallways
mine if deteriorated painted surfaces or stairwells shall be sampled.
and/or visible amounts of dust, debris
(C) Following an exterior paint
or residue are still present. If deterio-
abatement, a visible inspection shall be
rated painted surfaces or visible
conducted. All horizontal surfaces in
amounts of dust, debris or residue are
the outdoor living area closest to the
present, these conditions must be
abated surface shall be found to be
eliminated prior to the continuation of
cleaned of visible dust and debris. In
the clearance procedures.
addition, a visual inspection shall be
(ii) Following the visual inspection
and any post-abatement cleanup re- conducted to determine the presence of
quired by paragraph (e)(8)(i) of this sec- paint chips on the dripline or next to
tion, clearance sampling for lead in the foundation below any exterior sur-
dust shall be conducted. Clearance face abated. If paint chips are present,
sampling may be conducted by employ- they must be removed from the site
ing single-surface sampling or com- and properly disposed of, according to
posite sampling techniques. all applicable Federal, State and local
(iii) Dust samples for clearance pur- requirements.
poses shall be taken using documented (vi) The rooms, hallways or stair-
methodologies that incorporate ade- wells selected for sampling shall be se-
quate quality control procedures. lected according to documented meth-
(iv) Dust samples for clearance pur- odologies.
poses shall be taken a minimum of 1 (vii) The certified inspector or risk
hour after completion of final post- assessor shall compare the residual
abatement cleanup activities. lead level (as determined by the labora-
(v) The following post-abatement tory analysis) from each single surface
clearance activities shall be conducted dust sample with clearance levels in
as appropriate based upon the extent or paragraph (e)(8)(viii) of this section for
manner of abatement activities con- lead in dust on floors, interior window
ducted in or to the residential dwelling sills, and window troughs or from each
or child-occupied facility: composite dust sample with the appli-
(A) After conducting an abatement cable clearance levels for lead in dust
with containment between abated and on floors, interior window sills, and
unabated areas, one dust sample shall window troughs divided by half the
be taken from one interior window sill number of subsamples in the composite
and from one window trough (if sample. If the residual lead level in a
123
§ 745.227 40 CFR Ch. I (7–1–17 Edition)
single surface dust sample equals or ex- methods used, locations of rooms and/
ceeds the applicable clearance level or or components where abatement oc-
if the residual lead level in a composite curred, reason for selecting particular
dust sample equals or exceeds the ap- abatement methods for each compo-
plicable clearance level divided by half nent, and any suggested monitoring of
the number of subsamples in the com- encapsulants or enclosures.
posite sample, the components rep- (f) Collection and laboratory analysis of
resented by the failed sample shall be samples. Any paint chip, dust, or soil
recleaned and retested. samples collected pursuant to the work
(viii) The clearance levels for lead in practice standards contained in this
dust are 40 μg/ft2 for floors, 250 μg/ft2 for section shall be:
interior window sills, and 400 μg/ft2 for (1) Collected by persons certified by
window troughs. EPA as an inspector or risk assessor;
(9) In a multi-family dwelling with and
similarly constructed and maintained (2) Analyzed by a laboratory recog-
residential dwellings, random sampling nized by EPA pursuant to section 405(b)
for the purposes of clearance may be of TSCA as being capable of performing
conducted provided: analyses for lead compounds in paint
(i) The certified individuals who chip, dust, and soil samples.
abate or clean the residential dwellings (g) Composite dust sampling. Com-
do not know which residential dwelling posite dust sampling may only be con-
will be selected for the random sample. ducted in the situations specified in
(ii) A sufficient number of residential paragraphs (c) through (e) of this sec-
dwellings are selected for dust sam- tion. If such sampling is conducted, the
pling to provide a 95 percent level of following conditions shall apply:
confidence that no more than 5 percent (1) Composite dust samples shall con-
or 50 of the residential dwellings sist of at least two subsamples;
(whichever is smaller) in the randomly
(2) Every component that is being
sampled population exceed the appro-
tested shall be included in the sam-
priate clearance levels.
pling; and
(iii) The randomly selected residen-
(3) Composite dust samples shall not
tial dwellings shall be sampled and
consist of subsamples from more than
evaluated for clearance according to
one type of component.
the procedures found in paragraph
(e)(8) of this section. (h) Determinations. (1) Lead-based
(10) An abatement report shall be paint is present:
prepared by a certified supervisor or (i) On any surface that is tested and
project designer. The abatement report found to contain lead equal to or in ex-
shall include the following informa- cess of 1.0 milligrams per square centi-
tion: meter or equal to or in excess of 0.5%
(i) Start and completion dates of by weight; and
abatement. (ii) On any surface like a surface
(ii) The name and address of each cer- tested in the same room equivalent
tified firm conducting the abatement that has a similar painting history and
and the name of each supervisor as- that is found to be lead-based paint.
signed to the abatement project. (2) A paint-lead hazard is present:
(iii) The occupant protection plan (i) On any friction surface that is
prepared pursuant to paragraph (e)(5) subject to abrasion and where the lead
of this section. dust levels on the nearest horizontal
(iv) The name, address, and signature surface underneath the friction surface
of each certified risk assessor or in- (e.g., the window sill or floor) are equal
spector conducting clearance sampling to or greater than the dust hazard lev-
and the date of clearance testing. els identified in § 745.227(b);
(v) The results of clearance testing (ii) On any chewable lead-based paint
and all soil analyses (if applicable) and surface on which there is evidence of
the name of each recognized laboratory teeth marks;
that conducted the analyses. (iii) Where there is any damaged or

(vi) A detailed written description of otherwise deteriorated lead-based paint
the abatement, including abatement on an impact surface that is cause by
124
impact from a related building compo- § 745.228 Accreditation of training pro-

nent (such as a door knob that knocks grams: public and commercial
into a wall or a door that knocks buildings, bridges and super-
against its door frame; and structures. [Reserved]
(iv) If there is any other deteriorated § 745.229 Certification of individuals
lead-based paint in any residential and firms engaged in lead-based
building or child-occupied facility or paint activities: public and commer-
on the exterior of any residential build- cial buildings, bridges and super-
ing or child-occupied facility. structures. [Reserved]
(3) A dust-lead hazard is present in a
residential dwelling or child occupied § 745.230 Work practice standards for
conducting lead-based paint activi-
facility: ties: public and commercial build-
(i) In a residential dwelling on floors ings, bridges and superstructures.
and interior window sills when the [Reserved]
weighted arithmetic mean lead loading
for all single surface or composite sam- § 745.233 Lead-based paint activities
ples of floors and interior window sills requirements.
are equal to or greater than 40 μg/ft2 for Lead-based paint activities, as de-
floors and 250 μg/ft2 for interior window fined in this part, shall only be con-
sills, respectively; ducted according to the procedures and
(ii) On floors or interior window sills work practice standards contained in
in an unsampled residential dwelling in § 745.227 of this subpart. No individual
a multi-family dwelling, if a dust-lead or firm may offer to perform or per-
hazard is present on floors or interior form any lead-based paint activity as
window sills, respectively, in at least defined in this part, unless certified to
one sampled residential unit on the perform that activity according to the
property; and procedures in § 745.226.
(iii) On floors or interior window sills
§ 745.235 Enforcement.
in an unsampled common area in a
multi-family dwelling, if a dust-lead (a) Failure or refusal to comply with
hazard is present on floors or interior any requirement of § 745.225, § 745.226,
window sills, respectively, in at least § 745.227, or § 745.233 is a prohibited act
one sampled common area in the same under sections 15 and 409 of TSCA (15
common area group on the property. U.S.C. 2614, 2689).
(4) A soil-lead hazard is present: (b) Failure or refusal to establish,
(i) In a play area when the soil-lead maintain, provide, copy, or permit ac-
concentration from a composite play cess to records or reports as required
area sample of bare soil is equal to or by § 745.225, § 745.226, or § 745.227 is a pro-
greater than 400 parts per million; or hibited act under sections 15 and 409 of
TSCA (15 U.S.C. 2614, 2689).
(ii) In the rest of the yard when the
(c) Failure or refusal to permit entry
arithmetic mean lead concentration
or inspection as required by § 745.237
from a composite sample (or arith-
and section 11 of TSCA (15 U.S.C. 2610)
metic mean of composite samples) of
is a prohibited act under sections 15
bare soil from the rest of the yard (i.e.,
and 409 of TSCA (15 U.S.C. 2614, 2689).
non-play areas) for each residential (d) In addition to the above, any indi-
building on a property is equal to or vidual or firm that performs any of the
greater than 1,200 parts per million. following acts shall be deemed to have
(i) Recordkeeping. All reports or plans committed a prohibited act under sec-
required in this section shall be main- tions 15 and 409 of TSCA (15 U.S.C. 2614,
tained by the certified firm or indi- 2689). These include the following:
vidual who prepared the report for no (i) Obtaining certification through
fewer than 3 years. The certified firm fraudulent representation;
or individual also shall provide copies (ii) Failing to obtain certification
of these reports to the building owner from EPA and performing work requir-
who contracted for its services. ing certification at a job site; or
[61 FR 45813, Aug. 29, 1996, as amended at 64 (iii) Fraudulently obtaining certifi-
FR 42852, Aug. 6, 1999; 66 FR 1239, Jan. 5, 2001; cation and engaging in any lead-based
69 FR 18496, Apr. 8, 2004] paint activities requiring certification.
125
§ 745.237 40 CFR Ch. I (7–1–17 Edition)
(e) Violators are subject to civil and EPA for the accreditation and re-ac-
criminal sanctions pursuant to section creditation of training programs in one
16 of TSCA (15 U.S.C. 2615) for each vio- or more of the following disciplines: in-
lation. spector, risk assessor, supervisor,
project designer, abatement worker.
§ 745.237 Inspections.
(ii) Exemptions. No fee shall be im-
EPA may conduct reasonable inspec- posed on any training program oper-
tions pursuant to the provisions of sec- ated by a State, federally recognized
tion 11 of TSCA (15 U.S.C. 2610) to en- Indian Tribe, local government, or non-
sure compliance with this subpart.
profit organization. This exemption
§ 745.238 Fees for accreditation and does not apply to the certification of
certification of lead-based paint ac- firms or individuals.
tivities. (2) Firms and individuals. All firms
(a) Purpose. To establish and impose and individuals seeking certification
fees for certified individuals and firms and re-certification from EPA to en-
engaged in lead-based paint activities gage in lead-based paint activities in
and persons operating accredited train- one or more of the following dis-
ing programs under section 402(a) of ciplines: inspector, risk assessor, super-
the Toxic Substances Control Act visor, project designer, abatement
(TSCA). worker.
(b) Persons who must pay fees. Fees in (c) Fee amounts—(1) Certification and
accordance with paragraph (c) of this accreditation fees. Initial and renewal
section must be paid by: certification and accreditation fees are
(1) Training programs. (i) All non-ex- specified in the following table:
empt training programs applying to
Re-accreditation (every 4 years,
Training Program Accreditation see 40 CFR 745.225(f)(1) for de-
tails)
Initial Course
Inspector $870 $620
Risk assessor $870 $620
Supervisor $870 $620
Worker $870 $620
Project Designer $870 $620
Refresher Course
Inspector $690 $580
Worker $690 $580
Project Designer $690 $580
Lead-based Paint Activities—Individual Certification Re-certification (every 3 years, see

40 CFR 745.226(e)(1) for de-
tails)
Inspector $410 $410

Worker $310 $310
Project designer $410 $410
Tribal certification (each discipline) $10 $10
Lead-based Paint Activities—Firm Certification Re-certification (every 3 years, see

40 CFR 745.226(f)(7) for details)
Firm $550 $550

Combined Renovation and Lead-based Paint Activi- $550 $550
ties Firm Application
Combined Renovation and Lead-based Paint Activi- $20 $20
ties Tribal Firm Application
Tribal Firm $20 $20
126
(2) Certification examination fee. Indi- with the administration and enforce-
viduals required to take a certification ment of subpart L of this part with the
exam in accordance with § 745.226 will exception of costs associated with the
be assessed a fee of $70 for each exam accreditation of training programs op-
attempt. erated by a State, federally recognized
(3) Lost identification card or certifi- Indian Tribe, local government, and
cate. A $15 fee shall be charged for re- nonprofit organization. In order to do
placement of an identification card or this, EPA will periodically adjust the
certificate. (See replacement procedure fees to reflect changed economic condi-
in paragraph (e) of this section.) tions.
(4) Accreditation amendment fees. No (2) The fees will be evaluated based
fee will be charged for accreditation on the cost to administer and enforce
amendments. the program, and the number of appli-
(d) Application/payment procedure—(1) cants. New fee schedules will be pub-
Certification and re-certification—(i) In- lished in the FEDERAL REGISTER.
dividuals. Submit a completed applica- (g) Failure to remit a fee. (1) EPA will
tion (titled ‘‘Application for Individ- not provide certification, re-certifi-
uals to Conduct Lead-based Paint Ac- cation, accreditation, or re-accredita-
tivities’’), the materials described at tion for any individual, firm, or train-
§ 745.226, and the application fee(s) de- ing program which does not remit fees
scribed in paragraph (c) of this section. described in paragraph (c) of this sec-
(ii) Firms. Submit a completed appli- tion in accordance with the procedures
cation (titled ‘‘Application for Firms specified in paragraph (d) of this sec-
’’), the materials described at § 745.226, tion.
and the application fee(s) described in (2) EPA will not replace identifica-
paragraph (c) of this section. tion cards or certificates for any indi-
(2) Accreditation and re-accreditation. vidual, firm, or training program which
Submit a completed application (titled does not remit fees described in para-
‘‘Accreditation Application for Train- graph (c) of this section in accordance
ing Programs’’), the materials de- with the procedures specified in para-
scribed at § 745.225, and the application graph (e) of this section.
fee described in paragraph (c) of this [64 FR 31098, June 9, 1999, as amended at 74
section. FR 11870, Mar. 20, 2009; 76 FR 47945, Aug. 5,
(3) Application forms. Application 2011; 81 FR 7996, Feb. 17, 2016]
forms and instructions can be obtained
from the National Lead Information § 745.239 Effective dates.
Center at: 1–800–424–LEAD. This subpart L shall apply in any
(e) Identification card replacement and State or Indian Country that does not
certificate replacement. (1) Parties seek- have an authorized program under sub-
ing identification card or certificate part Q, effective August 31, 1998. In
replacement shall complete the appli- such States or Indian Country:
cable portions of the appropriate appli- (a) Training programs shall not pro-
cation in accordance with the instruc- vide, offer or claim to provide training
tions provided. The appropriate appli- or refresher training for certification
cations are: without accreditation from EPA pursu-
(i) Individuals. ‘‘Application for Indi- ant to § 745.225 on or after March 1, 1999.
viduals to Conduct Lead-based Paint (b) No individual or firm shall per-
Activities.’’ form, offer, or claim to perform lead-
(ii) Firms. ‘‘Application for Firms.’’ based paint activities, as defined in
(iii) Training programs. ‘‘Accredita- this subpart, without certification
tion Application for Training Pro- from EPA to conduct such activities
grams.’’ pursuant to § 745.226 on or after March
(2) Submit application and payment 1, 2000.
in the amount specified in paragraph (c) All lead-based paint activities
(c)(3) of this section in accordance with shall be performed pursuant to the
the instructions provided with the ap- work practice standards contained in
plication package. § 745.227 on or after March 1, 2000.

(f) Adjustment of fees. (1) EPA will col- [61 FR 45813, Aug. 29, 1996, as amended at 64
lect fees reflecting the costs associated FR 42852, Aug. 6, 1999]
127
§ 745.320 40 CFR Ch. I (7–1–17 Edition)
Subparts M–P [Reserved] not impair a State’s ability to obtain

full program authorization in accord-
ance with this subpart. EPA will ad-
Subpart Q—State and Indian Tribal minister the program in Indian Coun-
Programs try if neither the State nor Indian
Tribe has been granted program au-
SOURCE: 61 FR 45825, Aug. 29, 1996, unless thorization by EPA.
otherwise noted.
§ 745.320 Scope and purpose. FR 21767, Apr. 22, 2008]
(a) This subpart establishes the re- § 745.323 Definitions.

quirements that State or Tribal pro- The definitions in subpart A apply to
grams must meet for authorization by this subpart. In addition, the defini-
the Administrator to administer and tions in § 745.223 and the following defi-
enforce the standards, regulations, or nitions apply:
other requirements established under Indian Country means (1) all land
TSCA section 402 and/or section 406 and within the limits of any American In-
establishes the procedures EPA will dian reservation under the jurisdiction
follow in approving, revising, and with- of the U.S. government, notwith-
drawing approval of State or Tribal standing the issuance of any patent,
programs. and including rights-of-way running
(b) For State or Tribal lead-based throughout the reservation; (2) all de-
paint training and certification pro- pendent Indian communities within the
grams, a State or Indian Tribe may borders of the United States whether
seek authorization to administer and within the original or subsequently ac-
enforce §§ 745.225, 745.226, and 745.227. quired territory thereof, and whether
The provisions of §§ 745.220, 745.223, within or outside the limits of a State;
745.233, 745.235, 745.237, and 745.239 shall and (3) all Indian allotments, the In-
be applicable for the purposes of such dian titles which have not been extin-
program authorization. guished, including rights-of-way run-
(c) A State or Indian Tribe may seek ning through the same.
authorization to administer and en- Indian Tribe means any Indian Tribe,
force all of the provisions of subpart E band, nation, or community recognized
of this part, just the pre-renovation by the Secretary of the Interior and ex-
education provisions of subpart E of ercising substantial governmental du-
this part, or just the training, certifi- ties and powers.
cation, accreditation, and work prac-
tice provisions of subpart E of this § 745.324 Authorization of State or
part. The provisions of §§ 745.324 and Tribal programs.
745.326 apply for the purposes of such (a) Application content and procedures.
program authorizations. (1) Any State or Indian Tribe that
(d) A State or Indian Tribe applying seeks authorization from EPA to ad-
for program authorization may seek ei- minister and enforce the provisions of
ther interim approval or final approval subpart E or subpart L of this part
of the compliance and enforcement must submit an application to the Ad-
portion of the State or Tribal lead- ministrator in accordance with this
based paint program pursuant to the paragraph.
procedures at § 745.327(a). (2) Before developing an application
(e) State or Tribal submissions for for authorization, a State or Indian
program authorization shall comply Tribe shall disseminate a public notice
with the procedures set out in this sub- of intent to seek such authorization
part. and provide an opportunity for a public
(f) Any State or Tribal program ap- hearing.
proved by the Administrator under this (3) A State or Tribal application shall
subpart shall at all times comply with include:
the requirements of this subpart. (i) A transmittal letter from the
(g) In many cases States will lack au- State Governor or Tribal Chairperson
thority to regulate activities in Indian (or equivalent official) requesting pro-
Country. This lack of authority does gram approval.
128
(ii) A summary of the State or Tribal program and serve as the primary con-
program. This summary will be used to tact with EPA.
provide notice to residents of the State (iii) In the event that more than one
or Tribe. agency is or will be responsible for ad-
(iii) A description of the State or ministering and enforcing the program,
Tribal program in accordance with the application must also include a de-
paragraph (b) of this section. scription of the functions to be per-
(iv) An Attorney General’s or Tribal formed by each agency. The desciption
Counsel’s (or equivalent) statement in shall explain and how the program will
accordance with paragraph (c) of this be coordinated by the primary agency
section. to ensure consistency and effective ad-
(v) Copies of all applicable State or ministration of the within the State or
Tribal statutes, regulations, standards, Indian Tribe.
and other materials that provide the (2) To demonstrate that the State or
State or Indian Tribe with the author- Tribal program is at least as protective
ity to administer and enforce a lead- as the Federal program, fulfilling the
based paint program. criteria in paragraph (e)(2)(i) of this
section, the State or Tribal application
(4) After submitting an application,
must include:
the Agency will publish a FEDERAL
(i) A description of the program that
REGISTER notice that contains an an-
demonstrates that the program con-
nouncement of the receipt of the State
tains all of the elements specified in
or Tribal application, the summary of
§ 745.325, § 745.326, or both; and
the program as provided by the State (ii) An analysis of the State or Tribal
or Tribe, and a request for public com- program that compares the program to
ments to be mailed to the appropriate the Federal program in subpart E or
EPA Regional Office. This comment subpart L of this part, or both. This
period shall last for no less than 45 analysis must demonstrate how the
days. EPA will consider these com- program is, in the State’s or Indian
ments during its review of the State or Tribe’s assessment, at least as protec-
Tribal application. tive as the elements in the Federal pro-
(5) Within 60 days of submission of a gram at subpart E or subpart L of this
State or Tribal application, EPA will, part, or both. EPA will use this anal-
if requested, conduct a public hearing ysis to evaluate the protectiveness of
in each State or Indian Country seek- the State or Tribal program in making
ing program authorization and will its determination pursuant to para-
consider all comments submitted at graph (e)(2)(i) of this section.
that hearing during the review of the (3) To demonstrate that the State or
State or Tribal application. Tribal program provides adequate en-
(b) Program description. A State or In- forcement, fulfilling the criteria in
dian Tribe seeking to administer and paragraph (e)(2)(ii) of this section, the
enforce a program under this subpart State or Tribal application must in-
must submit a description of the pro- clude a description of the State or
gram. The description of the State or Tribal lead-based paint compliance and
Tribal program must include: enforcement program that dem-
(1)(i) The name of the State or Tribal onstrates that the program contains
agency that is or will be responsible for all of the elements specified at § 745.327.
administering and enforcing the pro- This description shall include copies of
gram, the name of the official in that all policies, certifications, plans, re-
agency designated as the point of con- ports, and other materials that dem-
tact with EPA, and addresses and onstrate that the State or Tribal pro-
phone numbers where this official can gram contains all of the elements spec-
be contacted. ified at § 745.327.
(ii) Where more than one agency is or (4)(i) The program description for an
will be responsible for administering Indian Tribe shall also include a map,
and enforcing the program, the State legal description, or other information
or Indian Tribe must designate a pri- sufficient to identify the geographical

mary agency to oversee and coordinate extent of the territory over which the
administration and enforcement of the Indian Tribe exercises jurisdiction.
129
§ 745.324 40 CFR Ch. I (7–1–17 Edition)
(ii) The program description for an (d) Program certification. (1) At the
Indian Tribe shall also include a dem- time of submitting an application, a
onstration that the Indian Tribe: State may also certify to the Adminis-
(A) Is recognized by the Secretary of trator that the State program meets
the Interior. the requirements contained in para-
(B) has an existing government exer- graphs (e)(2)(i) and (e)(2)(ii) of this sec-
cising substantial governmental duties tion.
and powers. (2) If this certification is contained
(C) has adequate civil regulatory ju- in a State’s application, the program
risdiction (as shown in the Tribal legal shall be deemed to be authorized by
certification in paragraph (c)(2) of this EPA until such time as the Adminis-
section) over the subject matter and trator disapproves the program appli-
entities regulated. cation or withdraws the program au-
(D) is reasonably expected to be capa- thorization. A program shall not be
ble of administering the Federal pro- deemed authorized pursuant to this
gram for which it is seeking authoriza- subpart to the extent that jurisdiction
tion. is asserted over Indian Country, includ-
(iii) If the Administrator has pre- ing non-member fee lands within an In-
viously determined that an Indian dian reservation.
Tribe has met the prerequisites in (3) If the application does not contain
paragraphs (b)(4)(ii)(A) and (B) of this such certification, the State program
section for another EPA program, the will be authorized only after the Ad-
Indian Tribe need provide only that in- ministrator authorizes the program in
formation unique to the lead-based accordance with paragraph (e) of this
paint program required by paragraphs section.
(b)(4)(ii)(C) and (D) of this section.
(4) This certification shall take the
(c) Attorney General’s statement. (1) A
form of a letter from the Governor or
State or Indian Tribe must submit a
the Attorney General to the Adminis-
written statement signed by the Attor-
trator. The certification shall ref-
ney General or Tribal Counsel (or
erence the program analysis in para-
equivalent) certifying that the laws
graph (b)(3) of this section as the basis
and regulations of the State or Indian
for concluding that the State program
Tribe provide adequate legal authority
is at least as protective as the Federal
to administer and enforce the State or
program, and provides adequate en-
Tribal program. This statement shall
forcement.
include citations to the specific stat-
utes and regulations providing that (e) EPA approval. (1) EPA will fully
legal authority. review and consider all portions of a
(2) The Tribal legal certification (the State or Tribal application.
equivalent to the Attorney General’s (2) Within 180 days of receipt of a
statement) may also be submitted and complete State or Tribal application,
signed by an independent attorney re- the Administrator shall either author-
tained by the Indian Tribe for represen- ize the program or disapprove the ap-
tation in matters before EPA or the plication. The Administrator shall au-
courts pertaining to the Indian Tribe’s thorize the program, after notice and
program. The certification shall in- the opportunity for public comment
clude an assertion that the attorney and a public hearing, only if the Ad-
has the authority to represent the In- ministrator finds that:
dian Tribe with respect to the Indian (i) The State or Tribal program is at
Tribe’s authorization application. least as protective of human health
(3) If a State application seeks ap- and the environment as the cor-
proval of its program to operate in In- responding Federal program under sub-
dian Country, the required legal cer- part E or subpart L of this part, or
tification shall include an analysis of both; and
the applicant’s authority to implement (ii) The State or Tribal program pro-
its provisions in Indian Country. The vides adequate enforcement.
applicant shall include a map delin- (3) EPA shall notify in writing the
eating the area over which it seeks to State or Indian Tribe of the Adminis-
operate the program. trator’s decision to authorize the State
130
or Tribal program or disapprove the reports demonstrate successful pro-

State’s or Indian Tribe’s application. gram implementation, the Agency will
(4) If the State or Indian Tribe ap- automatically extend the reporting in-
plies for authorization of State or Trib- terval to every 2 years. If the subse-
al programs under both subpart E and quent reports demonstrate problems
subpart L, EPA may, as appropriate, with implementation, EPA will require
authorize one program and disapprove a return to annual reporting until the
the other. reports demonstrate successful pro-
(f) EPA administration and enforce- gram implementation, at which time
ment. (1) If a State or Indian Tribe does the Agency will extend the reporting
not have an authorized program to ad- interval to every 2 years.
minister and enforce subpart L of this The report shall include the fol-
part in effect by August 31, 1998, the lowing information:
Administrator shall, by such date, es- (1) Any significant changes in the
tablish and enforce the provisions of content or administration of the State
subpart L of this part as the Federal or Tribal program implemented since
program for that State or Indian Coun- the previous reporting period; and
try. (2) All information regarding the
(2) If a State or Indian Tribe does not lead-based paint enforcement and com-
have an authorized program to admin- pliance activities listed at § 745.327(d)
ister and enforce the pre-renovation ‘‘Summary on Progress and Perform-
education requirements of subpart E of ance.’’
this part by August 31, 1998, the Admin- (i) Withdrawal of authorization. (1) If
istrator will, by such date, enforce EPA concludes that a State or Indian
those provisions of subpart E of this Tribe is not administering and enforc-
part as the Federal program for that ing an authorized program in compli-
State or Indian Country. If a State or ance with the standards, regulations,
Indian Tribe does not have an author- and other requirements of sections 401
ized program to administer and enforce through 412 of TSCA and this subpart,
the training, certification and accredi- the Administrator shall notify the pri-
tation requirements and work practice mary agency for the State or Indian
standards of subpart E of this part by Tribe in writing and indicate EPA’s in-
April 22, 2009, the Administrator will, tent to withdraw authorization of the
by such date, enforce those provisions program.
of subpart E of this part as the Federal (2) The Notice of Intent to Withdraw
program for that State or Indian Coun- shall:
try. (i) Identify the program aspects that
(3) Upon authorization of a State or EPA believes are inadequate and pro-
Tribal program, pursuant to paragraph vide a factual basis for such findings.
(d) or (e) of this section, it shall be an (ii) Include copies of relevant docu-
unlawful act under sections 15 and 409 ments.
of TSCA for any person to fail or refuse (iii) Provide an opportunity for the
to comply with any requirements of State or Indian Tribe to respond either
such program. in writing or at a meeting with appro-
(g) Oversight. EPA shall periodically priate EPA officials.
evaluate the adequacy of a State’s or (3) EPA may request that an infor-
Indian Tribe’s implementation and en- mal conference be held between rep-
forcement of its authorized programs. resentatives of the State or Indian
(h) Reports. Beginning 12 months Tribe and EPA officials.
after the date of program authoriza- (4) Prior to issuance of a withdrawal,
tion, the primary agency for each a State or Indian Tribe may request
State or Indian Tribe that has an au- that EPA hold a public hearing. At this
thorized program shall submit a writ- hearing, EPA, the State or Indian
ten report to the EPA Regional Admin- Tribe, and the public may present facts
istrator for the Region in which the bearing on whether the State’s or In-
State or Indian Tribe is located. This dian Tribe’s authorization should be
report shall be submitted at least once withdrawn.

every 12 months for the first 3 years (5) If EPA finds that deficiencies war-
after program authorization. If these ranting withdrawal did not exist or
131
§ 745.325 40 CFR Ch. I (7–1–17 Edition)
were corrected by the State or Indian (b) Accreditation of training programs.

Tribe, EPA may rescind its Notice of The State or Indian Tribe must have
Intent to Withdraw authorization. either:
(6) Where EPA finds that deficiencies (1) Procedures and requirements for
in the State or Tribal program exist the accreditation of training programs
that warrant withdrawal, an agree- that establish:
ment to correct the deficiencies shall (i) Requirements for the accredita-
be jointly prepared by the State or In- tion of training programs, including
dian Tribe and EPA. The agreement but not limited to:
shall describe the deficiencies found in (A) Training curriculum require-
the program, specify the steps the ments.
State or Indian Tribe has taken or will (B) Training hour requirements.
take to remedy the deficiencies, and (C) Hands-on training requirements.
establish a schedule, no longer than 180 (D) Trainee competency and pro-
days, for each remedial action to be ficiency requirements.
initiated. (E) Requirements for training pro-
(7) If the State or Indian Tribe does gram quality control.
not respond within 60 days of issuance (ii) Procedures for the re-accredita-
of the Notice of Intent to Withdraw or tion of training programs.
an agreement is not reached within 180 (iii) Procedures for the oversight of
days after EPA determines that a training programs.
State or Indian Tribe is not in compli- (iv) Procedures for the suspension,
ance with the Federal program, the revocation, or modification of training
Agency shall issue an order with- program accreditations; or
drawing the State’s or Indian Tribe’s (2) Procedures or regulations, for the
authorization. purposes of certification, for the ac-
(8) By the date of such order, the Ad- ceptance of training offered by an ac-
ministrator will establish and enforce credited training provider in a State or
the provisions of subpart E or subpart Tribe authorized by EPA.
L of this part, or both, as the Federal (c) Certification of individuals. The
program for that State or Indian Coun- State or Indian Tribe must have re-
try. quirements for the certification of in-
dividuals that:
[61 FR 45825, Aug. 29, 1996, as amended at 73 (1) Ensure that certified individuals:
FR 21767, Apr. 22, 2008] (i) Are trained by an accredited
training program; and
§ 745.325 Lead-based paint activities:
State and Tribal program require- (ii) Possess appropriate education or
ments. experience qualifications for certifi-
cation.
(a) Program elements. To receive au- (2) Establish procedures for re-certifi-
thorization from EPA, a State or Trib- cation.
al program must contain at least the (3) Require the conduct of lead-based
following program elements for lead- paint activities in accordance with
based paint activities: work practice standards established by
(1) Procedures and requirements for the State or Indian Tribe.
the accreditation of lead-based paint (4) Establish procedures for the sus-
activities training programs. pension, revocation, or modification of
(2) Procedures and requirements for certifications.
the certification of individuals engaged (5) Establish requirements and proce-
in lead-based paint activities. dures for the administration of a third-
(3) Work practice standards for the party certification exam.
conduct of lead-based paint activities. (d) Work practice standards for the con-
(4) Requirements that all lead-based duct of lead-based paint activities. The
paint activities be conducted by appro- State or Indian Tribe must have re-
priately certified contractors. quirements or standards that ensure
(5) Development of the appropriate that lead-based paint activities are
infrastructure or government capacity conducted reliably, effectively, and

to effectively carry out a State or Trib- safely. At a minimum the State’s or In-
al program. dian Tribe’s work practice standards
132
for conducting inspections, risk assess- (iv) The program elements required
ments, and abatements must contain in paragraph (d)(2)(iii)(C) and
the requirements specified in para- (d)(2)(iii)(D) of this section shall be
graphs (d)(1), (d)(2), and (d)(3) of this adopted in accordance with the sched-
section. ule for the demonstration required in
(1) The work practice standards for paragraph (e) of this section.
the inspection for the presence of lead- (v) The risk assessor develops a re-
based paint must require that: port that clearly presents the results of
(i) Inspections are conducted only by the assessment and recommendations
individuals certified by the appropriate for the control or elimination of all
State or Tribal authority to conduct identified hazards.
inspections.
(vi) The certified risk assessor or the
(ii) Inspections are conducted in a
firm retains the appropriate records.
way that identifies the presence of
lead-based paint on painted surfaces (3) The work practice standards for
within the interior or on the exterior abatement must require that:
of a residential dwelling or child-occu- (i) Abatements are conducted only by
pied facility. individuals certified by the appropriate
(iii) Inspections are conducted in a State or Tribal authority to conduct or
way that uses documented methodolo- supervise abatements.
gies that incorporate adequate quality (ii) Abatements permanently elimi-
control procedures. nate lead-based paint hazards and are
(iv) A report is developed that clearly conducted in a way that does not in-
documents the results of the inspec- crease the hazards of lead-based paint
tion. to the occupants of the dwelling or
(v) Records are retained by the cer- child-occupied facility.
tified inspector or the firm. (iii) Abatements include post-abate-
(2) The work practice standards for ment lead in dust clearance sampling
risk assessment must require that: and conformance with clearance levels
(i) Risk assessments are conducted established or adopted by the State or
only by individuals certified by the ap- Indian Tribe.
propriate State or Tribal authority to (iv) The abatement contractor devel-
conduct risk assessments. ops a report that describes areas of the
(ii) Risk assessments are conducted residential dwelling or child-occupied
in a way that identifies and reports the facility abated and the techniques em-
presence of lead-based paint hazards. ployed.
(iii) Risk assessments consist of, at
(v) The certified abatement con-
least:
tractor or the firm retains appropriate
(A) An assessment, including a visual
records.
inspection, of the physical characteris-
tics of the residential dwelling or (e) The State or Indian Tribe must
child-occupied facility; demonstrate that it has standards for
(B) Environmental sampling for lead identifying lead-based paint hazards
in paint, dust, and soil; and clearance standards for dust, that
(C) Environmental sampling require- are at least as protective as the stand-
ments for lead in paint, dust, and soil ards in § 745.227 as amended on Feb-
that allow for comparison to the stand- ruary 5, 2001. A State or Indian Tribe
ards for lead-based paint hazards estab- with such a section 402 program ap-
lished or revised by the State or Indian proved before February 5, 2003 shall
Tribe pursuant to paragraph (e) of this make this demonstration no later than
section; and the first report submitted pursuant to
(D) A determination of the presence § 745.324(h) on or after February 5, 2003.
of lead-based paint hazards made by A State or Indian Tribe with such a
comparing the results of visual inspec- program submitted but not approved
tion and environmental sampling to before February 5, 2003 may make this
the standards for lead-based paint haz- demonstration by amending its appli-
ards established or revised by the State cation or in its first report submitted
or Indian Tribe pursuant to paragraph pursuant to § 745.324(h). A State or In-
(e) of this section. dian Tribe submitting its program on
133
§ 745.326 40 CFR Ch. I (7–1–17 Edition)
or after February 5, 2003 shall make (2) Establish procedures for distrib-
this demonstration in its application. uting the lead hazard information to
[61 FR 45825, Aug. 29, 1996, as amended at 66 owners and occupants of housing and
FR 1240, Jan. 5, 2001] child-occupied facilities prior to ren-
ovation activities.
§ 745.326 Renovation: State and Tribal (3) Require that the information to
program requirements. be distributed include either the pam-
(a) Program elements. To receive au- phlet titled Renovate Right: Important
thorization from EPA, a State or Trib- Lead Hazard Information for Families,
al program must contain the following Child Care Providers and Schools, devel-
program elements: oped by EPA under section 406(a) of
(1) For pre-renovation education pro- TSCA, or an alternate pamphlet or
grams, procedures and requirements package of lead hazard information
for the distribution of lead hazard in- that has been submitted by the State
formation to owners and occupants of or Tribe, reviewed by EPA, and ap-
target housing and child-occupied fa- proved by EPA for that State or Tribe.
cilities before renovations for com- Such information must contain renova-
pensation. tion-specific information similar to
(2) For renovation training, certifi- that in Renovate Right: Important Lead
cation, accreditation, and work prac- Hazard Information for Families, Child
tice standards programs: Care Providers and Schools, must meet
(i) Procedures and requirements for the content requirements prescribed by
the accreditation of renovation and section 406(a) of TSCA, and must be in
dust sampling technician training pro- a format that is readable to the diverse
grams. A State and Tribal program is audience of housing and child-occupied
not required to include procedures and facility owners and occupants in that
requirements for the dust sampling State or Tribe.
technician training discipline if the (i) A State or Tribe with a pre-ren-
State or Tribal program requires dust ovation education program approved
sampling to be performed by a certified before June 23, 2008, must demonstrate
lead-based paint inspector or risk as- that it meets the requirements of this
sessor. section no later than the first report
(ii) Procedures and requirements for that it submits pursuant to § 745.324(h)
accredited initial and refresher train- on or after April 22, 2009.
ing for renovators and dust sampling
(ii) A State or Tribe with an applica-
technicians and on-the-job training for
tion for approval of a pre-renovation
other individuals who perform renova-
education program submitted but not
tions.
approved before June 23, 2008, must
(iii) Procedures and requirements for
demonstrate that it meets the require-
the certification of individuals and/or
firms. ments of this section either by amend-
(iv) Requirements that all renova- ing its application or in the first report
tions be conducted by appropriately that it submits pursuant to § 745.324(h)
certified individuals and/or firms. of this part on or after April 22, 2009.
(v) Work practice standards for the (iii) A State or Indian Tribe submit-
conduct of renovations. ting its application for approval of a
(3) For all renovation programs, de- pre-renovation education program on
velopment of the appropriate infra- or after June 23, 2008, must dem-
structure or government capacity to onstrate in its application that it
effectively carry out a State or Tribal meets the requirements of this section.
program. (c) Accreditation of training programs.
(b) Pre-renovation education. To be To be considered at least as protective
considered at least as protective as the as the Federal program, the State or
Federal program, the State or Tribal Tribal program must meet the require-
program must: ments of either paragraph (c)(1) or
(1) Establish clear standards for iden- (c)(2) of this section:
tifying renovation activities that trig- (1) The State or Tribal program must
ger the information distribution re- establish accreditation procedures and
quirements. requirements, including:
134
(i) Procedures and requirements for (3) Establish procedures for the sus-
the accreditation of training programs, pension, revocation, or modification of
including, but not limited to: certifications.
(A) Training curriculum require- (e) Work practice standards for renova-
ments. tions. To be considered at least as pro-
(B) Training hour requirements. tective as the Federal program, the
(C) Hands-on training requirements. State or Tribal program must establish
(D) Trainee competency and pro- standards that ensure that renovations
ficiency requirements. are conducted reliably, effectively, and
(E) Requirements for training pro- safely. At a minimum, the State or
gram quality control.
Tribal program must contain the fol-
(ii) Procedures and requirements for
lowing requirements:
the re-accreditation of training pro-
grams. (1) Renovations must be conducted
(iii) Procedures for the oversight of only by certified renovation firms,
training programs. using trained individuals.
(iv) Procedures and standards for the (2) Renovations are conducted using
suspension, revocation, or modification lead-safe work practices that are at
of training program accreditations; or least as protective to occupants as the
(2) The State or Tribal program must requirements in § 745.85.
establish procedures and requirements (3) Certified individuals and/or ren-
for the acceptance of renovation train- ovation firms must retain appropriate
ing offered by training providers ac- records.
credited by EPA or a State or Tribal (f) Revisions to renovation program re-
program authorized by EPA under this quirements. When EPA publishes in the
subpart. FEDERAL REGISTER revisions to the
(d) Certification of individuals and/or renovation program requirements con-
renovation firms. To be considered at tained in subparts E and L of this part:
least as protective as the Federal pro-
(1) A State or Tribe with a renova-
gram, the State or Tribal program
tion program approved before the effec-
must:
tive date of the revisions to the renova-
(1) Establish procedures and require-
ments that ensure that individuals who tion program requirements in subparts
perform or direct renovations are prop- E and L of this part must demonstrate
erly trained. These procedures and re- that it meets the requirements of this
quirements must include: section no later than the first report
(i) A requirement that renovations be that it submits pursuant to § 745.324(h)
performed and directed by at least one but no later than 2 years after the ef-
individual who has been trained by an fective date of the revisions.
accredited training program. (2) A State or Tribe with an applica-
(ii) Procedures and requirements for tion for approval of a renovation pro-
accredited refresher training for these gram submitted but not approved be-
individuals. fore the effective date of the revisions
(iii) Procedures and requirements for to the renovation program require-
individuals who have received accred- ments in subparts E and L of this part
ited training to provide on-the-job must demonstrate that it meets the re-
training for those individuals who per- quirements of this section either by
form renovations but do not receive ac- amending its application or in the first
credited training. A State and Tribal report that it submits pursuant to
program is not required to include pro- § 745.324(h) of this part but no later
cedures and requirements for on-the-
than 2 years after the effective date of
job training for renovation workers if
the revisions.
the State or Tribal program requires
accredited initial and refresher train- (3) A State or Tribe submitting its
ing for all persons who perform renova- application for approval of a renova-
tions. tion program on or after the effective
(2) Establish procedures and require- date of the revisions must demonstrate
ments for the formal certification and
re-certification of renovation firms.
135
§ 745.327 40 CFR Ch. I (7–1–17 Edition)
in its application that it meets the re- or Tribal plan which identifies what re-
quirements of the new renovation pro- sources the State or Indian Tribe in-
gram requirements in subparts E and L tends to devote to the administration
of this part. of its lead-based paint compliance and
[73 FR 21768, Apr. 22, 2008, as amended at 75 enforcement program.
FR 24819, May 6, 2010; 76 FR 47945, Aug. 5, (C) Agree to submit to EPA the Sum-
2011] mary on Progress and Performance of
lead-based paint compliance and en-
§ 745.327 State or Indian Tribal lead- forcement activities as described at
based paint compliance and en- paragraph (d) of this section.
forcement programs.
(ii) Any interim approval granted by
(a) Approval of compliance and enforce- EPA for the compliance and enforce-
ment programs. A State or Indian Tribe ment program portion of a State or
seeking authorization of a lead-based Tribal lead-based paint program will
paint program can apply for and re- expire no later than 3 years from the
ceive either interim or final approval date of EPA’s interim approval. One
of the compliance and enforcement hundred and eighty days prior to this
program portion of its lead-based paint expiration date, a State or Indian Tribe
program. Indian Tribes are not re- shall apply to EPA for final approval of
quired to exercise criminal enforce- the compliance and enforcement pro-
ment jurisdiction as a condition for gram portion of a State or Tribal lead-
program authorization. based paint program. Final approval
(1) Interim approval. Interim approval shall be given to any State or Indian
of the compliance and enforcement Tribe which has in place all of the ele-
program portion of the State or Tribal ments of paragraphs (b), (c), and (d) of
lead-based paint program may be this section. If a State or Indian Tribe
granted by EPA only once, and subject does not receive final approval for the
to a specific expiration date. compliance and enforcement program
(i) To be considered adequate for pur- portion of a State or Tribal lead-based
poses of obtaining interim approval for
paint program by the date 3 years after
the compliance and enforcement pro-
the date of EPA’s interim approval, the
gram portion of a State or Tribal lead-
Administrator shall, by such date, ini-
based paint program, a State or Indian
tiate the process to withdraw the State
Tribe must, in its application described
or Indian Tribe’s authorization pursu-
at § 745.324(a):
ant to § 745.324(i).
(A) Demonstrate it has the legal au-
thority and ability to immediately im- (2) Final approval. Final approval of
plement the elements in paragraph (b) the compliance and enforcement pro-
of this section. This demonstration gram portion of a State or Tribal lead-
shall include a statement that the based paint program can be granted by
State or Indian Tribe, during the in- EPA either through the application
terim approval period, shall carry out a process described at § 745.324(a), or, for
level of compliance monitoring and en- States or Indian Tribes which pre-
forcement necessary to ensure that the viously received interim approval as
State or Indian Tribe addresses any described in paragraph (a)(1) of this
significant risks posed by noncompli- section, through a separate application
ance with lead-based paint activity re- addressing only the compliance and en-
quirements. forcement program portion of a State
(B) Present a plan with time frames or Tribal lead-based paint program.
identified for implementing in the field (i) For the compliance and enforce-
each element in paragraph (c) of this ment program to be considered ade-
section. All elements of paragraph (c) quate for final approval through the
of this section must be fully imple- application described at § 745.324(a), a
mented no later than 3 years from the State or Indian Tribe must, in its ap-
date of EPA’s interim approval of the plication:
compliance and enforcement program (A) Demonstrate it has the legal au-
portion of a State or Tribal lead-based thority and ability to immediately im-

paint program. A statement of re- plement the elements in paragraphs (b)
sources must be included in the State and (c) of this section.
136
(B) Submit a statement of resources State or Tribal lead-based paint pro-

which identifies what resources the gram.
State or Indian Tribe intends to devote (1) Lead-based paint activities or ren-
to the administration of its lead-based ovation requirements. State or Tribal
paint compliance and enforcement pro- lead-based paint compliance and en-
gram. forcement programs will be considered
(C) Agree to submit to EPA the Sum- adequate if the State or Indian Tribe
mary on Progress and Performance of demonstrates, in its application at
lead-based paint compliance and en- § 745.324(b)(2), that it has established a
forcement activities as described at lead-based paint program that contains
paragraph (d) of this section. all of the elements specified in § 745.325
(ii) For States or Indian Tribes which or § 745.326, or both, as applicable.
previously received interim approval as (2) Authority to enter. State or Tribal
described in paragraph (a)(1) of this officials must be able to enter, through
section, in order for the State or Tribal consent, warrant, or other authority,
compliance and enforcement program premises or facilities where lead-based
to be considered adequate for final ap- paint violations may occur for pur-
proval through a separate application poses of conducting inspections.
addressing only the compliance and en- (i) State or Tribal officials must be
forcement program portion of a State able to enter premises or facilities
or Tribal lead-based paint program, a where those engaged in training for
State or Indian Tribe must, in its ap- lead-based paint activities or renova-
plication: tions conduct business.
(A) Demonstrate that it has the legal (ii) For the purposes of enforcing a
authority and ability to immediately renovation program, State or Tribal of-
implement the elements in paragraphs ficials must be able to enter a firm’s
(b) and (c) of this section. place of business or work site.
(B) Submit a statement which identi- (iii) State or Tribal officials must
fies the resources the State or Indian have authority to take samples and re-
Tribe intends to devote to the adminis- view records as part of the lead-based
tration of its lead-based paint compli- paint inspection process.
ance and enforcement program. (3) Flexible remedies. A State or Tribal
(C) Agree to submit to EPA the Sum- lead-based paint compliance and en-
mary on Progress and Performance of forcement program must provide for a
lead-based paint compliance and en- diverse and flexible array of enforce-
forcement activities as described at ment statutory and regulatory au-
paragraph (d) of this section. thorities and remedies. At a minimum,
(D) To the extent not previously sub- these authorities and remedies, which
mitted through the application de- must also be reflected in an enforce-
scribed at § 745.324(a), submit copies of ment response policy, must include the
all applicable State or Tribal statutes, following:
regulations, standards, and other mate- (i) The authority to issue warning
rial that provide the State or Indian letters, Notices of Noncompliance, No-
Tribe with authority to administer and tices of Violation, or the equivalent;
enforce the lead-based paint compli- (ii) The authority to assess adminis-
ance and enforcement program, and trative or civil fines, including a max-
copies of the policies, certifications, imum penalty authority for any viola-
plans, reports, and any other docu- tion in an amount no less than $5,000
ments that demonstrate that the proper violation per day;
gram meets the requirements estab- (iii) The authority to assess the max-
lished in paragraphs (b) and (c) of this imum penalties or fines for each in-
section. stance of violation and, if the violation
(b) Standards, regulations, and author- is continuous, the authority to assess
ity. The standards, regulations, and au- penalties or fines up to the maximum
thority described in paragraphs (b)(1) amount for each day of violation, with
through (b)(4) of this section are part all penalties assessed or collected being
of the required elements for the com- appropriate for the violation after con-
pliance and enforcement portion of a sideration of factors as the State or
137
§ 745.327 40 CFR Ch. I (7–1–17 Edition)
Tribe determine to be relevant, includ- ments of the particular discipline (e.g.,

ing the size or viability of the business, abatement supervisor, and/or abate-
enforcement history, risks to human ment worker, and/or lead-based paint
health or the environment posed by the inspector, and/or risk assessor, and/or
violation, and other similar factors; project designer) for which they have
(iv) The authority to commence an compliance monitoring and enforce-
administrative proceeding or to sue in ment responsibilities. Inspectors must
courts of competent jurisdiction to re- also be trained in violation discovery,
cover penalties; methods of obtaining consent, evidence
(v) The authority to suspend, revoke, gathering, preservation of evidence and
or modify the accreditation of any chain-of-custody, and sampling proce-
training provider or the certification of dures. A State or Tribal lead-based
any individual or firm; paint compliance and enforcement pro-
(vi) The authority to commence an gram must also implement a process
administrative proceeding or to sue in for the continuing education of en-
courts of competent jurisdiction to enforcement and inspection personnel.
join any threatened or continuing vio- (2) Compliance assistance. A State or
lation of any program requirement, Tribal lead-based paint compliance and
without the necessity of a prior suspen- enforcement program must provide
sion or revocation of a trainer’s accred- compliance assistance to the public
itation or a firm’s or individual’s cer- and the regulated community to facili-
tification; tate awareness and understanding of
(vii) The authority to apply criminal and compliance with State or Tribal
sanctions, including recovering fines; requirements governing the conduct of
and lead-based paint activities or renova-
(viii) The authority to enforce its au- tions. The type and nature of this as-
thorized program using a burden of sistance can be defined by the State or
proof standard, including the degree of Indian Tribe to achieve this goal.
knowledge or intent of the respondent (3) Sampling techniques. A State or
that is no greater than it is for EPA Tribal lead-based paint compliance and
under TSCA. enforcement program must have the
(4) Adequate resources. An application technological capability to ensure
must include a statement that identi- compliance with the lead-based paint
fies the resources that will be devoted program requirements. A State or
by the State or Indian Tribe to the ad- Tribal application for approval of a
ministration of the State or Tribal lead-based paint program must show
lead-based paint compliance and en- that the State or Indian Tribe is tech-
forcement program. This statement nologically capable of conducting a
must address fiscal and personnel re- lead-based paint compliance and en-
sources that will be devoted to the pro- forcement program. The State or Trib-
gram. al program must have access to the fa-
(c) Performance elements. The perform- cilities and equipment necessary to
ance elements described in paragraphs perform sampling and laboratory anal-
(c)(1) through (c)(7) of this section are ysis as needed. This laboratory facility
part of the required elements for the must be a recognized laboratory as de-
compliance and enforcement program fined at § 745.223, or the State or Tribal
portion of a State or Tribal lead-based program must implement a quality as-
paint program. surance program that ensures appro-
(1) Training. A State or Tribal lead- priate quality of laboratory personnel
based paint compliance and enforce- and protects the integrity of analytical
ment program must implement a proc- data.
ess for training enforcement and in- (4) Tracking tips and complaints. A
spection personnel and ensure that en- State or Tribal lead-based paint com-
forcement personnel and inspectors are pliance and enforcement program must
well trained. Enforcement personnel demonstrate the ability to process and
must understand case development pro- react to tips and complaints or other
cedures and the maintenance of proper information indicating a violation.

case files. Inspectors must successfully (5) Targeting inspections. A State or
demonstrate knowledge of the require- Tribal lead-based paint compliance and
138
enforcement program must dem- tions taken, compliance assistance pro-

onstrate the ability to target inspec- vided, and the level of resources com-
tions to ensure compliance with the mitted by the State or Indian Tribe to
lead-based paint program require- these activities. The report shall be
ments. Such targeting must include a submitted according to the require-
method for obtaining and using notifi- ments at § 745.324(h).
cations of commencement of abate- (e) Memorandum of Agreement. An In-
ment activities. dian Tribe that obtains program ap-
(6) Follow up to inspection reports. A proval must establish a Memorandum
State or Tribal lead-based paint com- of Agreement with the Regional Ad-
pliance and enforcement program must
ministrator. The Memorandum of
demonstrate the ability to reasonably,
Agreement shall be executed by the In-
and in a timely manner, process and
dian Tribe’s counterpart to the State
follow-up on inspection reports and
other information generated through Director (e.g., the Director of Tribal
enforcement-related activities associ- Environmental Office, Program or
ated with a lead-based paint program. Agency). The Memorandum of Agree-
The State or Tribal program must be ment must include provisions for the
in a position to ensure correction of timely and appropriate referral to the
violations and, as appropriate, effec- Regional Administrator for those
tively develop and issue enforcement criminal enforcement matters where
remedies/responses to follow up on the that Indian Tribe does not have the au-
identification of violations. thority (e.g., those addressing criminal
(7) Compliance monitoring and enforce- violations by non-Indians or violations
ment. A State or Tribal lead-based meriting penalties over $5,000). The
paint compliance and enforcement pro- Agreement must also identify any en-
gram must demonstrate, in its applica- forcement agreements that may exist
tion for approval, that it is in a posi- between the Indian Tribe and any
tion to implement a compliance moni- State.
toring and enforcement program. Such (f) Electronic reporting under State or
a compliance monitoring and enforce- Indian Tribe programs. States and tribes
ment program must ensure correction that choose to receive electronic docu-
of violations, and encompass either ments under the authorized state or In-
planned and/or responsive lead-based dian tribe lead-based paint program,
paint compliance inspections and de- must ensure that the requirements of
velopment/issuance of State or Tribal 40 CFR part 3—(Electronic reporting)
enforcement responses which are ap- are satisfied in their lead-based paint
propriate to the violations. program.
(d) Summary on Progress and Perform-
ance. The Summary on Progress and [61 FR 45825, Aug. 29, 1996, as amended at 70
Performance described below is part of FR 59889, Oct. 13, 2005; 73 FR 21769, Apr. 22,
the required elements for the compli- 2008; 76 FR 47946, Aug. 5, 2011]
ance and enforcement program portion
of a State or Tribal lead-based paint § 745.339 Effective date.
program. A State or Tribal lead-based States and Indian Tribes may seek
paint compliance and enforcement pro- authorization to administer and en-
gram must submit to the appropriate force subpart L of this part pursuant to
EPA Regional Administrator a report this subpart at any time. States and
which summarizes the results of imple- Indian Tribes may seek authorization
menting the State or Tribal lead-based to administer and enforce the pre-ren-
paint compliance and enforcement pro- ovation education provisions of subpart
gram, including a summary of the E of this part pursuant to this subpart
scope of the regulated community at any time. States and Indian Tribes
within the State or Indian Tribe (which may seek authorization to administer
would include the number of individ- and enforce all of subpart E of this part
uals and firms certified in lead-based
pursuant to this subpart effective June

paint activities and the number of
23, 2008.
training programs accredited), the in-
spections conducted, enforcement ac- [73 FR 21769, Apr. 22, 2008]
139
Pt. 747 40 CFR Ch. I (7–1–17 Edition)
PART 747—METALWORKING FLUIDS (4) Process or distribute in commerce

solely for export means to process or dis-
Subpart A [Reserved] tribute in commerce solely for export
from the United States under the fol-
Subpart B—Specific Use Requirements for lowing restrictions on domestic activ-
Certain Chemical Substances ity:
Sec. (i) Processing must be performed at
747.115 Mixed mono and diamides of an or- sites under the control of the proc-
ganic acid. essor.
747.195 Triethanolamine salt of a sub- (ii) Distribution in commerce is lim-
stituted organic acid. ited to purposes of export.
747.200 Triethanolamine salt of
tricarboxylic acid.
(iii) The processor or distributor may
not use the substance except in small
AUTHORITY: 15 U.S.C. 2604 and 2605. quantities solely for research and de-
velopment.
Subpart A [Reserved] (c) Use limitations. (1) Any person pro-
ducing a metalworking fluid, or a prod-
Subpart B—Specific Use Require- uct which could be used in or as a met-
ments for Certain Chemical alworking fluid, which includes as one
Substances of its components P-84–529, is prohib-
ited from adding any nitrosating agent
§ 747.115 Mixed mono and diamides of to the metalworking fluid or product.
an organic acid. (2) Any person using as a metal-
This section identifies activities with working fluid a product containing P-
respect to a chemical substance which 84–529 is prohibited from adding any
are prohibited and requires that warn- nitrosating agent to the product.
ings and instructions accompany the (d) Warnings and instructions. (1) Any
substance when distributed in com- person who distributes in commerce P-
merce. 84–529 in a metalworking fluid, or in
(a) Chemical substance subject to this any form in which it could be used as
section. The following chemical sub- a component of a metalworking fluid,
stance, referred to by its must send to each recipient of P-84–529
premanufacture notice number and ge- and confirm receipt in writing prior to
neric chemical name, is subject to this the first shipment to that person:
section: P-84–529, mixed mono and
(i) A letter that includes the fol-
diamides of an organic acid.
lowing statements:
(b) Definitions. Definitions in section
3 of the Act, 15 U.S.C. 2602, apply to A substance, identified generically as
this section unless otherwise specified mixed mono and diamides of an organic acid,
in this paragraph. In addition, the fol- contained in the product (insert distributor’s
lowing definitions apply: other identifier for product containing P-84–529)
(1) The terms Act, article, chemical has been regulated by the Environmental
substance, commerce, importer, impurity, Protection Agency, at 40 CFR 747.115, as pub-
Inventory, manufacturer, person, process, lished in the FEDERAL REGISTER of Sep-
tember 20, 1984. A copy of the regulation is
processor, and small quantities solely for
enclosed. The regulation prohibits the addi-
research and development have the same tion of any nitrosating agent, including
meaning as in § 720.3 of this chapter. nitrites, to the mixed mono and diamides of
(2) Metalworking fluid means a liquid an organic acid, when the substance is or
of any viscosity or color containing in- could be used in metalworking fluids. The
tentionally added water used in metal addition of nitrites or other nitrosating
machining operations for the purpose agents to this substance leads to formation
of cooling, lubricating, or rust inhibi- of a substance known to cause cancer in lab-
tion. oratory animals. The mixed mono and
(3) Nitrosating agent means any sub- diamides of an organic acid has been specifi-
stance that has the potential to trans- cally designed to be used without nitrites.
Consult the enclosed regulation for further

fer a nitrosyl group (–NO) to a primary,
information.
secondary, or tertiary amine to form
the corresponding nitrosamine. (ii) A copy of this § 747.115.
140
(2)(i) Any person who distributes in container with the label specified in
commerce a metalworking fluid con- paragraph (d)(2) of this section.
taining P-84–529 must affix a label to (f) Exemptions. A person identified in
each container containing the fluid. paragraphs (c) and (d) of this section is
(ii) The label shall contain a warning not subject to the requirements of
statement which shall consist only of those paragraphs if:
the following language: (1) The person manufactures, im-
ports, processes, distributes in com-
WARNING! Do Not Add Nitrites to This merce, or uses the substance only in
Metalworking Fluid under Penalty of Fed- small quantities solely for research and
eral Law. Addition of nitrites leads to forma-
development and in accordance with
tion of a substance known to cause cancer.
This product is designed to be used without
section 5(h)(3) of the Act.
nitrites. (2) The person manufactures, im-
ports, processes, distributes in com-
(iii) The first work of the warning merce, or uses the substance only as an
statement shall be capitalized, and the impurity.
type size for the first word shall be no (3) The person imports, processes,
smaller than six point type for a label distributes in commerce, or uses the
five square inches or less in area, ten substance only as part of an article.
point type for a label above five but (4) The person processes or distrib-
below ten square inches in area, twelve utes the substance in commerce solely
point type for a label above ten but for export and, when distributing in
below fifteen square inches in area, commerce, lables the substance in ac-
fourteen point type for a label above cordance with section 12(a)(1)(B) of the
fifteen but below thirty square inches Act.
in area, or eighteen point type for a (g) Enforcement. (1) Failure to comply
label over thirty square inches in area. with any provision of this section is a
The type size of the remainder of the violation of section 15 of the Act [15
warning statement shall be no smaller U.S.C. 2614].
than six point type. All required label (2) Failure or refusal to permit access
text shall be of sufficient prominence, to or copying of records, as required
and shall be placed with such conspicu- under section 11 of the Act, is a viola-
ousness relative to other label text and tion of section 15 of the Act [15 U.S.C.
graphic material, to insure that the 2614].
warning statement is read and under- (3) Failure or refusal to permit entry
stood by the ordinary individual under or inspection, as required under section
customary conditions of purchase and 11 of the Act, is a violation of section
use. 15 of the Act [15 U.S.C. 2614].
(e) Liability and determining whether a (4) Violators may be subject to the
chemical substance is subject to this sec- civil and criminal penalties in section
tion. (1) If a manufacturer or importer 16 of the Act [15 U.S.C. 2615] for each
of a chemical substance which is de- violation.
scribed by the generic chemical name (5) EPA may seek to enjoin the proc-
in paragraph (a) of this section makes essing, distribution in commerce, or
an inquiry under § 710.7(g) of this chap- use of a chemical substance in viola-
ter or § 720.25(b) of this chapter as to tion of this section; act to seize any
whether the specific substance is on chemical substance processed, distrib-
the Inventory and EPA informs the uted in commerce, or used in violation
manufacturer or importer that the sub- of this section; or take other actions
stance is on the Inventory, EPA will under the authority of sections 7 and 17
also inform the manufacturer or im- of the Act [15 U.S.C. 2605 and 2616].
porter whether the substance is subject [49 FR 36855, Sept. 20, 1984]
to this section.
(2) Except for manufacturers and im- § 747.195 Triethanolamine salt of a
porters of P-84–529, no processor, dis- substituted organic acid.
tributor, or user of P-84–529 will be in This section identifies activities with
violation of this section unless that respect to a chemical substance which

person has received a letter specified in are prohibited and requires that warn-
paragraph (d)(1) of this section or a ings and instructions accompany the
141
§ 747.195 40 CFR Ch. I (7–1–17 Edition)
substance when distributed in com- 84–310 in a metalworking fluid, or in

merce. any form in which it could be used as
(a) Chemical substance subject to this a component of a metalworking fluid,
section. The following chemical sub- must send to each recipient of P-84–310
stance, referred to by its and confirm receipt in writing prior to
premanufacture notice number and ge- the first shipment to that person:
neric chemical name, is subject to this (i) A letter that includes the fol-
section: P-84–310, triethanolamine salt lowing statements: A substance, identi-
of a substituted organic acid. fied generically as a triethanolamine
(b) Definitions. Definitions in section salt of a substituted organic acid, con-
3 of the Act, 15 U.S.C. 2602, apply to tained in the product (insert distribu-
this section unless otherwise specified tor’s trade name or other identifier for
in this paragraph. In addition, the fol- product containing P-84–310) has been
lowing definitions apply: regulated by the Environmental Pro-
(1) The terms Act, article, chemical tection Agency, at 40 CFR 747.195, as
substance, commerce, importer, impurity, published in the FEDERAL REGISTER of
Inventory, manufacturer, person, process, June 14, 1984. A copy of the regulation
processor, and small quantities solely for is enclosed. The regulation prohibits
research and development, have the same the addition of any nitrosating agent,
meaning as in § 720.3 of this chapter. including nitrites, to the triethanol-
(2) Metalworking fluid means a liquid amine salt of a substituted organic
of any viscosity or color containing in- acid, when the substance is or could be
tentionally added water used in metal used in metalworking fluids. The addi-
machining operations for the purpose tion of nitrites or other nitrosating
of cooling, lubricating, or rust inhibi- agents to this substance leads to for-
tion. mation of a substance known to cause
(3) Nitrosating agent means any sub- cancer in laboratory animals. The tri-
stance that has the potential to trans- ethanolamine salt of a substituted or-
fer a nitrosyl group (—NO) to a pri- ganic acid has been specifically de-
mary, secondary, or tertiary amine to signed to be used without nitrites. Con-
form the corresponding nitrosamine. sult the enclosed regulation for further
(4) Process or distribute in commerce information.
solely for export means to process or dis- (ii) A copy of this § 747.195.
tribute in commerce solely for export (2)(i) Any person who distributes in
from the United States under the fol- commerce a metalworking fluid con-
lowing restrictions on domestic activ- taining P-84–310 must affix a label to
ity: each container containing the fluid.
(i) Processing must be performed at (ii) The label shall contain a warning
sites under the control of the proc- statement which shall consist only of
essor. the following language:
(ii) Distribution in commerce is lim- WARNING! Do Not Add Nitrites to This
ited to purposes of export. Metalworking Fluid under Penalty of Fed-
(iii) The processor or distributor may eral Law. Addition of nitrites leads to forma-
not use the substance except in small tion of a substance known to cause cancer.
quantities solely for research and de- This product is designed to be used without
nitrites.
velopment.
(c) Use limitations. (1) Any person pro- (iii) The first word of the warning
ducing a metalworking fluid, or a prod- statement shall be capitalized, and the
uct which could be used in or as a met- type size for the first word shall be no
alworking fluid, which includes as one smaller than six point type for a label
of its components P-84–310, is prohib- five square inches or less in area, ten
ited from adding any nitrosating agent point type for a label above five but
to the metalworking fluid or product. below ten square inches in area, twelve
(2) A person using as a metalworking point type for a label above ten but
fluid a product containing P-84–310 is below fifteen square inches in area,
prohibited from adding any nitrosating fourteen point type for a label above
agent to the product. fifteen but below thirty square inches

(d) Warnings and instructions. (1) Any in area, or eighteen point type for a
person who distributes in commerce P- label over thirty square inches in area.
142
The type size of the remainder of the violation of section 15 of the Act (15
warning statement shall be no smaller U.S.C. 2614).
than six point type. All required label (2) Failure or refusal to permit access
text shall be of sufficient prominence, to or copying of records, as required
and shall be placed with such conspicu- under section 11 of the Act, is a viola-
ousness relative to other label text and tion of section 15 of the Act (15 U.S.C.
graphic material, to insure that the 2614).
warning statement is read and under- (3) Failure or refusal to permit entry
stood by the ordinary individual under or inspection, as required under section
customary conditions of purchase and 11 of the Act, is a violation of section
use. 15 of the Act (15 U.S.C. 2614).
(e) Liability and determining whether a [49 FR 24668, June 14, 1984]
chemical substance is subject to this sec-
tion. (1) If a manufacturer or importer § 747.200 Triethanolamine salt of
of a chemical substance which is de- tricarboxylic acid.
scribed by the generic chemical name This section identifies activities with
in paragraph (a) of this section makes respect to two chemical substances
an inquiry under § 710.7(g) of this chap- which are prohibited and requires that
ter or § 720.25(b) of this chapter as to warnings and instructions accompany
whether the specific substance is on the substances when distributed in
the Inventory and EPA informs the commerce.
manufacturer or importer that the sub- (a) Chemical substances subject to this
stance is on the Inventory, EPA will section. The following chemical sub-
also inform the manufacturer or im- stances, referred to by their
porter whether the substance is subject premanufacture notice numbers and
to this section. generic chemical names, are subject to
(2) Except for manufacturers and im- this section:
porters of P-84–310, no processor, dis-
tributor, or user of P-84–310 will be in P-83–1005, triethanolamine salt of
violation of this section unless that tricarboxylic acid; and
P-83–1062, tricarboxylic acid.
person has received a letter specified in
paragraph (d)(1) of this section or a (b) Definitions. Definitions in section
container with the label specified in 3 of the Act, 15 U.S.C. 2602, apply to
paragraph (d)(2) of this section. this section unless otherwise specified
(f) Exemptions. A person identified in in this paragraph. In addition, the fol-
paragraphs (c) and (d) of this section is lowing definitions apply:
not subject to the requirements of (1) The terms Act, article, byproducts,
those paragraphs if: chemical substance, commerce, imported,
(1) The person manufactures, im- impurity, Inventory, manufacture or im-
ports, processes, distributes in com- port for commercial purposes, manufac-
merce, or uses the substance only in ture solely for export, manufacturer, new
small quantities solely for research and chemical substance, person, process, proc-
development and in accordance with essor, and small quantities solely for re-
section 5(h)(3) of the Act. search and development have the same
(2) The person manufactures, im- meaning as in § 720.3 of this chapter.
ports, processes, distributes in com- (2) Metalworking fluid means a liquid
merce, or uses the substance only as an of any viscosity or color containing in-
impurity. tentionally added water used in metal
(3) The person imports, processes, machining operations for the purpose
distributes in commerce, or uses the of cooling or lubricating.
substance only as part of an article. (3) Nitrosating agent means any sub-
(4) The person processes or distrib- stance that has the potential to trans-
utes the substance in commerce solely fer a nitrosyl group (—NO) to a sec-
for export, and when distributing in ondary or tertiary amine to form the
commerce, labels the substance in ac- corresponding nitrosamine.
cordance with section 12(a)(1)(B) of the (c) Use limitations. (1) Any person pro-
Act. ducing a metalworking fluid, or a prod-

(g) Enforcement. (1) Failure to comply uct which could be used in or as a met-
with any provision of this section is a alworking fluid, which includes as one
143
§ 747.200 40 CFR Ch. I (7–1–17 Edition)
of its components P-83–1005 is prohib- (i) A letter that includes the fol-
ited from adding any nitrosating agent lowing statements:
to the metalworking fluid or product.
A substance, identified generically as
(2) Any person using as metalworking tricarboxylic acid, contained in the product
fluid a product containing P-83–1005 is (insert distributor’s trade name or other identi-
prohibited from adding any nitrosating fier for product containing P-83–1062) has been
agent to the product. regulated by the Environmental Protection
(d) Warnings and instructions. (1) Any Agency (40 CFR 747.200 published in the FED-
ERAL REGISTER of January 23, 1984. A copy of
person who distributes in commerce P-
the regulation is enclosed. Combining
83–1005 in a metalworking fluid, or in tricarboxylic acid with water and the tri-
any form in which it could be used as ethanolamine produces a substance, identi-
a component of a metalworking fluid, fied generically as the triethanolamine salt
must sent to each recipient of P-83–1005 of the tricarboxylic acid. The regulation pro-
and confirm receipt prior to the first hibits the addition of nitrosating agents, in-
shipment to that person: cluding nitrites, to the triethanolamine salt
of tricarboxylic acid, when that substance is
(i) A letter that includes the fol- or could be used in metalworking fluids. The
lowing statements: addition of nitrites or other nitrosating
A substance, identified generically as tri- agents to that substance leads to formation
ethanolamine salt, of tricarboxylic acid, con- of a substance known to cause cancer in lab-
tained in the product (insert distributor’s trade oratory animals. Consult the enclosed regu-
name or other identifier for product containing lation for further information.
P-83–1005) has been regulated by the Environ- (ii) A copy of this rule.
mental Protection Agency, at 40 CFR 747.200,
(e) Liability and determining whether a
as published in the FEDERAL REGISTER of
January 23, 1984. A copy of the regulation is
chemical substance is subject to this sec-
enclosed. The regulation prohibits the addition. (1) If a manufacturer or importer
tion of any nitrosating agent, including of a chemical substance which is de-
nitrites, to the triethanolamine salt of scribed by one of the generic names in
tricarboxylic acid, when the substance is or paragraph (a) of this section makes an
could be used in metalworking fluids. The inquiry under § 710.7(g) of this chapter
addition of nitrites or other nitrosating or § 720.25(b) of this chapter as to
agents to this substance leads to formation whether the specific substance is on
of a substance known to cause cancer in lab-
the Inventory and EPA informs the
oratory animals. The triethanolamine salt of
the tricarboxylic acid, has been specifically manufacturer or importer that the sub-
designed to be used without nitrites. Consult stance is on the Inventory, EPA will
the enclosed regulation for further informa- also inform the manufacturer or im-
tion. porter whether the substance is subject
to this section.
(ii) A copy of this rule.
(2) Except for manufacturers and im-
(2) Any person who distributes in porters of P-83–1005 and P-83–1062, no
commerce a metalworking fluid con- processor, distributor, or user of P-83–
taining P-83–1005 must affix to each 1005 or P-83–1062 will be in violation of
container containing the fluid a label this section unless that person has re-
that includes, in letters no smaller ceived a letter specified in paragraph
than ten point type, the following (d)(1) or (3) of this section or a con-
statement: tainer with the label specified in para-
WARNING! Do Not Add Nitrites to This graph (d)(2) of this section.
Metalworking Fluid under Penalty of Fed- (f) Exemptions and exclusions. The
eral Law. Addition of nitrite leads to forma- chemical substances identified in para-
tion of a substance known to cause cancer. graph (a) of this section are not subject
This product is designed to be used without to the requirements of paragraphs (c)
nitrites.
and (d) of this section, if:
(3) Any person who distributes in (1) The substance is manufactured,
commerce P-83–1062 in any form in imported, processed, distributed in
which it could be combined with water commerce, and used only in small
and triethanolamine to produce P-83– quantities solely for research and de-
1005 must send to each recipient of P- velopment, and if the substance is

83–1062, and confirm receipt prior to manufactured, imported, processed,
the first shipment to that person: distributed in commerce, and used in
144
accordance with section 5(h)(3) of the Subpart D—Air Conditioning and

Act. Cooling Systems
(2) The substance is manufactured,
imported, processed, distributed in § 749.68 Hexavalent chromium-based
commerce, or used only as an impurity. water treatment chemicals in cool-
ing systems.
(3) The substance is imported, proc-
essed, distributed in commerce, or used (a) Chemicals subject to this section.
only as part of an article. Hexavalent chromium-based water
(4) The substance is manufactured treatment chemicals that contain
solely for export. hexavalent chromium, usually in the
form of sodium dichromate (CAS No.
(g) Enforcement. (1) Failure to comply
10588–01–9), are subject to this section.
with any provision of this section is a
Other examples of hexavalent chro-
violation of section 15 of the Act (15 mium compounds that can be used to
U.S.C. 2614). treat water are: Chromic acid (CAS No.
(2) Failure or refusal to permit access 7738–94–5), chromium trioxide (CAS No.
to or copying of records, as required 1333–83–0), dichromic acid (CAS
under section 11 of the Act, is a viola- No.13530–68–2), potassium chromate
tion of a section 15 of the Act (15 U.S.C. (CAS No. 7789–00–6), potassium dichro-
2614). mate (CAS No. 7778–50–9), sodium chro-
(3) Failure or refusal to permit entry mate (CAS No. 7775–11–3), zinc chro-
or inspection, as required under section mate (CAS No. 13530–65–9), zinc chro-
11 of the Act, is a violation of section mate hydroxide (CAS No. 153936–94–6),
15 of the Act (15 U.S.C. 2614). zinc dichromate (CAS No. 14018–95–2),
(4) Violators may be subject to the and zinc potassium chromate (CAS No.
civil and criminal penalties in section 11103–86–9).
16 of the Act (15 U.S.C 2615) for each (b) Purpose. The purpose of this sec-
violation. tion is to impose certain requirements
on activities involving hexavalent
(5) EPA may seek to enjoin the proc-
chromium-based water treatment
essing, distribution in commerce, or
chemicals to prevent unreasonable
use of a chemical substance in viola-
risks associated with human exposure
tion of this section, act to seize any to air emissions of hexavalent chro-
chemical substance, processed, distrib- mium from comfort cooling towers.
uted in commerce, or used in violation (c) Applicability. This section is appli-
of this section or take other actions cable to use of hexavalent chromium-
under the authority of section 7 or 17 of based water treatment chemicals in
the Act (15 U.S.C. 2605 or 2616). comfort cooling towers and to distribu-
[49 FR 2772, Jan. 23, 1984] tion in commerce of hexavalent chro-
mium-based water treatment chemi-
cals for use in cooling systems.
PART 749—WATER TREATMENT (d) Definitions. Definitions in section
CHEMICALS 3 of the Toxic Substances Control Act,
15 U.S.C. 2602, apply to this section un-
Subparts A–C [Reserved] less otherwise specified in this para-
graph. In addition, the following defini-
Subpart D—Air Conditioning and Cooling tions apply:
Systems (1) Act means the Toxic Substances
Control Act, 15 U.S.C. 2601 et seq.
Sec.
(2) Chilled water loop means any
749.68 Hexavalent chromium-based water
treatment chemicals in cooling systems.
closed cooling water system that trans-
fers heat from air handling units or re-
AUTHORITY: 15 U.S.C. 2605 and 2607. frigeration equipment to a refrigera-
tion machine, or chiller.
Subparts A–C [Reserved] (3) Closed cooling water system means
any configuration of equipment in
which heat is transferred by circu-

lating water that is contained within
the equipment and not discharged to
145
§ 749.68 40 CFR Ch. I (7–1–17 Edition)
the air; chilled water loops are in- (16) Water treatment chemicals means
cluded. any combination of chemical sub-
(4) Comfort cooling towers means cool- stances used to treat water in cooling
ing towers that are dedicated systems and can include corrosion in-
exlusively to and are an integral part hibitors, antiscalants, dispersants, and
of heating, ventilation, and air condi- any other chemical substances except
tioning or refrigeration systems. biocides.
(5) Container means any bag, barrel, (e) Prohibition of distribution in com-
bottle, box, can, cylinder, drum, or the merce and commercial use. (1) All persons
like that holds hexavalent chromium- are prohibited from distributing in
based water treatment chemicals for commerce hexavalent chromium-based
use in cooling systems. water treatment chemicals for use in
(6) Cooling tower means an open water comfort cooling towers.
recirculating device that uses fans or (2) All persons are prohibited from
natural draft to draw or force ambient commercial use of hexavalent chro-
air through the device to cool warm mium-based water treatment chemi-
water by direct contact. cals in comfort cooling towers.
(7) Cooling system means any cooling (3) Distribution in commerce of
tower or closed cooling water system. hexavalent chromium-based water
(8) Distributor means any person who treatment chemicals for use in, and
distributes in commerce water treat- commercial use of hexavalent chro-
ment chemicals for use in cooling sys- mium-based water treatment chemi-
tems. cals in, industrial cooling towers and
(9) EPA means the Environmental closed cooling water systems are not
Protection Agency. prohibited.
(10) Hexavalent chromium means the (f) Effective dates. (1) The prohibition
oxidation state of chromium with an described in paragraph (e)(1) of this
oxidation number of + 6; a coordination section against distributing in com-
number of 4 and tetrahedral geometry. merce hexavalent chromium-based
(11) Hexavalent chromium-based water water treatment chemicals for use in
treatment chemicals means any chemical comfort cooling towers is effective
containing hexavalent chromium February 20, 1990.
which can be used to treat water, ei- (2) The prohibition described in para-
ther alone or in combination with graph (e)(2) of this section against
other chemicals, where the mixture using hexavalent chromium-based
can be used to treat water. water treatment chemicals in comfort
(12) Industrial cooling tower means any cooling towers is effective May 18, 1990.
cooling tower used to remove heat (g) Labeling. (1) Each person who dis-
from industrial processes, chemical re- tributes in commerce hexavalent chro-
actions, or plants producing electrical mium-based water treatment chemi-
power. cals for use in cooling systems after
(13) Label means any written, printed, February 20, 1990, shall affix a label or
or graphic material displayed on or af- keep affixed an existing label in ac-
fixed to containers of hexavalent chro- cordance with this paragraph, to each
mium-based water treatment chemi- container of the chemicals. The label
cals that are to be used in cooling sys- shall consist of the following language:
tems.
WARNING: This product contains
(14) Person means any natural person, hexavalent chromium. Inhalation of
firm, company, corporation, joint ven- hexavalent chromium air emissions in-
ture, partnership, sole proprietorship, creases the risk of lung cancer. Federal Law
association, or any other business enti- prohibits use of this substance in comfort
ty; any State or political subdivision cooling towers, which are towers that are
thereof; any municipality; any inter- open water recirculation devices and that
state body; and any department, agen- are dedicated exclusively to, and are an inte-
cy, or instrumentality of the Federal gral part of, heating, ventilation, and air
conditioning or refrigeration systems.
Government.
(15) Shipment means the act or proc- (2) The first word of the warning
ess of shipping goods by any form of statement shall be capitalized, and the
conveyance. type size for the first word shall be no
146
smaller than 10-point type for a label name, address, telephone number, and
less than or equal to 10 square inches the name of a contact.
in area, 12-point type for a label above (2) The report identified in paragraph
10 but less than or equal to 15 square (i)(1) of this section shall be updated as
inches in area, 14-point type for a label changes occur in the distributor head-
above 15 but less than or equal to 30 quarters or shipment office informa-
square inches in area, or 18-point type tion. The updated report shall be sub-
for a label above 30 square inches in mitted to the Regional Administrator
area. The type size of the remainder of and postmarked no later than 10 cal-
the warning statement shall be no endar days after the change occurs.
smaller than 6-point type. All required
(3) A person may assert a claim of
label text shall be in English and of
sufficient prominence and shall be confidentiality for any information
placed with such conspicuousness, rel- submitted to EPA in connection with
ative to other label text and graphic this rule. Any claim of confidentiality
material, to ensure that the warning must accompany the information when
statement is read and understood by submitted to EPA. Persons claiming
the ordinary individual under cus- information as confidential should do
tomary conditions of purchase and use. so by circling, bracketing, or under-
(h) Recordkeeping. (1) Each person lining it and marking it with ‘‘CON-
who distributes in commerce any FIDENTIAL.’’ EPA will disclose infor-
hexavalent chromium-based water mation subject to a claim of confiden-
treatment chemicals for use in cooling tiality only to the extent permitted by
systems after February 20, 1990, shall section 14 of TSCA and 40 CFR part 2,
retain in one location at the head- subpart B. If a person does not assert a
quarters of the distributor documenta- claim of confidentiality for informa-
tion showing: tion at the time it is submitted to
(i) The name, address, contact, and EPA, EPA may make the information
telephone number of the cooling sys- public without further notice to that
tem owners/operators to whom the person.
chemicals were shipped. (j) Enforcement. (1) Failure to comply
(ii) The chemicals included in the
with any provision of this section is a
shipment, the amount of each chemical
violation of section 15 of the Act (15
shipped, and the location(s) at which
the chemicals will be used. U.S.C. 2614).
(2) The information described in (2) Failure or refusal to establish and
paragraph (h)(1) of this section shall be maintain records or to permit access to
retained for 2 years from the date of or copying of records, as required by
shipment. the Act, is a violation of section 15 of
(i) Reporting. (1) Each person who dis- the Act (15 U.S.C. 2614).
tributes in commerce any hexavalent (3) Failure or refusal to permit entry
chromium-based water treatment or inspection as required by section 11
chemicals for use in cooling systems of the Act (15 U.S.C. 2610) is a violation
shall report to the Regional Adminis- of section 15 of the Act (15 U.S.C. 2614).
trator of the EPA Region in which the (4) Violators may be subject to the
distibutor headquarters is located. The civil and criminal penalties in section
report shall be postmarked not later 16 of the Act (15 U.S.C. 2615) for each
than February 20, 1990, or 30 days after violation.
the person first begins the distribution (k) Inspections. EPA will conduct in-
in commerce of hexavalent chromium- spections under section 11 of the Act
based water treatment chemicals, (15 U.S.C. 2610) to ensure compliance
whichever is later, and shall include:
with this section.
(i) For the headquarters, the dis-
tributor name, address, telephone num- [55 FR 240, Jan. 3, 1990, as amended at 59 FR
ber, and the name of a contact. 42773, Aug. 19, 1994]
(ii) For the shipment offices through
which hexavalent chromium-based

water treatment chemicals are sold for
use in cooling systems, the distributor
147
PART 750—PROCEDURES FOR RULE- (1) PCB use, which includes storage
MAKING UNDER SECTION 6 OF for use or reuse, manufacture, proc-
THE TOXIC SUBSTANCES CON- essing related to manufacture and use,
and distribution in commerce related
TROL ACT to use or processing for use, must be
submitted to: OPPT Document Control
Subpart A [Reserved]
Officer (7407T), Environmental Protec-
Subpart B—Interim Procedural Rules for tion Agency, 1200 Pennsylvania Ave.,
Manufacturing Exemptions NW., Washington, DC 20460–0001.
(2) PCB disposal, which includes
Sec. cleanup, storage for disposal, proc-
750.10 Applicability. essing related to disposal, distribution
750.11 Filing of petitions for exemption.
750.12 Consolidation of rulemakings.
in commerce related to disposal or
750.13 Notice of proposed rulemaking. processing for disposal, and decon-
750.14 Confidentiality. tamination, must be submitted to:
750.15 Final rule. Document Control Officer, Office of Re-
source Conservation and Recovery
Subpart C—Interim Procedural Rules for (5305P), Environmental Protection
Processing and Distribution in Com- Agency, 1200 Pennsylvania, NW., Wash-
merce Exemptions ington, DC 20460–0001.
750.30 Applicability. (c) Content of petition. Each petition
750.31 Filing of petitions for exemption. shall contain the following:
750.32 Consolidation of rulemaking. (1) Name, address and telephone num-
750.33 Notice of proposed rulemaking. ber of petitioner.
750.34 Confidentiality. (2) Description of PCB ban exemption
750.35 Final rule. requested, including items to be manu-
AUTHORITY: 15 U.S.C. 2605. factured and nature of manufacturing
process—such as smelting.
Subpart A [Reserved] (3) Location(s) of manufacturing sites
requiring exemption.
Subpart B—Interim Procedural (4) Length of time requested for ex-
Rules for Manufacturing Ex- emption (maximum length of exemp-
tion is 1 year).
emptions (5) Amount of PCB chemical sub-
stance or PCB mixture (by pounds and/
SOURCE: 43 FR 50905, Nov. 1, 1978, unless or volume) to be manufactured or used
otherwise noted.
during requested exemption period and
§ 750.10 Applicability. the manner of release of PCB’s into the
environment associated with such
Sections 750.10–750.15 apply to all manufacture or use.
rulemakings under authority of section (6) The basis for the petitioner’s con-
6(e)(3)(B) of the Toxic Substances Con- tention that under section 6(e)(3)(B)(i)
trol Act (TSCA), 15 U.S.C. 2605(e)(3)(B) of TSCA ‘‘an unreasonable risk of in-
with respect to petitions filed pursuant jury to health or environment would
to § 750.11(a). not result’’ from the granting of his pe-
[81 FR 93636, Dec. 21, 2016] tition for exemption.
(7) The basis for the petitioner’s con-
§ 750.11 Filing of petitions for exemp- tention that he meets the criterion of
tion. section 6(e)(3)(B)(ii) of TSCA con-
(a) Who may file. Any person seeking cerning substitutes for PCB’s.
an exemption from the PCB manufac- (8) Quantification of the reasonably
turing ban imposed by section ascertainable economic consequences
6(e)(3)(A) of TSCA may file a petition of denial of the petition for exemption
for exemption. Petitions must be sub- from the 1979 manufacturing ban and
mitted on an individual basis for each an explanation of the manner of com-
manufacturer or individual affected by putation.
the 1979 manufacturing ban. (d) Request for further information. The
(b) Where to file. All petitions per- Agency reserves the right to request
taining to: further information as to each petition
148
prior to or after publication of the no- activity conforms to the terms of the
tice of proposed rulemaking required original exemption approved by EPA.
by § 750.13.
[43 FR 50905, Nov. 1, 1978, as amended at 53
(e) Renewal requests. (1) Any peti- FR 12524, Apr. 15, 1988; 59 FR 16998, Apr. 11,
tioner who has been granted an exemp- 1994; 72 FR 57238, Oct. 9, 2007; 74 FR 30232,
tion under section 6(e)(3)(B) of TSCA, June 25, 2009]
on or after May 25, 1994, and who seeks
to renew that exemption without § 750.12 Consolidation of rulemakings.
changing its terms, must submit a let- All petitions received pursuant to
ter by certified mail to EPA requesting § 750.11(a) will be consolidated into one
that the exemption be granted for the rulemaking with one informal hearing
following year. held on all petitions.
(i) This letter must contain a certifi-
cation by the petitioner that the type § 750.13 Notice of proposed rule-
of activities, the procedures for han- making.
dling the PCBs, the amount of PCBs Rulemaking for PCB exemptions
handled, and any other aspect of the filed pursuant to § 750.11(a) shall begin
exemption have not changed from the with the publication of a notice of pro-
original exemption petition request. posed rulemaking in the FEDERAL REG-
(ii) This letter must be received by ISTER. The notice shall state in sum-
EPA at least 6 months prior to the ex- mary form the required information
piration of the existing exemption. described in § 750.11(c). Due to time con-
(iii) If a petitioner fails to make a straints, the notice need not indicate
submission or the submission is not what action EPA proposes to take on
timely under this section, the exemp- the exemption petitions.
tion will expire 1 year from the effec-
tive date of granting that exemption. [81 FR 93636, Dec. 21, 2016]
(iv) EPA will address a timely sub-
mission of a renewal request by rule- § 750.14 Confidentiality.
making and either grant or deny the The Agency encourages the submis-
request. sion of nonconfidential information by
(2) Any petitioner who has been petitioners and commenters. The Agen-
granted an exemption on or after May cy does not wish to have unnecessary
25, 1994, and who seeks to increase the restrictions on access to the rule-
amount of PCBs handled or to change making record. However, if a petitioner
the type of activities, the procedures or commenter believes that he can only
for handling the PCBs, and any other state his position through the use of
aspect of their existing exemption information claimed to be confidential,
must submit a new exemption petition he may submit it. Such information
to EPA. The existing exemption activ- must be separately submitted for the
ity may continue until the new submis- rulemaking record and marked ‘‘con-
sion is addressed by rulemaking, pro- fidential’’ by the submitter. For the in-
vided the activity conforms to the formation claimed to be confidential,
terms of the current exemption ap- the Agency will list only the date and
proved by EPA, and the petitioner the name and address of the petitioner
complies with the conditions of para- or commenter in the public file, noting
graph (e)(1) of this section. that the petitioner or commenter has
(3) Any petitioner who has been requested confidential treatment. The
granted a TSCA section 6(e)(3)(B) ex- information claimed to be confidential
emption in a rule prior to May 25, 1994, will be placed in a confidential file. A
and who seeks to increase the amount petitioner must also file a nonconfiden-
of PCBs handled or to change the type tial petition with a nonconfidential
of activities, the procedures for han- summary of the confidential informa-
dling the PCBs, and any other aspect of tion to be placed in the public file.
their existing exemption must submit Similarly, a commenter must supply a
a new exemption petition to EPA. The nonconfidential summary of the infor-
existing exemption activity may con- mation claimed to be confidential to be

tinue until the new submission is ad- placed in the public file. Any informa-
dressed by rulemaking, provided the tion not marked as confidential will be
149
§ 750.15 40 CFR Ch. I (7–1–17 Edition)
placed in the public file. Information Contaminated Transformers may sub-

marked confidential will be treated in mit a single consolidated petition on
accordance with the procedures in part behalf of any number of petitioners.
2, subpart B of this title. The name and address of each peti-
[43 FR 50905, Nov. 1, 1978. Redesignated at 81 tioner must be stated in the petition.
FR 93636, Dec. 21, 2016] (2) Contaminated substances and mix-
tures—processing. Persons who process
§ 750.15 Final rule. the same chemical substance or the
(a) [Reserved] same mixture containing 50 ppm or
(b) EPA will grant or deny petitions greater PCB as an impurity or con-
under TSCA section 6(e)(3)(B) sub- taminant may submit a consolidated
mitted pursuant to § 750.11. petition if the chemical substance or
(c) In determining whether to grant mixture is processed for the same use
an exemption to the PCB ban, the by each person represented by the peti-
Agency shall apply the two standards tion. For example, persons who process
enunciated in TSCA section 6(e)(3)(B). a PCB-contaminated pigment into
printing inks may combine their peti-
[81 FR 93636, Dec. 21, 2016]
tions into one petition. The name and
address of each petitioner must be stat-
Subpart C—Interim Procedural ed in the petition.
Rules for Processing and Dis- (3) Contaminated substances and mix-
tribution in Commerce Ex- tures—distribution in commerce. Persons
emptions who distribute in commerce the same
chemical substance or the same mix-
SOURCE: 44 FR 31560, Mar. 31, 1979, unless ture containing 50 ppm or greater PCB
otherwise noted. as an impurity or contaminant may
submit a consolidated petition if the
§ 750.30 Applicability. chemical substance or mixture is dis-
Sections 750.30 through 750.35 apply tributed in commerce for a common
to all rulemakings under authority of use. Such a petition is not required to
section 6(e)(3)(B) of the Toxic Sub- name each person who distributes in
stances Control Act (TSCA), 15 U.S.C. commerce the chemical substance or
2605(e)(3)(B) with respect to petitions mixture.
for PCB processing and distribution in (4) PCB capacitor distribution for pur-
commerce exemptions filed pursuant to poses of repair. Persons who distribute
§ 750.31(a). in commerce PCB capacitors for serv-
[81 FR 93636, Dec. 21, 2016] icing (repair) of PCB Equipment may
submit a single consolidated petition
§ 750.31 Filing of petitions for exemp- on behalf of any number of petitioners
tion. engaged in such distribution in com-
(a) Who may file. Any person seeking merce for purposes of repair. The name
an exemption from the PCB processing of each petitioner need not be stated in
and distribution in commerce prohibi- the petition.
tions imposed by section 6(e)(3)(A)(ii) (5) Small quantities for research and de-
of TSCA may file a petition for exemp- velopment. Persons who process or dis-
tion. Petitions must be submitted on tribute in commerce small quantities
an individual basis for each processor, of PCBs for research and development
distributor, seller or individual af- may submit a single consolidated peti-
fected by the 1979 processing and dis- tion. The name and address of each pe-
tribution in commerce prohibitions, titioner must be stated in the petition.
except as described in paragraphs (a) (6) Microscopy. Persons who process
(1) through (9) of this section. or distribute in commerce PCBs for use
(1) Processing and distribution in com- as a mounting medium in microscopy
merce of PCB-contaminated transformer may submit a single consolidated peti-
dielectric fluid. Persons who process or tion on behalf of any number of peti-
distribute in commerce dielectric fluid tioners. The name and address of each
containing 50 ppm or greater PCB (but petitioner must be stated in the peti-
less than 500 ppm PCB) for use in PCB- tion.
150
(7) Processing of PCB Articles into PCB in commerce related to disposal or

Equipment. A person who processes (in- processing for disposal, and decon-
corporates) PCB Articles (such as small tamination, must be submitted to:
PCB Capacitors) into PCB Equipment Document Control Officer, Office of Re-
may submit a petition on behalf of source Conservation and Recovery
himself and all persons who further (5305P), Environmental Protection
process or distribute in commerce PCB Agency, 1200 Pennsylvania Avenue,
Equipment built by the petitioner. For NW., Washington, DC 20460–0001.
example, a builder of motors who (c) Content of petition. Each petition
places small PCB Capacitors in the mo- must contain the following:
tors may submit a petition on behalf of (1) Name, address and telephone num-
all persons who process or incorporate ber of petitioner. See also paragraphs
motors built by the petitioner into (a) (1) through (9) of this section for ad-
other pieces of PCB Equipment and all ditional identification requirements
those who sell the equipment. Such a applicable to certain consolidated peti-
petition is not required to identify the tions.
persons who distribute in commerce or (2) Description of PCB processing or
further process the PCB Equipment. A distribution in commerce exemption
separate petition must be filed, how- requested, including a description of
ever, by each processor of PCB Articles the chemical substances, mixtures or
into PCB Equipment.
items to be processed or distributed in
(8) Processing of PCB Equipment into
commerce and, if processing is in-
other PCB Equipment. A person who
volved, the nature of the processing.
processes (incorporates) PCB Equip-
(3) For processing petitions, loca-
ment into other PCB Equipment may
tion(s) of sites requiring exemption.
submit a petition on behalf of himself
and all persons who further process or (4) Length of time requested for ex-
distribute in commerce PCB Equip- emption (maximum length of exemp-
ment built by the petitioner. Such a tion is one year).
petition is not required to identify the (5) Estimated amount of PCBs (by
persons who distribute in commerce or pound and/or volume) to be processed,
further process the PCB Equipment. If distributed in commerce, or used dur-
a petition has been filed under para- ing requested exemption period and the
graph (a)(7) of this section by the build- manner of release of PCBs into the en-
er of the original PCB Equipment, no vironment associated with such proc-
other petition is required. essing, distribution in commerce, or
(9) Distribution of PCB Equipment. Dis- use. Where the PCB concentration is
tributors in commerce of PCB Equip- less than 500 ppm, both the total liquid
ment may submit a consolidated peti- volume and the total PCB volume must
tion on behalf of persons who dis- be provided.
tribute in commerce PCB Equipment of (6) The basis for the petitioner’s con-
one type (such as air conditioners). The tention that under section 6(e)(3)(B)(i)
petition is not required to name the of TSCA ‘‘an unreasonable risk of in-
persons who distribute in commerce jury to health or environment would
the affected PCB Equipment. not result’’ from the granting of the
(b) Where to file. All petitions per- petition for exemption.
taining to: (7) The basis for the petitioner’s con-
(1) PCB use, which includes storage tention that under section 6(e)(3)(B)(ii)
for use or reuse, manufacture, proc- ‘‘good faith efforts have been made to
essing related to manufacture and use, develop a chemical substance which
and distribution in commerce related does not present an unreasonable risk
to use or processing for use, must be of injury to health or the environment
submitted to: OPPT Document Control and which may be substituted for’’ the
Officer (7407T), Environmental Protec- PCB.
tion Agency, 1200 Pennsylvania Ave., (8) Quantification of the reasonably
NW., Washington, DC 20460–0001. ascertainable economic consequences
(2) PCB disposal, which includes of denying the petition for exemption
cleanup, storage for disposal, proc- and an explanation of the manner of
essing related to disposal, distribution computation.
151
§ 750.31 40 CFR Ch. I (7–1–17 Edition)
(9) In addition to the information in of the expected total number of PCB

paragraphs (c)(1) through (c)(8) of this Capacitors to be distributed in com-
section, certain petitions must contain merce under the requested exemption.
additional information as follows: All information may be provided on a
(i) Persons who process or distribute group basis.
in commerce dielectric fluids con- (v) Persons filing petitions under
taining 50 ppm or greater PCB for use paragraphs (a) (7) and (8) of this section
in PCB Transformers, railroad trans- (Processing of PCB Articles into PCB
formers, or PCB electromagnets must Equipment and Processing of PCB
also state the expected number of PCB Equipment into Other PCB Equipment)
Transformers, railroad transformers, must provide a description of each type
or PCB electromagnets to be serviced of PCB Equipment (including the
under the exemption. In addition, a
amount of PCBs by poundage and/or
person must identify all the facilities
volume in the PCB Equipment) to be
which he owns or operates where he
processed and/or distributed in com-
services PCB transformers, railroad
merce under the exemption, the num-
transformers, or PCB electromagnets.
(ii) Persons filing petitions under ber of each type of equipment expected
paragraph (a)(1) of this section (Proc- to be processed and/or distributed in
essing and Distribution in Commerce of commerce, and the approximate num-
PCB-Contaminated Transformer Di- ber of distributors or further proc-
electric Fluid) must also provide the essors covered by the petition. All in-
expected number of PCB-Contaminated formation may be provided on a group
Transformers to be serviced under the basis. However, in the case of a peti-
requested exemption and the expected tion under paragraph (a)(7) of this sec-
method of disposal of waste dielectric tion, the processor of PCB Articles into
fluid. In addition, a person must iden- PCB Equipment must be identified in
tify all the facilities which he owns or the petition. In the case of a petition
operates where he services PCB-Con- under paragraph (a)(8) of this section,
taminated Transformers. This informa- the processor of PCB Equipment who
tion, as well as the information re- files the petition must be identified.
quired by paragraphs (c)(1), (c)(3), and (vi) Persons filing petitions under
(c)(5) of this section, must be provided paragraph (a)(9) of this section (Dis-
for each person represented by the peti- tribution of PCB Equipment) must pro-
tion. All other information may be provide a description of each type of PCB
vided on a group basis. Equipment (including the amount of
(iii) Persons filing petitions under PCBs by poundage and/or volume in the
paragraphs (a)(2) (Contaminated Sub- PCB Equipment) to be distributed in
stances and Mixtures-Processing) and commerce under the exemption, the
(a)(3) (Contaminated Substances and number of each type of equipment to be
Mixtures-Distribution in Commerce) distributed in commerce, and the ap-
must also provide a justification for
proximate number of distributors cov-
the class grouping selected and a de-
ered by the petition. All information
scription of the uses and the human
may be provided on a group basis.
and environmental exposure associated
with each use of the PCB-contaminated (vii) Persons filing petitions under
chemical substance or mixture for paragraphs (a) (5) and (6) of this section
which an exemption is sought. Infor- must provide the information required
mation may be provided on a group by paragraphs (c) (1) through (8) of this
basis, except that the information re- section for each petitioner named in
quired by paragraphs (c)(1), (c)(3) and the petition.
(c)(5) of this section, must be provided (d) EPA reserves the right to request
for each person represented by a peti- further information as to each petition
tion under paragraph (a)(2) of this sec- where necessary to determine whether
tion. the petition meets the statutory tests
(iv) Persons filing petitions under of section 6(e)(3)(B) of TSCA prior to or
paragraph (a)(4) of this section (PCB after publication of the notice of pro-
Capacitor Distribution for Purposes of posed rulemaking required by § 750.33 of
Repair) must also provide an estimate these rules.
152
(e) Renewal requests. (1) Any peti- activity conforms to the terms of the
tioner who has been granted an exemp- original exemption approved by EPA.
tion under 40 CFR 761.80, except para-
[44 FR 31560, Mar. 31, 1979, as amended at 53
graph (g) of 40 CFR 761.80, on or after FR 12524, Apr. 15, 1988; 59 FR 16998, Apr. 11,
May 25, 1994, and who seeks to renew 1994; 63 FR 35436, June 29, 1998; 72 FR 57238,
that exemption without changing its Oct. 9, 2007; 74 FR 30232, June 25, 2009]
terms, must submit a letter by cer-
tified mail to EPA requesting that the § 750.32 Consolidation of rulemaking.
exemption be granted for the following All petitions received pursuant to
year. § 750.31(a) will be consolidated into one
(i) This letter must contain a certifi- rulemaking with one informal hearing
cation by the petitioner that the type held on all petitions.
of activities, the procedures for han-
dling the PCBs, the amount of PCBs § 750.33 Notice of proposed rule-
handled, and any other aspect of the making.
exemption have not changed from the Rulemaking for PCB exemptions
original exemption petition request. filed pursuant to § 750.31(a) shall begin
(ii) This letter must be received by with the publication of a notice of pro-
EPA at least 6 months prior to the exposed rulemaking in the FEDERAL REG-
piration of the existing exemption. ISTER. The notice shall state in sum-
(iii) If a petitioner fails to make a mary form the required information
submission or the submission is not described in § 750.31(c).
timely under this section, the exemp-
[81 FR 93636, Dec. 21, 2016]
tion will expire 1 year from the effec-
tive date of granting that exemption. § 750.34 Confidentiality.
(iv) EPA will address a timely sub-
mission of a renewal request by rule- EPA encourages the submission of
non-confidential information by peti-
making and either grant or deny the
tioners and commentors. EPA does not
request.
wish to have unnecessary restrictions
(2) Any petitioner who has been
on access to the rulemaking record.
granted an exemption on or after May However, if a petitioner or commentor
25, 1994, and who seeks to increase the believes that he can only state his posi-
amount of PCBs handled or to change tion through the use of information
the type of activities, the procedures claimed to be confidential, he may sub-
for handling the PCBs, and any other mit it. Such information must be sepa-
aspect of their existing exemption rately submitted for the rulemaking
must submit a new exemption petition record and marked ‘‘confidential’’ by
to EPA. The existing exemption activ- the submitter. For the information
ity may continue until the new submis- claimed to be confidential, EPA will
sion is addressed by rulemaking, pro- list only the date and the name and ad-
vided the activity conforms to the dress of the petitioner or commentor in
terms of the current exemption ap- the public file, noting that the peti-
proved by EPA, and the petitioner tioner or commentor has requested
complies with the conditions of para- confidential treatment. The informa-
graph (e)(1) of this section. tion claimed to be confidential will be
(3) Any petitioner who has been placed in a confidential file. A peti-
granted a TSCA section 6(e)(3)(B) ex- tioner must also file a non-confidential
emption in a rule prior to May 25, 1994, petition with a non-confidential sum-
and who seeks to increase the amount mary of the confidential information
of PCBs handled or to change the type to be placed in the public file. Simi-
of activities, the procedures for han- larly, a commentor must supply a non-
dling the PCBs, and any other aspect of confidential summary of the informa-
their existing exemption must submit tion claimed to be confidential to be
a new exemption petition to EPA. The placed in the public file. Any informa-
existing exemption activity may con- tion not marked as confidential will be
tinue until the new submission is ad- placed in the public file. Information
dressed by rulemaking, provided the marked confidential will be treated in
153
§ 750.35 40 CFR Ch. I (7–1–17 Edition)
accordance with the procedures in part 761.77 Coordinated approval.

2, subpart B of this title. 761.79 Decontamination standards and pro-
cedures.
[44 FR 31560, Mar. 31, 1979. Redesignated at 81
FR 93636, Dec. 21, 2016] Subpart E—Exemptions
§ 750.35 Final rule. 761.80 Manufacturing, processing and dis-
tribution in commerce exemptions.
(a) [Reserved]
(b) EPA will grant or deny petitions Subpart F—Transboundary Shipments of
under TSCA section 6(e)(3)(B) sub- PCBs for Disposal
mitted pursuant to § 750.31.
(c) In determining whether to grant 761.91 Applicability.
an exemption to the PCB ban, EPA will 761.93 Import for disposal.
apply the two standards enunciated in 761.97 Export for disposal.
TSCA section 6(e)(3)(B). 761.99 Other transboundary shipments.
[81 FR 93636, Dec. 21, 2016] Subpart G—PCB Spill Cleanup Policy
761.120 Scope.
PART 761—POLYCHLORINATED 761.123 Definitions.
BIPHENYLS (PCBs) MANUFAC- 761.125 Requirements for PCB spill cleanup.
TURING, PROCESSING, DISTRIBU- 761.130 Sampling requirements.
TION IN COMMERCE, AND USE 761.135 Effect of compliance with this policy
and enforcement.
PROHIBITIONS
Subparts H–I [Reserved]
Subpart A—General
Subpart J—General Records and Reports
Sec.
761.1 Applicability. 761.180 Records and monitoring.
761.2 PCB concentration assumptions for 761.185 Certification program and retention
use. of records by importers and persons gen-
761.3 Definitions. erating PCBs in excluded manufacturing
761.19 References. processes.
761.187 Reporting importers and by persons
Subpart B—Manufacturing, Processing, Dis- generating PCBs in excluded manufac-
tribution in Commerce, and Use of turing processes.
PCBs and PCB Items 761.193 Maintenance of monitoring records
by persons who import, manufacture,
761.20 Prohibitions and exceptions. process, distribute in commerce, or use
761.30 Authorizations. chemicals containing inadvertently gen-
761.35 Storage for reuse. erated PCBs.
Subpart C—Marking of PCBs and PCB Subpart K—PCB Waste Disposal Records
Items and Reports
761.40 Marking requirements.
761.202 EPA identification numbers.
761.45 Marking formats.
761.205 Notification of PCB waste activity
(EPA Form 7710-53).
Subpart D—Storage and Disposal
761.207 The manifest—general requirements.
761.50 Applicability. 761.208 Obtaining manifests.
761.60 Disposal requirements. 761.209 Number of copies of a manifest.
761.61 PCB remediation waste. 761.210 Use of the manifest—Generator re-
761.62 Disposal of PCB bulk product waste. quirements.
761.63 PCB household waste storage and dis- 761.211 Manifest system—Transporter re-
posal. quirements.
761.64 Disposal of wastes generated as a re- 761.212 Transporter compliance with the
sult of research and development activi- manifest.
ties authorized under § 761.30(j) and chem- 761.213 Use of manifest—Commercial stor-
ical analysis of PCBs. age and disposal facility requirements.
761.65 Storage for disposal. 761.214 Retention of manifest records.
761.70 Incineration. 761.215 Manifest discrepancies.
761.71 High efficiency boilers. 761.216 Unmanifested waste report.

761.72 Scrap metal recovery ovens and 761.217 Exception reporting.
smelters. 761.218 Certificate of disposal.
761.75 Chemical waste landfills. 761.219 One-year exception reporting.
154
Subpart L [Reserved] 761.304 Determining sample location.

761.306 Sampling 1 meter square surfaces by
Subpart M—Determining a PCB Concentra- random selection of halves.
tion for Purposes of Abandonment or 761.308 Sample selection by random number
Disposal of Natural Gas Pipeline: Se- generation on any two-dimensional
lecting Sample Sites, Collecting Sur- square grid.
face Samples, and Analyzing Standard 761.310 Collecting the sample.
PCB Wipe Samples 761.312 Compositing of samples.
761.314 Chemical analysis of standard wipe
761.240 Scope and definitions. test samples.
761.243 Standard wipe sample method and 761.316 Interpreting PCB concentration
size. measurements resulting from this sam-
761.247 Sample site selection for pipe seg-
pling scheme.
ment removal.
761.250 Sample site selection for pipeline
section abandonment. Subpart Q—Self-Implementing Alternative
761.253 Chemical analysis. Extraction and Chemical Analysis Pro-
761.257 Determining the regulatory status cedures for Non-liquid PCB Remedi-
of sampled pipe. ation Waste Samples
Subpart N—Cleanup Site Characterization 761.320 Applicability.
Sampling for PCB Remediation Waste 761.323 Sample preparation.
in Accordance with § 761.61(a)(2) 761.326 Conducting the comparison study.
761.260 Applicability. Subpart R—Sampling Non-Liquid, Non-

761.265 Sampling bulk PCB remediation Metal PCB Bulk Product Waste for Pur-
waste and porous surfaces.
761.267 Sampling non-porous surfaces.
poses of Characterization for PCB Dis-
761.269 Sampling liquid PCB remediation posal in Accordance With § 761.62,
waste. and Sampling PCB Remediation Waste
761.272 Chemical extraction and analysis of Destined for Off-Site Disposal, in Ac-
samples. cordance With § 761.61
761.274 Reporting PCB concentrations in
samples. 761.340 Applicability.
761.345 Form of the waste to be sampled.
Subpart O—Sampling To Verify Completion 761.346 Three levels of sampling.
of Self-Implementing Cleanup and 761.347 First level sampling—waste from ex-
On-Site Disposal of Bulk PCB Remedi- isting piles.
ation Waste and Porous Surfaces in 761.348 Contemporaneous sampling.
Accordance with § 761.61(a)(6) 761.350 Subsampling from composite sam-
ples.
761.280 Application and scope.
761.353 Second level of sample selection.
761.283 Determination of the number of
samples to collect and sample collection 761.355 Third level of sample selection.
locations. 761.356 Conducting a leach test.
761.286 Sample size and procedure for col- 761.357 Reporting the results of the proce-
lecting a sample. dure used to simulate leachate genera-
761.289 Compositing samples. tion.
761.292 Chemical extraction and analysis of 761.358 Determining the PCB concentration
individual samples and composite sam- of samples of waste.
ples. 761.359 Reporting the PCB concentrations in
761.295 Reporting and recordkeeping of the samples.
PCB concentrations in samples.
761.298 Decisions based on PCB concentra- Subpart S—Double Wash/Rinse Method for
tion measurements resulting from sam-
pling.
Decontaminating Non-Porous Surfaces
761.360 Background.
Subpart P—Sampling Non-Porous Surfaces
761.363 Applicability.
for Measurement-Based Use, Reuse, 761.366 Cleanup equipment.
and On-Site or Off-Site Disposal Under 761.369 Pre-cleaning the surface.
§ 761.61(a)(6) and Determination 761.372 Specific requirements for relatively
Under § 761.79(b)(3) clean surfaces.
761.300 Applicability. 761.375 Specific requirements for surfaces

761.302 Proportion of the total surface area coated or covered with dust, dirt, grime,
to sample. grease, or another absorbent material.
155
§ 761.1 40 CFR Ch. I (7–1–17 Edition)
761.378 Decontamination, reuse, and dis- (3) Most provisions in this part apply
posal of solvents, cleaners, and equip- only if PCBs are present in concentra-
ment. tions above a specified level. Provi-
Subpart T—Comparison Study for Vali- sions that apply to PCBs at concentra-
dating a New Performance-Based De- tions of <50 ppm apply also to contami-
contamination Solvent Under nated surfaces at PCB concentrations
§ 761.79(d)(4) of ≤10 μg/100 cm2. Provisions that apply
to PCBs at concentrations of ≥50 to
761.380 Background. <500 ppm apply also to contaminated
761.383 Applicability. surfaces at PCB concentrations of >10/
761.386 Required experimental conditions 100 cm2 to <100 μg/100 cm2. Provisions
for the validation study and subsequent that apply to PCBs at concentrations
use during decontamination.
of ≥500 ppm apply also to contaminated
761.389 Testing parameter requirements.
761.392 Preparing validation study samples. surfaces at PCB concentrations of ≥100
761.395 A validation study. μg/100 cm2.
761.398 Reporting and recordkeeping. (4) PCBs can be found in liquid, non-
AUTHORITY: 15 U.S.C. 2605, 2607, 2611, 2614,
liquid and multi-phasic (combinations
and 2616. of liquid and non-liquid) forms. A per-
son should use the following criteria to
determine PCB concentrations to de-
Subpart A—General termine which provisions of this part
§ 761.1 Applicability. apply to such PCBs.
(i) Any person determining PCB con-
(a) This part establishes prohibitions
centrations for non-liquid PCBs must
of, and requirements for, the manufac-
do so on a dry weight basis.
ture, processing, distribution in com-
(ii) Any person determining PCB con-
merce, use, disposal, storage, and
marking of PCBs and PCB Items. centrations for liquid PCBs must do so
on a wet weight basis. Liquid PCBs
(b)(1) This part applies to all persons
who manufacture, process, distribute containing more than 0.5 percent by
in commerce, use, or dispose of PCBs or weight non-dissolved material shall be
PCB Items. Substances that are regu- analyzed as multi-phasic non-liquid/liq-
lated by this part include, but are not uid mixtures.
limited to: dielectric fluids; solvents; (iii) Any person determining the PCB
oils; waste oils; heat transfer fluids; concentration of samples containing
hydraulic fluids; paints or coatings; PCBs and non-dissolved non-liquid ma-
sludges; slurries; sediments; dredge terials ≥0.5 percent, must separate the
spoils; soils; materials containing PCBs non-dissolved materials into non-liquid
as a result of spills; and other chemical PCBs and liquid PCBs. For multi-pha-
substances or combinations of sub- sic non-liquid/liquid or liquid/liquid
stances, including impurities and by- mixtures, the phases shall be separated
products and any byproduct, inter- before chemical analysis. Following
mediate, or impurity manufactured at phase separation, the PCB concentra-
any point in a process. tion in each non-liquid phase shall be
(2) Unless otherwise noted, PCB con- determined on a dry weight basis and
centrations shall be determined on a the PCB concentration in each liquid
weight-per-weight basis (e.g., milli- phase shall be determined separately
grams per kilogram), or for liquids, on on a wet weight basis.
a weight-per-volume basis (e.g., milli- (iv) Any person disposing of multi-
grams per liter) if the density of the phasic non-liquid/liquid or liquid/liquid
liquid is also reported. Unless other- mixtures must use the PCB disposal re-
wise provided, PCBs are quantified quirements that apply to the indi-
based on the formulation of PCBs vidual phase with the highest PCB con-
present in the material analyzed. For centration except where otherwise
example, measure Aroclor TM 1242 PCBs noted. Alternatively, phases may be
based on a comparison with Aroclor TM separated and disposed of using the
1242 standards. Measure individual con- PCB disposal requirements that apply
gener PCBs based on a comparison with to each separated, single-phase mate-
individual PCB congener standards. rial.
156
(5) No person may avoid any provi- (1) Persons who inadvertently manu-
sion specifying a PCB concentration by facture or import PCBs generated as
diluting the PCBs, unless otherwise unintentional impurities in excluded
specifically provided. manufacturing processes, as defined in
(6) Unless otherwise specified, ref- § 761.3, are exempt from the require-
erences to weights or volumes of PCBs ments of subpart B of this part, pro-
in this part apply to the total weight vided that such persons comply with
or total volume of the material (oil, subpart J of this part, as applicable.
soil, debris, etc.) that contains regu- (2) Persons who process, distribute in
lated concentrations of PCBs, not the commerce, or use products containing
calculated weight or volume of only PCBs generated in excluded manufac-
the PCB molecules contained in the turing processes defined in § 761.3 are
material. exempt from the requirements of sub-
(c) Definitions of the terms used in part B provided that such persons com-
these regulations are in subpart A. The ply with subpart J of this part, as ap-
basic requirements applicable to dis- plicable.
posal and marking of PCBs and PCB (3) Persons who process, distribute in
Items are set forth in subpart D—Dis- commerce, or use products containing
posal of PCBs and PCB Items and in recycled PCBs defined in § 761.3, are ex-
subpart C—Marking of PCBs and PCB empt from the requirements of subpart
Items. Prohibitions applicable to PCB B of this part, provided that such per-
activities are set forth in subpart B— sons comply with subpart J of this
Manufacture, Processing, Distribution part, as applicable.
in Commerce, and Use of PCBs and (4) Except as provided in § 761.20 (d)
PCB Items. Subpart B also includes au- and (e), persons who process, distribute
thorizations from the prohibitions. in commerce, or use products con-
Subparts C and D set forth the specific taining excluded PCB products as de-
requirements for disposal and marking fined in § 761.3, are exempt from the re-
of PCBs and PCB Items. quirements of subpart B of this part.
(d) Section 15 of the Toxic Sub-
stances Control Act (TSCA) states that (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
failure to comply with these regula- 2605)
tions is unlawful. Section 16 imposes li- [44 FR 31542, May 31, 1979, as amended at 49
ability for civil penalties upon any per- FR 28189, July 10, 1984; 53 FR 24220, June 27,
son who violates these regulations, and 1988; 63 FR 35436, June 29, 1998; 64 FR 33759,
the Administrator can establish appro- June 24, 1999]
priate remedies for any violations sub-
ject to any limitations included in sec- § 761.2 PCB concentration assump-
tions for use.
tion 16 of TSCA. Section 16 also sub-
jects a person to criminal prosecution (a)(1) Any person may assume that
for a violation which is knowing or transformers with <3 pounds (1.36 kilo-
willful. In addition, section 17 author- grams (kgs)) of fluid, circuit breakers,
izes Federal district courts to enjoin reclosers, oil-filled cable, and rectifiers
activities prohibited by these regula- whose PCB concentration is not estab-
tions, compel the taking of actions re- lished contain PCBs at <50 ppm.
quired by these regulations, and issue (2) Any person must assume that
orders to seize PCBs and PCB Items mineral oil-filled electrical equipment
manufactured, processed or distributed that was manufactured before July 2,
in violation of these regulations. 1979, and whose PCB concentration is
(e) These regulations do not preempt not established is PCB-Contaminated
other more stringent Federal statutes Electrical Equipment (i.e., contains ≥50
and regulations. ppm PCB, but <500 ppm PCB). All pole-
(f) Unless and until superseded by top and pad-mounted distribution
any new more stringent regulations transformers manufactured before July
issued under EPA authorities, or any 2, 1979, must be assumed to be mineral-
permits or any pretreatment require- oil filled. Any person may assume that
ments issued by EPA, a state or local electrical equipment manufactured

government that affect release of PCBs after July 2, 1979, is non-PCB (i.e., <50
to any particular medium: ppm PCBs). If the date of manufacture
157
§ 761.3 40 CFR Ch. I (7–1–17 Edition)
of mineral oil-filled electrical equip- ume tanks and bottles, dryers, airlines,
ment is unknown, any person must as- and related appurtenances.
sume it to be PCB-Contaminated. Annual document log means the de-
(3) Any person must assume that a tailed information maintained at the
transformer manufactured prior to facility on the PCB waste handling at
July 2, 1979, that contains 1.36 kg (3 the facility.
pounds) or more of fluid other than Annual report means the written doc-
mineral oil and whose PCB concentra- ument submitted each year by each
tion is not established, is a PCB Trans- disposer and commercial storer of PCB
former (i.e., ≥500 ppm). If the date of waste to the appropriate EPA Regional
manufacture and the type of dielectric Administrator. The annual report is a
fluid are unknown, any person must as- brief summary of the information in-
sume the transformer to be a PCB cluded in the annual document log.
Transformer. ASTM means American Society for
(4) Any person must assume that a Testing and Materials, 100 Barr Harbor
capacitor manufactured prior to July 2, Drive, West Conshohocken, PA 19428–
1979, whose PCB concentration is not 2959.
established contains ≥500 ppm PCBs. Byproduct means a chemical sub-
Any person may assume that a capac- stance produced without separate com-
itor manufactured after July 2, 1979, is mercial intent during the manufac-
non-PCB (i.e., <50 ppm PCBs). If the turing or processing of another chem-
date of manufacture is unknown, any ical substance(s) or mixture(s).
person must assume the capacitor con- Capacitor means a device for accumu-
tains ≥500 ppm PCBs. Any person may lating and holding a charge of elec-
assume that a capacitor marked at the tricity and consisting of conducting
time of manufacture with the state- surfaces separated by a dielectric.
ment ‘‘No PCBs’’ in accordance with Types of capacitors are as follows:
§ 761.40(g) is non-PCB. (1) Small capacitor means a capacitor
(b) PCB concentration may be estab- which contains less than 1.36 kg (3 lbs.)
lished by: of dielectric fluid. The following as-
(1) Testing the equipment; or sumptions may be used if the actual
(2)(i) A permanent label, mark, or weight of the dielectric fluid is un-
other documentation from the manu- known. A capacitor whose total volume
facturer of the equipment indicating is less than 1,639 cubic centimeters (100
its PCB concentration at the time of cubic inches) may be considered to con-
manufacture; and tain less than 1.36 kgs (3 lbs.) of dielec-
(ii) Service records or other docu- tric fluid and a capacitor whose total
mentation indicating the PCB con- volume is more than 3,278 cubic centi-
centration of all fluids used in serv- meters (200 cubic inches) must be con-
icing the equipment since it was first sidered to contain more than 1.36 kg (3
manufactured. lbs.) of dielectric fluid. A capacitor
whose volume is between 1,639 and 3,278
[63 FR 35436, June 29, 1998, as amended at 64 cubic centimeters may be considered to
FR 33759, June 24, 1999] contain less then 1.36 kg (3 lbs.) of di-
electric fluid if the total weight of the
§ 761.3 Definitions.
capacitor is less than 4.08 kg (9 lbs.).
For the purpose of this part: (2) Large high voltage capacitor means
Administrator means the Adminis- a capacitor which contains 1.36 kg (3
trator of the Environmental Protection lbs.) or more of dielectric fluid and
Agency, or any employee of the Agency which operates at 2,000 volts (a.c. or
to whom the Administrator may either d.c.) or above.
herein or by order delegate his author- (3) Large low voltage capacitor means a
ity to carry out his functions, or any capacitor which contains 1.36 kg (3 lbs.)
person who shall by operation of law be or more of dielectric fluid and which
authorized to carry out such functions. operates below 2,000 volts (a.c. or d.c.).
Agency means the United States En- CERCLA means the Comprehensive
vironmental Protection Agency. Environmental Response, Compensa-

Air compressor system means air com- tion, and Liability Act (42 U.S.C. 9601-
pressors, piping, receiver tanks, vol- 9657).
158
Certification means a written state- Cleanup site means the areal extent of
ment regarding a specific fact or rep- contamination and all suitable areas in
resentation that contains the following very close proximity to the contamina-
language: tion necessary for implementation of a
Under civil and criminal penalties of law
cleanup of PCB remediation waste, re-
for the making or submission of false or gardless of whether the site was in-
fraudulent statements or representations (18 tended for management of waste.
U.S.C. 1001 and 15 U.S.C. 2615), I certify that Commerce means trade, traffic, trans-
the information contained in or accom- portation, or other commerce:
panying this document is true, accurate, and (1) Between a place in a State and
complete. As to the identified section(s) of any place outside of such State, or
this document for which I cannot personally
verify truth and accuracy, I certify as the
(2) Which affects trade, traffic, trans-
company official having supervisory respon- portation, or commerce described in
sibility for the persons who, acting under my paragraph (1) of this definition.
direct instructions, made the verification Commercial storer of PCB waste means
that this information is true, accurate, and the owner or operator of each facility
complete. that is subject to the PCB storage unit
Chemical substance, (1) except as pro- standards of § 761.65(b)(1) or (c)(7) or
vided in paragraph (2) of this defini- meets the alternate storage criteria of
tion, means any organic or inorganic § 761.65(b)(2), and who engages in stor-
substance of a particular molecular age activities involving either PCB
identity, including: Any combination waste generated by others or that was
of such substances occurring in whole removed while servicing the equipment
or part as a result of a chemical reac- owned by others and brokered for dis-
tion or occurring in nature, and any posal. The receipt of a fee or any other
element or uncombined radical. form of compensation for storage serv-
(2) Such term does not include: Any ices is not necessary to qualify as a
mixture; any pesticide (as defined in commercial storer of PCB waste. A
the Federal Insecticide, Fungicide, and generator who only stores its own
Rodenticide Act) when manufactured, waste is subject to the storage require-
processed, or distributed in commerce ments of § 761.65, but is not required to
for use as a pesticide; tobacco or any obtain approval as a commercial stor-
tobacco product; any source material, er. If a facility’s storage of PCB waste
special nuclear material, or byproduct generated by others at no time exceeds
material (as such terms are defined in a total of 500 gallons of liquid and/or
the Atomic Energy Act of 1954 and reg- non-liquid material containing PCBs at
ulations issued under such Act); any regulated levels, the owner or operator
article the sale of which is subject to is a commercial storer but is not re-
the tax imposed by section 4181 of the quired to seek EPA approval as a com-
Internal Revenue Code of 1954 (deter- mercial storer of PCB waste. Storage of
mined without regard to any exemp- one company’s PCB waste by a related
tions from such tax provided by section company is not considered commercial
4182 or section 4221 or any provisions of storage. A ‘‘related company’’ includes,
such Code); and any food, food additive, but is not limited to: a parent company
drug, cosmetic, or device (as such and its subsidiaries; sibling companies
terms are defined in section 201 of the owned by the same parent company;
Federal Food, Drug, and Cosmetic Act) companies owned by a common holding
when manufactured, processed, or dis- company; members of electric coopera-
tributed in commerce for use as a food, tives; entities within the same Execu-
food additive, drug, cosmetic, or de- tive agency as defined at 5 U.S.C. 105;
vice. and a company having a joint owner-
Chemical waste landfill means a land- ship interest in a facility from which
fill at which protection against risk of PCB waste is generated (such as a
injury to health or the environment jointly owned electric power gener-
from migration of PCBs to land, water, ating station) where the PCB waste is
or the atmosphere is provided from stored by one of the co-owners of the
PCBs and PCB Items deposited therein facility. A ‘‘related company’’ does not
by locating, engineering, and operating include another voluntary member of
the landfill as specified in § 761.75. the same trade association. Change in
159
§ 761.3 40 CFR Ch. I (7–1–17 Edition)
ownership or title of a generator’s fa- justing for moisture content may also
cility, where the generator is storing be used.
PCB waste, does not make the new EPA identification number means the
owner of the facility a commercial 12-digit number assigned to a facility
storer of PCB waste. by EPA upon notification of PCB waste
Designated facility means the off-site activity under § 761.205.
disposer or commercial storer of PCB Excluded manufacturing process means
waste designated on the manifest as a manufacturing process in which
the facility that will receive a mani- quantities of PCBs, as determined in
fested shipment of PCB waste. accordance with the definition of inad-
Disposal means intentionally or acci- vertently generated PCBs, calculated
dentally to discard, throw away, or as defined, and from which releases to
otherwise complete or terminate the products, air, and water meet the re-
useful life of PCBs and PCB Items. Dis- quirements of paragraphs (1) through
posal includes spills, leaks, and other (5) of this definition, or the importa-
uncontrolled discharges of PCBs as tion of products containing PCBs as
well as actions related to containing, unintentional impurities, which prod-
transporting, destroying, degrading, ucts meet the requirements of para-
decontaminating, or confining PCBs graphs (1) and (2) of this definition.
and PCB Items. (1) The concentration of inadvert-
Disposer of PCB waste, as the term is ently generated PCBs in products leav-
used in subparts J and K of this part, ing any manufacturing site or im-
means any person who owns or oper- ported into the United States must
ates a facility approved by EPA for the have an annual average of less than 25
disposal of PCB waste which is regu- ppm, with a 50 ppm maximum.
lated for disposal under the require- (2) The concentration of inadvert-
ments of subpart D of this part. ently generated PCBs in the compo-
Distribute in commerce and Distribution nents of detergent bars leaving the
in Commerce when used to describe an manufacturing site or imported into
action taken with respect to a chem- the United States must be less than 5
ical substance, mixture, or article con- ppm.
taining a substance or mixture means (3) The release of inadvertently gen-
to sell, or the sale of, the substance, erated PCBs at the point at which
mixture, or article in commerce; to in- emissions are vented to ambient air
troduce or deliver for introduction into must be less than 10 ppm.
commerce, or the introduction or de- (4) The amount of inadvertently gen-
livery for introduction into commerce erated PCBs added to water discharged
of the substance, mixture, or article; or from a manufacturing site must be less
to hold or the holding of, the sub- than 100 micrograms per resolvable gas
stance, mixture, or article after its in- chromatographic peak per liter of
troduction into commerce. water discharged.
DOT means the United States De- (5) Disposal of any other process
partment of Transportation. wastes above concentrations of 50 ppm
Dry weight means the weight of the PCB must be in accordance with sub-
sample, excluding the weight of the part D of this part.
water in the sample. Prior to chemical Excluded PCB products means PCB
analysis the water may be removed by materials which appear at concentra-
any reproducible method that is appli- tions less than 50 ppm, including but
cable to measuring PCBs in the sample not limited to:
matrix at the concentration of con- (1) Non-Aroclor inadvertently gen-
cern, such as air drying at ambient erated PCBs as a byproduct or impu-
temperature, filtration, decantation, rity resulting from a chemical manu-
heating at low temperature followed by facturing process.
cooling in the presence of a desiccant, (2) Products contaminated with
or other processes or combinations of Aroclor or other PCB materials from
processes which would remove water historic PCB uses (investment casting
but not remove PCBs from the sample. waxes are one example).
Analytical procedures which calculate (3) Recycled fluids and/or equipment
the dry weight concentration by ad- contaminated during use involving the
160
products described in paragraphs (1) pancy for any individual not wearing
and (2) of this definition (heat transfer dermal and respiratory protection for a
and hydraulic fluids and equipment and calendar year is: 840 hours or more (an
other electrical equipment components average of 16.8 hours or more per week)
and fluids are examples). for non-porous surfaces and 335 hours
(4) Used oils, provided that in the or more (an average of 6.7 hours or
cases of paragraphs (1) through (4) of more per week) for bulk PCB remedi-
this definition: ation waste. Examples could include a
(i) The products or source of the residence, school, day care center,
products containing <50 ppm con- sleeping quarters, a single or multiple
centration PCBs were legally manufac- occupancy 40 hours per week work sta-
tured, processed, distributed in com- tion, a school class room, a cafeteria in
merce, or used before October 1, 1984. an industrial facility, a control room,
(ii) The products or source of the and a work station at an assembly line.
products containing <50 ppm con-
Importer means any person defined as
centrations PCBs were legally manu-
an ‘‘importer’’ at § 720.3(l) of this chap-
factured, processed, distributed in com-
merce, or used, i.e., pursuant to au- ter who imports PCBs or PCB Items
thority granted by EPA regulation, by and is under the jurisdiction of the
exemption petition, by settlement United States.
agreement, or pursuant to other Agen- Impurity means a chemical substance
cy-approved programs; which is unintentionally present with
(iii) The resulting PCB concentration another chemical substance.
(i.e. below 50 ppm) is not a result of di- In or Near Commercial Buildings means
lution, or leaks and spills of PCBs in within the interior of, on the roof of,
concentrations over 50 ppm. attached to the exterior wall of, in the
Facility means all contiguous land, parking area serving, or within 30 me-
and structures, other appurtenances, ters of a non-industrial non-substation
and improvements on the land, used for building. Commercial buildings are
the treatment, storage, or disposal of typically accessible to both members
PCB waste. A facility may consist of of the general public and employees,
one or more treatment, storage, or dis- and include: (1) Public assembly prop-
posal units. erties, (2) educational properties, (3) in-
Fluorescent light ballast means a de- stitutional properties, (4) residential
vice that electrically controls fluores- properties, (5) stores, (6) office build-
cent light fixtures and that includes a ings, and (7) transportation centers
capacitor containing 0.1 kg or less of (e.g., airport terminal buildings, sub-
dielectric. way stations, bus stations, or train sta-
Generator of PCB waste means any tions).
person whose act or process produces
Incinerator means an engineered de-
PCBs that are regulated for disposal
vice using controlled flame combustion
under subpart D of this part, or whose
act first causes PCBs or PCB Items to to thermally degrade PCBs and PCB
become subject to the disposal require- Items. Examples of devices used for in-
ments of subpart D of this part, or who cineration include rotary kilns, liquid
has physical control over the PCBs injection incinerators, cement kilns,
when a decision is made that the use of and high temperature boilers.
the PCBs has been terminated and Industrial building means a building
therefore is subject to the disposal re- directly used in manufacturing or tech-
quirements of subpart D of this part. nically productive enterprises. Indus-
Unless another provision of this part trial buildings are not generally or
specifically requires a site-specific typically accessible to other than
meaning, ‘‘generator of PCB waste’’ in- workers. Industrial buildings include
cludes all of the sites of PCB waste buildings used directly in the produc-
generation owned or operated by the tion of power, the manufacture of prod-
person who generates PCB waste. ucts, the mining of raw materials, and
High occupancy area means any area the storage of textiles, petroleum prod-
where PCB remediation waste has been ucts, wood and paper products, chemi-
disposed of on-site and where occu- cals, plastics, and metals.
161
§ 761.3 40 CFR Ch. I (7–1–17 Edition)
Laboratory means a facility that ana- Mark means the descriptive name, in-
lyzes samples for PCBs and is unaffili- structions, cautions, or other informa-
ated with any entity whose activities tion applied to PCBs and PCB Items, or
involve PCBs. other objects subject to these regula-
Leak or leaking means any instance tions.
in which a PCB Article, PCB Con- Marked means the marking of PCB
tainer, or PCB Equipment has any Items and PCB storage areas and trans-
PCBs on any portion of its external port vehicles by means of applying a
surface. legible mark by painting, fixation of an
Liquid PCBs means a homogenous adhesive label, or by any other method
flowable material containing PCBs and that meets the requirements of these
no more than 0.5 percent by weight regulations.
non-dissolved material. Market/Marketers means the proc-
Low occupancy area means any area essing or distributing in commerce, or
where PCB remediation waste has been the person who processes or distributes
disposed of on-site and where occu- in commerce, used oil fuels to burners
pancy for any individual not wearing or other marketers, and may include
dermal and respiratory protection for a the generator of the fuel if it markets
calendar year is: less than 840 hours (an the fuel directly to the burner.
average of 16.8 hours per week) for non- Mineral Oil PCB Transformer means
porous surfaces and less than 335 hours
any transformer originally designed to
(an average of 6.7 hours per week) for
contain mineral oil as the dielectric
bulk PCB remediation waste. Examples
fluid and which has been tested and
could include an electrical substation
found to contain 500 ppm or greater
or a location in an industrial facility
PCBs.
where a worker spends small amounts
of time per week (such as an unoccu- Mixture means any combination of
pied area outside a building, an elec- two or more chemical substances if the
trical equipment vault, or in the non- combination does not occur in nature
office space in a warehouse where occu- and is not, in whole or in part, the re-
pancy is transitory). sult of a chemical reaction; except that
Manifest means the shipping docu- such term does include any combina-
ment EPA form 8700–22 and any con- tion which occurs, in whole or in part,
tinuation sheet attached to EPA form as a result of a chemical reaction if
8700–22, originated and signed by the none of the chemical substances com-
generator of PCB waste in accordance prising the combination is a new chem-
with the instructions included with the ical substance and if the combination
form and subpart K of this part. could have been manufactured for com-
Manned Control Center means an elec- mercial purposes without a chemical
trical power distribution control room reaction at the time the chemical sub-
where the operating conditions of a stances comprising the combination
PCB Transformer are continuously were combined.
monitored during the normal hours of Municipal solid wastes means garbage,
operation (of the facility), and, where refuse, sludges, wastes, and other dis-
the duty engineers, electricians, or carded materials resulting from resi-
other trained personnel have the capa- dential and non-industrial operations
bility to deenergize a PCB Transformer and activities, such as household ac-
completely within 1 minute of the re- tivities, office functions, and commer-
ceipt of a signal indicating abnormal cial housekeeping wastes.
operating conditions such as an over- Natural gas pipeline system means nat-
temperature condition or overpressure ural gas gathering facilities, natural
condition in a PCB Transformer. gas pipe, natural gas compressors, nat-
Manufacture means to produce, man- ural gas storage facilities, and natural
ufacture, or import into the customs gas pipeline appurtenances (including
territory of the United States. instrumentation and vessels directly in
Manufacturing process means all of a contact with transported natural gas
series of unit operations operating at a such as valves, regulators, drips, filter

site, resulting in the production of a separators, etc., but not including air
product. compressors).
162
Non-liquid PCBs means materials con- PCB and PCBs as contained in PCB
taining PCBs that by visual inspection items are defined in § 761.3. For any
do not flow at room temperature (25 °C purposes under this part, inadvertently
or 77 °F) or from which no liquid passes generated non-Aroclor PCBs are de-
when a 100 g or 100 ml representative fined as the total PCBs calculated fol-
sample is placed in a mesh number 60 lowing division of the quantity of
±5 percent paint filter and allowed to monochlorinated biphenyls by 50 and
drain at room temperature for 5 min- dichlorinated biphenyls by 5.
utes. PCB Article means any manufactured
Non-PCB Transformer means any article, other than a PCB Container,
transformer that contains less than 50 that contains PCBs and whose sur-
ppm PCB; except that any transformer face(s) has been in direct contact with
that has been converted from a PCB PCBs. ‘‘PCB Article’’ includes capaci-
Transformer or a PCB-Contaminated tors, transformers, electric motors,
Transformer cannot be classified as a pumps, pipes and any other manufac-
non-PCB Transformer until reclassi- tured item (1) which is formed to a spe-
fication has occurred, in accordance cific shape or design during manufac-
with the requirements of ture, (2) which has end use function(s)
§ 761.30(a)(2)(v). dependent in whole or in part upon its
Non-porous surface means a smooth, shape or design during end use, and (3)
unpainted solid surface that limits pen- which has either no change of chemical
etration of liquid containing PCBs be- composition during its end use or only
yond the immediate surface. Examples those changes of composition which
are: smooth uncorroded metal; natural have no commercial purpose separate
gas pipe with a thin porous coating from that of the PCB Article.
originally applied to inhibit corrosion; PCB Article Container means any
smooth glass; smooth glazed ceramics; package, can, bottle, bag, barrel, drum,
impermeable polished building stone
tank, or other device used to contain
such as marble or granite; and high
PCB Articles or PCB Equipment, and
density plastics, such as
whose surface(s) has not been in direct
polycarbonates and melamines, that do
contact with PCBs.
not absorb organic solvents.
NTIS means the National Technical PCB bulk product waste means waste
Information Service, U.S. Department derived from manufactured products
of Commerce, 5285 Port Royal Rd., containing PCBs in a non-liquid state,
Springfield, VA 22161. at any concentration where the con-
On site means within the boundaries centration at the time of designation
of a contiguous property unit. for disposal was ≥50 ppm PCBs. PCB
Open burning means the combustion bulk product waste does not include
of any PCB regulated for disposal, in a PCBs or PCB Items regulated for dis-
manner not approved or otherwise al- posal under § 761.60(a) through (c),
lowed under subpart D of this part, and § 761.61, § 761.63, or § 761.64. PCB bulk
without any of the following: product waste includes, but is not lim-
(1) Control of combustion air to ited to:
maintain adequate temperature for ef- (1) Non-liquid bulk wastes or debris
ficient combustion. from the demolition of buildings and
(2) Containment of the combustion other man-made structures manufac-
reaction in an enclosed device to pro- tured, coated, or serviced with PCBs.
vide sufficient residence time and mix- PCB bulk product waste does not in-
ing for complete combustion. clude debris from the demolition of
(3) Control of emission of the gaseous buildings or other man-made struc-
combustion products. tures that is contaminated by spills
PCB and PCBs means any chemical from regulated PCBs which have not
substance that is limited to the been disposed of, decontaminated, or
biphenyl molecule that has been otherwise cleaned up in accordance
chlorinated to varying degrees or any with subpart D of this part.
combination of substances which con- (2) PCB-containing wastes from the

tains such substance. Refer to § 761.1(b) shredding of automobiles, household
for applicable concentrations of PCBs. appliances, or industrial appliances.
163
§ 761.3 40 CFR Ch. I (7–1–17 Edition)
(3) Plastics (such as plastic insula- measures PCBs. PCB field screening
tion from wire or cable; radio, tele- tests usually report less than or great-
vision and computer casings; vehicle er than a specific numerical PCB con-
parts; or furniture laminates); centration. These tests normally build
preformed or molded rubber parts and in a safety factor which increases the
components; applied dried paints, var- probability of a false positive report
nishes, waxes or other similar coatings and decreases the probability of a false
or sealants; caulking; adhesives; paper; negative report. PCB field screening
Galbestos; sound deadening or other tests do not usually provide: an iden-
types of insulation; and felt or fabric tity record generated by an instru-
products such as gaskets. ment; a quantitative comparison
(4) Fluorescent light ballasts con- record from calibration standards; any
taining PCBs in the potting material. identification of PCBs; and/or any indi-
PCB Capacitor means any capacitor cation or identification of inter-
that contains ≥500 ppm PCB. Con- ferences with the measurement of the
centration assumptions applicable to PCBs. PCB field screening test tech-
capacitors appear under § 761.2. nologies include, but are not limited
PCB Container means any package, to, total chlorine colorimetric tests,
can, bottle, bag, barrel, drum, tank, or total chlorine x-ray fluorescence tests,
other device that contains PCBs or total chlorine microcoulometric tests,
PCB Articles and whose surface(s) has and rapid immunoassay tests.
been in direct contact with PCBs. PCB household waste means PCB
PCB-Contaminated means a non-liquid waste that is generated by residents on
material containing PCBs at con- the premises of a temporary or perma-
centrations ≥50 ppm but <500 ppm; a nent residence for individuals (includ-
liquid material containing PCBs at ing individually owned or rented units
concentrations ≥50 ppm but <500 ppm or of a multi-unit construction), and that
where insufficient liquid material is is composed primarily of materials
available for analysis, a non-porous found in wastes generated by con-
surface having a surface concentration sumers in their homes. PCB household
>10 μg/100 cm2 but <100 μg/100 cm2, waste includes unwanted or discarded
measured by a standard wipe test as non-commercial vehicles (prior to
defined in § 761.123. shredding), household items, and appli-
PCB-Contaminated Electrical Equip- ances or appliance parts and wastes
ment means any electrical equipment generated on the premises of a resi-
including, but not limited to, trans- dence for individuals as a result of rou-
formers (including those used in rail- tine household maintenance by or on
way locomotives and self-propelled behalf of the resident. Bulk or commin-
cars), capacitors, circuit breakers, re- gled liquid PCB wastes at concentra-
closers, voltage regulators, switches tions of ≥50 ppm, demolition and ren-
(including sectionalizers and motor ovation wastes, and industrial or heavy
starters), electromagnets, and cable, duty equipment with PCBs are not
that contains PCBs at concentrations household wastes.
of ≥50 ppm and <500 ppm in the con- PCB Item means any PCB Article,
taminating fluid. In the absence of liq- PCB Article Container, PCB Container,
uids, electrical equipment is PCB-Con- PCB Equipment, or anything that de-
taminated if it has PCBs at >10 μg/100 liberately or unintentionally contains
cm2 and <100 μg/100 cm2 as measured by or has as a part of it any PCB or PCBs.
a standard wipe test (as defined in PCB/radioactive waste means PCBs
§ 761.123) of a non-porous surface. regulated for disposal under subpart D
PCB Equipment means any manufac- of this part that also contain source,
tured item, other than a PCB Con- special nuclear, or byproduct material
tainer or a PCB Article Container, subject to regulation under the Atomic
which contains a PCB Article or other Energy Act of 1954, as amended, or nat-
PCB Equipment, and includes micro- urally-occurring or accelerator-pro-
wave ovens, electronic equipment, and duced radioactive material.
fluorescent light ballasts and fixtures. PCB remediation waste means waste
PCB field screening test means a port- containing PCBs as a result of a spill,
able analytical device or kit which release, or other unauthorized disposal,
164
at the following concentrations: Mate- osene, diesel fuel, terpene hydro-

rials disposed of prior to April 18, 1978, carbons, and terpene hydrocarbon/alco-
that are currently at concentrations hol mixtures.
≥50 ppm PCBs, regardless of the con- Person means any natural or judicial
centration of the original spill; mate- person including any individual, cor-
rials which are currently at any vol- poration, partnership, or association;
ume or concentration where the origi- any State or political subdivision
nal source was ≥500 ppm PCBs begin- thereof; any interstate body; and any
ning on April 18, 1978, or ≥50 ppm PCBs department, agency, or instrumen-
beginning on July 2, 1979; and mate- tality of the Federal Government.
rials which are currently at any con- Porous surface means any surface
centration if the PCBs are spilled or re- that allows PCBs to penetrate or pass
leased from a source not authorized for into itself including, but not limited
use under this part. PCB remediation to, paint or coating on metal; corroded
waste means soil, rags, and other de- metal; fibrous glass or glass wool;
bris generated as a result of any PCB unglazed ceramics; ceramics with a po-
spill cleanup, including, but not lim- rous glaze; porous building stone such
ited to: as sandstone, travertine, limestone, or
(1) Environmental media containing coral rock; low-density plastics such as
PCBs, such as soil and gravel; dredged styrofoam and low-density poly-
materials, such as sediments, settled ethylene; coated (varnished or painted)
sediment fines, and aqueous decantate or uncoated wood; concrete or cement;
from sediment. plaster; plasterboard; wallboard; rub-
(2) Sewage sludge containing <50 ppm ber; fiberboard; chipboard; asphalt; or
PCBs and not in use according to tar paper. For purposes of cleaning and
§ 761.20(a)(4); PCB sewage sludge; com- disposing of PCB remediation waste,
mercial or industrial sludge contami- porous surfaces have different require-
nated as the result of a spill of PCBs
ments than non-porous surfaces.
including sludges located in or re-
Posing an exposure risk to food or feed
moved from any pollution control de-
means being in any location where
vice; aqueous decantate from an indus-
trial sludge. human food or animal feed products
(3) Buildings and other man-made could be exposed to PCBs released from
structures (such as concrete floors, a PCB Item. A PCB Item poses an expo-
wood floors, or walls contaminated sure risk to food or feed if PCBs re-
from a leaking PCB or PCB-Contami- leased in any way from the PCB Item
nated Transformer), porous surfaces, have a potential pathway to human
and non-porous surfaces. food or animal feed. EPA considers
PCB sewage sludge means sewage human food or animal feed to include
sludge as defined in 40 CFR 503.9(w) items regulated by the U.S. Depart-
which contains ≥50 ppm PCBs, as meas- ment of Agriculture or the Food and
ured on a dry weight basis. Drug Administration as human food or
PCB Transformer means any trans- animal feed; this includes direct addi-
former that contains ≥500 ppm PCBs. tives. Food or feed is excluded from
For PCB concentration assumptions this definition if it is used or stored in
applicable to transformers containing private homes.
1.36 kilograms (3 lbs.) or more of fluid Process means the preparation of a
other than mineral oil, see § 761.2. For chemical substance or mixture, after
provisions permitting reclassification its manufacture, for distribution in
of electrical equipment, including PCB commerce:
Transformers, containing ≥500 ppm (1) In the same form or physical state
PCBs to PCB-Contaminated Electrical as, or in a different form or physical
Equipment, see § 761.30(a) and (h). state from, that in which it was re-
PCB waste(s) means those PCBs and ceived by the person so preparing such
PCB Items that are subject to the dis- substance or mixture, or
posal requirements of subpart D of this (2) As part of an article containing
part. the chemical substance or mixture.

Performance-based organic decon- Qualified incinerator means one of the
tamination fluid (PODF) means ker- following:
165
§ 761.3 40 CFR Ch. I (7–1–17 Edition)
(1) An incinerator approved under the Aroclors (roughly 3 ppb), or comply

provisions of § 761.70. Any level of PCB with the equivalent mass-based limita-
concentration can be destroyed in an tion.
incinerator approved under § 761.70. (5) Disposal of any other process
(2) A high efficiency boiler which wastes at concentrations of 50 ppm or
complies with the criteria of greater must be in accordance with
§ 761.71(a)(1), and for which the operator subpart D of this part.
has given written notice to the appro- Research and development (R&D) for
priate EPA Regional Administrator in PCB disposal means demonstrations for
accordance with the notification re- commercial PCB disposal approvals,
quirements for the burning of mineral pre-demonstration tests, tests of major
oil dielectric fluid under § 761.71(a)(2). modifications to previously approved
(3) An incinerator approved under PCB disposal technologies, treatability
section 3005(c) of the Resource Con- studies for PCB disposal technologies
servation and Recovery Act (42 U.S.C. which have not been approved, develop-
6925(c)) (RCRA). ment of new disposal technologies, and
(4) Industrial furnaces and boilers research on chemical transformation
which are identified in 40 CFR 260.10 processes including, but not limited to,
and 40 CFR 279.61 (a)(1) and (2) when op- biodegradation.
erating at their normal operating tem- Retrofill means to remove PCB or
peratures (this prohibits feeding fluids, PCB-contaminated dielectric fluid and
above the level of detection, during ei- to replace it with either PCB, PCB-con-
ther startup or shutdown operations). taminated, or non-PCB dielectric fluid.
Quantifiable Level/Level of Detection Rupture of a PCB Transformer means a
means 2 micrograms per gram from violent or non-violent break in the in-
any resolvable gas chromatographic tegrity of a PCB Transformer caused
peak, i.e. 2 ppm. by an overtemperature and/or over-
RCRA means the Resource Conserva- pressure condition that results in the
tion and Recovery Act (40 U.S.C. 6901 et release of PCBs.
seq.). Sale for purposes other than resale
Recycled PCBs means those PCBs means sale of PCBs for purposes of dis-
which appear in the processing of paper posal and for purposes of use, except
products or asphalt roofing materials where use involves sale for distribution
from PCB-contaminated raw materials. in commerce. PCB Equipment which is
Processes which recycle PCBs must first leased for purposes of use any
meet the following requirements: time before July 1, 1979, will be consid-
(1) There are no detectable con- ered sold for purposes other than re-
centrations of PCBs in asphalt roofing sale.
material products leaving the proc- Sewage sludge means sewage sludge as
essing site. defined in § 503.9(w) of this chapter that
(2) The concentration of PCBs in contains <50 ppm (on a dry weight
paper products leaving any manufac- basis) PCBs.
turing site processing paper products, Small quantities for research and devel-
or in paper products imported into the opment means any quantity of PCBs (1)
United States, must have an annual av- that is originally packaged in one or
erage of less than 25 ppm with a 50 ppm more hermetically sealed containers of
maximum. a volume of no more than five (5.0) mil-
(3) The release of PCBs at the point liliters, and (2) that is used only for
at which emissions are vented to ambi- purposes of scientific experimentation
ent air must be less than 10 ppm. or analysis, or chemical research on, or
(4) The amount of Aroclor PCBs analysis of, PCBs, but not for research
added to water discharged from an as- or analysis for the development of a
phalt roofing processing site must at PCB product.
all times be less than 3 micrograms per Soil washing means the extraction of
liter (μg/L) for total Aroclors (roughly PCBs from soil using a solvent, recov-
3 parts per billion (3 ppb)). Water dis- ering the solvent from the soil, sepa-
charges from the processing of paper rating the PCBs from the recovered
products must at all times be less than solvent for disposal, and then disposal
3 micrograms per liter (μg/L) for total or reuse of the solvent.
166
Standard wipe sample means a sample Treatability Study means a study in

collected for chemical extraction and which PCB waste is subjected to a
analysis using the standard wipe test treatment process to determine:
as defined in § 761.123. Except as des- (1) Whether the waste is amenable to
ignated elsewhere in part 761, the min- the treatment process;
imum surface area to be sampled shall (2) What pretreatment (if any) is re-
be 100 cm2. quired;
Storage for disposal means temporary (3) The optimal process conditions
storage of PCBs that have been des- needed to achieve the desired treat-
ignated for disposal. ment;
SW–846 means the document having (4) The efficiency of a treatment
the title ‘‘SW-846, Test Methods for process for the specific type of waste
Evaluating Solid Waste,’’ which is (i.e., soil, sludge, liquid, etc.); or,
available from either the National
(5) The characteristics and volumes
Technical Information Service (NTIS,
of residuals from a particular treat-
U.S. Department of Commerce, 5285
Port Royal Rd., Springfield, VA 22161, ment process. A ‘‘treatability study’’ is
telephone: (703) 487-4650 or the U.S. not a mechanism to commercially
Government Printing Office (U.S. GPO, treat or dispose of PCB waste. Treat-
710 North Capitol St., NW., Wash- ment is a form of disposal under this
ington, DC 20401, telephone: (202) 783- part.
3238. TSCA means the Toxic Substances
Totally enclosed manner means any Control Act (15 U.S.C. 2601 et seq.).
manner that will ensure no exposure of TSCA PCB Coordinated Approval
human beings or the environment to means the process used to recognize
any concentration of PCBs. other Federal or State waste manage-
Transfer facility means any transpor- ment documents governing the storage,
tation-related facility including load- cleanup, treatment, and disposal of
ing docks, parking areas, and other PCB wastes. It is the mechanism under
similar areas where shipments of PCB TSCA for accomplishing review, co-
waste are held during the normal ordination, and approval of PCB waste
course of transportation. Transport ve- management activities which are con-
hicles are not transfer facilities under ducted outside of the TSCA PCB ap-
this definition, unless they are used for proval process, but require approval
the storage of PCB waste, rather than under the TSCA PCB regulations at 40
for actual transport activities. Storage CFR part 761.
areas for PCB waste at transfer facili- Unit means a particular building,
ties are subject to the storage facility structure, or cell used to manage PCB
standards of § 761.65, but such storage waste (including, but not limited to, a
areas are exempt from the approval rebuilding used for PCB waste storage, a
quirements of § 761.65(d) and the record- landfill, an industrial boiler, or an in-
keeping requirements of § 761.180, un- cinerator).
less the same PCB waste is stored there
U.S. GPO means the U.S. Government
for a period of more than 10 consecu-
Printing Office, 710 North Capitol St.,
tive days between destinations.
NW., Washington, DC 20401.
Transporter of PCB waste means, for
Waste Oil means used products pri-
the purposes of subpart K of this part,
marily derived from petroleum, which
any person engaged in the transpor-
tation of regulated PCB waste by air, include, but are not limited to, fuel
rail, highway, or water for purposes oils, motor oils, gear oils, cutting oils,
other than consolidation by a gener- transmission fluids, hydraulic fluids,
ator. and dielectric fluids.
Transport vehicle means a motor vehi- Wet weight means reporting chemical
cle or rail car used for the transpor- analysis results by including either the
tation of cargo by any mode. Each
cargo-carrying body (e.g., trailer, rail-

road freight car) is a separate trans-
port vehicle.
167
§ 761.19 40 CFR Ch. I (7–1–17 Edition)
weight, or the volume and density, of (2) ASTM D129–64 (Reapproved 1978),
all liquids. Standard Test Method for Sulfur in Pe-
troleum Products (General Bomb Meth-
(Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
2605) od), IBR approved for § 761.71.
(3) ASTM D240–87, Standard Test
[49 FR 25239, June 20, 1984, as amended at 49 Method for Heat of Combustion of Liq-
FR 28189, July 10, 1984; 49 FR 29066, July 18,
1984; 49 FR 44638, Nov. 8, 1984; 50 FR 29199,
uid Hydrocarbon Fuel by Bomb Calo-
July 17, 1985; 50 FR 32176, Aug. 9, 1985; 53 FR rimeter, IBR approved for § 761.71.
24220, June 27, 1988; 53 FR 27327, July 19, 1988; (4) ASTM D482–87, Standard Test
54 FR 52745, Dec. 21, 1989; 55 FR 26205, June Method for Ash from Petroleum Prod-
27, 1990; 58 FR 32061, June 8, 1993; 61 FR 11106, ucts, IBR approved for § 761.71.
Mar. 18, 1996; 63 FR 35437, June 29, 1998; 64 FR (5) ASTM D524–88, Standard Test
33759, June 24, 1999]
Method for Ramsbottom Carbon Res-
§ 761.19 References. idue of Petroleum Products, IBR ap-
proved for § 761.71.
The materials listed in this section (6) ASTM D808–87, Standard Test
are incorporated by reference into this Method for Chlorine in New and Used
part with the approval of the Director Petroleum Products (Bomb Method),
of the Federal Register under 5 U.S.C. IBR approved for § 761.71.
552(a) and 1 CFR part 51. To enforce (7) ASTM D923–86, Standard Test
any edition other than that specified in Method for Sampling Electrical Insu-
this section, a document must be pub- lating Liquids, IBR approved for
lished in the FEDERAL REGISTER and § 761.60.
the material must be available to the
(8) ASTM D923–89, Standard Methods
public. All approved materials are
of Sampling Electrical Insulating Liq-
available for inspection at the OPPT
uids, IBR approved for § 761.60.
Docket in the EPA Docket Center
(EPA/DC) at Rm. 3334, EPA West Bldg., (9) ASTM D1266–87, Standard Test
1301 Constitution Ave., NW., Wash- Method for Sulfur in Petroleum Prod-
ington, DC. The EPA/DC Public Read- ucts (Lamp Method), IBR approved for
ing Room hours of operation are 8:30 § 761.71.
a.m. to 4:30 p.m., Monday through Fri- (10) ASTM D1796–83 (Reapproved
day, excluding legal holidays. The tele- 1990), Standard Test Method for Water
phone number of the EPA/DC Public and Sediment in Fuel Oils by the Cen-
Reading Room is (202) 566–1744, and the trifuge Method (Laboratory Proce-
telephone number for the OPPT Docket dure), IBR approved for § 761.71.
is (202) 566–0280. These approved mate- (11) ASTM D2158–89, Standard Test
rials are also available for inspection Method for Residues in Liquified Pe-
at the National Archives and Records troleum (LP) Gases, IBR approved for
Administration (NARA). For informa- § 761.71.
tion on the availability of this mate- (12) ASTM D2709–88, Standard Test
rial at NARA, call (202) 741–6030 or go Method for Water and Sediment in Dis-
to http://www.archives.gov/ tillate Fuels by Centrifuge, IBR ap-
federallregister/ proved for § 761.71.
codeloflfederallregulations/ (13) ASTM D2784–89, Standard Test
ibrllocations.html. In addition, these Method for Sulfur in Liquified Petro-
materials are available from the leum Gases (Oxy-hydrogen Burner or
sources listed below. Lamp), IBR approved for § 761.71.
(a) ASTM materials. Copies of these (14) ASTM D3178–84, Standard Test
materials may be obtained from ASTM Methods for Carbon and Hydrogen in
International, 100 Barr Harbor Dr., P.O. the Analysis Sample of Coke and Coal,
Box C700, West Conshohocken, PA IBR approved for § 761.71.
19428–2959, or by calling (877) 909–ASTM, (15) ASTM D3278–89, Standard Test
or at http://www.astm.org. Methods for Flash Point of Liquids by
(1) ASTM D93–09 (Approved December Setaflash Closed-Cup Apparatus, IBR
15, 2009), Standard Test Methods for approved for § 761.75.
Flash Point by Pensky-Martens Closed (16) ASTM E258–67 (Reapproved 1987),

Tester, IBR approved for §§ 761.71, Standard Test Method for Total Nitro-
761.75. gen Inorganic Material by Modified
168
KJELDAHL Method, IBR approved for fect of exposure. For purposes of deter-
§ 761.71. mining which PCB Items are totally
(b) [Reserved] enclosed, pursuant to section 6(e)(2)(C)
[77 FR 2463, Jan. 18, 2012] of TSCA, since exposure to such Items
may be significant, the Administrator
further finds that a totally enclosed
Subpart B—Manufacturing, Proc- manner is a manner which results in no
essing, Distribution in Com- exposure to humans or the environ-
merce, and Use of PCBs and ment to PCBs. The following activities
PCB Items are considered totally enclosed: dis-
tribution in commerce of intact, non-
§ 761.20 Prohibitions and exceptions. leaking electrical equipment such as
Except as authorized in § 761.30, the transformers (including transformers
activities listed in paragraphs (a) and used in railway locomotives and self-
(d) of this section are prohibited pursu- propelled cars), capacitors,
ant to section 6(e)(2) of TSCA. The re- electromagnets, voltage regulators,
quirements set forth in paragraph (c) of switches (including sectionalizers and
this section and subpart F of this part motor starters), circuit breakers, re-
concerning export and import of PCBs closers, and cable that contain PCBs at
and PCB Items for disposal are estab- any concentration and processing and
lished pursuant to section 6(e)(1) of distribution in commerce of PCB
TSCA. Subject to any exemptions Equipment containing an intact, non-
granted pursuant to section 6(e)(3)(B) leaking PCB Capacitor. See paragraph
of TSCA, the activities listed in para- (c)(1) of this section for provisions al-
graphs (b) and (c) of this section are lowing the distribution in commerce of
prohibited pursuant to section PCBs and PCB Items.
(6)(e)(3)(A) of TSCA. In addition, the (a) No persons may use any PCB, or
Administrator hereby finds, under the any PCB Item regardless of concentra-
authority of section 12(a)(2) of TSCA, tion, in any manner other than in a to-
that the manufacture, processing, and tally enclosed manner within the
distribution in commerce of PCBs at United States unless authorized under
concentrations of 50 ppm or greater § 761.30, except that:
and PCB Items with PCB concentra-
(1) An authorization is not required
tions of 50 ppm or greater present an
to use those PCBs or PCB Items which
unreasonable risk of injury to health
consist of excluded PCB products as de-
within the United States. This finding
fined in § 761.3.
is based upon the well-documented
human health and environmental haz- (2) An authorization is not required
ard of PCB exposure, the high prob- to use those PCBs or PCB Items result-
ability of human and environmental ing from an excluded manufacturing
exposure to PCBs and PCB Items from process or recycled PCBs as defined in
manufacturing, processing, or distribu- § 761.3, provided all applicable condi-
tion activities; the potential hazard of tions of § 761.1(f) are met.
PCB exposure posed by the transpor- (3) An authorization is not required
tation of PCBs or PCB Items within to use those PCB Items which contain
the United States; and the evidence or whose surfaces have been in contact
that contamination of the environment with excluded PCB products as defined
by PCBs is spread far beyond the areas in § 761.3.
where they are used. In addition, the (4) An authorization is not required
Administrator hereby finds, for pur- to use sewage sludge where the uses are
poses of section 6(e)(2)(C) of TSCA, that regulated at parts 257, 258, and 503 of
any exposure of human beings or the this chapter. No person may blend or
environment to PCBs, as measured or otherwise dilute PCBs regulated for
detected by any scientifically accept- disposal, including PCB sewage sludge
able analytical method, may be signifi- and sewage sludge not used pursuant to
cant, depending on such factors as the parts 257, 258, and 503 of this chapter,
quantity of PCBs involved in the expo- for purposes of use or to avoid disposal
sure, the likelihood of exposure to hu- requirements under this part. Except
mans and the environment, and the ef- as explicitly provided in subpart D of
169
§ 761.20 40 CFR Ch. I (7–1–17 Edition)
this part, no person may dispose of reg- TSCA PCB disposal approval unless
ulated PCB wastes including, but not they are part of an existing approval,
limited to, PCB remediation waste, are part of a self-implementing activ-
PCB bulk product waste, PCBs, and ity under § 761.61(a) or § 761.79 (b) or (c),
PCB industrial sludges, into treatment or are otherwise specifically allowed
works, as defined in § 503.9(aa) of this under subpart D of this part.
chapter. (iii) With the exception of provisions
(b) No person may manufacture PCBs in § 761.60 (a)(2) and (a)(3), in order to
for use within the United States or meet the intent of § 761.1(b), processing,
manufacture PCBs for export from the diluting, or otherwise blending of
United States without an exemption, waste prior to being introduced into a
except that: an exemption is not re- disposal unit for purposes of meeting a
quired for PCBs manufactured in an ex- PCB concentration limit shall be done
cluded manufacturing process as de- in accordance with a TSCA PCB dis-
fined in § 761.3, provided all applicable posal approval or comply with the re-
conditions of § 761.1(f) are met. quirements of § 761.79.
(c) No persons may process or dis- (iv) Where the rate of delivering liq-
tribute in commerce any PCB, or any uids or non-liquids into a PCB disposal
PCB Item regardless of concentration, unit is an operating parameter, this
for use within the United States or for rate shall be a condition of the TSCA
export from the United States without PCB disposal approval for the unit
an exemption, except that an exemp- when an approval is required.
tion is not required to process or dis-
(3) PCBs and PCB Items may be ex-
tribute in commerce PCBs or PCB
ported for disposal in accordance with
Items resulting from an excluded man-
the requirements of subpart F of this
ufacturing process as defined in § 761.3,
part.
or to process or distribute in commerce
recycled PCBs as defined in § 761.3, or (4) PCBs, at concentrations of less
to process or distribute in commerce than 50 ppm, or PCB Items, with con-
excluded PCB products as defined in centrations of less than 50 ppm, may be
§ 761.3, provided that all applicable con- processed and distributed in commerce
ditions of § 761.1(f) are met. In addition, for purposes of disposal.
the activities described in paragraphs (5) Decontaminated materials. Any
(c) (1) through (5) of this section may person may distribute in commerce
also be conducted without an exemp- equipment, structures, or other liquid
tion, under the conditions specified or non-liquid materials that were con-
therein. taminated with PCBs ≥50 ppm, includ-
(1) PCBs at concentrations of 50 ppm ing those not otherwise authorized for
or greater, or PCB Items with PCB con- distribution in commerce under this
centrations of 50 ppm or greater, sold part, provided that one of the following
before July 1, 1979 for purposes other applies:
than resale may be distributed in com- (i) The materials were decontami-
merce only in a totally enclosed man- nated in accordance with a TSCA PCB
ner after that date. disposal approval issued under subpart
(2) Any person may process and dis- D of this part, with § 761.79, or with ap-
tribute in commerce for disposal PCBs plicable EPA PCB spill cleanup policies
at concentrations of ≥50 ppm, or PCB in effect at the time of the decon-
Items with PCB concentrations of ≥50 tamination.
ppm, if they comply with the applica- (ii) If not previously decontaminated,
ble provisions of this part. the materials now meet an applicable
(i) Processing activities which are decontamination standard in § 761.79(b).
primarily associated with and facili- (d) The use of waste oil that contains
tate storage or transportation for dis- any detectable concentration of PCB as
posal do not require a TSCA PCB stor- a sealant, coating, or dust control
age or disposal approval. agent is prohibited. Prohibited uses in-
(ii) Processing activities which are clude, but are not limited to, road oil-
primarily associated with and facili- ing, general dust control, use as a pes-
tate treatment, as defined in § 260.10 of ticide or herbicide carrier, and use as a
this chapter, or disposal require a rust preventative on pipes.
170
(e) In addition to any applicable re- have been added to the container or
quirements under 40 CFR part 279, sub- equipment, then the total container
parts G and H, marketers and burners contents must be considered as having
of used oil who market (process or dis- a PCB concentration of 50 ppm or
tribute in commerce) for energy recov- greater for purposes of complying with
ery, used oil containing any quantifi- the disposal requirements of this part.
able level of PCBs are subject to the (iii) Other information documenting
following requirements: that the used oil fuel does not contain
(1) Restrictions on marketing. Used oil quantifiable levels (2 ppm) of PCBs
containing any quantifiable level of may consist of either personal, special
PCBs (2 ppm) may be marketed only to: knowledge of the source and composi-
(i) Qualified incinerators as defined tion of the used oil, or a certification
in 40 CFR 761.3. from the person generating the used oil
(ii) Marketers who market off-speci- claiming that the oil contains no de-
fication used oil for energy recovery tectable PCBs.
only to other marketers who have noti- (3) Restrictions on burning. (i) Used oil
fied EPA of their used oil management containing any quantifiable levels of
activities, and who have an EPA iden- PCB may be burned for energy recov-
tification number where an identifica- ery only in the combustion facilities
tion number is required by 40 CFR identified in paragraph (e)(1) of this
279.73. This would include persons who section when such facilities are oper-
market off-specification used oil who ating at normal operating tempera-
are subject to the requirements at 40 tures (this prohibits feeding these fuels
CFR part 279 and the notification re- during either startup or shutdown op-
quirements of 40 CFR 279.73. erations). Owners and operators of such
(iii) Burners identified in 40 CFR facilities are ‘‘burners’’ of used oil
279.61(a)(1) and (2). Only burners in the fuels.
automotive industry may burn used oil
(ii) Before a burner accepts from a
generated from automotive sources in
marketer the first shipment of used oil
used oil-fired space heaters provided
fuel containing detectable PCBs (2
the provisions of 40 CFR 279.23 are met.
The Regional Administrator may grant ppm), the burner must provide the
a variance for a boiler that does not marketer a one-time written and
meet the 40 CFR 279.61(a)(1) and (2) cri- signed notice certifying that:
teria after considering the criteria list- (A) The burner has complied with
ed in 40 CFR 260.32 (a) through (f). The any notification requirements applica-
applicant must address the relevant ble to ‘‘qualified incinerators’’ (§ 761.3)
criteria contained in 40 CFR 260.32 (a) or to ‘‘burners’’ regulated under 40 CFR
through (f) in an application to the Re- part 279, subpart G.
gional Administrator. (B) The burner will burn the used oil
(2) Testing of used oil fuel. Used oil to only in a combustion facility identified
be burned for energy recovery is pre- in paragraph (e)(1) of this section and
sumed to contain quantifiable levels (2 identify the class of burner he quali-
ppm) of PCB unless the marketer ob- fies.
tains analyses (testing) or other infor- (4) Recordkeeping requirements. The
mation that the used oil fuel does not following recordkeeping requirements
contain quantifiable levels of PCBs. are in addition to the recordkeeping re-
(i) The person who first claims that a quirements for marketers found in 40
used oil fuel does not contain quantifi- CFR 279.72(b), 279.74(a), (b) and (c), and
able level (2 ppm) PCB must obtain 279.75, and for burners found in 40 CFR
analyses or other information to sup- 279.65 and 279.66.
port that claim. (i) Marketers. Marketers who first
(ii) Testing to determine the PCB claim that the used oil fuel contains no
concentration in used oil may be con- detectable PCBs must include among
ducted on individual samples, or in ac- the records required by 40 CFR 279.72(b)
cordance with the testing procedures and 279.74(b) and (c), copies of the anal-
described in § 761.60(g)(2). However, for ysis or other information documenting

purposes of this part, if any PCBs at a his claim, and he must include among
concentration of 50 ppm or greater the records required by 40 CFR 279.74(a)
171
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
and (c) and 279.75, a copy of each cer- tion, in or near commercial buildings
tification notice received or prepared is prohibited.
relating to transactions involving PCB- (A) Retrofilled mineral oil PCB
containing used oil. Transformers may be installed for re-
(ii) Burners. Burners must include classification purposes indefinitely
among the records required by 40 CFR after October 1, 1990.
279.65 and 279.66, a copy of each certifi- (B) Once a retrofilled transformer has
cation notice required by paragraph been installed for reclassification pur-
(e)(3)(ii) of this section that he sends to poses, it must be tested 3 months after
a marketer. installation to ascertain the concentra-
tion of PCBs. If the PCB concentration
(Sec. 6, Pub. L. 94–469, 90 Stat. 2020, (15 U.S.C. is below 50 ppm, the transformer can be
2605)
reclassified as a non-PCB Transformer.
[44 FR 31542, May 31, 1979. Redesignated at 47 If the PCB concentration is between 50
FR 19527, May 6, 1982, and amended at 49 FR and 500 ppm, the transformer can be re-
25241, June 20, 1984; 49 FR 28190, July 10, 1984; classified as a PCB-Contaminated
49 FR 44638, Nov. 8, 1984; 53 FR 12524, Apr. 15, transformer. If the PCB concentration
1988; 53 FR 24220, June 27, 1988; 58 FR 15435, remains at 500 ppm or greater, the en-
Mar. 23, 1993; 58 FR 34205, June 23, 1993; 60 FR
34465, July 3, 1995; 61 FR 11106, Mar. 18, 1996;
tire process must either be repeated
63 FR 35439, June 29, 1998; 64 FR 33760, June until the transformer has been reclassi-
24, 1999] fied to a non-PCB or PCB-Contami-
nated transformer in accordance with
§ 761.30 Authorizations. paragraph (a)(2)(v) of this section or
the transformer must be removed from
The following non-totally enclosed
service.
PCB activities are authorized pursuant
(iv) As of October 1, 1990, all higher
to section 6(e)(2)(B) of TSCA:
secondary voltage radial PCB Trans-
(a) Use in and servicing of transformers formers, in use in or near commercial
(other than railroad transformers). PCBs buildings, and lower secondary voltage
at any concentration may be used in network PCB Transformers not located
transformers (other than in railroad lo- in sidewalk vaults in or near commer-
comotives and self-propelled railroad cial buildings (network transformers
cars) and may be used for purposes of with secondary voltages below 480
servicing including rebuilding these volts) that have not been removed from
transformers for the remainder of their service as provided in paragraph
useful lives, subject to the following (a)(1)(iv)(B) of this section, must be
conditions: equipped with electrical protection to
(1) Use conditions. (i) As of October 1, avoid transformer ruptures caused by
1985, the use and storage for reuse of high current faults. As of February 25,
PCB Transformers that pose an expo- 1991, all lower secondary voltage radial
sure risk to food or feed is prohibited. PCB Transformers, in use in or near
(ii) As of October 1, 1990, the use of commercial buildings, must be
network PCB Transformers with higher equipped with electrical protection to
secondary voltages (secondary voltages avoid transformer ruptures caused by
equal to or greater than 480 volts, in- high current faults.
cluding 480/277 volt systems) in or near (A) Current-limiting fuses or other
commercial buildings is prohibited. equivalent technology must be used to
Network PCB Transformers with high- detect sustained high current faults
er secondary voltages which are re- and provide for the complete
moved from service in accordance with deenergization of the transformer
this requirement must either be reclas- (within several hundredths of a second
sified to PCB Contaminated or non in the case of higher secondary voltage
PCB status, placed into storage for dis- radial PCB Transformers and within
posal, or disposed. tenths of a second in the case of lower
(iii) Except as otherwise provided, as secondary voltage network PCB Trans-
of October 1, 1985, the installation of formers), before transformer rupture
PCB Transformers, which have been occurs. Lower secondary voltage radial
placed into storage for reuse or which PCB Transformers must be equipped
have been removed from another loca- with electrical protection as provided
172
in paragraph (a)(1)(iv)(E) of this sec- former ruptures from sustained high

tion. The installation, setting, and current faults must be completed in ac-
maintenance of current-limiting fuses cordance with good engineering prac-
or other equivalent technology to tices.
avoid PCB Transformer ruptures from (v) As of October 1, 1990, all radial
sustained high current faults must be PCB Transformers with higher sec-
completed in accordance with good en- ondary voltages (480 volts and above,
gineering practices. including 480/277 volt systems) in use in
(B) All lower secondary voltage net- or near commercial buildings must, in
work PCB Transformers not located in addition to the requirements of para-
sidewalk vaults (network transformers graph (a)(1)(iv)(A) of this section, be
with secondary voltages below 480 equipped with protection to avoid
volts), in use in or near commercial transformer ruptures caused by sus-
buildings, which have not been pro- tained low current faults.
tected as specified in paragraph (A) Pressure and temperature sensors
(a)(1)(iv)(A) of this section by October (or other equivalent technology which
1, 1990, must be removed from service has been demonstrated to be effective
by October 1, 1993. in early detection of sustained low cur-
(C) As of October 1, 1990, owners of rent faults) must be used in these
lower secondary voltage network PCB transformers to detect sustained low
Transformers, in use in or near com- current faults.
mercial buildings which have not been (B) Disconnect equipment must be
protected as specified in paragraph provided to insure complete
(a)(1)(iv)(A) of this section and which deenergization of the transformer in
are not located in sidewalk vaults, the event of a sensed abnormal condi-
must register in writing those trans- tion (e.g., an overpressure or over-
formers with the EPA Regional Admin- temperature condition in the trans-
istrator in the appropriate region. The former), caused by a sustained low cur-
information required to be provided in rent fault. The disconnect equipment
writing to the Regional Administrator must be configured to operate auto-
includes: matically within 30 seconds to 1
(1) The specific location of the PCB minute of the receipt of a signal indi-
Transformer(s). cating an abnormal condition from a
(2) The address(es) of the building(s) sustained low current fault, or can be
and the physical location of the PCB configured to allow for manual
Transformer(s) on the building site(s). deenergization from a manned on-site
(3) The identification number(s) of control center upon the receipt of an
the PCB Transformer(s). audio or visual signal indicating an ab-
(D) As of October 1, 1993, all lower normal condition caused by a sustained
secondary voltage network PCB Trans- low current fault. Manual
formers located in sidewalk vaults deenergization from a manned on-site
(network transformers with secondary control center must occur within 1
voltages below 480 volts) in use near minute of the receipt of the audio or
commercial buildings must be removed visual signal indicating an abnormal
from service. condition caused by a sustained low
(E) As of February 25, 1991, all lower current fault. If automatic operation is
secondary voltage radial PCB Trans- selected and a circuit breaker is uti-
formers must be equipped with elec- lized for disconnection, it must also
trical protection, such as current-lim- have the capability to be manually
iting fuses or other equivalent tech- opened if necessary.
nology, to detect sustained high cur- (C) The enhanced electrical protec-
rent faults and provide for the com- tive system required for the detection
plete deenergization of the transformer of sustained low current faults and the
or complete deenergization of the complete and rapid deenergization of
faulted phase of the transformer within transformers must be properly in-
several hundredths of a second. The installed, maintained, and set sensitive
stallation, setting, and maintenance of enough (in accordance with good engi-
current-limiting fuses or other equiva- neering practices) to detect sustained
lent technology to avoid PCB Trans- low current faults and allow for rapid
173
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
and total deenergization prior to PCB tenance records required for each PCB
Transformer rupture (either violent or Transformer under paragraph
non violent rupture) and release of (a)(1)(xii)(I) of this section.
PCBs. (D) A transformer owner must com-
(vi)(A) No later than December 28, ply with all requirements of paragraph
1998 all owners of PCB Transformers, (a)(1)(vi)(A) of this section to continue
including those in storage for reuse, the PCB-Transformer’s authorization
must register their transformers with for use, or storage for reuse, pursuant
the Environmental Protection Agency, to this section and TSCA section
National Program Chemicals Division, 6(e)(2)(B).
Office of Pollution Prevention and (vii) As of December 1, 1985, PCB
Toxics (7404), 1200 Pennsylvania Ave., Transformers in use in or near com-
NW., Washington, DC 20460. This reg- mercial buildings must be registered
istration requirement is subject to the with building owners. For PCB Trans-
limitations in paragraph (a)(1) of this formers located in commercial build-
section. ings, PCB Transformer owners must
(1) A transformer owner who assumes register the transformers with the
a transformer is a PCB-Contaminated building owner of record. For PCB
transformer, and discovers after De- Transformers located near commercial
cember 28, 1998 that it is a PCB-Trans- buildings, PCB Transformer owners
former, must register the newly-identi- must register the transformers with all
fied PCB Transformer, in writing, with owners of buildings located within 30
the Environmental Protection Agency meters of the PCB Transformer(s). In-
no later than 30 days after it is identi- formation required to be provided to
fied as such. This requirement does not building owners by PCB Transformer
apply to transformer owners who have owners includes but is not limited to:
previously registered with the EPA (A) The specific location of the PCB
PCB Transformers located at the same Transformer(s).
address as the transformer that they (B) The principal constituent of the
assumed to be PCB-Contaminated and dielectric fluid in the transformer(s)
later determined to be a PCB Trans- (e.g., PCBs, mineral oil, or silicone oil).
former. (C) The type of transformer installa-
(2) A person who takes possession of tion (e.g., 208/120 volt network, 208/120
a PCB Transformer after December 28, volt radial, 208 volt radial, 480 volt net-
1998 is not required to register or rework, 480/277 volt network, 480 volt ra-
register the transformer with the EPA. dial, 480/277 volt radial).
(B) Any person submitting a registra- (viii) As of December 1, 1985, combus-
tion under this section must include: tible materials, including, but not lim-
(1) Company name and address. ited to paints, solvents, plastics, paper,
(2) Contact name and telephone num- and sawn wood must not be stored
ber. within a PCB Transformer enclosure
(3) Address where these transformers (i.e., in a transformer vault or in a par-
are located. For mobile sources such as titioned area housing a transformer);
ships, provide the name of the ship. within 5 meters of a transformer enclo-
(4) Number of PCB Transformers and sure, or, if unenclosed (unpartitioned),
the total weight in kilograms of PCBs within 5 meters of a PCB Transformer.
contained in the transformers. (ix) A visual inspection of each PCB
(5) Whether any transformers at this Transformer (as defined in the defini-
location contain flammable dielectric tion of ‘‘PCB Transformer’’ under
fluid (optional). § 761.3) in use or stored for reuse shall
(6) Signature of the owner, operator, be performed at least once every 3
or other authorized representative cer- months. These inspections may take
tifying the accuracy of the information place any time during the 3-month pe-
submitted. riods: January-March, April-June,
(C) A transformer owner must retain July-September, and October-Decem-
a record of each PCB Transformer’s ber as long as there is a minimum of 30
registration (e.g., a copy of the reg- days between inspections. The visual
istration and the return receipt signed inspection must include investigation
by EPA) with the inspection and main- for any leak of dielectric fluid on or
174
around the transformer. The extent of measures include, but are not limited
the visual inspections will depend on to:
the physical constraints of each trans- (A) The blocking of all floor drains in
former installation and should not re- the vicinity of the transformer.
quire an electrical shutdown of the (B) The containment of water runoff.
transformer being inspected. (C) The control and treatment (prior
(x) If a PCB Transformer is found to to release) of any water used in subse-
have a leak which results in any quan- quent cleanup operations.
tity of PCBs running off or about to (xii) Records of inspection and main-
run off the external surface of the tenance history shall be maintained at
transformer, then the transformer least 3 years after disposing of the
must be repaired or replaced to elimi- transformer and shall be made avail-
nate the source of the leak. In all cases able for inspection, upon request by
any leaking material must be cleaned EPA. Such records shall contain the
up and properly disposed of according following information for each PCB
to disposal requirements of subpart D Transformer:
of this part. Cleanup of the released (A) Its location.
PCBs must be initiated as soon as pos- (B) The date of each visual inspection
sible, but in no case later than 48 hours and the date that leak was discovered,
of its discovery. Until appropriate ac- if different from the inspection date.
tion is completed, any active leak of (C) The person performing the inspec-
PCBs must be contained to prevent ex- tion.
posure of humans or the environment (D) The location of any leak(s).
and inspected daily to verify contain-
(E) An estimate of the amount of di-
ment of the leak. Trenches, dikes,
electric fluid released from any leak.
buckets, and pans are examples of
(F) The date of any cleanup, contain-
proper containment measures.
ment, repair, or replacement.
(xi) If a PCB Transformer is involved
in a fire-related incident, the owner of (G) A description of any cleanup, con-
the transformer must immediately re- tainment, or repair performed.
port the incident to the National Re- (H) The results of any containment
sponse Center (toll-free 1–800–424–8802; and daily inspection required for un-
in Washington, DC 202–426–2675). A fire- corrected active leaks.
related incident is defined as any inci- (I) Record of the registration of PCB
dent involving a PCB Transformer Transformer(s).
which involves the generation of suffi- (J) Records of transfer of ownership
cient heat and/or pressure (by any in compliance with § 761.180(a)(2)(ix).
source) to result in the violent or non- (xiii) A reduced visual inspection fre-
violent rupture of a PCB Transformer quency of at least once every 12
and the release of PCBs. Information months applies to PCB Transformers
must be provided regarding the type of that utilize either of the following risk
PCB Transformer installation involved reduction measures. These inspections
in the fire-related incident (e.g., high may take place any time during the
or low secondary voltage network calendar year as long as there is a min-
transformer, high or low secondary imum of 180 days between inspections.
voltage simple radial system, expanded (A) A PCB Transformer which has
radial system, primary selective sys- impervious, undrained, secondary con-
tem, primary loop system, or sec- tainment capacity of at least 100 per-
ondary selective system or other sys- cent of the total dielectric fluid vol-
tems) and the readily ascertainable ume of all transformers so contained or
cause of the fire-related incident (e.g., (B) A PCB Transformer which has
high current fault in the primary or been tested and found to contain less
secondary or low current fault in sec- than 60,000 ppm PCBs (after 3 months
ondary). The owner of the PCB Trans- of in service use if the transformer has
former must also take measures as been serviced for purposes of reducing
soon as practically and safely possible the PCB concentration).
to contain and control any potential (xiv) An increased visual inspection

releases of PCBs and incomplete com- frequency of at least once every week
bustion products into water. These applies to any PCB Transformer in use
175
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
or stored for reuse which poses an ex- building, within 18 months or by Octo-
posure risk to food or feed. The user of ber 1, 1990, whichever is later. This is
a PCB Transformer posing an exposure an option in lieu of installing electrical
risk to food is responsible for the in- protective equipment on a radial or
spection, recordkeeping, and mainte- lower secondary voltage network PCB
nance requirements under this section Transformer located in other than a
until the user notifies the owner that sidewalk vault or of removing a higher
the transformer may pose an exposure secondary voltage network PCB Trans-
risk to food or feed. Following such no- former or a lower secondary voltage
tification, it is the owner’s ultimate re- network PCB Transformer, located in a
sponsibility to determine whether the sidewalk vault, from service.
PCB Transformer poses an exposure (I) Retrofill and reclassify a lower
risk to food or feed. secondary voltage network PCB Trans-
(xv) In the event a mineral oil transformer, located in a sidewalk vault, in
former, assumed to contain less than or near a commercial building within
500 ppm of PCBs as provided in § 761.2, 18 months or by October 1, 1993, which-
is tested and found to be contaminated ever is later. This is an option in lieu
at 500 ppm or greater PCBs, it will be of installing electrical protective
subject to all the requirements of this equipment or removing the trans-
part 761. In addition, efforts must be former from service.
initiated immediately to bring the (J) Retrofill and reclassify a higher
transformer into compliance in accord- secondary voltage network PCB Trans-
ance with the following schedule: former, located in a sidewalk vault, in
(A) Report fire-related incidents, ef- or near a commercial building within
fective immediately after discovery. 18 months or by October 1, 1990, which-
(B) Mark the PCB transformer within ever is later. This is an option in lieu
7 days after discovery. of other requirements.
(C) Mark the vault door, machinery (2) Servicing conditions. (i) Trans-
room door, fence, hallway or other formers classified as PCB-Contami-
means of access to the PCB Trans- nated Electrical Equipment (as defined
former within 7 days after discovery. in the definition of ‘‘PCB-Contami-
(D) Register the PCB Transformer in nated Electrical Equipment’’ under
writing with the building owner within § 761.3) may be serviced (including re-
30 days of discovery. building) only with dielectric fluid con-
(E) Install electrical protective taining less than 500 ppm PCB.
equipment on a radial PCB Trans- (ii) Any servicing (including rebuild-
former and a non-sidewalk vault, lower ing) of PCB Transformers (as defined in
secondary voltage network PCB Trans- the definition of ‘‘PCB Transformer’’
former in or near a commercial build- under § 761.3) that requires the removal
ing within 18 months of discovery or by of the transformer coil from the trans-
October 1, 1990, whichever is later. former casing is prohibited. PCB
(F) Remove a non-sidewalk vault, Transformers may be serviced (includ-
lower secondary voltage network PCB ing topping off) with dielectric fluid at
Transformer in or near a commercial any PCB concentration.
building, if electrical protective equip- (iii) PCBs removed during any serv-
ment is not installed, within 18 months icing activity must be captured and ei-
of discovery or by October 1, 1993, ther reused as dielectric fluid or dis-
whichever is later. posed of in accordance with the re-
(G) Remove a lower secondary volt- quirements of § 761.60. PCBs from PCB
age network PCB Transformer located Transformers must not be mixed with
in a sidewalk vault in or near a com- or added to dielectric fluid from PCB-
mercial building, within 18 months of Contaminated Electrical Equipment.
discovery or by October 1, 1993, which- (iv) Regardless of its PCB concentra-
ever is later. tion, dielectric fluids containing less
(H) Retrofill and reclassify a radial than 500 ppm PCB that are mixed with
PCB Transformer or a lower or higher fluids that contain 500 ppm or greater
secondary voltage network PCB Trans- PCB must not be used as dielectric
former, located in other than a side- fluid in any electrical equipment. The
walk vault in or near a commercial entire mixture of dielectric fluid must
176
be considered to be greater than 500 tion of ≥50 ppm but <500 ppm to a non-
ppm PCB and must be disposed of in an PCB transformer, as follows:
incinerator that meets the require- (A) Remove the free-flowing PCB di-
ments in § 761.70. electric fluid from the transformer.
(v) You may reclassify a PCB Trans- Flushing is not required. Either test
former that has been tested and deter- the fluid or assume it contains ≥1,000
mined to have a concentration of ≥500 ppm PCBs. Retrofill the transformer
ppm PCBs to a PCB-Contaminated with fluid containing known PCB lev-
transformer (≥50 but <500 ppm) or to a els according to the following table.
Determine the transformer’s reclassi-
non-PCB transformer (<50 ppm), and
fied status according to the following
you may reclassify a PCB-Contami-
table (if following this process does not
nated transformer that has been tested
result in the reclassified status you de-
and determined to have a concentra- sire, you may repeat the process):
If test results show the and test results show
and you retrofill the
PCB concentration the PCB concentration then the transformer’s
transformer with dielec- and you . . .
(ppm) in the transformer (ppm) after retrofill is . . reclassified status is. . .
tric fluid containing . . .
prior to retrofill is . . . .
≥1,000 (or untested) <50 ppm PCBs operate the transformer ≥50 but <500 PCB-contaminated
electrically under
loaded conditions for
at least 90-contin-
uous days after
retrofill, then test the
fluid for PCBs
<50 ppm PCBs operate the transformer <50 non-PCB

electrically under
at least 90-contin-
uous days after
fluid for PCBs
≥500 but <1,000 <50 ppm PCBs test the fluid for PCBs ≥50 but <500 PCB-contaminated
at least 90 days after
retrofill
<50 ppm PCBs test the fluid for PCBs <50 non-PCB
retrofill
≥50 but <500 ≥2 but <50 ppm PCBs test the fluid for PCBs <50 non-PCB
retrofill
<2 ppm PCBs (no need to test) (not applicable) non-PCB
(B) If you discover that the PCB con- section to come into compliance with
centration of the fluid in a reclassified the regulations applicable to PCB
transformer has changed, causing the Transformers. You also have the option
reclassified status to change, the trans- of repeating the reclassification proc-
former is regulated based on the actual ess.
concentration of the fluid. For exam- (C) The Director, National Program
ple, a transformer that was reclassified Chemicals Division, may, without fur-
to non-PCB status is regulated as a ther rulemaking, grant approval on a
PCB-Contaminated transformer if you case-by-case basis for the use of alter-
discover that the concentration of the native methods to reclassify trans-
fluid has increased to ≥50 but <500 ppm formers. You may request an approval
PCBs. If you discover that the PCB by writing to the Director, National
concentration of the fluid has risen to Program Chemicals Division (7404), En-
≥500 ppm, the transformer is regulated vironmental Protection Agency, 1200

as a PCB Transformer. Follow para- Pennsylvania Ave., NW., Washington,
graphs (a)(1)(xv)(A) through (J) of this DC 20460. Describe the equipment you
177
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
plan to reclassify, the alternative re- (vi) A PCB Transformer may be con-
classification method you plan to use, verted to a PCB-Contaminated Trans-
and test data or other evidence on the former or to a non-PCB Transformer by
effectiveness of the method. draining, refilling, and/or otherwise
(D) You must keep records of the re- servicing the railroad transformer. In
classification required by § 761.180(g). order to reclassify, the railroad trans-
(vi) Any dielectric fluid containing 50 former’s dielectric fluid must contain
ppm or greater PCB used for servicing less than 500 ppm (for conversion to
transformers must be stored in accord- PCB-Contaminated Transformer) or
ance with the storage for disposal re- less than 50 ppm PCB (for conversion to
quirements of § 761.65. a non-PCB Transformer) after a min-
(vii) Processing and distribution in imum of three months of inservice use
commerce of PCBs for purposes of serv- subsequent to the last servicing con-
icing transformers is permitted only ducted for the purpose of reducing the
for persons who are granted an exemp- PCB concentration in the transformer.
tion under TSCA 6(e)(3)(B). (c) Use in mining equipment. After
(b) Use in and servicing of railroad January 1, 1982, PCBs may be used in
transformers. PCBs may be used in mining equipment only at a concentra-
transformers in railroad locomotives or tion level of <50 ppm.
railroad self-propelled cars (‘‘railroad (d) Use in heat transfer systems. After
transformers’’) and may be processed July 1, 1984, PCBs may be used in heat
and distributed in commerce for pur- transfer systems only at a concentra-
poses of servicing these transformers in tion level of <50 ppm. Heat transfer
a manner other than a totally enclosed systems that were in operation after
manner subject to the following condi- July 1, 1984, with a concentration level
tions: of <50 ppm PCBs may be serviced to
(1) Use restrictions. After July 1, 1986, maintain a concentration level of <50
use of railroad transformers that con-
ppm PCBs. Heat transfer systems may
tain dielectric fluids with a PCB con-
only be serviced with fluids containing
centration >1,000 ppm is prohibited.
<50 ppm PCBs.
(2) Servicing restrictions. (i) If the coil
is removed from the casing of a rail- (e) Use in hydraulic systems. After
road transformer (e.g., the transformer July 1, 1984, PCBs may be used in hy-
is rebuilt), after January 1, 1982, the draulic systems only at a concentra-
railroad transformer may not be re- tion level of <50 ppm. Hydraulic sys-
filled with dielectric fluid containing a tems that were in operation after July
PCB concentration greater than 50 1, 1984, with a concentration level of
ppm; <50 ppm PCBs may be serviced to main-
(ii) After January 1, 1984, railroad tain a concentration level of <50 ppm
transformers may only be serviced PCBs. Hydraulic systems may only be
with dielectric fluid containing less serviced with fluids containing <50 ppm
than 1000 ppm PCB, except as provided PCBs.
in paragraph (b)(2)(i) of this section; (f) Use in carbonless copy paper.
(iii) Dielectric fluid may be filtered Carbonless copy paper containing PCBs
through activated carbon or otherwise may be used in a manner other than a
industrially processed for the purpose totally enclosed manner indefinitely.
of reducing the PCB concentration in (g) [Reserved]
the fluid; (h) Use in and servicing of
(iv) Any PCB dielectric fluid that is electromagnets, switches and voltage reg-
used to service PCB railroad trans- ulators. PCBs at any concentration
formers must be stored in accordance may be used in electromagnets, switch-
with the storage for disposal require- es (including sectionalizers and motor
ments of § 761.65; starters), and voltage regulators and
(v) After July 1, 1979, processing and may be used for purposes of servicing
distribution in commerce of PCBs for this equipment (including rebuilding)
purposes of servicing railroad trans- for the remainder of their useful lives,
formers is permitted only for persons subject to the following conditions:

who are granted an exemption under (1) Use conditions. (i) After October 1,
TSCA section 6(e)(3)(B). 1985, the use and storage for reuse of
178
any electromagnet which poses an ex- (as defined in the definition of ‘‘PCB-
posure risk to food or feed is prohibited Contaminated Electrical Equipment’’
if the electromagnet contains greater under § 761.3) may be serviced (includ-
than 500 ppm PCBs. ing rebuilding) only with dielectric
(ii) Use and storage for reuse of volt- fluid containing less than 500 ppm PCB.
age regulators which contain 1.36 kilo- (iii) PCBs removed during any serv-
grams (3 lbs) or more of dielectric fluid icing activity must be captured and ei-
with a PCB concentration of ≥500 ppm ther reused as dielectric fluid or dis-
are subject to the following provisions: posed of in accordance with the re-
(A) The owner of the voltage regu- quirements of § 761.60. PCBs from
lator must mark its location in accord- electromagnets switches, and voltage
ance with § 761.40. regulators with a PCB concentration of
(B) If a voltage regulator is involved at least 500 ppm must not be mixed
in a fire-related incident, the owner with or added to dielectric fluid from
must immediately report the incident PCB-Contaminated Electrical Equip-
to the National Response Center (Toll- ment.
free: 1–800–424–8802; in Washington, DC: (iv) Regardless of its PCB concentra-
202–426–2675). A fire-related incident is tion, dielectric fluids containing less
defined as any incident that involves than 500 ppm PCB that are mixed with
the generation of sufficient heat and/or fluids that contain 500 ppm or greater
pressure, by any source, to result in PCB must not be used as dielectric
the violent or non-violent rupture of fluid in any electrical equipment. The
the voltage regulator and the release of entire mixture of dielectric fluid must
PCBs. be considered to be greater than 500
(C) The owner of the voltage regu- ppm PCB and must be disposed of in an
lator must inspect it in accordance incinerator that meets the require-
with the requirements of paragraphs ments of § 761.70.
(a)(1)(ix), (a)(1)(xiii), and (a)(1)(xiv) of (v) You may reclassify an electro-
this section that apply to PCB Trans- magnet, switch, or voltage regulator
formers. that has been tested and determined to
(D) The owner of the voltage regu- have a concentration of ≥500 ppm PCBs
lator must comply with the record- to PCB-Contaminated status (≥50 but
keeping and reporting requirements at <500 ppm) or to non-PCB status (<50
§ 761.180. ppm), and you may reclassify a PCB-
(iii) The owner of a voltage regulator Contaminated electromagnet, switch,
that assumes it contains <500 ppm or voltage regulator that has been test-
PCBs as provided in § 761.2, and dis- ed and determined to have a concentra-
covers by testing that it is contami- tion of ≥50 ppm but <500 ppm to a non-
nated at ≥500 ppm PCBs, must comply PCB status, as follows:
with paragraph (h)(1)(ii)(A) of this sec- (A) Remove the free-flowing PCB di-
tion 7 days after the discovery, and electric fluid from the electromagnet,
paragraphs (h)(1)(ii)(B), (h)(1)(ii)(C), switch, or voltage regulator. Flushing
and (h)(1)(ii)(D) of this section imme- is not required. Either test the fluid or
diately upon discovery. assume it contains ≥1,000 ppm PCBs.
(2) Servicing conditions. (i) Servicing Retrofill the electromagnet, switch, or
(including rebuilding) any electro- voltage regulator with fluid containing
magnet, switch, or voltage regulator known PCB levels according to the fol-
with a PCB concentration of 500 ppm or lowing table. Determine the electro-
greater which requires the removal and magnet, switch, or voltage regulator’s
rework of the internal components is reclassified status according to the fol-
prohibited. lowing table (if following this process
(ii) Electromagnets, switches, and does not result in the reclassified sta-
voltage regulators classified as PCB- tus you desire, you may repeat the
Contaminated Electrical Equipment process):
179
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
If test results show the and test results show then the electromagnet,
and you retrofill the
PCB concentration the PCB concentration switch, or voltage regu-
equipment with dielec- and you . . .
(ppm) in the equipment (ppm) after retrofill is . . lator’s reclassified sta-
tric fluid containing . . .
prior to retrofill is . . . . tus is . . .
≥1,000 (or untested) <50 ppm PCBs operate the equipment ≥50 but <500 PCB-contaminated
electrically under
at least 90-contin-
uous days after
fluid for PCBs
<50 ppm PCBs operate the equipment <50 non-PCB

electrically under
at least 90-contin-
uous days after
fluid for PCBs
≥500 but <1,000 <50 ppm PCBs test the fluid for PCBs ≥50 but <500 PCB-contaminated
retrofill
<50 ppm PCBs test the fluid for PCBs <50 non-PCB
retrofill
≥50 but <500 ≥2 but <50 ppm PCBs test the fluid for PCBs <50 non-PCB
retrofill
<2 ppm PCBs (no need to test) (not applicable) non-PCB
(B) If you discover that the PCB con- regulators. You may request an ap-
centration of the fluid in a reclassified proval by writing to the Director, Na-
electromagnet, switch, or voltage regu- tional Program Chemicals Division
lator has changed, causing the reclassi- (7404), Environmental Protection Agen-
fied status to change, the electro- cy,1200 Pennsylvania Ave., NW., Wash-
magnet, switch, or voltage regulator is ington, DC 20460. Describe the equip-
regulated based on the actual con- ment you plan to reclassify, the alter-
centration of the fluid. For example, an native reclassification method you
electromagnet, switch, or voltage regu- plan to use, and test data or other evi-
lator that was reclassified to non-PCB dence on the effectiveness of the meth-
status is regulated as a PCB-Contami- od.
nated electromagnet, switch, or volt- (D) You must keep records of the re-
age regulator if you discover that the classification required by § 761.180(g).
concentration of the fluid has in- (vi) Any dielectric fluid containing 50
creased to ≥50 but <500 ppm PCBs. If ppm or greater PCB used for servicing
you discover that the PCB concentra- electromagnets, switches, or voltage
tion of the fluid in a voltage regulator
regulators must be stored in accord-
has risen to ≥500 ppm, follow paragraph
ance with the storage for disposal re-
(h)(1)(iii) of this section to come into
quirements of § 761.65.
compliance with the regulations appli-
cable to voltage regulators containing (vii) Processing and distribution in
≥500 ppm PCBs. You also have the op- commerce of PCBs for purposes of serv-
tion of repeating the reclassification icing electromagnets, switches or volt-
process. age regulators is permitted only for
(C) The Director, National Program persons who are granted an exemption
Chemicals Division may, without fur- under TSCA 6(e)(3)(B).
ther rulemaking, grant approval on a (i) Use and reuse of PCBs in natural
case-by-case basis for the use of alter- gas pipeline systems; use and reuse of
native methods to reclassify PCB-Contaminated natural gas pipe and
electromagnets, switches or voltage
180
appurtenances. (1)(i) PCBs are author- into the natural gas pipeline system
ized for use in natural gas pipeline sys- (e.g., pigging, decontamination, in-line
tems at concentrations <50 ppm. filtration).
(ii) PCBs are authorized for use, at (5) Repeats sampling and analysis at
concentrations ≥50 ppm, in natural gas least annually where PCBs are ≥50 ppm,
pipeline systems not owned or operated until sampling results indicate the nat-
by a seller or distributor of natural ural gas pipeline segment or compo-
gas. nent is <50 ppm PCB in two successive
(iii)(A) PCBs are authorized for use, samples with a minimum interval be-
at concentrations ≥50 ppm, in natural tween samples of 180 days.
gas pipeline systems owned or operated (6) Marks aboveground sources of
by a seller or distributor of natural PCB liquids in natural gas pipeline sys-
gas, if the owner or operator: tems with the ML Mark in accordance
(1) Submits to EPA, upon request, a with § 761.45(a), where such sources
written description of the general na- have been demonstrated through his-
ture and location of PCBs ≥50 ppm in torical data or recent sampling to con-
their natural gas pipeline system. Each tain PCBs ≥50 ppm.
written description shall be submitted (B) Owners or operators of natural
to the EPA Regional Administrator gas pipeline systems which do not in-
having jurisdiction over the segment or clude potential sources of PCB con-
component of the system (or the Direc- tamination as described in paragraph
tor, National Program Chemicals Divi- (i)(1)(iii)(A)(3) of this section con-
sion, Office of Pollution Prevention taining ≥50 ppm PCB are not subject to
and Toxics, if the system is contami- paragraphs (i)(1)(iii)(A)(2),
nated in more than one region). (i)(1)(iii)(A)(3), (i)(1)(iii)(A)(4), or
(2) Within 120 days after discovery of (i)(1)(iii)(A)(6) of this section. Owners
PCBs ≥50 ppm in natural gas pipeline or operators of these systems, however,
systems, or by December 28, 1998, must comply with the other provisions
whichever is later, characterizes the of this section (e.g., sampling of any
extent of PCB contamination by col- collected PCB liquids and record-
lecting and analyzing samples to iden- keeping).
tify the upstream and downstream end (C) The owner or operator of a nat-
points of the segment or component ural gas pipeline system must docu-
where PCBs ≥50 ppm were discovered. ment in writing all data collected and
(3) Within 120 days of characteriza- actions taken, or not taken, pursuant
tion of the extent of PCB contamina- to the authorization in paragraph
tion, or by December 28, 1998, which- (i)(1)(iii)(A) of this section. They must
ever is later, samples and analyzes all maintain the information for 3 years
potential sources of introduction of after the PCB concentration in the
PCBs into the natural gas pipeline sys- component or segment is reduced to
tem for PCBs ≥50 ppm. Potential <50 ppm, and make it available to EPA
sources include natural gas compres- upon request.
sors, natural gas scrubbers, natural gas (D) The Director, National Program
filters, and interconnects where nat- Chemicals Division, after consulting
ural gas is received upstream from the with the appropriate EPA Region(s)
most downstream sampling point may, based on a finding of no unreason-
where PCBs ≥50 ppm were detected; po- able risk, modify in writing the re-
tential sources exclude valves, drips, or quirements of paragraph (i)(1)(iii)(A) of
other small liquid condensate collec- this section, including extending any
tion points. compliance date, approving alternative
(4) Within 1 year of characterization formats for documentation, waiving
of the extent of PCB contamination, one or more requirements for a seg-
reduces all demonstrated sources of ment or component, requiring sam-
PCBs ≥50 ppm to <50 ppm, or removes pling and analysis, and requiring im-
such sources from the natural gas pipe- plementation of engineering measures
line system; or implements other engi- to reduce PCB concentrations. EPA
neering measures or methods to reduce will make such modifications based on

PCB levels to <50 ppm and to prevent the natural gas pipeline system size,
further introduction of PCBs ≥50 ppm configuration, and current operating
181
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
conditions; nature, extent or source of to extend to the next collection point

contamination; proximity of contami- downstream. Any person character-
nation to end-users; or previous sam- izing multi-phasic liquids must do so in
pling, monitoring, remedial actions or accordance with § 761.1(b)(4); if no liq-
documentation of activities taken re- uids are present, they must use stand-
garding compliance with this author- ard wipe samples in accordance with
ization or other applicable Federal, subpart M of this part.
State, or local laws and regulations. (5)(i) Any person disposing of liquids
The Director, National Program containing PCBs ≥50 ppm removed,
Chemicals Division, may defer the au- spilled, or otherwise released from a
thority described in this paragraph, natural gas pipeline system must do so
upon request, to the appropriate EPA in accordance with § 761.61(a)(5)(iv)
Region.
based on the PCB concentration at the
(E) The owner or operator of a nat-
time of removal from the system. Any
ural gas pipeline system may use his-
person disposing of materials contami-
torical data to fulfill the requirements
nated by spills or other releases of
of paragraphs (i)(1)(iii)(A)(1),
(i)(1)(iii)(A)(2) and (i)(1)(iii)(A)(3) of PCBs ≥50 ppm from a natural gas pipe-
this section. They may use documented line systems, must do so in accordance
historical actions taken to reduce PCB with §§ 761.61 or 761.79, as applicable.
concentrations in known sources; de- (ii) Any person who markets or burns
contaminate components or segments for energy recovery liquids containing
of natural gas pipeline systems; or oth- PCBs at concentrations <50 ppm PCBs
erwise to reduce PCB levels to fulfill at the time of removal from a natural
the requirements of paragraph gas pipeline system must do so in ac-
(i)(1)(iii)(A)(4) of this section. cordance with the provisions per-
(2) Any person may reuse PCB-Con- taining to used oil at § 761.20(e). No
taminated natural gas pipe and appur- other use of liquid containing PCBs at
tenances in a natural gas pipeline sys- concentrations above the quantifiable
tem, provided all free-flowing liquids level/level of detection removed from a
have been removed. natural gas pipeline system is author-
(3) Any person may use PCB-Con- ized.
taminated natural gas pipe, drained of (j) Research and development. For pur-
all free-flowing liquids, in the trans- poses of this section, authorized re-
port of liquids (e.g., bulk hydrocarbons, search and development (R&D) activi-
chemicals, petroleum products, or coal ties include, but are not limited to: the
slurry), as casing to provide secondary chemical analysis of PCBs, including
containment or protection (e.g., pro- analyses to determine PCB concentra-
tection for electrical cable), as indus- tion; determinations of the physical
trial structural material (e.g., fence properties of PCBs; studies of environ-
posts, sign posts, or bridge supports),
mental transport processes; studies of
as temporary flume at construction
biochemical transport processes; stud-
sites, as equipment skids, as culverts
ies of effects of PCBs on the environ-
under transportation systems in inter-
mittent flow situations, for sewage ment; and studies of the health effects
service with written consent of the of PCBs, including direct toxicity and
Publicly Owned Treatment Works toxicity of metabolic products of PCBs.
(POTW), for steam service, as irriga- Authorized R&D activities do not in-
tion systems (<20 inch diameter) of less clude research, development, or anal-
than 200 miles in length, and in a to- ysis for the development of any PCB
tally enclosed compressed air system. product. Any person conducting R&D
(4) Any person characterizing PCB activities under this section is also re-
contamination in natural gas pipe or sponsible for determining and com-
natural gas pipeline systems must do plying with all other applicable Fed-
so by analyzing organic liquids col- eral, State, and local laws and regula-
lected at existing condensate collec- tions. Although the use of PCBs and
tion points in the pipe or pipeline sys- PCBs in analytical reference samples
tem. The level of PCB contamination derived from waste material is author-
found at a collection point is assumed ized in conjunction with PCB-disposal
182
related activities, R&D for PCB dis- restricted-access indoor installation. A

posal (as defined under § 761.3) is ad- restricted-access electrical substation
dressed in § 761.60(j). PCBs and PCBs in is an outdoor, fenced or walled-in facil-
analytical reference samples derived ity that restricts public access and is
from waste materials are authorized used in the transmission or distribu-
for use, in a manner other than a to- tion of electric power. A contained and
tally enclosed manner, provided that: restricted-access indoor installation
(1) They obtain the PCBs and PCBs in does not have public access and has an
analytical reference samples derived adequate roof, walls, and floor to con-
from waste materials from sources au- tain any release of PCBs within the in-
thorized under § 761.80 to manufacture, door location.
process, and distribute PCBs in com- (2) [Reserved]
merce and the PCBs are packaged in (m) Use in and servicing of circuit
compliance with the Hazardous Mate- breakers, reclosers and cable. PCBs at
rials Regulations at 49 CFR parts 171 any concentration may be used in cir-
through 180. cuit breakers, reclosers, and cable and
(2) They store all PCB wastes result- may be used for purposes of servicing
ing from R&D activities (e.g., spent this electrical equipment (including re-
laboratory samples, residuals, con- building) for the remainder of their
taminated media such as clothing, etc.) useful lives, subject to the following
in compliance with § 761.65(b) and dis- conditions:
pose of all PCB wastes in compliance (1) Servicing conditions. (i) Circuit
with § 761.64. breakers, reclosers, and cable may be
(3) [Reserved] serviced (including rebuilding) only
(4) No person may manufacture, proc- with dielectric fluid containing less
ess, or distribute in commerce PCBs for than 50 ppm PCB.
research and development unless they (ii) Any circuit breaker, recloser or
have been granted an exemption to do cable found to contain at least 50 ppm
so under TSCA section 6(e)(3)(B). PCBs may be serviced only in accord-
(k) Use in scientific instruments. PCBs ance with the conditions contained in
may be used indefinitely in scientific 40 CFR 761.30(h)(2).
instruments, for example, in oscilla- (2) [Reserved]
tory flow birefringence and
(n)–(o) [Reserved]
viscoelasticity instruments for the
(p) Continued use of porous surfaces
study of the physical properties of
contaminated with PCBs regulated for
polymers, as microscopy mounting
disposal by spills of liquid PCBs. (1) Any
fluids, as microscopy immersion oil,
person may use porous surfaces con-
and as optical liquids in a manner
taminated by spills of liquid PCBs at
other than a totally enclosed manner.
concentrations >10 μg/100 cm2 for the
No person may manufacture, process,
remainder of the useful life of the sur-
or distribute in commerce PCBs for use
faces and subsurface material if the
in scientific instruments unless they
following conditions are met:
have been granted an exemption to do
so under TSCA section 6(e)(3)(B). (i) The source of PCB contamination
(l) Use in capacitors. PCBs at any con- is removed or contained to prevent fur-
centration may be used in capacitors, ther release to porous surfaces.
subject to the following conditions: (ii) If the porous surface is accessible
(1) Use conditions. (i) After October 1, to superficial surface cleaning:
1988, the use and storage for reuse of (A) The double wash rinse procedure
PCB Large High Voltage Capacitors in subpart S of this part is conducted
and PCB Large Low Voltage Capacitors on the surface to remove surface PCBs.
which pose an exposure risk to food or (B) The treated surface is allowed to
feed is prohibited. dry for 24 hours.
(ii) After October 1, 1988, the use of (iii) After accessible surfaces have
PCB Large High Voltage Capacitors been cleaned according to paragraph
and PCB Large Low Voltage Capacitors (p)(1)(ii) of this section and for all sur-
is prohibited unless the capacitor is faces inaccessible to cleanup:

used within a restricted-access elec- (A) The surface is completely covered
trical substation or in a contained and to prevent release of PCBs with:
183
§ 761.30 40 CFR Ch. I (7–1–17 Edition)
(1) Two solvent resistant and water by August 30, 1999 or within 1 year of
repellent coatings of contrasting colors the date of discovery of PCBs at ≥50
to allow for a visual indication of wear ppm in the air compressor system,
through or loss of outer coating integ- whichever is later. The EPA Regional
rity; or Administrator for the EPA Region in
(2) A solid barrier fastened to the sur- which an air compressor system is lo-
face and covering the contaminated cated may, at his/her discretion and in
area or all accessible parts of the con- writing, extend this timeframe.
taminated area. Examples of inacces- (t) Use of PCBs in other gas or liquid
sible areas are underneath a floor- transmission systems. (1) PCBs are au-
mounted electrical transformer and in thorized for use in intact and non-leak-
an impassible space between an elec- ing gas or liquid transmission systems
trical transformer and a vault wall. at concentrations <50 ppm PCBs.
(B) The surface is marked with the (2) PCBs are authorized for use at
ML Mark in a location easily visible to concentrations ≥50 ppm in intact and
individuals present in the area; the ML non-leaking gas or liquid transmission
Mark shall be placed over the encap- systems not owned or operated by a
sulated area or the barrier to the en- seller or distributor of the gas or liquid
capsulated area. transmitted in the system.
(C) ML Marks shall be replaced when (3) Any person may use PCBs at con-
worn or illegible. centrations ≥50 ppm in intact and non-
(2) Removal of a porous surface con- leaking gas or liquid transmission sys-
taminated with PCBs from its location tems, with the written approval of the
or current use is prohibited except for Director, National Program Chemicals
removal for disposal in accordance Division, subject to the requirements
with §§ 761.61 or 761.79 for surfaces con- applicable to natural gas pipeline sys-
taminated by spills, or § 761.62 for man- tems at paragraphs (i)(1)(iii)(A),
ufactured porous surfaces. (i)(1)(iii)(C) through (i)(1)(iii)(E), and
(q) [Reserved] (i)(2) through (i)(5) of this section.
(r) Use in and servicing of rectifiers. (u) Use of decontaminated materials. (1)
Any person may use PCBs at any con- Any person may use equipment, struc-
centration in rectifiers for the remain- tures, other non-liquid or liquid mate-
der of the PCBs’ useful life, and may rials that were contaminated with
use PCBs <50 ppm in servicing (includ- PCBs during manufacture, use, serv-
ing rebuilding) rectifiers. icing, or because of spills from, or prox-
(s) Use of PCBs in air compressor sys- imity to, PCBs ≥50 ppm, including
tems. (1) Any person may use PCBs in those not otherwise authorized for use
air compressor systems at concentra- under this part, provided:
tions <50 ppm. (i) The materials were decontami-
(2) Any person may use PCBs in air nated in accordance with:
compressor systems (or components (A) A TSCA PCB disposal approval
thereof) at concentrations ≥50 ppm pro- issued under subpart D of this part;
vided that: (B) Section 761.79; or
(i) All free-flowing liquids containing (C) Applicable EPA PCB spill cleanup
PCBs ≥50 ppm are removed from the air policies (e.g., TSCA, RCRA, CERCLA,
compressor crankcase and the crank- EPA regional) in effect at the time of
case is refilled with non-PCB liquid. the decontamination; or
(ii) Other air compressor system (ii) If not previously decontaminated,
components contaminated with PCBs the materials now meet an applicable
≥50 ppm, are decontaminated in accord- decontamination standard in § 761.79(b).
ance with § 761.79 or disposed of in ac- (2) No person shall use or reuse mate-
cordance with subpart D of this part. rials decontaminated in accordance
(iii) Air compressor piping with a with paragraph (u)(1)(i) of this section
nominal inside diameter of <2 inches is or meeting an applicable decontamina-
decontaminated by continuous flushing tion standard in paragraph (u)(1)(ii) of
for 4 hours, at no <300 gallons per hour this section, in direct contact with
(§ 761.79 contains solvent requirements). food, feed, or drinking water unless

(3) The requirements in paragraph otherwise allowed under this section or
(s)(2) of this section must be completed this part.
184
(3) Any person may use water con- gional Administrator at least 6 months
taining PCBs at concentrations ≤0.5μg/ before the 5-year storage for reuse pe-
L PCBs without restriction. riod expires and must include an item-
(4) Any person may use water con- by-item justification for the desired ex-
taining PCBs at concentrations <200 μg/ tension. The EPA Regional Adminis-
L (i.e., <200 ppb PCBs) for non-contact trator may include any conditions to
use in a closed system where there are such approval deemed necessary to pro-
no releases (e.g., as a non-contact cool- tect health or the environment. The
ing water). owner or operator of the PCB Article
(Sec. 6, Pub. L. 94–469, 90 Stat. 2020, 2025 (15 being stored for reuse must comply
U.S.C. 2605) with the other applicable provisions of
this part, including the record reten-
[44 FR 31542, May 31, 1979. Redesignated at 47
FR 19527, May 6, 1982]
tion requirements at § 761.180(a).
(c) Any person may store a PCB Arti-
EDITORIAL NOTE: For FEDERAL REGISTER ci- cle for reuse indefinitely in:
tations affecting § 761.30, see the List of CFR
Sections Affected, which appears in the
(1) A unit in compliance with
Finding Aids section of the printed volume § 761.65(b).
and at www.fdsys.gov. (2) A unit permitted under section
3004 of RCRA to manage hazardous
§ 761.35 Storage for reuse. wastes in containers.
(a) The owner or operator of a PCB (3) A unit permitted by a State au-
Article may store it for reuse in an thorized under section 3006 of RCRA to
area which is not designed, con- manage hazardous waste.
structed, and operated in compliance [63 FR 35443, June 29, 1998]
with § 761.65(b), for no more than 5
years after the date the Article was
originally removed from use (e.g., dis-
Subpart C—Marking of PCBs and
connected electrical equipment) or 5 PCB Items
years after August 28, 1998, whichever § 761.40 Marking requirements.
is later, if the owner or operator com-
plies with the following conditions: (a) Each of the following items in ex-
(1) Follows all use requirements at istence on or after July 1, 1978 shall be
§ 761.30 and marking requirements at marked as illustrated in Figure 1 in
subpart C of this part that are applica- § 761.45(a): The mark illustrated in Fig-
ble to the PCB Article. ure 1 is referred to as ML throughout
(2) Maintains records starting at the this subpart.
time the PCB Article is removed from (1) PCB Containers;
use or August 28, 1998. The records (2) PCB Transformers at the time of
must indicate: manufacture, at the time of distribu-
(i) The date the PCB Article was re- tion in commerce if not already
moved from use or August 28, 1998, if marked, and at the time of removal
the removal date is not known. from use if not already marked. [Mark-
(ii) The projected location and the fu- ing of PCB-Contaminated Electrical
ture use of the PCB Article. Equipment is not required];
(iii) If applicable, the date the PCB (3) PCB Large High Voltage Capaci-
Article is scheduled for repair or serv- tors at the time of manufacture, at the
icing. time of distribution in commerce if not
(b) The owner or operator of a PCB already marked, and at the time of re-
Article may store it for reuse in an moval from use if not already marked;
area that does not comply with (4) Equipment containing a PCB
§ 761.65(b) for a period longer than 5 Transformer or a PCB Large High Volt-
years, provided that the owner or oper- age Capacitor at the time of manufac-
ator has received written approval ture, at the time of distribution in
from the EPA Regional Administrator commerce if not already marked, and
for the Region in which the PCB Arti- at the time of removal of the equip-
cle is stored. An owner or operator of a ment from use if not already marked;
PCB Article seeking approval to extend (5) PCB Large Low Voltage Capaci-
the 5–year period must submit a re- tors at the time of removal from use
quest for extension to the EPA Re- (see also paragraph (k) of this section).
185
§ 761.40 40 CFR Ch. I (7–1–17 Edition)
(6) Electric motors using PCB cool- (f) Where mark ML is specified but
ants (See also paragraph (e) of this sec- the PCB Article or PCB Equipment is
tion). too small to accomodate the smallest
(7) Hydraulic systems using PCB hy- permissible size of mark ML, mark MS
draulic fluid (See also paragraph (e) of as described in § 761.45(b), may be used
this section); instead of mark ML.
(8) Heat transfer systems (other than (g) Each large low voltage capacitor,
PCB Transformers) using PCBs (See each small capacitor normally used in
also paragraph (e) of this section); alternating current circuits, and each
(9) PCB Article Containers con- fluorescent light ballast manufactured
taining articles or equipment that (‘‘manufactured’’, for purposes of this
must be marked under paragraphs (a) sentence, means built) between July 1,
(1) through (8) of this section; 1978 and July 1, 1998 that do not con-
(10) Each storage area used to store tain PCBs shall be marked by the man-
PCBs and PCB Items for disposal. ufacturer at the time of manufacture
with the statement, ‘‘No PCBs’’. The
(b) As of October 1, 1978, each trans-
mark shall be of similar durability and
port vehicle loaded with PCB Con-
readability as other marking that indi-
tainers that contain more than 45 kg
cate electrical information, part num-
(99.4 lbs.) of liquid PCBs at concentra-
bers, or the manufacturer’s name. For
tions of ≥50 ppm or with one or more
purposes of this paragraph marking re-
PCB Transformers shall be marked on
quirement only is applicable to items
each end and each side with the ML
built domestically or abroad after June
mark as described in § 761.45(a).
30, 1978.
(c) As of January 1, 1979, the fol-
(h) All marks required by this sub-
lowing PCB Articles shall be marked
part must be placed in a position on
with mark ML as described in
the exterior of the PCB Items, storage
§ 761.45(a):
units, or transport vehicles so that the
(1) All PCB Transformers not marked marks can be easily read by any per-
under paragraph (a) of this section sons inspecting or servicing the
[marking of PCB-Contaminated Elec- marked PCB Items, storage units, or
trical Equipment is not required]; transport vehicles.
(2) All PCB Large High Voltage Ca- (i) Any chemical substance or mix-
pacitors not marked under paragraph ture that is manufactured after the ef-
(a) of this section fective date of this rule and that con-
(i) Will be marked individually with tains less than 500 ppm PCB (0.05% on
mark ML, or a dry weight basis), including PCB that
(ii) If one or more PCB Large High is a byproduct or impurity, must be
Voltage Capacitors are installed in a marked in accordance with any re-
protected location such as on a power quirements contained in the exemption
pole, or structure, or behind a fence; granted by EPA to permit such manu-
the pole, structure, or fence shall be facture and is not subject to any other
marked with mark ML, and a record or requirement in this subpart unless so
procedure identifying the PCB Capaci- specified in the exemption. This para-
tors shall be maintained by the owner graph applies only to containers of
or operator at the protected location. chemical substances or mixtures. PCB
(d) As of January 1, 1979, all PCB articles and equipment into which the
Equipment containing a PCB Small Ca- chemical substances or mixtures are
pacitor shall be marked at the time of processed, are subject to the marking
manufacture with the statement, ‘‘This requirements contained elsewhere in
equipment contains PCB Capacitor(s)’’. this subpart.
The mark shall be of the same size as (j) PCB Transformer locations shall
the mark ML. be marked as follows:
(e) As of October 1, 1979, applicable (1) Except as provided in paragraph
PCB Items in paragraphs (a)(1), (a)(6), (j)(2) of this section, as of December 1,
(a)(7), and (a)(8) of this section con- 1985, the vault door, machinery room
taining PCBs in concentrations of 50 to door, fence, hallway, or means of ac-

500 ppm shall be marked with the ML cess, other than grates and manhole
mark as described in § 761.45(a). covers, to a PCB Transformer must be
186
marked with the mark ML as required need not be marked individually, pro-
by paragraph (a) of this section. vided the owner or operator marks the
(2) A mark other than the ML mark equipment in accordance with para-
may be used provided all of the fol- graph (k)(2) of this section, and marks
lowing conditions are met: the individual capacitors at the time of
(i) The program using such an alter- removal from use in accordance with
native mark was initiated prior to Au- paragraph (a) of this section.
gust 15, 1985, and can be substantiated (2) All equipment not marked under
with documentation. paragraph (a) of this section containing
(ii) Prior to August 15, 1985, coordina- a PCB Transformer or a PCB Large
tion between the transformer owner High or Low Voltage Capacitor.
and the primary fire department oc- (l)(1) All voltage regulators which
curred, and the primary fire depart- contain 1.36 kilograms (3 lbs.) or more
ment knows, accepts, and recognizes of dielectric fluid with a PCB con-
what the alternative mark means, and centration of ≥500 ppm must be marked
that this can be substantiated with individually with the ML mark as de-
documentation. scribed in § 761.45(a).
(iii) The EPA Regional Adminis- (2) Locations of voltage regulators
trator in the appropriate region is in- which contain 1.36 kilograms (3 lbs.) or
formed in writing of the use of the al- more of dielectric fluid with a PCB
ternative mark by October 3, 1988 and concentration of ≥500 ppm shall be
is provided with documentation that marked as follows: The vault door, ma-
the program began before August 15, chinery room door, fence, hallway, or
1985, and documentation that dem- means of access, other than grates or
onstrates that prior to that date the manhole covers, must be marked with
primary fire department knew, accept- the ML mark as described in § 761.45(a).
ed and recognized the meaning of the [44 FR 31542, May 31, 1979. Redesignated at 47
mark, and included this information in FR 19527, May 6, 1982, and amended at 47 FR
firefighting training. 37359, Aug. 25, 1982; 50 FR 29201, July 17, 1985;
(iv) The Regional Administrator will 50 FR 32176, Aug. 9, 1985; 53 FR 12524, Apr. 15,
either approve or disapprove in writing 1988; 53 FR 27329, July 19, 1988; 63 FR 35443,
the use of an alternative mark within June 29, 1998; 64 FR 33760, June 24, 1999]
30 days of receipt of the documentation
of a program. § 761.45 Marking formats.
(3) Any mark placed in accordance The following formats shall be used
with the requirements of this section for marking:
must be placed in the locations de- (a) Large PCB Mark—ML. Mark ML
scribed in paragraph (j)(1) of this sec- shall be as shown in Figure 1, letters
tion and in a manner that can be easily and striping on a white or yellow back-
read by emergency response personnel ground and shall be sufficiently dura-
fighting a fire involving this equip- ble to equal or exceed the life (includ-
ment. ing storage for disposal) of the PCB Ar-
(k) As of April 26, 1999 the following ticle, PCB Equipment, or PCB Con-
PCB Items shall be marked with the tainer. The size of the mark shall be at
ML mark as described in § 761.45(a): least 15.25 cm (6 inches) on each side. If
(1) All PCB Large Low Voltage Ca- the PCB Article or PCB Equipment is
pacitors not marked under paragraph too small to accommodate this size,
(a) of this section shall be marked indi- the mark may be reduced in size pro-
vidually, or if one or more PCB Large portionately down to a minimum of 5
Low Voltage Capacitors are installed cm (2 inches) on each side.
in a protected location such as on a (b) Small PCB Mark—Ms. Mark Ms
power pole, or structure, or behind a shall be as shown in Figure 2, letters
fence, then the owner or operator shall and striping on a white or yellow back-
mark the pole, structure, or fence with ground, and shall be sufficiently dura-
the ML mark, and maintain a record or ble to equal or exceed the life (includ-
procedure identifying the PCB Capaci- ing storage for disposal) of the PCB Ar-
tors at the protected location. PCB ticle, PCB Equipment, or PCB Con-
Large Low Voltage Capacitors in inac- tainer. The mark shall be a rectangle
cessible locations inside equipment 2.5 by 5 cm (1 inch by 2 inches). If the
187
§ 761.50 40 CFR Ch. I (7–1–17 Edition)
PCB Article or PCB Equipment is too to navigable waters unless the PCB
small to accommodate this size, the concentration is <3 μg/L (approxi-
mark may be reduced in size propor- mately 3 ppb), or unless the discharge
tionately down to a minimum of 1 by 2 is in accordance with a PCB discharge
cm (.4 by .8 inches). limit included in a permit issued under
section 307(b) or 402 of the Clean Water
Act.
(4) Spills and other uncontrolled dis-
charges of PCBs at concentrations of
≥50 ppm constitute the disposal of
PCBs.
(5) Any person land disposing of non-
liquid PCBs may avoid otherwise-appli-
cable sampling requirements by pre-
suming that the PCBs disposed of are
≥500 ppm (or ≥100 μg/100 cm2 if no free-
flowing liquids are present).
(6) Any person storing or disposing of
PCBs is also responsible for deter-
mining and complying with all other
applicable Federal, State, and local
laws and regulations.
(b) PCB waste—(1) PCB liquids. Any
person removing PCB liquids from use
(i.e., not PCB remediation waste) must
dispose of them in accordance with
§ 761.60(a), or decontaminate them in
accordance with § 761.79.
(2) PCB Items. Any person removing
from use a PCB Item containing an in-
tact and non-leaking PCB Article must
dispose of it in accordance with
§ 761.60(b), or decontaminate it in ac-
cordance with § 761.79. PCB Items where
the PCB Articles are no longer intact
and non-leaking are regulated for dis-
[44 FR 31542, May 31, 1979. Redesignated at 47 posal as PCB bulk product waste under
FR 19527, May 6, 1982] § 761.62(a) or (c).
(i) Fluorescent light ballasts con-
Subpart D—Storage and Disposal taining PCBs only in an intact and
non-leaking PCB Small Capacitor are
§ 761.50 Applicability. regulated for disposal under
(a) General PCB disposal requirements. § 761.60(b)(2)(ii).
Any person storing or disposing of PCB (ii) Fluorescent light ballasts con-
waste must do so in accordance with taining PCBs in the potting material
subpart D of this part. The following are regulated for disposal as PCB bulk
prohibitions and conditions apply to all product waste under § 761.62.
PCB waste storage and disposal: (3) PCB remediation waste. PCB reme-
(1) No person may open burn PCBs. diation waste, including PCB sewage
Combustion of PCBs approved under sludge, is regulated for cleanup and dis-
§ 761.60 (a) or (e), or otherwise allowed posal in accordance with § 761.61.
under part 761, is not open burning. (i) Any person responsible for PCB
(2) No person may process liquid waste at as-found concentrations ≥50
PCBs into non-liquid forms to cir- ppm that was either placed in a land
cumvent the high temperature inciner- disposal facility, spilled, or otherwise
ation requirements of § 761.60(a). released into the environment prior to
(3) No person may discharge water April 18, 1978, regardless of the con-
containing PCBs to a treatment works centration of the spill or release; or
(as defined § 503.9(aa) of this chapter) or placed in a land disposal facility,
188
EC01AP92.000</GPH>
spilled, or otherwise released into the (ii) Any person responsible for PCB
environment on or after April 18, 1978, waste at as-found concentrations ≥50
but prior to July 2, 1979, where the con- ppm that was either placed in a land
centration of the spill or release was disposal facility, spilled, or otherwise
≥50 ppm but <500 ppm, must dispose of released into the environment on or
the waste as follows: after April 18, 1978, but prior to July 2,
(A) Sites containing these wastes are 1979, where the concentration of the
presumed not to present an unreason- spill or release was ≥500 ppm; or placed
able risk of injury to health or the en- in a land disposal facility, spilled, or
vironment from exposure to PCBs at otherwise released into the environ-
the site. However, the EPA Regional ment on or after July 2, 1979, where the
Administrator may inform the owner concentration of the spill or release
or operator of the site that there is was ≥50 ppm, must dispose of it in ac-
reason to believe that spills, leaks, or cordance with either of the following:
other uncontrolled releases or dis- (A) In accordance with the PCB Spill
charges, such as leaching, from the site Cleanup Policy (Policy) at subpart G of
constitute ongoing disposal that may this part, for those PCB remediation
present an unreasonable risk of injury wastes that meet the criteria of the
Policy. Consult the Policy for a de-
to health or the environment from ex-
scription of the spills it covers and its
posure to PCBs at the site, and may re-
notification and timing requirements.
quire the owner or operator to generate
(B) In accordance with § 761.61. Com-
data necessary to characterize the risk.
plete compliance with § 761.61 does not
If after reviewing any such data, the
create a presumption against enforce-
EPA Regional Administrator makes a
ment action for penalties for any unau-
finding, that an unreasonable risk ex-
thorized PCB disposal.
ists, then he or she may direct the (iii) The owner or operator of a site
owner or operator of the site to dispose containing PCB remediation waste has
of the PCB remediation waste in ac- the burden of proving the date that the
cordance with § 761.61 such that an un- waste was placed in a land disposal fa-
reasonable risk of injury no longer ex- cility, spilled, or otherwise released
ists. into the environment, and the con-
(B) Unless directed by the EPA Re- centration of the original spill.
gional Administrator to dispose of PCB (4) PCB bulk product waste—(i) Gen-
waste in accordance with paragraph eral. Any person disposing of PCB bulk
(b)(3)(i)(A) of this section, any person product waste must do so in accord-
responsible for PCB waste at as-found ance with § 761.62. PCB bulk product
concentrations ≥50 ppm that was either waste, as that term is defined in § 761.3,
placed in a land disposal facility, is waste that was ≥50 ppm when origi-
spilled, or otherwise released into the nally removed from service, even if its
environment prior to April 18, 1978, recurrent PCB concentration is <50 ppm.
gardless of the concentration of the PCB bulk product waste is regulated
spill or release; or placed in a land dis- for disposal based on the risk from the
posal facility, spilled, or otherwise re- waste once disposed of. For waste
leased into the environment on or after which is land disposed, the waste is
April 18, 1978, but prior to July 2, 1979, regulated based on how readily the
where the concentration of the spill or waste is released from disposal to the
release was ≥50 ppm but <500 ppm, who environment, in particular by leaching
unilaterally decides to dispose of that out from the land disposal unit.
waste (for example, to obtain insurance (ii) Metal surfaces in contact with
or to sell the property), is not required PCBs. Any person disposing of metal
to clean up in accordance with § 761.61. surfaces in contact with PCBs (e.g.,
Disposal of the PCB remediation waste painted metal) may use thermal decon-
must comply with § 761.61. However, tamination procedures in accordance
cleanup of those wastes that is not in with § 761.79(c)(6) (see § 761.62(a)(6)).
complete compliance with § 761.61 will (5) PCB household waste. Any person
not afford the responsible party with storing or disposing of PCB household
relief from the applicable PCB regula- waste, as that term is defined in § 761.3,
tions for that waste. must do so in accordance with § 761.63.
189
§ 761.60 40 CFR Ch. I (7–1–17 Edition)
(6) PCB research and development as underground metal fuel tanks coat-
waste. Any person disposing of PCB ed with fire retardant resin or pitch,
wastes generated during and as a result for purposes of unrestricted use or dis-
of research and development for use posal in a smelter in accordance with
under § 761.30(j), or for disposal under § 761.79(b)(3).
§ 761.60(j), must do so in accordance (c) Storage for disposal. Any person
with § 761.64. who holds PCB waste must store it in
(7) PCB/Radioactive waste. (i) Any per- accordance with § 761.65.
son storing PCB/radioactive waste ≥50 (d) Performance specifications for dis-
ppm PCBs must do so taking into ac- posal technologies—(1) Incinerators. Any
count both its PCB concentration and person using an incinerator to dispose
its radioactive properties, except as of PCBs must use an incinerator that
provided in § 761.65(a)(1), (b)(1)(ii), and meets the criteria set forth in § 761.70.
(c)(6)(i). (2) High efficiency boilers. Any person
(ii) Any person disposing of PCB/ra- using a high efficiency boiler to dispose
dioactive waste must do so taking into of PCBs must use a boiler that meets
account both its PCB concentration the criteria set forth in § 761.71.
and its radioactive properties. If, tak- (3) Scrap metal recovery ovens and
ing into account only the properties of smelters. Any person using scrap metal
the PCBs in the waste (and not the ra- recovery ovens and smelters to dispose
dioactive properties of the waste), the of PCBs must use a device that meets
waste meets the requirements for dis- the criteria set forth in § 761.72.
posal in a facility permitted, licensed, (4) Chemical waste landfills. Any per-
or registered by a State as a municipal son using a chemical waste landfill to
or non-municipal non-hazardous waste dispose of PCBs must use a chemical
landfill (e.g., PCB bulk product waste waste landfill that meets the criteria
under § 761.62(b)(1)), then the person set forth in § 761.75.
may dispose of the PCB/radioactive (e) TSCA PCB Coordinated Approval.
waste, without regard to the PCB com- Any person seeking a TSCA PCB Co-
ponent of the waste, on the basis of its ordinated Approval must follow the
radioactive properties in accordance procedures set forth in § 761.77.
with all applicable requirements for [63 FR 35444, June 29, 1998, as amended at 64
the radioactive component of the FR 33760, June 24, 1999]
waste.
(8) Porous surfaces. In most cases a § 761.60 Disposal requirements.
person must dispose of porous surfaces (a) PCB liquids. PCB liquids at con-
as materials where PCBs have pene- centrations ≥50 ppm must be disposed
trated far beneath the surface, rather of in an incinerator which complies
than a simple surface contamination. with § 761.70, except that PCB liquids at
Any person disposing of porous sur- concentrations ≥50 ppm and <500 ppm
faces on which PCBs have been spilled may be disposed of as follows:
and meeting the definition of PCB re- (1) For mineral oil dielectric fluid, in
mediation waste at § 761.3 must do so in a high efficiency boiler according to
accordance with § 761.61. Any person § 761.71(a).
disposing of porous surfaces which are (2) For liquids other than mineral oil
part of manufactured non-liquid prod- dielectric fluid, in a high efficiency
ucts containing PCBs and meeting the boiler according to § 761.71(b).
definition of PCB bulk product waste (3) For liquids from incidental
at § 761.3 must do so in accordance with sources, such as precipitation, con-
§ 761.62. Any person may decontaminate densation, leachate or load separation
concrete surfaces upon which PCBs and are associated with PCB Articles
have been spilled in accordance with or non-liquid PCB wastes, in a chem-
§ 761.79(b)(4), if the decontamination ical waste landfill which complies with
procedure is commenced within 72 § 761.75 if:
hours of the initial spill of PCBs to the (i) [Reserved]
concrete or portion thereof being de- (ii) Information is provided to or ob-
contaminated. Any person may decon- tained by the owner or operator of the
taminate porous non-liquid PCBs in chemical waste landfill that shows that
contact with non-porous surfaces, such the liquids do not exceed 500 ppm PCB
190
and are not an ignitable waste as de- (iv) Any person who manufactures or
scribed in § 761.75(b)(8)(iii). at any time manufactured PCB Capaci-
(b) PCB Articles. This paragraph does tors or PCB Equipment, and acquired
not authorize disposal that is other- the PCB Capacitor in the course of
wise prohibited in § 761.20 or elsewhere such manufacturing, shall place the
in this part. PCB Small Capacitors in a container
(1) Transformers. (i) PCB Trans- meeting the DOT packaging require-
formers shall be disposed of in accord- ments at 49 CFR parts 171 through 180
ance with either of the following: and dispose of them in accordance with
(A) In an incinerator that complies either of the following:
with § 761.70; or (A) Disposal in an incinerator which
(B) In a chemical waste landfill ap- complies with § 761.70; or
proved under § 761.75; provided that all (B) Until March 1, 1981, disposal in a
free-flowing liquid is removed from the chemical waste landfill which complies
transformer, the transformer is filled with § 761.75.
with a solvent, the transformer is al- (v) Notwithstanding the restrictions
lowed to stand for at least 18 contin- imposed by paragraph (b)(2)(iii)(B) or
uous hours, and then the solvent is (b)(2)(iv)(B) of this section, PCB capaci-
thoroughly removed. Any person dis- tors may be disposed of in PCB chem-
posing of PCB liquids that are removed ical waste landfills that comply with
from the transformer (including the di- § 761.75 subsequent to March 1, 1981, if
electric fluid and all solvents used as a EPA publishes a notice in the FEDERAL
flush), shall do so in an incinerator REGISTER declaring that those landfills
that complies with § 761.70 of this part, are available for such disposal and ex-
or shall decontaminate them in accord- plaining the reasons for the extension
ance with § 761.79. Solvents may include or reopening. An extension or reopen-
kerosene, xylene, toluene, and other ing for disposal of PCB capacitors that
solvents in which PCBs are readily is granted under this subsection shall
soluble. Any person disposing of these be subject to such terms and conditions
PCB liquids must ensure that the sol- as the Assistant Administrator may
vent flushing procedure is conducted in prescribe and shall be in effect for such
accordance with applicable safety and period as the Assistant Administrator
health standards as required by Fed- may prescribe. EPA may permit dis-
eral or State regulations. posal of PCB capacitors in EPA-ap-
(ii) [Reserved] proved chemical waste landfills after
(2) PCB Capacitors. (i) The disposal of March 1, 1981, if in its opinion,
any capacitor shall comply with all re- (A) Adequate incineration capability
quirements of this subpart unless it is for PCB capacitors is not available, or
known from label or nameplate infor-
(B) The incineration of PCB capaci-
mation, manufacturer’s literature (in-
tors will significantly interfere with
cluding documented communications
the incineration of liquid PCBs, or
with the manufacturer), or chemical
analysis that the capacitor does not (C) There is other good cause shown.
contain PCBs. As part of this evaluation, the Assist-
(ii) Any person may dispose of PCB ant Administrator will consider the
Small Capacitors as municipal solid impact of his action on the incentives
waste, unless that person is subject to to construct or expand PCB inciner-
the requirements of paragraph (b)(2)(iv) ators.
of this section. (vi) Any person disposing of large
(iii) Any PCB Large High or Low PCB capacitors or small PCB capaci-
Voltage Capacitor which contains 500 tors described in paragraph (b)(2)(iv) of
ppm or greater PCBs, owned by any this section in a chemical waste land-
person, shall be disposed of in accord- fill approved under § 761.75, shall first
ance with either of the following: place them in a container meeting the
(A) Disposal in an incinerator that DOT packaging requirements at 49 CFR
complies with § 761.70; or parts 171 through 180. In all cases, the
(B) Until March 1, 1981, disposal in a person must fill the interstitial space
chemical waste landfill that complies in the container with sufficient absorb-
with § 761.75. ent material (such as soil) to absorb
191
§ 761.60 40 CFR Ch. I (7–1–17 Edition)
any liquid PCBs remaining in the ca- (i) Abandonment. Natural gas pipe
pacitors. containing ≥50 ppm PCBs may be aban-
(3) PCB hydraulic machines. (i) Any doned in place under one or more of the
person disposing of PCB hydraulic ma- following provisions:
chines containing PCBs at concentra- (A) Natural gas pipe having a nomi-
tions of ≥50 ppm, such as die casting nal inside diameter of ≤4 inches, and
machines, shall do so by one of the fol- containing PCBs at any concentration
lowing methods: but no free-flowing liquids, may be
(A) In accordance with § 761.79. abandoned in the place it was used to
(B) In a facility which is permitted, transport natural gas if each end is
licensed, or registered by a State to sealed closed and the pipe is either:
manage municipal solid waste subject (1) Included in a public service notifi-
to part 258 of this chapter or non-mu- cation program, such as a ‘‘one-call’’
nicipal non-hazardous waste subject to system under 49 CFR 192.614(a) and (b).
§§ 257.5 through 257.30 of this chapter, as (2) Filled to 50 percent or more of the
applicable (excluding thermal treat- volume of the pipe with grout (such as
ment units). a hardening slurry consisting of ce-
(C) In a scrap metal recovery oven or ment, bentonite, or clay) or high den-
smelter operating in compliance with sity polyurethane foam.
§ 761.72.
(B) PCB-Contaminated natural gas
(D) In a disposal facility approved
pipe of any diameter, where the PCB
under this part.
concentration was determined after the
(ii) All free-flowing liquid must be re-
last transmission of gas through the
moved from each machine and the liq-
uid must be disposed of in accordance pipe or at the time of abandonment,
with the provisions of paragraph (a) of that contains no free-flowing liquids
this section. If the PCB liquid contains may be abandoned in the place it was
≥1,000 ppm PCB, then the hydraulic ma- used to transport natural gas if each
chine must be decontaminated in ac- end is sealed closed.
cordance with § 761.79 or flushed prior (C) Natural gas pipe of any diameter
to disposal with a solvent listed at which contains PCBs at any concentra-
paragraph (b)(1)(i)(B) of this section tion but no free-flowing liquids, may be
which contains <50 ppm PCB. The sol- abandoned in the place it was used to
vent must be disposed of in accordance transport natural gas, if each end is
with paragraph (a) of this section or sealed closed, and either:
§ 761.79. (1) The interior surface is decontami-
(4) PCB-Contaminated Electrical Equip- nated with one or more washes of a sol-
ment. Any person disposing of PCB- vent in accordance with the use and
Contaminated Electrical Equipment, disposal requirements of § 761.79(d).
except capacitors, shall do so in ac- This decontamination process must re-
cordance with paragraph (b)(6)(ii)(A) of sult in a recovery of 95 percent of the
this section. Any person disposing of solvent volume introduced into the
Large Capacitors that contain ≥50 ppm system, and the PCB concentration of
but <500 ppm PCBs shall do so in a dis- the recovered wash must be <50 ppm
posal facility approved under this part. (see § 761.79(a)(1) for requirements on
(5) Natural gas pipeline systems con- use and disposal of decontaminating
taining PCBs. The owner or operator of fluids).
natural gas pipeline systems con- (2) The pipe is filled to 50 percent or
taining ≥50 ppm PCBs, when no longer more of the volume of the pipe with
in use, shall dispose of the system ei- grout (such as a hardening slurry-like
ther by abandonment in place of the cement, bentonite, or clay) or high
pipe under paragraph (b)(5)(i) of this density polyurethane foam (except that
section or removal with subsequent ac- only cement shall be used as grout
tion under paragraph (b)(5)(ii) of this under rivers or streams) and each end
section. Any person determining the is sealed closed.
PCB concentrations in natural gas (D) Natural gas pipe of any diameter
pipeline systems shall do so in accord- which contains PCBs at any concentra-

ance with paragraph (b)(5)(iii) of this tion may be abandoned in place after
section. decontamination in accordance with
192
§ 761.79(c)(3), (c)(4) or (h) or a PCB dis- this part. Collect condensate within 72
posal approval issued under § 761.60(e) hours of the final transmission of nat-
or § 761.61(c). ural gas through the part of the system
(ii) Removal with subsequent action. to be abandoned or removed. Collect
Natural gas pipeline systems may be wipe samples after the last trans-
disposed of under one of the following mission of gas through the pipe or dur-
provisions: ing removal from the location it was
(A) The following classifications of used to transport natural gas.
natural gas pipe containing no free- (B) PCB concentration of the organic
flowing liquids may be disposed of in a phase of multi-phasic liquids shall be
facility permitted, licensed, or reg- determined in accordance with
istered by a State to manage municipal § 761.1(b)(4).
solid waste subject to part 258 of this (iv) Disposal of pipeline liquids. (A)
chapter or non-municipal non-haz- Any person disposing of liquids con-
ardous waste subject to §§ 257.5 through taining PCBs ≥50 ppm removed, spilled,
257.30 of this chapter, as applicable (ex- or otherwise released from a natural
cluding thermal treatment units); a gas pipeline system must do so in ac-
scrap metal recovery oven or smelter cordance with § 761.61(a)(5)(iv) based on
operating in compliance with the re- the PCB concentration at the time of
quirements of § 761.72; or a disposal fa- removal from the system. Any person
cility approved under this part: disposing of material contaminated by
(1) PCB-Contaminated natural gas spills or other releases of PCBs ≥50 ppm
pipe of any diameter where the PCB from a natural gas pipeline system,
concentration was determined after the must do so in accordance with § 761.61
last transmission of gas through the or § 761.79, as applicable.
pipe or during removal from the loca- (B) Any person who markets or burns
tion it was used to transport natural for energy recovery liquid containing
gas. PCBs at concentrations <50 ppm PCBs
(2) Natural gas pipe containing PCBs at the time of removal from a natural
at any concentration and having a gas pipeline system must do so in ac-
nominal inside diameter ≤4 inches. cordance with the provisions per-
(B) Any component of a natural gas taining to used oil at § 761.20(e). No
pipeline system may be disposed of other use of liquid containing PCBs at
under one of the following provisions: concentrations above the quantifiable
(1) In an incinerator operating in level/level of detection removed from a
compliance with § 761.70. natural gas pipeline system is author-
(2) In a chemical waste landfill oper- ized.
ating in compliance with § 761.75, pro- (6) Other PCB Articles. (i) PCB articles
vided that all free-flowing liquid PCBs with concentrations at 500 ppm or
have been thoroughly drained. greater must be disposed of:
(3) As a PCB remediation waste in (A) In an incinerator that complies
compliance with § 761.61. with § 761.70; or
(4) In accordance with § 761.79. (B) In a chemical waste landfill that
(iii) Characterization of natural gas complies with § 761.75, provided that all
pipeline systems by PCB concentration in free-flowing liquid PCBs have been
condensate. (A) Any person disposing of thoroughly drained from any articles
a natural gas pipeline system under before the articles are placed in the
paragraphs (b)(5)(i)(B) or (b)(5)(ii)(A)(1) chemical waste landfill and that the
of this section must characterize it for drained liquids are disposed of in an in-
PCB contamination by analyzing or- cinerator that complies with § 761.70.
ganic liquids collected at existing con- (ii)(A) Except as specifically provided
densate collection points in the natural in paragraphs (b)(1) through (b)(5) of
gas pipeline system. The level of PCB this section, any person disposing of a
contamination found at a collection PCB-Contaminated Article must do so
point is assumed to extend to the next by removing all free-flowing liquid
collection point downstream. If no or- from the article, disposing of the liquid
ganic liquids are present, drain free- in accordance with paragraph (a) of
flowing liquids and collect standard this section, and disposing of the PCB-
wipe samples according to subpart M of Contaminated Article with no free-
193
§ 761.60 40 CFR Ch. I (7–1–17 Edition)
flowing liquid by one of the following PCB Container shall first be drained
methods: and the PCB liquid disposed of in ac-
(1) In accordance with § 761.79. cordance with paragraph (a) of this sec-
(2) In a facility permitted, licensed, tion.
or registered by a State to manage mu- (2) Any PCB Container used to con-
nicipal solid waste subject to part 258 tain only PCBs at a concentration less
of this chapter or non-municipal non- than 500 ppm shall be disposed of as
hazardous waste subject to §§ 257.5 municipal solid wastes; provided that if
through 257.30 of this chapter, as appli- the PCBs are in a liquid state, the PCB
cable (excluding thermal treatment Container shall first be drained and the
units). PCB liquid shall be disposed of in ac-
(3) In a scrap metal recovery oven or cordance with paragraph (a) of this sec-
smelter operating in compliance with tion.
§ 761.72. (3) Prior to disposal, a PCB container
(4) In a disposal facility approved with PCB concentrations at 50 ppm or
under this part. greater shall be stored in a unit which
(B) Storage for disposal of PCB-Con- complies with § 761.65.
taminated Articles from which all free- (d) [Reserved]
flowing liquids have been removed is (e) Any person who is required to in-
not regulated under subpart D of this cinerate any PCBs and PCB items
part. under this subpart and who can dem-
(C) Requirements in subparts J and K onstrate that an alternative method of
of this part do not apply to PCB-Con- destroying PCBs and PCB items exists
taminated Articles from which all free- and that this alternative method can
flowing liquids have been removed. achieve a level of performance equiva-
(iii) Fluorescent light ballasts con- lent to an incinerator approved under
taining PCBs in their potting material § 761.70 or a high efficiency boiler oper-
must be disposed of in a TSCA-ap- ating in compliance with § 761.71, must
proved disposal facility, as bulk prod- submit a written request to the Re-
uct waste under § 761.62, as household gional Administrator or the Director,
waste under § 761.63 (where applicable), Office of Resource Conservation and
or in accordance with the decon- Recovery, for a waiver from the incin-
tamination provisions of § 761.79. eration requirements of § 761.70 or
(7) Storage of PCB Articles. Except for § 761.71. Requests for approval of alter-
a PCB Article described in paragraph nate methods that will be operated in
(b)(2)(ii) of this section and hydraulic more than one Region must be sub-
machines that comply with the munic- mitted to the Director, Office of Re-
ipal solid waste disposal provisions de- source Conservation and Recovery, ex-
scribed in paragraph (b)(3) of this sec- cept for research and development ac-
tion, any PCB Article, with PCB con- tivities involving less than 500 pounds
centrations at 50 ppm or greater, shall of PCB material (see paragraph (i)(2) of
be stored in accordance with § 761.65 this section). Requests for approval of
prior to disposal. alternate methods that will be oper-
(8) Persons disposing of PCB Articles ated in only one Region must be sub-
must wear or use protective clothing or mitted to the appropriate EPA Re-
equipment to protect against dermal gional Administrator. The applicant
contact with or inhalation of PCBs or must show that his or her method of
materials containing PCBs. destroying PCBs will not present an
(c) PCB Containers. (1) Unless decon- unreasonable risk of injury to health
taminated in compliance with § 761.79 or the environment. On the basis of
or as provided in paragraph (c)(2) of such information and any available in-
this section, a PCB container with PCB formation, EPA may, in its discretion,
concentrations at 500 ppm or greater approve the use of the alternate meth-
shall be disposed of: od if it finds that the alternate disposal
(i) In an incinerator which complies method provides PCB destruction
with § 761.70, or equivalent to disposal in a § 761.60 in-
(ii) In a chemical waste landfill that cinerator or a § 761.61 high efficiency

complies with § 761.75; provided that if boiler and will not present an unrea-
there are PCBs in a liquid state, the sonable risk of injury to health or the
194
environment. Any approval must be circuit breakers, reclosers, or cable is

stated in writing and may include such collected in a common container with
conditions and provisions as EPA dielectric fluid from other oil-filled
deems appropriate. The person to electrical equipment, the entire con-
whom such waiver is issued must com- tents of the container must be treated
ply with all limitations contained in as PCBs at a concentration of at least
such determination. No person may use 50 ppm, unless all of the fluid from the
the alternate method of destroying other oil-filled electrical equipment
PCBs or PCB items prior to obtaining has been tested and shown to contain
permission from the appropriate EPA less than 50 ppm PCBs.
official. (ii) For purposes of complying with
(f)(1) Each operator of a chemical the marking and disposal require-
waste landfill, incinerator, or alter- ments, representative samples may be
native to incineration approved under taken from either the common con-
paragraph (e) of this section shall give tainers or the individual electrical
the following written notices to the equipment to determine the PCB con-
state and local governments within centration, except that if any PCBs at
whose jurisdiction the disposal facility a concentration of 500 ppm or greater
is located: have been added to the container or
(i) Notice at least thirty (30) days be- equipment then the total container
fore a facility is first used for disposal contents must be considered as having
of PCBs required by these regulations; a PCB concentration of 500 ppm or
and
greater for purposes of complying with
(ii) At the request of any state or
the disposal requirements of this sub-
local government, annual notice of the
part. For purposes of this subpara-
quantities and general description of
graph, representative samples of min-
PCBs disposed of during the year. This
eral oil dielectric fluid are either sam-
annual notice shall be given no more
ples taken in accordance with ASTM D
than thirty (30) days after the end of
923–86 or ASTM D 923–89 or samples
the year covered.
taken from a container that has been
(iii) The Regional Administrator may
thoroughly mixed in a manner such
reduce the notice period required by
that any PCBs in the container are
paragraph (f)(1)(i) of this section from
thirty days to a period of no less than uniformly distributed throughout the
five days in order to expedite interim liquid in the container.
approval of the chemical waste landfill (iii) Unless otherwise specified in this
located in Sedgwick County, Kansas. part, any person conducting the chem-
(2) [Reserved] ical analysis of PCBs shall do so using
(g) Testing procedures. (1) Owners or gas chromatography. Any gas
users of mineral oil dielectric fluid chromatographic method that is appro-
electrical equipment may use the fol- priate for the material being analyzed
lowing procedures to determine the may be used, including EPA Method
concentration of PCBs in the dielectric 608, ‘‘Organochlorine Pesticides and
fluid: PCBs’’ at 40 CFR part 136, Appendix
(i) Dielectric fluid removed from A;’’ EPA Method 8082, ‘‘Poly-
mineral oil dielectric fluid electrical chlorinated Biphenyls (PCBs) by Cap-
equipment may be collected in a com- illary Column Gas Chromatography’’ of
mon container, provided that no other SW-846, ‘‘OSW Test Methods for Evalu-
chemical substances or mixtures are ating Solid Waste,’’ which is available
added to the container. This common from NTIS; and ASTM Standard D-4059,
container option does not permit dilu- ‘‘Standard Test Method for Analysis of
tion of the collected oil. Mineral oil Polychlorinated Biphenyls in Insu-
that is assumed or known to contain at lating Liquids by Gas Chroma-
least 50 ppm PCBs must not be mixed tography,’’ which is available from
with mineral oil that is known or as- ASTM.
sumed to contain less than 50 ppm (2) Owners or users of waste oil may
PCBs to reduce the concentration of use the following procedures to deter-

PCBs in the common container. If di- mine the PCB concentration of waste
electric fluid from untested, oil-filled oil:
195
§ 761.60 40 CFR Ch. I (7–1–17 Edition)
(i) Waste oil from more than one centration) will be reviewed and ap-
source may be collected in a common proved by the EPA Regional Adminis-
container, provided that no other trator for the Region where the R&D
chemical substances or mixtures, such will be conducted, and R&D for PCB
as non-waste oils, are added to the con- disposal using 500 pounds or more of
tainer. PCB material (regardless of PCB con-
(ii) For purposes of complying with centration) will be reviewed and ap-
the marking and disposal require- proved by the EPA.
ments, representative samples may be (j) Self-implementing requirements for
taken from either the common con- research and development (R&D) for PCB
tainers or the individual electrical disposal. (1) Any person may conduct
equipment to determine the PCB con- R&D for PCB disposal without prior
centration. Except, That if any PCBs at
written approval from EPA if they
a concentration of 500 ppm or greater
meet the following conditions:
have been added to the container or
equipment then the total container (i) File a notification and obtain an
contents must be considered as having EPA identification number pursuant to
a PCB concentration of 500 ppm or subpart K of this part.
greater for purposes of complying with (ii) Notify in writing the EPA Re-
the disposal requirements of this sub- gional Administrator, the State envi-
part. For purposes of this paragraph, ronmental protection agency, and local
representative samples of mineral oil environmental protection agency, hav-
dielectric fluid are either samples ing jurisdiction where the R&D for
taken in accordance with ASTM D 923– PCB disposal activity will occur at
86 or ASTM D 923–89 or samples taken least 30 days prior to the commence-
from a container that has been thor- ment of any R&D for PCB disposal ac-
oughly mixed in a manner such that tivity conducted under this section.
any PCBs in the container are uni- Each written notification shall include
formly distributed throughout the liq- the EPA identification number of the
uid in the container. site where the R&D for PCB disposal
(iii) Unless otherwise specified in this activities will be conducted, the quan-
part, any person conducting the chem- tity of PCBs to be treated, the type of
ical analysis of PCBs shall do so using R&D technology to be used, the general
gas chromatography. Any gas physical and chemical properties of
chromatographic method that is appro- material being treated, and an esti-
priate for the material being analyzed mate of the duration of the PCB activ-
may be used, including those indicated ity. The EPA Regional Administrator,
in paragraph (g)(1)(iii) of this section. the State environmental protection
(h) Requirements for export and im- agency, and the local environmental
port of PCBs and PCB Items for dis- protection agency may waive notifica-
posal are found in subpart F of this tion in writing prior to commencement
part. of the research.
(i) Approval authority for disposal
(iii) The amount of material con-
methods. (1) The officials designated in
taining PCBs treated annually by the
paragraph (e) of this section and
facility during R&D for PCB disposal
§ 761.70(a) and (b) to receive requests for
activities does not exceed 500 gallons or
approval of PCB disposal activities are
70 cubic feet of liquid or non-liquid
the primary approval authorities for
these activities. Notwithstanding, EPA PCBs and does not exceed a maximum
may, at its discretion, assign the au- concentration of 10,000 ppm PCBs.
thority to review and approve any as- (iv) No more than 1 kilogram total of
pect of a disposal system to the Office pure PCBs per year is disposed of in all
of Land and Emergency Management R&D for PCB disposal activities at a
or to a Regional Administrator. facility.
(2) Except for activity authorized (v) Each R&D for PCB disposal activ-
under paragraph (j) of this section, re- ity under this section lasts no more
search and development (R&D) for PCB than 1 calendar year.

disposal using a total of <500 pounds of (vi) Store all PCB wastes (treated
PCB material (regardless of PCB con- and untreated PCB materials, testing
196
samples, spent laboratory samples, re- the maximum concentration of PCBs,

siduals, untreated samples, contami- the total amount of pure PCBs, or the
nated media or instrumentation, cloth- duration of the R&D activity. Approv-
ing, etc.) in compliance with § 761.65(b) als will state all requirements applica-
and dispose of them according to the ble to the R&D for PCB disposal activ-
undiluted PCB concentration prior to ity.
treatment. However, PCB materials (3) The EPA Regional Administrator
not treated in the R&D for PCB dis- for the Region in which an R&D for
posal activity may be returned either PCB disposal activity is conducted may
to the physical location where the sam- determine, at any time, that an R&D
ples were collected or a location where PCB disposal approval is required
other regulated PCBs from the physical under paragraphs (e) and (i)(2) of this
location where the samples were col- section or § 761.70(d) to ensure that any
lected are being stored for disposal. R&D for PCB disposal activity does not
(vii) Use manifests pursuant to sub- present an unreasonable risk of injury
part K of this part for all R&D PCB to health or the environment.
wastes being transported from the R&D
facility to an approved PCB storage or (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
disposal facility. However, §§ 761.207 2605)
through 761.219 do not apply if the re- [44 FR 31542, May 31, 1979]
siduals or treated samples are returned
either to the physical location where EDITORIAL NOTE: For FEDERAL REGISTER ci-
tations affecting § 761.60, see the List of CFR
the samples were collected or a loca-
Sections Affected, which appears in the
tion where other regulated PCBs from Finding Aids section of the printed volume
the physical location where the sam- and at www.fdsys.gov.
ples were collected are being stored for
disposal. § 761.61 PCB remediation waste.
(viii) Package and ship all PCB
wastes pursuant to DOT requirements This section provides cleanup and
under 49 CFR parts 171 through 180. disposal options for PCB remediation
(ix) Comply with the recordkeeping waste. Any person cleaning up and dis-
requirements of § 761.180. posing of PCBs managed under this sec-
(2) Do not exceed material limitation shall do so based on the concentra-
tions set out in paragraphs (j)(1) (iii) tion at which the PCBs are found. This
and (iv) of this section and the time section does not prohibit any person
limitation set out in paragraph (j)(1)(v) from implementing temporary emer-
of this section without prior written gency measures to prevent, treat, or
approval from EPA. Requests for ap- contain further releases or mitigate
proval to exceed the material limita- migration to the environment of PCBs
tions for PCBs in R&D for PCB disposal or PCB remediation waste.
activities as specified in this section (a) Self-implementing on-site cleanup
must be submitted in writing to the and disposal of PCB remediation waste.
EPA Regional Administrator for the EPA designed the self-implementing
Region in which the facility con- procedure for a general, moderately-
ducting R&D for PCB disposal activi- sized site where there should be low re-
ties is located. Each request shall sidual environmental impact from re-
specify the quantity or concentration medial activities. The procedure may
requested or additional time needed for be less practical for larger or environ-
disposal and include a justification for mentally diverse sites. For these other
each increase. For extensions to the sites, the self-implementing procedure
duration of the R&D for PCB disposal still applies, but an EPA Regional Ad-
activity, the request shall also include ministrator may authorize more prac-
a report on the accomplishments and tical procedures through paragraph (c)
progress of the previously authorized of this section. Any person may con-
R&D for PCB disposal activity for duct self-implementing cleanup and
which the extension is sought. The disposal of PCB remediation waste in
EPA Regional Administrator may accordance with the following require-

grant a waiver in writing for an in- ments without prior written approval
crease in the volume of PCB material, from EPA.
197
§ 761.61 40 CFR Ch. I (7–1–17 Edition)
(1) Applicability. (i) The self-imple- from all previous characterization ac-
menting procedures may not be used to tivities at the cleanup site.
clean up: (C) The location and extent of the
(A) Surface or ground waters. identified contaminated area, includ-
(B) Sediments in marine and fresh- ing topographic maps with sample col-
water ecosystems. lection sites cross referenced to the
(C) Sewers or sewage treatment sys- sample identification numbers in the
tems. data summary from paragraph
(D) Any private or public drinking (a)(3)(i)(B) of this section.
water sources or distribution systems. (D) A cleanup plan for the site, in-
(E) Grazing lands. cluding schedule, disposal technology,
(F) Vegetable gardens. and approach. This plan should contain
(ii) The self-implementing cleanup options and contingencies to be used if
provisions shall not be binding upon unanticipated higher concentrations or
cleanups conducted under other au- wider distributions of PCB remediation
thorities, including but not limited to, waste are found or other obstacles
actions conducted under section 104 or force changes in the cleanup approach.
section 106 of CERCLA, or section (E) A written certification, signed by
3004(u) and (v) or section 3008(h) of the owner of the property where the
RCRA. cleanup site is located and the party
(2) Site characterization. Any person conducting the cleanup, that all sam-
conducting self-implementing cleanup pling plans, sample collection proce-
of PCB remediation waste must charac- dures, sample preparation procedures,
terize the site adequately to be able to extraction procedures, and instru-
provide the information required by mental/chemical analysis procedures
paragraph (a)(3) of this section. Sub- used to assess or characterize the PCB
part N of this part provides a method contamination at the cleanup site, are
for collecting new site characterization on file at the location designated in the
data or for assessing the sufficiency of certificate, and are available for EPA
existing site characterization data. inspection. Persons using alternate
(3) Notification and certification. (i) At methods for chemical extraction and
least 30 days prior to the date that the chemical analysis for site characteriza-
cleanup of a site begins, the person in tion must include in the certificate a
charge of the cleanup or the owner of statement that such a method will be
the property where the PCB remedi- used and that a comparison study
ation waste is located shall notify, in which meets or exceeds the require-
writing, the EPA Regional Adminis- ments of subpart Q of this part, and for
trator, the Director of the State or which records are on file, has been
Tribal environmental protection agen- completed prior to verification sam-
cy, and the Director of the county or pling.
local environmental protection agency (ii) Within 30 calendar days of receiv-
where the cleanup will be conducted. ing the notification, the EPA Regional
The notice shall include: Administrator will respond in writing
(A) The nature of the contamination, approving of the self-implementing
including kinds of materials contami- cleanup, disapproving of the self-imple-
nated. menting cleanup, or requiring addi-
(B) A summary of the procedures tional information. If the EPA Re-
used to sample contaminated and adja- gional Administrator does not respond
cent areas and a table or cleanup site within 30 calendar days of receiving the
map showing PCB concentrations notice, the person submitting the noti-
measured in all pre-cleanup character- fication may assume that it is com-
ization samples. The summary must in- plete and acceptable and proceed with
clude sample collection and analysis the cleanup according to the informa-
dates. The EPA Regional Adminis- tion the person provided to the EPA
trator may require more detailed infor- Regional Administrator. Once cleanup
mation including, but not limited to, is underway, the person conducting the
additional characterization sampling cleanup must provide any proposed
or all sample identification numbers changes from the notification to the
198
EPA Regional Administrator in writ- (2) Bulk PCB remediation wastes

ing no less than 14 calendar days prior may remain at a cleanup site at con-
to the proposed implementation of the centrations >25 ppm and ≤50 ppm if the
change. The EPA Regional Adminis- site is secured by a fence and marked
trator will determine in his or her dis- with a sign including the ML mark.
cretion whether to accept the change, (3) Bulk PCB remediation wastes
and will respond to the change notifi- may remain at a cleanup site at con-
cation verbally within 7 calendar days centrations >25 ppm and ≤100 ppm if
and in writing within 14 calendar days the site is covered with a cap meeting
of receiving it. If the EPA Regional Ad- the requirements of paragraphs (a)(7)
ministrator does not respond verbally and (a)(8) of this section.
within 7 calendar days and in writing
(ii) Non-porous surfaces. In high occu-
within 14 calendar days of receiving the
pancy areas, the surface PCB cleanup
change notice, the person who sub-
standard is ≤10 μg/100 cm2 of surface
mitted it may deem it complete and
acceptable and proceed with the clean- area. In low occupancy areas, the sur-
up according to the information in the face cleanup standard is <100 μg/100 cm2
change notice provided to the EPA Re- of surface area. Select sampling loca-
gional Administrator. tions in accordance with subpart P of
(iii) Any person conducting a cleanup this part or a sampling plan approved
activity may obtain a waiver of the 30- under paragraph (c) of this section.
day notification requirement, if they (iii) Porous surfaces. In both high and
receive a separate waiver, in writing, low occupancy areas, any person dis-
from each of the agencies they are re- posing of porous surfaces must do so
quired to notify under this section. The based on the levels in paragraph
person must retain the original written (a)(4)(i) of this section. Porous surfaces
waiver as required in paragraph (a)(9) may be cleaned up for use in accord-
of this section. ance with § 761.79(b)(4) or § 761.30(p).
(4) Cleanup levels. For purposes of (iv) Liquids. In both high and low oc-
cleaning, decontaminating, or remov- cupancy areas, cleanup levels are the
ing PCB remediation waste under this concentrations specified in § 761.79(b)(1)
section, there are four general waste and (b)(2).
categories: bulk PCB remediation (v) Change in the land use for a clean-
waste, non-porous surfaces, porous sur- up site. Where there is an actual or pro-
faces, and liquids. Cleanup levels are posed change in use of an area cleaned
based on the kind of material and the up to the levels of a low occupancy
potential exposure to PCBs left after area, and the exposure of people or ani-
cleanup is completed.
mal life in or at that area could reason-
(i) Bulk PCB remediation waste. Bulk
ably be expected to increase, resulting
PCB remediation waste includes, but is
in a change in status from a low occu-
not limited to, the following non-liquid
pancy area to a high occupancy area,
PCB remediation waste: soil, sedi-
ments, dredged materials, muds, PCB the owner of the area shall clean up the
sewage sludge, and industrial sludge. area in accordance with the high occu-
(A) High occupancy areas. The cleanup pancy area cleanup levels in para-
level for bulk PCB remediation waste graphs (a)(4)(i) through (a)(4)(iv) of this
in high occupancy areas is ≤1 ppm section.
without further conditions. High occu- (vi) The EPA Regional Adminis-
pancy areas where bulk PCB remedi- trator, as part of his or her response to
ation waste remains at concentrations a notification submitted in accordance
>1 ppm and ≤10 ppm shall be covered with § 761.61(a)(3) of this part, may re-
with a cap meeting the requirements of quire cleanup of the site, or portions of
paragraphs (a)(7) and (a)(8) of this sec- it, to more stringent cleanup levels
tion. than are otherwise required in this sec-
(B) Low occupancy areas. (1) The tion, based on the proximity to areas
cleanup level for bulk PCB remediation such as residential dwellings, hospitals,
waste in low occupancy areas is ≤25 schools, nursing homes, playgrounds,

ppm unless otherwise specified in this parks, day care centers, endangered
paragraph. species habitats, estuaries, wetlands,
199
§ 761.61 40 CFR Ch. I (7–1–17 Edition)
national parks, national wildlife ref- (iii) Bulk PCB remediation wastes
uges, commercial fisheries, and sport with a PCB concentration ≥50 ppm
fisheries. shall be disposed of in a hazardous
(5) Site cleanup. In addition to the op- waste landfill permitted by EPA under
tions set out in this paragraph, PCB section 3004 of RCRA, or by a State au-
disposal technologies approved under thorized under section 3006 of RCRA, or
§§ 761.60 and 761.70 are acceptable for a PCB disposal facility approved under
on-site self-implementing PCB remedi- this part.
ation waste disposal within the con- (iv) The generator must provide writ-
fines of the operating conditions of the ten notice, including the quantity to be
respective approvals. shipped and highest concentration of
(i) Bulk PCB remediation waste. Any PCBs (using extraction EPA Method
person cleaning up bulk PCB remedi- 3500B/3540C or Method 3500B/3550B fol-
ation waste shall do so to the levels in lowed by chemical analysis using EPA
paragraph (a)(4)(i) of this section.
Method 8082 in SW-846 or methods vali-
(A) Any person cleaning up bulk PCB
dated under subpart Q of this part) at
remediation waste on-site using a soil
least 15 days before the first shipment
washing process may do so without
of bulk PCB remediation waste from
EPA approval, subject to all of the fol-
each cleanup site by the generator, to
lowing:
(1) A non-chlorinated solvent is used. each off-site facility where the waste is
(2) The process occurs at ambient destined for an area not subject to a
temperature. TSCA PCB Disposal Approval.
(3) The process is not exothermic. (3) Any person may decontaminate
(4) The process uses no external heat. bulk PCB remediation waste in accord-
(5) The process has secondary con- ance with § 761.79 and return the waste
tainment to prevent any solvent from to the cleanup site for disposal as long
being released to the underlying or sur- as the cleanup standards of paragraph
rounding soils or surface waters. (a)(4) of this section are met.
(6) Solvent disposal, recovery, and/or (ii) Non-porous surfaces. PCB remedi-
reuse is in accordance with relevant ation waste non-porous surfaces shall
provisions of approvals issued accord- be cleaned on-site or off-site for dis-
ing to paragraphs (b)(1) or (c) of this posal on-site, disposal off-site, or use,
section or applicable paragraphs of as follows:
§ 761.79. (A) For on-site disposal, non-porous
(B) Bulk PCB remediation waste may surfaces shall be cleaned on-site or off-
be sent off-site for decontamination or site to the levels in paragraph (a)(4)(ii)
disposal in accordance with this para- of this section using:
graph, provided the waste is either (1) Procedures approved under
dewatered on-site or transported off- § 761.79.
site in containers meeting the require- (2) Technologies approved under
ments of the DOT Hazardous Materials § 761.60(e).
Regulations (HMR) at 49 CFR parts 171
(3) Procedures or technologies ap-
through 180.
proved under paragraph (c) of this sec-
(1) Removed water shall be disposed
tion.
of according to paragraph (b)(1) of this
section. (B) For off-site disposal, non-porous
(2) Any person disposing off-site of surfaces:
dewatered bulk PCB remediation waste (1) Having surface concentrations
shall do so as follows: <100 μg/100 cm2 shall be disposed of in
(i) Unless sampled and analyzed for accordance with paragraph
disposal according to the procedures (a)(5)(i)(B)(2)(ii) of this section. Metal
set out in §§ 761.283, 761.286, and 761.292, surfaces may be thermally decontami-
the bulk PCB remediation waste shall nated in accordance with
be assumed to contain ≥50 ppm PCBs. § 761.79(c)(6)(i).
(ii) Bulk PCB remediation wastes (2) Having surface concentrations
with a PCB concentration of <50 ppm ≥100 μg/100 cm2 shall be disposed of in
shall be disposed of in accordance with accordance with paragraph
paragraph (a)(5)(v)(A) of this section. (a)(5)(i)(B)(2)(iii) of this section. Metal
200
surfaces may be thermally decontami- (6) Cleanup verification—(i) Sampling

nated in accordance with and analysis. Any person collecting and
§ 761.79(c)(6)(ii). analyzing samples to verify the clean-
(C) For use, non-porous surfaces shall up and on-site disposal of bulk PCB re-
be decontaminated on-site or off-site to mediation wastes and porous surfaces
the standards specified in § 761.79(b)(3) must do so in accordance with subpart
or in accordance with § 761.79(c). O of this part. Any person collecting
(iii) Porous surfaces. Porous surfaces and analyzing samples from non-porous
shall be disposed on-site or off-site as surfaces must do so in accordance with
bulk PCB remediation waste according subpart P of this part. Any person col-
to paragraph (a)(5)(i) of this section or lecting and analyzing samples from liq-
decontaminated for use according to uids must do so in accordance with
§ 761.79(b)(4), as applicable. § 761.269. Any person conducting in-
(iv) Liquids. Any person disposing of terim sampling during PCB remedi-
liquid PCB remediation waste shall ei- ation waste cleanup to determine when
ther: to sample to verify that cleanup is
(A) Decontaminate the waste to the complete, may use PCB field screening
levels specified in § 761.79(b)(1) or (b)(2). tests.
(ii) Verification. (A) Where sample
(B) Dispose of the waste in accord-
analysis results in a measurement of
ance with paragraph (b) of this section
PCBs less than or equal to the levels
or an approval issued under paragraph
specified in paragraph (a)(4) of this sec-
(c) of this section.
tion, self-implementing cleanup is
(v) Cleanup wastes. Any person gener-
complete.
ating the following wastes during and
(B) Where sample analysis results in
from the cleanup of PCB remediation
a measurement of PCBs greater than
waste shall dispose of or reuse them
the levels specified in paragraph (a)(4)
using one of the following methods:
of this section, self-implementing
(A) Non-liquid cleaning materials cleanup of the sampled PCB remedi-
and personal protective equipment ation waste is not complete. The owner
waste at any concentration, including or operator of the site must either dis-
non-porous surfaces and other non-liq- pose of the sampled PCB remediation
uid materials such as rags, gloves, boo- waste, or reclean the waste represented
ties, other disposable personal protec- by the sample and reinitiate sampling
tive equipment, and similar materials and analysis in accordance with para-
resulting from cleanup activities shall graph (a)(6)(i) of this section.
be either decontaminated in accord- (7) Cap requirements. A cap means,
ance with § 761.79(b) or (c), or disposed when referring to on-site cleanup and
of in one of the following facilities, disposal of PCB remediation waste, a
without regard to the requirements of uniform placement of concrete, as-
subparts J and K of this part: phalt, or similar material of minimum
(1) A facility permitted, licensed, or thickness spread over the area where
registered by a State to manage munic- remediation waste was removed or left
ipal solid waste subject to part 258 of in place in order to prevent or mini-
this chapter. mize human exposure, infiltration of
(2) A facility permitted, licensed, or water, and erosion. Any person design-
registered by a State to manage non- ing and constructing a cap must do so
municipal non-hazardous waste subject in accordance with § 264.310(a) of this
to §§ 257.5 through 257.30 of this chapter, chapter, and ensure that it complies
as applicable. with the permeability, sieve, liquid
(3) A hazardous waste landfill per- limit, and plasticity index parameters
mitted by EPA under section 3004 of in § 761.75(b)(1)(ii) through (b)(1)(v). A
RCRA, or by a State authorized under cap of compacted soil shall have a min-
section 3006 of RCRA. imum thickness of 25 cm (10 inches). A
(4) A PCB disposal facility approved concrete or asphalt cap shall have a
under this part. minimum thickness of 15 cm (6 inches).
(B) Cleaning solvents, abrasives, and A cap must be of sufficient strength to

equipment may be reused after decon- maintain its effectiveness and integ-
tamination in accordance with § 761.79. rity during the use of the cap surface
201
§ 761.61 40 CFR Ch. I (7–1–17 Edition)
which is exposed to the environment. A (b) Performance-based disposal. (1) Any

cap shall not be contaminated at a person disposing of liquid PCB remedi-
level ≥1 ppm PCB per Aroclor TM (or ation waste shall do so according to
equivalent) or per congener. Repairs § 761.60(a) or (e), or decontaminate it in
shall begin within 72 hours of discovery accordance with § 761.79.
for any breaches which would impair (2) Any person disposing of non-liquid
the integrity of the cap. PCB remediation waste shall do so by
(8) Deed restrictions for caps, fences one of the following methods:
and low occupancy areas. When a clean- (i) Dispose of it in a high tempera-
up activity conducted under this sec- ture incinerator approved under
tion includes the use of a fence or a § 761.70(b), an alternate disposal method
cap, the owner of the site must main- approved under § 761.60(e), a chemical
tain the fence or cap, in perpetuity. In waste landfill approved under § 761.75,
addition, whenever a cap, or the proce- or in a facility with a coordinated ap-
dures and requirements for a low occu- proval issued under § 761.77.
pancy area, is used, the owner of the (ii) Decontaminate it in accordance
site must meet the following condi- with § 761.79.
tions: (3) Any person may manage or dis-
(i) Within 60 days of completion of a pose of material containing <50 ppm
cleanup activity under this section, the PCBs that has been dredged or exca-
owner of the property shall: vated from waters of the United States:
(A) Record, in accordance with State (i) In accordance with a permit that
law, a notation on the deed to the prop- has been issued under section 404 of the
erty, or on some other instrument Clean Water Act, or the equivalent of
which is normally examined during a such a permit as provided for in regula-
title search, that will in perpetuity no- tions of the U.S. Army Corps of Engi-
tify any potential purchaser of the neers at 33 CFR part 320.
property: (ii) In accordance with a permit
(1) That the land has been used for issued by the U.S. Army Corps of Engi-
PCB remediation waste disposal and is neers under section 103 of the Marine
restricted to use as a low occupancy Protection, Research, and Sanctuaries
area as defined in § 761.3. Act, or the equivalent of such a permit
(2) Of the existence of the fence or as provided for in regulations of the
cap and the requirement to maintain U.S. Army Corps of Engineers at 33
the fence or cap. CFR part 320.
(3) The applicable cleanup levels left (c) Risk-based disposal approval. (1)
at the site, inside the fence, and/or Any person wishing to sample, cleanup,
under the cap. or dispose of PCB remediation waste in
(B) Submit a certification, signed by a manner other than prescribed in
the owner, that he/she has recorded the paragraphs (a) or (b) of this section, or
notation specified in paragraph store PCB remediation waste in a man-
(a)(8)(i)(A) of this section to the EPA ner other than prescribed in § 761.65,
Regional Administrator. must apply in writing to the Regional
(ii) The owner of a site being cleaned Administrator in the Region where the
up under this section may remove a sampling, cleanup, disposal, or storage
fence or cap after conducting addi- site is located, for sampling, cleanup,
tional cleanup activities and achieving disposal, or storage occurring in a sin-
cleanup levels, specified in paragraph gle EPA Region; or to the Director, Of-
(a)(4) of this section, which do not re- fice of Resource Conservation and Re-
quire a cap or fence. The owner may recovery, for sampling, cleanup, disposal,
move the notice on the deed no earlier or storage occurring in more than one
than 30 days after achieving the clean- EPA Region. Each application must in-
up levels specified in this section which clude information described in the no-
do not require a fence or cap. tification required by paragraph (a)(3)
(9) Recordkeeping. For paragraphs of this section. EPA may request other
(a)(3), (a)(4), and (a)(5) of this section, information that it believes necessary
recordkeeping is required in accord- to evaluate the application. No person
ance with § 761.125(c)(5). may conduct cleanup activities under
202
this paragraph prior to obtaining writ- and computer casings; vehicle parts; or
ten approval by EPA. furniture laminates); preformed or
(2) EPA will issue a written decision molded rubber parts and components;
on each application for a risk-based applied dried paints, varnishes, waxes
method for PCB remediation wastes. or other similar coatings or sealants;
EPA will approve such an application if caulking; Galbestos; non-liquid build-
it finds that the method will not pose ing demolition debris; or non-liquid
an unreasonable risk of injury to PCB bulk product waste from the
health or the environment. shredding of automobiles or household
[63 FR 35448, June 29, 1998, as amended at 64 appliances from which PCB small ca-
FR 33761, June 24, 1999; 72 FR 57239, Oct. 9, pacitors have been removed (shredder
2007; 74 FR 30232, June 25, 2009] fluff).
(ii) Other PCB bulk product waste,
§ 761.62 Disposal of PCB bulk product sampled in accordance with the proto-
waste. cols set out in subpart R of this part,
PCB bulk product waste shall be dis- that leaches PCBs at <10 μg/L of water
posed of in accordance with paragraph measured using a procedure used to
(a), (b), or (c) of this section. Under simulate leachate generation.
some of these provisions, it may not be (2) Any person may dispose of PCB
necessary to determine the PCB con- bulk product waste other than those
centration or leaching characteristics materials meeting the conditions of
of the PCB bulk product waste. When it paragraph (b)(1) of this section, (e.g.,
is necessary to analyze the waste to paper or felt gaskets contaminated by
make either of these determinations, liquid PCBs in a facility that is per-
use the applicable procedures in submitted, licensed, or registered by a
part R of this part to sample the waste State to manage municipal solid waste
for analysis, unless EPA approves an- subject to part 258 of this chapter or
other sampling plan under paragraph non-municipal non-hazardous waste
(c) of this section. subject to §§ 257.5 through 257.30 of this
(a) Performance-based disposal. Any chapter, as applicable, if:
person disposing of PCB bulk product
(i) The PCB bulk product waste is
waste may do so as follows:
segregated from organic liquids dis-
(1) In an incinerator approved under
posed of in the landfill unit.
§ 761.70.
(2) In a chemical waste landfill ap- (ii) Leachate is collected from the
proved under § 761.75. landfill unit and monitored for PCBs.
(3) In a hazardous waste landfill per- (3) Any release of PCBs (including
mitted by EPA under section 3004 of but not limited to leachate) from the
RCRA, or by a State authorized under landfill unit shall be cleaned up in ac-
section 3006 of RCRA. cordance with § 761.61.
(4) Under an alternate disposal ap- (4)(i) Any person disposing off-site of
proval under § 761.60(e). PCB bulk product waste regulated
(5) In accordance with the decon- under paragraph (b)(1) of this section
tamination provisions of § 761.79. at a waste management facility not
(6) For metal surfaces in contact having a commercial PCB storage or
with PCBs, in accordance with the disposal approval must provide written
thermal decontamination provisions of notice to the facility a minimum of 15
§ 761.79(c)(6). days in advance of the first shipment
(7) In accordance with a TSCA PCB from the same disposal waste stream.
Coordinated Approval issued under The notice shall state that the PCB
§ 761.77. bulk product waste may include com-
(b) Disposal in solid waste landfills. (1) ponents containing PCBs at ≥50 ppm
Any person may dispose of the fol- based on analysis of the waste in the
lowing PCB bulk product waste in a fa- shipment or application of a general
cility permitted, licensed, or registered knowledge of the waste stream (or
by a State as a municipal or non-mu- similar material) which is known to
nicipal non-hazardous waste landfill: contain PCBs at those levels, and that
(i) Plastics (such as plastic insulation the PCB bulk product waste is known
from wire or cable; radio, television or presumed to leach <10 μg/L PCBs.
203
§ 761.63 40 CFR Ch. I (7–1–17 Edition)
(ii) Any person disposing off-site of pling, disposal, or storage activities

PCB bulk product waste regulated under this paragraph prior to obtaining
under paragraph (b)(2) of this section written approval by EPA.
at a waste management facility not (2) EPA will issue a written decision
having a commercial PCB storage or on each application for a risk-based
disposal approval must provide written sampling, disposal, or storage method
notice to the facility a minimum of 15 for PCB bulk product wastes. EPA will
days in advance of the first shipment approve such an application if it finds
from the same disposal waste stream that the method will not pose an un-
and with each shipment thereafter. The reasonable risk of injury to health or
notice shall state that the PCB bulk the environment.
product waste may include components (d) Disposal as daily landfill cover or
containing PCBs at ≥50 ppm based on roadbed. Bulk product waste described
analysis of the waste in the shipment in paragraph (b)(1) of this section may
or application of a general knowledge be disposed of:
of the waste stream (or similar mate- (1) As daily landfill cover as long as
rial) which is known to contain PCBs the daily cover remains in the landfill
at those levels, and that the PCB bulk and is not released or dispersed by wind
product waste is known or presumed to or other action; or
leach ≥10 μg/L PCBs. (2) Under asphalt as part of a road
(5) Any person disposing of PCB bulk bed.
product waste must maintain a written [63 FR 35451, June 29, 1998, as amended at 64
record of all sampling and analysis of FR 33761, June 24, 1999; 72 FR 57239, Oct. 9,
PCBs or notifications made under this 2007; 74 FR 30232, June 25, 2009]
paragraph for 3 years from the date of
the waste’s generation. The records § 761.63 PCB household waste storage
must be made available to EPA upon and disposal.
request. PCB household waste, as defined at
(6) Requirements in subparts C, J, § 761.3, managed in a facility permitted,
and K of this part do not apply to licensed, or registered by a State to
waste disposed of under paragraph (b) manage municipal or industrial solid
of this section. waste, or in a facility with an approval
(c) Risk-based disposal approval. (1) to dispose of PCB bulk product waste
Any person wishing to sample or dis- under § 761.62(c), is not subject to any
pose of PCB bulk product waste in a other requirements of part 761 of this
manner other than prescribed in para- chapter. PCB household waste stored in
graphs (a) or (b) of this section, or a unit regulated for storage of PCB
store PCB bulk product waste in a waste must not be commingled with
manner other than prescribed in PCB waste.
§ 761.65, must apply in writing to the [63 FR 35452, June 29, 1998]
Regional Administrator in the Region
where the sampling, disposal, or stor- § 761.64 Disposal of wastes generated
age site is located, for sampling, dis- as a result of research and develop-
posal, or storage occurring in a single ment activities authorized under
EPA Region; or to the Director, Office § 761.30(j) and chemical analysis of
of Resource Conservation and Recov- PCBs.
ery, for sampling, disposal, or storage This section provides disposal re-
occurring in more than one EPA Re- quirements for wastes generated during
gion. Each application must contain and as a result of research and develop-
information indicating that, based on ment authorized under § 761.30(j). This
technical, environmental, or waste-spe- section also provides disposal require-
cific characteristics or considerations, ments for wastes generated during the
the proposed sampling, disposal, or chemical analysis of samples con-
storage methods or locations will not taining PCBs under part 761, including
pose an unreasonable risk or injury to §§ 761.30, 761.60, 761.61, 761.62, and 761.79.
health or the environment. EPA may For determining the presence of PCBs
request other information that it be- in samples, chemical analysis includes:

lieves necessary to evaluate the appli- sample preparation, sample extraction,
cation. No person may conduct sam- extract cleanup, extract concentration,
204
addition of PCB standards, and instru- gional Administrator, the time for dis-
mental analysis. posal is automatically extended for 1
(a) Portions of samples of a size des- additional year (2 years total) if the
ignated in a chemical extraction and following conditions are met:
analysis method for PCBs and ex- (i) The notification is received by the
tracted for purposes of determining the EPA Regional Administrator at least
presence of PCBs or concentration of 30 days before the initial 1-year time
PCBs are unregulated for PCB disposal limit expires and the notice identifies
under this part. the storer, the types, volumes, and lo-
(b) All other wastes generated during
cations of the waste and the reasons
these activities are regulated for dis-
for failure to meet the initial 1-year
posal based on their concentration at
the time of disposal as follows: time limit.
(1) Liquid wastes, including rinse sol- (ii) A written record documenting all
vents, must be disposed of according to continuing attempts to secure disposal
§ 761.61(a)(5)(iv). is maintained until the waste is dis-
(2) Non-liquid wastes must be disposed of.
posed of in the same manner as non-liq- (iii) The written record required by
uid cleaning materials and personal paragraph (a)(2)(ii) of this section is
protective equipment waste according available for inspection or submission
to § 761.61(a)(5)(v)(A). if requested by EPA.
[63 FR 35452, June 29, 1998] (iv) Continuing attempts to secure
disposal were initiated within 270 days
§ 761.65 Storage for disposal. after the time the waste was first sub-
This section applies to the storage ject to the 1-year time limit require-
for disposal of PCBs at concentrations ment, as specified in paragraph (a)(1) of
of 50 ppm or greater and PCB Items this section. Failure to initiate and
with PCB concentrations of 50 ppm or continue attempts to secure disposal
greater. throughout the total time the waste is
(a)(1) Storage limitations. Any PCB in storage shall automatically dis-
waste shall be disposed of as required qualify the notifier from receiving an
by subpart D of this part within 1-year automatic extension under this sec-
from the date it was determined to be tion.
PCB waste and the decision was made (3) Additional extensions. Upon written
to dispose of it. This date is the date of request, the EPA Regional Adminis-
removal from service for disposal and trator for the Region in which the
the point at which the 1-year time wastes are stored or the appropriate of-
frame for disposal begins. PCB/radio- ficial at EPA Headquarters, may grant
active waste removed from service for
additional extensions beyond the 1-
disposal is exempt from the 1-year time
year extension authorized in paragraph
limit provided that the provisions at
paragraphs (a)(2)(ii) and (a)(2)(iii) of (a)(2) of this section. At the time of the
this section are followed and the waste request, the requestor must supply spe-
is managed in accordance with all cific justification for the additional ex-
other applicable Federal, State, and tension and indicate what measures
local laws and regulations for the man- the requestor is taking to secure dis-
agement of radioactive material. posal of the waste or indicate why dis-
(2) One-year extension. Any person posal could not be conducted during
storing PCB waste that is subject to the period of the prior extension. The
the 1-year time limit for storage and EPA Regional Administrator or the ap-
disposal in paragraph (a)(1) of this sec- propriate official at EPA Headquarters
tion may provide written notification may require, as a condition to granting
to the EPA Regional Administrator for any extension under this section, spe-
the Region in which the PCB waste is cific actions including, but not limited
stored that their continuing attempts to, marking, inspection, recordkeeping,
to dispose of or secure disposal for or financial assurance to ensure that
their waste within the 1-year time the waste does not pose an unreason-
limit have been unsuccessful. Upon re- able risk of injury to health or the en-
ceipt of the notice by the EPA Re- vironment.
205
§ 761.65 40 CFR Ch. I (7–1–17 Edition)
(4) Storage at an approved facility. In- openings that would permit liquids to
creased time for storage may be grant- flow from the curbed area;
ed as a condition of any TSCA PCB (iv) Floors and curbing constructed
storage or disposal approval, by the of Portland cement, concrete, or a con-
EPA Regional Administrator for the tinuous, smooth, non-porous surface as
Region in which the PCBs or PCB defined at § 761.3, which prevents or
Items are to be stored or disposed of, or minimizes penetration of PCBs.
by the appropriate official at EPA (v) Not located at a site that is below
Headquarters, if EPA determines that the 100-year flood water elevation.
there is a demonstrated need or jus- (2) No person may store PCBs and
tification for additional time, that the PCB Items designated for disposal in a
owner or operator of the facility is pur- storage unit other than one approved
suing relevant treatment or disposal pursuant to paragraph (d) of this sec-
options, and that no unreasonable risk tion or meeting the design require-
of injury to health or the environment ments of paragraph (b) of this section,
will result from the increased storage unless the unit meets one of the fol-
time. In making this determination, lowing conditions:
EPA will consider such factors as ab-
(i) Is permitted by EPA under section
sence of any approved treatment tech-
3004 of RCRA to manage hazardous
nology and insufficient time to com-
waste in containers, and spills of PCBs
plete the treatment or destruction
are cleaned up in accordance with sub-
process. EPA may require as a condi-
part G of this part.
tion of the approval that the owner or
(ii) Qualifies for interim status under
operator submit periodic progress re-
section 3005 of RCRA to manage haz-
ports.
ardous waste in containers, meets the
(b) Except as provided in paragraphs
requirements for containment at
(b)(2), (c)(1), (c)(7), (c)(9), and (c)(10) of
§ 264.175 of this chapter, and spills of
this section, after July 1, 1978, owners
PCBs are cleaned up in accordance
or operators of any facilities used for
with subpart G of this part.
the storage of PCBs and PCB Items
designated for disposal shall comply (iii) Is permitted by a State author-
with the following storage unit re- ized under section 3006 of RCRA to
quirements: manage hazardous waste in containers,
(1) The facilities shall meet the fol- and spills of PCBs are cleaned up in ac-
lowing criteria: cordance with subpart G of this part.
(i) Adequate roof and walls to pre- (iv) Is approved or otherwise regu-
vent rain water from reaching the lated pursuant to a State PCB waste
stored PCBs and PCB Items; management program no less stringent
(ii) An adequate floor that has con- in protection of health or the environ-
tinuous curbing with a minimum 6 inch ment than the applicable TSCA re-
high curb. The floor and curbing must quirements found in this part.
provide a containment volume equal to (v) Is subject to a TSCA Coordinated
at least two times the internal volume Approval, which includes provisions for
of the largest PCB Article or PCB Con- storage of PCBs, issued pursuant to
tainer or 25 percent of the total inter- § 761.77.
nal volume of all PCB Articles or PCB (vi) Has a TSCA PCB waste manage-
Containers stored there, whichever is ment approval, which includes provi-
greater. PCB/radioactive wastes are sions for storage, issued pursuant to
not required to be stored in an area § 761.61(c) or § 761.62(c).
with a minimum 6 inch high curbing. (c)(1) The following PCB Items may
However, the floor and curbing must be stored temporarily in an area that
still provide a containment volume does not comply with the requirements
equal to at least two times the internal of paragraph (b) of this section for up
volume of the largest PCB Container or to thirty days from the date of their
25 percent of the total internal volume removal from service, provided that a
of all PCB Containers stored there, notation is attached to the PCB Item
whichever is greater. or a PCB Container (containing the

(iii) No drain valves, floor drains, ex- item) indicating the date the item was
pansion joints, sewer lines, or other removed from service:
206
(i) Non-leaking PCB Articles and days. Any leaking PCB Items and their
PCB Equipment; contents shall be transferred imme-
(ii) Leaking PCB Articles and PCB diately to properly marked non-leak-
Equipment if the PCB Items are placed ing containers. Any spilled or leaked
in a non-leaking PCB Container that materials shall be immediately cleaned
contains sufficient sorbent materials up and the materials and residues con-
to absorb any liquid PCBs remaining in taining PCBs shall be disposed of in ac-
the PCB Items; cordance with § 761.61. Records of in-
(iii) PCB Containers containing non- spections, maintenance, cleanup and
liquid PCBs such as contaminated soil, disposal must be maintained in accord-
rags, and debris; and ance with § 761.180(a) and (b).
(iv) PCB containers containing liquid (6) Except as provided in paragraphs
PCBs at concentrations of ≥50 ppm, (c)(6)(i) and (c)(6)(ii) of this section,
provided a Spill Prevention, Control any container used for the storage of
and Countermeasure Plan has been pre- liquid or non-liquid PCB waste shall be
pared for the temporary storage area in in accordance with the requirements
accordance with part 112 of this chap- set forth in the DOT Hazardous Mate-
ter and the liquid PCB waste is in rials Regulations (HMR) at 49 CFR
packaging authorized in the DOT Haz- parts 171 through 180. PCB waste not
ardous Materials Regulations at 49 subject to the HMR (i.e., PCB wastes at
CFR parts 171 through 180 or stationary concentrations of <20 ppm or <1 pound
bulk storage tanks (including rolling of PCBs regardless of concentration)
stock such as, but not limited to, tank- must be packaged in accordance with
er trucks, as specified by DOT). Packaging Group III, unless other haz-
(2) Non-leaking and structurally ards associated with the PCB waste
undamaged PCB Large High Voltage cause it to require packaging in ac-
Capacitors and PCB-Contaminated cordance with Packaging Groups I or
Electrical Equipment that have not II. For purposes of describing PCB
been drained of free flowing dielectric waste not subject to DOT’s HMR on a
fluid may be stored on pallets next to manifest, one may use the term ‘‘Non-
a storage facility that meets the re- DOT Regulated PCBs.’’
quirements of paragraph (b) of this sec- (i) Containers other than those meet-
tion. PCB-Contaminated Electrical ing HMR performance standards may
Equipment that has been drained of be used for storage of PCB/radioactive
free flowing dielectric fluid is not sub- waste provided the following require-
ject to the storage provisions of § 761.65. ments are met:
Storage under this subparagraph will (A) Containers used for storage of liq-
be permitted only when the storage fa- uid PCB/radioactive wastes must be
cility has immediately available un- non-leaking.
filled storage space equal to 10 percent (B) Containers used for storage of
of the volume of capacitors and equip- non-liquid PCB/ radioactive wastes
ment stored outside the facility. The must be designed to prevent the build-
capacitors and equipment temporarily up of liquids if such containers are
stored outside the facility shall be stored in an area meeting the contain-
checked for leaks weekly. ment requirements of paragraph
(3) Any storage area subject to the (b)(1)(ii) of this section, as well as all
requirements of paragraph (b) or para- other applicable State or Federal regu-
graph (c)(1) of this section shall be lations or requirements for control of
marked as required in subpart C radioactive materials.
§ 761.40(a)(10). (C) Containers used to store both liq-
(4) No item of movable equipment uid and non-liquid PCB/radioactive
that is used for handling PCBs and PCB wastes must meet all regulations and
Items in the storage units and that requirements pertaining to nuclear
comes in direct contact with PCBs criticality safety. Acceptable container
shall be removed from the storage unit materials currently include poly-
area unless it has been decontaminated ethylene and stainless steel provided
as specified in § 761.79. that the container material is chemi-

(5) All PCB Items in storage shall be cally compatible with the wastes being
checked for leaks at least once every 30 stored. Other containers may be used
207
§ 761.65 40 CFR Ch. I (7–1–17 Edition)
to store both liquid and non-liquid shall not apply unless some fraction of
PCB/radioactive wastes if the users are the liquids stored in the container are
able to demonstrate, to the appropriate oils as defined by section 311 of the
Regional Administrator and other ap- Clean Water Act.
propriate regulatory authorities (i.e., (8) PCB Items shall be dated on the
Nuclear Regulatory Commission, De- item when they are removed from serv-
partment of Energy or the Department ice for disposal. The storage shall be
of Transportation), that the use of such managed so that the PCB Items can be
containers is protective of health and located by this date. Storage con-
the environment as well as public tainers provided in paragraph (c)(7) of
health and safety. this section, shall have a record that
(ii) The following DOT specification includes for each batch of PCBs the
containers that conform to the require- quantity of the batch and date the
ments of 49 CFR, chapter I, subchapter batch was added to the container. The
C in effect on September 30, 1991, may record shall also include the date,
be used for storage and transportation quantity, and disposition of any batch
activities that are not subject to DOT of PCBs removed from the container.
regulation, and may be used on a tran- (9) Bulk PCB remediation waste or
sitional basis as permitted at 49 CFR PCB bulk product waste may be stored
171.14. For liquid PCBs: Specification 5 at the clean-up site or site of genera-
container without removable head, tion for 180 days subject to the fol-
Specification 5B container without re- lowing conditions:
movable head, Specification 6D over- (i) The waste is placed in a pile de-
pack with Specification 2S or 2SL poly- signed and operated to control dis-
ethylene containers, or Specification persal of the waste by wind, where nec-
17E container. For non-liquid PCBs: essary, by means other than wetting.
Specification 5 container, Specification (ii) The waste must not generate
5B container, or Specification 17C con- leachate through decomposition or
tainer. other reactions.
(7) Stationary storage containers for (iii) The storage site must have:
liquid PCBs can be larger than the con- (A) A liner that is designed, con-
tainers specified in paragraph (c)(6) of structed, and installed to prevent any
this section provided that: migration of wastes off or through the
(i) The containers are designed, con- liner into the adjacent subsurface soil,
structed, and operated in compliance ground water or surface water at any
with Occupational Safety and Health time during the active life (including
Standards, 29 CFR 1910.106, Flammable the closure period) of the storage site.
and combustible liquids. Before using The liner may be constructed of mate-
these containers for storing PCBs, the rials that may allow waste to migrate
design of the containers must be re- into the liner. The liner must be:
viewed to determine the effect on the (1) Constructed of materials that
structural safety of the containers that have appropriate chemical properties
will result from placing liquids with and sufficient strength and thickness
the specific gravity of PCBs into the to prevent failure due to pressure gra-
containers (see 29 CFR dients (including static head and exter-
1910.106(b)(1)(i)(f)). nal hydrogeologic forces), physical con-
(ii) The owners or operators of any tact with the waste or leachate to
facility using containers described in which they are exposed, climatic condi-
paragraph (c)(7)(i) of this section, shall tions, the stress of installation, and
prepare and implement a Spill Preven- the stress of daily operation.
tion Control and Countermeasure (2) Placed upon a foundation or base
(SPCC) Plan as described in part 112 of capable of providing support to the
this title. In complying with 40 CFR liner and resistance to pressure gra-
part 112, the owner or operator shall dients above and below the liner to pre-
read ‘‘oil(s)’’ as ‘‘PCB(s)’’ whenever it vent failure of the liner due to settle-
appears. The exemptions for storage ment, compression, or uplift.
capacity, 40 CFR 112.1(d)(2), and the (3) Installed to cover all surrounding
amendment of SPCC plans by the Re- earth likely to be in contact with the
gional Administrator, 40 CFR 112.4, waste.
208
(B) A cover that meets the require- mercial storage facility are qualified to
ments of paragraph (c)(9)(iii)(A) of this engage in the business of commercial
section, is installed to cover all of the storage of PCB waste.
stored waste likely to be contacted (ii) The facility possesses the capac-
with precipitation, and is secured so as ity to handle the quantity of PCB
not to be functionally disabled by waste which the owner or operator of
winds expected under normal seasonal the facility has estimated will be the
meteorological conditions at the stor- maximum quantity of PCB waste that
age site. will be handled at any one time at the
(C) A run-on control system designed, facility.
constructed, operated, and maintained
(iii) The owner or operator of the
such that:
(1) It prevents flow onto the stored unit has certified compliance with the
waste during peak discharge from at storage facility standards in para-
least a 25-year storm. graphs (b) and (c)(7) of this section.
(2) It collects and controls at least (iv) The owner or operator has devel-
the water volume resulting from a 24- oped a written closure plan for the fa-
hour, 25-year storm. Collection and cility that is deemed acceptable by the
holding facilities (e.g., tanks or basins) Regional Administrator (or the appro-
must be emptied or otherwise managed priate official at EPA Headquarters, if
expeditiously after storms to maintain the commercial storage area is ancil-
design capacity of the system. lary to a disposal facility permitted by
(iv) The provisions of this paragraph an official at EPA Headquarters) under
may be modified under § 761.61(c). the closure plan standards of paragraph
(10) Owners or operators of storage (e) of this section.
facilities shall establish and maintain (v) The owner or operator has in-
records as provided in § 761.180. cluded in the application for final ap-
(d) Approval of commercial storers of proval a demonstration of financial re-
PCB waste. (1) All commercial storers sponsibility for closure that meets the
of PCB waste shall have interim ap- financial responsibility standards of
proval to operate commercial facilities
paragraph (g) of this section.
for the storage of PCB waste until Au-
gust 2, 1990. Commercial storers of PCB (vi) The operation of the storage fa-
waste are prohibited from storing any cility will not pose an unreasonable
PCB waste at their facilities after Au- risk of injury to health or the environ-
gust 2, 1990 unless they have submitted ment.
by August 2, 1990 a complete applica- (vii) The environmental compliance
tion for a final storage approval under history of the applicant, its principals,
paragraph (d)(2) of this section. The pe- and its key employees may be deemed
riod of interim approval shall continue to constitute a sufficient basis for de-
until EPA makes a final decision on nial of approval whenever in the judg-
the storage application at which time ment of the appropriate EPA official
such interim approval shall terminate. that history of environmental civil vio-
(2) The Regional Administrator for lations or criminal convictions evi-
the region in which the storage facility dences a pattern or practice of non-
is located (or the appropriate official compliance that demonstrates the ap-
at EPA Headquarters, if the commer- plicant’s unwillingness or inability to
cial storage area is ancillary to a dis- achieve and maintain compliance with
posal facility for which an official at the regulations.
EPA Headquarters has approval au- (3) Applicants for storage approvals
thority)shall grant written, final ap- shall submit a written application that
proval to engage in the commercial
includes any relevant information
storage of PCB waste upon a deter-
bearing upon the qualifications of the
mination that the criteria in paragraph
(d)(2)(i) through (d)(2)(vii) of this sec- facility’s principals and key employees
tion have been met by the applicant: to engage in the business of commer-
(i) The applicant, its principals, and cial storage of PCB wastes. This infor-
its key employees responsible for the mation shall include, but is not limited
establishment or operation of the com- to:
209
§ 761.65 40 CFR Ch. I (7–1–17 Edition)
(i) The identification of the owner (viii) A written closure plan for the
and the operator of the facility, includ- facility, as described in paragraph (e)
ing all general partners of a partner- of this section.
ship, any limited partner of a partner- (ix) The current closure cost esti-
ship, any stockholder of a corporation mate for the facility, as described in
or any participant in any other type of paragraph (f) of this section.
business organization or entity who (x) A demonstration of financial re-
owns or controls, directly or indirectly, sponsibility to close the facility, as de-
more than 5 percent of each partner- scribed in paragraph (g) of this section.
ship, corporation, or other business or- (4) The written approval issued by
ganization and all officials of the facil- EPA shall include, but not be limited
ity who have direct management re- to, the following:
sponsibility for the facility. (i) The determination that the appli-
(ii) The identification of the person cant has satisfied the requirements set
responsible for the overall operations forth in paragraph (d)(2) of this section,
of the facility (i.e., a plant manager, and a brief statement setting forth the
superintendent, or a person of similar basis for the determination.
responsibility) and the supervisory em- (ii) Incorporation of the closure plan
ployees who are or will be responsible submitted by the facility owner or op-
for the operation of the facility. erator and approved by EPA.
(iii) Information concerning the tech- (iii) A condition imposing a max-
nical qualifications and experience of imum PCB storage capacity which the
the persons responsible for the overall facility shall not exceed during its PCB
operation of the facility and the em- waste storage operations. The max-
ployees responsible for handling PCB imum storage capacity imposed under
waste or other wastes. this condition shall not be greater than
the estimated maximum inventory of
(iv) Information concerning any past
PCB waste included in the owner’s or
State or Federal environmental viola-
operator’s application for final ap-
tions involving the same business or
proval.
another business with which the prin-
(iv) Such other conditions as deemed
cipals or supervisory employees were necessary by EPA to ensure that the
affiliated directly that occurred within operations of the PCB storage facility
5 years preceding the date of submis- will not pose an unreasonable risk of
sion and which relate directly to viola- injury to health or the environment.
tions that resulted in either a civil (5) Storage areas at transfer facilities
penalty (irrespective of whether the are exempt from the requirement to
matter was disposed of by an adjudica- obtain approval as a commercial storer
tion or by a without prejudice settle- of PCB waste under this paragraph, un-
ment) or judgment of conviction less the same PCB waste is stored at
whether entered after trial or a plea, these facilities for a period of time
either of guilt or nolo contendere or greater than 10 consecutive days be-
civil injunctive relief and involved tween destinations.
storage, disposal, transport, or other (6) Storage areas at RCRA-permitted
waste handling activities. facilities may be exempt from the sepa-
(v) A list of all companies currently rate TSCA storage approval require-
owned or operated in the past by the ments in this paragraph (d) upon a
principals or key employees identified showing to the Regional Administra-
in paragraphs (d)(3)(i) and (d)(3)(ii) of tor’s satisfaction that the facility’s ex-
this section that are or were directly isting RCRA closure plan is substan-
or indirectly involved with waste han- tially equivalent to this rule’s closure
dling activities. plan standards, and that such facility’s
(vi) The owner’s or operator’s esti- closure cost estimate and financial as-
mate of maximum PCB waste quantity surance demonstration account for
to be handled at the facility. maximum PCB waste inventories, and
(vii) A written statement certifying the requirements of paragraph (d)(3)(i)
compliance with paragraph (b) or (c) of through (d)(3)(v) and (d)(3)(vii) of this
this section and containing a certifi- section are met. A pay-in period of
cation as defined in § 761.3. longer than 3 years after approval of
210
the storage facility pursuant to this (e) Closure. (1) A commercial storer of
rule, will be acceptable to EPA if that PCB waste shall have a written closure
pay-in period has already been estab- plan that identifies the steps that the
lished for a valid RCRA facility or pre- owner or operator of the facility shall
viously approved TSCA facility. take to close the PCB waste storage fa-
(7) Storage areas ancillary to TSCA- cility in a manner that eliminates the
approved disposal facilities may be ex- potential for post-closure releases of
empt from a separate facility approval PCBs which may present an unreason-
provided all of the following conditions able risk to human health or the envi-
are met: ronment. An acceptable closure plan
(i) The current disposal approval con- must include, at a minimum, all of the
tains an expiration date. following:
(ii) The current disposal approval’s (i) A description of how the PCB stor-
closure and financial responsibility age areas of the facility will be closed
conditions specifically extend to stor- in a manner that eliminates the poten-
age areas ancillary to disposal. tial for post-closure releases of PCBs
(iii) The current disposal approval’s into the environment.
closure and financial responsibility (ii) An identification of the max-
conditions provide for annual adjust- imum extent of storage operations that
ments for inflation, and for modifica- will be open during the active life of
tion when changes in operation would the facility, including an identification
affect closure costs. of the extent of PCB storage operations
(iv) The current disposal approval at the facility relative to other wastes
contains conditions on closure and fi- that will be handled at the facility.
nancial responsibility that are at least (iii) An estimate of the maximum in-
as stringent as those in paragraphs (e) ventory of PCB wastes that could be
and (g) of this section. However, the handled at one time at the facility over
provision for a 3-year closure trust its active life, and a detailed descrip-
pay-in period, as specified in paragraph tion of the methods or arrangements to
(g)(1)(i) of this section, would be be used during closure for removing,
waived in a case in which an approved transporting, storing, or disposing of
TSCA facility or RCRA facility that the facility’s inventory of PCB waste,
covers PCB storage has a longer pay-in including an identification of any off-
period for the trust. site facilities that will be used.
(v) The current disposal approval sat- (iv) A detailed description of the
isfies the requirements of paragraph steps needed to remove or decontami-
(d)(3)(i) through (d)(3)(v) of this sec- nate PCB waste residues and contami-
tion. nated containment system compo-
(8) The approval of any existing nents, equipment, structures, and soils
TSCA-approved disposal facility ancil- during closure in accordance with the
lary to a commercial storage facility levels specified in the PCB Spills
that is deficient in any of the condi- Cleanup Policy in subpart G of this
tions of paragraph (d)(7)(i) through part, including a description of the
(d)(7)(v) of this section shall be called methods for sampling and testing of
in by the Regional Administrator (or surrounding soils, and the criteria for
the appropriated official at EPA Head- determining the extent of removal or
quarters, if approval was granted by an decontamination.
official at EPA Headquarters). The ap- (v) A detailed description of other ac-
proval shall be modified to meet the re- tivities necessary during the closure
quirements of paragraph (d)(7) of this period to ensure that any post-closure
section within 180 days of the effective releases of PCBs will not present un-
date of this final rule, or a separate ap- reasonable risks to human health or
plication for approval of the storage fa- the environment. This includes activi-
cility may be submitted to the Re- ties such as ground-water monitoring,
gional Administrator or the Director, run-on and run-off control, and facility
Office of Resource Conservation and security.
Recovery, in the cases where an official (vi) A schedule for closure of each
at EPA Headquarters issued the ap- area of the facility where PCB waste is
proval. stored or handled, including the total
211
§ 761.65 40 CFR Ch. I (7–1–17 Edition)
time required to close each area of PCB trator or the Director, Office of Re-
waste storage or handling, and the source Conservation and Recovery, if
time required for any intervening clo- an official at EPA Headquarters ap-
sure activities. proved the closure plan, at least 60
(vii) An estimate of the expected days prior to the date on which final
year of closure of the PCB waste stor- closure of its PCB storage facility is
age areas, if a trust fund is opted for as expected to begin.
the financial mechanism. (ii) The date when a commercial stor-
(2) A written closure plan determined er of PCB waste ‘‘expects to begin clo-
to be acceptable by EPA under this sec- sure’’ shall be no later than 30 days
tion shall become a condition of any after the date on which the storage fa-
approval granted under paragraph (d) cility received its final quantities of
of this section. PCB waste. For good cause shown, EPA
(3) A separate and new closure plan may extend the date for commence-
need not be submitted in cases where a ment of closure for an additional 30-
facility is currently covered by a TSCA day period.
approval or a RCRA permit, upon a (iii) Within 90 days after receiving
showing to the satisfaction of the Re- the final quantity of PCB waste for
gional Administrator (or the appro- storage, a commercial storer of PCB
priate official at EPA Headquarters, if waste shall remove all PCB waste in
the commercial storage area is ancil- storage at the facility from the facility
lary to a disposal facility for which an in accordance with the approved clo-
official at EPA Headquarters has ap- sure plan. For good cause shown, EPA
proval authority) that the existing clo- may approve a reasonable extension to
sure plan is substantially equivalent to the period for removal of the PCB
closure plans required under para- waste.
graphs (d) through (g) of this section, (iv) A commercial storer of PCB
and that the plan adequately accounts waste shall complete closure activities
for PCB waste inventories. in accordance with the approved clo-
(4) The commercial storer of PCB sure plan and within 180 days after re-
waste shall submit a written request to ceiving the final quantity of PCB waste
the Regional Administrator (or the Di- for storage at the facility. For good
rector, Office of Resource Conservation cause shown, EPA may approve a rea-
and Recovery, if an official at EPA sonable extension to the closure period.
Headquarters approved the closure (7) During the closure period, all con-
plan) for a modification to its storage taminated system component equip-
approval to amend its closure plan, ment, structures, and soils shall be dis-
whenever: posed of in accordance with the dis-
(i) Changes in ownership, operating posal requirements of subpart D of this
plans, or facility design affect the ex- part, or, if applicable, decontaminated
isting closure plan. in accordance with the levels specified
(ii) There is a change in the expected in the PCB Spills Cleanup Policy at
date of closure, if applicable. subpart G of this part. When PCB waste
(iii) In conducting closure activities, is removed from the storage facility
unexpected events require a modifica- during closure, the owner or operator
tion of the approved closure plan. becomes a generator of PCB waste sub-
(5) The Regional Administrator or ject to the generator requirements of
the Director, appropriate official at subpart J of this part.
EPA Headquarters, if an official at (8) Within 60 days of completion of
EPA Headquarters approved the clo- closure of each facility for the storage
sure plan, may modify the existing clo- of PCB waste, the commercial storer of
sure plan under the conditions de- PCB waste shall submit to the Re-
scribed in paragraph (e)(4) of this sec- gional Administrator (or the Director,
tion. Office of Resource Conservation and
(6) Commercial storers of PCB waste Recovery, if an official at EPA Head-
shall comply with the following closure quarters approved the closure plan), by
schedule: registered mail, a certification that

(i) The commercial storer shall no- the PCB storage facility has been
tify in writing the Regional Adminis- closed in accordance with the approved
212
closure plan. The certification shall be closure in current dollars, or by using

signed by the owner or operator and by an inflation factor derived from the
an independent registered professional most recent Implicit Price Deflator for
engineer. Gross National Product published by
(f) Closure cost estimate. (1) A commer- the U.S. Department of Commerce in
cial storer of PCB wastes shall have a its Survey of Current Business. The Im-
detailed estimate, in current dollars, of plicit Price Deflator for Gross National
the cost of closing the facility in ac- Product is included in a monthly publi-
cordance with its approved closure cation titled Economic Indicators, which
plan. The closure cost estimate shall be is available from the Superintendent of
in writing, be certified by the person Documents, Government Printing Of-
preparing it (using the certification de- fice, Washington, DC 20402. The infla-
fined in § 761.3) and comply with all of tion factor used in the latter method is
the following criteria: the result of dividing the latest pub-
(i) The closure cost estimate shall lished annual Deflator by the Deflator
equal the cost of final closure at the for the previous year. The adjustment
point in the PCB storage facility’s ac- to the closure cost estimate is then
tive life when the extent and manner of made by multiplying the most recent
PCB storage operations would make closure cost estimate by the latest in-
closure the most expensive, as indi- flation factor.
cated by the facility’s closure plan. (3) Where EPA approves a modifica-
(ii) The closure cost estimate shall be tion to the facility’s closure plan, and
based on the costs to the owner or op- that modification increases the cost of
erator of hiring a third party to close closure, the owner or operator shall re-
the facility, and the third party shall vise the closure cost estimate no later
not be either a corporate parent or sub- than 30 days after the modification is
sidiary of the owner or operator, or approved. Any such revision shall also
member in joint ownership of the facil- be adjusted for inflation in accordance
ity. with paragraph (f)(2) of this section.
(iii) The owner or operator shall in-
(4) The owner or operator of the facil-
clude in the estimate the current mar-
ity shall keep at the facility during its
ket costs for off-site commercial dis-
operating life the most recent closure
posal of the facility’s maximum esti-
cost estimate, including any adjust-
mated inventory of PCB wastes, except
ments resulting from inflation or from
that on-site disposal costs may be used
modifications to the closure plan.
if on-site disposal capacity will exist at
the facility at all times over the life of (g) Financial assurance for closure. A
the PCB storage facility. commercial storer of PCB waste shall
(iv) The closure cost estimate may establish financial assurance for clo-
not incorporate any salvage value that sure of each PCB storage facility that
may be realized with the sale of wastes, he owns or operates. In establishing fi-
facility structures or equipment, land, nancial assurance for closure, the com-
or other assets associated with the fa- mercial storer of PCB waste may
cility at the time of closure. choose from the following financial as-
(2) During the active life of the PCB surance mechanisms or any combina-
storage facility, the commercial storer tion of mechanisms:
of PCB waste shall adjust annually for (1) The ‘‘closure trust fund,’’ as speci-
inflation the closure cost estimate fied in § 264.143(a) of this chapter, ex-
within 60 days prior to the anniversary cept for paragraph (a)(3) of § 264.143. For
date of the establishment of the finan- purposes of this paragraph, the fol-
cial instruments used to demonstrate lowing provisions also apply:
financial responsibility for closure, ex- (i) Payments into the trust fund shall
cept that owners or operators who use be made annually by the owner or oper-
the financial test or corporate guar- ator over the remaining operating life
antee shall adjust their closure cost es- of the facility as estimated in the clo-
timates for inflation within 30 days sure plan, or over 3 years, whichever
after the close of the storer’s fiscal period is shorter. This period of time is
year. The adjustment may be made by hereafter referred to as the ‘‘pay-in pe-
recalculating the maximum costs of riod.’’ For an existing facility, the first
213
§ 761.65 40 CFR Ch. I (7–1–17 Edition)
payment must be made within 30 cal- ing this difference by the number of
endar days after EPA has notified the years remaining in the pay-in period.
facility of its conditional approval. In- (iv) The submission of a trust agree-
terim approval to operate is canceled ment with the wording specified in
and the application is denied if EPA § 264.151(a)(1) of this chapter, including
does not receive verification that the any reference to hazardous waste man-
payment was made in that 30-day pe- agement facilities, shall be deemed to
riod. be in compliance with the requirement
(ii) For a new facility, the first pay- to submit a trust agreement under this
ment into the closure trust fund shall subpart.
be made before EPA grants final ap- (2) The ‘‘surety bond guaranteeing
proval of the application and before the payment into a closure trust fund,’’ as
facility may accept the initial ship- specified in § 264.143(b) of this chapter,
ment of PCB waste for commercial including the use of the surety bond in-
storage. A receipt from the trustee strument specified at § 264.151(b) of this
shall be submitted by the owner or op- chapter and the standby trust specified
erator to the Regional Administrator at § 264.143(b)(3) of this chapter. The use
(or the Director, Office of Resource of the surety bonds, surety bond instru-
ments, and standby trust agreements
Conservation and Recovery, if the com-
specified in §§ 264.143(b) and 264.151(b) of
mercial storage area is ancillary to a
this chapter shall be deemed to be in
disposal facility approved by an official
compliance with this subpart.
at EPA Headquarters) before this ini-
(3)(i) The ‘‘surety bond guaranteeing
tial delivery of PCB waste. The first
performance of closure,’’ as specified at
payment shall be at least equal to the
§ 264.143(c) of this chapter, except for
current closure cost estimate, divided
paragraph (c)(5) of § 264.143 of this chap-
by the number of years in the pay-in ter. The submission and use of the sur-
period, except as provided in paragraph ety bond instrument specified at
(g)(7) of this section for multiple mech- § 264.151(c) of this chapter and the
anisms. Subsequent payments shall be standby trust specified at § 264.143(c)(3)
made no later than 30 days after each of this chapter shall be deemed to be in
anniversary date of the first payment. compliance with the requirements
The amount of each subsequent pay- under this subpart relating to the use
ment shall be determined by sub- of surety bonds and standby trust
tracting the current value of the trust funds.
fund from the current closure cost esti- (ii) For the purposes of this para-
mate, and dividing this difference by graph, and under the terms of the bond,
the number of years remaining in the the surety shall become liable on the
pay-in period. bond obligation when the owner or op-
(iii) If an owner or operator of a facil- erator fails to perform as guaranteed
ity existing on the effective date of by the bond. Liability is established by
this paragraph establishes a trust fund a final administrative determination
to meet the financial assurance re- pursuant to section 16 of TSCA that
quirements of this paragraph, and the the owner or operator has failed to per-
value of the trust fund is less than the form final closure in accordance with
current closure cost estimate when a the closure plan and other approval or
final approval is granted for the facil- regulatory requirements when required
ity, the amount of the current closure to do so.
cost estimate still to be paid into the (4)(i) The ‘‘closure letter of credit’’
trust fund shall be paid in over the specified in § 264.143(d) of this chapter,
pay-in period as defined in paragraph except for paragraph (d)(8). The sub-
(g)(1)(i) of this section. Payments shall mission and use of the irrevocable let-
continue to be made no later than 30 ter of credit instrument specified in
days after each anniversary date of the § 264.151(d) of this chapter and the
first payment made into the trust fund. standby trust specified in § 264.143(d)(3)
The amount of each payment shall be of this chapter shall be deemed to be in
determined by subtracting the current compliance with the requirements of

value of the trust fund from the cur- this subpart relating to the use of let-
rent closure cost estimate, and divid- ters of credit and standby trust funds.
214
(ii) For the purposes of this para- the Federal or State issuing authority
graph, the Regional Administrator (or must be notified in writing no later
the appropriate official at EPA Head- than 30 days from the completion of
quarters, if the commercial storage the modification. The new or revised fi-
area is ancillary to a disposal facility nancial assurance mechanism must be
for which an official at EPA Head- established and activated no later than
quarters has approval authority) may 30 days after the Director of the Fed-
draw on the letter of credit following a eral or State issuing authority is noti-
final administrative determination fied of the completion of the modifica-
pursuant to section 16 of TSCA that tion, but prior to the use of the modi-
the owner or operator has failed to per- fied portion of the facility.
form final closure in accordance with (h) Release of owner or operator. With-
the closure plan and other approval or in 60 days after receiving certifications
regulatory requirements when required from the owner or operator and an
to do so. independent registered professional en-
(5) ‘‘Closure insurance,’’ as specified gineer that final closure has been com-
in § 264.143(e) of this chapter, utilizing pleted in accordance with the approved
the certificate of insurance for closure closure plan, EPA will notify the owner
specified at § 264.151(e) of this chapter. or operator in writing that the owner
The use of closure insurance as speci- or operator is no longer required by
fied in § 264.143(e) of this chapter and this section to maintain financial as-
the submission and use of the certifi- surance for final closure of the facility,
cate of insurance specified in unless EPA has reason to believe that
§ 264.151(e) of this chapter shall be final closure has not been completed in
deemed to be in compliance with the accordance with the approved closure
requirements of this subpart relating plan. EPA shall provide the owner or
to the use of closure insurance. operator with a detailed written state-
(6) The ‘‘financial test and corporate ment stating the reasons why EPA
guarantee for closure,’’ as described in shall provide the owner or operator
§ 264.143(f) of this chapter, including a with a detailed written statement stat-
letter signed by the owner’s or opera- ing the reasons why he believed closure
tor’s chief financial officer as specified was not conducted in accordance with
at § 264.151(f) of this chapter and, if ap- the approved closure plan.
plicable, the written corporate guar- (i) Laboratories and samples. (1) A lab-
antee specified at § 264.151(h) of this oratory is conditionally exempt from
chapter. The use of the financial test the notification and approval require-
and corporate guarantee specified in ments for a commercial storer under
§ 264.143(f) of this chapter, the submis- § 761.65 (d) through (h) when it stores
sion and use of the letter specified in samples held for disposal in a facility
§ 264.151(f) of this chapter, and the sub- that complies with the standards in
mission and use of the written cor- § 761.65 (b)(1)(i) through (b)(1)(iv).
porate guarantee specified at (2) A laboratory sample is exempt
§ 264.151(h) of this chapter shall be from the manifesting requirements in
deemed to be in compliance with the §§ 761.210 through 761.213 when:
requirements of this subpart relating (i) The sample is being transported to
to the use of financial tests and cor- a laboratory for the purpose of testing.
porate guarantees. (ii) The sample is being transported
(7) The corporate guarantee as speci- back to the sample collector after test-
fied in § 264.143(f)(10) of this chapter. ing.
(8) The use of multiple financial (iii) The sample is being stored by
mechanisms, as specified in § 264.143(g) the sample collector before transport
of this chapter is permitted. to a laboratory for testing.
(9) A modification to a facility stor- (iv) The sample is being stored in a
ing PCB waste that increases the max- laboratory before testing.
imum storage capacity indicated in the (v) The sample is being stored in a
permit requires that a new financial laboratory after testing but before it is
assurance mechanism be established or returned to the sample collector.

an existing one be amended. When such (vi) The sample is being stored tem-
a modification occurs, the Director of porarily in the laboratory after testing
215
§ 761.70 40 CFR Ch. I (7–1–17 Edition)
for a specific purpose (for example, The Agency will approve the transfer if
until conclusion of a court case or en- the following conditions are met:
forcement action where further testing (1) The transferee has established fi-
of the sample may be necessary). nancial assurance for closure pursuant
(3) In order to qualify for the exemp- to paragraph (g) of this section using a
tion in paragraph (i)(2)(i) and (i)(2)(ii) mechanism effective as of the date of
of this section, a sample collector ship- final approval so that there will be no
ping samples to a laboratory and a lab- lapse in financial assurance for the
oratory returning samples to a sample transferred facility.
collector must: (2) The transferor or transferee has
(i) Comply with applicable U.S. De- resolved any deficiencies (e.g., tech-
partment of Transportation (DOT) or nical operations, closure plans, cost es-
U.S. Postal Service (USPS) shipping re- timates, etc.) the Agency has identified
quirements, found respectively in 49 in the transferor’s application.
CFR 173.345 and U.S. Postal Regula- (k) States and the Federal Government.
tions 652.2 and 652.3. States and the Federal Government are
(ii) Assure that the following infor- exempt from the requirements of para-
mation accompanies the sample: graphs (f) and (g) of this section.
(A) The sample collector’s name,
(Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
mailing address, and telephone num-
2605)
ber.
(B) The laboratory’s name, mailing [44 FR 31542, May 31, 1979. Redesignated at 47
address, and telephone number. FR 19527, May 6, 1982, and amended at 47 FR
37359, Aug. 8, 1982; 49 FR 28191, July 10, 1984;
(C) The quantity of the sample. 53 FR 12524, Apr. 15, 1988; 54 FR 52746, Dec. 21,
(D) The date of shipment. 1989; 55 FR 695, Jan. 8, 1990; 55 FR 26205, June
(E) A description of the sample. 27, 1990; 58 FR 15809, Mar. 24, 1993; 58 FR 34205,
(iii) Package the sample so that it June 23, 1993; 58 FR 59374, Nov. 9, 1993; 63 FR
does not leak, spill, or vaporize from 35439, 35452, June 29, 1998; 72 FR 57239, 57240
its packaging. Oct. 9, 2007; 74 FR 30232, June 25, 2009; 77 FR
54830, Sept. 6, 2012]
(4) When the concentration of the
PCB sample has been determined, and § 761.70 Incineration.
its use is terminated, the sample must
be properly disposed. A laboratory This section applies to facilities used
must either manifest the PCB waste to to incinerate PCBs required to be in-
a disposer or commercial storer, as re- cinerated by this part.
quired under §§ 761.210 through 761.213, (a) Liquid PCBs. An incinerator used
retain a copy of each manifest, as re- for incinerating PCBs shall be approved
quired under §§ 761.213 and 761.214, and by EPA pursuant to paragraph (d) of
follow up on exception reporting, as re- this section. Requests for approval of
quired under § 761.217, or return the incinerators to be used in more than
sample to the sample collector who one region must be submitted to the
must then properly dispose of the sam- Director, Office of Resource Conserva-
ple. If the laboratory returns the sam- tion and Recovery, except for research
ple to the sample collector, the labora- and development involving less than
tory must comply with the shipping re- 500 pounds of PCB material (see
quirements set forth in paragraphs § 761.60(i)(2)). Requests for approval of
(i)(3)(i) through (i)(3)(iii) of this sec- incinerators to be used in only one re-
tion. gion must be submitted to the appro-
(j) Changes in ownership or operational priate Regional Administrator. The in-
control of a commercial storage facility. cinerator shall meet all of the require-
The date of transfer of interim status ments specified in paragraphs (a)(1)
or final approval shall be the date the through (9) of this section, unless a
EPA Regional Administrator (or appro- waiver from these requirements is ob-
priate official at EPA Headquarters) tained pursuant to paragraph (d)(5) of
provides written approval of the trans- this section, In addition, the inciner-
fer. EPA will provide a final written ator shall meet any other requirements
decision within 90 days of receipt of the which may be prescribed pursuant to
complete new or amended application. paragraph (d)(4) of this section.
216
(1) Combustion criteria shall be ei- whenever the incinerator is incin-

ther of the following: erating PCBs:
(i) Maintenance of the introduced liq- (i) O2; (ii) CO; and (iii) CO2. The moni-
uids for a 2-second dwell time at 1200 °C toring for O2 and CO shall be contin-
(±100 °C) and 3 percent excess oxygen in uous. The monitoring for CO2 shall be
the stack gas; or periodic, at a frequency specified by
(ii) Maintenance of the introduced the Regional Administrator or appro-
liquids for a 11⁄2 second dwell time at priate official at EPA Headquarters.
1600 °C(±100 °C) and 2 percent excess ox- (8) The flow of PCBs to the inciner-
ygen in the stack gas. ator shall stop automatically when any
(2) Combustion efficiency shall be at one or more of the following conditions
least 99.9 percent computed as follows: occur, unless a contingency plan is sub-
Combustion efficiency = [Cco2/(Cco2 + mitted by the incinerator owner or op-
Cco)]100 erator and approved by the Regional
Administrator or appropriate official
where
at EPA Headquarters. The contingency
Cco2 = Concentration of carbon dioxide. plan indicates what alternative meas-
Cco = Concentration of carbon monoxide.
ures the incinerator owner or operator
(3) The rate and quantity of PCBs would take if any of the following con-
which are fed to the combustion sys- ditions occur:
tem shall be measured and recorded at (i) Failure of monitoring operations
regular intervals of no longer than 15 specified in paragraph (a)(7) of this sec-
minutes. tion;
(4) The temperatures of the inciner- (ii) Failure of the PCB rate and quan-
ation process shall be continuously tity measuring and recording equip-
measured and recorded. The combus- ment specified in paragraph (a)(3) of
tion temperature of the incineration this section; or
process shall be based on either direct
(iii) Excess oxygen falls below the
(pyrometer) or indirect (wall thermo-
percentage specified in paragraph (a)(1)
couple-pyrometer correlation) tem-
of this section.
perature readings.
(5) The flow of PCBs to the inciner- (9) Water scrubbers shall be used for
ator shall stop automatically whenever HCl control during PCB incineration
the combustion temperature drops and shall meet any performance re-
below the temperatures specified in quirements specified by EPA. Scrubber
paragraph (a)(1) of this section. effluent shall be monitored and shall
(6) Monitoring of stack emission comply with applicable effluent or
products shall be conducted: pretreatment standards, and any other
(i) When an incinerator is first used State and Federal laws and regula-
for the disposal of PCBs under the pro- tions. An alternate method of HCl con-
visions of this regulation; trol may be used if the alternate meth-
(ii) When an incinerator is first used od has been approved by EPA. (The HCl
for the disposal of PCBs after the incin- neutralizing capability of cement kilns
erator has been modified in a manner is considered to be an alternate meth-
which may affect the characteristics of od.)
the stack emission products; and (b) Nonliquid PCBs. An incinerator
(iii) At a minimum such monitoring used for incinerating nonliquid PCBs,
shall be conducted for the following pa- PCB Articles, PCB Equipment, or PCB
rameters: Containers shall be approved by EPA
(a) O2; (b) CO; (c) CO2; (d) Oxides of pursuant to paragraph (d) of this sec-
Nitrogen (NOX); (e) Hydrochloric Acid tion. Requests for approval of inciner-
(HCl); (f) Total Chlorinated Organic ators to be used in more than one re-
Content (RCl); (g) PCBs; and (h) Total gion must be submitted to the Direc-
Particulate Matter. tor, Office of Resource Conservation
(7) At a minimum monitoring and re- and Recovery except for research and
cording of combustion products and in- development involving less that 500
cineration operations shall be con- pounds of PCB material (see
ducted for the following parameters § 761.60(i)(2)). Requests for approval of
217
§ 761.70 40 CFR Ch. I (7–1–17 Edition)
incinerators to be used in only one re- (2) Trial burn. (i) Following receipt of
gion must be submitted to the appro- the application described in paragraph
priate Regional Administrator. The in- (d)(1) of this section, EPA shall deter-
cinerator shall meet all of the require- mine if a trial burn is required and no-
ments specified in paragraphs (b)(1) tify the person who submitted the re-
and (2) of this section unless a waiver port whether a trial burn of PCBs and
from these requirements is obtained PCB Items must be conducted. EPA
pursuant to paragraph (d)(5) of this sec- may require the submission of any
tion. In addition, the incinerator shall other information that EPA finds to be
meet any other requirements that may reasonably necessary to determine the
be prescribed pursuant to paragraph need for a trial burn. Such other infor-
(d)(4) of this section. mation shall be restricted to the types
(1) The mass air emissions from the of information required in paragraphs
incinerator shall be no greater than (d)(1)(i) through (vii) of this section.
0.001g PCB/kg of the PCB introduced (ii) If EPA determines that a trail
into the incinerator.
burn must be held, the person who sub-
(2) The incinerator shall comply with mitted the report described in para-
the provisions of paragraphs (a)(2), (3), graph (d)(1) of this section shall submit
(4), (6), (7), (8)(i) and (ii), and (9) of this
to the Regional Administrator or the
section.
Director, Office of Resource Conserva-
(c) Maintenance of data and records.
tion and Recovery a detailed plan for
All data and records required by this
conducting and monitoring the trail
section shall be maintained in accord-
burn. At a minimum, the plan must in-
ance with § 761.180, Records and moni-
toring. clude:
(d) Approval of incinerators. Prior to (A) Date trial burn is to be con-
the incineration of PCBs and PCB ducted;
Items the owner or operator of an in- (B) Quantity and type of PCBs and
cinerator shall receive the written ap- PCB Items to be incinerated;
proval of the Agency Regional Admin- (C) Parameters to be monitored and
istrator for the region in which the in- location of sampling points;
cinerator is located, or the appropriate (D) Sampling frequency and methods
official at EPA Headquarters. Approval and schedules for sample analyses; and
from the appropriate official at EPA (E) Name, address, and qualifications
Headquarters may be effective in all of persons who will review analytical
ten EPA regions. Such approval shall results and other pertinent data, and
be obtained in the following manner: who will perform a technical evalua-
(1) Application. The owner or operator tion of the effectiveness of the trial
shall submit to the Regional Adminis- burn.
trator or the Director, Office of Re- (iii) Following receipt of the plan de-
source Conservation and Recovery an scribed in paragraph (d)(2)(ii) of this
application which contains: section, EPA will approve the plan, re-
(i) The location of the incinerator; quire additions or modifications to the
(ii) A detailed description of the in- plan, or disapprove the plan. If the plan
cinerator including general site plans is disapproved, EPA will notify the per-
and design drawings of the incinerator; son who submitted the plan of such dis-
(iii) Engineering reports or other in- approval, together with the reasons
formation on the anticipated perform- why it is disapproved. That person may
ance of the incinerator; thereafter submit a new plan in accord-
(iv) Sampling and monitoring equip- ance with paragraph (d)(2)(ii) of this
ment and facilities available; section. If the plan is approved (with
(v) Waste volumes expected to be in- any additions or modifications which
cinerated; EPA may prescribe), EPA will notify
(vi) Any local, State, or Federal per- the person who submitted the plan of
mits or approvals; and the approval. Thereafter, the trial burn
(vii) Schedules and plans for com- shall take place at a date and time to
plying with the approval requirements be agreed upon between EPA and the
of this regulation. person who submitted the plan.
218
(3) Other information. In addition to writing and included as part of the ap-
the information contained in the re- proval.
port and plan described in paragraphs (6) Persons approved. An approval will
(d)(1) and (2) of this section, EPA may designate the persons who own and who
require the owner or operator to sub- are authorized to operate the inciner-
mit any other information that the ator, and will apply only to such per-
EPA finds to be reasonably necessary sons, except as provided in paragraph
to determine whether an incinerator (d)(8) of this section.
shall be approved. (7) Final approval. Approval of an in-
cinerator will be in writing and signed
NOTE: The Regional Administrator will
have available for review and inspection an
by the appropriate EPA official. The
Agency manual containing information on approval will state all requirements
sampling methods and analytical procedures applicable to the approved incinerator.
for the parameters required in § 761.70(a) (3), (8) Transfer of property. Any person
(4), (6), and (7) plus any other parameters he/ who owns or operates an approved in-
she may determine to be appropriate. Owners cinerator must notify EPA at least 30
or operators are encouraged to review this days before transferring ownership in
manual prior to submitting any report re- the incinerator or the property it
quired in § 761.70.
stands upon, or transferring the right
(4) Contents of approval. (i) Except as to operate the incinerator. The trans-
provided in paragraph (d)(5) of this sec- feror must also submit to EPA, at least
tion, the Regional Administrator or 30 days before such transfer, a nota-
the appropriate official at EPA Head- rized affidavit signed by the transferee
quarters may not approve an inciner- which states that the transferee will
ator for the disposal of PCBs and PCB abide by the transferor’s EPA inciner-
Items unless he finds that the incinerator approval. Within 30 days of receiv-
ator meets all of the requirements of ing such notification and affidavit,
paragraphs (a) and/or (b) of this sec- EPA will issue an amended approval
tion. substituting the transferee’s name for
(ii) In addition to the requirements of the transferor’s name, or EPA may re-
paragraphs (a) and/or (b) of this sec- quire the transferee to apply for a new
tion, EPA may include in an approval incinerator approval. In the latter
any other requirements that EPA finds case, the transferee must abide by the
are necessary to ensure that operation transferor’s EPA approval until EPA
of the incinerator does not present an issues the new approval to the trans-
unreasonable risk of injury to health feree.
or the environment from PCBs. Such (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
requirements may include a fixed pe- 2605)
riod of time for which the approval is
[44 FR 31542, May 31, 1979. Redesignated at 47
valid.
FR 19527, May 6, 1982, and amended at 48 FR
(5) Waivers. An owner or operator of 13185, Mar. 30, 1983; 49 FR 28191, July 10, 1984;
the incinerator may submit evidence to 53 FR 12524, Apr. 15, 1988; 58 FR 15809, Mar. 24,
the Regional Administrator or the Di- 1993; 63 FR 35439, June 29, 1998; 72 FR 57240,
rector, Office of Resource Conservation Oct. 9, 2007; 74 FR 30233, June 25, 2009]
and Recovery that operation of the in-
cinerator will not present an unreason- § 761.71 High efficiency boilers.
able risk of injury to health or the en- (a) To burn mineral oil dielectric
vironment from PCBs, when one or fluid containing a PCB concentration
more of the requirements of paragraphs of ≥50 ppm, but <500 ppm:
(a) and/or (b) of this section are not (1) The boiler shall comply with the
met. On the basis of such evidence and following criteria:
any other available information, EPA (i) The boiler is rated at a minimum
may, in its discretion, find that any re- of 50 million BTU hours.
quirement of paragraphs (a) and (b) of (ii) If the boiler uses natural gas or
this section is not necessary to protect oil as the primary fuel, the carbon
against such a risk, and may waive the monoxide concentration in the stack is
requirements in any approval for that ≤50 ppm and the excess oxygen is at
incinerator. Any finding and waiver least 3 percent when PCBs are being
under this paragraph must be stated in burned.
219
§ 761.71 40 CFR Ch. I (7–1–17 Edition)
(iii) If the boiler uses coal as the pri- (iii) The carbon monoxide concentra-
mary fuel, the carbon monoxide con- tion and the excess oxygen percentage
centration in the stack is ≤100 ppm and in the stack of the boiler when it is op-
the excess oxygen is at least 3 percent erated in a manner similar to the man-
when PCBs are being burned. ner in which it will be operated when
(iv) The mineral oil dielectric fluid mineral oil dielectric fluid is burned.
does not comprise more than 10 percent (iv) The type of equipment, appa-
(on a volume basis) of the total fuel ratus, and procedures to be used to
feed rate. control the feed of mineral oil dielec-
(v) The mineral oil dielectric fluid is tric fluid to the boiler and to monitor
not fed into the boiler unless the boiler and record the carbon monoxide con-
is operating at its normal operating centration and excess oxygen percent-
temperature (this prohibits feeding age in the stack.
these fluids during either start up or (3) When burning mineral oil dielec-
shut down operations). tric fluid, the boiler must operate at a
(vi) The owner or operator of the level of output no less than the output
boiler: at which the measurements required
(A) Continuously monitors and under paragraph (a)(2)(iii) of this sec-
records the carbon monoxide con- tion were taken.
centration and excess oxygen percent- (4) Any person burning mineral oil di-
age in the stack gas while burning min- electric fluid in a boiler obtains the
eral oil dielectric fluid; or following information and retains the
(B) If the boiler will burn <30,000 gal- information for 5 years at the boiler lo-
lons of mineral oil dielectric fluid per cation:
year, measures and records the carbon (i) The data required to be collected
monoxide concentration and excess ox- under paragraphs (a)(1)(vi) and (vii) of
ygen percentage in the stack gas at this section.
regular intervals of no longer than 60 (ii) The quantity of mineral oil di-
minutes while burning mineral oil dielectric fluid burned in the boiler each
electric fluid. month.
(vii) The primary fuel feed rates, (b) To burn liquids, other than min-
mineral oil dielectric fluid feed rates, eral oil dielectric fluid, containing a
and total quantities of both primary PCB concentration of ≥50 ppm, but <500
fuel and mineral oil dielectric fluid fed ppm:
to the boiler are measured and re- (1) The boiler shall comply with the
corded at regular intervals of no longer following criteria:
than 15 minutes while burning mineral (i) The boiler is rated at a minimum
oil dielectric fluid. of 50 million BTU/hour.
(viii) The carbon monoxide con- (ii) If the boiler uses natural gas or
centration and the excess oxygen per- oil as the primary fuel, the carbon
centage are checked at least once monoxide concentration in the stack is
every hour that mineral oil dielectric ≤50 ppm and the excess oxygen is at
fluid is burned. If either measurement least 3 percent when PCBs are being
falls below the levels specified in this burned.
section, the flow of mineral oil dielec- (iii) If the boiler uses coal as the pri-
tric fluid to the boiler shall be stopped mary fuel, the carbon monoxide con-
immediately. centration in the stack is ≤100 ppm and
(2) Thirty days before any person the excess oxygen is at least 3 percent
burns mineral oil dielectric fluid in the when PCBs are being burned.
boiler, the person gives written notice (iv) The waste does not comprise
to the EPA Regional Administrator for more than 10 percent (on a volume
the EPA Region in which the boiler is basis) of the total fuel feed rate.
located and that the notice contains (v) The waste is not fed into the boil-
the following information: er unless the boiler is operating at its
(i) The name and address of the normal operating temperature (this
owner or operator of the boiler and the prohibits feeding these fluids during ei-
address of the boiler. ther start up or shut down operations).

(ii) The boiler rating in units of BTU/ (vi) The owner or operator of the
hour. boiler must:
220
(A) Continuously monitor and record (vi) The concentration of PCBs and of
the carbon monoxide concentration any other chlorinated hydrocarbon in
and excess oxygen percentage in the the waste and the results of analyses
stack gas while burning waste fluid; or using the ASTM International methods
(B) If the boiler will burn <30,000 gal- as follows: Carbon and hydrogen con-
lons of waste fluid per year, measure tent using ASTM D3178–84, nitrogen
and record the carbon monoxide con- content using ASTM E258–67 (Re-
centration and excess oxygen percent- approved 1987), sulfur content using
age in the stack gas at regular inter- ASTM D2784–89, ASTM D1266–87, or
vals of no longer than 60 minutes while ASTM D129–64 (Reapproved 1978), chlo-
burning waste fluid. rine content using ASTM D808–87,
(vii) The primary fuel feed rate, water and sediment content using ei-
waste fluid feed rate, and total quan- ther ASTM D2709–88 or ASTM D1796–83
tities of both primary fuel and waste (Reapproved 1990), ash content using
fluid fed to the boiler must be meas- ASTM D482–87, calorific value using
ured and recorded at regular intervals ASTM D240–87, carbon residue using ei-
of no longer than 15 minutes while ther ASTM D2158–89 or ASTM D524–88,
burning waste fluid. and flash point using ASTM D93–09 (all
(viii) The carbon monoxide con- standards incorporated by reference in
centration and the excess oxygen per- § 761.19).
centage must be checked at least once (vii) The quantity of wastes esti-
every hour that the waste is burned. If mated to be burned in a 30–day period.
either measurement falls below the (viii) An explanation of the proce-
levels specified in either (a)(1)(ii) or dures to be followed to ensure that
(a)(1)(iii) of this section, the flow of burning the waste will not adversely
waste to the boiler shall be stopped im- affect the operation of the boiler such
mediately. that combustion efficiency will de-
(2) Prior to any person burning these crease.
liquids in the boiler, approval must be (3) On the basis of the information in
obtained from the EPA Regional Ad- paragraph (b)(2) of this section and any
ministrator for the EPA Region in other available information, the Re-
which the boiler is located and any per- gional Administrator may, at his/her
sons seeking such approval must sub- discretion, find that the alternate dis-
mit to the EPA Regional Adminis- posal method will not present an un-
trator a request containing at least the reasonable risk of injury to health or
following information: the environment and approve the use of
(i) The name and address of the the boiler.
owner or operator of the boiler and the (4) When burning PCB wastes, the
address of the boiler. boiler must operate at a level of output
(ii) The boiler rating in units of BTU/ no less than the output at which the
hour. measurements required under para-
(iii) The carbon monoxide concentra- graph (b)(2)(iii) of this section were
tion and the excess oxygen percentage taken.
in the stack of the boiler when it is op- (5) Any person burning liquids in
erated in a manner similar to the man- boilers approved as provided in para-
ner in which it will be operated when graph (b)(3) of this section, must obtain
low concentration PCB liquid is the following information and retain
burned. the information for 5 years at the boil-
(iv) The type of equipment, appa- er location:
ratus, and procedures to be used to (i) The data required to be collected
control the feed of mineral oil dielec- in paragraphs (b)(1)(vi) and (b)(1)(vii) of
tric fluid to the boiler and to monitor this section.
and record the carbon monoxide con- (ii) The quantity of low concentra-
centration and excess oxygen percent- tion PCB liquid burned in the boiler
age in the stack. each month.
(v) The type of waste to be burned (iii) The analysis of the waste re-
(e.g., hydraulic fluid, contaminated quired by paragraph (b)(2)(vi) of this
fuel oil, heat transfer fluid, etc.). section taken once a month for each
221
§ 761.72 40 CFR Ch. I (7–1–17 Edition)
month during which low concentration (7) Emissions from the secondary
PCB liquid is burned in the boiler. chamber must be vented through an ex-
[63 FR 35454, June 29, 1998, as amended at 77
haust gas stack in accordance with ei-
FR 2464, Jan. 18, 2012] ther:
(i) State or local air regulations or
§ 761.72 Scrap metal recovery ovens permits, or
and smelters. (ii) The standards in paragraph (a)(8)
Any person may dispose of residual of this section.
PCBs associated with PCB-Contami- (8) Exhaust gas stack emissions shall
nated articles regulated for disposal be for: particulates <0.015 grains/dry
under § 761.60(b), metal surfaces in PCB standard cubic foot, sulfur dioxide <35
remediation waste regulated under parts per million by volume (ppmv), ni-
§ 761.61, or metal surfaces in PCB bulk trogen oxide <150 ppmv, carbon mon-
product waste regulated under oxide <35 ppmv, and hydrogen chloride
§§ 761.62(a)(6) and 761.79(c)(6), from <35 ppmv.
which all free-flowing liquids have been (9) A measurement of the tempera-
removed: ture in the secondary chamber at the
(a) In a scrap metal recovery oven: time the primary chamber starts heat-
(1) The oven shall have at least two ing must be taken, recorded and re-
enclosed (i.e., negative draft, no fugi- tained at the facility for 3 years from
tive emissions) interconnected cham- the date each charge is introduced into
bers. the primary chamber.
(2) The equipment with all free-flow- (b) By smelting:
ing liquid removed shall first be placed (1) The operating temperature of the
in the primary chamber at room tem- hearth must be at least 1,000 °C at the
perature. time it is charged with any PCB-Con-
(3) The primary chamber shall oper- taminated non-porous surface.
ate at a temperature between 537 °C (2) Each charge containing a PCB-
and 650 °C for a minimum of 21⁄2 hours Contaminated item must be added into
and reach a minimum temperature of molten metal or a hearth at ≥1,000 °C.
650 °C (1,202 °F) once during each heat- (3) Successive charges may not be in-
ing cycle or batch treatment of troduced into the hearth in less than
unheated, liquid-free equipment. 15–minute intervals.
(4) Heated gases from the primary (4) The smelter must operate in com-
chamber must feed directly into the pliance with any applicable emissions
secondary chamber (i.e., afterburner) standards in part 60 of this chapter.
which must operate at a minimum (5) The smelter must have an oper-
temperature of 1,200 °C (2,192 °F) with ational device which accurately meas-
at least a 3 percent excess oxygen and ures directly or indirectly, the tem-
a retention time of 2.0 seconds with a perature in the hearth.
minimum combustion efficiency of 99.9 (6) Take, record and retain at the dis-
percent according to the definition in posal facility for 3 years from the date
§ 761.70(a)(2). each charge is introduced, a reading of
(5) Heating of the primary chamber the temperature in the hearth at the
shall not commence until the sec- time it is charged with a non-porous
ondary chamber has reached a tem- surface item.
perature of 1,200 ±100 °C (2,192 ° ±180 °F). (c)(1) Scrap metal recovery ovens and
(6) Continuous emissions monitors smelters must either have a final per-
and recorders for carbon dioxide, car- mit under RCRA (part 266, subpart H of
bon monoxide, and excess oxygen in this chapter and § 270.66 of this chapter)
the secondary chamber and continuous or be operating under a valid State air
temperature recorders in the primary emissions permit which includes a
and secondary chambers shall be in- standard for PCBs.
stalled and operated while the primary (2) Scrap metal recovery ovens and
and secondary chambers are in oper- smelters disposing of PCBs must pro-
ation to assure that the two chambers vide notification as disposers of PCBs,
are within the operating parameters in are not required to submit annual re-
paragraphs (a)(3) through (a)(5) of this ports, and shall otherwise comply with
section. all applicable provisions of subparts J
222
and K of this part, as well as other ap- formations such as large-area clay
plicable Federal, State, and local laws pans. Where this is not possible, the
and regulations. soil shall have a high clay and silt con-
(3) In lieu of the requirements in tent with the following parameters:
paragraph (c)(1) of this section, upon (i) In-place soil thickness, 4 feet or
written request by the owner or oper- compacted soil liner thickness, 3 feet;
ator of a scrap metal recovery oven or (ii) Permeability (cm/sec), equal to or
smelter, the EPA Regional Adminis- less than 1 × 10¥7;
trator, for the Region where the oven
(iii) Percent soil passing No. 200
or smelter is located, may make a find-
ing in writing, based on a site-specific Sieve, >30;
risk assessment, that the oven or (iv) Liquid Limit, >30; and
smelter does not pose an unreasonable (v) Plasticity Index >15.
risk of injury to health or the environ- (2) Synthetic membrane liners. Syn-
ment because it is operating in compli- thetic membrane liners shall be used
ance with the parameters and condi- when, in the judgment of the Regional
tions listed in paragraph (a) or (b) of Administrator, the hydrologic or geo-
this section even though the oven or logic conditions at the landfill require
smelter does not have a RCRA or State such a liner in order to provide at least
air permit as required by paragraph a permeability equivalent to the soils
(c)(1) of this section. The written rein paragraph (b)(1) of this section.
quest shall include a site-specific risk Whenever a synthetic liner is used at a
assessment. landfill site, special precautions shall
(d) PCB liquids, other liquid waste be taken to insure that its integrity is
qualifying as waste oils which may be maintained and that it is chemically
used as provided for at § 761.20(e), or compatible with PCBs. Adequate soil
PCB remediation waste, other than underlining and soil cover shall be pro-
PCB-Contaminated articles, may not vided to prevent excessive stress on the
be disposed of in a scrap metal recov-
liner and to prevent rupture of the
ery oven or smelter unless approved or
liner. The liner must have a minimum
otherwise allowed under subpart D of
thickness of 30 mils.
this part.
(3) Hydrologic conditions. The bottom
[63 FR 35455, June 29, 1998, as amended at 64 of the landfill shall be above the histor-
FR 33761, June 24, 1999] ical high groundwater table as provided
§ 761.75 Chemical waste landfills. below. Floodplains, shorelands, and
groundwater recharge areas shall be
This section applies to facilities used avoided. There shall be no hydraulic
to dispose of PCBs in accordance with connection between the site and stand-
the part. ing or flowing surface water. The site
(a) General. A chemical waste landfill shall have monitoring wells and leach-
used for the disposal of PCBs and PCB
ate collection. The bottom of the land-
Items shall be approved by the Agency
fill liner system or natural in-place
Regional Administrator pursuant to
soil barrier shall be at least fifty feet
paragraph (c) of this section. The land-
from the historical high water table.
fill shall meet all of the requirements
specified in paragraph (b) of this sec- (4) Flood protection. (i) If the landfill
tion, unless a waiver from these re- site is below the 100-year floodwater
quirements is obtained pursuant to elevation, the operator shall provide
paragraph (c)(4) of this section. In addi- surface water diversion dikes around
tion, the landfill shall meet any other the perimeter of the landfill site with a
requirements that may be prescribed minimum height equal to two feet
pursuant to paragraph (c)(3) of this sec- above the 100-year floodwater ele-
tion. vation.
(b) Technical requirements. Require- (ii) If the landfill site is above the
ments for chemical waste landfills used 100-year floodwater elevation, the oper-
for the disposal of PCBs and PCB Items ators shall provide diversion structures
are as follows: capable of diverting all of the surface

(1) Soils. The landfill site shall be lo- water runoff from a 24-hour, 25-year
cated in thick, relatively impermeable storm.
223
§ 761.75 40 CFR Ch. I (7–1–17 Edition)
(5) Topography. The landfill site shall following parameters, and all data and
be located in an area of low to mod- records of the sampling and analysis
erate relief to minimize erosion and to shall be maintained as required in
help prevent landslides or slumping. § 761.180(d)(1). Sampling methods and
(6) Monitoring systems—(i) Water sam- analytical procedures for these param-
pling. (A) For all sites receiving PCBs, eters shall comply with those specified
the ground and surface water from the in 40 CFR part 136 as amended in 41 FR
disposal site area shall be sampled 52779 on December 1, 1976.
prior to commencing operations under (A) PCBs.
an approval provided in paragraph (c) (B) pH.
of this section for use as baseline data. (C) Specific conductance.
(B) Any surface watercourse des- (D) Chlorinated organics.
ignated by the Regional Administrator
(7) Leachate collection. A leachate col-
using the authority provided in para-
lection monitoring system shall be in-
graph (c)(3)(ii) of this section shall be
stalled above the chemical waste land-
sampled at least monthly when the
fill. Leachate collection systems shall
landfill is being used for disposal oper-
ations. be monitored monthly for quantity and
(C) Any surface watercourse des- physicochemical characteristics of
ignated by the Regional Administrator leachate produced. The leachate should
using the authority provided in para- be either treated to acceptable limits
graph (c)(3)(ii) of this section shall be for discharge in accordance with a
sampled for a time period specified by State or Federal permit or disposed of
the Regional Administrator on a fre- by another State or Federally approved
quency of no less than once every six method. Water analysis shall be con-
months after final closure of the dis- ducted as provided in paragraph
posal area. (b)(6)(iii) of this section. Acceptable
(ii) Groundwater monitor wells. (A) If leachate monitoring/collection systems
underlying earth materials are homog- shall be any of the following designs,
enous, impermeable, and uniformly unless a waiver is obtained pursuant to
sloping in one direction, only three paragraph (c)(4) of this section.
sampling points shall be necessary. (i) Simple leachate collection. This sys-
These three points shall be equally tem consists of a gravity flow
spaced on a line through the center of drainfield installed above the waste
the disposal area and extending from disposal unit liner. This design is rec-
the area of highest water table ele- ommended for use when semi-solid or
vation to the area of the lowest water leachable solid wastes are placed in a
table elevation on the property. lined pit excavated into a relatively
(B) All monitor wells shall be cased thick, unsaturated, homogenous layer
and the annular space between the of low permeability soil.
monitor zone (zone of saturation) and (ii) Compound leachate collection. This
the surface shall be completely system consists of a gravity flow
backfilled with Portland cement or an drainfield installed above the waste
equivalent material and plugged with disposal unit liner and above a sec-
Portland cement to effectively prevent ondary installed liner. This design is
percolation of surface water into the recommended for use when semi-liquid
well bore. The well opening at the sur- or leachable solid wastes are placed in
face shall have a removable cap to pro- a lined pit excavated into relatively
vide access and to prevent entrance of permeable soil.
rainfall or stormwater runoff. The well (iii) Suction lysimeters. This system
shall be pumped to remove the volume consists of a network of porous ceramic
of liquid initially contained in the well cups connected by hoses/tubing to a
before obtaining a sample for analysis. vacuum pump. The porous ceramic
The discharge shall be treated to meet cups or suction lysimeters are installed
applicable State or Federal discharge along the sides and under the bottom
standards or recycled to the chemical of the waste disposal unit liner. This
waste landfill. type of system works best when in-

(iii) Water analysis. As a minimum, stalled in a relatively permeable un-
all samples shall be analyzed for the saturated soil immediately adjacent to
224
the bottom and/or sides of the disposal Liquid ignitable wastes are wastes that
facility. have a flash point less than 60 °C (140
(8) Chemical waste landfill operations. °F) as determined by the following
(i) PCBs and PCB Items shall be placed method or an equivalent method: Flash
in a landfill in a manner that will pre- point of liquids shall be determined by
vent damage to containers or articles. a Pensky-Martens Closed Cup Tester,
Other wastes placed in the landfill that using the protocol specified in ASTM
are not chemically compatible with D93–09, or the Setaflash Closed Tester
PCBs and PCB Items including organic using the protocol specified in ASTM
solvents shall be segregated from the D3278–89 (all standards incorporated by
PCBs throughout the waste handling reference in § 761.19).
and disposal process. (iv) Records shall be maintained for
(ii) An operation plan shall be devel- all PCB disposal operations and shall
oped and submitted to the Regional include information on the PCB con-
Administrator for approval as required centration in liquid wastes and the
in paragraph (c) of this section. This three dimensional burial coordinates
plan shall include detailed expla- for PCBs and PCB Items. Additional
nations of the procedures to be used for records shall be developed and main-
recordkeeping, surface water handling tained as required in § 761.180.
procedures, excavation and backfilling, (9) Supporting facilities. (i) A six foot
waste segregation burial coordinates, woven mesh fence, wall, or similar de-
vehicle and equipment movement, use vice shall be placed around the site to
of roadways, leachate collection sys- prevent unauthorized persons and ani-
tems, sampling and monitoring proce- mals from entering.
dures, monitoring wells, environmental (ii) Roads shall be maintained to and
emergency contingency plans, and se- within the site which are adequate to
curity measures to protect against support the operation and maintenance
vandalism and unauthorized waste of the site without causing safety or
placements. EPA guidelines entitled nuisance problems or hazardous condi-
‘‘Thermal Processing and Land Dis- tions.
posal of Solid Waste’’ (39 FR 29337, Aug. (iii) The site shall be operated and
14, 1974) are a useful reference in prepa- maintained in a manner to prevent
ration of this plan. If the facility is to safety problems or hazardous condi-
be used to dispose of liquid wastes con- tions resulting from spilled liquids and
taining between 50 ppm and 500 ppm windblown materials.
PCB, the operations plan must include (c) Approval of chemical waste landfills.
procedures to determine that liquid Prior to the disposal of any PCBs and
PCBs to be disposed of at the landfill PCB Items in a chemical waste landfill,
do not exceed 500 ppm PCB and meas- the owner or operator of the landfill
ures to prevent the migration of PCBs shall receive written approval of the
from the landfill. Bulk liquids not ex- Agency Regional Administrator for the
ceeding 500 ppm PCBs may be disposed Region in which the landfill is located.
of provided such waste is pretreated The approval shall be obtained in the
and/or stabilized (e.g., chemically following manner:
fixed, evaporated, mixed with dry inert (1) Initial report. The owner or oper-
absorbant) to reduce its liquid content ator shall submit to the Regional Ad-
or increase its solid content so that a ministrator an initial report which
non-flowing consistency is achieved to contains:
eliminate the presence of free liquids (i) The location of the landfill;
prior to final disposal in a landfill. PCB (ii) A detailed description of the
Container of liquid PCBs with a con- landfill including general site plans
centration between 50 and 500 ppm PCB and design drawings;
may be disposed of if each container is (iii) An engineering report describing
surrounded by an amount of inert the manner is which the landfill com-
sorbant material capable of absorbing plies with the requirements for chem-
all of the liquid contents of the conical waste landfills specified in para-
tainer. graph (b) of this section;

(iii) Ignitable wastes shall not be dis- (iv) Sampling and monitoring equip-
posed of in chemical waste landfills. ment and facilities available;
225
§ 761.75 40 CFR Ch. I (7–1–17 Edition)
(v) Expected waste volumes of PCBs; tion are not met. On the basis of such
(vi) General description of waste ma- evidence and any other available infor-
terials other than PCBs that are ex- mation, the Regional Administrator
pected to be disposed of in the landfill; may in his discretion find that one or
(vii) Landfill operations plan as re- more of the requirements of paragraph
quired in paragraph (b) of this section; (b) of this section is not necessary to
(viii) Any local, State, or Federal protect against such a risk and may
permits or approvals; and waive the requirements in any ap-
(ix) Any schedules or plans for com-
proval for that landfill. Any finding
plying with the approval requirements
and waiver under this paragraph will
of these regulations.
(2) Other information. In addition to be stated in writing and included as
the information contained in the re- part of the approval.
port described in paragraph (c)(1) of (5) Persons approved. Any approval
this section, the Regional Adminis- will designate the persons who own and
trator may require the owner or oper- who are authorized to operate the
ator to submit any other information chemical waste landfill, and will apply
that the Regional Administrator finds only to such persons, except as pro-
to be reasonably necessary to deter- vided by paragraph (c)(7) of this sec-
mine whether a chemical waste landfill tion.
should be approved. Such other infor- (6) Final approval. Approval of a
mation shall be restricted to the types chemical waste landfill will be in writ-
of information required in paragraphs ing and will be signed by the Regional
(c)(1) (i) through (ix) of this section. Administrator. The approval will state
(3) Contents of approval. (i) Except as all requirements applicable to the ap-
provided in paragraph (c)(4) of this sec- proved landfill.
tion the Regional Administrator may (7) Transfer of property. Any person
not approve a chemical waste landfill
who owns or operates an approved
for the disposal of PCBs and PCB
chemical waste landfill must notify
Items, unless he finds that the landfill
EPA at least 30 days before transfer-
meets all of the requirements of para-
graph (b) of this section. ring ownership in the property or
(ii) In addition to the requirements of transferring the right to conduct the
paragraph (b) of this section, the Re- chemical waste landfill operation. The
gional Administrator may include in transferor must also submit to EPA, at
an approval any other requirements or least 30 days before such transfer, a no-
provisions that the Regional Adminis- tarized affidavit signed by the trans-
trator finds are necessary to ensure feree which states that the transferee
that operation of the chemical waste will abide by the transferor’s EPA
landfill does not present an unreason- chemical waste landfill approval. With-
able risk of injury to health or the en- in 30 days of receiving such notifica-
vironment from PCBs. Such provisions tion and affidavit, EPA will issue an
may include a fixed period of time for amended approval substituting the
which the approval is valid. transferee’s name for the transferor’s
The approval may also include a stipu- name, or EPA may require the trans-
lation that the operator of the chem- feree to apply for a new chemical waste
ical waste landfill report to the Re- landfill approval. In the latter case, the
gional Administrator any instance transferee must abide by the trans-
when PCBs are detectable during moni- feror’s EPA approval until EPA issues
toring activities conducted pursuant to the new approval to the transferee.
paragraph (b)(6) of this section.
(4) Waivers. An owner or operator of a (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
chemical waste landfill may submit 2605)
evidence to the Regional Adminis- [44 FR 31542, May 31, 1979. Redesignated at 47
trator that operation of the landfill FR 19527, May 6, 1982, and amended at 48 FR
will not present an unreasonable risk 5730, Feb. 8, 1983; 49 FR 28191, July 10, 1984; 53
of injury to health or the environment FR 12524, Apr. 15, 1988; 53 FR 21641, June 9,
from PCBs when one or more of the re- 1988; 57 FR 13323, Apr. 16, 1992; 63 FR 35456,
quirements of paragraph (b) of this sec- June 29, 1998; 77 FR 2464, Jan. 18, 2012]
226
§ 761.77 Coordinated approval. son who owns or operates the facility is

(a) General requirements. Notwith- aware of and will adhere to the TSCA
standing any other provision of this PCB reporting and recordkeeping re-
part, the EPA Regional Administrator quirements at subparts J and K of this
for the Region in which a PCB disposal part.
or PCB commercial storage facility de- (ii) The EPA Regional Administrator
scribed in paragraphs (b) and (c) of this shall review the request for complete-
section is located may issue a TSCA ness, for compliance with the require-
PCB Coordinated Approval to the per- ments of paragraphs (b) and (c) of this
sons described in those paragraphs if section, and to ensure that the PCB ac-
the conditions listed in this section are tivity for which approval is requested
met. A TSCA PCB Coordinated Ap- will not present an unreasonable risk
proval will designate the persons who of injury to health or the environment.
own and who are authorized to operate The EPA Regional Administrator shall
the facilities described in paragraphs either:
(b) and (c) of this section and will apply (A) Issue a written notice of defi-
only to such persons. All requirements, ciency explaining why the request for
conditions, and limitations of any approval is deficient. If appropriate,
other permit or waste management the EPA Regional Administrator may
document cited or described in para- either:
graphs (b) and (c) of this section, as the (1) Request additional information to
technical or legal basis on which the cure the deficiency.
TSCA PCB Coordinated Approval is (2) Deny the request for a TSCA PCB
issued, are conditions of the TSCA PCB Coordinated Approval.
Coordinated Approval. (B) Issue a letter granting or denying
(1) Persons seeking a TSCA PCB Co- the TSCA PCB Coordinated Approval.
ordinated Approval shall submit a re- If the EPA Regional Administrator
quest for approval by certified mail, to grants the TSCA PCB Coordinated Ap-
the EPA Regional Administrator for proval, he or she may acknowledge the
the Region in which the activity will non-TSCA approval meets the regu-
take place. Persons seeking a TSCA latory requirements under TSCA as
PCB Coordinated Approval for a new written, or require additional condi-
PCB activity shall submit the request tions the EPA Regional Administrator
for approval at the same time they has determined are necessary to pre-
seek a permit, approval, or other ac- vent unreasonable risk of injury to
tion for a PCB waste management ac- health or the environment.
tivity under any other Federal or State (C) If the EPA Regional Adminis-
authority. trator denies a request for a Coordi-
(i) The request for a TSCA PCB Co- nated Approval under paragraphs
ordinated Approval shall include a (a)(1)(ii)(A) or (a)(1)(ii)(B) of this sec-
copy of the letter from EPA announc- tion, the person who requested the
ing or confirming the EPA identifica- TSCA PCB Coordinated Approval may
tion number issued to the facility for submit an application for a TSCA Dis-
conducting PCB activities; the name, posal Approval.
organization, and telephone number of (2) The EPA Regional Administrator
the person who is the contact point for may issue a notice of deficiency, re-
the non-TSCA Federal or State waste voke the TSCA PCB Coordinated Ap-
management authority; a copy of the proval, require the person to whom the
relevant permit or waste management TSCA PCB Coordinated Approval was
document specified in paragraphs (b) issued to submit an application for a
and (c) of this section, including all re- TSCA PCB approval, or bring an en-
quirements, conditions, and limita- forcement action under TSCA if he or
tions, if the EPA Regional Adminis- she determines that:
trator does not have a copy of the doc- (i) Conditions of the approval relat-
ument, or a description of the waste ing to PCB waste management activi-
management activities to be conducted ties are not met.
if a permit or other relevant waste (ii) The PCB waste management

management document has not been process is being operated in a manner
issued; and a certification that the per- which may result in an unreasonable
227
§ 761.79 40 CFR Ch. I (7–1–17 Edition)
risk of injury to health or the environ- (2) Complies with the terms and con-
ment. ditions of the permit or other decision
(iii) The non-TSCA approval expires, or enforcement document described in
is revoked, is suspended, or otherwise paragraph (b)(1) of this section.
ceases to be in full effect. (3) Unless otherwise waived or modi-
(3) Any person with a TSCA PCB Co- fied in writing by the EPA Regional
ordinated Approval must notify the Administrator, complies with
EPA Regional Administrator in writ- § 761.75(b); § 761.70(a)(1) through (a)(9),
ing within 5 calendar days of changes (b)(1) and (b)(2), and (c); or the PCB
relating to PCB waste requirements in storage requirements at §§ 761.65(a), (c),
the non-TSCA waste management doc- and (d)(2), as appropriate.
ument which serves as the basis for a (4) Complies with the reporting and
TSCA PCB Coordinated Approval. recordkeeping requirements in sub-
Changes in the ownership of a commer- parts J and K of this part.
cial storage facility which holds a (c) A person conducting research and
TSCA PCB Coordinated Approval shall development (R&D) into PCB disposal
be handled pursuant to § 761.65(j). methods (regardless of PCB concentra-
(b) Any person who owns or operates tion), or conducting PCB remediation
a facility that he or she intends to use activities may apply for a TSCA PCB
to landfill PCB wastes; incinerate PCB Coordinated Approval. The EPA Re-
wastes; dispose of PCB wastes using an gional Administrator may approve the
alternative disposal method that is request if the EPA Regional Adminis-
equivalent to disposal in an incinerator trator determines that the activity
approved under § 761.70 or a high effi- will not pose an unreasonable risk of
ciency boiler operating in compliance injury to health or the environment
with § 761.71; or stores PCB wastes may and the person:
apply for a TSCA PCB Coordinated Ap- (1)(i) Has a permit or other decision
proval. The EPA Regional Adminis- and enforcement document issued or
trator may approve the request if the otherwise agreed to by EPA, or permit
EPA Regional Administrator deter- or other decision and enforcement doc-
mines that the activity will not pose ument issued by an authorized State
an unreasonable risk of injury to Director for a State program that has
health or the environment and the per- been approved by EPA, which exercises
son: control over the management of PCB
(1)(i) Has a waste management per- wastes, and that person is in compli-
mit or other decision or enforcement ance with all terms and conditions of
document which exercises control over that document; or
PCB wastes, issued by EPA or an au- (ii) Has a permit, which exercises
thorized State Director for a State pro- control over the management of PCB
gram that has been approved by EPA wastes, issued by a State Director pur-
and is no less stringent in protection of suant to a State PCB disposal program
health or the environment than the ap- no less stringent than the require-
plicable TSCA requirements found in ments in this part.
this part; or (2) Complies with the terms and con-
(ii) Has a PCB waste management ditions of that permit or other decision
permit or other decision or enforce- and enforcement document.
ment document issued by a State Di- (3) Complies with the reporting and
rector pursuant to a State PCB waste recordkeeping requirements in sub-
management program no less stringent parts J and K of this part.
in protection of health or the environ-
ment than the applicable TSCA re- [63 FR 35456, June 29, 1998]
quirements found in this part; or
(iii) Is subject to a waste manage- § 761.79 Decontamination standards
ment permit or other decision or en- and procedures.
forcement document which is applica- (a) Applicability. This section estab-
ble to the disposal of PCBs and which lishes decontamination standards and
was issued through the promulgation procedures for removing PCBs, which
of a regulation published in Title 40 of are regulated for disposal, from water,
the Code of Federal Regulations. organic liquids, non-porous surfaces
228
(including scrap metal from disassem- μg/L (approximately <3 ppb) or a PCB
bled electrical equipment), concrete, discharge limit included in a permit
and non-porous surfaces covered with a issued under section 307(b) or 402 of the
porous surface, such as paint or coat- Clean Water Act; or
ing on metal. (iii) Less than or equal to 0.5 μg/L
(1) Decontamination in accordance (i.e., approximately ≤0.5 ppb PCBs) for
with this section does not require a dis- unrestricted use.
posal approval under subpart D of this (2) The decontamination standard for
part. organic liquids and non-aqueous inor-
(2) Materials from which PCBs have ganic liquids containing PCBs is <2
been removed by decontamination in milligrams per kilogram (i.e., <2 ppm
accordance with this section may be PCBs).
distributed in commerce in accordance (3) The decontamination standard for
with § 761.20(c)(5). non-porous surfaces in contact with
(3) Materials from which PCBs have liquid and non-liquid PCBs is:
been removed by decontamination in (i) For unrestricted use:
accordance with this section may be (A) For non-porous surfaces pre-
used or reused in accordance with viously in contact with liquid PCBs at
§ 761.30(u). any concentration, where no free-flow-
(4) Materials from which PCBs have ing liquids are currently present, ≤10
been removed by decontamination in micrograms PCBs per 100 square centi-
accordance with this section, not in- meters (≤10 μg/100 cm2) as measured by
cluding decontamination waste and re- a standard wipe test (§ 761.123) at loca-
siduals under paragraph (g) of this sections selected in accordance with sub-
tion, are unregulated for disposal under part P of this part.
subpart D of this part. (B) For non-porous surfaces in con-
(5) Any person decontaminating po- tact with non-liquid PCBs (including
rous surfaces other than concrete non-porous surfaces covered with a po-
under paragraph (b)(4) of this section rous surface, such as paint or coating
and non-porous surfaces covered with a on metal), cleaning to Visual Standard
porous surface, such as paint or coat- No. 2, Near-White Blast Cleaned Sur-
ing on metal, under paragraph (b)(3) or face Finish, of the National Associa-
(c)(6) of this section must obtain an al- tion of Corrosion Engineers (NACE). A
ternative decontamination approval in person shall verify compliance with
accordance with paragraph (h) of this standard No. 2 by visually inspecting
section. all cleaned areas.
(6) Any person engaging in decon- (ii) For disposal in a smelter oper-
tamination under this section is re- ating in accordance with § 761.72(b):
sponsible for determining and com- (A) For non-porous surfaces pre-
plying with all other applicable Fed- viously in contact with liquid PCBs at
eral, State, and local laws and regula- any concentration, where no free-flow-
tions. ing liquids are currently present, <100
(b) Decontamination standards. Chop- μg/100 cm2 as measured by a standard
ping (including wire chopping), dis- wipe test (§ 761.123) at locations se-
tilling, filtering, oil/water separation, lected in accordance with subpart P of
spraying, soaking, wiping, stripping of this part.
insulation, scraping, scarification or (B) For non-porous surfaces in con-
the use of abrasives or solvents may be tact with non-liquid PCBs (including
used to remove or separate PCBs, to non-porous surfaces covered with a po-
the following standards, from liquids, rous surface, such as paint or coating
concrete, or non-porous surfaces. on metal), cleaning to Visual Standard
(1) The decontamination standard for No. 3, Commercial Blast Cleaned Sur-
water containing PCBs is: face Finish, of the National Associa-
(i) Less than 200 μg/L (i.e., <200 ppb tion of Corrosion Engineers (NACE). A
PCBs) for non-contact use in a closed person shall verify compliance with
system where there are no releases; standard No. 3 by visually inspecting
(ii) For water discharged to a treat- all cleaned areas.

ment works (as defined in § 503.9(aa) of (4) The decontamination standard for
this chapter) or to navigable waters, <3 concrete is ≤10 μg/100 cm2 as measured
229
§ 761.79 40 CFR Ch. I (7–1–17 Edition)
by a standard wipe test (§ 761.123) if the (v) Drain the PODF from the sur-
decontamination procedure is com- faces.
menced within 72 hours of the initial (vi) Dispose of the drained PODF in
spill of PCBs to the concrete or portion accordance with paragraph (g) of this
thereof being decontaminated. section.
(c) Self-implementing decontamination (4) Any person decontaminating a
procedures. The following self-imple- non-porous surface in contact with
menting decontamination procedures free-flowing MODEF containing >10,000
are available as an alternative to the ppm PCB in MODEF or askarel PCB
measurement-based decontamination (up to 70 percent PCB in a mixture of
methods specified in paragraph (b) of trichlorobenzenes and
this section. Any person performing tetrachlorobenzenes) must do so as fol-
self-implementing decontamination lows:
must comply with one of the following (i) Drain the free-flowing MODEF or
procedures. askarel and allow the residual surfaces
(1) Any person decontaminating a to drain for an additional 15 hours.
PCB Container must do so by flushing (ii) Dispose of drained MODEF or
the internal surfaces of the container askarel according to paragraph (g) of
three times with a solvent containing this section.
<50 ppm PCBs. Each rinse shall use a (iii) Soak the surfaces to be decon-
volume of the flushing solvent equal to taminated in a sufficient amount of
approximately 10 percent of the PCB clean PODF (containing <2 ppm PCBs)
Container capacity. such that there is a minimum of 800 ml
(2) Any person decontaminating mov- of PODF for each 100 cm2 of contami-
able equipment contaminated by PCBs, nated or potentially contaminated sur-
tools, and sampling equipment may do face for at least 15 hours at ≥20 °C.
so by: (iv) Approved PODFs include:
(i) Swabbing surfaces that have con- (A) Kerosene.
tacted PCBs with a solvent; (B) Diesel fuel.
(ii) A double wash/rinse as defined in (C) Terpene hydrocarbons.
subpart S of this part; or (D) Mixtures of terpene hydrocarbons
(iii) Another applicable decontamina- and terpene alcohols.
tion procedure in this section. (v) Drain the PODF from the sur-
(3) Any person decontaminating a faces.
non-porous surface in contact with (vi) Dispose of the drained PODF in
free-flowing mineral oil dielectric fluid accordance with paragraph (g) of this
(MODEF) at levels ≤10,000 ppm PCBs section.
must do so as follows: (vii) Resoak the surfaces to be decon-
(i) Drain the free-flowing MODEF and taminated, pursuant to paragraph
allow the residual surfaces to drain for (c)(3)(iii) of this section, in a sufficient
an additional 15 hours. amount of clean PODF (containing <2
(ii) Dispose of drained MODEF ac- ppm PCBs) such that there is a min-
cording to paragraph (g) of this sec- imum of 800 ml of PODF for each 100
tion. cm2 of surface for at least 15 hours at
(iii) Soak the surfaces to be decon- ≥20 °C.
taminated in a sufficient amount of (viii) Drain the PODF from the sur-
clean (containing <2 ppm PCBs) per- faces.
formance-based organic decontamina- (ix) Dispose of the drained PODF in
tion fluid (PODF) such that there is a accordance with paragraph (g) of this
minimum of 800 ml of PODF for each section.
100 cm2 of contaminated or potentially (5) Any person decontaminating pip-
contaminated surface for at least 15 ing and air lines in an air compressor
hours at ≥20 °C. system must do so as follows:
(iv) Approved PODFs include: (i) Before decontamination proceeds,
(A) Kerosene. disconnect or bypass the air compres-
(B) Diesel fuel. sors and air dryers from the piping and
(C) Terpene hydrocarbons. air lines and decontaminate the air

(D) Mixtures of terpene hydrocarbons compressors and air dryers separately
and terpene alcohols. in accordance with paragraphs (b),
230
(c)(1) through (c)(4), or (c)(6) of this (2) The solvent may be reused for de-
section. Dispose of filter media and contamination so long as its PCB con-
desiccant in the air dyers based on centration is <50 ppm.
their existing PCB concentration. (3) Solvent shall be disposed of under
(ii) Test the connecting line and ap- paragraph (g) of this section.
purtenances of the system to assure (4) Other than as allowed in para-
that there is no leakage. Test by intro- graphs (c)(3) and (c)(4) of this section,
ducing air into the closed system at solvents may be tested and validated
from 90 to 100 pounds per square inch for performance-based decontamina-
(psi). Only if there is a pressure drop of tion of non-porous surfaces contami-
<5 psi in 30 minutes may decontamina- nated with MODEF or other PCB liq-
tion take place. uids, in accordance with the self-imple-
(iii) When there is no leakage, fill the menting procedures found in subpart T
piping and air lines with clean (con- of this part. Specific conditions for the
taining <2 ppm PCBs) solvent. Solvents performance-based testing from this
include PODF, aqueous potassium hy- validation are determined in the vali-
droxide at a pH between 9 and 12, or dation study.
water containing 5 percent sodium hy- (e) Limitation of exposure and control
droxide by weight. of releases. (1) Any person conducting
decontamination activities under this
(iv) Circulate the solvent to achieve
section shall take necessary measures
turbulent flow through the piping and
to protect against direct release of
air lines in the air compressor system
PCBs to the environment from the de-
until the total volume of solvent cir-
contamination area.
culated equals 10 times the total vol-
(2) Persons participating in decon-
ume of the particular article being de-
tamination activities shall wear or use
contaminated, then drain the solvent.
protective clothing or equipment to
Calculate the total volume of solvent
protect against dermal contact or inha-
circulated by multiplying the pump
lation of PCBs or materials containing
rate by the time of pumping. Turbulent
PCBs.
flow means a Reynolds number range (f) Sampling and recordkeeping. (1)
from 20,000 to 43,000. Refill the system Confirmatory sampling is required
with clean solvent and repeat the cir- under paragraph (b) of this section. For
culation and drain process. liquids described in paragraphs (b)(1)
(6) Any person using thermal proc- and (b)(2) of this section, sample in ac-
esses to decontaminate metal surfaces cordance with §§ 761.269 and 761.272. For
in contact with PCBs, as required by non-porous surfaces and concrete de-
§ 761.62(a)(6), must use one of the fol- scribed in paragraphs (b)(3) and (b)(4) of
lowing options: this section, sample in accordance with
(i) Surfaces in contact with liquid subpart P of this part. A written record
and non-liquid PCBs at concentrations of such sampling must be established
<500 ppm may be decontaminated in a and maintained for 3 years from the
scrap metal recovery oven or smelter date of any decontamination under this
for purposes of disposal in accordance section. The record must show sam-
with § 761.72. pling locations and analytical results
(ii) Surfaces in contact with liquid or and must be retained at the site of the
non-liquid PCBs at concentrations ≥500 decontamination or a copy of the
ppm may be smelted in a smelter oper- record must be made available to EPA
ating in accordance with § 761.72(b), but in a timely manner, if requested. In ad-
must first be decontaminated in ac- dition, recordkeeping is required in ac-
cordance with § 761.72(a) or to a surface cordance with § 761.180(a) for all wastes
concentration of <100 μg/100 cm2. generated by a decontamination proc-
(d) Decontamination solvents. (1) Un- ess and regulated for disposal under
less otherwise provided in paragraphs this subpart.
(c)(3) through (c)(5) of this section, the (2) Confirmatory sampling is not re-
solubility of PCBs in any solvent used quired for self-implementing decon-
for purposes of decontamination under tamination procedures under para-

this section must be 5 percent or more graph (c) of this section. Any person
by weight. using these procedures must retain a
231
§ 761.79 40 CFR Ch. I (7–1–17 Edition)
written record documenting compli- take place, for decontamination activ-

ance with the procedures for 3 years ity occurring in a single EPA Region;
after completion of the decontamina- or to the Director, Office of Resource
tion procedures (e.g., video recordings, Conservation and Recovery, for decon-
photographs). tamination activity occurring in more
(g) Decontamination waste and resi- than one EPA Region. Each application
dues. Decontamination waste and resi- must describe the material to be de-
dues shall be disposed of at their exist- contaminated and the proposed decon-
ing PCB concentration unless other- tamination method, and must dem-
wise specified. onstrate that the proposed method is
(1) Distillation bottoms or residues capable of decontaminating the mate-
and filter media are regulated for dis- rial to the applicable level set out in
posal as PCB remediation waste. paragraphs (b)(1) through (b)(4) of this
(2) PCBs physically separated from section.
regulated waste during decontamina- (2) Any person wishing to decontami-
tion (such as by chopping, shredding, nate material described in paragraph
scraping, abrading or oil/water separa- (a) of this section using a self-imple-
tion, as opposed to solvent rinsing and menting procedure other than pre-
soaking), other than wastes described scribed in paragraph (c) of this section
in paragraph (g)(1) of this section, are must apply in writing to the Regional
regulated for disposal at their original Administrator in the Region where the
concentration. activity would take place, for decon-
(3) Hydrocarbon solvent used or re-
tamination activity occurring in a sin-
used for decontamination under this
gle EPA Region; or to the Director, Of-
section that contains <50 ppm PCB
fice of Resource Conservation and Re-
must be burned and marketed in ac-
covery, for decontamination activity
cordance with the requirements for
occurring in more than one EPA Re-
used oil in § 761.20(e), disposed of in ac-
gion. Each application must describe
cordance with § 761.60(a) or (e), or de-
the material to be decontaminated and
contaminated pursuant to this section.
the proposed self-implementing decon-
(4) Chlorinated solvent at any PCB
tamination method and must include a
concentration used for decontamina-
proposed validation study to confirm
tion under this section shall be dis-
posed of in an incinerator operating in performance of the method.
compliance with § 761.70, or decontami- (3) Any person wishing to sample de-
nated pursuant to this section. contaminated material in a manner
(5) Solvents ≥50 ppm other than those other than prescribed in paragraph (f)
described in paragraphs (g)(3) and (g)(4) of this section must apply in writing to
of this section shall be disposed of in the Regional Administrator in the Re-
accordance with § 761.60(a) or decon- gion where the activity would take
taminated pursuant to this section. place, for decontamination activity oc-
(6) Non-liquid cleaning materials and curring in a single EPA Region; or to
personal protective equipment waste at the Director, Office of Resource Con-
any concentration, including non-po- servation and Recovery, for decon-
rous surfaces and other non-liquid ma- tamination activity occurring in more
terials such as rags, gloves, booties, than one EPA Region. Each application
other disposable personal protective must contain a description of the ma-
equipment, and similar materials re- terial to be decontaminated, the nature
sulting from decontamination shall be and PCB concentration of the contami-
disposed of in accordance with nating material (if known), the decon-
§ 761.61(a)(5)(v). tamination method, the proposed sam-
(h) Alternative decontamination or sampling procedure, and a justification for
pling approval. (1) Any person wishing how the proposed sampling is equiva-
to decontaminate material described in lent to or more comprehensive than
paragraph (a) of this section in a man- the sampling procedure required under
ner other than prescribed in paragraph paragraph (f) of this section.
(b) of this section must apply in writ- (4) EPA may request additional infor-
ing to the Regional Administrator in mation that it believes necessary to
the Region where the activity would evaluate the application.
232
(5) EPA will issue a written decision each of the following conditions are
on each application for risk-based de- met:
contamination or sampling. No person (i) The samples must be shipped in 5.0
may conduct decontamination or sam- ml or less, hermetically sealed vials.
pling under this paragraph prior to ob- (ii) The exemption is limited to no
taining written approval from EPA. more than 250 total samples per year.
EPA will approve an application if it (iii) Unison makes quarterly inspec-
finds that the proposed decontamina- tions of its laboratories to ensure that
tion or sampling method will not pose proper safety procedures are being fol-
an unreasonable risk of injury to lowed.
health or the environment. (iv) Unison annually notifies and de-
scribes to EPA its attempts to have
FR 33761, June 24, 1999; 72 FR 57240, Oct. 9,
samples analyzed abroad.
2007; 74 FR 30233, June 25, 2009] (2) [Reserved]
(e) The Administrator grants a class
exemption to all research and develop-
Subpart E—Exemptions ment (R&D) facilities for a period of 1
§ 761.80 Manufacturing, processing year to manufacture or import PCBs
and distribution in commerce ex- for use solely in the manufacturer or
emptions. importer’s own research for the devel-
opment of PCB disposal technologies.
(a) The Administrator grants the fol- Each person that wishes to be part of
lowing petitioner(s) an exemption for 1 the exemption must meet the following
year to process and distribute in com- conditions:
merce PCBs for use as a mounting me- (1) A petition for an exemption from
dium in microscopy: the PCB prohibition on manufacturing
(1) McCrone Accessories Components, PCBs must be received by EPA 60 days
Division of Walter C. McCrone Associ- prior to engaging in these activities.
ates, Inc., 2820 South Michigan Avenue, (2) Requests for renewal must be filed
Chicago, IL. 60616. pursuant to § 750.11 of this chapter.
(2) [Reserved] EPA will deem any properly filed re-
(b) The Administrator grants the fol- quest for the renewal of the exemption
lowing petitioner(s) an exemption for 1 by any member of the class as a re-
year to process and distribute in com- newal request for the entire class.
merce PCBs for use as a mounting me- (3) The quantity of the PCBs manu-
dium in microscopy, an immersion oil factured annually must not exceed 500
in low fluorescence microscopy and an grams by total weight of pure PCBs.
optical liquid: Any person who wishes to manufacture
(1) R.P. Cargille Laboratories, Inc., 55 or import more than 500 grams of PCBs
Commerce Road, Cedar Grove, N.J. in 1 year must receive written approval
07009. from the Director, National Program
(2) [Reserved] Chemicals Division to exceed the limi-
(c) The Administrator grants the fol- tations established by this provision.
lowing petitioner(s) an exemption for 1 The Director, National Program
year to export PCBs for use in small Chemicals Division may grant approval
quantities for research and develop- without further rulemaking. Any in-
ment: crease granted will be in writing and
(1) Accu-Standard, New Haven, CT. will extend only for a maximum of the
06503. time remaining in a specific exemption
(2) ManTech, Research Triangle year.
Park, NC 27709. (4) The owner or operator of the facil-
(d) The Administrator grants the fol- ity must notify the EPA Regional Ad-
lowing petitioner(s) an exemption for 1 ministrator in writing 30 days prior to
year to import (manufacture) into the the commencement of R&D activities
United States, small quantities of ex- that include the manufacture or im-
isting PCB fluids from electrical equip- port of PCBs under the exemption, un-
ment for analysis: less the facility has obtained a PCB

(1) Unison Transformer Services, R&D approval from EPA pursuant to
Inc., Tarrytown, N.Y. 10591, provided § 761.60(e), § 761.60(i)(2), § 761.70(a), or
233
§ 761.80 40 CFR Ch. I (7–1–17 Edition)
§ 761.70(b) and the approval contains a samples derived from actual waste ma-
provision allowing the manufacture of terials:
PCBs. (1) R.T. Corporation, Laramie, WY
(5) Records are maintained of their 82070.
PCB activities for a period of 3 years (2) [Reserved]
after ceasing operations. The records (i) The Administrator grants a class
must include the sources and the an- exemption to all persons who manufac-
nual amounts of PCBs received if im- ture, import, process, distribute in
ported and the type and annual amount commerce, or export PCBs, or analyt-
of PCBs that were manufactured. ical reference samples derived from
(6) All PCBs and materials con- PCB waste material, provided the PCBs
taining PCBs, regardless of concentra- are manufactured, imported, processed,
tion, remaining from the disposal-re- distributed in commerce, or exported
lated studies must be disposed of ac- solely for the purpose of R&D and the
cording to § 761.60(j)(1)(vi), or decon- following conditions are met:
taminated pursuant to § 761.79, based on
(1) Notification in the form of a peti-
the original PCB concentration.
tion for an exemption from the PCB
(f) The Administrator grants the fol-
prohibitions on manufacture, import,
lowing petitioner(s) an exemption for 1
processing, distribution in commerce,
year to manufacture PCBs for use in
or export is received by EPA 60 days
small quantities for research and de-
prior to engaging in these activities.
velopment:
(1) California Bionuclear Corp., Sun (2) Requests for renewal are filed pur-
Valley, CA 91352 (ME–13). suant to §§ 750.11 and 750.31 of this chap-
(2) Foxboro Co., North Haven, CT ter. EPA will deem any properly filed
06473 (ME–6). request for the renewal of the exemp-
(3) ULTRA-Scientific, Inc.,Hope, RI tion by any member of the class as a
02831 (ME–99.1). renewal request for the entire class.
(4) Midwest Research Institute, Kan- (3) The PCBs are packaged in one or
sas City, MO 64110 (ME–70.1). more hermetically sealed containers of
(5) Pathfinder Laboratories, St. a volume of no more than 5.0 ml each.
Louis, MO 63146 (A division of Sigma Analytical reference samples derived
Aldridge Corporation, St. Louis, MO, from PCB waste material may be pack-
63178 (ME–76). aged in a container larger than 5.0 ml
(6) Radian Corp., Austin, TX 78766 when packaged pursuant to applicable
(ME–81.2). DOT performance standards.
(7) Wellington Sciences USA, College (4) The quantity of PCBs manufac-
Station, TX 77840 (ME–104.1). tured, imported, processed, distributed
(8) Accu-Standard, 25 Science Park, in commerce, or exported annually
New Haven, CT. 06503. must not exceed 500 grams by total
(g) The Administrator grants a class weight of pure PCBs. Any person who
exemption to all processors and dis- expects to manufacture, import, proc-
tributors of PCBs in small quantities ess, distribute in commerce, or export
for research and development provided more than 500 grams of PCBs in 1 year
that the following conditions are met: or to exceed the 5.0 ml packaging re-
(1) All processors and distributors quirement must obtain a written ap-
must maintain records of their PCB ac- proval from the Director, National Pro-
tivities for a period of 5 years. gram Chemicals Division and must
(2) Any person or company which ex- identify the sites of PCB activities and
pects to process or distribute in com- the quantity of PCBs to be manufac-
merce 100 grams (.22 lb) or more PCBs tured, imported, processed, distributed
in 1 year must report to EPA identi- in commerce, or exported. Each request
fying the sites of PCB activities and must include a justification. The Di-
the quantity of PCBs to be processed or rector, National Program Chemicals
distributed in commerce. Division, may grant approval without
(h) The Administrator grants the fol- further rulemaking. Any increase
lowing petitioners an exemption for 1 granted will be in writing and will ex-
year to process and distribute in com- tend only for a maximum of the time
merce PCBs for analytical reference remaining in a specific exemption year.
234
(5) All treated and untreated PCB tion must be submitted to EPA and it
regulated material and material com- will be addressed through an exemption
ing into contact with regulated mate- rulemaking. In such a case, the activi-
rial must be stored and disposed of ac- ties granted under the existing exemp-
cording to subpart D of this part, or de- tion may continue until the new peti-
contaminated pursuant to § 761.79. tion is addressed by rulemaking, but
(6) All PCB materials must be dis- must conform to the terms of the exist-
tributed in DOT-authorized packaging. ing exemption approved by EPA. The 1–
(7) Records are maintained of their year exemption granted to petitioners
PCB activities for a period of 3 years in paragraphs (c)(2), (h) and (m)(7) of
after ceasing operations. The records this section may be extended pursuant
must include the sources and the an- to 40 CFR 750.11(e) or 750.31(e).
nual amounts of PCBs received if im- (o) The 1–year class exemption grant-
ported, the annual amount of PCBs ed to all processors and distributors of
that were manufactured, the annual PCBs in small quantities for research
amount of PCBs that were processed and development in paragraph (g) of
and/or distributed in commerce (to in- this section shall be renewed automati-
clude export), and the persons to whom cally unless information is submitted
the PCBs were shipped. affecting EPA’s conclusion that the
(j) The Administrator grants the class exemption, or the activities of
United States Defense Logistics Agen- any individual or company included in
cy’s April 23, 2013 petition for an ex- the exemption, will not pose an unrea-
emption for 1 year beginning on Octo- sonable risk of injury to health or the
ber 1, 2014, to import up to 1,014,222 environment. EPA will evaluate the in-
pounds of PCBs and PCB Items stored formation, issue a proposed rule for
or in use in Japan as identified in its public comment, and issue a final rule
petition for disposal. affecting the class exemption or indi-
(k)–(l) [Reserved] viduals or companies included in the
(m) The Administrator grants the class exemption. Until EPA issues a
following petitioner(s) an exemption final rule, individuals and companies
for 1 year to process and export small included in the class exemption will be
quantities of PCBs for research and de- allowed to continue processing and dis-
velopment: tributing PCBs in small quantities for
(1) Chem Service, Inc., West Chester, research and development.
PA 19380 (PDE–41).
[55 FR 38999, Sept. 24, 1990, as amended at 59
(2) Foxboro Co., North Haven, CT
FR 16998, Apr. 11, 1994; 63 FR 35460, June 29,
06473 (ME–6). 1998; 68 FR 4941, Jan. 31, 2003; 72 FR 53158,
(3) PolyScience Corp., Niles, IL 60648 Sept. 18, 2007; 79 FR 58270, Sept. 29, 2014]
(PDE–178).
(4) ULTRA-Scientific, Inc., Hope, RI
02831 (PDE–282.1).
Subpart F—Transboundary
(5) Supelco, Inc., Bellefonte, PA Shipments of PCBs for Disposal
16823–0048 (PDE–41.2).
(6) Radian Corp., Austin, TX 78766 SOURCE: 61 FR 11107, Mar. 18, 1996, unless
(PDE–182.1). otherwise noted.
(7) Restek Corporation, Bellefonte,
PA § 761.91 Applicability.
(n) The 1–year exemption granted to This subpart establishes require-
petitioners in paragraphs (a) through ments under section 6 of TSCA applica-
(c)(1), (d), (f), and (m)(1) through (m)(6) ble to the transboundary shipments of
of this section shall be renewed auto- PCBs and PCB Items into and out of
matically as long as there is no in- the United States for disposal. Nothing
crease in the amount of PCBs to be in this subpart is intended to obviate
processed and distributed, imported or otherwise alter obligations applica-
(manufactured), or exported, nor any ble to imported or exported PCBs and
change in the manner of processing and PCB Items under foreign laws, inter-
distributing, importing (manufac- national agreements or arrangements,

turing), or exporting of PCBs. If there other United States statutes and regu-
is such a change, a new exemption peti- lations, other sections of TSCA (e.g.,
235
§ 761.93 40 CFR Ch. I (7–1–17 Edition)
sections 13 and 14), or laws of the var- United States, provided that the PCB
ious States of the United States. No waste or the PCBs from which the
provision of this section shall be con- waste was derived were present in the
strued to affect or limit the applica- United States on January 1, 1979, and
bility of any requirement applicable to have remained within the United
transporters of PCB waste under regu- States since that date.
lations issued by the U.S. Department
of Transportation (DOT) and set forth FR 17478, Mar. 30, 2001]
at 49 CFR parts 171-180.
§ 761.93 Import for disposal. Subpart G—PCB Spill Cleanup

(a) General provisions. No person may Policy
import PCBs or PCB Items for disposal
without an exemption issued under the SOURCE: 52 FR 10705, Apr. 2, 1987, unless
authority of TSCA section 6(e)(3). otherwise noted.
(b) [Reserved]
§ 761.120 Scope.
[63 FR 35460, June 29, 1998]
(a) General. This policy establishes
§ 761.97 Export for disposal. criteria EPA will use to determine the
adequacy of the cleanup of spills re-
(a) General provisions. No person sulting from the release of materials
may export PCBs or PCB Items for dis- containing PCBs at concentrations of
posal without an exemption, except 50 ppm or greater. The policy applies to
that: spills which occur after May 4, 1987.
(1) PCBs and PCB Items at con- (1) Existing spills (spills which oc-
centrations <50 ppm (or <10 μg PCB/100 curred prior to May 4, 1987, are ex-
cm2 if no free-flowing liquids are cluded from the scope of this policy for
present) may be exported for disposal. two reasons:
(2) For the purposes of this section, (i) For old spills which have already
PCBs and PCB Items of unknown con- been discovered, this policy is not in-
centrations shall be treated as if they tended to require additional cleanup
contain ≥50 ppm. where a party has already cleaned a
(b) [Reserved] spill in accordance with requirements
[61 FR 11107, Mar. 18, 1996, as amended at 63 imposed by EPA through its regional
FR 35460, June 29, 1998] offices, nor is this policy intended to
interfere with ongoing litigation of en-
§ 761.99 Other transboundary ship- forcement actions which bring into
ments. issue PCB spills cleanup.
For purposes of this subpart, the fol- (ii) EPA recognizes that old spills
lowing transboundary shipments are which are discovered after the effective
not considered exports or imports: date of this policy will require site-by-
(a) PCB waste generated in the site evaluation because of the likeli-
United States, transported outside the hood that the site involves more perva-
Customs Territory of the United States sive PCB contamination than fresh
(including any residuals resulting from spills and because old spills are gen-
cleanup of spills of such wastes in tran- erally more difficult to clean up than
sit) through another country or its ter- fresh spills (particularly on porous sur-
ritorial waters, or through inter- faces such as concrete). Therefore,
national waters, and returned to the spills which occurred before the effec-
United States for disposal. tive date of this policy are to be decon-
(b) PCB waste in transit, including taminated to requirements established
any residuals resulting from cleanup of at the discretion of EPA, usually
spills during transit, through the through its regional offices.
United States (e.g., from Mexico to (2) EPA expects most PCB spills sub-
Canada, from Canada to Mexico). ject to the TSCA PCB regulations to
(c) PCB waste transported from any conform to the typical spill situations
State to any other State for disposal, considered in developing this policy.
regardless of whether the waste enters This policy does, however, exclude
or leaves the customs territory of the from application of the final numerical
236
cleanup standards certain spill situa- the authority to require cleanup to lev-
tions from its scope: Spills directly els lower than those included in this
into surface waters, drinking water, policy upon finding that further clean-
sewers, grazing lands, and vegetable up must occur to prevent unreasonable
gardens. These types of spills are sub- risk. The Regional Administrator will
ject to final cleanup standards to be es- consult with the Director, Office of Re-
tablished at the discretion of the resource Conservation and Recovery,
gional office. These spills are, however, prior to making such a finding.
subject to the immediate notification (1) For example, site-specific charac-
requirements and measures to mini- teristics, such as short depth to ground
mize further environmental contami- water, type of soil, or the presence of a
nation. shallow well, may pose exceptionally
(3) For all other spills, EPA generally high potential for ground water con-
expects the decontamination standards tamination by PCBs remaining after
of this policy to apply. Occasionally, cleanup to the standards specified in
some small percentage of spills covered this policy. Spills that pose such a high
by this policy may warrant more strin- degree of potential for ground water
gent cleanup requirements because of contamination have not been excluded
additional routes of exposure or signifi- from the policy under paragraph (d) of
cantly greater exposures than those as- this section because the presence of
sumed in developing the final cleanup such potential may not be readily ap-
standards of this policy. While the EPA parent. EPA feels that automatically
regional offices have the authority to excluding such spills from the scope of
require additional cleanup in these cir- the policy could result in the delay of
cumstances, the Regional Adminis- cleanup—a particularly undesirable
trator must first make a finding based outcome if potential ground water con-
on the specific facts of a spill that ad- tamination is, in fact, a significant
ditional cleanup must occur to prevent concern.
unreasonable risk. In addition, before a (2) In those situations, the Regional
final decision is made to require addi- Administrator may require cleanup in
tional cleanup, the Regional Adminis- addition to that required under
trator must notify the Director, Office § 761.125(b) and (c). However, the Re-
of Resource Conservation and Recovery gional Administrator must first make
of his/her finding and the basis for the a finding, based on the specific facts of
finding. a spill, that additional cleanup is nec-
(4) There may also be exceptional essary to prevent unreasonable risk. In
spill situations that requires less strin- addition, before making a final deci-
gent cleanup or a different approach to sion on additional cleanup, the Re-
cleanup because of factors associated gional Administrator must notify the
with the particular spill. These factors Director, Office of Resource Conserva-
may mitigate expected exposures and tion and Recovery of his finding and
risks or make cleanup to these require- the basis for the finding.
ments impracticable. (c) Flexibility to allow less stringent or
(b) Spills that may require more strin- alternative requirements. EPA retains
gent cleanup levels. For spills within the the flexibility to allow less stringent or
scope of this policy, EPA generally re- alternative decontamination measures
tains, under § 761.135, the authority to based upon site-specific considerations.
require additional cleanup upon finding EPA will exercise this flexibility if the
that, despite good faith efforts by the responsible party demonstrates that
responsible party, the numerical de- cleanup to the numerical decontamina-
contamination levels in the policy tion levels is clearly unwarranted be-
have not been met. In addition, EPA cause of risk-mitigating factors, that
foresees the possibility of exceptional compliance with the procedural re-
spill situations in which site-specific quirements or numerical standards in
risk factors may warrant additional the policy is impracticable at a par-
cleanup to more stringent numerical ticular site, or that site-specific char-
decontamination levels than are re- acteristics make the costs of cleanup
quired by the policy. In these situa- prohibitive. The Regional Adminis-
tions, the Regional Administrator has trator will notify the Director, Office
237
§ 761.123 40 CFR Ch. I (7–1–17 Edition)
of Resource Conservation and Recovery cleanup standards or requirements for

of any decision and the basis for the de- the reporting of spills imposed, or to be
cision to allow less stringent cleanup. imposed, under other Federal statutory
The purpose of this notification is to authorities, including but not limited
enable the Director, Office of Resource to, the Clean Water Act (CWA), the Re-
Conservation and Recovery to ensure source Conservation and Recovery Act
consistency of spill cleanup standards (RCRA), and the Comprehensive Envi-
under special circumstances across the ronmental Response Compensation and
regions. Liability Act of 1980 (CERCLA) as
(d) Excluded spills. (1) Although the amended by the Superfund Amend-
spill situations in paragraphs (d)(2) (i) ments and Reauthorization Act
through (vi) of this section are ex- (SARA). Where more than one require-
cluded from the automatic application ment applies, the stricter standard
of final decontamination standards must be met.
under § 761.125 (b) and (c), the general (2) The Agency recognizes that the
requirements under § 761.125(a) do apply existence of this policy will inevitably
to these spills. In addition, all of these result in attempts to apply the stand-
excluded situations require prac- ards to situations within the scope of
ticable, immediate actions to contain other statutory authorities. However,
the area of contamination. While these other statutes require the Agency to
situations may not always require consider different or alternative fac-
more stringent cleanup measures, the tors in determining appropriate correc-
Agency is excluding these scenarios be- tive actions. In addition, the types and
cause they will always involve signifi- magnitudes of exposures associated
cant factors that may not be ade- with sites requiring corrective action
quately addressed by cleanup standards under other statutes often involve im-
based upon typical spill characteris- portant differences from those ex-
tics. pected of the typical, electrical equip-
(2) For the spill situations in para- ment-type spills considered in devel-
graphs (d)(2)(i) through (vi) of this sec- oping this policy. Thus, cleanups under
tion, the responsible party shall decon- other statutes, such as RCRA correc-
taminate the spill in accordance with tive actions or remedial and response
site-specific requirements established actions under SARA may result in dif-
by the EPA regional offices. ferent outcomes.
(i) Spills that result in the direct [52 FR 10705, Apr. 2, 1987, as amended at 72
contamination of surface waters (sur- FR 57241, Oct. 9, 2007; 74 FR 30234, June 25,
face waters include, but are not limited 2009]
to, ‘‘waters of the United States’’ as
defined in part 122 of this chapter, § 761.123 Definitions.
ponds, lagoons, wetlands, and storage For purposes of this policy, certain
reservoirs). words and phrases are used to denote
(ii) Spills that result in the direct specific materials, procedures, or cir-
contamination of sewers or sewage cumstances. The following definitions
treatment systems. are provided for purposes of clarity and
(iii) Spills that result in the direct are not to be taken as exhaustive lists
contamination of any private or public of situations and materials covered by
drinking water sources or distribution the policy.
systems. Double wash/rinse means a minimum
(iv) Spills which migrate to and con- requirement to cleanse solid surfaces
taminate surface waters, sewers, or (both impervious and nonimpervious)
drinking water supplies before cleanup two times with an appropriate solvent
has been completed in accordance with or other material in which PCBs are at
this policy. least 5 percent soluble (by weight). A
(v) Spills that contaminate animal volume of PCB-free fluid sufficient to
grazing lands. cover the contaminated surface com-
(vi) Spills that contaminate vege- pletely must be used in each wash/
table gradens. rinse. The wash/rinse requirement does

(e) Relationship of policy to other stat- not mean the mere spreading of solvent
utes. (1) This policy does not affect or other fluid over the surface, nor does
238
the requirement mean a once-over wipe less than 500 ppm PCBs, or those PCB-
with a soaked cloth. Precautions must containing materials which EPA re-
be taken to contain any runoff result- quires to be assumed to be at con-
ing from the cleansing and to dispose centrations below 500 ppm (i.e., untest-
properly of wastes generated during ed mineral oil dielectric fluid).
the cleansing. Nonimpervious solid surfaces means
High-concentration PCBs means PCBs solid surfaces which are porous and are
that contain 500 ppm or greater PCBs, more likely to absorb spilled PCBs
or those materials which EPA requires prior to completion of the cleanup re-
to be assumed to contain 500 ppm or quirements prescribed in this policy.
greater PCBs in the absence of testing. Nonimpervious solid surfaces include,
High-contact industrial surface means but are not limited to, wood, concrete,
a surface in an industrial setting which asphalt, and plasterboard.
is repeatedly touched, often for rel- Nonrestricted access areas means any
atively long periods of time. Manned area other than restricted access, out-
machinery and control panels are ex- door electrical substations, and other
amples of high-contact industrial sur- restricted access locations, as defined
faces. High-contact industrial surfaces in this section. In addition to residen-
are generally of impervious solid mate- tial/commercial areas, these areas in-
rial. Examples of low-contact indus- clude unrestricted access rural areas
trial surfaces include ceilings, walls, (areas of low density development and
floors, roofs, roadways and sidewalks population where access is uncon-
in the industrial area, utility poles, un- trolled by either man-made barriers or
manned machinery, concrete pads be- naturally occurring barriers, such as
neath electrical equipment, curbing, rough terrain, mountains, or cliffs).
exterior structural building compo- Other restricted access (nonsubstation)
nents, indoor vaults, and pipes. locations means areas other than elec-
High-contact residential/commercial sur- trical substations that are at least 0.1
face means a surface in a residential/ kilometer (km) from a residential/com-
commercial area which is repeatedly mercial area and limited by man-made
touched, often for relatively long peri- barriers (e.g., fences and walls) to sub-
ods of time. Doors, wall areas below 6 stantially limited by naturally occur-
feet in height, uncovered flooring, ring barriers such as mountains, cliffs,
windowsills, fencing, bannisters, stairs, or rough terrain. These areas generally
automobiles, and children’s play areas include industrial facilities and ex-
such as outdoor patios and sidewalks tremely remote rural locations. (Areas
are examples of high-contact residen- where access is restricted but are less
tial/commercial surfaces. Examples of than 0.1 km from a residential/commer-
low-contact residential/commercial cial area are considered to be residen-
surfaces include interior ceilings, inte- tial/commercial areas.)
rior wall areas above 6 feet in height, Outdoor electrical substations means
roofs, asphalt roadways, concrete road- outdoor, fenced-off, and restricted ac-
ways, wooden utility poles, unmanned cess areas used in the transmission
machinery, concrete pads beneath elec- and/or distribution of electrical power
trical equipment, curbing, exterior Outdoor electrical substations restrict
structural building components (e.g., public access by being fenced or walled
aluminum/vinyl siding, cinder block, off as defined under § 761.30(l)(1)(ii). For
asphalt tiles), and pipes. purposes of this TSCA policy, outdoor
Impervious solid surfaces means solid electrical substations are defined as
surfaces which are nonporous and thus being located at least 0.1 km from a
unlikely to absorb spilled PCBs within residential/commercial area. Outdoor
the short period of time required for fenced-off and restricted access areas
cleanup of spills under this policy. Im- used in the transmission and/or dis-
pervious solid surfaces include, but are tribution of electrical power which are
not limited to, metals, glass, alu- located less than 0.1. km from a resi-
minum siding, and enameled or lami- dential/commercial area are considered
nated surfaces. to be residential/commercial areas.

Low-concentration PCBs means PCBs PCBs means polychlorinated
that are tested and found to contain biphenyls as defined under § 761.3. As
239
§ 761.125 40 CFR Ch. I (7–1–17 Edition)
specified under § 761.1(b), no require- observed plus a buffer zone of 1 foot be-
ments may be avoided through dilution yond the visible traces. Any surface or
of the PCB concentration. object (e.g., concrete sidewalk or auto-
Requirements and standards means: mobile) within the visible traces area
(1) ‘‘Requirements’’ as used in this or on which visible traces of the spilled
policy refers to both the procedural re- material are observed is included in
sponses and numerical decontamina- the spill area. This area represents the
tion levels set forth in this policy as minimum area assumed to be contami-
constituting adequate cleanup of PCBs. nated by PCBs in the absence of
(2) ‘‘Standards’’ refers to the numer- precleanup sampling data and is thus
ical decontamination levels set forth in the minimum area which must be
this policy. cleaned.
Residential/commercial areas means Spill boundaries means the actual
those areas where people live or reside, area of contamination as determined
or where people work in other than by postcleanup verification sampling
manufacturing or farming industries. or by precleanup sampling to deter-
Residential areas include housing and mine actual spill boundaries. EPA can
the property on which housing is lo- require additional cleanup when nec-
cated, as well as playgrounds, road- essary to decontaminate all areas with-
ways, sidewalks, parks, and other simi- in the spill boundaries to the levels re-
lar areas within a residential commu- quired in this policy (e.g., additional
nity. Commercial areas are typically cleanup will be required if postcleanup
accessible to both members of the gen- sampling indicates that the area decon-
eral public and employees and include taminated by the responsible party,
public assembly properties, institu- such as the spill area as defined in this
tional properties, stores, office build- section, did not encompass the actual
ings, and transportation centers. boundaries of PCB contamination).
Responsible party means the owner of Standard wipe test means, for spills of
the PCB equipment, facility, or other high-concentration PCBs on solid sur-
source of PCBs or his/her designated faces, a cleanup to numerical surface
agent (e.g., a facility manager or fore- standards and sampling by a standard
man). wipe test to verify that the numerical
Soil means all vegetation, soils and standards have been met. This defini-
other ground media, including but not tion constitutes the minimum require-
limited to, sand, grass, gravel, and oys- ments for an appropriate wipe testing
ter shells. It does not include concrete protocol. A standard-size template (10
and asphalt. centimeters (cm) × 10 cm) will be used
Spill means both intentional and un- to delineate the area of cleanup; the
intentional spills, leaks, and other un- wiping medium will be a gauze pad or
controlled discharges where the release glass wool of known size which has
results in any quantity of PCBs run- been saturated with hexane. It is im-
ning off or about to run off the exter- portant that the wipe be performed
nal surface of the equipment or other very quickly after the hexane is ex-
PCB source, as well as the contamina- posed to air. EPA strongly recommends
tion resulting from those releases. This that the gauze (or glass wool) be pre-
policy applies to spills of 50 ppm or pared with hexane in the laboratory
greater PCBs. The concentration of and that the wiping medium be stored
PCBs spilled is determined by the PCB in sealed glass vials until it is used for
concentration in the material spilled the wipe test. Further, EPA requires
as opposed to the concentration of the collection and testing of field
PCBs in the material onto which the blanks and replicates.
PCBs were spilled. Where a spill of un- [52 FR 10705, Apr. 2, 1987; 52 FR 23397, June 19,
tested mineral oil occurs, the oil is pre- 1987]
sumed to contain greater than 50 ppm,
but less than 500 ppm PCBs and is sub- § 761.125 Requirements for PCB spill
ject to the relevant requirements of cleanup.
this policy. (a) General. Unless expressly limited,

Spill area means the area of soil on the reporting, disposal, and precleanup
which visible traces of the spill can be sampling requirements in paragraphs
240
(a) (1) through (3) of this section apply (iv) Spills of 10 pounds or less, which
to all spills of PCBs at concentrations are not addressed in paragraph (a)(1) (i)
of 50 ppm or greater which are subject or (ii) of this section, must be cleaned
to decontamination requirements up in accordance with this policy (in
under TSCA, including those spills list- order to avoid EPA enforcement liabil-
ed under § 761.120(b) which are excluded ity), but notification of EPA is not re-
from the cleanup standards at para- quired.
graphs (b) and (c) of this section. (2) Disposal of cleanup debris and mate-
(1) Reporting requirements. The report- rials. All concentrated soils, solvents,
ing in paragraphs (a)(1) (i) through (iv) rags, and other materials resulting
of this section is required in addition from the cleanup of PCBs under this
to applicable reporting requirements policy shall be properly stored, labeled,
under the Clean Water Act (CWA) or and disposed of in accordance with the
the Comprehensive Environmental Re- provisions of subpart D of this part.
sponse Compensation and Liability Act (3) Determination of spill boundaries in
of 1980 (CERCLA). For example, under the absence of visible traces. For spills
the National Contingency Plan all where there are insufficient visible
spills involving 1 pound or more by traces yet there is evidence of a leak or
weight of PCBs must currently be re- spill, the boundaries of the spill are to
ported to the National Response Center be determined by using a statistically
(1-800-424-8802). The requirements in based sampling scheme.
paragraphs (a)(1) (i) through (iv) of this (b) Requirements for cleanup of low-
section are designed to be consistent concentration spills which involve less
with existing reporting requirements than 1 pound of PCBs by weight (less
to the extent possible so as to mini- than 270 gallons of untested mineral oil)—
mize reporting burdens on governments (1) Decontamination requirements. Spills
as well as the regulated community. of less than 270 gallons of untested
mineral oil, low-concentration PCBs,
(i) Where a spill directly contami-
as defined under § 761.123, which involve
nates surface water, sewers, or drink-
less than 1 pound of PCBs by weight
ing water supplies, as discussed under
(e.g., less than 270 gallons of untested
§ 761.120(d), the responsible party shall
mineral oil containing less than 500
notify the appropriate EPA regional of-
ppm PCBs) shall be cleaned in the fol-
fice and obtain guidance for appro- lowing manner:
priate cleanup measures in the shortest (i) Solid surfaces must be double
possible time after discovery, but in no washed/rinsed (as defined under
case later than 24 hours after dis- § 761.123); except that all indoor, resi-
covery. dential surfaces other than vault areas
(ii) Where a spill directly contami- must be cleaned to 10 micrograms per
nates grazing lands or vegetable gar- 100 square centimeters (10 μg/100 cm2)
dens, as discussed under § 761.120(d), the by standard commercial wipe tests.
responsible party shall notify the ap- (ii) All soil within the spill area (i.e.,
propriate EPA regional office and pro- visible traces of soil and a buffer of 1
ceed with the immediate requirements lateral foot around the visible traces)
specified under paragraph (b) or (c) of must be excavated, and the ground be
this section, depending on the source of restored to its original configuration
the spill, in the shortest possible time by back-filling with clean soil (i.e.,
after discovery, but in no case later containing less than 1 ppm PCBs).
than 24 hours after discovery. (iii) Requirements of paragraphs
(iii) Where a spill exceeds 10 pounds (b)(1) (i) and (ii) of this section must be
of PCBs by weight and is not addressed completed within 48 hours after the re-
in paragraph (a)(1) (i) or (ii) of this sec- sponsible party was notified or became
tion, the responsible party will notify aware of the spill.
the appropriate EPA regional office (2) Effect of emergency or adverse
and proceed to decontaminate the spill weather. Completion of cleanup may be
area in accordance with this TSCA pol- delayed beyond 48 hours in case of cir-
icy in the shortest possible time after cumstances including but not limited
discovery, but in no case later than 24 to, civil emergency, adverse weather
hours after discovery. conditions, lack of access to the site,
241
§ 761.125 40 CFR Ch. I (7–1–17 Edition)
and emergency operating conditions. tion spills involving 1 pound or more

The occurrence of a spill on a weekend PCBs by weight (270 gallons or more of
or overtime costs are not acceptable untested mineral oil). Cleanup of low-
reasons to delay response. Completion concentration spills involving 1 lb or
of cleanup may be delayed only for the more PCBs by weight and of all spills
duration of the adverse conditions. If of materials other than low-concentra-
the adverse weather conditions, or tion materials shall be considered com-
time lapse due to other emergency, has plete if all of the immediate require-
left insufficient visible traces, the re- ments, cleanup standards, sampling,
sponsible party must use a statistically and recordkeeping requirements of
based sampling scheme to determine paragraphs (c) (1) through (5) of this
the spill boundaries as required under section are met.
paragraph (a)(3) of this section. (1) Immediate requirements. The four
(3) Records and certification. At the actions in paragraphs (c)(1) (i) through
completion of cleanup, the responsible (iv) of this section must be taken as
party shall document the cleanup with quickly as possible and within no more
records and certification of decon- than 24 hours (or within 48 hours for
tamination. The records and certifi- PCB Transformers) after the respon-
cation must be maintained for a period sible party was notified or became
of 5 years. The records and certifi- aware of the spill, except that actions
cation shall consist of the following: described in paragraphs (c)(1) (ii)
(i) Identification of the source of the through (iv) of this section can be de-
spill (e.g., type of equipment). layed beyond 24 hours if circumstances
(ii) Estimated or actual date and (e.g., civil emergency, hurricane, tor-
time of the spill occurrence. nado, or other similar adverse weather
(iii) The date and time cleanup was conditions, lack of access due to phys-
completed or terminated (if cleanup ical impossibility, or emergency oper-
was delayed by emergency or adverse ating conditions) so require for the du-
weather: the nature and duration of ration of the adverse conditions. The
the delay).
occurrence of a spill on a weekend or
(iv) A brief description of the spill lo-
overtime costs are not acceptable rea-
cation.
sons to delay response. Owners of
(v) Precleanup sampling data used to
spilled PCBs who have delayed cleanup
establish the spill boundaries if re-
because of these types of circumstances
quired because of insufficient visible
must keep records documenting the
traces, and a brief description of the
fact that circumstances precluded
sampling methodology used to estab-
rapid response.
lish the spill boundaries.
(vi) A brief description of the solid (i) The responsible party shall notify
surfaces cleaned and of the double the EPA regional office and the NRC as
wash/rinse method used. required by § 761.125(a)(1) or by other
(vii) Approximate depth of soil exca- applicable statutes.
vation and the amount of soil removed. (ii) The responsible party shall effec-
(viii) A certification statement tively cordon off or otherwise delineate
signed by the responsible party stating and restrict an area encompassing any
that the cleanup requirements have visible traces plus a 3-foot buffer and
been met and that the information con- place clearly visible signs advising per-
tained in the record is true to the best sons to avoid the area to minimize the
of his/her knowledge. spread of contamination as well as the
(ix) While not required for compli- potential for human exposure.
ance with this policy, the following in- (iii) The responsible party shall
formation would be useful if main- record and document the area of visible
tained in the records: contamination, noting the extent of
(A) Additional pre- or post-cleanup the visible trace areas and the center
sampling. of the visible trace area. If there are no
(B) The estimated cost of the cleanup visible traces, the responsible party
by man-hours, dollars, or both. shall record this fact and contact the
(c) Requirements for cleanup of high- regional office of the EPA for guidance
concentration spills and low-concentra- in completing statistical sampling of
242
the spill area to establish spill bound- will be cleaned either to 25 ppm PCBs
aries. by weight, or to 50 ppm PCBs by weight
(iv) The responsible party shall ini- provided that a label or notice is visi-
tiate cleanup of all visible traces of the bly placed in the area. Upon dem-
fluid on hard surfaces and initiate re- onstration by the responsible party
moval of all visible traces of the spill that cleanup to 25 ppm or 50 ppm will
on soil and other media, such as gravel, jeopardize the integrity of the elec-
sand, oyster shells, etc. trical equipment at the substation, the
(v) If there has been a delay in reach- EPA regional office may establish an
ing the site and there are insufficient alternative cleanup method or level
visible traces of PCBs remaining at the and place the responsible party on a
spill site, the responsible party must reasonably timely schedule for comple-
estimate (based on the amount of mation of cleanup.
terial missing from the equipment or
(3) Requirements for decontaminating
container) the area of the spill and im-
spills in other restricted access areas.
mediately cordon off the area of sus-
pect contamination. The responsible Spills which occur in restricted access
party must then utilize a statistically locations other than outdoor electrical
based sampling scheme to identify the substations, as defined under § 761.123,
boundaries of the spill area as soon as shall be decontaminated in accordance
practicable. with paragraphs (c)(3) (i) through (v) of
(vi) Although this policy requires this section. Conformance to the clean-
certain immediate actions, as de- up standards in paragraphs (c)(3) (i)
scribed in paragraphs (c)(1)(i) through through (v) of this section shall be
(iv) of this section, EPA is not placing verified by postcleanup sampling as
a time limit on completion of the specified under § 761.130. At such times
cleanup effort since the time required as restricted access areas other than
for completion will vary from case to outdoor electrical substations are con-
case. However, EPA expects that de- verted to another use, the spill site
contamination will be achieved shall be cleaned up to the nonrestricted
promptly in all cases and will consider access area requirements of paragraph
promptness of completion in deter- (c)(4) of this section.
mining whether the responsible party (i) High-contact solid surfaces, as de-
made good faith efforts to clean up in fined under § 761.163 shall be cleaned to
accordance with this policy. 10 μg/100 cm2 (as measured by standard
(2) Requirements for decontaminating wipe tests).
spills in outdoor electrical substations. (ii) Low-contact, indoor, impervious
Spills which occur in outdoor electrical solid surfaces will be decontaminated
substations, as defined under § 761.123, to 10 μg/100 cm2.
shall be decontaminated in accordance
(iii) At the option of the responsible
with paragraphs (c)(2) (i) and (ii) of this
party, low-contact, indoor, nonimper-
section. Conformance to the cleanup
vious surfaces will be cleaned either to
standards under paragraphs (c)(2) (i)
and (ii) of this section shall be verified 10 μg/100 cm2 or to 100 μg/100 cm2 and
by post-cleanup sampling as specified encapsulated. The Regional Adminis-
under § 761.130. At such times as out- trator, however, retains the authority
door electrical substations are con- to disallow the encapsulation option
verted to another use, the spill site for a particular spill situation upon
shall be cleaned up to the nonrestricted finding that the uncertainties associ-
access requirements under paragraph ated with that option pose special con-
(c)(4) of this section. cerns at that site. That is, the Re-
(i) Contaminated solid surfaces (both gional Administrator would not permit
impervious and non-impervious) shall encapsulation if he/she determined that
be cleaned to a PCB concentration of if the encapsulation failed the failure
100 micrograms (μg)/100 square centi- would create an imminent hazard at
meters (cm2) (as measured by standard the site.
wipe tests). (iv) Low-contact, outdoor surfaces

(ii) At the option of the responsible (both impervious and nonimpervious)
party, soil contaminated by the spill shall be cleaned to 100 μg/100 cm2.
243
§ 761.130 40 CFR Ch. I (7–1–17 Edition)
(v) Soil contaminated by the spill (i) Identification of the source of the
will be cleaned to 25 ppm PCBs by spill, e.g., type of equipment.
weight. (ii) Estimated or actual date and
(4) Requirements for decontaminating time of the spill occurrence.
spills in nonrestricted access areas. Spills (iii) The date and time cleanup was
which occur in nonrestricted access lo- completed or terminated (if cleanup
cations, as defined under § 761.123, shall was delayed by emergency or adverse
be decontaminated in accordance with weather: the nature and duration of
paragraphs (c)(4) (i) through (v) of this the delay).
section. Conformance to the cleanup (iv) A brief description of the spill lo-
standards at paragraphs (c)(4) (i) cation and the nature of the materials
through (v) of this section shall be contaminated. This information should
verified by postcleanup sampling as include whether the spill occurred in
specified under § 761.130. an outdoor electrical substation, other
(i) Furnishings, toys, and other eas- restricted access location, or in a non-
ily replaceable household items shall restricted access area.
be disposed of in accordance with the (v) Precleanup sampling data used to
provisions of subpart D of this part and establish the spill boundaries if re-
replaced by the responsible party. quired because of insufficient visible
(ii) Indoor solid surfaces and high- traces and a brief description of the
contact outdoor solid surfaces, defined sampling methodology used to estab-
as high contact residential/commercial lish the spill boundaries.
surfaces under § 761.123, shall be cleaned (vi) A brief description of the solid
to 10 μg/100 cm2 (as measured by stand- surfaces cleaned.
ard wipe tests). (vii) Approximate depth of soil exca-
(iii) Indoor vault areas and low-con- vation and the amount of soil removed.
tact, outdoor, impervious solid surfaces (viii) Postcleanup verification sam-
shall be decontaminated to 10 μg/100 pling data and, if not otherwise appar-
cm2. ent from the documentation, a brief de-
(iv) At the option of the responsible scription of the sampling methodology
party, low-contact, outdoor, nonimper- and analytical technique used.
vious solid surfaces shall be either (ix) While not required for compli-
cleaned to 10 μg/100 cm2 or cleaned to ance with this policy, information on
100 μg/100 cm2 and encapsulated. The the estimated cost of cleanup (by man-
Regional Administrator, however, re- hours, dollars, or both) would be useful
tains the authority to disallow the en- if maintained in the records.
capsulation option for a particular spill
situation upon finding that the uncer- [52 FR 10705, Apr. 2, 1987, as amended at 53
tainties associated with that option FR 40884, Oct. 19, 1988; 63 FR 35461, June 29,
pose special concerns at that site. That 1998; 72 FR 57241, Oct. 9, 2007]
is, the Regional Administrator would
§ 761.130 Sampling requirements.
not permit encapsulation if he/she de-
termined that if the encapsulation Postcleanup sampling is required to
failed the failure would create an im- verify the level of cleanup under
minent hazard at the site. § 761.125(c) (2) through (4). The respon-
(v) Soil contaminated by the spill sible party may use any statistically
will be decontaminated to 10 ppm PCBs valid, reproducible, sampling scheme
by weight provided that soil is exca- (either random samples or grid sam-
vated to a minimum depth of 10 inches. ples) provided that the requirements of
The excavated soil will be replaced paragraphs (a) and (b) of this section
with clean soil, i.e., containing less are satisfied.
than 1 ppm PCBs, and the spill site will (a) The sampling area is the greater
be restored (e.g., replacement of turf). of (1) an area equal to the area cleaned
(5) Records. The responsible party plus an additional 1-foot boundary, or
shall document the cleanup with (2) an area 20 percent larger than the
records of decontamination. The original area of contamination.
records must be maintained for a pe- (b) The sampling scheme must ensure
riod of 5 years. The records and certifi- 95 percent confidence against false
cation shall consist of the following: positives.
244
(c) The number of samples must be quarters will provide guidance to the
sufficient to ensure that areas of con- EPA regions on the degree of certainty
tamination of a radius of 2 feet or more associated with various grab sample re-
within the sampling area will be de- sults.
tected, except that the minimum num-
ber of samples is 3 and the maximum FR 34465, July 3, 1995; 72 FR 57241, Oct. 9,
number of samples is 40. 2007; 74 FR 30234, June 25, 2009]
(d) The sampling scheme must in-
clude calculation for expected varia- § 761.135 Effect of compliance with
bility due to analytical error. this policy and enforcement.
(e) EPA recommends the use of a (a) Although a spill of material con-
sampling scheme developed by the Mid- taining 50 ppm or greater PCBs is con-
west Research Institute (MRI) for use sidered improper PCB disposal, this
in enforcement inspections: policy establishes requirements that
‘‘Verification of PCB Spill Cleanup by EPA considers to be adequate cleanup
Sampling and Analysis.’’ Guidance for of the spilled PCBs. Cleanup in accord-
the use of this sampling scheme is ance with this policy means compli-
available in the MRI report ‘‘Field ance with the procedural as well as the
Manual for Grid Sampling of PCB Spill numerical requirements of this policy.
Sites to Verify Cleanup.’’ Both the MRI Compliance with this policy creates a
sampling scheme and the guidance doc- presumption against both enforcement
ument are available on EPA’s PCB Web action for penalties and the need for
site at http://www.epa.gov/pcb, or from further cleanup under TSCA. The
the Program Management, Commu- Agency reserves the right, however, to
nications, and Analysis Office, Office of initiate appropriate action to compel
Resource Conservation and Recovery cleanup where, upon review of the
(5305P), 1200 Pennsylvania Ave., NW., records of cleanup or EPA sampling
Washington, DC 20460–0001. The major following cleanup, EPA finds that the
advantage of this sampling scheme is decontamination levels in the policy
that it is designed to characterize the have not been achieved. The Agency
degree of contamination within the en- also reserves the right to seek pen-
tire sampling area with a high degree alties where the Agency believes that
of confidence while using fewer sam- the responsible party has not made a
ples than any other grid or random good faith effort to comply with all
sampling scheme. This sampling provisions of this policy, such as
scheme also allows some sites to be prompt notification of EPA of a spill,
characterized on the basis of composite recordkeeping, etc.
samples. (b) EPA’s exercise of enforcement
(f) EPA may, at its discretion, take discretion does not preclude enforce-
samples from any spill site. If EPA’s ment action under other provisions of
sampling indicates that the remaining TSCA or any other Federal statute.
concentration level exceeds the re- This includes, even in cases where the
quired level, EPA will require further numerical decontamination levels set
cleanup. For this purpose, the numer- forth in this policy have been met, civil
ical level of cleanup required for spills or criminal action for penalties where
cleaned in accordance with § 761.125(b) EPA believes the spill to have been the
is deemed to be the equivalent of nu- result of gross negligence or knowing
merical cleanup requirements required violation.
for cleanups under § 761.125(c) (2)
through (4). Using its best engineering
judgment, EPA may sample a statis-
Subparts H–I [Reserved]
tically valid random or grid sampling
technique, or both. When using engi- Subpart J—General Records and
neering judgment or random ‘‘grab’’ Reports
samples, EPA will take into account
that there are limits on the power of a § 761.180 Records and monitoring.
grab sample to dispute statistically This section contains recordkeeping

based sampling of the type required of and reporting requirements that apply
the responsible party. EPA head- to PCBs, PCB Items, and PCB storage
245
§ 761.180 40 CFR Ch. I (7–1–17 Edition)
and disposal facilities that are subject (i) The name, address, and EPA iden-
to the requirements of the part. tification number of the facility cov-
(a) PCBs and PCB Items in service or ered by the annual document log and
projected for disposal. Beginning Feb- the calendar year covered by the an-
ruary 5, 1990, each owner or operator of nual document log.
a facility, other than a commercial (ii) The unique manifest number of
storer or a disposer of PCB waste, every manifest generated by the facil-
using or storing at any one time at ity during the calendar year, and from
least 45 kilograms (99.4 pounds) of each manifest and for unmanifested
PCBs contained in PCB Container(s), or waste that may be stored at the facil-
one or more PCB Transformers, or 50 or ity, the following information:
more PCB Large High or Low Voltage
(A) For bulk PCB waste (e.g., in a
Capacitors shall develop and maintain
tanker or truck), its weight in kilo-
at the facility, or a central facility pro-
grams, the first date it was removed
vided they are maintained at that fa-
cility, all annual records and the writ- from service for disposal, the date it
ten annual document log of the disposi- was placed into transport for off-site
tion of PCBs and PCB Items. The writ- storage or disposal, and the date of dis-
ten annual document log must be pre- posal, if known.
pared for each facility by July 1 cov- (B) The serial number (if available)
ering the previous calendar year (Janu- or other means of identifying each PCB
ary through December). The annual Article (e.g., transformer or capacitor),
document log shall be maintained for the weight in kilograms of the PCB
at least 3 years after the facility ceases waste in each transformer or capacitor,
using or storing PCBs and PCB Items the date it was removed from service
in the quantities prescribed in this for disposal, the date it was placed in
paragraph. Annual records (manifests transport for off-site storage or dis-
and certificates of disposal) shall be posal, and the date of disposal, if
maintained for the same period. The known.
annual records and the annual docu- (C) A unique number identifying each
ment log shall be available for inspec- PCB Container, a description of the
tion at the facility where they are contents of each PCB Container, such
maintained by authorized representa- as liquid, soil, cleanup debris, etc., in-
tives of EPA during normal business cluding the total weight of the mate-
hours, and each owner or operator of a rial in kilograms in each PCB Con-
facility subject to these requirements tainer, the first date material placed in
shall know the location of these each PCB Container was removed from
records. All records and annual docu- service for disposal, and the date each
ments required to be prepared and
PCB Container was placed in transport
maintained by this section prior to
for off-site storage or disposal, and the
February 5, 1990 shall continue to be
date of disposal (if known).
maintained at the facility for the same
time as the annual records and the an- (D) A unique number identifying each
nual document log. The annual docu- PCB Article Container, a description of
ment required for 1989 shall cover the the contents of each PCB Article Con-
period from January 1, 1989 to Feb- tainer, such as pipes, capacitors, elec-
ruary 5, 1990. tric motors, pumps, etc., including the
(1) The annual records shall include total weight in kilograms of the con-
the following: tent of each PCB Article Container, the
(i) All signed manifests generated by first date a PCB Article placed in each
the facility during the calendar year. PCB Article Container was removed
(ii) All Certificates of Disposal that from service for disposal, and the date
have been received by the facility dur- the PCB Article Container was placed
ing the calendar year. in transport for off-site storage or dis-
(iii) Records of inspections and clean- posal, and the date of disposal (if
ups performed in accordance with known.)
§ 761.65(c)(5). (iii) The total number by specific

(2) The written annual document log type of PCB Articles and the total
shall include the following: weight in kilograms of PCBs in PCB
246
Articles, the total number of PCB Arti- tain a written annual document log
cle Containers and total weight in kilo- that includes the information required
grams of the contents of PCB Article by paragraphs (b)(2) of this section for
Containers, the total number of PCB PCBs and PCB Items that were handled
Containers and the total weight in as PCB waste at the facility. The writ-
kilograms of the contents of PCB Con- ten annual document log shall be pre-
tainers, and the total weight in kilo- pared by July 1 for the previous cal-
grams of bulk PCB waste that was endar year (January through Decem-
placed into storage for disposal or dis- ber). The written annual document log
posed during the calendar year. shall be maintained at each facility for
(iv) The total number of PCB Trans- at least 3 years after the facility is no
formers and total weight in kilograms longer used for the storage or disposal
of PCBs contained in the transformers of PCBs and PCB Items except that, in
remaining in service at the end of the the case of chemical waste landfills,
calendar year. the annual document log shall be main-
(v) The total number of Large High tained at least 20 years after the chem-
or Low Voltage PCB Capacitors re- ical waste landfill is no longer used for
maining in service at the end of the the disposal of PCBs and PCB Items.
calendar year. The annual records shall be maintained
(vi) The total weight in kilograms of for the same period. The annual
any PCBs and PCB Items in PCB Con- records and written annual document
tainers, including the identification of log shall be available at the facility for
container contents, remaining in serv- inspection by authorized representa-
ice at the facility at the end of the cal- tives of the EPA. All records and an-
endar year. nual documents required to be prepared
(vii) For any PCBs or PCB item re- and maintained by this section prior to
ceived from or shipped to another facil- February 5, 1990 shall continue to be
ity owned or operated by the same gen- maintained at the facility for the same
erator, the information required under time as the annual records and the an-
paragraph (a)(2)(ii)(A) through nual document log. The annual docu-
(a)(2)(ii)(D) of this section. ment for 1989 shall cover the period
(viii) [Reserved] from January 1, 1989 to February 5,
(ix) Whenever a PCB Item, excluding 1990. From the written annual docu-
small capacitors, with a concentration ment log the owner or operator of a fa-
of ≥50 ppm is distributed in commerce cility must prepare the annual report
for reuse pursuant to § 761.20(c)(1), the containing the information required by
name, address, and telephone number paragraphs (b)(3)(i) through (b)(3)(vi) of
of the person to whom the item was this section for PCBs and PCB Items
transferred, date of transfer, and the that were handled as PCB waste at the
serial number of the item or the inter- facility during the previous calendar
nal identification number, if a serial year (January through December). The
number is not available, must be re- annual report must be submitted by
corded in the annual document log. July 15 of each year for the preceding
The serial number or internal identi- calendar year. If the facility ceases
fication number shall be permanently commercial PCB storage or disposal
marked on the equipment. operations, the owner or operator of
(3) [Reserved] the facility shall provide at least 60
(4) For purposes of this paragraph, days advance written notice to the Re-
PCB Voltage Regulators shall be regional Administrator for the region in
corded as PCB Transformers. which the facility is located of the date
(b) Disposers and commercial storers of the facility intends to begin closure. d
PCB waste. Beginning February 5, 1990, (1) The annual records shall include
each owner or operator of a facility (in- the following:
cluding high efficiency boiler oper- (i) All signed manifests generated or
ations) used for the commercial stor- received at the facility during the cal-
age or disposal of PCBs and PCB Items endar year.
shall maintain annual records on the (ii) All Certificates of Disposal that
disposition of all PCBs and PCB items have been generated or received by the
at the facility and prepare and main- facility during the calendar year.
247
§ 761.180 40 CFR Ch. I (7–1–17 Edition)
(iii) Records of inspections and clean- the first date a PCB Article placed in
ups performed in accordance with each PCB Article Container was re-
§ 761.65(c)(5). moved from service for disposal, the
(2) The written annual document log date it was received at the facility, the
shall include the following: date each PCB Article Container was
(i) The name, address, and EPA iden- placed in transport for off-site storage
tification number of the storage or dis- or disposal (as applicable), and the date
posal facility covered by the annual the PCB Article Container was dis-
document log and the calendar year posed of (if known).
covered by the annual document log. (E) Disposers of PCB waste shall in-
(ii) For each manifest generated or clude the confirmed date of disposal for
received by the facility during the cal- items in paragraphs (b)(2)(ii)(A)
endar year, the unique manifest num- through (b)(2)(ii)(D) of this section.
ber and the name and address of the fa- (iii) For any PCB waste disposed at a
cility that generated the manifest and facility that generated the PCB waste
the following information: or any PCB waste that was not mani-
(A) For bulk PCB waste (e.g., in a fested to the facility, the information
tanker or truck), its weight in kilo- required under paragraph (b)(2)(ii)(A)
grams, the first date PCB waste placed through (b)(2)(ii)(E) of this section.
in the tanker or truck was removed (3) The owner or operator of a PCB
from service for disposal, the date it disposal facility (including an owner or
was received at the facility, the date it operator who disposes of his/her own
was placed in transport for off-site dis- waste and does not receive or generate
posal (if applicable), and the date of manifests) or a commercial storage fa-
disposal, (if known). cility shall submit an annual report,
(B) The serial number or other means which briefly summarizes the records
of identifying each PCB Article, not in and annual document log required to
a PCB Container or PCB Article Con- be maintained and prepared under
tainer, the weight in kilograms of the paragraphs (b)(1) and (b)(2) of this sec-
PCB waste in the PCB Article, the date tion to the EPA Regional Adminis-
it was removed from service for dis- trator of the Region in which the facil-
posal, the date it was received at the ity is located by July 15 of each year,
facility, the date it was placed in beginning with July 15, 1991. The first
transport for off-site disposal (if appli- annual report submitted on July 15,
cable), and the date of disposal (if 1991, shall be for the period starting
known). February 5, 1990, and ending December
(C) The unique number assigned by 31, 1990. The annual report shall con-
the generator identifying each PCB tain no confidential business informa-
Container, a description of the con- tion. The annual report shall consist of
tents of each PCB Container, such as the information listed in paragraphs
liquid, soil, cleanup debris, etc., includ- (b)(3)(i) through (b)(3)(vi) of this sec-
ing the total weight of the PCB waste tion.
in kilograms in each PCB Container, (i) The name, address, and EPA iden-
the first date PCB waste placed in each tification number of the facility cov-
PCB Container was removed from serv- ered by the annual report for the cal-
ice for disposal, the date it was re- endar year.
ceived at the facility, the date each (ii) A list of the numbers of all signed
PCB Container was placed in transport manifests of PCB waste initiated or re-
for off-site storage or disposal (as ap- ceived by the facility during that year.
plicable), and the date the PCB Con- (iii) The total weight in kilograms of
tainer was disposed of (if known). bulk PCB waste, PCB waste in PCB
(D) The unique number assigned by Transformers, PCB waste in PCB Large
the generator identifying each PCB Ar- High or Low Voltage Capacitors, PCB
ticle Container, a description of the waste in PCB Article Containers, and
contents of each PCB Article Con- PCB waste in PCB Containers in stor-
tainer, such as pipes, capacitors, elec- age at the facility at the beginning of
tric motors, pumps, etc., including the the calendar year, received or gen-
total weight in kilograms of the PCB erated at the facility, transferred to
waste in each PCB Article Container, another facility, or disposed of at the
248
facility during the calendar year. The volume of PCBs is not known, a best esti-
information must be provided for each mate may be used.
of these categories, as appropriate. (5) For purposes of this paragraph,
(iv) The total number of PCB Trans- PCB Voltage Regulators shall be re-
formers, the total number of PCB corded and reported as PCB Trans-
Large High or Low Voltage Capacitors, formers.
(c) Incineration facilities. Each owner
the total number of PCB Article Con-
or operator of a PCB incinerator facil-
tainers, and the total number of PCB
ity shall collect and maintain for a pe-
Containers in storage at the facility at
riod of 5 years from the date of collec-
the beginning of the calendar year, re-
tion the following information, in addi-
ceived or generated at the facility, tion to the information required in
transferred to another facility, or dis- paragraph (b) of this section:
posed of at the facility during the cal- (1) When PCBs are being incinerated,
endar year. The information must be the following continuous and short-in-
provided for each of these categories, terval data:
as appropriate. (i) Rate and quantity of PCBs fed to
(v) The total weight in kilograms of the combustion system as required in
each of the following PCB categories: § 761.70(a)(3);
bulk PCB waste, PCB waste in PCB (ii) Temperature of the combustion
Transformers, PCB waste in PCB Large process as required in § 761.70(a)(4); and
High or Low Voltage Capacitors, PCB (iii) Stack emission product to in-
waste in PCB Article Containers, and clude O2, CO, and CO2 as required in
PCB waste in PCB Containers remain- § 761.70(a)(7).
ing in storage for disposal at the facil- (2) When PCBs are being incinerated,
ity at the end of the calendar year. data and records on the monitoring of
(vi) The total number of PCB Trans- stack emissions as required in
formers, the total number of PCB § 761.70(a)(6).
Large High or Low Voltage Capacitors, (3) Total weight in kilograms of any
the total number of PCB Article Con- solid residues generated by the inciner-
tainers, and the total number of PCB ation of PCBs and PCB Items during
Containers remaining in storage for the calendar year, the total weight in
disposal at the facility at the end of kilograms of any solid residues dis-
the calendar year. posed of by the facility in chemical
(vii) The requirement to submit an- waste landfills, and the total weight in
nual reports to the Regional Adminis- kilograms of any solid residues remain-
trator continues until the submission ing on the facility site.
of the annual report for the calendar (4) When PCBs and PCB Items are
year during which the facility ceases being incinerated, additional periodic
PCB storage or disposal operations. data shall be collected and maintained
Storage operations have not ceased as specified by the Regional Adminis-
until all PCB waste, including any PCB trator pursuant to § 761.70(d)(4).
waste generated during closure, has (5) Upon any suspension of the oper-
been removed from the facility. ation of any incinerator pursuant to
(4) Whenever a commercial storer of § 761.70(a)(8), the owner or operator of
PCB waste accepts PCBs or PCB Items such an incinerator shall prepare a doc-
at his storage facility and transfers the ument. The document shall, at a min-
PCB waste off-site to another facility imum, include the date and time of the
suspension and an explanation of the
for storage or disposal, the commercial
circumstances causing the suspension
storer of PCB waste shall initiate a
of operation. The document shall be
manifest under subpart K of this part
sent to the appropriate Regional Ad-
for the transfer of PCBs or PCB Items
ministrator within 30 days of any such
to the next storage or disposal facility.
suspension.
NOTE: Any requirements for weights in (d) Chemical waste landfill facilities.
kilograms of PCBs may be calculated values
if the internal volume of PCBs in containers
Each owner or operator of a PCB chem-
ical waste landfill facility shall collect
and transformers is known and included in

the reports, together with any assumptions and maintain until at least 20 years
on the density of the PCBs contained in the after the chemical waste landfill is no
containers or tranformers. If the internal longer used for the disposal of PCBs
249
§ 761.185 40 CFR Ch. I (7–1–17 Edition)
the following information in addition those required by §§ 761.70(d) and

to the information required in para- 761.75(c).
graph (b) of this section: (g) Reclassification records. If you re-
(1) Any water analysis obtained in classify electrical equipment using the
compliance with § 761.75(b)(6)(iii); and procedures in § 761.30(a)(2)(v) or
(2) Any operations records including § 761.30(h)(2)(v), you must keep records
burial coordinates of wastes obtained showing that you followed the required
in compliance with § 761.75(b)(8)(ii). reclassification procedures. Where
(e) High efficiency boiler facilities. these procedures require testing, the
records must include copies of pre- and
Each owner or operator of a high effi-
post-reclassification PCB concentra-
ciency boiler used for the disposal of
tion measurements from a laboratory
liquids between 50 and 500 ppm PCB
using quality control and quality as-
shall collect and maintain for a period
surance procedures. You must make
of 5 years the following information, in
these records available promptly to
addition to the information required in
EPA or to any party possessing the
paragraph (b) of this section: equipment through sale, loan, lease, or
(1) For each month PCBs are burned for servicing. You must retain the
in the boiler the carbon monoxide and records for at least 3 years after you
excess oxygen data required in sell or dispose of the equipment.
§ 761.71(a)(1)(viii) and § 761.71(b)(1)(viii);
(2) The quantity of PCBs burned each (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
2605)
month as required in § 761.71(a)(1)(vii)
and § 761.71(b)(1)(vii); and [44 FR 31542, May 31, 1979. Redesignated at 47
(3) For each month PCBs (other than FR 19527, May 6, 1982, and further redesig-
nated at 47 FR 37360, Aug. 25, 1982; 49 FR
mineral oil dielectric fluid) are burned, 28191, July 10, 1984; 53 FR 12524, Apr. 15, 1988;
chemical analysis data of the waste as 54 FR 52750, Dec. 21, 1989; 55 FR 26205, June
required in § 761.71(b)(2)(vi). 27, 1990; 58 FR 34205, June 23, 1993; 63 FR
(f) Retention of special records by stor- 35461, June 29, 1998; 66 FR 17619, Apr. 2, 2001;
age and disposal facilities. In addition to 77 FR 54830, Sept. 6, 2012]
the information required to be main-
§ 761.185 Certification program and re-
tained under paragraphs (b), (c), (d) and tention of records by importers and
(e) of this section, each owner or oper- persons generating PCBs in ex-
ator of a PCB storage or disposal facil- cluded manufacturing processes.
ity (including high efficiency boiler op-
(a) In addition to meeting the basic
erations) shall collect and maintain for
requirements of § 761.1(f) and the defini-
the time period specified in paragraph
tion of excluded manufacturing proc-
(b) of this section the following data:
esses at § 761.3, manufacturers with
(1) All documents, correspondence, processes inadvertently generating
and data that have been provided to PCBs and importers of products con-
the owner or operator of the facility by taining inadvertently generated PCBs
any State or local government agency must report to EPA any excluded man-
and that pertain to the storage or dis- ufacturing process or imports for which
posal of PCBs and PCB Items at the fa- the concentration of PCBs in products
cility. leaving the manufacturing site or im-
(2) All documents, correspondence, ported is greater than 2 micrograms
and data that have been provided by per gram (2 μg/g, roughly 2 ppm) for
the owner or operator of the facility to any resolvable gas chromatographic
any State or local government agency peak. Such reports must be filed by Oc-
and that pertain to the storage or dis- tober 1, 1984 or, if no processes or im-
posal of PCBs and PCB Items at the fa- ports require reports at the time, with-
cility. in 90 days of having processes or im-
(3) Any applications and related cor- ports for which such reports are re-
respondence sent by the owner or oper- quired.
ator of the facility to any local, State, (b) Manufacturers required to report
or Federal authorities in regard to by paragraph (a) of this section must
waste water discharge permits, solid transmit a letter notifying EPA of the
waste permits, building permits, or number, the type, and the location of
other permits or authorizations such as excluded manufacturing processes in
250
which PCBs are generated when the (E) The date and time of the analysis.
PCB level in products leaving any man- (F) Numbers for the lots from which
ufacturing site is greater than 2 μg/g the samples are taken.
for any resolvable gas chromatographic (d) The certification required by
peak. Importers required to report by paragraph (b) of this section must be
paragraph (a) of this section must signed by a responsible corporate offi-
transmit a letter notifying EPA of the cer. This certification must be main-
concentration of PCBs in imported tained by each facility or importer for
products when the PCB concentration a period of three years after ceasing
of products being imported is greater process operation or importation, or
than 2 μg/g for any resolvable gas for seven years, whichever is shorter,
chromatographic peak. Persons must and must be made available to EPA
also certify the following: upon request. For the purpose of this
(1) Their compliance with all applica- section, a responsible corporate officer
ble requirements of § 761.1(f), including means:
any applicable requirements for air and (1) A president, secretary, treasurer,
water releases and process waste dis- or vice-president of the corporation in
posal. charge of a principal business function,
(2) Whether determinations of com- or any other person who performs simi-
pliance are based on actual monitoring lar policy or decision-making functions
of PCB levels or on theoretical assess- for the corporation.
ments. (2) The manager of one or more man-
(3) That such determinations of com- ufacturing, production, or operating fa-
pliance are being maintained. cilities employing more than 250 per-
(4) If the determination of compli- sons or having gross annual sales or ex-
ance is based on a theoretical assess- penditures exceeding $25,000,000 (in sec-
ment, the letter must also notify EPA ond quarter 1980 dollars), if authority
of the estimated PCB concentration to sign documents has been assigned or
levels generated and released. delegated to the manager in accord-
(c) Any person who reports pursuant ance with corporate procedures.
to paragraph (a) of this section: (e) Any person signing a document
(1) Must have performed either a the- under paragraph (d) of this section
oretical analysis or actual monitoring shall also make the following certifi-
of PCB concentrations. cation:
(2) Must maintain for a period of I certify under penalty of law that this
three years after ceasing process oper- document and all attachments were prepared
ations or importation, or for seven under my direction or supervision in accord-
years, whichever is shorter, records ance with a system designed to assure that
containing the following information: qualified personnel properly gather and
evaluate information. Based on my inquiry
(i) Theoretical analysis. Manufacturers of the person or persons directly responsible
records must include: the reaction or for gathering information, the information
reactions believed to be generating is, to the best of my knowledge and belief,
PCBs; the levels of PCBs generated; true, accurate, and complete. I am aware
and the levels of PCBs released. Im- that there are significant penalties for fal-
porters records must include: the reac- sifying information, including the possibility
tion or reactions believed to be gener- of fines and imprisonment for knowing viola-
ating PCBs and the levels of PCBs gen- tions.
erated; the basis for all estimations of Dated: llllllllllllllllllll
Signature: llllllllllllllllll
PCB concentrations; and the name and
qualifications of the person or persons (f) This report must be submitted to
performing the theoretical analysis; or the Document Control Office (DCO)
(ii) Actual monitoring. (A) The method (7407M), Office of Pollution Prevention
of analysis. and Toxics (OPPT), Environmental
(B) The results of the analysis, in- Protection Agency, 1200 Pennsylvania
cluding data from the Quality Assur- Ave., NW., Washington, DC 20460–0001,
ance Plan. ATTN: PCB Notification. This report
(C) Description of the sample matrix. must be submitted by October 1, 1984 or

(D) The name of the analyst or ana- within 90 days of starting up processes
lysts. or commencing importation of PCBs.
251
§ 761.187 40 CFR Ch. I (7–1–17 Edition)
(g) This certification process must be and Toxics (OPPT), Environmental

repeated whenever process conditions Protection Agency, 1200 Pennsylvania
are significantly modified to make the Ave., NW., Washington, DC 20460–0001,
previous certification no longer valid. ATTN: PCB Notification.
(Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C. (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
2605) 2605)
[49 FR 28191, July 10, 1984; 49 FR 33019, Aug. [49 FR 28192, July 10, 1984, as amended at 53
20, 1984, as amended at 53 FR 12524, Apr. 15, FR 12524, Apr. 15, 1988; 58 FR 34205, June 23,
1988; 58 FR 34205, June 23, 1993; 59 FR 33697, 1993; 59 FR 33697, June 30, 1994; 60 FR 34465,
June 30, 1994; 60 FR 34465, July 3, 1995; 71 FR July 3, 1995; 71 FR 33642, June 12, 2006]
33642, June 12, 2006]
§ 761.193 Maintenance of monitoring
§ 761.187 Reporting importers and by records by persons who import,
persons generating PCBs in ex- manufacture, process, distribute in
cluded manufacturing processes. commerce, or use chemicals con-
In addition to meeting the basic retaining inadvertently generated
PCBs.
quirements of § 761.1(f) and the defini-
tion of excluded manufacturing process (a) Persons who import, manufac-
at § 761.3, PCB-generating manufacture, process, distribute in commerce,
turing processes or importers of PCB- or use chemicals containing PCBs
containing products shall be considered present as a result of inadvertent gen-
‘‘excluded manufacturing processes’’ eration or recycling who perform any
only when the following conditions are actual monitoring of PCB concentra-
met: tions must maintain records of any
(a) Data are reported to the EPA by such monitoring for a period of three
the owner/operator or importer con- years after a process ceases operation
cerning the total quantity of PCBs in or importing ceases, or for seven years,
product from excluded manufacturing whichever is shorter.
processes leaving any manufacturing (b) Monitoring records maintained
site in any calendar year when such pursuant to paragraph (a) of this sec-
quantity exceeds 0.0025 percent of that tion must contain:
site’s rated capacity for such manufac- (1) The method of analysis.
turing processes as of October 1, 1984; (2) The results of the analysis, in-
or the total quantity of PCBs imported cluding data from the Quality Assur-
in any calendar year when such quan- ance Plan.
tity exceeds 0.0025 percent of the aver- (3) Description of the sample matrix.
age total quantity of such product con- (4) The name of the analyst or ana-
taining PCBs imported by such im- lysts.
porter during the years 1978, 1979, 1980, (5) The date and time of the analysis.
1981 and 1982. (6) Numbers for the lots from which
(b) Data are reported to the EPA by the samples are taken.
the owner/operator concerning the (Sec. 6, Pub. L. 94–469, 90 Stat. 2020 (15 U.S.C.
total quantity of inadvertently gen- 2605)
erated PCBs released to the air from
[49 FR 28193, July 10, 1984, as amended at 58
excluded manufacturing processes at FR 34205, June 23, 1993]
any manufacturing site in any calendar
year when such quantity exceeds 10
pounds. Subpart K—PCB Waste Disposal
(c) Data are reported to the EPA by Records and Reports
the owner/operator concerning the
total quantity of inadvertently gen- SOURCE: 54 FR 52752, Dec. 21, 1989, unless
erated PCBs released to water from ex- otherwise noted.
cluded manufacturing processes from
any manufacturing site in any calendar § 761.202 EPA identification numbers.
year when such quantity exceeds 10 (a) General. Any generator, commer-
pounds. cial storer, transporter, or disposer of
(d) These reports must be submitted PCB waste who is required to have an
to the Document Control Office (DCO) EPA identification number under this
(7407M), Office of Pollution Prevention subpart must notify EPA of his/her
252
PCB waste handling activities, using prohibitions of paragraph (b) of this

the notification procedures and form section if they have applied for an EPA
described in § 761.205. EPA will confirm identification number in accordance
the EPA identification number of fa- with the applicable notification proce-
cilities already assigned one, and will dures of § 761.205. Such persons shall
assign an EPA identification number use the EPA identification number ‘‘40
to facilities that do not have one. CFR PART 761,’’ or a number assigned
(b) Prohibitions. After June 4, 1990: to the persons by EPA or a State under
(1) A generator of PCB waste shall RCRA, until EPA issues to such per-
not: sons a specific identification number
(i) Process, store, dispose of, trans- under § 761.205(a), (b), or (c).
port, or offer for transportation PCB (d) PCB waste first handled after effec-
waste without having received an EPA tive date of this subpart. Generators
identification number from the Agen- (other than generators exempt from
cy. A generator of PCB waste who is notification under § 761.205(c)(1)), com-
exempted from notification under mercial storers, transporters, and dis-
§ 761.205(c)(1) or who notifies EPA in a posers of PCB waste who are required
timely manner under § 761.205(c)(2)(i), to have EPA identification numbers
but has not yet received a unique iden- under this subpart, and who first en-
tification number, shall be regarded as gage in PCB waste activities after Feb-
having received from EPA the identi- ruary 5, 1990, are subject to the prohibi-
fication number ‘‘40 CFR PART 761.’’ tions in paragraph (b) of this section.
(ii) Offer the PCB waste to trans-
porters, disposers, or commercial stor- § 761.205 Notification of PCB waste ac-
ers of PCB waste who have not received tivity (EPA Form 7710–53).
an EPA identification number. (a)(1) All commercial storers, trans-
(2) A transporter of PCB waste shall porters, and disposers of PCB waste
not: who were engaged in PCB waste han-
(i) Transport PCB waste without hav- dling activities on or prior to February
ing received an EPA identification 5, 1990 shall notify EPA of their PCB
number from EPA. waste activities by filing EPA Form
(ii) Deliver PCB waste to trans- 7710–53 with EPA by no later than April
porters, disposers, or commercial stor- 4, 1990. Upon receiving the notification
ers of PCB waste that have not re- form, EPA will assign an EPA identi-
ceived an EPA identification number. fication number to each entity that no-
(3) A commercial storer of PCB waste tifies.
shall not accept any PCB waste for (2) All generators (other than genera-
storage without having received an tors exempt from notification under
EPA identification number from EPA. paragraph (c)(1) of this section), com-
(4) A disposer of PCB waste shall not mercial storers, transporters, and dis-
accept any PCB waste for disposal posers of PCB waste who first engage
without having received an EPA identi- in PCB waste handling activities after
fication number from EPA. A disposer February 5, 1990, shall notify EPA of
of PCB waste who owns more than one their PCB waste activities by filing
disposal facility or mobile treatment EPA Form 7710–53 with EPA prior to
unit shall not accept waste unless the engaging in PCB waste handling activi-
disposer has received an EPA identities.
fication number for each facility or (3) Any person required to notify
mobile unit. EPA under this section shall file with
(c) PCB waste handled prior to effective EPA Form 7710–53. Copies of EPA Form
date of this subpart. Generators (other 7710–53 are available on EPA’s Web site
than generators exempt from notifica- at http://www.epa.gov/pcb, or from the
tion under § 761.205(c)(1)), commercial Program Management, Communica-
storers, transporters, and disposers of tions, and Analysis Office, Office of Re-
PCB waste who are required to have source Conservation and Recovery
EPA identification numbers under this (5305P), Environmental Protection
subpart, and who were engaged in PCB Agency, 1200 Pennsylvania Ave., NW.,
waste handling activities on or prior to Washington, DC 20460–0001. Descriptive
February 5, 1990, are not subject to the information and instructions for filling
253
§ 761.205 40 CFR Ch. I (7–1–17 Edition)
in the form are included in paragraphs manifests, records, and reports which
(a)(4)(i) through (vii) of this section. they shall prepare under this subpart,
(4) All of the following information unless such generators elect to use a
shall be provided to EPA on Form 7710– unique EPA identification number pre-
53: viously assigned to them under RCRA
(i) The name of the facility, and the by EPA or a State.
name of the owner or operator of the (2) Generators of PCB waste who use,
facility. own, service, or process PCBs or PCB
(ii) EPA identification number, if Items shall notify EPA of their PCB
any, previously issued to the facility. waste activities only if they own or op-
(iii) The facility’s mailing address. erate PCB storage facilities subject to
(iv) The location of the facility. the storage requirements of § 761.65 (b)
(v) The facility’s installation contact or (c)(7). Such generators shall notify
and telephone number. EPA in the following manner:
(vi) The type of PCB waste activity (i) Generators storing PCB waste sub-
engaged in at the facility. ject to the storage requirements of
(vii) Signature of the signer of the § 761.65 (b) or (c)(7) shall notify EPA by
certification statement, typed or print- filing EPA Form 7710–53 with EPA by
ed name and official title of signer, and no later than April 4, 1990.
date signed. (ii) Generators who desire to com-
(viii) EPA has determined that the mence storage of PCB waste after Feb-
information in paragraphs (a)(4)(i) ruary 5, 1990 shall notify EPA and re-
through (a)(4)(vii) of this section shall ceive an EPA identification number be-
not be treated as confidential business fore they may commence storage of
information. This information will be PCBs at their facilities established
disclosed to the public without further under § 761.65 (b) or (c)(7).
notice to the submitter unless the sub- (iii) A separate notification shall be
mitter provides a written justification submitted to EPA for each PCB storage
(submitted with the notification form) facility owned or operated by genera-
which demonstrates extraordinary rea- tors of PCB waste. Upon receiving
sons why the information should be en- these notifications, EPA will assign
titled to confidential treatment. generators unique EPA identification
(b) Generators (other than those gen- numbers for each storage facility noti-
erators exempt from notification under fying EPA under this section.
paragraph (c)(1) of this section), com- (d) Persons required to notify under
mercial storers, transporters, and dis- this section shall file EPA Form 7710–53
posers of PCB waste who have pre- with EPA by mailing the form to the
viously notified EPA or a State of haz- following address: Document Control
ardous waste activities under RCRA Officer, Office of Resource Conserva-
shall notify EPA of their PCB waste tion and Recovery (5305P), Environ-
activities under this part by filing EPA mental Protection Agency, 1200 Penn-
Form 7710–53 with EPA by no later sylvania Ave., NW., Washington, DC
than April 4, 1990. The notification 20460–0001.
shall include the EPA identification (e) The requirements under this sec-
number previously issued by EPA or tion to notify EPA and obtain EPA
the State and upon receipt of the noti- identification numbers shall in no case
fication, EPA shall verify and author- excuse compliance by any person sub-
ize the use of the previously issued ject to the 1-year limit on storage prior
identification number for PCB waste to disposal under § 761.65(a).
activities. (f) When a facility has previously no-
(c)(1) Generators of PCB waste need tified EPA of its PCB waste handling
not notify EPA and receive unique activities using EPA Form 7710-53 and
EPA identification numbers under this those activities change, the facility
section, unless their PCB waste activi- must resubmit EPA Form 7710-53 to re-
ties are described in paragraph (c)(2) of flect those changes no later than 30
this section. Generators exempted from days from when a change is made. Ex-
notifying EPA under this paragraph amples of when a PCB waste handler
shall use the generic identification must renotify the Agency include, but
number ‘‘40 CFR PART 761’’ on the are not limited to the following: the
254
company changes location of the facil- structions as a guide, but should defer to the
ity; or the company had notified solely Part 761 manifest regulations whenever there
as engaging in a certain type of PCB is any difference between the Part 761 re-
waste handling activity and now wish- quirements and the instructions in the ap-
pendix to Part 262. The differences should be
es to engage in another PCB waste ac-
minimal.
tivity (e.g., previously only commer-
NOTE 3 TO PARAGRAPH (a): PCBs are not
cially stored PCB waste and now wish- regulated under RCRA, thus do not have a
es to transport PCB waste). RCRA waste code. EPA does not require
[54 FR 52752, Dec. 21, 1989, as amended at 58 boxes 13 and 31 on forms 8700–22 and 8700–22A
FR 15809, Mar. 24, 1993; 58 FR 34205, June 23, (if used), respectively, to be completed for
1993; 59 FR 33697, June 30, 1994; 63 FR 35461, shipments only containing PCB waste. How-
June 29, 1998; 72 FR 57241, Oct. 9, 2007; 74 FR ever, some States track PCB wastes as
30234, June 25, 2009] State-regulated hazardous wastes, and assign
State hazardous waste codes to these wastes.
§ 761.207 The manifest—general re- In such a case, the user should follow the
quirements. State instructions for completing the waste
(a) A generator who transports, or of- code fields.
fers for transport PCB waste for com- (b) A generator must designate on
mercial off-site storage or off-site dis- the manifest one facility which is ap-
posal, and commercial storage or dis- proved to handle the PCB waste de-
posal facility who offers for transport a scribed on the manifest.
rejected load of PCB waste, must pre- (c) A generator may also designate
pare a manifest on EPA Form 8700–22, on the manifest one alternate facility
and, if necessary, a continuation sheet,
which is approved to handle his PCB
according to the instructions included
waste in the event an emergency pre-
in the appendix of 40 CFR Part 262. The
vents delivery of the waste to the pri-
generator shall specify:
(1) For each bulk load of PCBs, the mary designated facility.
identity of the PCB waste, the earliest (d) If the transporter is unable to de-
date of removal from service for dis- liver the PCB waste to the designated
posal, and the weight in kilograms of facility or the alternate facility, the
the PCB waste. (Item 14—Special Han- generator must either designate an-
dling Instructions box) other facility or instruct the trans-
(2) For each PCB Article Container or porter to return the PCB waste.
PCB Container, the unique identifying (e) The requirements of this section
number, type of PCB waste (e.g., soil, apply only to PCB wastes as defined in
debris, small capacitors), earliest date § 761.3. This includes PCB wastes with
of removal from service for disposal, PCB concentrations below 50 ppm
and weight in kilograms of the PCB where the PCB concentration below 50
waste contained. (Item 14—Special ppm was the result of dilution; these
Handling Instructions box) PCB wastes are required under § 761.1(b)
(3) For each PCB Article not in a to be managed as if they contained
PCB Container or PCB Article Con- PCB concentrations of 50 ppm and
tainer, the serial number if available, above. An example of such a PCB waste
or other identification if there is no se- is spill cleanup material containing <50
rial number, the date of removal from ppm PCBs when the spill involved ma-
service for disposal, and weight in kilo- terial containing PCBs at a concentra-
grams of the PCB waste in each PCB tion of ≥50 ppm. However, there is no
Article. (Item 14—Special Handling In- manifest requirement for material cur-
structions box) rently below 50 ppm which derives from
NOTE 1 TO PARAGRAPH (a): EPA Form 8700– pre-April 18, 1978, spills of any con-
22A is not required as the PCB manifest concentration, pre-July 2, 1979, spills of
tinuation sheet. In practice, form 8700–22A <500 ppm PCBs, or materials decon-
does not have adequate space to list required taminated in accordance with § 761.79.
PCB-specific information for several PCB ar- (f) The requirements of this subpart
ticles. However, if form 8700–22A fits the
do not apply to the transport of PCB
needs of the user community, the form is

permissible. wastes on a public or private right-of-
NOTE 2 TO PARAGRAPH (a): PCB waste han- way within or along the border of con-
dlers should use the Part 262 appendix in- tiguous property under the control of
255
§ 761.208 40 CFR Ch. I (7–1–17 Edition)
the same person, even if such contig- (b) The generator must give the
uous property is divided by a public or transporter the remaining copies of the
private right-of-way. manifest.
(c) For shipments of PCB waste with-
[77 FR 54830, Sept. 6, 2012, as amended at 80
FR 37995, July 2, 2015] in the United States solely by water
(bulk shipments only), the generator
§ 761.208 Obtaining manifests. must send three copies of the manifest
dated and signed in accordance with
(a)(1) A generator may use manifests
this section to the owner or operator of
printed by any source so long as the
the designated facility. Copies of the
source of the printed form has received
manifest are not required for each
approval from EPA to print the mani-
transporter.
fest under 40 CFR 262.21 (c) and (e). A
(d) For rail shipments of PCB waste
registered source may be a:
within the United States which origi-
(i) State agency;
nate at the site of generation, the gen-
(ii) Commercial printer;
erator must send at least three copies
(iii) PCB waste generator, trans-
of the manifest dated and signed in ac-
porter or, designated facility; or
cordance with this section to:
(iv) PCB waste broker or other pre-
(1) The next non-rail transporter, if
parer who prepares or arranges ship-
any; or
ments of PCB waste for transportation.
(2) The designated facility if trans-
(2) A generator must determine
ported solely by rail.
whether the generator state or the con-
(e) For rejected shipments of PCB
signment state for a shipment regu-
waste that are returned to the gener-
lates PCB waste as a State-regulated
ator by the designated facility (fol-
hazardous waste. Generators also must
lowing the procedures of § 761.215(f)),
determine whether the consignment
the generator must:
state or generator state requires the
(1) Sign either:
generator to submit any copies of the
(i) Item 20 of the new manifest if a
manifest to these states. In cases
new manifest is used for the returned
where the generator must supply cop-
shipment; or
ies to either the generator’s state or (ii) Item 18c of the original manifest
the consignment state, the generator is if the original manifest is used for the
responsible for supplying legible photo- returned shipment;
copies of the manifest to these states. (2) Provide the transporter a copy of
(b) [Reserved] the manifest;
[77 FR 54831, Sept. 6, 2012] (3) Within 30 days of delivery of the
rejected shipment, send a copy of the
§ 761.209 Number of copies of a mani- manifest to the designated facility that
fest. returned the shipment to the gener-
The manifest consists of at least the ator; and
number of copies which will provide (4) Retain at the generator’s site a
the generator, each transporter, and copy of each manifest for at least three
the owner or operator of the designated years from the date of delivery.
facility with one copy each for their
[77 FR 54831, Sept. 6, 2012]
records and another copy to be re-
turned to the generator. § 761.211 Manifest system—Trans-
[77 FR 54831, Sept. 6, 2012] porter requirements.
(a)(1) A transporter shall not accept
§ 761.210 Use of the manifest—Gener- PCB waste from a generator unless it is
ator requirements. accompanied by a manifest signed by
(a) The generator must: the generator in accordance with
(1) Sign the manifest certification by § 761.210(a)(1), except that a manifest is
hand; and not required if any one of the following
(2) Obtain the handwritten signature conditions exists:
of the initial transporter and date of (i) The shipment of PCB waste con-
acceptance on the manifest; and sists solely of PCB wastes with PCB
(3) Retain one copy, in accordance concentrations below 50 ppm, unless
with § 761.214(a)(1). the PCB concentration below 50 ppm
256
was the result of dilution, in which (5) A copy of the shipping paper or
case § 761.1(b) requires that the waste manifest is retained by each water
be managed as if it contained PCBs at (bulk shipment) transporter in accord-
the concentration prior to dilution. ance with § 761.214.
(ii) The PCB waste is accepted by the (f) For shipments involving rail
transporter for transport only to a transportation, the requirements of
storage or disposal facility owned or paragraphs (c), (d) and (e) do not apply
operated by the generator of the PCB and the following requirements do
waste. apply:
(2) [Reserved] (1) When accepting PCB waste from a
(b) Before transporting the PCB non-rail transporter, the initial rail
waste, the transporter must sign and transporter must:
date the manifest acknowledging ac- (i) Sign and date the manifest ac-
ceptance of the PCB waste from the knowledging acceptance of the PCB
generator. The transporter must return waste;
a signed copy to the generator before (ii) Return a signed copy of the mani-
leaving the generator’s property. fest to the non-rail transporter;
(c) The transporter shall ensure that (iii) Forward at least three copies of
the manifest accompanies the PCB the manifest to:
waste. (A) The next non-rail transporter, if
(d) A transporter who delivers PCB any; or,
waste to another transporter or to the (B) The designated facility, if the
designated facility must: shipment is delivered to that facility
(1) Obtain the date of delivery and by rail;
the handwritten signature of that (iv) Retain one copy of the manifest
transporter or of the owner or operator and rail shipping paper in accordance
of the designated facility on the mani- with § 761.214.
fest; and (2) Rail transporters must ensure
(2) Retain one copy of the manifest in that a shipping paper containing all
accordance with § 761.214; and the information required on the mani-
(3) Give the remaining copies of the fest (excluding the EPA identification
manifest to the accepting transporter numbers, generator certification, and
or designated facility. signatures) accompanies the PCB waste
(e) The requirements of paragraphs at all times.
(c), (d) and (f) of this section do not NOTE: Intermediate rail transporters are
apply to water (bulk shipment) trans- not required to sign either the manifest or
porters if: shipping paper.
(1) The PCB waste is delivered by (3) When delivering PCB waste to the
water (bulk shipment) to the des- designated facility, a rail transporter
ignated facility; and must:
(2) A shipping paper containing all (i) Obtain the date of delivery and
the information required on the mani- handwritten signature of the owner or
fest (excluding EPA identification operator of the designated facility on
number, generator certification, and the manifest or the shipping paper (if
signatures) accompanies the PCB the manifest has not been received by
waste; and the facility); and
(3) The delivering transporter obtains (ii) Retain a copy of the manifest or
the date of delivery and handwritten signed shipping paper in accordance
signature of the owner or operator of with § 761.214.
the designated facility on either the (4) When delivering PCB waste to a
manifest or the shipping paper; and non-rail transporter a rail transporter
(4) The person delivering the PCB must:
waste to the initial water (bulk ship- (i) Obtain the date of delivery and
ment) transporter obtains the date of the handwritten signature of the next
delivery and signature of the water non-rail transporter on the manifest;
(bulk shipment) transporter on the and

manifest and forwards it to the des- (ii) Retain a copy of the manifest in
ignated facility; and accordance with § 761.214.
257
§ 761.212 40 CFR Ch. I (7–1–17 Edition)
(5) Before accepting PCB waste from and date attesting to the rejection, the
a rail transporter, a non-rail trans- description of the rejection in the dis-
porter must sign and date the manifest crepancy block of the manifest, and the
and provide a copy to the rail trans- name, address, phone number, and
porter. Identification Number for the alternate
[77 FR 54832, Sept. 6, 2012] facility or generator to whom the ship-
ment must be delivered. The trans-
§ 761.212 Transporter compliance with porter must retain a copy of the mani-
the manifest. fest in accordance with § 761.214, and
(a) The transporter must deliver the give a copy of the manifest containing
entire quantity of PCB waste which he this information to the rejecting des-
has accepted from a generator or a ignated facility. If the original mani-
transporter to: fest is not used, then the transporter
(1) The designated facility listed on must obtain a new manifest for the
the manifest; or shipment and comply with 40 CFR
(2) The alternate designated facility, 761.215(e)(1) through (6).
if the PCB waste cannot be delivered to (iii) No provision of this section shall
the designated facility because an be construed to affect or limit the ap-
emergency prevents delivery; or plicability of any requirement applica-
(3) The next designated transporter. ble to transporters of PCB waste under
(b)(1) If the PCB waste cannot be de- regulations issued by the Department
livered in accordance with paragraph of Transportation (DOT) and set forth
(a) of this section because of an emer- at 49 CFR Part 171.
gency condition other than rejection of
the waste by the designated facility, [77 FR 54832, Sept. 6, 2012]
then the transporter must contact the
generator for further directions and § 761.213 Use of manifest—Commercial
must revise the manifest according to storage and disposal facility re-
the generator’s instructions. quirements.
(2) If PCB waste is rejected by the (a)(1) If a commercial storage or dis-
designated facility while the trans- posal facility receives PCB waste ac-
porter is on the facility’s premises, companied by a manifest, the owner,
then the transporter must obtain the operator or his/her agent must sign and
following: date the manifest as indicated in para-
(i) For a partial load rejection, a graph (a)(2) of this section to certify
copy of the original manifest that in- that the PCB waste covered by the
cludes the facility’s date and signature, manifest was received, that the PCB
and the Manifest Tracking Number of waste was received except as noted in
the new manifest that will accompany the discrepancy space of the manifest,
the shipment, and a description of the or that the PCB waste was rejected as
partial rejection in the discrepancy noted in the manifest discrepancy
block of the original manifest. The space.
transporter must retain a copy of this
(2) If a commercial storage or dis-
manifest in accordance with § 761.214,
posal facility receives an off-site ship-
and give the remaining copies of the
ment of PCB waste accompanied by a
original manifest to the rejecting des-
manifest, the owner or operator, or his
ignated facility. If the transporter is
agent, shall:
forwarding the rejected part of the
shipment to an alternate facility or re- (i) Sign and date, by hand, each copy
turning it to the generator, the trans- of the manifest;
porter must obtain a new manifest to (ii) Note any discrepancies (as de-
accompany the shipment, and the new fined in § 761.215(a)) on each copy of the
manifest must include all of the infor- manifest;
mation required in 40 CFR 761.215(e)(1) (iii) Immediately give the trans-
through (6) or (f)(1) through (6). porter at least one copy of the mani-
(ii) For a full load rejection that will fest;
be taken back by the transporter, a (iv) Within 30 days of delivery, send a

copy of the original manifest that in- copy of the manifest to the generator;
cludes the rejecting facility’s signature and
258
(v) Retain at the facility a copy of that apply to generators of PCB waste
each manifest for at least three years (§ 761.207).
from the date of delivery.
[77 FR 54833, Sept. 6, 2012]
(b) If a commercial storage or dis-
posal facility receives, from a rail or
§ 761.214 Retention of manifest
water (bulk shipment) transporter, records.
PCB waste which is accompanied by a
shipping paper containing all the infor- (a)(1) A generator must keep a copy
mation required on the manifest (ex- of each manifest signed in accordance
cluding the EPA identification num- with § 761.210(a) for three years or until
bers, generator’s certification, and sig- he receives a signed copy from the des-
natures), the owner or operator, or his ignated facility which received the
agent, must: PCB waste. This signed copy must be
(1) Sign and date each copy of the retained as a record for at least three
manifest or shipping paper (if the years from the date the waste was ac-
manifest has not been received) to cer- cepted by the initial transporter. A
tify that the PCB waste covered by the generator subject to annual document
manifest or shipping paper was re- requirements under § 761.180 shall re-
ceived; tain copies of each manifest for the pe-
(2) Note any significant discrepancies riod required by § 761.180(a).
(as defined in § 761.215(a)) in the mani- (2) A transporter of PCB waste must
fest or shipping paper (if the manifest keep a copy of the manifest signed by
has not been received) on each copy of the generator, himself, and the next
the manifest or shipping paper. designated transporter or the owner or
NOTE TO PARAGRAPH (b)(2): The Agency operator of the designated facility for a
does not intend that the owner or operator of period of three years from the date the
a facility whose procedures include waste PCB waste was accepted by the initial
analysis must perform that analysis before transporter.
signing the shipping paper and giving it to (b) For shipments delivered to the
the transporter. Section 761.215(a), however, designated facility by water (bulk ship-
requires reporting an unreconciled discrep-
ancy discovered during later analysis.
ment), each water (bulk shipment)
transporter must retain a copy of the
(3) Immediately give the rail or water shipping paper containing all the infor-
(bulk shipment) transporter at least mation required in § 761.211(e)(2) for a
one copy of the manifest or shipping period of three years from the date the
paper (if the manifest has not been re- PCB waste was accepted by the initial
ceived); transporter.
(4) Within 30 days after the delivery, (c) For shipments of PCB waste by
send a copy of the signed and dated rail within the United States:
manifest or a signed and dated copy of
(1) The initial rail transporter must
the shipping paper (if the manifest has
keep a copy of the manifest and ship-
not been received within 30 days after
ping paper with all the information re-
delivery) to the generator; and
quired in § 761.211(f)(2) for a period of
NOTE TO PARAGRAPH (b)(4): Section three years from the date the PCB
761.210(c) requires the generator to send waste was accepted by the initial
three copies of the manifest to the facility transporter; and
when PCB waste is sent by rail or water
(2) The final rail transporter must
(bulk shipment).]
keep a copy of the signed manifest (or
(5) Retain at the facility a copy of the shipping paper if signed by the des-
the manifest and shipping paper (if ignated facility in lieu of the manifest)
signed in lieu of the manifest at the for a period of three years from the
time of delivery) for at least three date the PCB waste was accepted by
years from the date of delivery. the initial transporter.
(c) Whenever an off-site shipment of
PCB waste is initiated from a commer- NOTE TO PARAGRAPH (c): Intermediate rail
transporters are not required to keep records
cial storage or disposal facility, the
pursuant to these regulations.

owner or operator of the commercial
storage or disposal facility shall com- (d) A generator must keep a copy of
ply with the manifest requirements each Exception Report for a period of
259
§ 761.215 40 CFR Ch. I (7–1–17 Edition)
at least three years from the due date rejected waste to the generator. The fa-
of the report. cility must send the waste to the alter-
(e) The periods of retention referred native facility or to the generator
to in this Section are extended auto- within 60 days of the rejection identi-
matically during the course of any un- fication.
resolved enforcement action regarding (2) While the facility is making ar-
the regulated activity or as requested rangements for forwarding rejected
by the Administrator. wastes to another facility under this
[77 FR 54833, Sept. 6, 2012] section, it must ensure that either the
delivering transporter retains custody
§ 761.215 Manifest discrepancies. of the waste, or, the facility must pro-
(a) Manifest discrepancies are: vide for secure, temporary custody of
(1) Significant differences (as defined the waste, pending delivery of the
by paragraph (b) of this section) be- waste to the first transporter des-
tween the quantity or type of PCB ignated on the manifest prepared under
waste designated on the manifest or paragraph (e) or (f) of this section.
shipping paper, and the quantity and (e) Except as provided in paragraph
type of PCB waste a facility actually (e)(7) of this section, for full or partial
receives; or load rejections that are to be sent off-
(2) Rejected wastes, which may be a site to an alternate facility, the facil-
full or partial shipment of PCB waste ity is required to prepare a new mani-
that the designated facility cannot ac- fest in accordance with § 761.207(a) and
cept. the following instructions:
(b) Significant differences in quan- (1) Write the generator’s U.S. EPA ID
tity are: For bulk waste, variations number in Item 1 of the new manifest.
greater than 10 percent in weight or Write the generator’s name and mail-
variations greater than 10 percent in ing address in Item 5 of the new mani-
weight of PCB waste in containers; for fest. If the mailing address is different
batch waste, any variation in piece from the generator’s site address, then
count, such as a discrepancy of one write the generator’s site address in
PCB Transformer or PCB Container or the designated space for Item 5.
PCB Article Container in a truckload. (2) Write the name of the alternate
Significant differences in type are ob- designated facility and the facility’s
vious differences which can be discov- U.S. EPA ID number in the designated
ered by inspection or waste analysis, facility block (Item 8) of the new mani-
such as the substitution of solids for fest.
liquids or the substitution of high con- (3) Copy the manifest tracking num-
centration PCBs (above 500 ppm) with ber found in Item 4 of the old manifest
lower concentration materials. to the Special Handling and Additional
(c) Upon discovering a significant dif- Information Block of the new manifest,
ference in quantity or type, the owner and indicate that the shipment is a re-
or operator must attempt to reconcile jected waste from the previous ship-
the discrepancy with the waste gener- ment.
ator or transporter (e.g., with tele- (4) Copy the manifest tracking num-
phone conversations). If the discrep- ber found in Item 4 of the new manifest
ancy is not resolved within 15 days to the manifest reference number line
after receiving the waste, the owner or in the Discrepancy Block of the old
operator must immediately submit to manifest (Item 18a).
the Regional Administrator a letter de- (5) Write the DOT description for the
scribing the discrepancy and attempts rejected load in Item 9 (U.S. DOT De-
to reconcile it, and a copy of the mani- scription) of the new manifest and
fest or shipping paper at issue. write the container types, quantity,
(d)(1) Upon rejecting the PCB waste, and volume(s) of waste.
the facility must consult with the gen- (6) Sign the Generator’s/Offeror’s Cer-
erator prior to forwarding the waste to tification to certify, as the offeror of
another facility that can manage the the shipment, that the waste has been
waste. If it is impossible to locate an properly packaged, marked and labeled

alternative facility that can receive and is in proper condition for transpor-
the waste, the facility may return the tation, and mail a signed copy of the
260
manifest to the generator identified in properly packaged, marked and labeled

Item 5 of the new manifest. and is in proper condition for transpor-
(7) For full load rejections that are tation.
made while the transporter remains (7) For full load rejections that are
present at the facility, the facility may made while the transporter remains at
forward the rejected shipment to the the facility, the facility may return
alternate facility by completing Item the shipment to the generator with the
18b of the original manifest and sup- original manifest by completing Item
plying the information on the next des- 18a and 18b of the manifest and sup-
tination facility in the Alternate Fa- plying the generator’s information in
cility space. The facility must retain a the Alternate Facility space. The facil-
copy of this manifest for its records, ity must retain a copy for its records
and then give the remaining copies of and then give the remaining copies of
the manifest to the transporter to ac- the manifest to the transporter to ac-
company the shipment. If the original company the shipment. If the original
manifest is not used, then the facility manifest is not used, then the facility
must use a new manifest and comply must use a new manifest and comply
with paragraphs (e)(1), (2), (3), (4), (5), with paragraphs (f)(1), (2), (3), (4), (5),
and (6) of this section. (6), and (8) of this section.
(f) Except as provided in paragraph (8) For full or partial load rejections
(f)(7) of this section, for rejected wastes that are returned to the generator, the
that must be sent back to the gener- facility must also comply with the ex-
ator, the facility is required to prepare ception reporting requirements in
a new manifest in accordance with § 761.217(a).
§ 761.207(a) and the following instruc- (g) If a facility rejects a waste after
tions: it has signed, dated, and returned a
(1) Write the facility’s U.S. EPA ID copy of the manifest to the delivering
number in Item 1 of the new manifest. transporter or to the generator, the fa-
Write the facility’s name and mailing cility must amend its copy of the
address in Item 5 of the new manifest. manifest to indicate the rejected
If the mailing address is different from wastes in the discrepancy space of the
the facility’s site address, then write amended manifest. The facility must
the facility’s site address in the des- also copy the manifest tracking num-
ignated space for Item 5 of the new ber from Item 4 of the new manifest to
manifest. the Discrepancy space of the amended
(2) Write the name of the initial gen- manifest, and must re-sign and date
erator and the generator’s U.S. EPA ID the manifest to certify to the informa-
tion as amended. The facility must re-
number in the designated facility block
tain the amended manifest for at least
(Item 8) of the new manifest.
three years from the date of amend-
(3) Copy the manifest tracking num-
ment, and must within 30 days, send a
ber found in Item 4 of the old manifest
copy of the amended manifest to the
to the Special Handling and Additional
transporter and generator that re-
Information Block of the new manifest,
ceived copies prior to their being
and indicate that the shipment is a re-
amended.
jected waste from the previous ship-
ment. [77 FR 54833, Sept. 6, 2012]
(4) Copy the manifest tracking num-
ber found in Item 4 of the new manifest § 761.216 Unmanifested waste report.
to the manifest reference number line (a) If a facility accepts for storage or
in the Discrepancy Block of the old disposal any PCB waste from an off-
manifest (Item 18a). site source without an accompanying
(5) Write the DOT description for the manifest, or without an accompanying
rejected load in Item 9 (U.S. DOT De- shipping paper as described by
scription) of the new manifest and § 761.211(e), and the owner or operator
write the container types, quantity, of the commercial storage or disposal
and volume(s) of waste. facility cannot contact the generator
(6) Sign the Generator’s/Offeror’s Cer- of the PCB waste, then he shall notify
tification to certify, as offeror of the the Regional Administrator of the EPA
shipment, that the waste has been region in which his facility is located
261
§ 761.217 40 CFR Ch. I (7–1–17 Edition)
of the unmanifested PCB waste so that written signature of the owner or oper-
the Regional Administrator can deter- ator of the designated facility within 45
mine whether further actions are re- days of the date the waste was accept-
quired before the owner or operator ed by the initial transporter. The ex-
may store or dispose of the ception report shall be submitted to
unmanifested PCB waste, and addition- EPA no later than 45 days from the
ally the owner or operator must pre- date on which the generator should
pare and submit a letter to the Re- have received the manifest. The Excep-
gional Administrator within 15 days tion Report shall include the following:
after receiving the waste. The (i) A legible copy of the manifest for
unmanifested waste report must con- which the generator does not have con-
tain the following information: firmation of delivery;
(1) The EPA identification number, (ii) A cover letter signed by the gen-
name and address of the facility; erator or his authorized representative
(2) The date the facility received the explaining the efforts taken to locate
waste; the PCB waste and the results of those
(3) The EPA identification number, efforts.
name and address of the generator and (b) For rejected shipments of PCB
the transporter, if available; waste that are forwarded to an alter-
(4) A description and the quantity of nate facility by a designated facility
each unmanifested PCB waste the fa- using a new manifest (following the
cility received; procedures of § 761.215(e)(1) through (6)),
(5) The method of storage or disposal the generator must comply with the re-
for each PCB waste; quirements of paragraph (a) of this sec-
(6) Signature of the owner or oper- tion, as applicable, for the shipment
ator of the facility or his authorized forwarding the material from the des-
representative; and, ignated facility to the alternate facil-
(7) A brief explanation of why the ity instead of for the shipment from
waste was unmanifested, if known. the generator to the designated facil-
(8) The disposition made of the ity. For purposes of paragraph (a) of
unmanifested waste by the commercial this section for a shipment forwarding
storage or disposal facility, including: such waste to an alternate facility by a
(i) If the waste was stored or disposed designated facility:
by that facility, was the generator (1) The copy of the manifest received
identified and was a manifest subse- by the generator must have the hand-
quently supplied. written signature of the owner or oper-
(ii) If the waste was sent back to the ator of the alternate facility in place of
generator, why and when. the signature of the owner or operator
(b) [Reserved] of the designated facility, and
[77 FR 54834, Sept. 6, 2012]
(2) The 35- and 45-day timeframes
begin the date the waste was accepted
§ 761.217 Exception reporting. by the initial transporter forwarding
the PCB waste shipment from the des-
(a)(1) A generator of PCB waste, who
ignated facility to the alternate facil-
does not receive a copy of the manifest
ity.
with the handwritten signature of the
owner or operator of the designated fa- [77 FR 54835, Sept. 6, 2012]
cility within 35 days of the date the
waste was accepted by the initial § 761.218 Certificate of disposal.
transporter, shall immediately contact (a) For each shipment of manifested
the transporter and/or the owner or op- PCB waste that the owner or operator
erator of the designated facility to de- of a disposal facility accepts by signing
termine the status of the PCB waste. the manifest, the owner or operator of
(2) A generator of PCB waste subject the disposal facility shall prepare a
to the manifesting requirements shall Certificate of Disposal for the PCBs
submit an Exception Report to the and PCB Items disposed of at the facil-
EPA Regional Administrator for the ity, which shall include:
Region in which the generator is lo- (1) The identity of the disposal facil-
cated if the generator has not received ity, by name, address, and EPA identi-
a copy of the manifest with the hand fication number.
262
(2) The identity of the PCB waste af- year of the date of removal from serv-
fected by the Certificate of Disposal in- ice for disposal.
cluding reference to the manifest num- (b) A generator or commercial storer
ber for the shipment. of PCB waste who manifests PCBs or
(3) A statement certifying the fact of PCB Items to a disposer of PCB waste
disposal of the identified PCB waste, shall submit a One-year Exception Re-
including the date(s) of disposal, and port to the EPA Regional Adminis-
identifying the disposal process used. trator for the Region in which the gen-
(4) A certification as defined in erator or commercial storer is located
§ 761.3. no later than 45 days from the date the
(b) The owner or operator of the dis- following occurs:
posal facility shall send the Certificate (1) The generator or commercial stor-
of Disposal to the generator identified er transferred the PCBs or PCB Items
on the manifest which accompanied the to the disposer of PCB waste on a date
shipment of PCB waste within 30 days within 9 months from the date of re-
of the date that disposal of each item moval from service for disposal of the
of PCB waste identified on the mani- affected PCBs or PCB Items, as indi-
fest was completed unless the gener- cated on the manifest or continuation
ator and the disposer contractually sheet; and
agree to another time frame. (2) The generator or commercial stor-
(c) The disposal facility shall keep a er either has not received within 13
copy of each Certificate of Disposal months from the date of removal from
among the records that it retains service for disposal a Certificate of Dis-
under § 761.180(b). posal confirming the disposal of the af-
(d)(1) Generators of PCB waste shall fected PCBs or PCB Items, or the gen-
keep a copy of each Certificate of Dis- erator or commercial storer receives a
posal that they receive from disposers Certificate of Disposal confirming dis-
of PCB waste among the records they posal of the affected PCBs or PCB
retain under § 761.180(a). Items on a date more than 1 year after
(2) Commercial storers of PCB waste the date of removal from service.
shall keep a copy of each Certificate of (c) The One-year Exception Report
Disposal that they receive from dis- shall include:
posers of PCB waste among the records (1) A legible copy of any manifest or
they retain under § 761.180(b). other written communication relevant
to the transfer and disposal of the af-
[54 FR 52752, Dec. 21, 1984, as amended at 63 fected PCBs or PCB Items.
FR 35462, June 29, 1998] (2) A cover letter signed by the sub-
mitter or an authorized representative
§ 761.219 One-year exception report- explaining:
ing.
(i) The date(s) when the PCBs or PCB
(a) A disposer of PCB waste shall sub- Items were removed from service for
mit a One-year Exception Report to disposal.
the EPA Regional Administrator for (ii) The date(s) when the PCBs or
the Region in which the disposal facil- PCB Items were received by the sub-
ity is located no later than 45 days mitter of the report, if applicable.
from the end of the 1-year storage for (iii) The date(s) when the affected
disposal date when the following oc- PCBs or PCB Items were transferred to
curs: a designated disposal facility.
(1) The disposal facility receives (iv) The identity of the transporters,
PCBs or PCB Items on a date more commercial storers, or disposers known
than 9 months from the date the PCBs to be involved with the transaction.
or PCB Items were removed from serv- (v) The reason, if known, for the
ice for disposal, as indicated on the delay in bringing about the disposal of
manifest or continuation sheet; and the affected PCBs or PCB Items within
(2) Because of contractual commit- 1 year from the date of removal from
ments or other factors affecting the fa- service for disposal.
cility’s disposal capacity, the disposer (d) PCB/radioactive waste that is ex-
of PCB waste could not dispose of the empt from the 1-year storage for dis-
affected PCBs or PCB Items within 1 posal time limit pursuant to
263
§ 761.240 40 CFR Ch. I (7–1–17 Edition)
§ 761.65(a)(1) is also exempt from the ex- nications, and Analysis Office, Office of
ception reporting requirements of para- Resource Conservation and Recovery
graphs (a), (b), and (c) of this section. (5305P), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
[77 FR 54835, Sept. 6, 2012]
Washington, DC 20460–0001.
(b) Collect a surface sample from a
Subpart L [Reserved] minimum surface area of 100 cm2 at
each sampling site selected. The EPA
Subpart M—Determining a PCB Regional Administrator may approve,
Concentration for Purposes of in writing, requests to collect a sample
Abandonment or Disposal of from smaller surface areas, when <100
Natural Gas Pipeline: Select- cm2 of surface eligible for sampling is
ing Sample Sites, Collecting present; e.g., when sampling a small di-
ameter pipe, a small valve, or a small
Surface Samples, and Ana- regulator. When smaller surfaces are
lyzing Standard PCB Wipe sampled, convert the measurement to
Samples the equivalent measurement for 100
cm2 for purposes of comparison to
SOURCE: 63 FR 35462, June 29, 1998, unless standards based on 100 cm2.
otherwise noted.
§ 761.240 Scope and definitions. FR 57241, Oct. 9, 2007; 74 FR 30235, June 25,
2009]
(a) Use these procedures to select
surface sampling sites for natural gas § 761.247 Sample site selection for pipe
pipe to determine its PCB surface con- segment removal.
centration for abandonment-in-place or (a) General. (1) Select the pipe seg-
removal and disposal off-site in accord- ments to be sampled by following the
ance with § 761.60(b)(5). directions in paragraph (b) of this sec-
(b) ‘‘Pipe segment’’ means a length of tion.
natural gas pipe that has been removed (2) Locate the proper position along
from the pipeline system to be disposed the length of the pipe segment that
of or reused, and that is usually ap- you have selected for sampling, by fol-
proximately 12.2 meters (40 feet) or lowing the directions in paragraph (c)
shorter in length. Pipe segments are of this section.
usually linear. (3) Select the proper sampling posi-
(c) ‘‘Pipeline section’’ means a length tion around the circumference of the
of natural gas pipe that has been cut or pipe segment that you have selected
otherwise separated from the active for sampling, by following the direc-
pipeline, usually for purposes of aban- tions in paragraph (d) of this section.
donment, and that is usually longer (4) Prior to removing pipe from the
than 12.2 meters in length. Pipeline ground or lifting the pipe from its loca-
sections may be branched. tion during former operations, mark
the top side of the pipe.
§ 761.243 Standard wipe sample meth- (5) Do not sample if there are free-
od and size. flowing liquids in the pipe segment.
(a) Collect a surface sample from a Free-flowing liquids must be removed
natural gas pipe segment or pipeline prior to sampling.
section using a standard wipe test as (b) Selecting pipe segments to sample.
defined in § 761.123. Detailed guidance Select the pipe segment(s) that you
for the entire wipe sampling process will sample from a length of pipe or
appears in the document entitled, group of pipe segments, as follows:
‘‘Wipe Sampling and Double Wash/ (1) Do not sample a pipe segment
Rinse Cleanup as Recommended by the that is longer than 12.2 meters (40 feet).
Environmental Protection Agency PCB If a segment is longer than 12.2 meters
Spill Cleanup Policy,’’ dated June 23, in length, cut the segment so that all
1987 and revised on April 18, 1991. This resulting segments are 12.2 meters or
document is available on EPA’s Web less in length.

site at http://www.epa.gov/pcb, or from (2) Determine which pipe segments to
the Program Management, Commu- sample as follows:
264
(i) When a length of pipe having along the length of the pipe segment,
seven or fewer segments is removed for as follows:
purposes of disposal, sample each pipe (1) Take samples at the end upstream
segment. of the former gas flow of each segment
(ii) When removing a length of pipe removed.
having multiple contiguous segments (2) If the pipe segment is cut with a
less than 3 miles in total length, take torch or other high temperature heat
samples from a total of seven seg- source, take the sample at least 15 cm
ments. (6 inches) inside the cut end of the pipe
(A) Sample the first and last seg- segment.
ments removed. (3) If the pipe segment is cut with a
(B) Select the five additional seg- saw or other mechanical device, take
ments according to one of the two fol- the sample at least 2 cm (1 inch) inside
lowing procedures: the end of the pipe segment.
(1) Assign all segments a unique se- (4) If the sample site location se-
quential number. Then select five num- lected in the procedure at paragraph
bers using a random number table or (c)(2) or (c)(3) of this section is a porous
random number generator. If the ran- surface (for example, there is signifi-
dom number generator or random num- cant corrosion so that the wipe mate-
ber table produces either the first pipe rial will be shredded), then move the
segment, the last pipe segment, or any sample site further inside the pipe seg-
previously selected segment, select an- ment (away from the end of the pipe or
other random number until there are pipe segment) until there is no such po-
seven different numbers, each cor- rous surface. For purposes of this sub-
responding to a different pipe segment. part, natural gas pipe with a thin po-
(2) Divide the total number of seg- rous corrosion preventive coating is a
ments by six. Round the resulting non-porous surface.
quotient off to the nearest whole num- (5) If there is not a non-porous sur-
ber. The resulting number is the inter- face accessible by paragraphs (c)(2) and
val between the segments you will (c)(3) of this section, use one of the fol-
sample. For example, cut a 2.9 mile lowing three options:
length of pipeline into 383 segments of
(i) Sample the downstream end of the
approximately 40 feet each. Sample the
pipe segment using the same sample
first (number 1) and last (number 383)
site location procedure as for the up-
segments. To determine which addi-
stream end.
tional five segments to sample, divide
the total number of segments, 383, by 6. (ii) Select another pipe segment
Round up the resulting number in this using the random selection procedure
example, 63.8, to the next whole num- described in paragraph (b) of this sec-
ber, 64. Add 64 to the number of each tion.
preceding pipe segment five separate (iii) If there is no other pipe segment
times to select five additional pipe seg- in the population to be sampled and
ments for sampling. In this example, both ends of a pipe segment have po-
the first pipe segment has the number rous surfaces at all possible sample col-
1, add 64 to 1 to select segment 65. lection sites, then assume that the pipe
Next, add 64 to 65 to select segment 129. segment contains ≥50 ppm PCB but <500
Continue in this fashion to select all ppm PCB.
seven segments: 1, 65, 129, 193, 257, 321, (d) Selecting the sample position—cir-
and 383. cumference. Based on the mark on the
(iii) When removing a length of pipe top of the pipe segment made prior to
having multiple contiguous segments removing pipe from the ground or lift-
more than 3 miles in total length for ing the pipe from its location during
purposes of disposal, take samples of former operations, sample the inside
each segment that is 1⁄2 mile distant center of the bottom of the pipe being
from the segment previously sampled. sampled. Make sure the sample is cen-
Sample a minimum of seven segments. tered on the bottom of the pipe seg-
(c) Selecting the sampling position— ment; that is, sample an equal area on
length. Select the sampling position both sides of the middle of the bottom
265
§ 761.250 40 CFR Ch. I (7–1–17 Edition)
of the pipe segment for the entire (ii) Use a random number table or a
length of the sample. random number generator to select
each representative sample collection
FR 33762, June 24, 1999] site from a complete list of the sequen-
tial identification numbers.
§ 761.250 Sample site selection for (iii) Samples may be collected by re-
pipeline section abandonment. moving any covering soil, cutting the
This procedure is for the sample site pipe to gain access to the sampling lo-
selection for a pipeline section to be cation, and collecting the surface sam-
abandoned, in accordance with ple with the pipe in place, rather than
§ 761.60(b)(5)(i)(B). completely removing the pipeline sec-
(a) General. (1) Select sample collec- tions to collect the surface sample.
tion sites in the pipeline section(s) by [63 FR 35462, June 29, 1998, as amended at 64
following the directions in paragraph FR 33762, June 24, 1999]
(b) of this section.
(2) Select the proper sampling posi- § 761.253 Chemical analysis.
tion along the pipe by following the di- (a) Extract PCBs from the standard
rections in § 761.247 (c) and (d). wipe sample collection medium and
(3) Assure, by visual inspection, the clean-up the extracted PCBs in accord-
absence of free-flowing liquids in the ance with either Method 3500B/3540C or
pipe by affirming no liquids at all liq- Method 3500B/3550B from EPA’s SW-846,
uid collection points and all ends of the Test Methods for Evaluating Solid
pipeline section to be abandoned. Waste, or a method validated under
(b) Selection sample collection sites. At subpart Q of this part. Use Method 8082
a minimum, sample all ends of all pipe- from SW-846, or a method validated
line sections to be abandoned in place. under subpart Q of this part, to analyze
(1) If the pipeline section to be aban- these extracts for PCBs.
doned is between the pressure side of (b) Report all PCB sample concentra-
one compressor station and the suction tions in μg/100 cm2 (16 square inches) of
side of the next compressor station surface sampled. If sampling an area
downstream of the former gas flow, at smaller than 100 cm2, report converted
a minimum, sample all ends of the sample concentrations in accordance
abandoned pipe. with § 761.243(b).
(2) If the pipeline section to be aban-
doned is longer than the distance be- § 761.257 Determining the regulatory
tween the pressure side of one com- status of sampled pipe.
pressor station and the suction side of (a) For purposes of removal for dis-
the next compressor station down- posal of a pipe segment that has been
stream of the former gas flow, divide sampled, the sample results for that
the pipeline section, for purposes of segment determines its PCB surface
sampling, into smaller pipeline sec- concentration. Determine the PCB sur-
tions no longer than the distance from face concentration of a segment which
the pressure side of one compressor was not sampled as follows:
station to the suction side of the next (1) If the unsampled pipe segment is
compressor station downstream of the between two pipe segments which have
former gas flow. Consider each of the been sampled, assume that the
smaller sections to be a separate aban- unsampled segment has the same PCB
donment and sample each one, at a surface concentration as the nearest
minimum, at all ends. sampled pipe segment.
(3) Use the following procedure to lo- (2) If an unsampled pipe segment is
cate representative sample collection equidistant between two pipe segments
sites in pipeline sections at points which have been sampled, assume the
other than the suction and pressure PCB surface concentration of the
side of compressor stations, or the ends unsampled segment to be the arith-
of the pipeline section to be abandoned. metic mean of the PCB surface con-
(i) First, assign a unique identifying centrations measured in the two equi-
sequential number to each kilometer distant, sampled, pipe segments.

or fraction of a kilometer length of (b) For purposes of abandonment of a
pipe within the entire pipeline section. pipeline section, assume that the PCB
266
surface concentration for an entire of a minimum of 50 cm3 from the mixed

pipeline section is the arithmetic mean composite for analysis.
of the PCB surface concentrations (c) Use the following procedures to
measured at the ends of the pipeline sample bulk PCB remediation waste
section. If additional representative that is in more than one container.
samples were taken in a pipeline sec- (1) Segregate the containers by type
tion, assume that the PCB surface con- (for example, a 55-gallon drum and a
centration for the entire pipeline sec- roll-off container are types of con-
tion is the arithmetic mean of the containers).
centrations measured in all representa- (2) For fewer than three containers of
tive samples taken. the same type, sample all containers.
(c) For purposes of removal for dis- (3) For more than three containers of
posal under § 761.60(b)(5)(ii)(A)(1) or the same type, list the containers and
abandonment under § 761.60(b)(5)(i)(B), assign each container an unique se-
if the surface PCB concentration of a quential number. Use a random number
pipe segment, determined by direct generator or table to select a minimum
measurement or in accordance with of 10 percent of the containers from the
paragraph (a) of this section, or of a list, or select three containers, which-
pipeline section as determined in ac- ever is the larger.
cordance with paragraph (b) of this sec- (4) Sample the selected container(s)
tion, is >10 μg/100 cm2, but <100 μg/100 according to paragraph (b) of this sec-
cm2, then that segment or section is tion.
PCB-Contaminated.
§ 761.267 Sampling non-porous sur-
Subpart N—Cleanup Site Charac- faces.
terization Sampling for PCB (a) Sample large, nearly flat, non-po-
Remediation Waste in Ac- rous surfaces by dividing the surface
cordance with § 761.61(a)(2) into roughly square portions approxi-
mately 2 meters on each side. Follow
SOURCE: 63 FR 35464, June 29, 1998, unless the procedures in § 761.302(a).
otherwise noted. (b) It is not necessary to sample
small or irregularly shaped surfaces.
§ 761.260 Applicability.
§ 761.269 Sampling liquid PCB remedi-
This subpart provides a method for ation waste.
collecting new data for characterizing
a PCB remediation waste cleanup site (a) If the liquid is single phase, col-
or for assessing the sufficiency of exist- lect and analyze one sample. There are
ing site characterization data, as re- no required procedures for collecting a
quired by § 761.61(a)(2). sample.
(b) If the liquid is multi-phasic, sepa-
§ 761.265 Sampling bulk PCB remedi- rate the phases, and collect and ana-
ation waste and porous surfaces. lyze a sample from each liquid phase.
(a) Use a grid interval of 3 meters and There are no required procedures for
the procedures in §§ 761.283 and 761.286 collecting a sample from each single
to sample bulk PCB remediation waste phase liquid.
that is not in a container and porous (c) If the liquid has a non-liquid
surfaces. phase which is >0.5 percent by total
(b) Use the following procedures to weight of the waste, separate the non-
sample bulk PCB remediation waste liquid phase from the liquid phase and
that is in a single container. sample it separately as a non-liquid in
(1) Use a core sampler to collect a accordance with § 761.265.
minimum of one core sample for the
entire depth of the waste at the center § 761.272 Chemical extraction and
of the container. Collect a minimum of analysis of samples.
50 cm3 of waste for analysis. Use either Method 3500B/3540C or
(2) If more than one core sample is Method 3500B/3550B from EPA’s SW-846,
taken, thoroughly mix all samples into Test Methods for Evaluating Solid
a composite sample. Take a subsample Waste, or a method validated under
267
§ 761.274 40 CFR Ch. I (7–1–17 Edition)
subpart Q of this part, for chemical ex- § 761.283 Determination of the number
traction of PCBs from individual and of samples to collect and sample
composite samples of PCB remediation collection locations.
waste. Use Method 8082 from SW-846, or This section addresses how to deter-
a method validated under subpart Q of mine the number of samples to collect
this part, to analyze these extracts for and sample collection locations for
PCBs. bulk PCB remediation waste and po-
rous surfaces destined to remain at a
§ 761.274 Reporting PCB concentra- cleanup site after cleanup.
tions in samples. (a) Minimum number of samples. (1) At
(a) Report all sample concentrations each separate cleanup site at a PCB re-
mediation waste location, take a min-
for non-liquid PCBs on a dry weight
imum of three samples for each type of
basis as micrograms of PCBs per gram
bulk PCB remediation waste or porous
of sample (ppm by weight). Report sur- surface at the cleanup site, regardless
face sampling results as μg/100 cm2. Di- of the amount of each type of waste
vide 100 cm2 by the surface area and that is present. There is no upper limit
multiply this quotient by the total to the number of samples required or
number of micrograms of PCBs on the allowed.
surface to obtain the equivalent meas- (2) This is an example of how to cal-
urement of micrograms per 100 cm2. culate the minimum number of re-
(b) Report all sample concentrations quired samples at a PCB remediation
for liquid PCBs on a wet weight basis waste location. There are three dis-
as micrograms of PCBs per gram of tinct cleanup sites at this example lo-
sample (ppm by weight). cation: a loading dock, a transformer
storage lot, and a disposal pit. The
Subpart O—Sampling To Verify minimum number of samples to take
appears in parentheses after each type
Completion of Self-Imple- of waste for each cleanup site. The PCB
menting Cleanup and On-Site remediation wastes present at the load-
Disposal of Bulk PCB Remedi- ing dock are concrete (three samples)
ation Waste and Porous Sur- and clay soil (three samples). The non-
faces in Accordance With liquid PCB remediation wastes present
§ 761.61(a)(6) at the transformer storage lot are oily
soil (three samples), clay soil (three
samples) and gravel (three samples).
SOURCE: 63 FR 35465, June 29, 1998, unless The PCB remediation wastes present at
otherwise noted.
the disposal pit are sandy soil (three
§ 761.280 Application and scope. samples), clay soil (three samples), oily
soil (three samples), industrial sludge
Follow the procedures in this subpart (three samples), and gravel (three sam-
when sampling to verify completion of ples).
the cleanup for self-implementing, on- (b) Selection of sample locations—gen-
site disposal of bulk PCB remediation eral. (1)(i) Use a square-based grid sys-
waste and porous surfaces consistent tem to overlay the entire area to be
with the levels of § 761.61(a)(4)(i) and sampled. Orient the grid axes on a
(iii). The objective of this subpart is magnetic north-south line centered in
not to search for new contamination. the area and an east-west axis perpen-
Confirmation of compliance with the dicular to the magnetic north-south
cleanup levels in § 761.61(a)(4) is only axis also centered in the area.
verifiable for the area sampled in ac- (ii) If the site is recleaned based on
cordance with this subpart. Do not the results of cleanup verification con-
make conclusions or extrapolations ducted in accordance with § 761.61(a)(6),
follow the procedures in paragraph (b)
about PCB concentrations outside of
of this section for locating sampling
the area which has been cleaned up and
points after the recleaning, but reori-
verified based on the results of this ent the grid axes established in para-
verification sampling. graph (b)(1)(i) of this section by moving
the origin one meter in the direction of
268
magnetic north and one meter in the The first coordinate in the pair is the
direction east of magnetic north. measurement on the north-south axis.
(2) Mark out a series of sampling The second coordinate in the pair is
points 1.5 meters apart oriented to the the measurement on the east-west axis.
grid axes. The sampling points shall Collect the sample at the intersection
proceed in every direction to the ex- of an east-west line drawn through the
tent sufficient to result in a two-di- measured spot on the north-south axis,
mensional grid completely overlaying and a north-south line drawn through
the sampling area. the measured spot on the east-west
(3) Collect a sample at each point if axis. If the cleanup site is irregularly
the grid falls in the cleanup area. Ana- shaped and this intersection falls out-
lyze all samples either individually or side the cleanup site, select a new pair
according to the compositing schemes of sampling coordinates. Continue to
provided in the procedures at § 761.289. select pairs of sampling coordinates
So long as every sample collected at a until three are selected for each type of
grid point is analyzed as either an indi- bulk PCB remediation waste or porous
vidual sample or as part of a composite surface at the cleanup site.
sample, there are no other restrictions (d) Area of inference. Analytical re-
on how many samples are analyzed. sults for an individual sample point
(c) Selection of sample locations—small apply to the sample point and to an
cleanup sites. When a cleanup site is area of inference extending to four
sufficiently small or irregularly shaped imaginary lines parallel to the grid
that a square grid with a grid interval axes and one half grid interval distant
of 1.5 meters will not result in a min- from the sample point in four different
imum of three sampling points for each directions. The area of inference forms
type of bulk PCB remediation waste or a square around the sample point. The
porous surface at the cleanup site, sides of the square are parallel to the
there are two options. grid axes and one grid interval in
(1) Use a smaller square grid interval length. The sample point is in the cen-
and the procedures in paragraph (b) of ter of the square area of inference. The
this section. area of inference from a composite
(2) Use the following coordinate- sample is the total of the areas of the
based random sampling scheme. If the individual samples included in the
site is recleaned based on the results of composite.
cleanup verification conducted in ac-
cordance with § 761.61(a)(6), follow the § 761.286 Sample size and procedure
procedures in this section for locating for collecting a sample.
sampling points after the recleaning, At each selected sampling location
but select three new pairs of sampling for bulk PCB remediation waste or po-
coordinates. rous surfaces, collect at least 20 milli-
(i) Beginning in the southwest corner liters of waste, or a portion of suffi-
(lower left when facing magnetic cient weight for the chemical analyst
north) of the area to be sampled, meas- to measure the concentration of PCBs
ure in centimeters (or inches) the max- and still have sufficient analytical de-
imum magnetic north-south dimension tection sensitivity to reproducibly
of the area to be sampled. Next, begin- measure PCBs at the levels designated
ning in the southwest corner, measure in § 761.61(a)(4). Use a core sampler hav-
in centimeters (or inches) the max- ing a diameter ≥2 cm and ≤3 cm. Collect
imum magnetic east-west dimension of waste to a maximum depth of 7.5 cms.
the area to be sampled. Designate the
north-south and east-west dimensions § 761.289 Compositing samples.
(describing the west and south bound- Compositing is a method of com-
aries, respectively, of the area to be bining several samples of a specific
sampled), as the reference axes of a type of bulk PCB remediation waste or
square-based grid system. porous surface from nearby locations
(ii) Use a random number table or for a single chemical analysis. There
random number generator to select a are two procedures for compositing

pair of coordinates that will locate the bulk PCB remediation waste samples.
sample within the area to be sampled. These procedures are based on the
269
§ 761.289 40 CFR Ch. I (7–1–17 Edition)
method for selecting sampling site lo- ration pond), or a leak onto soil from a
cations in § 761.283(b) and (c). The single single drum or tank. Single point
chemical analysis of a composite sam- source contamination may be from a
ple results in an averaging of the con- one-time or continuous contamination.
centrations of its component samples. Composites come from two stages: an
The area of inference of a composite is initial compositing area centered in
determined by the area of inference of the area to be sampled, and subsequent
each of its component samples as de- compositing areas forming concentric
scribed in § 761.283(d). Compositing is square zones around the initial
not mandatory. However, if compositing area. The center of the
compositing is used, it must be per- initial compositing area and each of
formed in accordance with the fol- the subsequent compositing areas is
lowing procedures. the origin of the grid axes.
(a) Compositing in the field or in a lab- (A) Definition of the initial compositing
oratory. Compositing may occur either area. The initial compositing area is
in the field or in a laboratory. Prepare based on a square that contains nine
composite samples using equal volumes grid points, is centered on the grid ori-
of each constituent or component sam- gin, and has sides two grid intervals
ple. Composited samples must be from long. The initial compositing area has
the same type of bulk PCB remediation the same center as this square and
waste or porous surface (see the exam- sides one half a grid interval more dis-
ple at § 761.283(a)(2)). Mix composite tant from the center than the square.
samples thoroughly. From each well-
The initial compositing area has sides
mixed composite sample, take a por-
three grid intervals long.
tion of sufficient weight for the chem-
(B) Definition of subsequent
ical analyst to measure the concentra-
tion of PCBs and still have sufficient compositing areas. Subsequent com-
analytical detection sensitivity to posite sampling areas are in concentric
reproducibly measure PCBs at the lev- square zones one grid interval wide
els designated in § 761.61(a)(4). around the initial compositing area
(b)(1) Compositing from samples col- and around each successive subsequent
lected at grid points in accordance with compositing area. The inner boundary
§ 761.283(b). There are two kinds of com- of the first subsequent compositing
posite sampling procedures depending area is the outer boundary of the ini-
on the original source of contamina- tial compositing area. The outer
tion of the site. boundary of the first subsequent
(i) The first procedure is for sites compositing area is centered on the
with multiple point sources of con- grid origin, has sides one grid interval
tamination (such as an old electrical more distant from the grid origin than
equipment storage area, a scrap yard, the inner boundary, and is two grid in-
or repair shop) or for unknown sources tervals longer on a side than the inner
of contamination. Under this boundary. The inner boundary of each
compositing scheme, composite a max- further subsequent compositing area is
imum of nine samples for each type of the outer boundary of the previous sub-
bulk PCB remediation waste or porous sequent compositing area. The outer
surface at the cleanup site. The max- boundary of each further subsequent
imum dimensions of the area enclosing compositing area is centered on the
a nine grid point composite is two grid grid origin, has sides one grid interval
intervals bounded by three collinear more distant from the grid origin than
grid points (3.0 meters or approxi- the inner boundary, and is two grid in-
mately 10 feet long). Take all samples tervals longer on a side than the inner
in the composite at the same depth. boundary.
Assure that composite sample areas (C) Taking composite samples from the
and individually analyzed samples initial and subsequent compositing areas.
completely overlay the cleanup site. (1) Select composite sampling areas
(ii) The second procedure is for a sin- from the initial compositing area and
gle point source of contamination, such subsequent compositing areas such

as discharge into a large containment that all grid points in the initial
area (e.g., pit, waste lagoon, or evapo- compositing area and subsequent
270
compositing areas are part of a com- § 761.298 Decisions based on PCB con-
posite or individual sample. centration measurements resulting
(2) A person may include in a single from sampling.
composite sample a maximum of all (a) For grid samples which are chemi-
nine grid points in the initial cally analyzed individually, the PCB
compositing area. The maximum num- concentration applies to the area of in-
ber of grid points in a composite sam- ference as described in § 761.283(d).
ple taken from a subsequent (b) For grid samples analyzed as part
compositing area is eight. These eight of a composite sample, the PCB con-
grid points must be adjacent to one an- centration applies to the area of infer-
other in the subsequent compositing ence of the composite sample as de-
area, but need not be collinear. scribed in § 761.283(d) (i.e., the area of
(2) Compositing from samples taken at inference is the total of the areas of
grid points or pairs of coordinates in ac- the individual samples included in the
cordance with § 761.283(c). Samples col- composite).
lected at small sites are based on se- (c) For coordinate pair samples ana-
lecting pairs of coordinates or using lyzed as part of a composite sample, in
the sample site selection procedure for accordance with §§ 761.283(c)(2) and
grid sampling with a smaller grid in- 761.289(b)(2)(ii), the PCB concentration
terval. applies to the entire cleanup site.
(i) Samples collected from a grid having
a smaller grid interval. Use the proce- Subpart P—Sampling Non-Porous
dure in paragraph (b)(1)(i) of this sec- Surfaces for Measurement-
tion to composite samples and deter- Based Use, Reuse, and On-
mine the area of inference for com- Site or Off-Site Disposal Under
posite samples. § 761.61(a)(6) and Decon-
(ii) Samples collected from pairs of co- tamination Under
ordinates. All three samples must be § 761.79(b)(3)
composited. The area of inference for
the composite is the entire area sam-
SOURCE: 63 FR 35467, June 29, 1998, unless
pled. otherwise noted.
§ 761.292 Chemical extraction and § 761.300 Applicability.
analysis of individual samples and
composite samples. This subpart provides sample site se-
lection procedures for large, nearly flat
Use either Method 3500B/3540C or non-porous surfaces, and for small or
Method 3500B/3550B from EPA’s SW-846, irregularly shaped non-porous surfaces.
Test Methods for Evaluating Solid This subpart also provides procedures
Waste, or a method validated under for analyzing the samples and inter-
subpart Q of this part, for chemical ex- preting the results of the sampling.
traction of PCBs from individual and Any person verifying completion of
composite samples of PCB remediation self-implementing cleanup and on-site
waste. Use Method 8082 from SW-846, or disposal of non-porous surfaces under
a method validated under subpart Q of § 761.61(a)(6), or verifying that decon-
this part, to analyze these extracts for tamination standards under
PCBs. § 761.79(b)(3) are met, must use these
procedures.
§ 761.295 Reporting and recordkeeping
of the PCB concentrations in sam- § 761.302 Proportion of the total sur-
ples. face area to sample.
(a) Report all sample concentrations (a) Large nearly flat surfaces. Divide
for bulk PCB remediation waste and the entire surface into approximately 1
porous surfaces on a dry weight basis meter square portions and mark the
and as micrograms of PCBs per gram of portions so that they are clearly iden-
sample (ppm by weight). tified. Determine the sample location
(b) Record and keep on file for 3 years in each portion as directed in § 761.304.
the PCB concentration for each sample (1) For large nearly flat surfaces con-
or composite sample. taminated by a single source of PCBs
271
§ 761.304 40 CFR Ch. I (7–1–17 Edition)
with a uniform concentration, assign § 761.306 Sampling 1 meter square sur-

each 1 meter square surface a unique faces by random selection of halves.
sequential number. (a) Divide each 1 meter square por-
(i) For three or fewer 1 meter square tion where it is necessary to collect a
areas, sample all of the areas. surface wipe test sample into two equal
(ii) For four or more 1 meter square (or as nearly equal as possible) halves.
areas, use a random number generator For example, divide the area into top
or table to select a minimum of 10 per- and bottom halves or left and right
cent of the areas from the list, or to se- halves. Choose the top/bottom or left/
lect three areas, whichever is more. right division that produces halves
(2) For other large nearly flat sur- having as close to the shape of a circle
faces, sample all of the one meter as possible. For example, a square is
square areas. closer to the shape of a circle than is a
(b) Small or irregularly shaped surfaces. rectangle and a rectangle having a
For small surfaces having irregular length to width ratio of 2:1 is closer to
contours, such as hand tools, natural the shape of a circle than a rectangle
gas pipeline valves, and most exterior having a length to width ratio of 3:1.
surfaces of machine tools, sample the (b) Assign a unique identifier to each
entire surface. Any person may select half and then select one of the halves
sampling locations for small, nearly for further sampling with a random
flat surfaces in accordance with number generator or other device (i.e.,
§ 761.308 with the exception that the by flipping a coin).
maximum area in § 761.308(a) is <1 (c) Continue selecting progressively
meter square. smaller halves by dividing the pre-
(c) Preparation of surfaces. Drain all viously selected half, in accordance
free-flowing liquids from surfaces and with paragraphs (a) and (b) of this sec-
brush off dust or loose grit. tion, until the final selected half is
larger than or equal to 100 cm2 and
§ 761.304 Determining sample location. smaller than 200 cm2.
(d) Perform a standard PCB wipe test
(a) For 1 square meter non-porous on the final selected halves from each 1
surface areas having the same size and meter square portion.
shape, it is permissible to sample the (e) The following is an example of ap-
same 10 cm by 10 cm location or posi- plying sampling by halves. Assume
tion in each identical 1 square meter that the area to sample is a 1 meter
area. This location or position is deter- square surface area (a square that has
mined in accordance with § 761.306 or sides 1 meter long). Assign each half to
§ 761.308. one face of a coin. After flipping the
(b) If some 1 square meter surfaces coin, the half assigned to the face of
for a larger non-porous surface area the coin that is showing is the half se-
have different sizes and shapes, sepa- lected.
rately select the 10 cm by 10 cm sam- (1) Selecting the first half:
pling position for each different 1 (i) For a square shape the top/bottom
square meter surface in accordance halves have the same shape as the left/
with § 761.308. right halves when compared to a circle,
(c) If non-porous surfaces have been i.e., regardless of which way the sur-
cleaned and the cleaned surfaces do not face is divided, each half is 1 half meter
meet the applicable standards or lev- wide by 1 meter long. Therefore, divide
els, surfaces may be recleaned and re- the area either top/bottom or left/right.
sampled. When resampling surfaces For selecting the first half, this exam-
previously sampled to verify cleanup ple will select from left/right halves.
levels, use the sampling procedures in (ii) A coin flip selects the left half.
§§ 761.306 through 761.316 to resample The dimensions of this selected surface
the surfaces. If any sample site se- area are 1 meter high and 1⁄2 meter
lected coincides with a previous sam- wide.
pling site, restart the sample selection (2) Selecting the second half:
process until all resampling sites are (i) If the next selection of halves was
different from any previous sampling left/right, the halves would be rectan-
sites. gles four times as long as they are wide
272
(1⁄4 meter wide and 1 meter high). Halves selected from top/bottom would
Halves selected from top/bottom would be square (1⁄8 meter on a side). There-
be square (1⁄2 meter on a side). There- fore, select the next halves top/bottom,
fore, select the next halves top/bottom, because the shape of the top/bottom
because the shape of the top/bottom halves (square) are closer to the shape
halves (square) is closer to the shape of of a circle than the shape of the left/
a circle than the shape of the left/right right halves (long narrow rectangles).
halves (long narrow rectangles). (ii) A coin flip selects the top half.
(ii) A coin flip selects the top half. The dimensions of this selected surface
The dimensions of this selected surface are 1⁄8 meter high and 1⁄8 meter wide or
area are 1⁄2 meter high and 1⁄2 meter 12.5 cm by 12.5 cm.
wide. (7) Collect a standard wipe test sam-
(3) Selecting the third half: ple in the sixth half. Since the dimen-
(i) Just as for the selection of the sions of half of the sixth half would be
first half, which divided the original 12.5 cm by 6.25 cm, the area (approxi-
square area, both the left/right and the mately 78 cm2) would be less than the
top/bottom halves have the same shape required 100 cm2 minimum area for the
when compared to a circle (both are standard wipe test. Therefore, no fur-
rectangles having the same dimen- ther sampling by halves is necessary.
sions). Therefore, choose either left/ Take the standard wipe test samples of
right or top/bottom halves. This exam- the entire selected sixth half.
ple will select from left/right halves.
(ii) A coin flip selects the right half. § 761.308 Sample selection by random
The dimensions of this selected surface number generation on any two-di-
are 1⁄4 meter by 1⁄2 meter. mensional square grid.
(4) Selecting the fourth half:
(a) Divide the surface area of the
(i) If the next selection of halves was
non-porous surface into rectangular or
left/right, the halves would be rectan-
square areas having a maximum area
gles four times as long as they are wide
of 1 square meter and a minimum di-
(1⁄8 meter wide and 1⁄2 meter high.
mension of 10 centimeters.
Halves selected from top/bottom would
be square (1⁄4 meter on a side). There- (b) Measure the length and width, in
fore, select the next halves top/bottom, centimeters, of each area created in
because the shape of the top/bottom paragraph (a) of this section. Round off
halves (square) are closer to the shape the number of centimeters in the
of a circle than the shape of the left/ length and the width measurements to
right halves (long narrow rectangles). the nearest centimeter.
(ii) A coin flip selects the bottom (c) For each 1 square meter area cre-
half. The dimensions of this selected ated in accordance with paragraph (a)
surface area are 1⁄4 meter high and 1⁄4 of this section, select two random num-
meter wide. bers: one each for the length and width
(5) Selecting the fifth half: borders measured in paragraph (b) of
(i) Just as for the selection of the this section. An eligible random num-
first and third halves, both the left/ ber can be from zero up to the total
right and the top/bottom halves have width, minus 10 centimeters.
the same shape when compared to a (d) Locate the 10 centimeter by 10
circle (both are rectangles having the centimeter sample.
same dimensions). Therefore, choose (1) Orient the 1 square meter surface
either left/right or top/bottom halves. area so that, when you are facing the
This example will select from left/right area, the length is left to right and the
halves. width is top to bottom. The origin, or
(ii) A coin flip selects the right half. reference point for measuring selected
The dimensions of the selected surface random numbers of centimeters to the
are 1⁄8 meter by 1⁄4 meter. sampling area, is on the lower left cor-
(6) Selecting the sixth half: ner when facing the surface.
(i) If the next selection of halves was (2) Mark the random number selected
left/right, the halves would be rectan- for the length distance, in centimeters,
gles four times as long as they are wide from the origin to the right (at the bot-
(1⁄16 meter wide and 1⁄4 meter high. tom of the area away from the origin).
273
§ 761.310 40 CFR Ch. I (7–1–17 Edition)
(3) From the marked length distance ance with § 761.272. Report sample re-
on the bottom of the area, move per- sults in micrograms per 100 cm2.
pendicularly up from the bottom of the
area into the area for the distance ran- § 761.316 Interpreting PCB concentra-
domly selected for the width. tion measurements resulting from
(4) Use the point determined in para- this sampling scheme.
graph (d)(3) of this section as the lower (a) For an individual sample taken
left corner of the 10 centimeter by 10 from an approximately 1 meter square
centimeter sample. portion of the entire surface area and
not composited with other samples, the
§ 761.310 Collecting the sample. status of the portion is based on the
Use the standard wipe test as defined surface concentration measured in that
in § 761.123 to sample one 10 centimeter sample. If the sample surface con-
by 10 centimeter square (100 cm2) area centration is not equal to or lower
to represent surface area PCB con- than the cleanup level, by inference the
centrations of each square meter or entire 1 meter area, and not just the
fraction of a square meter of a nearly immediate area where the sample was
flat, non-porous surface. For small sur- taken, is not equal to or lower than the
faces, use the same procedure as for the cleanup level.
standard wipe test, only sample the en- (b) For areas represented by the
tire area, rather than 10 centimeter by measurement results from compositing
10 centimeter squares. more than one 10 centimeter by 10 cen-
timeter sample, the measurement for
§ 761.312 Compositing of samples. the composite is the measurement for
For a surface originally contami- the entire area. For example, when
nated by a single source of PCBs with there is a composite of 10 standard
a uniform concentration, it is permis- wipe test samples representing 9.5
sible to composite surface wipe test square meters of surface area and the
samples and to use the composite result of the analysis of the composite
measurement to represent the PCB is 20 μg/100 cm2, then the entire 9.5
concentration of the entire surface. square meters has a PCB surface con-
Composite samples consist of more centration of 20 μg/100 cm2, not just the
than one sample gauze extracted and area in the 10 cm by 10 cm sampled
chemically analyzed together resulting areas.
in a single measurement. The com- (c) For small surfaces having irreg-
posite measurement represents an ular contours, where the entire surface
arithmetic mean of the composited was sampled, measure the surface area.
samples. Divide 100 cm2 by the surface area and
(a) Compositing samples from surfaces multiply this quotient by the total
to be used or reused. For small or irregu- number of micrograms of PCBs on the
larly shaped surfaces or large nearly surface to obtain the equivalent meas-
flat surfaces, if the surfaces are con- urement of micrograms per 100 cm2.
taminated by a single source of PCBs
with a uniform concentration, com- Subpart Q—Self-Implementing Al-
posite a maximum of three adjacent ternative Extraction and
samples. Chemical Analysis Procedures
(b) Compositing samples from surfaces
to be disposed of off-site or on-site. (1)
for Non-liquid PCB Remedi-
For small or irregularly shaped sur- ation Waste Samples
faces, composite a maximum of three
adjacent samples. SOURCE: 63 FR 35468, June 29, 1998, unless
(2) For large nearly flat surfaces, otherwise noted.
composite a maximum of 10 adjacent
samples. § 761.320 Applicability.
This subpart describes self-imple-
§ 761.314 Chemical analysis of stand- menting comparison testing require-
ard wipe test samples. ments for chemical extraction and

Perform the chemical analysis of chemical analysis methods used as an
standard wipe test samples in accord- alternative to the methods required in
274
§ 761.272 or § 761.292. Any person con- samples using the methods specified in
ducting comparison testing under this § 761.292. All samples of non-liquid PCB
subpart must comply with the require- remediation waste must have PCB con-
ments of § 761.80(i), including notifica- centrations between 0.1 and 150 ppm.
tion. Use alternative methods only (1) A minimum of three comparison
after successful completion of these study samples must have PCB con-
comparison testing requirements and centrations above the cleanup level
after documentation of the results of specified for the site in § 761.61(a)(4) and
the testing. a minimum of three comparison study
samples must have PCB concentrations
§ 761.323 Sample preparation. below the specified cleanup level.
(a) The comparison study requires (2) At least one comparison study
analysis of a minimum of 10 samples sample must have a PCB concentration
weighing at least 300 grams each. Sam- ≥90 percent and ≤100 percent of the
ples of PCB remediation waste used in cleanup level.
the comparison study must meet the (3) At least one comparison study
following three requirements. sample must have a PCB concentration
(1) The samples must either be taken ≥100 percent and ≤110 percent of the
from the PCB remediation waste at the cleanup level.
cleanup site, or must be the same kind (c) If the comparison study samples
of material as that waste. For example, do not have the concentrations or con-
if the waste at the cleanup site is centration ranges required by para-
sandy soil, you must use the same kind graph (b) of this section, for purposes
of sandy soil in the comparison study. of use in this chemical extraction and
Do not use unrelated materials such as chemical analysis comparison study, a
clay soil or dredged sediments in place person may adjust PCB concentrations
of sandy soil. by dilution. Any excess material re-
(2) PCB remediation waste may consulting from the preparation of these
tain interferences which confound or samples, which is not used as an ana-
hamper sample extraction and chem- lytical sample, is regulated as the PCB
ical analysis. These interferences may concentration in the component having
be from chemicals or other attributes the highest PCB concentration of the
preexisting in the waste material, re- component materials in the sample.
sulting from the PCB contamination
source, or resulting from treatment to § 761.326 Conducting the comparison
remove or destroy PCBs. Comparison study.
study samples must also contain these Extract or analyze the comparison
interfering materials to demonstrate study samples using the alternative
successful analysis in their presence. method. For an alternative extraction
For example, a PCB remediation waste method or alternative analytical meth-
may have been co-disposed with chloro- od to be comparable to the methods re-
benzene solvents or chlorinated pes- quired in § 761.292, all of the following
ticides. These chlorinated compounds conditions must be met.
would have to be present in the com- (a) All samples having PCB con-
parison study compounds at the same centrations greater than or equal to
levels found, or at the highest levels the level of concern, as measured by
expected to be found, in the PCB reme- the methods required in § 761.292, are
diation waste. As another example, for found to be greater than or equal to
PCB remediation waste which had been the level of concern as measured by the
solvent washed with liquid amines to alternative method (no false nega-
remove PCBs, comparison study sam- tives).
ples would have to contain concentra- (b) Only one sample which contains
tions of these amines at the same lev- PCBs at a level less than the level of
els found, or at the highest levels ex- concern, as measured by the methods
pected to be found, in the PCB remedi- required in § 761.292, is found to have a
ation waste. PCB concentration greater than the
(b) Prior to initiating the comparison level of concern as measured by the al-
study, confirm the following PCB con- ternative method (false positive); and
centrations in the comparison study all other samples which contain PCBs
275
§ 761.340 40 CFR Ch. I (7–1–17 Edition)
at levels less than the level of concern, lection procedures for the first level of
as measured by the methods required sampling from existing piles of waste
in § 761.292, are found by the alternative are in § 761.347. Collection procedures
method to have PCBs less than the for the first level of sampling from a
level of concern (there are no addi- contemporaneous generation of waste
tional false positives). are in § 761.348. Compositing require-
ments and requirements for the sub-
Subpart R—Sampling Non-Liquid, sampling of composite samples to re-
Non-Metal PCB Bulk Product sult in a single 19-liter sample are in
Waste for Purposes of Charac- § 761.350. Send the 19-liter sample to the
laboratory for the second and third lev-
terization for PCB Disposal in
els of sampling, including particle size
Accordance With § 761.62, reduction for leach testing and drying
and Sampling PCB Remedi- as required by § 761.1(b)(4).
ation Waste Destined for Off- (b) Second, at the laboratory, select
Site Disposal, in Accordance one quarter of the 19-liter sample. Pro-
With § 761.61 cedures the laboratory must use for
this second level of sample selection
SOURCE: 63 FR 35469, June 29, 1998, unless appear in § 761.353.
otherwise noted. (c) Third, select a 100 gram sub-
sample from the second level sub-
§ 761.340 Applicability. sample. Procedures the laboratory
Use the procedures specified in this must use for this third level of sample
subpart to sample the following types selection appear in § 761.355.
of waste when it is necessary to ana-
lyze the waste to determine PCB con- § 761.347 First level sampling—waste
centration or leaching characteristics from existing piles.
for storage or disposal. (a) General. Sample piles that are ei-
(a) Existing accumulations of non- ther specifically configured for sam-
liquid, non-metal PCB bulk product pling (see paragraph (b) of this section)
waste. or that are of conical shape (see para-
(b) Non-liquid, non-metal PCB bulk graph (c) of this section). If sampling
product waste from processes that con- from either of these shapes is not pos-
tinuously generate new waste. sible, conduct contemporaneous sam-
(c) Non-liquid PCB remediation pling, in accordance with the proce-
waste from processes that continuously dures in § 761.348, or obtain the ap-
generate new waste, that will be sent proval of the Regional Administrator
off-site for disposal. for an alternate sampling plan in ac-
cordance with § 761.62(c).
§ 761.345 Form of the waste to be sam- (b) Specifically configured piles. A spe-
pled. cifically configured pile is a single flat-
PCB bulk product waste and PCB re- tened pile in the shape of a square or
mediation waste destined for off-site rectangle having no restrictions on
disposal must be in the form of either length or width but restricted to 30 cm
flattened or roughly conical piles. This (1 foot) in depth. A square shaped pile
subpart also contains a procedure for facilitates sampling site selection for
contemporaneous sampling of waste as the first level sample. Select eight 19-
it is being generated. liter samples from the pile and com-
posite them into one 19-liter sample as
§ 761.346 Three levels of sampling. follows:
To select a sample of the waste and (1) Divide the pile into quarters.
prepare it for chemical extraction and (2) Divide each of the quarter sec-
analysis, there are three required lev- tions into quarters (i.e., into sixteenths
els of random sampling. of the original pile).
(a) First, select a single 19-liter (5 (3) Select two sixteenths from each of
gallon) portion from a composite accu- the four quarters, according to one of
mulated either contemporaneously the two following options:

with the generation of the waste or by (i) Randomly select the two six-
sampling an existing pile of waste. Col- teenths from one quarter and sample
276
the sixteenths occupying the same po- each pile or container an integer num-
sitions in each of the other three quar- ber and then generate seven random in-
ters. teger numbers to select the piles from
(ii) Randomly select two sixteenths which you will collect samples. It is
from each of the four quarters (i.e., possible that this random selection
perform a random selection four dif- procedure will result in selecting the
ferent times). same pile number more than once, even
(4) At this point the eight selected if seven or more piles are present. If so,
sixteenths undergo further division and sample the pile once and restart the
sample selection. Divide each of the sampling collection process to collect
eight selected sixteenths into four additional samples. Do not collect mul-
equal parts. Using a random number tiple samples from the same location
generator or random number table, se- in the pile.
lect one of the four equal parts from (2) Collecting samples from a single pile.
each of the eight equal areas. If each of If only one pile or container is present,
the four equal parts has a volume >76 collect all eight samples from the same
liters when projected downwards 30 cm, pile.
continue to divide each selected area (3) Setting up the sample site selection
into four equal parts, and select one of system from a pile. Locate a sample in a
the parts, until each selected area has pile by the use of three parameters: a
a volume of <76 liters but ≥19 liters. particular radial direction, ‘‘r,’’ from
When projected to a depth of 30 cm, a the peak at the center of the pile to the
square having a 25 cm side or a circle
outer edge at the base of the pile; a
having a diameter of approximately
point, ‘‘s,’’ along that radial direction
28.5 cm equals a volume of approxi-
between the peak of the pile and the
mately 19 liters. The volume of 76 liters
outer edge of the base of the pile; and
is equal to the volume enclosed by a
a depth, ‘‘t’’, beneath point ‘‘s.’’ The
square having a side of 50 cm (or other
top of the sample material will be
shape having an area of 250 cm2) pro-
below depth t, at point s, on radius r.
jected to a depth of 30 cm.
Use a rod, dowel, stake, or broom han-
(5) Take one sample of approximately
dle as a marker. Nail or otherwise fas-
19 unsorted liters of waste from each of
ten to the top of the marker two pieces
the eight selected areas. Place each
sample into a separate 19-liter con- of string or cord of sufficient length
tainer, allowing only sufficient space and strength to reach from the top of
at the top of the container to secure the marker at the top of the pile to the
the lid. farthest peripheral edge at the bottom
(6) Composite the eight 19-liter sam- of the pile, when the marker is posi-
ples in accordance with § 761.350. tioned at the top or apex of the pile.
(c) Conical-shaped piles. If it is nec- Pound or push the marker into the top
essary to sample a pile which is too center (apex) of the pile, downward to-
large to be spread on the site to a uni- ward the center of the base. Insert the
form thickness of 1 foot or 30 cm, or if marker for at least 30 cm or one foot
there are too many piles to spread out until the marker is rigidly standing on
in the space available, use the fol- its own, even when the cord is pulled
lowing procedure to sample the piles. tight to the bottom peripheral edge of
This procedure assumes that the shape the pile. Ensure that the marker pro-
of the piles is analogous to a cone; that trudes from the top of the pile suffi-
is, having a circular base with PCB ciently to allow the strings to move
bulk product waste or PCB remediation easily around the pile when they are
waste destined for off-site disposal pulled tight. Select the three param-
stacked up uniformly to a peak that is eters and the sampling location as fol-
a point centered above the center of lows:
the circular base. Collect eight 19-liter (i) Determine the radial component
samples as follows: (r) of the location for each sample.
(1) Collecting samples from more than (A) Tie to a stake or otherwise fasten
one pile. If the PCB bulk product waste one of the strings at ‘‘b,’’ the bottom of
or PCB remediation waste consists of the pile, as a reference point for find-
more than one pile or container, assign ing r.
277
§ 761.348 40 CFR Ch. I (7–1–17 Edition)
(B) Measure the circumference ‘‘c,’’ distance ‘‘v’’ is the number of centi-
the distance around the bottom of the meters from the surface of the pile at
pile. Determine r from b in one of two point s on the string to the bottom of
ways: the pile or ground level. Read the dis-
(1) Multiply c by a randomly gen- tance v on the measuring device at the
erated fraction or percentage of one. surface of the pile. From the distance
(2) Select a random number between v, determine t, in one of two ways:
one and the total number of centi- (1) Randomly generate a fraction of
meters in c. one and multiply the fraction times v.
(C) Locate r by starting at b, the (2) Select a random number between
place where the fixed string meets the zero and the total number of centi-
base of the pile, and travel clockwise meters of the vertical distance v.
around the edge of the pile at the base (iv) Dig a hole straight down into the
for the distance you selected in para- pile for t centimeters (inches) from the
graph (c)(3)(i)(B) of this section. surface of the pile at s.
(D) Fasten the second string at the
(v) At depth t, directly under the s
selected distance. The second string
mark on the string, outline the top of
marks the first parameter r.
the sample container and collect (shov-
(ii) Determine the second parameter
el) all waste under the outline in the
s of the location for each sample.
following order of preference in para-
(A) Measure the distance, l, along the
graphs (c)(3)(v)(A) through (c)(3)(v)(C)
string, positioned in paragraph
of this section. It is possible that some
(c)(3)(i)(D) of this section, from the top
to the bottom of the pile at the se- of the eight sampling locations will not
lected radial distance r. Determine the provide 19 liters of sample.
distance s from l in one of two ways: (A) For a depth of 30 cm.
(1) Multiply l by a randomly gen- (B) Until the container is full.
erated fraction or percentage of one. (C) Until the ground level is reached.
(2) Select a random number between (d) Compositing the samples. Composite
one and the total number of centi- the eight 19-liter samples and sub-
meters in l. sample in accordance with § 761.350.
(B) Mark, for example by placing a Send the subsample to a laboratory for
piece of tape on the string positioned further sampling as described in
according to paragraph (c)(3)(i)(D) of §§ 761.353 and 761.355 and for chemical
this section, the distance s, up from the extraction and analysis. If there is in-
bottom of the pile on the string at r. sufficient sample for a 19-liter sample
(iii) Determine the third and final pa- from the composite sample composed
rameter t of the location for each sam- of the eight iterations of sample site
ple. selection, according to the procedures
(A) Mark and number 1 cm intervals in paragraphs (c)(3)(i) through (c)(3)(v)
from one end of a rigid device, for ex- of this section, select additional sam-
ample a rod, dowel, stake, or broom ple sites, collect additional samples
handle, for measuring the distance and composite the additional waste in
from the top of the pile to the bottom the samples until a minimum of 19 li-
at the point s selected in paragraph ters is in the composite.
(c)(3)(ii)(B) of this section. The marked
and numbered device shall be of suffi- [63 FR 35469, June 29, 1998, as amended at 64
FR 33762, June 24, 1999]
cient strength to be forced down
through the maximum depth of the pile § 761.348 Contemporaneous sampling.
and sufficient length to measure the
depth of the waste in the pile at any Contemporaneous sampling is pos-
point. sible when there is active generation of
(B) Take the measuring device, con- waste and it is possible to sample the
structed according to paragraph waste stream as it is generated. Collect
(c)(3)(iii)(A) of this section, and at posi- eight 19-liter samples as follows.
tion s, push the end of the device (a) Collect each sample by filling a
marked with zero straight down into 19-liter (5 gallon) container at a loca-
the pile until it reaches the bottom of tion where the PCB bulk product waste
the pile or ground level. The vertical is released from the waste generator
278
onto a pile or into a receptacle con- olutions of the stirring instrument

tainer before the waste reaches the pile around the container at a distance ap-
or receptacle container. proximately half way between the out-
(b) Determine a sample collection side and center of the container.
start time using a random number gen- (b) Selecting a 19-liter subsample from
erator or a random number table to se- the composite. Once the composite is
lect a number between 1 and 60. Collect mixed, pour the mixture of waste out
the first sample at the randomly se- on a plastic sheet and either divide it
lected time in minutes after start up of into 19-liter size piles or make one
the waste output, or if the waste is cur- large pile.
rently being generated, after the ran- (1) From 19-liter sized piles, use a
dom time is selected. For example, if random number generator or random
the randomly selected time is 35, begin number table to select one of the piles.
collection 35 minutes after the start up (2) From one large pile, flatten the
of waste generation. Similarly, if waste pile to a depth of 30 cm and divide it
output is ongoing and the random start into 4 quarters of equal size. Use a ran-
determination occurred at 8:35 a.m., dom number generator or random num-
collect the first sample at 9:10 a.m. (35 ber table to select one quarter of the
minutes after the random start deter- pile. Further divide the selected quar-
mination). ter pile into 19-liter portions and use a
(c) Collect seven more samples, one random number generator or random
every 60 minutes after the initial sam- number table to select one 19-liter por-
ple is collected. If the waste output tion. A square having a 25 cm side or a
process stops, stop the 60–minute inter- circle having a diameter of approxi-
val time clock. When the process re- mately 28.5 cm when projected down-
starts, restart the 60–minute interval wards 30 cm equals approximately 19 li-
time clock and complete the incom- ters.
plete 60–minute interval. (c) Transferring the sample to the ana-
(d) Composite the eight 19-liter sam- lytical laboratory. Place the selected 19-
ples and subsample in accordance with liter subsample in a container, ap-
§ 761.350. proved for shipment of the sample, to
the chemical extraction and analysis
§ 761.350 Subsampling from composite laboratory, for the next step in sample
samples. selection in accordance with § 761.353.
(a) Preparing the composite. Composite
the samples (eight from a flattened § 761.353 Second level of sample selec-
pile; eight or more from a conical pile; tion.
eight from waste that is continuously The second level of sample selection
generated) and select a 19-liter sub- reduces the size of the 19-liter sub-
sample for shipment to the chemical sample that was collected according to
extraction and analysis laboratory for either § 761.347 or § 761.348 and subsam-
further subsampling. There are two op- pled according to § 761.350. The purpose
tions for the preparation of the com- of the sample size reduction is to limit
posite: the amount of time required to manu-
(1) Option one. Place all of the con- ally cut up larger particles of the waste
tents of all 19-liter samples that you to pass through a 9.5 millimeter (mm)
collected into a 209 liter (55 gallon) screen.
drum or similar sized, cylinder-shaped (a) Selecting a portion of the subsample
container. Completely close the con- for particle size reduction. At the chem-
tainer, and roll it 10 or more complete ical extraction and analysis labora-
revolutions to mix the contents. tory, pour the 19-liter subsample onto a
(2) Option two. Add the 19-liter sam- plastic sheet or into a pan and divide
ples one at a time to a 209 liter (55 gal- the subsample into quarters. Use a ran-
lon) drum. Between the addition of dom number generator or random num-
each 19-liter sample, stir the composite ber table to select one of these quar-
using a broom handle or similar long, ters.
narrow, sturdy rod that reaches the (b) Reduction of the particle size by the
bottom of the container. Stir the mix- use of a 9.5 mm screen. Collect the con-
ture for a minimum of 10 complete rev- tents of the selected quarter of waste
279
§ 761.355 40 CFR Ch. I (7–1–17 Edition)
resulting from conducting the proce- cool it to the analytical laboratory

dures in paragraph (a) of this section room temperature before analysis
and shake the waste in a 9.5 mm using a procedure used to simulate
screen. Separate the waste material leachate generation. This sample was
which passes through the screen from dried previously in the larger quantity
the waste material which does not pass sample at the second level of sampling
through the screen. Manually cut or (§ 761.353(c)) and is dried a second time
otherwise reduce the size of all parts of here (in the third level of sample selec-
the waste portion which did not pass tion). This dried and cooled sample
through the 9.5 mm screen, such that must weigh at least 50 grams.
each part of the waste shall pass (d) If the dried and cooled sample
through the 9.5 mm screen by shaking. weighs <50 grams, select additional 100
(c) Drying the reduced particle size gram portions of sample one at a time
waste. Dry all of the waste portion re- by repeating the directions in para-
sulting from conducting the procedures graph (b) and (c) of this section, and
in paragraph (b) of this section, from 10 add each additional 100 gram portion of
to 15 hours in a drying oven at 100 °C. sample to the first 100 gram portion
Allow the dried waste to cool to room until at least 50 grams of dried mate-
temperature. rial is in the sample to be analyzed
(d) Mixing the dried waste. Place all of using a procedure used to simulate
the waste resulting from conducting leachate generation.
the procedures in paragraph (c) of this
section in a 19-liter pail or similarly § 761.356 Conducting a leach test.
sized, cylinder-shaped container. Mix
the dried material according to one of No method is specified as a procedure
the two following options: used to simulate leachate generation.
(1) First mixing option. Completely § 761.357 Reporting the results of the
close the container and roll the con- procedure used to simulate leach-
tainer a minimum of 10 complete revo- ate generation.
lutions to mix the contents.
(2) Second mixing option. Use a sturdy Report the results of the procedure
stirring rod, such as a broom handle or used to simulate leachate generation
other device that reaches the bottom of as micrograms PCBs per liter of ex-
the container, to stir the waste for a tract from a 100 gram sample of dry
minimum of 10 complete revolutions bulk product waste. Divide 100 grams
around the container at a distance ap- by the grams in the sample and mul-
proximately half way between the out- tiply this quotient by the number of
side and the center of the container. micrograms PCBs per liter of extract
to obtain the equivalent measurement
§ 761.355 Third level of sample selec- from a 100 gram sample.
tion.
§ 761.358 Determining the PCB con-
The third level of sample selection centration of samples of waste.
further reduces the size of the sub-
sample to 100 grams which is suitable Use either Method 3500B/3540C or
for the chemical extraction and anal- Method 3500B/3550B from EPA’s SW-846,
ysis procedure. Test Methods for Evaluating Solid
(a) Divide the subsample resulting Waste, or a method validated under
from conducting the procedures in subpart Q of this part, for chemical ex-
§ 761.353 of this part into 100 gram por- traction of PCBs from individual and
tions. composite samples of PCB bulk prod-
(b) Use a random number generator uct waste. Use Method 8082 from SW-
or random number table to select one 846, or a method validated under sub-
100 gram size portion as a sample for a part Q of this part, to analyze these ex-
procedure used to simulate leachate tracts for PCBs.
generation.
(c) Dry the 100 gram sample, selected § 761.359 Reporting the PCB con-
after conducting the procedure in para- centrations in samples.

graph (b) of this section, for 10 to 15 Report all sample concentrations as
hours in a drying oven at 100 °C and ppm by weight on a dry weight basis.
280
Subpart S—Double Wash/Rinse § 761.372 Specific requirements for rel-

Method for Decontaminating atively clean surfaces.
Non-Porous Surfaces For surfaces that do not appear dusty
or grimy before a spill, such as glass,
automobile surfaces, newly-poured con-
crete, and desk tops, use the double
otherwise noted.
wash/rinse procedures in this section.
§ 761.360 Background. (a) First wash. Cover the entire sur-
face with organic solvent in which
The double wash/rinse procedure is PCBs are soluble to at least 5 percent
used to quickly and effectively remove by weight. Contain and collect any
PCBs on surfaces. It is important to se- runoff solvent for disposal. Scrub rough
lect and use the proper cleanup equip- surfaces with a scrub brush or dispos-
ment, to conduct the procedure cor- able scrubbing pad and solvent such
rectly so as not to redistribute PCBs, that each 900 cm2 (1 square foot) of the
and to comply with disposal require- surface is always very wet for 1
ments for all cleanup materials. minute. Wipe smooth surfaces with a
solvent-soaked, disposable absorbent
§ 761.363 Applicability. pad such that each 900 cm2 (1 square
The double wash/rinse procedure in- foot) is wiped for 1 minute. Any surface
cludes two washing steps and two rins- <1 square foot shall also be wiped for 1
minute. Wipe, mop, and/or sorb the sol-
ing steps. The two washing and rinsing
vent onto absorbent material until no
steps are slightly different depending
visible traces of the solvent remain.
on whether a contaminated surface was (b) First rinse. Wet the surface with
relatively clean before the spill (see clean rinse solvent such that the entire
§ 761.372), or whether the surface was surfaces is very wet for 1 minute. Drain
coated or covered with dust, dirt, and contain the solvent from the sur-
grime, grease or another absorbent ma- face. Wipe the residual solvent off the
terial (see § 761.375). drained surface using a clean, dispos-
able absorbent pad until no liquid is
§ 761.366 Cleanup equipment. visible on the surface.
(a) Use scrubbers and absorbent pads (c) Second wash. Repeat the proce-
that are not dissolved by the solvents dures in paragraph (a) of this section.
or cleaners used, and that do not shred, The rinse solvent from the first rinse
crumble, or leave visible fragments on (paragraph (b) of this section) may be
the surface. Scrubbers and absorbent used.
pads used to wash contaminated sur- (d) Second rinse. Repeat the proce-
faces must not be reused. Scrubbers dures in paragraph (b) of this section.
and absorbent pads for rinsing must § 761.375 Specific requirements for
not contain ≥2 ppm PCBs. Scrubbers surfaces coated or covered with
and absorbent pads used in the second dust, dirt, grime, grease, or another
rinse of contaminated surfaces may be absorbent material.
reused to wash contaminated surfaces. (a) First wash. Cover the entire sur-
(b) Capture and contain all solvents face with concentrated or industrial
and cleaners for reuse, decontamina- strength detergent or non-ionic surfac-
tion, or disposal. Clean organic sol- tant solution. Contain and collect all
vents contain <2 ppm PCBs. Clean cleaning solutions for proper disposal.
water contains <3 ppb PCBs. Scrub rough surfaces with a scrub
brush or scrubbing pad, adding clean-
§ 761.369 Pre-cleaning the surface. ing solution such that the surface is al-
If visible PCB-containing liquid is ways very wet, such that each 900 cm2
present on the surface to be cleaned, (1 square foot) is washed for 1 minute.
Wipe smooth surfaces with a cleaning
thoroughly wipe or mop the entire sur-
solution-soaked disposable absorbent
face with absorbent paper or cloth

pad such that each 900 cm2 (1 square
until no liquid is visible on the surface. foot) is wiped for 1 minute. Wash any
surface <1 square foot for 1 minute.
281
§ 761.378 40 CFR Ch. I (7–1–17 Edition)
Mop up or absorb the residual cleaner trade name whether or not the con-
solution and suds with a clean, dispos- stituents of the product are propri-
able, absorbent pad until the surface etary.
appears dry. This cleaning should re-
move any residual dirt, dust, grime, or § 761.383 Applicability.
other absorbent materials left on the Use the self-implementing decon-
surface during the first wash. tamination procedure only on smooth,
(b) First rinse. Rinse off the wash so- non-porous surfaces that were once in
lution with 1 gallon of clean water per contact with liquid PCBs. Decon-
square foot and capture the rinse
tamination procedures under this sub-
water. Mop up the wet surface with a
part shall exactly parallel § 761.79(c)(3)
clean, disposable, absorbent pad until
and (c)(4), except that the procedures
the surface appears dry.
described in § 761.79(c)(3)(iii) and
(c) Second wash. Follow the procedure
in § 761.372(a). (c)(3)(iv) and (c)(4)(iii), (c)(4)(iv) and
(d) Second rinse. Follow the procedure (c)(4)(vii) may be revised to contain pa-
in § 761.372(b). rameters validated in accordance with
this subpart.
§ 761.378 Decontamination, reuse, and
disposal of solvents, cleaners, and § 761.386 Required experimental con-
equipment. ditions for the validation study and
subsequent use during decon-
(a) Decontamination. Decontaminate tamination.
solvents and non-porous surfaces on
equipment in accordance with the The following experimental condi-
standards and procedures in § 761.79(b) tions apply for any solvent:
and (c). (a) Temperature and pressure. Conduct
(b) Reuse. A solvent may be reused so the validation study and perform de-
long as its PCB concentration is <50 contamination at room temperature
ppm. Decontaminated equipment may (from ≥15 °C to ≤30 °C) and at atmos-
be reused in accordance with § 761.30(u). pheric pressure.
Store solvents and equipment for reuse (b) Agitation. Limit the movement in
in accordance with § 761.35. the solvent to the short-term move-
(c) Disposal. Dispose of all solvents, ment from placing the contaminated
cleaners, and absorbent materials in surface into the soak solvent and from
accordance with § 761.79(g). Dispose of removing the surface from the soak
equipment in accordance with solvent.
§ 761.61(a)(5)(v)(A), or decontaminate in (c) Time of soak. Soak the surface for
accordance with § 761.79(b) or (c). Store a minimum of 1 hour.
for disposal equipment, solvents, clean-
(d) Surface conditions for the validation
ers, and absorbent materials in accord-
study. Prior to beginning the validation
ance with § 761.65.
study, ensure that there are no free-
flowing liquids on surfaces and that
Subpart T—Comparison Study for surfaces are dry (i.e., there are no liq-
Validating a New Perform- uids visible without magnification).
ance-Based Decontamination Also ensure that surfaces are virtually
Solvent Under § 761.79(d)(4) free from non-liquid residues, corro-
sion, and other defects which would
SOURCE: 63 FR 35473, June 29, 1998, unless prevent the solvent from freely circu-
otherwise noted. lating over the surface.
(e) Confirmatory sampling for the vali-
§ 761.380 Background. dation study. Select surface sample lo-
This subpart provides self-imple- cations using representative sampling
menting criteria for validating the or a census. Sample a minimum area of
conditions for use in performance- 100 cm2 on each individual surface in
based decontamination of solvents the validation study. Measure surface
other than those listed in § 761.79(c)(3) concentrations using the standard wipe
and (c)(4). Any person may use this test, as defined in § 761.123, from which
subpart for validating either a chem- a standard wipe sample is generated for
ical formulation or a product with a chemical analysis. Guidance for wipe
282
sampling appears in the document enti- study, use the same ratio of contami-
tled ‘‘Wipe Sampling and Double Wash/ nated surface area to soak solvent vol-
Rinse Cleanup as Recommended by the ume as would be used during actual de-
Environmental Protection Agency PCB contamination. It is also permissible to
Spill Cleanup Policy,’’ available on use a smaller surface area to soaking
EPA’s Web site at http://www.epa.gov/ solvent volume than used in the valida-
pcb, or from the Program Management, tion study, so long as all other required
Communications, and Analysis Office, parameters are used as validated in the
Office of Resource Conservation and confirmation required in § 761.386 (a)
Recovery (5305P), Environmental Pro- through (f), and paragraphs (a) through
tection Agency, 1200 Pennsylvania (c) of this section. Do not use a larger
Ave., NW., Washington, DC 20460–0001. surface-area-to-solvent-volumes ratio
(f) Concentration of PCBs. The method or different kind of solvent based on
validated may be used only to decon- the results of the validation study.
taminate surfaces containing PCBs at (b) Except for the minimum soak
concentrations on which the validation time of 1 hour (as required in
study was performed and lower con- § 761.386(c)), the length of soak time is
centrations. not otherwise restricted in the valida-
[63 FR 35473, June 29, 1998, as amended at 72 tion study. The soak time used in the
FR 57241, Oct. 9, 2007; 74 FR 30235, June 25, validation study, however, is a use re-
2009] quirement for subsequent decon-
tamination using the solvent being
§ 761.389 Testing parameter require-
ments. validated. It is permissible to use
longer soak times for decontamination
There are no restrictions on the vari- than the soak time used in the valida-
able testing parameters described in tion study, if all other parameters re-
this section which may be used in the quired in § 761.386, and paragraphs (a)
validation study. The conditions dem- and (c) of this section are used.
onstrated in the validation study for (c) There is no restriction on the
these variables shall become the re-
kind of material containing PCBs to
quired conditions for decontamination
use to create the surface contamina-
using the solvent being validated and
tion for the validation study. There is
shall replace the comparable condi-
also no restriction on the level of start-
tions in § 761.79(b)(3) through (b)(6).
ing PCB surface concentration. It is
There are limited potential options for
permissible to use lower concentra-
varying a single requirement in this
tions of PCB than the concentration
section. If you change one of these
used in the validation study, if all
variable requirements, change it only
other parameters required in § 761.386
in the way listed in this section and do
(a) through (f), and paragraphs (a)
not change any other validated condi-
tions. If you desire to change more through (c) of this section are used.
than one of the requirements in this § 761.392 Preparing validation study
section, you must conduct a new study samples.
to validate the decontamination under
the desired conditions. (a)(1) To validate a procedure to de-
(a) The study apparatus is not stand- contaminate a surface contaminated
ardized. Critical components of the with a spill from liquid of a known con-
study are the PCB material (for exam- centration, contaminate (spike) the
ple MODEF or some other spiking solu- surface to be used in the validation
tion), the volume of the soaking sol- study as follows:
vent, and the area of the contaminated (i) Use a spiking solution made of
surface. The EPA study used beakers PCBs mixed with a solvent to contami-
and shallow dishes as the experimental nate clean surfaces. Clean surfaces are
vessels to contain the surface and sol- surfaces having PCB surface concentra-
vent during the soaking process. In tions <1 μg/100 cm2 before intentionally
order to minimize surface-to-volume contaminating the surface.
ratios, it is convenient to utilize flat (ii) Prior to contaminating a surface

contaminated surfaces and shallow sol- for the validation study, mark the sur-
vent containers. During the validation face sampling area to assure that it is
283
§ 761.395 40 CFR Ch. I (7–1–17 Edition)
completely covered with the spiking Method 8082 for the chemical analysis,
solution. or methods validated under subpart Q
(iii) Deliver the spiking solution onto of this part.
the surface, covering all of the sam- (2) Report all validation study sur-
pling area. Contain any liquids which face sample concentrations on the
spill or flow off the surface. Allow the basis of micrograms of PCBs per 100
spiking solution to drip drain off into a cm2 of surface sampled.
container and then evaporate the spik- (c) Following completion of the vali-
ing solution off the contaminated sur- dation study, measurements from the
face prior to beginning the validation contaminated surfaces must have an
study. Contaminate a minimum of arithmetic mean of ≤10 μg/100 cm2. If
eight surfaces for a complete valida- the arithmetic mean is >10 μg/100 cm2,
tion study. then the validation study failed and
(iv) As a quality control step, test at the solvent may not be used for decon-
least one contaminated surface to de- tamination under § 761.79(d)(4) accord-
termine the PCB concentration to ing to the parameters tested.
verify that there are measurable sur-
face levels of PCBs resulting from the § 761.398 Reporting and record-
contamination before soaking the sur- keeping.
face in the decontamination solvent.
(a) Submit validation study results
The surface levels of PCBs on the con-
to the Director, Office of Resource Con-
taminated surfaces must be ≥20 μg/100
cm2. servation and Recovery (5301P), Envi-
(2) To validate a procedure to decon- ronmental Protection Agency, 1200
taminate a specified surface concentra- Pennsylvania Ave., NW., Washington,
tions of PCBs as measured by a stand- DC 20460–0001, prior to the first use of a
ard wipe sample, contaminate a min- new solvent for alternate decontamina-
imum of 10 surfaces. Contaminate all tion under § 761.79(d)(4). The use of a
the surfaces identically following the new solvent is not TSCA Confidential
procedures in paragraph (a)(1) of this Business Information (CBI). From time
section and measure the PCB surface to time, EPA will confirm the use of
concentrations of at least three of the validated new decontamination sol-
surfaces using a standard wipe test to vents and publish the new solvents and
establish a surface concentration to be validated decontamination procedures
included in the standard operating pro- in the FEDERAL REGISTER.
cedure. The surface levels of PCBs on (b) Any person may begin to use sol-
the contaminated surfaces must be ≥20 vent validated in accordance with this
μg/100 cm2. subpart at the time results are sub-
(b) [Reserved] mitted to EPA.
(c) Record all testing parameters and
§ 761.395 A validation study. experimental conditions from the suc-
(a) Decontaminate the following pre- cessful validation study into a stand-
pared sample surfaces using the se- ard operating procedure (SOP) for ref-
lected testing parameters and experi- erence whenever the decontamination
mental conditions. Take a standard procedure is used. Include in the SOP
wipe sample of the decontaminated the identity of the soaking solvent, the
surface. length of time of the soak, and the
(1) At least one uncontaminated sur- ratio of the soak solvent to contami-
face. The surface levels of PCBs on the nated surface area during the soaking
uncontaminated surface must be <1 μg/ process. Also include in the SOP the
100 cm2. maximum concentration of PCBs in the
(2) At least seven contaminated sur- spilled material and the identity of the
faces. spilled material, and/or the measured
(b)(1) Use SW-846, Test Methods for maximum surface concentration of the
Evaluating Solid Waste methods for contaminated surface used in the vali-
sample extraction and chemical anal- dation study. Record and keep the re-
ysis as follows: Use Method 3500B/3540C sults of the validation study as an ap-
or Method 3500B/3550B for the extrac- pendix to the SOP. Include in this ap-
tion and cleanup of the extract and pendix, the solvent used to make the
284
spiking solution, the PCB concentra- Subpart H [Reserved]

tion of the spiking solution used to
contaminate the surfaces in the valida- Subpart I—Prohibition of the Manufacture,
tion study, and all of the validation Importation, Processing, and Distribu-
study testing parameters and experi- tion in Commerce of Certain Asbestos-
mental conditions. Containing Products; Labeling Require-
ments
FR 57241, Oct. 9, 2007; 74 FR 30235, June 25, 763.160 Scope.
2009] 763.163 Definitions.
763.165 Manufacture and importation prohi-
bitions.
PART 763—ASBESTOS 763.167 Processing prohibitions.
763.169 Distribution in commerce prohibi-
Subparts A–D [Reserved] tions.
763.171 Labeling requirements.
Subpart E—Asbestos-Containing Materials 763.173 Exemptions.
in Schools 763.175 Enforcement.
763.176 Inspections.
Sec. 763.178 Recordkeeping.
763.80 Scope and purpose. 763.179 Confidential business information
763.83 Definitions. claims.
763.84 General local education agency re- AUTHORITY: 15 U.S.C. 2605, 2607(c), 2643, and
sponsibilities. 2646.
763.85 Inspection and reinspections.
763.86 Sampling.
763.87 Analysis. Subparts A–D [Reserved]
763.88 Assessment.
763.90 Response actions. Subpart E—Asbestos-Containing
763.91 Operations and maintenance. Materials in Schools
763.92 Training and periodic surveillance.
763.93 Management plans.
SOURCE: 52 FR 41846, Oct. 30, 1987, unless
763.94 Recordkeeping.
otherwise noted.
763.95 Warning labels.
763.97 Compliance and enforcement. § 763.80 Scope and purpose.
763.98 Waiver; delegation to State.
763.99 Exclusions. (a) This rule requires local education
agencies to identify friable and nonfri-
APPENDIX A TO SUBPART E OF PART 763—IN-
TERIM TRANSMISSION ELECTRON MICROS-
able asbestos-containing material
COPY ANALYTICAL METHODS—MANDATORY (ACM) in public and private elemen-
AND NONMANDATORY—AND MANDATORY tary and secondary schools by visually
SECTION TO DETERMINE COMPLETION OF inspecting school buildings for such
RESPONSE ACTIONS materials, sampling such materials if
APPENDIX B TO SUBPART E OF PART 763 [RE- they are not assumed to be ACM, and
SERVED] having samples analyzed by appro-
APPENDIX C TO SUBPART E OF PART 763—AS- priate techniques referred to in this
BESTOS MODEL ACCREDITATION PLAN
rule. The rule requires local education
APPENDIX D TO SUBPART E OF PART 763—
agencies to submit management plans
TRANSPORT AND DISPOSAL OF ASBESTOS
WASTE to the Governor of their State by Octo-
APPENDIX E TO SUBPART E OF PART 763—IN- ber 12, 1988, begin to implement the
TERIM METHOD OF THE DETERMINATION OF plans by July 9, 1989, and complete im-
ASBESTOS IN BULK INSULATION SAMPLES plementation of the plans in a timely
fashion. In addition, local education
Subpart F [Reserved] agencies are required to use persons
who have been accredited to conduct
Subpart G—Asbestos Worker Protection inspections, reinspections, develop
763.120 What is the purpose of this subpart? management plans, or perform re-
763.121 Does this subpart apply to me? sponse actions. The rule also includes
763.122 What does this subpart require me to recordkeeping requirements. Local
do? education agencies may contractually

763.123 May a State implement its own as- delegate their duties under this rule,
bestos worker protection plan? but they remain responsible for the
proper performance of those duties.
285
§ 763.83 40 CFR Ch. I (7–1–17 Edition)
Local education agencies are encour- or composition, or means dust, if the

aged to consult with EPA Regional As- dust is determined by an accredited in-
bestos Coordinators, or if applicable, a spector to be ACM.
State’s lead agency designated by the Damaged friable miscellaneous ACM
State Governor, for assistance in com- means friable miscellaneous ACM
plying with this rule. which has deteriorated or sustained
(b) Local education agencies must physical injury such that the internal
provide for the transportation and dis- structure (cohesion) of the material is
posal of asbestos in accordance with inadequate or, if applicable, which has
EPA’s ‘‘Asbestos Waste Management delaminated such that its bond to the
Guidance.’’ For convenience, applicable substrate (adhesion) is inadequate or
sections of this guidance are reprinted which for any other reason lacks fiber
as appendix D of this subpart. There cohesion or adhesion qualities. Such
are regulations in place, however, that damage or deterioration may be illus-
affect transportation and disposal of trated by the separation of ACM into
asbestos waste generated by this rule. layers; separation of ACM from the
The transportation of asbestos waste is substrate; flaking, blistering, or crum-
covered by the Department of Trans- bling of the ACM surface; water dam-
portation (49 CFR part 173, subpart J) age; significant or repeated water
and disposal is covered by the National stains, scrapes, gouges, mars or other
Emissions Standards for Hazardous Air signs of physical injury on the ACM.
Pollutants (NESHAP) (40 CFR part 61,
Asbestos debris originating from the
subpart M).
ACBM in question may also indicate
§ 763.83 Definitions. damage.
Damaged friable surfacing ACM means
For purposes of this subpart:
friable surfacing ACM which has dete-
Act means the Toxic Substances Con-
riorated or sustained physical injury
trol Act (TSCA), 15 U.S.C. 2601, et seq.
such that the internal structure (cohe-
Accessible when referring to ACM
sion) of the material is inadequate or
means that the material is subject to
which has delaminated such that its
disturbance by school building occu-
pants or custodial or maintenance per- bond to the substrate (adhesion) is in-
sonnel in the course of their normal ac- adequate, or which, for any other rea-
tivities. son, lacks fiber cohesion or adhesion
Accredited or accreditation when refer- qualities. Such damage or deteriora-
ring to a person or laboratory means tion may be illustrated by the separa-
that such person or laboratory is action of ACM into layers; separation of
credited in accordance with section 206 ACM from the substrate; flaking, blis-
of Title II of the Act. tering, or crumbling of the ACM sur-
Air erosion means the passage of air face; water damage; significant or re-
over friable ACBM which may result in peated water stains, scrapes, gouges,
the release of asbestos fibers. mars or other signs of physical injury
Asbestos means the asbestiform vari- on the ACM. Asbestos debris origi-
eties of: Chrysotile (serpentine); cro- nating from the ACBM in question may
cidolite (riebeckite); amosite (cum- also indicate damage.
mingtonitegrunerite); anthophyllite; Damaged or significantly damaged ther-
tremolite; and actinolite. mal system insulation ACM means ther-
Asbestos-containing material (ACM) mal system insulation ACM on pipes,
when referring to school buildings boilers, tanks, ducts, and other ther-
means any material or product which mal system insulation equipment
contains more than 1 percent asbestos. where the insulation has lost its struc-
Asbestos-containing building material tural integrity, or its covering, in
(ACBM) means surfacing ACM, thermal whole or in part, is crushed, water-
system insulation ACM, or miscella- stained, gouged, punctured, missing, or
neous ACM that is found in or on inte- not intact such that it is not able to
rior structural members or other parts contain fibers. Damage may be further
of a school building. illustrated by occasional punctures,

Asbestos debris means pieces of ACBM gouges or other signs of physical injury
that can be identified by color, texture, to ACM; occasional water damage on
286
the protective coverings/jackets; or ex- (3) The governing authority of any

posed ACM ends or joints. Asbestos de- school operated under the defense de-
bris originating from the ACBM in pendent’s education system provided
question may also indicate damage. for under the Defense Dependents’ Edu-
Encapsulation means the treatment of cation Act of 1978 (20 U.S.C. 921, et seq.).
ACBM with a material that surrounds Miscellaneous ACM means miscella-
or embeds asbestos fibers in an adhe- neous material that is ACM in a school
sive matrix to prevent the release of fi- building.
bers, as the encapsulant creates a Miscellaneous material means interior
membrane over the surface (bridging
building material on structural compo-
encapsulant) or penetrates the mate-
nents, structural members or fixtures,
rial and binds its components together
(penetrating encapsulant). such as floor and ceiling tiles, and does
Enclosure means an airtight, imper- not include surfacing material or ther-
meable, permanent barrier around mal system insulation.
ACBM to prevent the release of asbes- Nonfriable means material in a school
tos fibers into the air. building which when dry may not be
Fiber release episode means any un- crumbled, pulverized, or reduced to
controlled or unintentional disturb- powder by hand pressure.
ance of ACBM resulting in visible emis- Operations and maintenance program
sion. means a program of work practices to
Friable when referring to material in maintain friable ACBM in good condi-
a school building means that the mate- tion, ensure clean up of asbestos fibers
rial, when dry, may be crumbled, pul- previously released, and prevent fur-
verized, or reduced to powder by hand ther release by minimizing and con-
pressure, and includes previously non- trolling friable ACBM disturbance or
friable material after such previously damage.
nonfriable material becomes damaged Potential damage means cir-
to the extent that when dry it may be cumstances in which:
crumbled, pulverized, or reduced to
(1) Friable ACBM is in an area regu-
powder by hand pressure.
Functional space means a room, group larly used by building occupants, in-
of rooms, or homogeneous area (includ- cluding maintenance personnel, in the
ing crawl spaces or the space between a course of their normal activities.
dropped ceiling and the floor or roof (2) There are indications that there is
deck above), such as classroom(s), a a reasonable likelihood that the mate-
cafeteria, gymnasium, hallway(s), des- rial or its covering will become dam-
ignated by a person accredited to pre- aged, deteriorated, or delaminated due
pare management plans, design abate- to factors such as changes in building
ment projects, or conduct response ac- use, changes in operations and mainte-
tions. nance practices, changes in occupancy,
High-efficiency particulate air (HEPA) or recurrent damage.
refers to a filtering system capable of Potential significant damage means
trapping and retaining at least 99.97 circumstances in which:
percent of all monodispersed particles (1) Friable ACBM is in an area regu-
0.3 μm in diameter or larger. larly used by building occupants, in-
Homogeneous area means an area of cluding maintenance personnel, in the
surfacing material, thermal system in- course of their normal activities.
sulation material, or miscellaneous
(2) There are indications that there is
material that is uniform in color and
a reasonable likelihood that the mate-
texture.
Local education agency means: rial or its covering will become signifi-
(1) Any local educational agency as cantly damaged, deteriorated, or
defined in section 198 of the Elemen- delaminated due to factors such as
tary and Secondary Education Act of changes in building use, changes in op-
1965 (20 U.S.C. 3381). erations and maintenance practices,
(2) The owner of any nonpublic, non- changes in occupancy, or recurrent

profit elementary, or secondary school damage.
building.
287
§ 763.84 40 CFR Ch. I (7–1–17 Edition)
(3) The material is subject to major (6) Any exterior portion of a mechan-
or continuing disturbance, due to fac- ical system used to condition interior
tors including, but not limited to, ac- space.
cessibility or, under certain cir- Significantly damaged friable miscella-
cumstances, vibration or air erosion. neous ACM means damaged friable mis-
Preventive measures means actions cellaneous ACM where the damage is
taken to reduce disturbance of ACBM extensive and severe.
or otherwise eliminate the reasonable Significantly damaged friable surfacing
likelihood of the material’s becoming ACM means damaged friable surfacing
damaged or significantly damaged. ACM in a functional space where the
Removal means the taking out or the damage is extensive and severe.
stripping of substantially all ACBM State means a State, the District of
from a damaged area, a functional Columbia, the Commonwealth of Puer-
space, or a homogeneous area in a to Rico, Guam, American Samoa, the
school building. Northern Marianas, the Trust Terri-
Repair means returning damaged tory of the Pacific Islands, and the Vir-
ACBM to an undamaged condition or to gin Islands.
an intact state so as to prevent fiber Surfacing ACM means surfacing mate-
release. rial that is ACM.
Response action means a method, in- Surfacing material means material in
cluding removal, encapsulation, enclo- a school building that is sprayed-on,
sure, repair, operations and mainte- troweled-on, or otherwise applied to
nance, that protects human health and surfaces, such as acoustical plaster on
the environment from friable ACBM.
ceilings and fireproofing materials on
Routine maintenance area means an structural members, or other materials
area, such as a boiler room or mechan-
on surfaces for acoustical, fireproofing,
ical room, that is not normally fre-
or other purposes.
quented by students and in which
Thermal system insulation means ma-
maintenance employees or contract
terial in a school building applied to
workers regularly conduct mainte-
nance activities. pipes, fittings, boilers, breeching,
tanks, ducts, or other interior struc-
School means any elementary or sec-
tural components to prevent heat loss
ondary school as defined in section 198
or gain, or water condensation, or for
of the Elementary and Secondary Edu-
cation Act of 1965 (20 U.S.C. 2854). other purposes.
School building means: Thermal system insulation ACM means
thermal system insulation that is
(1) Any structure suitable for use as a
ACM.
classroom, including a school facility
such as a laboratory, library, school Vibration means the periodic motion
eating facility, or facility used for the of friable ACBM which may result in
preparation of food. the release of asbestos fibers.
(2) Any gymnasium or other facility § 763.84 General local education agen-
which is specially designed for athletic cy responsibilities.
or recreational activities for an aca-
demic course in physical education. Each local education agency shall:
(3) Any other facility used for the in- (a) Ensure that the activities of any
struction or housing of students or for persons who perform inspections, re-
the administration of educational or inspections, and periodic surveillance,
research programs. develop and update management plans,
(4) Any maintenance, storage, or util- and develop and implement response
ity facility, including any hallway, es- actions, including operations and
sential to the operation of any facility maintenance, are carried out in accord-
described in this definition of ‘‘school ance with subpart E of this part.
building’’ under paragraphs (1), (2), or (b) Ensure that all custodial and
(3). maintenance employees are properly

(5) Any portico or covered exterior trained as required by this subpart E
hallway or walkway. and other applicable Federal and/or
288
State regulations (e.g., the Occupa- fore October 12, 1988, local education
tional Safety and Health Administra- agencies shall inspect each school
tion asbestos standard for construc- building that they lease, own, or other-
tion, the EPA worker protection rule, wise use as a school building to iden-
or applicable State regulations). tify all locations of friable and nonfri-
(c) Ensure that workers and building able ACBM.
occupants, or their legal guardians, are (2) Any building leased or acquired on
informed at least once each school year or after October 12, 1988, that is to be
about inspections, response actions, used as a school building shall be in-
and post-response action activities, inspected as described under paragraphs
cluding periodic reinspection and sur- (a) (3) and (4) of this section prior to
veillance activities that are planned or use as a school building. In the event
in progress. that emergency use of an uninspected
(d) Ensure that short-term workers building as a school building is neces-
(e.g., telephone repair workers, utility sitated, such buildings shall be in-
workers, or exterminators) who may spected within 30 days after commence-
come in contact with asbestos in a ment of such use.
school are provided information re- (3) Each inspection shall be made by
garding the locations of ACBM and sus- an accredited inspector.
pected ACBM assumed to be ACM. (4) For each area of a school building,
(e) Ensure that warning labels are except as excluded under § 763.99, each
posted in accordance with § 763.95. person performing an inspection shall:
(f) Ensure that management plans (i) Visually inspect the area to iden-
are available for inspection and notifi- tify the locations of all suspected
cation of such availability has been ACBM.
provided as specified in the manage-
(ii) Touch all suspected ACBM to de-
ment plan under § 763.93(g).
termine whether they are friable.
(g)(1) Designate a person to ensure
that requirements under this section (iii) Identify all homogeneous areas
are properly implemented. of friable suspected ACBM and all ho-
(2) Ensure that the designated person mogeneous areas of nonfriable sus-
receives adequate training to perform pected ACBM.
duties assigned under this section. (iv) Assume that some or all of the
Such training shall provide, as nec- homogeneous areas are ACM, and, for
essary, basic knowledge of: each homogeneous area that is not as-
(i) Health effects of asbestos. sumed to be ACM, collect and submit
(ii) Detection, identification, and as- for analysis bulk samples under
sessment of ACM. §§ 763.86 and 763.87.
(iii) Options for controlling ACBM. (v) Assess, under § 763.88, friable ma-
(iv) Asbestos management programs. terial in areas where samples are col-
(v) Relevant Federal and State regu- lected, friable material in areas that
lations concerning asbestos, including are assumed to be ACBM, and friable
those in this subpart E and those of the ACBM identified during a previous in-
Occupational Safety and Health Ad- spection.
ministration, U.S. Department of (vi) Record the following and submit
Labor, the U.S. Department of Trans- to the person designated under § 763.84
portation and the U.S. Environmental a copy of such record for inclusion in
Protection Agency. the management plan within 30 days of
(h) Consider whether any conflict of the inspection:
interest may arise from the inter- (A) An inspection report with the
relationship among accredited per- date of the inspection signed by each
sonnel and whether that should influ- accredited person making the inspec-
ence the selection of accredited per- tion, State of accreditation, and if ap-
sonnel to perform activities under this plicable, his or her accreditation num-
subpart. ber.
(B) An inventory of the locations of
§ 763.85 Inspection and reinspections. the homogeneous areas where samples

(a) Inspection. (1) Except as provided are collected, exact location where
in paragraph (a)(2) of this section, be- each bulk sample is collected, dates
289
§ 763.86 40 CFR Ch. I (7–1–17 Edition)
that samples are collected, homo- (vi) Reassess, under § 763.88, the con-
geneous areas where friable suspected dition of friable known or assumed
ACBM is assumed to be ACM, and ho- ACBM previously identified.
mogeneous areas where nonfriable sus- (vii) Record the following and submit
pected ACBM is assumed to be ACM. to the person designated under § 763.84
(C) A description of the manner used a copy of such record for inclusion in
to determine sampling locations, the the management plan within 30 days of
name and signature of each accredited the reinspection:
inspector who collected the samples, (A) The date of the reinspection, the
State of accreditation, and, if applica- name and signature of the person mak-
ble, his or her accreditation number. ing the reinspection, State of accredi-
(D) A list of whether the homo- tation, and if applicable, his or her ac-
geneous areas identified under para- creditation number, and any changes
graph (a)(4)(vi)(B) of this section, are in the condition of known or assumed
surfacing material, thermal system in- ACBM.
sulation, or miscellaneous material. (B) The exact locations where sam-
(E) Assessments made of friable ma- ples are collected during the reinspec-
terial, the name and signature of each tion, a description of the manner used
accredited inspector making the as- to determine sampling locations, the
sessment, State of accreditation, and if name and signature of each accredited
applicable, his or her accreditation inspector who collected the samples,
number. State of accreditation, and, if applica-
(b) Reinspection. (1) At least once ble, his or her accreditation number.
every 3 years after a management plan (C) Any assessments or reassess-
is in effect, each local education agen- ments made of friable material, the
cy shall conduct a reinspection of all name and signature of the accredited
friable and nonfriable known or as- inspector making the assessments,
sumed ACBM in each school building State of accreditation, and if applica-
that they lease, own, or otherwise use ble, his or her accreditation number.
as a school building. (c) General. Thermal system insula-
(2) Each inspection shall be made by tion that has retained its structural in-
an accredited inspector. tegrity and that has an undamaged
(3) For each area of a school building, protective jacket or wrap that prevents
each person performing a reinspection fiber release shall be treated as nonfri-
shall: able and therefore is subject only to
(i) Visually reinspect, and reassess, periodic surveillance and preventive
under § 763.88, the condition of all fri- measures as necessary.
able known or assumed ACBM.
(ii) Visually inspect material that § 763.86 Sampling.
was previously considered nonfriable
ACBM and touch the material to deter- (a) Surfacing material. An accredited
mine whether it has become friable inspector shall collect, in a statis-
since the last inspection or reinspec- tically random manner that is rep-
tion. resentative of the homogeneous area,
(iii) Identify any homogeneous areas bulk samples from each homogeneous
with material that has become friable area of friable surfacing material that
since the last inspection or reinspec- is not assumed to be ACM, and shall
tion. collect the samples as follows:
(iv) For each homogeneous area of (1) At least three bulk samples shall
newly friable material that is already be collected from each homogeneous
assumed to be ACBM, bulk samples area that is 1,000 ft2 or less, except as
may be collected and submitted for provided in § 763.87(c)(2).
analysis in accordance with §§ 763.86 (2) At least five bulk samples shall be
and 763.87. collected from each homogeneous area
(v) Assess, under § 763.88, the condi- that is greater than 1,000 ft2 but less
tion of the newly friable material in than or equal to 5,000 ft2, except as pro-
areas where samples are collected, and vided in § 763.87(c)(2).

newly friable materials in areas that (3) At least seven bulk samples shall
are assumed to be ACBM. be collected from each homogeneous
290
area that is greater than 5,000 ft2, ex- ysis under the EPA Interim Asbestos
cept as provided in § 763.87(c)(2). Bulk Sample Analysis Quality Assur-
(b) Thermal system insulation. (1) Ex- ance Program until the NBS PLM lab-
cept as provided in paragraphs (b) (2) oratory accreditation program for PLM
through (4) of this section and is operational.
§ 763.87(c), an accredited inspector shall (b) Bulk samples shall not be compos-
collect, in a randomly distributed man- ited for analysis and shall be analyzed
ner, at least three bulk samples from for asbestos content by PLM, using the
each homogeneous area of thermal sys- ‘‘Interim Method for the Determina-
tem insulation that is not assumed to tion of Asbestos in Bulk Insulation
be ACM. Samples’’ found at appendix E to sub-
(2) Collect at least one bulk sample part E of this part.
from each homogeneous area of (c)(1) A homogeneous area is consid-
patched thermal system insulation ered not to contain ACM only if the re-
that is not assumed to be ACM if the sults of all samples required to be col-
patched section is less than 6 linear or lected from the area show asbestos in
square feet. amounts of 1 percent or less.
(3) In a manner sufficient to deter- (2) A homogeneous area shall be de-
mine whether the material is ACM or termined to contain ACM based on a
not ACM, collect bulk samples from finding that the results of at least one
each insulated mechanical system that sample collected from that area shows
is not assumed to be ACM where ce- that asbestos is present in an amount
ment or plaster is used on fittings such greater than 1 percent.
as tees, elbows, or valves, except as (d) The name and address of each lab-
provided under § 763.87(c)(2). oratory performing an analysis, the
(4) Bulk samples are not required to date of analysis, and the name and sig-
be collected from any homogeneous nature of the person performing the
area where the accredited inspector has analysis shall be submitted to the per-
determined that the thermal system son designated under § 763.84 for inclu-
insulation is fiberglass, foam glass, sion into the management plan within
rubber, or other non-ACBM. 30 days of the analysis.
(c) Miscellaneous material. In a man-
ner sufficient to determine whether [52 FR 41846, Oct. 30, 1987, as amended at 60
material is ACM or not ACM, an ac- FR 31922, June 19, 1995]
credited inspector shall collect bulk
samples from each homogeneous area § 763.88 Assessment.
of friable miscellaneous material that (a)(1) For each inspection and rein-
is not assumed to be ACM. spection conducted under § 763.85 (a)
(d) Nonfriable suspected ACBM. If any and (c) and previous inspections speci-
homogeneous area of nonfriable sus- fied under § 763.99, the local education
pected ACBM is not assumed to be agency shall have an accredited inspec-
ACM, then an accredited inspector tor provide a written assessment of all
shall collect, in a manner sufficient to friable known or assumed ACBM in the
determine whether the material is school building.
ACM or not ACM, bulk samples from (2) Each accredited inspector pro-
the homogeneous area of nonfriable viding a written assessment shall sign
suspected ACBM that is not assumed to and date the assessment, provide his or
be ACM. her State of accreditation, and if appli-
cable, accreditation number, and sub-
§ 763.87 Analysis. mit a copy of the assessment to the
(a) Local education agencies shall person designated under § 763.84 for in-
have bulk samples, collected under clusion in the management plan within
§ 763.86 and submitted for analysis, ana- 30 days of the assessment.
lyzed for asbestos using laboratories (b) The inspector shall classify and
accredited by the National Bureau of give reasons in the written assessment
Standards (NBS). Local education for classifying the ACBM and suspected
agencies shall use laboratories which ACBM assumed to be ACM in the

have received interim accreditation for school building into one of the fol-
polarized light microscopy (PLM) anal- lowing categories:
291
§ 763.90 40 CFR Ch. I (7–1–17 Edition)
(1) Damaged or significantly dam- § 763.90 Response actions.

aged thermal system insulation ACM.
(a) The local education agency shall
(2) Damaged friable surfacing ACM.
select and implement in a timely man-
(3) Significantly damaged friable sur- ner the appropriate response actions in
facing ACM. this section consistent with the assess-
(4) Damaged or significantly dam- ment conducted in § 763.88. The re-
aged friable miscellaneous ACM. sponse actions selected shall be suffi-
(5) ACBM with potential for damage. cient to protect human health and the
(6) ACBM with potential for signifi- environment. The local education
cant damage. agency may then select, from the re-
(7) Any remaining friable ACBM or sponse actions which protect human
friable suspected ACBM. health and the environment, that ac-
(c) Assessment may include the fol- tion which is the least burdensome
lowing considerations: method. Nothing in this section shall
(1) Location and the amount of the be construed to prohibit removal of
material, both in total quantity and as ACBM from a school building at any
a percentage of the functional space. time, should removal be the preferred
(2) Condition of the material, speci- response action of the local education
fying: agency.
(i) Type of damage or significant (b) If damaged or significantly dam-
damage (e.g., flaking, blistering, water aged thermal system insulation ACM is
damage, or other signs of physical present in a building, the local edu-
damage). cation agency shall:
(ii) Severity of damage (e.g., major (1) At least repair the damaged area.
flaking, severely torn jackets, as op- (2) Remove the damaged material if
posed to occasional flaking, minor it is not feasible, due to technological
tears to jackets). factors, to repair the damage.
(iii) Extent or spread of damage over (3) Maintain all thermal system insu-
large areas or large percentages of the lation ACM and its covering in an in-
homogeneous area. tact state and undamaged condition.
(3) Whether the material is acces- (c)(1) If damaged friable surfacing
sible. ACM or damaged friable miscellaneous
(4) The material’s potential for dis- ACM is present in a building, the local
turbance. education agency shall select from
(5) Known or suspected causes of among the following response actions:
damage or significant damage (e.g., air encapsulation, enclosure, removal, or
erosion, vandalism, vibration, water). repair of the damaged material.
(6) Preventive measures which might (2) In selecting the response action
eliminate the reasonable likelihood of from among those which meet the defi-
undamaged ACM from becoming sig- nitional standards in § 763.83, the local
nificantly damaged. education agency shall determine
(d) The local education agency shall which of these response actions pro-
select a person accredited to develop tects human health and the environ-
management plans to review the re- ment. For purposes of determining
sults of each inspection, reinspection, which of these response actions are the
and assessment for the school building least burdensome, the local education
and to conduct any other necessary ac- agency may then consider local cir-
tivities in order to recommend in writ- cumstances, including occupancy and
ing to the local education agency ap- use patterns within the school build-
propriate response actions. The accred- ing, and its economic concerns, includ-
ited person shall sign and date the rec- ing short- and long-term costs.
ommendation, provide his or her State (d) If significantly damaged friable
of accreditation, and, if applicable, pro- surfacing ACM or significantly dam-
vide his or her accreditation number, aged friable miscellaneous ACM is
and submit a copy of the recommenda- present in a building the local edu-
tion to the person designated under cation agency shall:

§ 763.84 for inclusion in the manage- (1) Immediately isolate the func-
ment plan. tional space and restrict access, unless
292
isolation is not necessary to protect (i) Completion of response actions. (1)

human health and the environment. At the conclusion of any action to re-
(2) Remove the material in the func- move, encapsulate, or enclose ACBM or
tional space or, depending upon wheth- material assumed to be ACBM, a per-
er enclosure or encapsulation would be son designated by the local education
sufficient to protect human health and agency shall visually inspect each
the environment, enclose or encap- functional space where such action was
sulate. conducted to determine whether the
(e) If any friable surfacing ACM, action has been properly completed.
thermal system insulation ACM, or fri- (2)(i) A person designated by the local
able miscellaneous ACM that has po- education agency shall collect air sam-
tential for damage is present in a ples using aggressive sampling as de-
building, the local education agency scribed in appendix A to this subpart E
shall at least implement an operations to monitor air for clearance after each
and maintenance (O&M) program, as removal, encapsulation, and enclosure
described under § 763.91. project involving ACBM, except for
(f) If any friable surfacing ACM, ther- projects that are of small-scale, short-
mal system insulation ACM, or friable duration.
miscellaneous ACM that has potential (ii) Local education agencies shall
have air samples collected under this
for significant damage is present in a
section analyzed for asbestos using lab-
building, the local education agency
oratories accredited by the National
shall:
Bureau of Standards to conduct such
(1) Implement an O&M program, as analysis using transmission electron
described under § 763.91. microscopy (TEM) or, under cir-
(2) Institute preventive measures ap- cumstances permitted in this section,
propriate to eliminate the reasonable laboratories enrolled in the American
likelihood that the ACM or its covering Industrial Hygiene Association Pro-
will become significantly damaged, deficiency Analytical Testing Program
teriorated, or delaminated. for phase contrast microscopy (PCM).
(3) Remove the material as soon as (iii) Until the National Bureau of
possible if appropriate preventive Standards TEM laboratory accredita-
measures cannot be effectively imple- tion program is operational, local edu-
mented, or unless other response ac- cational agencies shall use laboratories
tions are determined to protect human that use the protocol described in ap-
health and the environment. Imme- pendix A to subpart E of this part.
diately isolate the area and restrict ac- (3) Except as provided in paragraphs
cess if necessary to avoid an imminent (i)(4), and (i)(5), of this section, an ac-
and substantial endangerment to tion to remove, encapsulate, or enclose
human health or the environment. ACBM shall be considered complete
(g) Response actions including re- when the average concentration of as-
moval, encapsulation, enclosure, or re- bestos of five air samples collected
pair, other than small-scale, short-du- within the affected functional space
ration repairs, shall be designed and and analyzed by the TEM method in
conducted by persons accredited to de- appendix A of this subpart E, is not
sign and conduct response actions. statistically significantly different, as
(h) The requirements of this subpart determined by the Z-test calculation
E in no way supersede the worker pro- found in appendix A of this subpart E,
tection and work practice require- from the average asbestos concentra-
ments under 29 CFR 1926.58 (Occupa- tion of five air samples collected at the
tional Safety and Health Administra- same time outside the affected func-
tion (OSHA) asbestos worker protec- tional space and analyzed in the same
tion standards for construction), 40 manner, and the average asbestos con-
CFR part 763, subpart G (EPA asbestos centration of the three field blanks de-
worker protection standards for public scribed in appendix A of this subpart E
employees), and 40 CFR part 61, sub- is below the filter background level, as
part M (National Emission Standards defined in appendix A of this subpart E,

for Hazardous Air Pollutants—Asbes- of 70 structures per square millimeter
tos). (70 s/mm2).
293
§ 763.91 40 CFR Ch. I (7–1–17 Edition)
(4) An action may also be considered it exists on the effective date of this
complete if the volume of air drawn for rule, and a notice of any change to the
each of the five samples collected with- method will be published in the FED-
in the affected functional space is ERAL REGISTER.
equal to or greater than 1,199 L of air (6) To determine the amount of
for a 25 mm filter or equal to or greater ACBM affected under paragraph (i)(5)
than 2,799 L of air for a 37 mm filter, of this section, the local education
and the average concentration of asbes- agency shall add the total square or
tos as analyzed by the TEM method in linear footage of ACBM within the con-
appendix A of this subpart E, for the tainment barriers used to isolate the
five air samples does not exceed the fil- functional space for the action to re-
ter background level, as defined in ap- move, encapsulate, or enclose the
pendix A, of 70 structures per square ACBM. Contiguous portions of material
millimeter (70 s/mm2). If the average subject to such action conducted con-
concentration of asbestos of the five currently or at approximately the
air samples within the affected func- same time within the same school
tional space exceeds 70 s/mm2, or if the building shall not be separated to qual-
volume of air in each of the samples is ify under paragraph (i)(5), of this sec-
less than 1,199 L of air for a 25 mm fil- tion.
ter or less than 2,799 L of air for a 37 [52 FR 41846, Oct. 30, 1987, as amended at 53
mm filter, the action shall be consid- FR 12525, Apr. 15, 1988; 60 FR 31922, June 19,
ered complete only when the require- 1995; 60 FR 34465, July 3, 1995; 69 FR 18803,
ments of paragraph (i)(3) or (i)(5), of Apr. 9, 2004; 77 FR 46292, Aug. 3, 2012]
this section are met.
(5) At any time, a local education § 763.91 Operations and maintenance.
agency may analyze air monitoring (a) Applicability. The local education
samples collected for clearance pur- agency shall implement an operations,
poses by phase contrast microscopy maintenance, and repair (O&M) pro-
(PCM) to confirm completion of re- gram under this section whenever any
moval, encapsulation, or enclosure of friable ACBM is present or assumed to
ACBM that is greater than small-scale, be present in a building that it leases,
short-duration and less than or equal owns, or otherwise uses as a school
to 160 square feet or 260 linear feet. The building. Any material identified as
action shall be considered complete nonfriable ACBM or nonfriable as-
when the results of samples collected sumed ACBM must be treated as friable
in the affected functional space and ACBM for purposes of this section
analyzed by phase contrast microscopy when the material is about to become
using the National Institute for Occu- friable as a result of activities per-
pational Safety and Health (NIOSH) formed in the school building.
Method 7400 entitled ‘‘Fibers’’ pub- (b) Worker protection. Local education
lished in the NIOSH Manual of Analyt- agencies must comply with either the
ical Methods, 3rd Edition, Second Sup- OSHA Asbestos Construction Standard
plement, August 1987, show that the at 29 CFR 1926.1101, or the Asbestos
concentration of fibers for each of the Worker Protection Rule at 40 CFR
five samples is less than or equal to a 763.120, whichever is applicable.
limit of quantitation for PCM (0.01 fi- (c) Cleaning—(1) Initial cleaning. Un-
bers per cubic centimeter (0.01 f/cm3) of less the building has been cleaned
air). The method is available at the ad- using equivalent methods within the
dresses in § 700.17(b)(1) and (2) of this previous 6 months, all areas of a school
chapter. For information on the avail- building where friable ACBM, damaged
ability of this material at NARA, call or significantly damaged thermal sys-
202–741–6030, or go to: http:// tem insulation ACM, or friable sus-
www.archives.gov/federallregister/ pected ACBM assumed to be ACM are
codeloflfederallregulations/ present shall be cleaned at least once
ibrllocations.html. This incorporation after the completion of the inspection
by reference was approved by the Di- required by § 763.85(a) and before the
rector of the Federal Register in ac- initiation of any response action, other
cordance with 5 U.S.C. 552(a) and 1 CFR than O&M activities or repair, accord-
part 51. The method is incorporated as ing to the following procedures:
294
(i) HEPA-vacuum or steam-clean all (i) Thoroughly saturate the debris

carpets. using wet methods.
(ii) HEPA-vacuum or wet-clean all (ii) Clean the area, as described in
other floors and all other horizontal paragraph (e) of this section.
surfaces. (iii) Place the asbestos debris in a
(iii) Dispose of all debris, filters, sealed, leak-tight container.
mopheads, and cloths in sealed, leak- (iv) Repair the area of damaged ACM
tight containers. with materials such as asbestos-free
(2) Additional cleaning. The accredited spackling, plaster, cement, or insula-
management planner shall make a tion, or seal with latex paint or an
written recommendation to the local encapsulant, or immediately have the
education agency whether additional appropriate response action imple-
cleaning is needed, and if so, the meth- mented as required by § 763.90.
ods and frequency of such cleaning. (2) Major fiber release episode. The
local education agency shall ensure
(d) Operations and maintenance activi-
that the procedures described below are
ties. The local education agency shall
followed in the event of a major fiber
ensure that the procedures described
release episode (i.e., the falling or dis-
below to protect building occupants
lodging of more than 3 square or linear
shall be followed for any operations
feet of friable ACBM):
and maintenance activities disturbing
(i) Restrict entry into the area and
friable ACBM:
post signs to prevent entry into the
(1) Restrict entry into the area by area by persons other than those nec-
persons other than those necessary to essary to perform the response action.
perform the maintenance project, ei- (ii) Shut off or temporarily modify
ther by physically isolating the area or the air-handling system to prevent the
by scheduling. distribution of fibers to other areas in
(2) Post signs to prevent entry by un- the building.
authorized persons. (iii) The response action for any
(3) Shut off or temporarily modify major fiber release episode must be de-
the air-handling system and restrict signed by persons accredited to design
other sources of air movement. response actions and conducted by per-
(4) Use work practices or other con- sons accredited to conduct response ac-
trols, such as, wet methods, protective tions.
clothing, HEPA-vacuums, mini-enclo-
[52 FR 41846, Oct. 30, 1987, as amended at 65
sures, glove bags, as necessary to in- FR 69216, Nov. 15, 2000]
hibit the spread of any released fibers.
(5) Clean all fixtures or other compo- § 763.92 Training and periodic surveil-
nents in the immediate work area. lance.
(6) Place the asbestos debris and (a) Training. (1) The local education
other cleaning materials in a sealed, agency shall ensure, prior to the imple-
leak-tight container. mentation of the O&M provisions of
(e) Maintenance activities other than the management plan, that all mem-
small-scale, short-duration. The response bers of its maintenance and custodial
action for any maintenance activities staff (custodians, electricians, heating/
disturbing friable ACBM, other than air conditioning engineers, plumbers,
small-scale, short-duration mainte- etc.) who may work in a building that
nance activities, shall be designed by contains ACBM receive awareness
persons accredited to design response training of at least 2 hours, whether or
actions and conducted by persons ac- not they are required to work with
credited to conduct response actions. ACBM. New custodial and maintenance
(f) Fiber release episodes—(1) Minor employees shall be trained within 60
fiber release episode. The local education days after commencement of employ-
agency shall ensure that the proce- ment. Training shall include, but not
dures described below are followed in be limited to:
the event of a minor fiber release epi- (i) Information regarding asbestos
sode (i.e., the falling or dislodging of 3 and its various uses and forms.
square or linear feet or less of friable (ii) Information on the health effects
ACBM): 5 associated with asbestos exposure.
295
§ 763.93 40 CFR Ch. I (7–1–17 Edition)
(iii) Locations of ACBM identified surveillance in each building that it

throughout each school building in leases, owns, or otherwise uses as a
which they work. school building that contains ACBM or
(iv) Recognition of damage, deterio- is assumed to contain ACBM.
ration, and delamination of ACBM. (2) Each person performing periodic
(v) Name and telephone number of surveillance shall:
the person designated to carry out gen- (i) Visually inspect all areas that are
eral local education agency respon- identified in the management plan as
sibilities under § 763.84 and the avail- ACBM or assumed ACBM.
ability and location of the manage- (ii) Record the date of the surveil-
ment plan. lance, his or her name, and any
(2) The local education agency shall changes in the condition of the mate-
ensure that all members of its mainte- rials.
nance and custodial staff who conduct (iii) Submit to the person designated
any activities that will result in the to carry out general local education
disturbance of ACBM shall receive agency responsibilities under § 763.84 a
training described in paragraph (a)(1) copy of such record for inclusion in the
of this section and 14 hours of addi- management plan.
tional training. Additional training
shall include, but not be limited to: [52 FR 41846, Oct. 30, 1987, as amended at 60
(i) Descriptions of the proper meth- FR 34465, July 3, 1995; 65 FR 69216, Nov. 15,
2000]
ods of handling ACBM.
(ii) Information on the use of res- § 763.93 Management plans.
piratory protection as contained in the
EPA/NIOSH Guide to Respiratory Protec- (a)(1) On or before October 12, 1988,
tion for the Asbestos Abatement Industry, each local education agency shall de-
September 1986 (EPA 560/OPPTS–86– velop an asbestos management plan for
001), available from the Director, Envi- each school, including all buildings
ronmental Assistance Division (7408), that they lease, own, or otherwise use
Office of Pollution Prevention and as school buildings, and submit the
Toxics, U.S. Environmental Protection plan to an Agency designated by the
Agency, Room E–543B, 1200 Pennsyl- Governor of the State in which the
vania Ave., NW., Washington, DC 20460, local education agency is located. The
Telephone: (202) 554–1404, TDD: (202) plan may be submitted in stages that
544–0551 and other personal protection cover a portion of the school buildings
measures. under the authority of the local edu-
(iii) The provisions of this section cation agency.
and § 763.91, appendices A, C, and D of (2) If a building to be used as part of
this subpart E of this part, EPA regula- a school is leased or otherwise acquired
tions contained in 40 CFR part 763, sub- after October 12, 1988, the local edu-
part G, and in 40 CFR part 61, subpart cation agency shall include the new
M, and OSHA regulations contained in building in the management plan for
29 CFR 1926.58. the school prior to its use as a school
(iv) Hands-on training in the use of building. The revised portions of the
respiratory protection, other personal management plan shall be submitted to
protection measures, and good work the Agency designated by the Gov-
practices. ernor.
(3) Local education agency mainte- (3) If a local education agency begins
nance and custodial staff who have at- to use a building as a school after Octo-
tended EPA-approved asbestos training ber 12, 1988, the local education agency
or received equivalent training for shall submit a management plan for
O&M and periodic surveillance activi- the school to the Agency designated by
ties involving asbestos shall be consid- the Governor prior to its use as a
ered trained for the purposes of this school.
section. (b) On or before October 17, 1987, the
(b) Periodic surveillance. (1) At least Governor of each State shall notify
once every 6 months after a manage- local education agencies in the State
ment plan is in effect, each local edu- regarding where to submit their man-
cation agency shall conduct periodic agement plans. States may establish
296
administrative procedures for review- cember 14, 1987, as friable ACBM or fri-
ing management plans. If the Governor able suspected ACBM assumed to be
does not disapprove a management ACM, and the name and signature,
plan within 90 days after receipt of the State of accreditation, and if applica-
plan, the local education agency shall ble, accreditation number of each ac-
implement the plan. credited person making the assess-
(c) Each local education agency must ments.
begin implementation of its manage- (3) For each inspection and reinspec-
ment plan on or before July 9, 1989, and tion conducted under § 763.85:
complete implementation in a timely (i) The date of the inspection or rein-
fashion. spection and the name and signature,
(d) Each local education agency shall State of accreditation and, if applica-
maintain and update its management ble, the accreditation number of each
plan to keep it current with ongoing accredited inspector performing the in-
operations and maintenance, periodic spection or reinspection.
surveillance, inspection, reinspection, (ii) A blueprint, diagram, or written
and response action activities. All pro- description of each school building that
visions required to be included in the identifies clearly each location and ap-
management plan under this section proximate square or linear footage of
shall be retained as part of the man- homogeneous areas where material was
agement plan, as well as any informa- sampled for ACM, the exact location
tion that has been revised to bring the where each bulk sample was collected,
plan up-to-date. date of collection, homogeneous areas
(e) The management plan shall be de- where friable suspected ACBM is as-
veloped by an accredited management sumed to be ACM, and where nonfriable
planner and shall include: suspected ACBM is assumed to be ACM.
(1) A list of the name and address of (iii) A description of the manner used
each school building and whether the to determine sampling locations, and
school building contains friable ACBM, the name and signature of each accred-
nonfriable ACBM, and friable and non- ited inspector collecting samples, the
friable suspected ACBM assumed to be State of accreditation, and if applica-
ACM. ble, his or her accreditation number.
(2) For each inspection conducted be- (iv) A copy of the analyses of any
fore the December 14, 1987: bulk samples collected and analyzed,
(i) The date of the inspection. the name and address of any laboratory
(ii) A blueprint, diagram, or written that analyzed bulk samples, a state-
description of each school building that ment that the laboratory meets the ap-
identifies clearly each location and applicable requirements of § 763.87(a) the
proximate square or linear footage of date of analysis, and the name and sig-
any homogeneous or sampling area nature of the person performing the
where material was sampled for ACM, analysis.
and, if possible, the exact locations (v) A description of assessments, re-
where bulk samples were collected, and quired to be made under § 763.88, of all
the dates of collection. ACBM and suspected ACBM assumed to
(iii) A copy of the analyses of any be ACM, and the name, signature,
bulk samples, dates of analyses, and a State of accreditation, and if applica-
copy of any other laboratory reports ble, accreditation number of each ac-
pertaining to the analyses. credited person making the assess-
(iv) A description of any response ac- ments.
tions or preventive measures taken to (4) The name, address, and telephone
reduce asbestos exposure, including if number of the person designated under
possible, the names and addresses of all § 763.84 to ensure that the duties of the
contractors involved, start and comple- local education agency are carried out,
tion dates of the work, and results of and the course name, and dates and
any air samples analyzed during and hours of training taken by that person
upon completion of the work. to carry out the duties.
(v) A description of assessments, re- (5) The recommendations made to the

quired to be made under § 763.88, of ma- local education agency regarding re-
terial that was identified before De- sponse actions, under § 763.88(d), the
297
§ 763.93 40 CFR Ch. I (7–1–17 Edition)
name, signature, State of accreditation and surveillance activities that are

of each person making the rec- planned or in progress.
ommendations, and if applicable, his or (11) An evaluation of the resources
her accreditation number. needed to complete response actions
(6) A detailed description of preven- successfully and carry out reinspec-
tive measures and response actions to tion, operations and maintenance ac-
be taken, including methods to be used, tivities, periodic surveillance and
for any friable ACBM, the locations training.
where such measures and action will be (12) With respect to each consultant
taken, reasons for selecting the re- who contributed to the management
sponse action or preventive measure, plan, the name of the consultant and
and a schedule for beginning and com- one of the following statements:
pleting each preventive measure and (i) If the State has adopted a con-
response action. tractor accreditation plan under sec-
(7) With respect to the person or per- tion 206(b) of Title II of the Act, a
sons who inspected for ACBM and who statement that the consultant is ac-
will design or carry out response accredited under such plan.
tions, except for operations and main- (ii) A statement that the contractor
tenance, with respect to the ACBM, is accredited by another State which
one of the following statements: has adopted a contractor accreditation
(i) If the State has adopted a con- plan under section 206(b) of Title II of
tractor accreditation program under the Act, or is accredited by an EPA-ap-
section 206(b) of Title II of the Act, a proved course developed under section
statement that the person(s) is accred- 206(c) of Title II of the Act.
ited under such plan. (f) A local education agency may re-
(ii) A statement that the local edu- quire each management plan to con-
cation agency used (or will use) persons tain a statement signed by an accred-
who have been accredited by another ited management plan developer that
State which has adopted a contractor such person has prepared or assisted in
accreditation plan under section 206(b) the preparation of such plan or has re-
of Title II of the Act or is accredited by viewed such plan, and that such plan is
an EPA-approved course under section in compliance with this subpart E.
206(c) of Title II of the Act. Such statement may not be signed by a
(8) A detailed description in the form person who, in addition to preparing or
of a blueprint, diagram, or in writing of assisting in preparing the management
any ACBM or suspected ACBM assumed plan, also implements (or will imple-
to be ACM which remains in the school ment) the management plan.
once response actions are undertaken (g)(1) Upon submission of a manage-
pursuant to § 763.90. This description ment plan to the Governor for review,
shall be updated as response actions a local education agency shall keep a
are completed. copy of the plan in its administrative
(9) A plan for reinspection under office. The management plans shall be
§ 763.85, a plan for operations and main- available, without cost or restriction,
tenance activities under § 763.91, and a for inspection by representatives of
plan for periodic surveillance under EPA and the State, the public, includ-
§ 763.92, a description of the rec- ing teachers, other school personnel
ommendation made by the manage- and their representatives, and parents.
ment planner regarding additional The local education agency may charge
cleaning under § 763.91(c)(2) as part of a reasonable cost to make copies of
an operations and maintenance pro- management plans.
gram, and the response of the local (2) Each local education agency shall
education agency to that recommenda- maintain in its administrative office a
tion. complete, updated copy of a manage-
(10) A description of steps taken to ment plan for each school under its ad-
inform workers and building occu- ministrative control or direction. The
pants, or their legal guardians, about management plans shall be available,
inspections, reinspections, response ac- during normal business hours, without

tions, and post-response action activi- cost or restriction, for inspection by
ties, including periodic reinspection representatives of EPA and the State,
298
the public, including teachers, other education agency as part of the man-
school personnel and their representa- agement plan. For each homogeneous
tives, and parents. The local education area where all ACBM has been re-
agency may charge a reasonable cost moved, the local education agency
to make copies of management plans. shall ensure that such records are re-
(3) Each school shall maintain in its tained for 3 years after the next rein-
administrative office a complete, up- spection required under § 763.85(b)(1), or
dated copy of the management plan for for an equivalent period.
that school. Management plans shall be (b) For each preventive measure and
available for inspection, without cost response action taken for friable and
or restriction, to workers before work nonfriable ACBM and friable and non-
begins in any area of a school building. friable suspected ACBM assumed to be
The school shall make management ACM, the local education agency shall
plans available for inspection to rep- provide:
resentatives of EPA and the State, the (1) A detailed written description of
public, including parents, teachers, and the measure or action, including meth-
other school personnel and their rep- ods used, the location where the meas-
resentatives within 5 working days ure or action was taken, reasons for se-
after receiving a request for inspection. lecting the measure or action, start
The school may charge a reasonable and completion dates of the work,
cost to make copies of the manage- names and addresses of all contractors
ment plan. involved, and if applicable, their State
(4) Upon submission of its manage- of accreditation, and accreditation
ment plan to the Governor and at least numbers, and if ACBM is removed, the
once each school year, the local edu- name and location of storage or dis-
cation agency shall notify in writing posal site of the ACM.
parent, teacher, and employee organi- (2) The name and signature of any
zations of the availability of manage- person collecting any air sample re-
ment plans and shall include in the quired to be collected at the comple-
management plan a description of the tion of certain response actions speci-
steps taken to notify such organiza- fied by § 763.90(i), the locations where
tions, and a dated copy of the notifica- samples were collected, date of collec-
tion. In the absence of any such organi- tion, the name and address of the lab-
zations for parents, teachers, or em- oratory analyzing the samples, the
ployees, the local education agency date of analysis, the results of the
shall provide written notice to that rel- analysis, the method of analysis, the
evant group of the availability of man- name and signature of the person per-
agement plans and shall include in the forming the analysis, and a statement
management plan a description of the that the laboratory meets the applica-
steps taken to notify such groups, and ble requirements of § 763.90(i)(2)(ii).
a dated copy of the notification. (c) For each person required to be
(h) Records required under § 763.94 trained under § 763.92(a) (1) and (2), the
shall be made by local education agen- local education agency shall provide
cies and maintained as part of the the person’s name and job title, the
management plan. date that training was completed by
(i) Each management plan must con- that person, the location of the train-
tain a true and correct statement, ing, and the number of hours com-
signed by the individual designated by pleted in such training.
the local education agency under (d) For each time that periodic sur-
§ 763.84, which certifies that the gen- veillance under § 763.92(b) is performed,
eral, local education agency respon- the local education agency shall record
sibilities, as stipulated by § 763.84, have the name of each person performing
been met or will be met. the surveillance, the date of the sur-
veillance, and any changes in the con-
§ 763.94 Recordkeeping. ditions of the materials.
(a) Records required under this sec- (e) For each time that cleaning under
tion shall be maintained in a central- § 763.91(c) is performed, the local edu-

ized location in the administrative of- cation agency shall record the name of
fice of both the school and the local each person performing the cleaning,
299
§ 763.95 40 CFR Ch. I (7–1–17 Edition)
the date of such cleaning, the locations (c) The warning label shall read, in
cleaned, and the methods used to per- print which is readily visible because
form such cleaning. of large size or bright color, as follows:
(f) For each time that operations and CAUTION: ASBESTOS. HAZARDOUS.
maintenance activities under § 763.91(d) DO NOT DISTURB WITHOUT PROPER
are performed, the local education TRAINING AND EQUIPMENT.
agency shall record the name of each
person performing the activity, the § 763.97 Compliance and enforcement.
start and completion dates of the ac-
(a) Compliance with Title II of the Act.
tivity, the locations where such activ-
(1) Section 207(a) of Title II of the Act
ity occurred, a description of the activ-
(15 U.S.C. 2647) makes it unlawful for
ity including preventive measures
used, and if ACBM is removed, the any local education agency to:
name and location of storage or dis- (i) Fail to conduct inspections pursu-
posal site of the ACM. ant to section 203(b) of Title II of the
(g) For each time that major asbestos Act, including failure to follow proce-
activity under § 763.91(e) is performed, dures and failure to use accredited per-
the local education agency shall pro- sonnel and laboratories.
vide the name and signature, State of (ii) Knowingly submit false informa-
accreditation, and if applicable, the action to the Governor regarding any in-
creditation number of each person per- spection pursuant to regulations under
forming the activity, the start and section 203(i) of Title II of the Act.
completion dates of the activity, the (iii) Fail to develop a management
locations where such activity occurred, plan pursuant to regulations under sec-
a description of the activity including tion 203(i) of Title II of the Act.
preventive measures used, and if ACBM (2) Section 207(a) of Title II of the
is removed, the name and location of Act (15 U.S.C. 2647) also provides that
storage or disposal site of the ACM. any local education agency which vio-
(h) For each fiber release episode lates any provision of section 207 shall
under § 763.91(f), the local education be liable for a civil penalty of not more
agency shall provide the date and loca- than $5,000 for each day during which
tion of the episode, the method of re- the violation continues. For the pur-
pair, preventive measures or response poses of this subpart, a ‘‘violation’’
action taken, the name of each person means a failure to comply with respect
performing the work, and if ACBM is to a single school building.
removed, the name and location of (b) Compliance with Title I of the Act.
storage or disposal site of the ACM. (1) Section 15(1)(D) of Title I of the Act
(Approved by the Office of Management and (15 U.S.C. 2614) makes it unlawful for
Budget under control number 2070–0091) any person to fail or refuse to comply
with any requirement of Title II or any
§ 763.95 Warning labels. rule promulgated or order issued under
(a) The local education agency shall Title II. Therefore, any person who vio-
attach a warning label immediately ad- lates any requirement of this subpart
jacent to any friable and nonfriable is in violation of section 15 of Title I of
ACBM and suspected ACBM assumed to the Act.
be ACM located in routine mainte- (2) Section 15(3) of Title I of the Act
nance areas (such as boiler rooms) at (15 U.S.C. 2614) makes it unlawful for
each school building. This shall in- any person to fail or refuse to establish
clude: or maintain records, submit reports,
(1) Friable ACBM that was responded notices or other information, or permit
to by a means other than removal. access to or copying of records, as re-
(2) ACBM for which no response acquired by this Act or a rule thereunder.
tion was carried out. (3) Section 15(4) (15 U.S.C. 2614) of
(b) All labels shall be prominently Title I of the Act makes it unlawful for
displayed in readily visible locations any person to fail or refuse to permit

and shall remain posted until the entry or inspection as required by sec-
ACBM that is labeled is removed. tion 11 of Title I of the Act.
300
(4) Section 16(a) of Title I of the Act lic hearing in accordance with para-
(15 U.S.C. 2615) provides that any per- graphs (b) and (c) of this section, EPA
son who violates any provision of sec- may waive some or all of the require-
tion 15 of Title I of the Act shall be lia- ments of this subpart E if the state has
ble to the United States for a civil pen- established and is implementing or in-
alty in an amount not to exceed $25,000 tends to implement a program of asbes-
for each such violation. Each day such tos inspection and management that
a violation continues shall, for pur- contains requirements that are at least
poses of this paragraph, constitute a as stringent as the requirements of this
separate violation of section 15. A local subpart. In addition, if the state choos-
education agency is not liable for any es to receive electronic documents, the
civil penalty under Title I of the Act state program must include, at a min-
for failing or refusing to comply with imum, the requirements of 40 CFR part
any rule promulgated or order issued 3—(Electronic reporting).
under Title II of the Act. (2) A waiver from any requirement of
(c) Criminal penalties. If any violation this subpart E shall apply only to the
committed by any person (including a specific provision for which a waiver
local education agency) is knowing or has been granted under this section.
willful, criminal penalties may be as- All requirements of this subpart E
sessed under section 16(b) of Title I of shall apply until a waiver is granted
the Act. under this section.
(d) Injunctive relief. The Agency may (b) Request. Each request by a Gov-
obtain injunctive relief under section ernor to waive any requirement of this
208(b) of Title II of the Act to respond subpart E shall be sent with three com-
to a hazard which poses an imminent plete copies of the request to the Re-
and substantial endangerment to gional Administrator for the EPA Re-
human health or the environment or gion in which the State is located and
section 17 (15 U.S.C. 2616) of Title I of shall include:
the Act to restrain any violation of (1) A copy of the State provisions or
section 15 of Title I of the Act or to proposed provisions relating to its pro-
compel the taking of any action re- gram of asbestos inspection and man-
quired by or under Title I of the Act. agement in schools for which the re-
(e) Citizen complaints. Any citizen who quest is made.
wishes to file a complaint pursuant to (2)(i) The name of the State agency
section 207(d) of Title II of the Act that is or will be responsible for admin-
should direct the complaint to the Gov- istering and enforcing the require-
ernor of the State or the EPA Asbestos ments for which a waiver is requested,
Ombudsman, 1200 Pennsylvania Ave., the names and job titles of responsible
NW., Washington, DC 20460. The citizen officials in that agency, and phone
complaint should be in writing and numbers where the officials can be con-
identified as a citizen complaint pursu- tacted.
ant to section 207(d) of Title II of (ii) In the event that more than one
TSCA. The EPA Asbestos Ombudsman agency is or will be responsible for ad-
or the Governor shall investigate and ministering and enforcing the require-
respond to the complaint within a rea- ments for which a waiver is requested,
sonable period of time if the allega- a description of the functions to be per-
tions provide a reasonable basis to be- formed by each agency, how the pro-
lieve that a violation of the Act has oc- gram will be coordinated by the lead
curred. agency to ensure consistency and effec-
(f) Inspections. EPA may conduct in- tive administration in the asbestos in-
spections and review management spection and management program
plans under section 11 of Title I of the within the State, the names and job ti-
Act (15 U.S.C. 2610) to ensure compli- tles of responsible officials in the agen-
ance. cies, and phone numbers where the offi-
cials can be contacted. The lead agency
§ 763.98 Waiver; delegation to State. will serve as the central contact point
(a) General. (1) Upon request from a for the EPA.

state Governor and after notice and (3) Detailed reasons, supporting pa-
comment and an opportunity for a pub- pers, and the rationale for concluding
301
§ 763.98 40 CFR Ch. I (7–1–17 Edition)
that the state’s asbestos inspection and the FEDERAL REGISTER before the date
management program provisions for of the hearing. Each comment shall in-
which the request is made are at least clude the name and address of the per-
as stringent as the requirements of son submitting the comment.
subpart E of this part, and that, if the (d) Criteria. EPA may waive some or
state chooses to receive electronic doc- all of the requirements of subpart E of
uments, the state program includes, at this part if:
a minimum, the requirements of 40 (1) The State’s lead agency and other
CFR part 3—(Electronic reporting). cooperating agencies have the legal au-
(4) A discussion of any special situa- thority necessary to carry out the pro-
tions, problems, and needs pertaining visions of asbestos inspection and man-
to the waiver request accompanied by agement in schools relating to the
an explanation of how the State in- waiver request.
tends to handle them. (2) The State’s program of asbestos
(5) A statement of the resources that inspection and management in schools
the State intends to devote to the ad- relating to the waiver request and im-
ministration and enforcement of the plementation of the program are or
provisions relating to the waiver re- will be at least as stringent as the re-
quest. quirements of this subpart E.
(6) Copies of any specific or enabling
(3) The state has an enforcement
State laws (enacted and pending enact-
mechanism to allow it to implement
ment) and regulations (promulgated
the program described in the waiver re-
and pending promulgation) relating to
quest and any electronic reporting re-
the request, including provisions for
assessing criminal and/or civil pen- quirements are at least as stringent as
alties. 40 CFR part 3—(Electronic reporting).
(7) Assurance from the Governor, the (4) The lead agency and any cooper-
Attorney General, or the legal counsel ating agencies have or will have quali-
of the lead agency that the lead agency fied personnel to carry out the provi-
or other cooperating agencies have the sions relating to the waiver request.
legal authority necessary to carry out (5) The State will devote adequate re-
the requirements relating to the resources to the administration and en-
quest. forcement of the asbestos inspection
(c) General notice—hearing. (1) Within and management provisions relating to
30 days after receipt of a request for a the waiver request.
waiver, EPA will determine the com- (6) When specified by EPA, the State
pleteness of the request. If EPA does gives satisfactory assurances that nec-
not request further information within essary steps, including specific actions
the 30-day period, the request will be it proposes to take and a time schedule
deemed complete. for their accomplishment, will be
(2) Within 30 days after EPA deter- taken within a reasonable time to con-
mines that a request is complete, EPA form with applicable criteria under
will issue for publication in the FED- paragraphs (d) (2) through (4) of this
ERAL REGISTER a notice that announces section.
receipt of the request, describes the in- (e) Decision. EPA will issue for publi-
formation submitted under paragraph cation in the FEDERAL REGISTER a no-
(b) of this section, and solicits written tice announcing its decision to grant or
comment from interested members of deny, in whole or in part, a Governor’s
the public. Comments must be sub- request for a waiver from some or all of
mitted within 60 days. the requirements of this subpart E
(3) If, during the comment period, within 30 days after the close of the
EPA receives a written objection to a comment period or within 30 days fol-
Governor’s request and a request for a lowing a public hearing, whichever is
public hearing detailing specific objec- applicable. The notice will include the
tions to the granting of a waiver, EPA Agency’s reasons and rationale for
will schedule a public hearing to be granting or denying the Governor’s re-
held in the affected State after the quest. The 30-day period may be ex-
close of the comment period and will tended if mutually agreed upon by EPA
announce the public hearing date in and the State.
302
(f) Modifications. When any substan- exist or were corrected by the State, no
tial change is made in the administra- further action is required.
tion or enforcement of a State program (4) Where EPA finds that deficiencies
for which a waiver was granted under in the State program exist, a plan to
this section, a responsible official in correct the deficiencies shall be nego-
the lead agency shall submit such tiated between the State and EPA. The
changes to EPA. plan shall detail the deficiencies found
(g) Reports. The lead agency in each in the State program, specify the steps
State that has been granted a waiver the State has taken or will take to
by EPA from any requirement of sub- remedy the deficiencies, and establish
part E of this part shall submit a re- a schedule for each remedial action to
port to the Regional Administrator for be initiated.
the Region in which the State is lo- (j) Rescission. (1) If the State fails to
cated at least once every 12 months to meet with EPA or fails to correct defi-
include the following information: ciencies raised at the informal con-
(1) A summary of the State’s imple- ference, EPA will deliver to the Gov-
mentation and enforcement activities ernor of the State and a responsible of-
during the last reporting period relat- ficial in the lead agency a written no-
ing to provisions waived under this sec- tice of its intent to rescind, in whole or
tion, including enforcement actions part, the waiver.
taken. (2) EPA will issue for publication in
(2) Any changes in the administra- the FEDERAL REGISTER a notice that
tion or enforcement of the State pro- announces the rescission of the waiver,
gram implemented during the last re- describes those aspects of the State’s
porting period. program determined to be inadequate,
(3) Other reports as may be required and specifies the facts that underlie
by EPA to carry out effective oversight the findings of inadequacy.
of any requirement of this subpart E [52 FR 41846, Oct. 30, 1987, as amended at 70
that was waived under this section. FR 59889, Oct. 13, 2005]
(h) Oversight. EPA may periodically
evaluate the adequacy of a State’s im- § 763.99 Exclusions.
plementation and enforcement of and (a) A local education agency shall
resources devoted to carrying out re- not be required to perform an inspec-
quirements relating to the waiver. This tion under § 763.85(a) in any sampling
evaluation may include, but is not lim- area as defined in 40 CFR 763.103 or ho-
ited to, site visits to local education mogeneous area of a school building
agencies without prior notice to the where:
State. (1) An accredited inspector has deter-
(i) Informal conference. (1) EPA may mined that, based on sampling records,
request that an informal conference be friable ACBM was identified in that ho-
held between appropriate State and mogeneous or sampling area during an
EPA officials when EPA has reason to inspection conducted before December
believe that a State has failed to: 14, 1987. The inspector shall sign and
(i) Substantially comply with the date a statement to that effect with his
terms of any provision that was waived or her State of accreditation and if ap-
under this section. plicable, accreditation number and,
(ii) Meet the criteria under paragraph within 30 days after such determina-
(d) of this section, including the failure tion, submit a copy of the statement to
to carry out enforcement activities or the person designated under § 763.84 for
act on violations of the State program. inclusion in the management plan.
(2) EPA will: However, an accredited inspector shall
(i) Specify to the State those aspects assess the friable ACBM under § 763.88.
of the State’s program believed to be (2) An accredited inspector has deter-
inadequate. mined that, based on sampling records,
(ii) Specify to the State the facts nonfriable ACBM was identified in that
that underlie the belief of inadequacy. homogeneous or sampling area during
(3) If EPA finds, on the basis of infor- an inspection conducted before Decem-
mation submitted by the State at the ber 14, 1987. The inspector shall sign
conference, that deficiencies did not and date a statement to that effect
303
§ 763.99 40 CFR Ch. I (7–1–17 Edition)
with his or her State of accreditation tion and if applicable, accreditation

and if applicable, accreditation number number and, within 30 days of such de-
and, within 30 days after such deter- termination, submit a copy of the
mination, submit a copy of the state- statement to the person designated
ment to the person designated under under § 763.84 for inclusion in the man-
§ 763.84 for inclusion in the manage- agement plan. However, an accredited
ment plan. However, an accredited in- inspector shall identify whether mate-
spector shall identify whether material rial that was nonfriable suspected
that was nonfriable has become friable ACBM assumed to be ACM has become
since that previous inspection and friable since the previous inspection
shall assess the newly-friable ACBM and shall assess the newly friable ma-
under § 763.88. terial and previously identified friable
(3) Based on sampling records and in- suspected ACBM assumed to be ACM
spection records, an accredited inspec- under § 763.88.
tor has determined that no ACBM is (6) Based on inspection records and
present in the homogeneous or sam- contractor and clearance records, an
pling area and the records show that accredited inspector has determined
the area was sampled, before December that no ACBM is present in the homo-
14, 1987 in substantial compliance with geneous or sampling area where asbes-
§ 763.85(a), which for purposes of this tos removal operations have been con-
section means in a random manner and ducted before December 14, 1987, and
with a sufficient number of samples to shall sign and date a statement to that
reasonably ensure that the area is not effect and include his or her State of
ACBM. accreditation and, if applicable, accred-
(i) The accredited inspector shall itation number. The local education
sign and date a statement, with his or agency shall submit a copy of the
her State of accreditation and if appli- statement to the EPA Regional Office
cable, accreditation number that the and shall include the statement in the
homogeneous or sampling area deter- management plan for that school.
mined not to be ACBM was sampled in (7) An architect or project engineer
substantial compliance with § 763.85(a). responsible for the construction of a
(ii) Within 30 days after the inspec- new school building built after October
tor’s determination, the local edu- 12, 1988, or an accredited inspector
cation agency shall submit a copy of signs a statement that no ACBM was
the inspector’s statement to the EPA specified as a building material in any
Regional Office and shall include the construction document for the build-
statement in the management plan for ing, or, to the best of his or her knowl-
that school. edge, no ACBM was used as a building
(4) The lead agency responsible for material in the building. The local edu-
asbestos inspection in a State that has cation agency shall submit a copy of
been granted a waiver from § 763.85(a) the signed statement of the architect,
has determined that, based on sam- project engineer, or accredited inspec-
pling records and inspection records, tor to the EPA Regional Office and
no ACBM is present in the homo- shall include the statement in the
geneous or sampling area and the management plan for that school.
records show that the area was sam- (b) The exclusion, under paragraphs
pled before December 14, 1987, in sub- (a) (1) through (4) of this section, from
stantial compliance with § 763.85(a). conducting the inspection under
Such determination shall be included § 763.85(a) shall apply only to homo-
in the management plan for that geneous or sampling areas of a school
school. building that were inspected and sam-
(5) An accredited inspector has deter- pled before October 17, 1987. The local
mined that, based on records of an in- education agency shall conduct an in-
spection conducted before December 14, spection under § 763.85(a) of all areas in-
1987, suspected ACBM identified in that spected before October 17, 1987, that
homogeneous or sampling area is as- were not sampled or were not assumed
sumed to be ACM. The inspector shall to be ACM.

sign and date a statement to that ef- (c) If ACBM is subsequently found in
fect, with his or her State of accredita- a homogeneous or sampling area of a
304
Environmental Protection Agency Pt. 763, Subpt. E, App. A
local education agency that had been defined by this method is equal to or greater
identified as receiving an exclusion by than 5:1.
an accredited inspector under para- 4. Bundle—A structure composed of three
or more fibers in a parallel arrangement
graphs (a) (3), (4), (5) of this section, or with each fiber closer than one fiber diame-
an architect, project engineer or ac- ter.
credited inspector under paragraph 5. Clean area—A controlled environment
(a)(7) of this section, the local edu- which is maintained and monitored to assure
cation agency shall have 180 days fol- a low probability of asbestos contamination
lowing the date of identification of to materials in that space. Clean areas used
in this method have HEPA filtered air under
ACBM to comply with this subpart E. positive pressure and are capable of sus-
tained operation with an open laboratory
APPENDIX A TO SUBPART E OF PART blank which on subsequent analysis has an
763—INTERIM TRANSMISSION ELEC- average of less than 18 structures/mm2 in an
TRON MICROSCOPY ANALYTICAL area of 0.057 mm2 (nominally 10 200-mesh grid
METHODS—MANDATORY AND NON- openings) and a maximum of 53 structures/
MANDATORY—AND MANDATORY SEC- mm2 for any single preparation for that same
TION TO DETERMINE COMPLETION OF area.
6. Cluster—A structure with fibers in a ran-
RESPONSE ACTIONS dom arrangement such that all fibers are
I. Introduction intermixed and no single fiber is isolated
from the group. Groupings must have more
The following appendix contains three than two intersections.
units. The first unit is the mandatory trans- 7. ED—Electron diffraction.
mission electron microscopy (TEM) method 8. EDXA—Energy dispersive X-ray anal-
which all laboratories must follow; it is the ysis.
minimum requirement for analysis of air 9. Fiber—A structure greater than or equal
samples for asbestos by TEM. The manda- to 0.5 μm in length with an aspect ratio
tory method contains the essential elements (length to width) of 5:1 or greater and having
of the TEM method. The second unit con- substantially parallel sides.
tains the complete non-mandatory method. 10. Grid—An open structure for mounting
The non-mandatory method supplements the on the sample to aid in its examination in
mandatory method by including additional the TEM. The term is used here to denote a
steps to improve the analysis. EPA rec- 200-mesh copper lattice approximately 3 mm
ommends that the non-mandatory method be in diameter.
employed for analyzing air filters; however, 11. Intersection—Nonparallel touching or
the laboratory may choose to employ the crossing of fibers, with the projection having
mandatory method. The non-mandatory an aspect ratio of 5:1 or greater.
method contains the same minimum require- 12. Laboratory sample coordinator—That per-
ments as are outlined in the mandatory son responsible for the conduct of sample
method. Hence, laboratories may choose ei- handling and the certification of the testing
ther of the two methods for analyzing air procedures.
samples by TEM. 13. Filter background level—The concentra-
The final unit of this Appendix A to sub- tion of structures per square millimeter of
part E defines the steps which must be taken filter that is considered indistinguishable
to determine completion of response actions. from the concentration measured on a blank
This unit is mandatory. (filters through which no air has been
drawn). For this method the filter back-
II. Mandatory Transmission Electron ground level is defined as 70 structures/mm2.
Microscopy Method 14. Matrix—Fiber or fibers with one end
free and the other end embedded in or hidden
A. Definitions of Terms by a particulate. The exposed fiber must
meet the fiber definition.
1. Analytical sensitivity—Airborne asbestos 15. NSD—No structure detected.
concentration represented by each fiber 16. Operator—A person responsible for the
counted under the electron microscope. It is TEM instrumental analysis of the sample.
determined by the air volume collected and 17. PCM—Phase contrast microscopy.
the proportion of the filter examined. This 18. SAED—Selected area electron diffrac-
method requires that the analytical sensi- tion.
tivity be no greater than 0.005 structures/ 19. SEM—Scanning electron microscope.
cm3. 20. STEM—Scanning transmission electron
2. Asbestiform—A specific type of mineral microscope.
fibrosity in which the fibers and fibrils pos-
21. Structure—a microscopic bundle, clus-

sess high tensile strength and flexibility. ter, fiber, or matrix which may contain as-
3. Aspect ratio—A ratio of the length to the bestos.
width of a particle. Minimum aspect ratio as 22. S/cm3—Structures per cubic centimeter.
305
Pt. 763, Subpt. E, App. A 40 CFR Ch. I (7–1–17 Edition)
23. S/mm2—Structures per square milli- 4. Prescreen the loaded cassette collection
meter. filters to assure that they do not contain
24. TEM—Transmission electron micro- concentrations of asbestos which may inter-
scope. fere with the analysis of the sample. A filter
blank average of less than 18 s/mm2 in an
B. Sampling area of 0.057 mm2 (nominally 10 200-mesh grid
1. The sampling agency must have written openings) and a single preparation with a
quality control procedures and documents maximum of 53 s/mm2 for that same area is
which verify compliance. acceptable for this method.
2. Sampling operations must be performed 5. Use sample collection filters which are
by qualified individuals completely inde- either polycarbonate having a pore size less
pendent of the abatement contractor to than or equal to 0.4 μm or mixed cellulose
avoid possible conflict of interest (Ref- ester having a pore size less than or equal to
erences 1, 2, 3, and 5 of Unit II.J.). 0.45 μm.
3. Sampling for airborne asbestos following 6. Place these filters in series with a 5.0 μm
an abatement action must use commercially backup filter (to serve as a diffuser) and a
available cassettes. support pad. See the following Figure 1:
306
7. Reloading of used cassettes is not per- 9. Maintain a log of all pertinent sampling
mitted. information.
8. Orient the cassette downward at ap-
proximately 45 degrees from the horizontal.
307
EC01AP92.001</GPH>
10. Calibrate sampling pumps and their 17. A minimum of 13 samples are to be col-
flow indicators over the range of their in- lected for each testing site consisting of the
tended use with a recognized standard. As- following:
semble the sampling system with a rep- a. A minimum of five samples per abate-
resentative filter (not the filter which will ment area.
be used in sampling) before and after the b. A minimum of five samples per ambient
sampling operation. area positioned at locations representative
11. Record all calibration information. of the air entering the abatement site.
c. Two field blanks are to be taken by re-
12. Ensure that the mechanical vibrations
moving the cap for not more than 30 seconds
from the pump will be minimized to prevent
and replacing it at the time of sampling be-
transferral of vibration to the cassette. fore sampling is initiated at the following
13. Ensure that a continuous smooth flow places:
of negative pressure is delivered by the pump i. Near the entrance to each abatement
by damping out any pump action fluctua- area.
tions if necessary. ii. At one of the ambient sites. (DO NOT
14. The final plastic barrier around the leave the field blanks open during the sam-
abatement area remains in place for the pling period.)
sampling period. d. A sealed blank is to be carried with each
15. After the area has passed a thorough sample set. This representative cassette is
visual inspection, use aggressive sampling not to be opened in the field.
conditions to dislodge any remaining dust. 18. Perform a leak check of the sampling
(See suggested protocol in Unit III.B.7.d.) system at each indoor and outdoor sampling
16. Select an appropriate flow rate equal to site by activating the pump with the closed
sampling cassette in line. Any flow indicates
or greater than 1 liter per minute (L/min) or
a leak which must be eliminated before initi-
less than 10 L/min for 25 mm cassettes. Larg-
ating the sampling operation.
er filters may be operated at proportionally
19. The following Table I specifies volume
higher flow rates. ranges to be used:
308
20. Ensure that the sampler is turned up- 22. Ensure that the samples are stored in a
right before interrupting the pump flow. secure and representative location.
21. Check that all samples are clearly la- 23. Do not change containers if portions of
beled and that all pertinent information has these filters are taken for other purposes.
been enclosed before transfer of the samples 24. A summary of Sample Data Quality Ob-
to the laboratory. jectives is shown in the following Table II:
309
EC01AP92.002</MATH>
C. Sample Shipment a. TEM Grid Opening Area measurement

must be done as follows:
Ship bulk samples to the analytical lab-
oratory in a separate container from air i. The filter portion being used for sample
samples. preparation must have the surface collapsed
using an acetone vapor technique.
D. Sample Receiving ii. Measure 20 grid openings on each of 20
random 200-mesh copper grids by placing a
1. Designate one individual as sample coor-
grid on a glass and examining it under the
dinator at the laboratory. While that indi-
PCM. Use a calibrated graticule to measure
vidual will normally be available to receive
the average field diameters. From the data,
samples, the coordinator may train and su-
calculate the field area for an average grid
pervise others in receiving procedures for
opening.
those times when he/she is not available.
2. Bulk samples and air samples delivered iii. Measurements can also be made on the
to the analytical laboratory in the same con- TEM at a properly calibrated low magnifica-
tainer shall be rejected. tion or on an optical microscope at a mag-
nification of approximately 400X by using an
E. Sample Preparation eyepiece fitted with a scale that has been
calibrated against a stage micrometer. Opti-
1. All sample preparation and analysis cal microscopy utilizing manual or auto-
shall be performed by a laboratory inde- mated procedures may be used providing in-
pendent of the abatement contractor. strument calibration can be verified.
2. Wet-wipe the exterior of the cassettes to
b. TEM specimen preparation from
minimize contamination possibilities before
polycarbonate (PC) filters. Procedures as de-
taking them into the clean room facility.
scribed in Unit III.G. or other equivalent
3. Perform sample preparation in a well-
methods may be used.
equipped clean facility.
NOTE: The clean area is required to have c. TEM specimen preparation from mixed
the following minimum characteristics. The cellulose ester (MCE) filters.
area or hood must be capable of maintaining i. Filter portion being used for sample
a positive pressure with make-up air being preparation must have the surface collapsed
HEPA-filtered. The cumulative analytical using an acetone vapor technique or the
blank concentration must average less than Burdette procedure (Ref. 7 of Unit II.J.)
18 s/mm2 in an area of 0.057 mm2 (nominally ii. Plasma etching of the collapsed filter is
10 200-mesh grid openings) and a single prep- required. The microscope slide to which the
aration with a maximum of 53 s/mm2 for that collapsed filter pieces are attached is placed
same area. in a plasma asher. Because plasma ashers
4. Preparation areas for air samples must vary greatly in their performance, both from
not only be separated from preparation areas unit to unit and between different positions
for bulk samples, but they must be prepared in the asher chamber, it is difficult to speci-
in separate rooms. fy the conditions that should be used. Insuf-
5. Direct preparation techniques are re- ficient etching will result in a failure to ex-
quired. The object is to produce an intact pose embedded filters, and too much etching
film containing the particulates of the filter may result in loss of particulate from the
surface which is sufficiently clear for TEM surface. As an interim measure, it is rec-
analysis. ommended that the time for ashing of a
310
EC01AP92.003</MATH>
known weight of a collapsed filter be estab- be metric). A logbook must be maintained,
lished and that the etching rate be cal- and the dates of calibration and the values
culated in terms of micrometers per second. obtained must be recorded. The frequency of
The actual etching time used for the particu- calibration depends on the past history of
late asher and operating conditions will then the particular microscope. After any mainte-
be set such that a 1–2 μm (10 percent) layer nance of the microscope that involved ad-
of collapsed surface will be removed. justment of the power supplied to the lenses
iii. Procedures as described in Unit III. or or the high-voltage system or the mechan-
other equivalent methods may be used to ical disassembly of the electron optical col-
prepare samples. umn apart from filament exchange, the mag-
nification must be recalibrated. Before the
F. TEM Method TEM calibration is performed, the analyst
1. An 80–120 kV TEM capable of performing must ensure that the cross grating replica is
electron diffraction with a fluorescent screen placed at the same distance from the objec-
inscribed with calibrated gradations is re- tive lens as the specimens are. For instru-
quired. If the TEM is equipped with EDXA it ments that incorporate a eucentric tilting
must either have a STEM attachment or be specimen stage, all specimens and the cross
capable of producing a spot less than 250 nm grating replica must be placed at the
in diameter at crossover. The microscope eucentric position.
shall be calibrated routinely for magnifica- 4. While not required on every microscope
tion and camera constant. in the laboratory, the laboratory must have
2. Determination of Camera Constant and ED either one microscope equipped with energy
Pattern Analysis. The camera length of the dispersive X-ray analysis or access to an
TEM in ED operating mode must be cali- equivalent system on a TEM in another lab-
brated before ED patterns on unknown sam- oratory.
ples are observed. This can be achieved by 5. Microscope settings: 80–120 kV, grid as-
using a carbon-coated grid on which a thin sessment 250–1,000X, then 15,000–20,000X
film of gold has been sputtered or evapo- screen magnification for analysis.
rated. A thin film of gold is evaporated on 6. Approximately one-half (0.5) of the pre-
the specimen TEM grid to obtain zone-axis determined sample area to be analyzed shall
ED patterns superimposed with a ring pat- be performed on one sample grid preparation
tern from the polycrystalline gold film. In and the remaining half on a second sample
practice, it is desirable to optimize the grid preparation.
thickness of the gold film so that only one or 7. Individual grid openings with greater
two sharp rings are obtained on the super- than 5 percent openings (holes) or covered
imposed ED pattern. Thicker gold film would with greater than 25 percent particulate
normally give multiple gold rings, but it will matter or obviously having nonuniform load-
tend to mask weaker diffraction spots from ing must not be analyzed.
the unknown fibrous particulate. Since the 8. Reject the grid if:
unknown d-spacings of most interest in as- a. Less than 50 percent of the grid openings
bestos analysis are those which lie closest to covered by the replica are intact.
the transmitted beam, multiple gold rings b. The replica is doubled or folded.
are unnecessary on zone-axis ED patterns. c. The replica is too dark because of incom-
An average camera constant using multiple plete dissolution of the filter.
gold rings can be determined. The camera 9. Recording Rules.
constant is one-half the diameter of the a. Any continuous grouping of particles in
rings times the interplanar spacing of the which an asbestos fiber with an aspect ratio
ring being measured. greater than or equal to 5:1 and a length
3. Magnification Calibration. The magnifica- greater than or equal to 0.5 μm is detected
tion calibration must be done at the fluores- shall be recorded on the count sheet. These
cent screen. The TEM must be calibrated at will be designated asbestos structures and
the grid opening magnification (if used) and will be classified as fibers, bundles, clusters,
also at the magnification used for fiber or matrices. Record as individual fibers any
counting. This is performed with a cross contiguous grouping having 0, 1, or 2 defin-
grating replica (e.g., one containing 2,160 able intersections. Groupings having more
lines/mm). Define a field of view on the fluo- than 2 intersections are to be described as
rescent screen either by markings or phys- cluster or matrix. An intersection is a non-
ical boundaries. The field of view must be parallel touching or crossing of fibers, with
measurable or previously inscribed with a the projection having an aspect ratio of 5:1
scale or concentric circles (all scales should or greater. See the following Figure 2:
311
312
EC01AP92.004</GPH>
i. Fiber. A structure having a minimum from the group. Groupings must have more
length greater than or equal to 0.5 μm and an than two intersections.
aspect ratio (length to width) of 5:1 or great- iv. Matrix. Fiber or fibers with one end free
er and substantially parallel sides. Note the and the other end embedded in or hidden by
appearance of the end of the fiber, i.e., a particulate. The exposed fiber must meet
whether it is flat, rounded or dovetailed. the fiber definition.
ii. Bundle. A structure composed of three b. Separate categories will be maintained
or more fibers in a parallel arrangement for fibers less than 5 μm and for fibers equal
with each fiber closer than one fiber diame- to or greater than 5 μm in length.
ter. c. Record NSD when no structures are de-
iii. Cluster. A structure with fibers in a tected in the field.
random arrangement such that all fibers are d. Visual identification of electron diffrac-
intermixed and no single fiber is isolated tion (ED) patterns is required for each asbes-
tos structure counted which would cause the
313
EC01AP92.005</GPH>
analysis to exceed the 70 s/mm2 concentra- 11. After finishing with a grid, remove it
tion. (Generally this means the first four fi- from the microscope, and replace it in the
bers identified as asbestos must exhibit an appropriate grid holder. Sample grids must
identifiable diffraction pattern for chrysotile be stored for a minimum of 1 year from the
or amphibole.) date of the analysis; the sample cassette
e. The micrograph number of the recorded must be retained for a minimum of 30 days
diffraction patterns must be reported to the by the laboratory or returned at the client’s
client and maintained in the laboratory’s request.
quality assurance records. In the event that
examination of the pattern by a qualified in- G. Sample Analytical Sequence
dividual indicates that the pattern has been 1. Under the present sampling require-
misidentified visually, the client shall be ments a minimum of 13 samples is to be col-
contacted. lected for the clearance testing of an abate-
f. Energy Dispersive X-ray Analysis ment site. These include five abatement area
(EDXA) is required of all amphiboles which samples, five ambient samples, two field
would cause the analysis results to exceed blanks, and one sealed blank.
the 70 s/mm2 concentration. (Generally 2. Carry out visual inspection of work site
speaking, the first 4 amphiboles would re- prior to air monitoring.
quire EDXA.) 3. Collect a minimum of 5 air samples in-
g. If the number of fibers in the non- side the work site and 5 samples outside the
asbestos class would cause the analysis to work site. The indoor and outdoor samples
exceed the 70 s/mm2 concentration, the fact shall be taken during the same time period.
that they are not asbestos must be con- 4. Remaining steps in the analytical se-
firmed by EDXA or measurement of a zone quence are contained in Unit IV of this Ap-
axis diffraction pattern. pendix.
h. Fibers classified as chrysotile must be
identified by diffraction or X-ray analysis H. Reporting
and recorded on a count sheet. X-ray anal- 1. The following information must be re-
ysis alone can be used only after 70 s/mm2 ported to the client for each sample ana-
have been exceeded for a particular sample. lyzed:
i. Fibers classified as amphiboles must be a. Concentration in structures per square
identified by X-ray analysis and electron dif- millimeter and structures per cubic centi-
fraction and recorded on the count sheet. (X- meter.
ray analysis alone can be used only after 70 b. Analytical sensitivity used for the anal-
s/mm2 have been exceeded for a particular ysis.
sample.) c. Number of asbestos structures.
j. If a diffraction pattern was recorded on d. Area analyzed.
film, record the micrograph number on the e. Volume of air sampled (which must be
count sheet. initially supplied to lab by client).
k. If an electron diffraction was attempted f. Copy of the count sheet must be included
but no pattern was observed, record N on the with the report.
count sheet. g. Signature of laboratory official to indi-
l. If an EDXA spectrum was attempted but cate that the laboratory met specifications
not observed, record N on the count sheet. of the method.
m. If an X-ray analysis spectrum is stored, h. Report form must contain official lab-
record the file and disk number on the count oratory identification (e.g., letterhead).
sheet. i. Type of asbestos.
10. Classification Rules.
a. Fiber. A structure having a minimum I. Quality Control/Quality Assurance
length greater than or equal to 0.5 μm and an Procedures (Data Quality Indicators)
aspect ratio (length to width) of 5:1 or great- Monitoring the environment for airborne
er and substantially parallel sides. Note the asbestos requires the use of sensitive sam-
appearance of the end of the fiber, i.e., pling and analysis procedures. Because the
whether it is flat, rounded or dovetailed. test is sensitive, it may be influenced by a
b. Bundle. A structure composed of three or variety of factors. These include the supplies
more fibers in a parallel arrangement with used in the sampling operation, the perform-
each fiber closer than one fiber diameter. ance of the sampling, the preparation of the
c. Cluster. A structure with fibers in a ran- grid from the filter and the actual examina-
dom arrangement such that all fibers are tion of this grid in the microscope. Each of
intermixed and no single fiber is isolated these unit operations must produce a prod-
from the group. Groupings must have more uct of defined quality if the analytical result
than two intersections. is to be a reliable and meaningful test result.
d. Matrix. Fiber or fibers with one end free Accordingly, a series of control checks and
and the other end embedded in or hidden by reference standards are to be performed
a particulate. The exposed fiber must meet along with the sample analysis as indicators
the fiber definition. that the materials used are adequate and the
314
operations are within acceptable limits. In develop within the sampling and analysis op-
this way, the quality of the data is defined erations. A description of these quality con-
and the results are of known value. These trol/quality assurance procedures is summa-
checks and tests also provide timely and spe- rized in the following Table III:
cific warning of any problems which might
1. When the samples arrive at the labora- 3. Conduct all sample preparation in a
tory, check the samples and documentation clean room environment monitored by lab-
for completeness and requirements before oratory blanks. Testing with blanks must
initiating the analysis. also be done after cleaning or servicing the

2. Check all laboratory reagents and sup- room.
plies for acceptable asbestos background lev- 4. Prepare multiple grids of each sample.
els.
315
EC01AP92.006</MATH>
5. Provide laboratory blanks with each ‘‘Proposed Analytical Method for Determina-
sample batch. Maintain a cumulative aver- tion of Asbestos in Air.’’
age of these results. If there are more than 53 8. Chatfield, E.J., Chatfield Tech. Cons.,
fibers/mm2 per 10 200-mesh grid openings, the Ltd., Clark, T., PEI Assoc., ‘‘Standard Oper-
system must be checked for possible sources ating Procedure for Determination of Air-
of contamination. borne Asbestos Fibers by Transmission Elec-
6. Perform a system check on the trans- tron Microscopy Using Polycarbonate Mem-
mission electron microscope daily. brane Filters,’’ WERL SOP 87–1, March 5,
7. Make periodic performance checks of 1987.
magnification, electron diffraction and en- 9. NIOSH Method 7402 for Asbestos Fibers,
ergy dispersive X-ray systems as set forth in 12–11–86 Draft.
Table III under Unit II.I. 10. Yamate, G., Agarwall, S.C., Gibbons,
8. Ensure qualified operator performance R.D., IIT Research Institute, ‘‘Methodology
by evaluation of replicate analysis and for the Measurement of Airborne Asbestos by
standard sample comparisons as set forth in Electron Microscopy,’’ Draft report, USEPA
Table III under Unit II.I. Contract 68–02–3266, July 1984.
9. Validate all data entries. 11. ‘‘Guidance to the Preparation of Qual-
10. Recalculate a percentage of all com- ity Assurance Project Plans,’’ USEPA, Office
putations and automatic data reduction of Pollution Prevention and Toxics, 1984.
steps as specified in Table III under Unit II.I. III. Nonmandatory Transmission Electron
11. Record an electron diffraction pattern Microscopy Method
of one asbestos structure from every five
samples that contain asbestos. Verify the A. Definitions of Terms
identification of the pattern by measure-
ment or comparison of the pattern with pat- 1. Analytical sensitivity—Airborne asbestos
concentration represented by each fiber
terns collected from standards under the
counted under the electron microscope. It is
same conditions. The records must also dem-
determined by the air volume collected and
onstrate that the identification of the pat-
the proportion of the filter examined. This
tern has been verified by a qualified indi-
method requires that the analytical sensi-
vidual and that the operator who made the
tivity be no greater than 0.005 s/cm3.
identification is maintaining at least an 80
2. Asbestiform—A specific type of mineral
percent correct visual identification based
fibrosity in which the fibers and fibrils pos-
on his measured patterns.
sess high tensile strength and flexibility.
12. Appropriate logs or records must be 3. Aspect ratio—A ratio of the length to the
maintained by the analytical laboratory width of a particle. Minimum aspect ratio as
verifying that it is in compliance with the defined by this method is equal to or greater
mandatory quality assurance procedures. than 5:1.
J. References 4. Bundle—A structure composed of three
or more fibers in a parallel arrangement
For additional background information on with each fiber closer than one fiber diame-
this method, the following references should ter.
be consulted. 5. Clean area—A controlled environment
1. ‘‘Guidance for Controlling Asbestos-Con- which is maintained and monitored to assure
taining Materials in Buildings,’’ EPA 560/5– a low probability of asbestos contamination
85–024, June 1985. to materials in that space. Clean areas used
2. ‘‘Measuring Airborne Asbestos Following in this method have HEPA filtered air under
an Abatement Action,’’ USEPA, Office of positive pressure and are capable of sus-
Pollution Prevention and Toxics, EPA 600/4– tained operation with an open laboratory
85–049, 1985. blank which on subsequent analysis has an
3. Small, John and E. Steel. Asbestos average of less than 18 structures/mm2 in an
Standards: Materials and Analytical Meth- area of 0.057 mm2 (nominally 10 200 mesh grid
ods. N.B.S. Special Publication 619, 1982. openings) and a maximum of 53 structures/
4. Campbell, W.J., R.L. Blake, L.L. Brown, mm2 for no more than one single preparation
E.E. Cather, and J.J. Sjoberg. Selected Sili- for that same area.
cate Minerals and Their Asbestiform Vari- 6. Cluster—A structure with fibers in a ran-
eties. Information Circular 8751, U.S. Bureau dom arrangement such that all fibers are
of Mines, 1977. intermixed and no single fiber is isolated
5. Quality Assurance Handbook for Air Pol- from the group. Groupings must have more
lution Measurement System. Ambient Air than two intersections.
Methods, EPA 600/4–77–027a, USEPA, Office of 7. ED—Electron diffraction.
Research and Development, 1977. 8. EDXA—Energy dispersive X-ray anal-
6. Method 2A: Direct Measurement of Gas ysis.
Volume through Pipes and Small Ducts. 40 9. Fiber—A structure greater than or equal
CFR Part 60 Appendix A. to 0.5 μm in length with an aspect ratio
7. Burdette, G.J., Health & Safety Exec. (length to width) of 5:1 or greater and having
Research & Lab. Services Div., London, substantially parallel sides.
316
10. Grid—An open structure for mounting do not take cross contamination possibilities
on the sample to aid in its examination in into account should not be used.
the TEM. The term is used here to denote a 2. Material and supply checks for asbestos
200-mesh copper lattice approximately 3 mm contamination should be made on all critical
in diameter. supplies, reagents, and procedures before
11. Intersection—Nonparallel touching or their use in a monitoring study.
crossing of fibers, with the projection having 3. Quality control and quality assurance
an aspect ratio of 5:1 or greater. steps are needed to identify problem areas
12. Laboratory sample coordinator—That per- and isolate the cause of the contamination
son responsible for the conduct of sample (see Reference 5 of Unit III.L.). Control
handling and the certification of the testing checks shall be permanently recorded to doc-
procedures. ument the quality of the information pro-
13. Filter background level—The concentra- duced. The sampling firm must have written
tion of structures per square millimeter of quality control procedures and documents
filter that is considered indistinguishable which verify compliance. Independent audits
from the concentration measured on blanks by a qualified consultant or firm should be
(filters through which no air has been performed once a year. All documentation of
drawn). For this method the filter back- compliance should be retained indefinitely
ground level is defined as 70 structures/mm2. to provide a guarantee of quality. A sum-
14. Matrix—Fiber or fibers with one end mary of Sample Data Quality Objectives is
free and the other end embedded in or hidden shown in Table II of Unit II.B.
by a particulate. The exposed fiber must 4. Sampling materials.
meet the fiber definition. a. Sample for airborne asbestos following
15. NSD—No structure detected. an abatement action using commercially
16. Operator—A person responsible for the available cassettes.
TEM instrumental analysis of the sample. b. Use either a cowling or a filter-retaining
17. PCM—Phase contrast microscopy. middle piece. Conductive material may re-
18. SAED—Selected area electron diffrac- duce the potential for particulates to adhere
tion. to the walls of the cowl.
19. SEM—Scanning electron microscope. c. Cassettes must be verified as ‘‘clean’’
20. STEM—Scanning transmission electron prior to use in the field. If packaged filters
microscope. are used for loading or preloaded cassettes
21. Structure—a microscopic bundle, clus- are purchased from the manufacturer or a
ter, fiber, or matrix which may contain as- distributor, the manufacturer’s name and lot
bestos. number should be entered on all field data
22. S/cm3—Structures per cubic centimeter. sheets provided to the laboratory, and are re-
23. S/mm2—Structures per square milli- quired to be listed on all reports from the
meter. laboratory.
24. TEM—Transmission electron micro- d. Assemble the cassettes in a clean facil-
scope. ity (See definition of clean area under Unit
III.A.).
B. Sampling
e. Reloading of used cassettes is not per-
1. Sampling operations must be performed mitted.
by qualified individuals completely inde- f. Use sample collection filters which are
pendent of the abatement contractor to either polycarbonate having a pore size of
avoid possible conflict of interest (See Ref- less than or equal to 0.4 μm or mixed cel-
erences 1, 2, and 5 of Unit III.L.) Special pre- lulose ester having a pore size of less than or
cautions should be taken to avoid contami- equal to 0.45 μm.
nation of the sample. For example, materials g. Place these filters in series with a
that have not been prescreened for their as- backup filter with a pore size of 5.0 μm (to
bestos background content should not be serve as a diffuser) and a support pad. See
used; also, sample handling procedures which the following Figure 1:
317
h. When polycarbonate filters are used, po- i. Seal the cassettes to prevent leakage
sition the highly reflective face such that around the filter edges or between cassette
the incoming particulate is received on this part joints. A mechanical press may be use-
surface. ful to achieve a reproducible leak-free seal.
318
EC01AP92.007</GPH>
Shrink fit gel-bands may be used for this d. Check the sampling system for leaks
purpose and are available from filter manu- with the end cap still in place and the pump
facturers and their authorized distributors. operating before initiating sample collec-
j. Use wrinkle-free loaded cassettes in the tion. Trace and stop the source of any flow
sampling operation. indicated by the flowmeter under these con-
5. Pump setup. ditions.
a. Calibrate the sampling pump over the e. Select an appropriate flow rate equal to
range of flow rates and loads anticipated for or greater than 1 L/min or less than 10 L/min
the monitoring period with this flow meas- for 25 mm cassettes. Larger filters may be
uring device in series. Perform this calibra-
operated at proportionally higher flow rates.
tion using guidance from EPA Method 2A
each time the unit is sent to the field (See f. Orient the cassette downward at approxi-
Reference 6 of Unit III.L.). mately 45 degrees from the horizontal.
b. Configure the sampling system to pre- g. Maintain a log of all pertinent sampling
clude pump vibrations from being trans- information, such as pump identification
mitted to the cassette by using a sampling number, calibration data, sample location,
stand separate from the pump station and date, sample identification number, flow
making connections with flexible tubing. rates at the beginning, middle, and end, start
c. Maintain continuous smooth flow condi- and stop times, and other useful information
tions by damping out any pump action fluc- or comments. Use of a sampling log form is
tuations if necessary. recommended. See the following Figure 2:
319
h. Initiate a chain of custody procedure at j. Continue sampling until at least the

the start of each sampling, if this is re- minimum volume is collected, as specified in
quested by the client. the following Table I:

i. Maintain a close check of all aspects of
the sampling operation on a regular basis.
320
EC01AP92.008</GPH>
k. At the conclusion of sampling, turn the closed and appropriately identified using a
cassette upward before stopping the flow to waterproof label. Protect cassettes in indi-
minimize possible particle loss. If the sam- vidual clean resealed polyethylene bags.
pling is resumed, restart the flow before re- Bags are to be used for storing cassette caps
orienting the cassette downward. Note the when they are removed for sampling pur-
condition of the filter at the conclusion of poses. Caps and plugs should only be re-
sampling. moved or replaced using clean hands or clean
l. Double check to see that all information disposable plastic gloves.

has been recorded on the data collection m. Do not change containers if portions of
forms and that the cassette is securely these filters are taken for other purposes.
321
EC01AP92.009</MATH>
6. Minimum sample number per site. A that electrical equipment does not become
minimum of 13 samples are to be collected wet while operational.
for each testing consisting of the following: vi. Low volume pumps may be carefully
a. A minimum of five samples per abate- wrapped in 6-mil polyethylene to insulate
ment area. the pump from the air. High volume pumps
b. A minimum of five samples per ambient cannot be sealed in this manner since the
area positioned at locations representative heat of the motor may melt the plastic. The
of the air entering the abatement site. pump exhausts should be kept free.
c. Two field blanks are to be taken by re- vii. If recleaning is necessary, removal of
moving the cap for not more than 30 sec and this equipment from the work area must be
replacing it at the time of sampling before handled with care. It is not possible to com-
sampling is initiated at the following places: pletely decontaminate the pump motor and
i. Near the entrance to each ambient area. parts since these areas cannot be wetted. To
ii. At one of the ambient sites. minimize any problems in this area, all
(NOTE: Do not leave the blank open during equipment such as fans and pumps should be
the sampling period.) carefully wet wiped prior to removal from
d. A sealed blank is to be carried with each the abatement area. Wrapping and sealing
sample set. This representative cassette is low volume pumps in 6-mil polyethylene will
not to be opened in the field. provide easier decontamination of this
7. Abatement area sampling. equipment. Use of clean water and disposable
a. Conduct final clearance sampling only wipes should be available for this purpose.
after the primary containment barriers have e. Pump flow rate equal to or greater than
been removed; the abatement area has been 1 L/min or less than 10 L/min may be used for
thoroughly dried; and, it has passed visual 25 mm cassettes. The larger cassette diame-
inspection tests by qualified personnel. (See ters may have comparably increased flow.
Reference 1 of Unit III.L.) f. Sample a volume of air sufficient to en-
b. Containment barriers over windows, sure the minimum quantitation limits. (See
doors, and air passageways must remain in Table I of Unit III.B.5.j.)
place until the TEM clearance sampling and 8. Ambient sampling.
analysis is completed and results meet clear- a. Position ambient samplers at locations
ance test criteria. The final plastic barrier representative of the air entering the abate-
remains in place for the sampling period. ment site. If makeup air entering the abate-
c. Select sampling sites in the abatement ment site is drawn from another area of the
area on a random basis to provide unbiased building which is outside of the abatement
and representative samples. area, place the pumps in the building, pumps
d. After the area has passed a thorough vis- should be placed out of doors located near
ual inspection, use aggressive sampling con- the building and away from any obstructions
ditions to dislodge any remaining dust. that may influence wind patterns. If con-
i. Equipment used in aggressive sampling struction is in progress immediately outside
such as a leaf blower and/or fan should be the enclosure, it may be necessary to select
properly cleaned and decontaminated before another ambient site. Samples should be rep-
use. resentative of any air entering the work site.
ii. Air filtration units shall remain on dur- b. Locate the ambient samplers at least 3
ing the air monitoring period. ft apart and protect them from adverse
iii. Prior to air monitoring, floors, ceiling weather conditions.
and walls shall be swept with the exhaust of c. Sample same volume of air as samples
a minimum one (1) horsepower leaf blower. taken inside the abatement site.
iv. Stationary fans are placed in locations
C. Sample Shipment
which will not interfere with air monitoring
equipment. Fan air is directed toward the 1. Ship bulk samples in a separate con-
ceiling. One fan shall be used for each 10,000 tainer from air samples. Bulk samples and
ft3 of worksite. air samples delivered to the analytical lab-
v. Monitoring of an abatement work area oratory in the same container shall be re-
with high-volume pumps and the use of cir- jected.
culating fans will require electrical power. 2. Select a rigid shipping container and
Electrical outlets in the abatement area pack the cassettes upright in a noncontami-
may be used if available. If no such outlets nating nonfibrous medium such as a bubble
are available, the equipment must be sup- pack. The use of resealable polyethylene
plied with electricity by the use of extension bags may help to prevent jostling of indi-
cords and strip plug units. All electrical vidual cassettes.
power supply equipment of this type must be 3. Avoid using expanded polystyrene be-
approved Underwriter Laboratory equipment cause of its static charge potential. Also
that has not been modified. All wiring must avoid using particle-based packaging mate-
be grounded. Ground fault interrupters rials because of possible contamination.
should be used. Extreme care must be taken 4. Include a shipping bill and a detailed
to clean up any residual water and ensure listing of samples shipped, their descriptions
322
and all identifying numbers or marks, sam- 4. Ensure that the samples are stored in a
pling data, shipper’s name, and contact in- secure and representative location.
formation. For each sample set, designate 5. Ensure that mechanical calibrations
which are the ambient samples, which are from the pump will be minimized to prevent
the abatement area samples, which are the transferral of vibration to the cassette.
field blanks, and which is the sealed blank if 6. Ensure that a continuous smooth flow of
sequential analysis is to be performed. negative pressure is delivered by the pump
5. Hand-carry samples to the laboratory in by installing a damping chamber if nec-
an upright position if possible; otherwise essary.
choose that mode of transportation least 7. Open a loaded cassette momentarily at
likely to jar the samples in transit. one of the indoor sampling sites when sam-
6. Address the package to the laboratory pling is initiated. This sample will serve as
sample coordinator by name when known an indoor field blank.
and alert him or her of the package descrip- 8. Open a loaded cassette momentarily at
tion, shipment mode, and anticipated arrival one of the outdoor sampling sites when sam-
as part of the chain of custody and sample pling is initiated. This sample will serve as
tracking procedures. This will also help the an outdoor field blank.
laboratory schedule timely analysis for the 9. Carry a sealed blank into the field with
samples when they are received. each sample series. Do not open this cassette
in the field.
D. Quality Control/Quality Assurance 10. Perform a leak check of the sampling
Procedures (Data Quality Indicators) system at each indoor and outdoor sampling
Monitoring the environment for airborne site by activating the pump with the closed
asbestos requires the use of sensitive sam- sampling cassette in line. Any flow indicates
pling and analysis procedures. Because the a leak which must be eliminated before initi-
test is sensitive, it may be influenced by a ating the sampling operation.
variety of factors. These include the supplies 11. Ensure that the sampler is turned up-
used in the sampling operation, the perform- right before interrupting the pump flow.
ance of the sampling, the preparation of the 12. Check that all samples are clearly la-
grid from the filter and the actual examina- beled and that all pertinent information has
tion of this grid in the microscope. Each of been enclosed before transfer of the samples
these unit operations must produce a prod- to the laboratory.
uct of defined quality if the analytical result
E. Sample Receiving
is to be a reliable and meaningful test result.
Accordingly, a series of control checks and 1. Designate one individual as sample coor-
reference standards is performed along with dinator at the laboratory. While that indi-
the sample analysis as indicators that the vidual will normally be available to receive
materials used are adequate and the oper- samples, the coordinator may train and su-
ations are within acceptable limits. In this pervise others in receiving procedures for
way, the quality of the data is defined, and those times when he/she is not available.
the results are of known value. These checks 2. Adhere to the following procedures to
and tests also provide timely and specific ensure both the continued chain-of-custody
warning of any problems which might de- and the accountability of all samples passing
velop within the sampling and analysis oper- through the laboratory:
ations. A description of these quality con- a. Note the condition of the shipping pack-
trol/quality assurance procedures is summa- age and data written on it upon receipt.
rized in the text below. b. Retain all bills of lading or shipping
1. Prescreen the loaded cassette collection slips to document the shipper and delivery
filters to assure that they do not contain time.
concentrations of asbestos which may inter- c. Examine the chain-of-custody seal, if
fere with the analysis of the sample. A filter any, and the package for its integrity.
blank average of less than 18 s/mm2 in an d. If there has been a break in the seal or
area of 0.057 mm2 (nominally 10 200-mesh grid substantive damage to the package, the sam-
openings) and a maximum of 53 s/mm2 for ple coordinator shall immediately notify the
that same area for any single preparation is shipper and a responsible laboratory man-
acceptable for this method. ager before any action is taken to unpack
2. Calibrate sampling pumps and their flow the shipment.
indicators over the range of their intended e. Packages with significant damage shall
use with a recognized standard. Assemble the be accepted only by the responsible labora-
sampling system with a representative fil- tory manager after discussions with the cli-
ter—not the filter which will be used in sam- ent.
pling—before and after the sampling oper- 3. Unwrap the shipment in a clean,
ation. uncluttered facility. The sample coordinator

3. Record all calibration information with or his or her designee will record the con-
the data to be used on a standard sampling tents, including a description of each item
form. and all identifying numbers or marks. A
323
Sample Receiving Form to document this in-
formation is attached for use when nec-
essary. (See the following Figure 3.)
324
EC01AP92.010</GPH>
NOTE: The person breaking the chain-of- f. Store the three grids to be measured in
custody seal and itemizing the contents as- appropriately labeled grid holders or poly-
sumes responsibility for the shipment and ethylene capsules.
signs documents accordingly. 5. Equipment.
4. Assign a laboratory number and sched- a. Clean area.
ule an analysis sequence. b. Tweezers. Fine-point tweezers for han-
5. Manage all chain-of-custody samples dling of filters and TEM grids.
within the laboratory such that their integ- c. Scalpel Holder and Curved No. 10 Sur-
rity can be ensured and documented. gical Blades.
d. Microscope slides.
F. Sample Preparation e. Double-coated adhesive tape.
f. Gummed page reinforcements.
1. Personnel not affiliated with the Abate- g. Micro-pipet with disposal tips 10 to 100
ment Contractor shall be used to prepare μL variable volume.
samples and conduct TEM analysis. Wet- h. Vacuum coating unit with facilities for
wipe the exterior of the cassettes to mini- evaporation of carbon. Use of a liquid nitro-
mize contamination possibilities before tak- gen cold trap above the diffusion pump will
ing them to the clean sample preparation fa- minimize the possibility of contamination of
cility. the filter surface by oil from the pumping
2. Perform sample preparation in a well- system. The vacuum-coating unit can also be
equipped clean facility. used for deposition of a thin film of gold.
NOTE: The clean area is required to have i. Carbon rod electrodes. Spectrochemically
the following minimum characteristics. The pure carbon rods are required for use in the
area or hood must be capable of maintaining vacuum evaporator for carbon coating of fil-
a positive pressure with make-up air being ters.
HEPA filtered. The cumulative analytical j. Carbon rod sharpener. This is used to
blank concentration must average less than sharpen carbon rods to a neck. The use of
18 s/mm2 in an area of 0.057 s/mm2 (nominally necked carbon rods (or equivalent) allows
10 200-mesh grid openings) with no more than the carbon to be applied to the filters with a
one single preparation to exceed 53 s/mm2 for minimum of heating.
that same area. k. Low-temperature plasma asher. This is
3. Preparation areas for air samples must used to etch the surface of collapsed mixed
be separated from preparation areas for bulk cellulose ester (MCE) filters. The asher
samples. Personnel must not prepare air should be supplied with oxygen, and should
samples if they have previously been pre- be modified as necessary to provide a throt-
paring bulk samples without performing ap- tle or bleed valve to control the speed of the
propriate personal hygiene procedures, i.e., vacuum to minimize disturbance of the fil-
clothing change, showering, etc. ter. Some early models of ashers admit air
4. Preparation. Direct preparation tech- too rapidly, which may disturb particulates
niques are required. The objective is to on the surface of the filter during the etch-
produce an intact carbon film containing the ing step.
particulates from the filter surface which is l. Glass petri dishes, 10 cm in diameter, 1 cm
sufficiently clear for TEM analysis. Cur- high. For prevention of excessive evaporation
rently recommended direct preparation proof solvent when these are in use, a good seal
cedures for polycarbonate (PC) and mixed must be provided between the base and the
cellulose ester (MCE) filters are described in lid. The seal can be improved by grinding the
Unit III.F.7. and 8. Sample preparation is a base and lid together with an abrasive grind-
subject requiring additional research. Vari- ing material.
ation on those steps which do not sub- m. Stainless steel mesh.
stantively change the procedure, which im- n. Lens tissue.
prove filter clearing or which reduce con- o. Copper 200-mesh TEM grids, 3 mm in di-
tamination problems in a laboratory are per- ameter, or equivalent.
mitted. p. Gold 200-mesh TEM grids, 3 mm in di-
ameter, or equivalent.
a. Use only TEM grids that have had grid
q. Condensation washer.
opening areas measured according to direc-
r. Carbon-coated, 200-mesh TEM grids, or
tions in Unit III.J.
equivalent.
b. Remove the inlet and outlet plugs prior s. Analytical balance, 0.1 mg sensitivity.
to opening the cassette to minimize any t. Filter paper, 9 cm in diameter.
pressure differential that may be present. u. Oven or slide warmer. Must be capable
c. Examples of techniques used to prepare of maintaining a temperature of 65–70 °C.
polycarbonate filters are described in Unit v. Polyurethane foam, 6 mm thickness.
III.F.7. w. Gold wire for evaporation.
d. Examples of techniques used to prepare
6. Reagents.
mixed cellulose ester filters are described in a. General. A supply of ultra-clean, fiber-
Unit III.F.8. free water must be available for washing of
e. Prepare multiple grids for each sample. all components used in the analysis. Water
325
that has been distilled in glass or filtered or strips on the same microscope slide, taking
deionized water is satisfactory for this pur- care to rinse and wet-wipe the scalpel blade
pose. Reagents must be fiber-free. and tweezers before handling a new sample.
b. Polycarbonate preparation method— The filter strips should be identified by etch-
chloroform. ing the glass slide or marking the slide using
c. Mixed Cellulose Ester (MCE) preparation a marker insoluble in water and solvents.
method—acetone or the Burdette procedure After the filter strip has been cut from each
(Ref. 7 of Unit III.L.). filter, the residual parts of the filter must be
7. TEM specimen preparation from returned to the cassette and held in position
polycarbonate filters. by reassembly of the cassette. The cassette
a. Specimen preparation laboratory. It is will then be archived for a period of 30 days
most important to ensure that contamina- or returned to the client upon request.
tion of TEM specimens by extraneous asbes- e. Carbon coating of filter strips. The glass
tos fibers is minimized during preparation. slide holding the filter strips is placed on the
b. Cleaning of sample cassettes. Upon re- rotation-tilting device, and the evaporator
ceipt at the analytical laboratory and before chamber is evacuated. The evaporation must
they are taken into the clean facility or lam- be performed in very short bursts, separated
inar flow hood, the sample cassettes must be by some seconds to allow the electrodes to
cleaned of any contamination adhering to cool. If evaporation is too rapid, the strips of
the outside surfaces. polycarbonate filter will begin to curl, which
c. Preparation of the carbon evaporator. If will lead to cross-linking of the surface ma-
the polycarbonate filter has already been terial and make it relatively insoluble in
carbon-coated prior to receipt, the carbon chloroform. An experienced analyst can
coating step will be omitted, unless the ana- judge the thickness of carbon film to be ap-
lyst believes the carbon film is too thin. If plied, and some test should be made first on
there is a need to apply more carbon, the fil- unused filters. If the film is too thin, large
ter will be treated in the same way as an particles will be lost from the TEM speci-
uncoated filter. Carbon coating must be per- men, and there will be few complete and
formed with a high-vacuum coating unit. undamaged grid openings on the specimen. If
Units that are based on evaporation of car- the coating is too thick, the filter will tend
bon filaments in a vacuum generated only by to curl when exposed to chloroform vapor
an oil rotary pump have not been evaluated and the carbon film may not adhere to the
for this application, and must not be used. support mesh. Too thick a carbon film will
The carbon rods should be sharpened by a also lead to a TEM image that is lacking in
carbon rod sharpener to necks of about 4 mm contrast, and the ability to obtain ED pat-
long and 1 mm in diameter. The rods are in- terns will be compromised. The carbon film
stalled in the evaporator in such a manner should be as thin as possible and remain in-
that the points are approximately 10 to 12 tact on most of the grid openings of the TEM
cm from the surface of a microscope slide specimen intact.
held in the rotating and tilting device. f. Preparation of the Jaffe washer. The pre-
d. Selection of filter area for carbon coat- cise design of the Jaffe washer is not consid-
ing. Before preparation of the filters, a 75 ered important, so any one of the published
mm × 50 mm microscope slide is washed and designs may be used. A washer consisting of
dried. This slide is used to support strips of a simple stainless steel bridge is rec-
filter during the carbon evaporation. Two ommended. Several pieces of lens tissue ap-
parallel strips of double-sided adhesive tape proximately 1.0 cm × 0.5 cm are placed on the
are applied along the length of the slide. stainless steel bridge, and the washer is
Polycarbonate filters are easily stretched filled with chloroform to a level where the
during handling, and cutting of areas for fur- meniscus contacts the underside of the mesh,
ther preparation must be performed with which results in saturation of the lens tis-
great care. The filter and the MCE backing sue. See References 8 and 10 of Unit III.L.
filter are removed together from the cassette g. Placing of specimens into the Jaffe
and placed on a cleaned glass microscope washer. The TEM grids are first placed on a
slide. The filter can be cut with a curved piece of lens tissue so that individual grids
scalpel blade by rocking the blade from the can be picked up with tweezers. Using a
point placed in contact with the filter. The curved scalpel blade, the analyst excises
process can be repeated to cut a strip ap- three 3 mm square pieces of the carbon-coat-
proximately 3 mm wide across the diameter ed polycarbonate filter from the filter strip.
of the filter. The strip of polycarbonate filter The three squares are selected from the cen-
is separated from the corresponding strip of ter of the strip and from two points between
backing filter and carefully placed so that it the outer periphery of the active surface and
bridges the gap between the adhesive tape the center. The piece of filter is placed on a
strips on the microscope slide. The filter TEM specimen grid with the shiny side of
strip can be held with fine-point tweezers the TEM grid facing upwards, and the whole
and supported underneath by the scalpel assembly is placed boldly onto the saturated
blade during placement on the microscope lens tissue in the Jaffe washer. If carbon-
slide. The analyst can place several such coated grids are used, the filter should be
326
placed carbon-coated side down. The three the conditions that should be used. This is
excised squares of filters are placed on the one area of the method that requires further
same piece of lens tissue. Any number of sep- evaluation. Insufficient etching will result in
arate pieces of lens tissue may be placed in a failure to expose embedded filters, and too
the same Jaffe washer. The lid is then placed much etching may result in loss of particu-
on the Jaffe washer, and the system is al- late from the surface. As an interim meas-
lowed to stand for several hours, preferably ure, it is recommended that the time for
overnight. ashing of a known weight of a collapsed fil-
h. Condensation washing. It has been found ter be established and that the etching rate
that many polycarbonate filters will not dis- be calculated in terms of micrometers per
solve completely in the Jaffe washer, even second. The actual etching time used for a
after being exposed to chloroform for as long particular asher and operating conditions
as 3 days. This problem becomes more seri- will then be set such that a 1–2 μm (10 per-
ous if the surface of the filter was overheated cent) layer of collapsed surface will be re-
during the carbon evaporation. The presence moved.
of undissolved filter medium on the TEM ii. Place the slide containing the collapsed
preparation leads to partial or complete ob- filters into a low-temperature plasma asher,
scuration of areas of the sample, and fibers and etch the filter.
that may be present in these areas of the g. Transfer the slide to a rotating stage in-
specimen will be overlooked; this will lead to side the bell jar of a vacuum evaporator.
a low result. Undissolved filter medium also Evaporate a 1 mm × 5 mm section of graphite
compromises the ability to obtain ED pat- rod onto the cleared filter. Remove the slide
terns. Before they are counted, TEM grids to a clean, dry, covered petri dish.
must be examined critically to determine h. Prepare a second petri dish as a Jaffe
whether they are adequately cleared of resid- washer with the wicking substrate prepared
ual filter medium. It has been found that from filter or lens paper placed on top of a 6
condensation washing of the grids after the mm thick disk of clean spongy polyurethane
initial Jaffe washer treatment, with chloro- foam. Cut a V-notch on the edge of the foam
form as the solvent, clears all residual filter and filter paper. Use the V-notch as a res-
medium in a period of approximately 1 hour. ervoir for adding solvent. The wicking sub-
In practice, the piece of lens tissue sup- strate should be thin enough to fit into the
porting the specimen grids is transferred to petri dish without touching the lid.
the cold finger of the condensation washer, i. Place carbon-coated TEM grids face up
and the washer is operated for about 1 hour. on the filter or lens paper. Label the grids by
If the specimens are cleared satisfactorily by marking with a pencil on the filter paper or
the Jaffe washer alone, the condensation by putting registration marks on the petri
washer step may be unnecessary. dish lid and marking with a waterproof
8. TEM specimen preparation from MCE marker on the dish lid. In a fume hood, fill
filters. the dish with acetone until the wicking sub-
a. This method of preparing TEM speci- strate is saturated. The level of acetone
mens from MCE filters is similar to that should be just high enough to saturate the
specified in NIOSH Method 7402. See Ref- filter paper without creating puddles.
erences 7, 8, and 9 of Unit III.L. j. Remove about a quarter section of the
b. Upon receipt at the analytical labora- carbon-coated filter samples from the glass
tory, the sample cassettes must be cleaned of slides using a surgical knife and tweezers.
any contamination adhering to the outside Carefully place the section of the filter, car-
surfaces before entering the clean sample bon side down, on the appropriately labeled
preparation area. grid in the acetone-saturated petri dish.
c. Remove a section from any quadrant of When all filter sections have been trans-
the sample and blank filters. ferred, slowly add more solvent to the wedge-
d. Place the section on a clean microscope shaped trough to bring the acetone level up
slide. Affix the filter section to the slide to the highest possible level without dis-
with a gummed paged reinforcement or other turbing the sample preparations. Cover the
suitable means. Label the slide with a water petri dish. Elevate one side of the petri dish
and solvent-proof marking pen. by placing a slide under it. This allows drops
e. Place the slide in a petri dish which con- of condensed solvent vapors to form near the
tains several paper filters soaked with 2 to 3 edge rather than in the center where they
mL acetone. Cover the dish. Wait 2 to 4 min- would drip onto the grid preparation.
utes for the sample filter to fuse and clear.
G. TEM Method
f. Plasma etching of the collapsed filter is
required. 1. Instrumentation.
i. The microscope slide to which the col- a. Use an 80–120 kV TEM capable of per-
lapsed filter pieces are attached is placed in forming electron diffraction with a fluores-
a plasma asher. Because plasma ashers vary cent screen inscribed with calibrated grada-
greatly in their performance, both from unit tions. If the TEM is equipped with EDXA it
to unit and between different positions in must either have a STEM attachment or be
the asher chamber, it is difficult to specify capable of producing a spot less than 250 nm
327
in diameter at crossover. The microscope i. Standard replica grating may be used to
shall be calibrated routinely (see Unit III.J.) determine magnification (e.g., 2160 lines/
for magnification and camera constant. mm).
b. While not required on every microscope ii. Gold standard may be used to determine
in the laboratory, the laboratory must have camera constant.
either one microscope equipped with energy c. Use a specimen holder with single tilt
dispersive X-ray analysis or access to an and/or double tilt capabilities.
equivalent system on a TEM in another lab- 2. Procedure.
oratory. This must be an Energy Dispersive a. Start a new Count Sheet for each sample
X-ray Detector mounted on TEM column and to be analyzed. Record on count sheet: ana-
associated hardware/software to collect, lyst’s initials and date; lab sample number;
save, and read out spectral information. client sample number microscope identifica-
Calibration of Multi-Channel Analyzer shall tion; magnification for analysis; number of
be checked regularly for A1 at 1.48 KeV and predetermined grid openings to be analyzed;
Cu at 8.04 KeV, as well as the manufacturer’s and grid identification. See the following
procedures. Figure 4:
328
b. Check that the microscope is properly d. Approximately one-half (0.5) of the pre-
aligned and calibrated according to the man- determined sample area to be analyzed shall
ufacturer’s specifications and instructions. be performed on one sample grid preparation
c. Microscope settings: 80–120 kV, grid as- and the remaining half on a second sample
sessment 250–1000X, then 15,000–20,000X grid preparation.

screen magnification for analysis. e. Determine the suitability of the grid.
329
EC01AP92.011</GPH>
i. Individual grid openings with greater loaded into the microscope and a particular
than 5 percent openings (holes) or covered field is to be reliably identified.
with greater than 25 percent particulate g. Scan the grid.
matter or obviously having nonuniform load- i. Select a field to start the examination.
ing shall not be analyzed. ii. Choose the appropriate magnification
ii. Examine the grid at low magnification (15,000 to 20,000X screen magnification).
(<1000X) to determine its suitability for de- iii. Scan the grid as follows.
tailed study at higher magnifications. (1) At the selected magnification, make a
iii. Reject the grid if: series of parallel traverses across the field.
(1) Less than 50 percent of the grid open- On reaching the end of one traverse, move
ings covered by the replica are intact. the image one window and reverse the tra-
(2) It is doubled or folded. verse.
(3) It is too dark because of incomplete dis- NOTE: A slight overlap should be used so as
solution of the filter. not to miss any part of the grid opening
iv. If the grid is rejected, load the next (field).
sample grid. (2) Make parallel traverses until the entire
v. If the grid is acceptable, continue on to grid opening (field) has been scanned.
Step 6 if mapping is to be used; otherwise h. Identify each structure for appearance
proceed to Step 7. and size.
f. Grid Map (Optional). i. Appearance and size: Any continuous
i. Set the TEM to the low magnification grouping of particles in which an asbestos
mode. fiber within aspect ratio greater than or
ii. Use flat edge or finder grids for map- equal to 5:1 and a length greater than or
ping. equal to 0.5 μm is detected shall be recorded
iii. Index the grid openings (fields) to be on the count sheet. These will be designated
counted by marking the acceptable fields for asbestos structures and will be classified as
one-half (0.5) of the area needed for analysis fibers, bundles, clusters, or matrices. Record
on each of the two grids to be analyzed. as individual fibers any contiguous grouping
These may be marked just before examining having 0, 1, or 2 definable intersections.
each grid opening (field), if desired. Groupings having more than 2 intersections
iv. Draw in any details which will allow are to be described as cluster or matrix. See
the grid to be properly oriented if it is re- the following Figure 5:
330
331
EC01AP92.012</GPH>
An intersection is a non-parallel touching or (1) Fiber. A structure having a minimum

crossing of fibers, with the projection having length greater than 0.5 μm and an aspect
an aspect ratio of 5:1 or greater. Combina- ratio (length to width) of 5:1 or greater and
tions such as a matrix and cluster, matrix substantially parallel sides. Note the appear-
and bundle, or bundle and cluster are cat- ance of the end of the fiber, i.e., whether it
egorized by the dominant fiber quality—clus- is flat, rounded or dovetailed, no intersec-
ter, bundle, and matrix, respectively. Sepa- tions.
rate categories will be maintained for fibers (2) Bundle. A structure composed of 3 or
less than 5 μm and for fibers greater than or more fibers in a parallel arrangement with
each fiber closer than one fiber diameter.
equal to 5 μm in length. Not required, but
(3) Cluster. A structure with fibers in a ran-
useful, may be to record the fiber length in
dom arrangement such that all fibers are

1 μm intervals. (Identify each structure
intermixed and no single fiber is isolated
morphologically and analyze it as it enters from the group; groupings must have more
the ‘‘window’’.) than 2 intersections.
332
EC01AP92.013</GPH>
(4) Matrix. Fiber or fibers with one end free iii. The micrograph number of the recorded
and the other end embedded in or hidden by diffraction patterns must be reported to the
a particulate. The exposed fiber must meet client and maintained in the laboratory’s
the fiber definition. quality assurance records. The records must
(5) NSD. Record NSD when no structures also demonstrate that the identification of
are detected in the field. the pattern has been verified by a qualified
(6) Intersection. Non-parallel touching or individual and that the operator who made
crossing of fibers, with the projection having the identification is maintaining at least an
an aspect ratio 5:1 or greater. 80 percent correct visual identification based
ii. Structure Measurement. on his measured patterns. In the event that
(1) Recognize the structure that is to be examination of the pattern by the qualified
sized. individual indicates that the pattern had
(2) Memorize its location in the ‘‘window’’ been misidentified visually, the client shall
relative to the sides, inscribed square and to be contacted. If the pattern is a suspected
other particulates in the field so this exact chrysotile, take a photograph of the diffrac-
location can be found again when scanning is tion pattern at 0 degrees tilt. If the structure
resumed. is suspected to be amphibole, the sample
(3) Measure the structure using the scale may have to be tilted to obtain a simple geo-
on the screen. metric array of spots.
(4) Record the length category and struc- j. Energy Dispersive X-Ray Analysis
ture type classification on the count sheet (EDXA).
after the field number and fiber number. i. Required of all amphiboles which would
(5) Return the fiber to its original location cause the analysis results to exceed the 70 s/
in the window and scan the rest of the field mm2 concentration. (Generally speaking, the
for other fibers; if the direction of travel is first 4 amphiboles would require EDXA.)
not remembered, return to the right side of ii. Can be used alone to confirm chrysotile
the field and begin the traverse again. after the 70 s/mm2 concentration has been ex-
i. Visual identification of Electron Diffrac- ceeded.
tion (ED) patterns is required for each asbes- iii. Can be used alone to confirm all non-
tos structure counted which would cause the asbestos.
analysis to exceed the 70 s/mm2 concentra- iv. Compare spectrum profiles with profiles
tion. (Generally this means the first four fi- obtained from asbestos standards. The clos-
bers identified as asbestos must exhibit an est match identifies and categorizes the
identifiable diffraction pattern for chrysotile structure.
or amphibole.) v. If the EDXA is used for confirmation,
i. Center the structure, focus, and obtain record the properly labeled spectrum on a
an ED pattern. (See Microscope Instruction computer disk, or if a hard copy, file with
Manual for more detailed instructions.) analysis data.
ii. From a visual examination of the ED vi. If the number of fibers in the non-
pattern, obtained with a short camera asbestos class would cause the analysis to
length, classify the observed structure as be- exceed the 70 s/mm2 concentration, their
longing to one of the following classifica- identities must be confirmed by EDXA or
tions: chrysotile, amphibole, or nonasbestos. measurement of a zone axis diffraction pat-
(1) Chrysotile: The chrysotile asbestos pattern to establish that the particles are non-
tern has characteristic streaks on the layer asbestos.
lines other than the central line and some k. Stopping Rules.
streaking also on the central line. There will i. If more than 50 asbestiform structures
be spots of normal sharpness on the central are counted in a particular grid opening, the
layer line and on alternate lines (2nd, 4th, analysis may be terminated.
etc.). The repeat distance between layer lines ii. After having counted 50 asbestiform
is 0.53 nm and the center doublet is at 0.73 structures in a minimum of 4 grid openings,
nm. The pattern should display (002), (110), the analysis may be terminated. The grid
(130) diffraction maxima; distances and ge- opening in which the 50th fiber was counted
ometry should match a chrysotile pattern must be completed.
and be measured semiquantitatively. iii. For blank samples, the analysis is al-
(2) Amphibole Group [includes grunerite ways continued until 10 grid openings have
(amosite), crocidolite, anthophyllite, been analyzed.
tremolite, and actinolite]: Amphibole asbes- iv. In all other samples the analysis shall
tos fiber patterns show layer lines formed by be continued until an analytical sensitivity
very closely spaced dots, and the repeat dis- of 0.005 s/cm3 is reached.
tance between layer lines is also about 0.53 l. Recording Rules. The count sheet should
nm. Streaking in layer lines is occasionally contain the following information:
present due to crystal structure defects. i. Field (grid opening): List field number.
(3) Nonasbestos: Incomplete or ii. Record ‘‘NSD’’ if no structures are de-
unobtainable ED patterns, a nonasbestos tected.
EDXA, or a nonasbestos morphology. iii. Structure information.
333
(1) If fibers, bundles, clusters, and/or mat- from the group. Groupings must have more
rices are found, list them in consecutive nu- than two intersections.
merical order, starting over with each field. iv. Matrix. Fiber or fibers with one end free
(2) Length. Record length category of as- and the other end embedded in or hidden by
bestos fibers examined. Indicate if less than a particulate. The exposed fiber must meet
5 μm or greater than or equal to 5 μm. the fiber definition.
(3) Structure Type. Positive identification v. NSD. Record NSD when no structures
of asbestos fibers is required by the method. are detected in the field.
At least one diffraction pattern of each fiber n. After all necessary analyses of a particle
type from every five samples must be re- structure have been completed, return the
corded and compared with a standard diffrac- goniometer stage to 0 degrees, and return
tion pattern. For each asbestos fiber re- the structure to its original location by re-
ported, both a morphological descriptor and call of the original location.
an identification descriptor shall be specified
o. Continue scanning until all the struc-
on the count sheet.
tures are identified, classified and sized in
(4) Fibers classified as chrysotile must be
the field.
identified by diffraction and/or X-ray anal-
p. Select additional fields (grid openings)
ysis and recorded on the count sheet. X-ray
analysis alone can be used as sole identifica- at low magnification; scan at a chosen mag-
tion only after 70s/mm2 have been exceeded nification (15,000 to 20,000X screen magnifica-
for a particular sample. tion); and analyze until the stopping rule be-
(5) Fibers classified as amphiboles must be comes applicable.
identified by X-ray analysis and electron dif- q. Carefully record all data as they are
fraction and recorded on the count sheet. (X- being collected, and check for accuracy.
ray analysis alone can be used as sole identi- r. After finishing with a grid, remove it
fication only after 70s/mm2 have been exceed- from the microscope, and replace it in the
ed for a particular sample.) appropriate grid hold. Sample grids must be
(6) If a diffraction pattern was recorded on stored for a minimum of 1 year from the date
film, the micrograph number must be indi- of the analysis; the sample cassette must be
cated on the count sheet. retained for a minimum of 30 days by the
(7) If an electron diffraction was attempted laboratory or returned at the client’s re-
and an appropriate spectra is not observed, N quest.
should be recorded on the count sheet.
(8) If an X-ray analysis is attempted but H. Sample Analytical Sequence
not observed, N should be recorded on the 1. Carry out visual inspection of work site
count sheet. prior to air monitoring.
(9) If an X-ray analysis spectrum is stored, 2. Collect a minimum of five air samples
the file and disk number must be recorded on inside the work site and five samples outside
the count sheet. the work site. The indoor and outdoor sam-
m. Classification Rules. ples shall be taken during the same time pe-
i. Fiber. A structure having a minimum riod.
length greater than or equal to 0.5 μm and an
3. Analyze the abatement area samples ac-
aspect ratio (length to width) of 5:1 or great-
cording to this protocol. The analysis must
er and substantially parallel sides. Note the
meet the 0.005 s/cm3 analytical sensitivity.
appearance of the end of the fiber, i.e.,
whether it is flat, rounded or dovetailed. 4. Remaining steps in the analytical se-
ii. Bundle. A structure composed of three quence are contained in Unit IV. of this Ap-
or more fibers in a parallel arrangement pendix.
with each fiber closer than one fiber diame- I. Reporting
ter.
iii. Cluster. A structure with fibers in a The following information must be re-
random arrangement such that all fibers are ported to the client. See the following Table
intermixed and no single fiber is isolated II:
334
1. Concentration in structures per square 5. Volume of air samples (which was ini-
millimeter and structures per cubic centi- tially provided by client).
meter. 6. Average grid size opening.
2. Analytical sensitivity used for the anal- 7. Number of grids analyzed.

ysis. 8. Copy of the count sheet must be included
3. Number of asbestos structures. with the report.
4. Area analyzed.
335
EC01AP92.014</GPH>
9. Signature of laboratory official to indi- calculation. On most microscopes, however,
cate that the laboratory met specifications the magnification is substantially constant
of the AHERA method. only within the central 8–10 cm diameter re-
10. Report form must contain official lab- gion of the fluorescent screen.
oratory identification (e.g., letterhead). iv. Calculate the true magnification (M) on
11. Type of asbestos. the fluorescent screen:
M = XG/Y
J. Calibration Methodology
where:
NOTE: Appropriate implementation of the
X = total distance (mm) between the des-
method requires a person knowledgeable in
ignated grating lines;
electron diffraction and mineral identifica-
G = calibration constant of the grating rep-
tion by ED and EDXA. Those inexperienced
lica (lines/mm):
laboratories wishing to develop capabilities
Y = number of grating replica spaces counted
may acquire necessary knowledge through
along X.
analysis of appropriate standards and by fol-
lowing detailed methods as described in Ref- c. Calibration of the EDXA System. Ini-
erences 8 and 10 of Unit III.L. tially, the EDXA system must be calibrated
1. Equipment Calibration. In this method, by using two reference elements to calibrate
calibration is required for the air-sampling the energy scale of the instrument. When
equipment and the transmission electron mi- this has been completed in accordance with
croscope (TEM). the manufacturer’s instructions, calibration
a. TEM Magnification. The magnification at in terms of the different types of asbestos
the fluorescent screen of the TEM must be can proceed. The EDXA detectors vary in
calibrated at the grid opening magnification both solid angle of detection and in window
(if used) and also at the magnification used thickness. Therefore, at a particular accel-
for fiber counting. This is performed with a erating voltage in use on the TEM, the count
cross grating replica. A logbook must be rate obtained from specific dimensions of
maintained, and the dates of calibration de- fiber will vary both in absolute X-ray count
pend on the past history of the particular rate and in the relative X-ray peak heights
microscope; no frequency is specified. After for different elements. Only a few minerals
any maintenance of the microscope that in- are relevant for asbestos abatement work,
volved adjustment of the power supplied to and in this procedure the calibration is spec-
the lenses or the high-voltage system or the ified in terms of a ‘‘fingerprint’’ technique.
mechanical disassembly of the electron opti- The EDXA spectra must be recorded from in-
cal column apart from filament exchange, dividual fibers of the relevant minerals, and
the magnification must be recalibrated. Be- identifications are made on the basis of
fore the TEM calibration is performed, the semiquantitative comparisons with these
analyst must ensure that the cross grating reference spectra.
replica is placed at the same distance from d. Calibration of Grid Openings.
the objective lens as the specimens are. For i. Measure 20 grid openings on each of 20
instruments that incorporate an eucentric random 200-mesh copper grids by placing a
tilting specimen stage, all speciments and grid on a glass slide and examining it under
the cross grating replica must be placed at the PCM. Use a calibrated graticule to meas-
the eucentric position. ure the average field diameter and use this
b. Determination of the TEM magnifica- number to calculate the field area for an av-
tion on the fluorescent screen. erage grid opening. Grids are to be randomly
i. Define a field of view on the fluorescent selected from batches up to 1,000.
screen either by markings or physical bound- NOTE: A grid opening is considered as one
aries. The field of view must be measurable field.
or previously inscribed with a scale or con- ii. The mean grid opening area must be
centric circles (all scales should be metric). measured for the type of specimen grids in
ii. Insert a diffraction grating replica (for use. This can be accomplished on the TEM at
example a grating containing 2,160 lines/mm) a properly calibrated low magnification or
into the specimen holder and place into the on an optical microscope at a magnification
microscope. Orient the replica so that the of approximately 400X by using an eyepiece
grating lines fall perpendicular to the scale fitted with a scale that has been calibrated
on the TEM fluorescent screen. Ensure that against a stage micrometer. Optical micros-
the goniometer stage tilt is 0 degrees. copy utilizing manual or automated proce-
iii. Adjust microscope magnification to dures may be used providing instrument cali-
10,000X or 20,000X. Measure the distance bration can be verified.
(mm) between two widely separated lines on e. Determination of Camera Constant and
the grating replica. Note the number of ED Pattern Analysis.
spaces between the lines. Take care to meas- i. The camera length of the TEM in ED op-
ure between the same relative positions on erating mode must be calibrated before ED
the lines (e.g., between left edges of lines). patterns on unknown samples are observed.
NOTE: The more spaces included in the This can be achieved by using a carbon-coat-
measurement, the more accurate the final ed grid on which a thin film of gold has been
336
sputtered or evaporated. A thin film of gold pling and analysis procedures. Because the
is evaporated on the specimen TEM grid to test is sensitive, it may be influenced by a
obtain zone-axis ED patterns superimposed variety of factors. These include the supplies
with a ring pattern from the polycrystalline used in the sampling operation, the perform-
gold film. ance of the sampling, the preparation of the
ii. In practice, it is desirable to optimize grid from the filter and the actual examina-
the thickness of the gold film so that only tion of this grid in the microscope. Each of
one or two sharp rings are obtained on the
these unit operations must produce a prod-
superimposed ED pattern. Thicker gold film
uct of defined quality if the analytical result
would normally give multiple gold rings, but
it will tend to mask weaker diffraction spots is to be a reliable and meaningful test result.
from the unknown fibrous particulates. Accordingly, a series of control checks and
Since the unknown d-spacings of most inter- reference standards is performed along with
est in asbestos analysis are those which lie the sample analysis as indicators that the
closest to the transmitted beam, multiple materials used are adequate and the oper-
gold rings are unnecessary on zone-axis ED ations are within acceptable limits. In this
patterns. An average camera constant using way, the quality of the data is defined and
multiple gold rings can be determined. The the results are of known value. These checks
camera constant is one-half the diameter, D, and tests also provide timely and specific
of the rings times the interplanar spacing, d, warning of any problems which might de-
of the ring being measured. velop within the sampling and analysis oper-
ations. A description of these quality con-
K. Quality Control/Quality Assurance
Procedures (Data Quality Indicators) trol/quality assurance procedures is summa-
rized in the following Table III:
Monitoring the environment for airborne
asbestos requires the use of sensitive sam-
337
1. When the samples arrive at the labora- 5. Provide laboratory blanks with each
tory, check the samples and documentation sample batch. Maintain a cumulative aver-
for completeness and requirements before age of these results. If this average is greater
initiating the analysis. than 53 f/mm2 per 10 200-mesh grid openings,
2. Check all laboratory reagents and sup- check the system for possible sources of con-
plies for acceptable asbestos background lev- tamination.
els. 6. Check for recovery of asbestos from cel-
3. Conduct all sample preparation in a lulose ester filters submitted to plasma
clean room environment monitored by lab- asher.
oratory blanks and special testing after 7. Check for asbestos carryover in the plas-
cleaning or servicing the room. ma asher by including a blank alongside the

4. Prepare multiple grids of each sample. positive control sample.
338
EC01AP92.015</MATH>
8. Perform a systems check on the trans- tron Microscopy Using Polycarbonate Mem-
mission electron microscope daily. brane Filters.’’ WERL SOP 87–1, March 5,
9. Make periodic performance checks of 1987.
magnification, electron diffraction and en- 9. NIOSH. Method 7402 for Asbestos Fibers,
ergy dispersive X-ray systems as set forth in December 11, 1986 Draft.
Table III of Unit III.K. 10. Yamate, G., S.C. Agarwall, R.D. Gib-
10. Ensure qualified operator performance bons, IIT Research Institute, ‘‘Methodology
by evaluation of replicate counting, dupli- for the Measurement of Airborne Asbestos by
cate analysis, and standard sample compari- Electron Microscopy.’’ Draft report, USEPA
sons as set forth in Table III of Unit III.K. Contract 68–02–3266, July 1984.
11. Validate all data entries. 11. Guidance to the Preparation of Quality
12. Recalculate a percentage of all com- Assurance Project Plans. USEPA, Office of
putations and automatic data reduction Pollution Prevention and Toxics, 1984.
steps as specified in Table III.
13. Record an electron diffraction pattern IV. Mandatory Interpretation of Transmission
of one asbestos structure from every five Electron Microscopy Results To Determine
samples that contain asbestos. Verify the Completion of Response Actions
identification of the pattern by measure- A. Introduction
ment or comparison of the pattern with pat-
terns collected from standards under the A response action is determined to be com-
same conditions. pleted by TEM when the abatement area has
been cleaned and the airborne asbestos con-
The outline of quality control procedures
centration inside the abatement area is no
presented above is viewed as the minimum
higher than concentrations at locations out-
required to assure that quality data is pro-
side the abatement area. ‘‘Outside’’ means
duced for clearance testing of an asbestos
outside the abatement area, but not nec-
abated area. Additional information may be
essarily outside the building. EPA reasons
gained by other control tests. Specifics on
that an asbestos removal contractor cannot
those control procedures and options avail- be expected to clean an abatement area to an
able for environmental testing can be ob- airborne asbestos concentration that is
tained by consulting References 6, 7, and 11 lower than the concentration of air entering
of Unit III.L. the abatement area from outdoors or from
L. References other parts of the building. After the abate-
ment area has passed a thorough visual in-
For additional background information on spection, and before the outer containment
this method the following references should barrier is removed, a minimum of five air
be consulted. samples inside the abatement area and a
1. ‘‘Guidelines for Controlling Asbestos- minimum of five air samples outside the
Containing Materials in Buildings,’’ EPA 560/ abatement area must be collected. Hence,
5–85–024, June 1985. the response action is determined to be com-
2. ‘‘Measuring Airborne Asbestos Following pleted when the average airborne asbestos
an Abatement Action,’’ USEP/Office of Pol- concentration measured inside the abate-
lution Prevention and Toxics, EPA 600/4–85– ment area is not statistically different from
049, 1985. the average airborne asbestos concentration
3. Small, John and E. Steel. Asbestos measured outside the abatement area.
Standards: Materials and Analytical Meth- The inside and outside concentrations are
ods. N.B.S. Special Publication 619, 1982. compared by the Z-test, a statistical test
4. Campbell, W.J., R.L. Blake, L.L. Brown, that takes into account the variability in
E.E. Cather, and J.J. Sjoberg. Selected Sili- the measurement process. A minimum of
cate Minerals and Their Asbestiform Vari- five samples inside the abatement area and
eties. Information Circular 8751, U.S. Bureau five samples outside the abatement area are
of Mines, 1977. required to control the false negative error
5. Quality Assurance Handbook for Air Pol- rate, i.e., the probability of declaring the re-
lution Measurement System. Ambient Air moval complete when, in fact, the air con-
Methods, EPA 600/4–77–027a, USEPA, Office of centration inside the abatement area is sig-
Research and Development, 1977. nificantly higher than outside the abatement
6. Method 2A: Direct Measurement of Gas area. Additional quality control is provided
Volume Through Pipes and Small Ducts. 40 by requiring three blanks (filters through
CFR Part 60 Appendix A. which no air has been drawn) to be analyzed
7. Burdette, G.J. Health & Safety Exec., to check for unusually high filter contami-
Research & Lab. Services Div., London, nation that would distort the test results.
‘‘Proposed Analytical Method for Determina- When volumes greater than or equal to
tion of Asbestos in Air.’’ 1,199 L for a 25 mm filter and 2,799 L for a 37
8. Chatfield, E.J., Chatfield Tech. Cons., mm filter have been collected and the aver-
Ltd., Clark, T., PEI Assoc. ‘‘Standard Oper- age number of asbestos structures on sam-
ating Procedure for Determination of Air- ples inside the abatement area is no greater
borne Asbestos Fibers by Transmission Elec- than 70 s/mm 2 of filter, the response action
339
may be considered complete without com- centration on the blank filters that is less
paring the inside samples to the outside sam- than or equal to 70 s/mm 2 and the average
ples. EPA is permitting this initial screening airborne asbestos concentration measured
test to save analysis costs in situations inside the abatement area is not statistically
where the airborne asbestos concentration is higher than the average airborne asbestos
sufficiently low so that it cannot be distin- concentration measured outside the abate-
guished from the filter contamination/back- ment area as determined by the Z-test. The
ground level (fibers deposited on the filter Z-test is carried out by calculating
that are unrelated to the air being sampled).
The screening test cannot be used when vol-
umes of less than 1,199 L for 25 mm filter or
2,799 L for a 37 mm filter are collected be-
cause the ability to distinguish levels sig-
nificantly different from filter background is
reduced at low volumes.
The initial screening test is expressed in where YI is the average of the natural loga-
structures per square millimeter of filter be- rithms of the inside samples and YO is the
cause filter background levels come from average of the natural logarithms of the out-
sources other than the air being sampled and side samples, nI is the number of inside sam-
cannot be meaningfully expressed as a con- ples and nO is the number of outside samples.
centration per cubic centimeter of air. The The response action is considered complete if
value of 70 s/mm 2 is based on the experience Z is less than or equal to 1.65.
of the panel of microscopists who consider NOTE: When no fibers are counted, the cal-
one structure in 10 grid openings (each grid culated detection limit for that analysis is
opening with an area of 0.0057 mm 2) to be inserted for the concentration.
comparable with contamination/background
2. If the abatement site does not satisfy ei-
levels of blank filters. The decision is based,
ther (1) or (2) of this Section C, the site must
in part, on Poisson statistics which indicate
be recleaned and a new set of samples col-
that four structures must be counted on a
lected.
filter before the fiber count is statistically
distinguishable from the count for one struc- D. Sequence for Analyzing Samples
ture. As more information on the perform-
ance of the method is collected, this cri- It is possible to determine completion of
terion may be modified. Since different com- the response action without analyzing all
binations of the number and size of grid samples. Also, at any point in the process, a
openings are permitted under the TEM pro- decision may be made to terminate the anal-
tocol, the criterion is expressed in structures ysis of existing samples, reclean the abate-
per square millimeter of filter to be con- ment site, and collect a new set of samples.
sistent across all combinations. Four struc- The following sequence is outlined to mini-
tures per 10 grid openings corresponds to ap- mize the number of analyses needed to reach
proximately 70 s/mm2. a decision.
1. Analyze the inside samples.
B. Sample Collection and Analysis 2. If at least 1,199 L of air for a 25 mm filter
1. A minimum of 13 samples is required: or 2,799 L of air for a 37 mm filter is collected
five samples collected inside the abatement for each inside sample and the arithmetic
area, five samples collected outside the mean concentration of structures per square
abatement area, two field blanks, and one millimeter of filter is less than or equal to 70
sealed blank. s/mm 2, the response action is complete and
2. Sampling and TEM analysis must be no further analysis is needed.
done according to either the mandatory or 3. If less than 1,199 L of air for a 25 mm fil-
nonmandatory protocols in Appendix A. At ter or 2,799 L of air for a 37 mm filter is col-
least 0.057 mm2 of filter must be examined on lected for any of the inside samples, or the
blank filters. arithmetic mean concentration of structures
per square millimeter of filter is greater
C. Interpretation of Results than 70 s/mm 2, analyze the three blanks.
1. The response action shall be considered 4. If the arithmetic mean concentration of
complete if either: structures per square millimeter on the
a. Each sample collected inside the abate- blank filters is greater than 70 s/mm 2, termi-
ment area consists of at least 1,199 L of air nate the analysis, identify and correct the
for a 25 mm filter, or 2,799 L of air for a 37 source of blank contamination, and collect a
mm filter, and the arithmetic mean of their new set of samples.
asbestos structure concentrations per square 5. If the arithmetic mean concentration of
millimeter of filter is less than or equal to 70 structures per square millimeter on the
s/mm 2; or blank filters is less than or equal to 70 s/
b. The three blank samples have an arith- mm2, analyze the outside samples and per-
metic mean of the asbestos structure conform the Z-test.
340
EC01AP92.016</MATH>
Environmental Protection Agency Pt. 763, Subpt. E, App. C
6. If the Z-statistic is less than or equal to compliance with applicable statutes or regu-
1.65, the response action is complete. If the lations; or
Z-statistic is greater than 1.65, reclean the c. visual inspections of the type described
abatement site and collect a new set of sam- in 40 CFR 763.90(i) solely for the purpose of
ples. determining completion of response actions.
[52 FR 41857, Oct. 30, 1987] 4. ‘‘Major fiber release episode’’ means any
uncontrolled or unintentional disturbance of
APPENDIX B TO SUBPART E OF PART 763 ACBM, resulting in a visible emission, which
involves the falling or dislodging of more
[RESERVED]
than 3 square or linear feet of friable ACBM.
APPENDIX C TO SUBPART E OF PART 5. ‘‘Minor fiber release episode’’ means any
uncontrolled or unintentional disturbance of
763—ASBESTOS MODEL ACCREDITA- ACBM, resulting in a visible emission, which
TION PLAN involves the falling or dislodging of 3 square
I. Asbestos Model Accreditation Plan for States or linear feet or less of friable ACBM.
6. ‘‘Public and commercial building’’
The Asbestos Model Accreditation Plan means the interior space of any building
(MAP) for States has eight components: which is not a school building, except that
(A) Definitions the term does not include any residential
(B) Initial Training apartment building of fewer than 10 units or
(C) Examinations detached single-family homes. The term in-
(D) Continuing Education cludes, but is not limited to: industrial and
(E) Qualifications office buildings, residential apartment build-
(F) Recordkeeping Requirements for Train- ings and condominiums of 10 or more dwell-
ing Providers ing units, government-owned buildings, col-
(G) Deaccreditation leges, museums, airports, hospitals, church-
(H) Reciprocity es, preschools, stores, warehouses and fac-
(I) Electronic reporting
tories. Interior space includes exterior hall-
A. Definitions
ways connecting buildings, porticos, and me-
For purposes of Appendix C:
chanical systems used to condition interior
1. ‘‘Friable asbestos-containing material
space.
(ACM)’’ means any material containing more
than one percent asbestos which has been ap- 7. ‘‘Response action’’ means a method, in-
plied on ceilings, walls, structural members, cluding removal, encapsulation, enclosure,
piping, duct work, or any other part of a repair, and operation and maintenance, that
building, which when dry, may be crumbled, protects human health and the environment
pulverized, or reduced to powder by hand from friable ACBM.
pressure. The term includes non-friable as- 8. ‘‘Small-scale, short-duration activities
bestos-containing material after such pre- (SSSD)’’ are tasks such as, but not limited
viously non-friable material becomes dam- to:
aged to the extent that when dry it may be a. Removal of asbestos-containing insula-
crumbled, pulverized, or reduced to powder tion on pipes.
by hand pressure. b. Removal of small quantities of asbestos-
2. ‘‘Friable asbestos-containing building containing insulation on beams or above
material (ACBM)’’ means any friable ACM ceilings.
that is in or on interior structural members c. Replacement of an asbestos-containing
or other parts of a school or public and com- gasket on a valve.
mercial building. d. Installation or removal of a small sec-
3. ‘‘Inspection’’ means an activity under- tion of drywall.
taken in a school building, or a public and e. Installation of electrical conduits
commercial building, to determine the pres- through or proximate to asbestos-containing
ence or location, or to assess the condition materials.
of, friable or non-friable asbestos-containing SSSD can be further defined by the fol-
building material (ACBM) or suspected lowing considerations:
ACBM, whether by visual or physical exam- f. Removal of small quantities of ACM only
ination, or by collecting samples of such ma- if required in the performance of another
terial. This term includes reinspections of maintenance activity not intended as asbes-
friable and non-friable known or assumed tos abatement.
ACBM which has been previously identified. g. Removal of asbestos-containing thermal
The term does not include the following: system insulation not to exceed amounts
a. Periodic surveillance of the type de- greater than those which can be contained in
scribed in 40 CFR 763.92(b) solely for the pur- a single glove bag.
pose of recording or reporting a change in h. Minor repairs to damaged thermal sys-
the condition of known or assumed ACBM; tem insulation which do not require re-
b. Inspections performed by employees or moval.
agents of Federal, State, or local govern- i. Repairs to a piece of asbestos-containing
ment solely for the purpose of determining wallboard.
341
Pt. 763, Subpt. E, App. C 40 CFR Ch. I (7–1–17 Edition)
j. Repairs, involving encapsulation, enclo- seeking accreditation in any of the five ac-
sure, or removal, to small amounts of friable credited MAP disciplines cannot attend two
ACM only if required in the performance of or more courses concurrently, but may at-
emergency or routine maintenance activity tend such courses sequentially.
and not intended solely as asbestos abate- In several instances, initial training
ment. Such work may not exceed amounts courses for a specific discipline (e.g., work-
greater than those which can be contained in ers, inspectors) require hands-on training.
a single prefabricated mini-enclosure. Such For asbestos abatement contractor/super-
an enclosure shall conform spatially and geo- visors and workers, hands-on training should
metrically to the localized work area, in include working with asbestos-substitute
order to perform its intended containment materials, fitting and using respirators, use
function. of glovebags, donning protective clothing,
B. Initial Training and constructing a decontamination unit as
well as other abatement work activities.
Training requirements for purposes of ac-
creditation are specified both in terms of re- 1. WORKERS
quired subjects of instruction and in terms of
length of training. Each initial training A person must be accredited as a worker to
course has a prescribed curriculum and num- carry out any of the following activities with
ber of days of training. One day of training respect to friable ACBM in a school or public
equals 8 hours, including breaks and lunch. and commercial building: (1) A response ac-
Course instruction must be provided by EPA tion other than a SSSD activity, (2) a main-
or State-approved instructors. EPA or State tenance activity that disturbs friable ACBM
instructor approval shall be based upon a re- other than a SSSD activity, or (3) a response
view of the instructor’s academic credentials action for a major fiber release episode. All
and/or field experience in asbestos abate- persons seeking accreditation as asbestos
ment. abatement workers shall complete at least a
Beyond the initial training requirements, 4–day training course as outlined below. The
individual States may wish to consider re- 4–day worker training course shall include
quiring additional days of training for pur- lectures, demonstrations, at least 14 hours of
poses of supplementing hands-on activities hands-on training, individual respirator fit
or for reviewing relevant state regulations. testing, course review, and an examination.
States also may wish to consider the relative Hands-on training must permit workers to
merits of a worker apprenticeship program. have actual experience performing tasks as-
Further, they might consider more stringent sociated with asbestos abatement. A person
minimum qualification standards for the ap- who is otherwise accredited as a contractor/
proval of training instructors. EPA rec- supervisor may perform in the role of a
ommends that the enrollment in any given worker without possessing separate accredi-
course be limited to 25 students so that ade- tation as a worker.
quate opportunities exist for individual Because of cultural diversity associated
hands-on experience. with the asbestos workforce, EPA rec-
States have the option to provide initial ommends that States adopt specific stand-
training directly or approve other entities to ards for the approval of foreign language
offer training. The following requirements courses for abatement workers. EPA further
are for the initial training of persons re- recommends the use of audio-visual mate-
quired to have accreditation under TSCA rials to complement lectures, where appro-
Title II. priate.
Training requirements for each of the five
The training course shall adequately ad-
accredited disciplines are outlined below.
dress the following topics:
Persons in each discipline perform a dif-
ferent job function and distinct role. Inspec- (a) Physical characteristics of asbestos. Iden-
tors identify and assess the condition of tification of asbestos, aerodynamic charac-
ACBM, or suspect ACBM. Management plan- teristics, typical uses, and physical appear-
ners use data gathered by inspectors to as- ance, and a summary of abatement control
sess the degree of hazard posed by ACBM in options.
schools to determine the scope and timing of (b) Potential health effects related to asbestos
appropriate response actions needed for exposure. The nature of asbestos-related dis-
schools. Project designers determine how as- eases; routes of exposure; dose-response rela-
bestos abatement work should be conducted. tionships and the lack of a safe exposure
Lastly, workers and contractor/supervisors level; the synergistic effect between ciga-
carry out and oversee abatement work. In rette smoking and asbestos exposure; the la-
addition, a recommended training cur- tency periods for asbestos-related diseases; a
riculum is also presented for a sixth dis- discussion of the relationship of asbestos ex-
posure to asbestosis, lung cancer, mesothe-
cipline, which is not federally-accredited,

that of ‘‘Project Monitor.’’ Each accredited lioma, and cancers of other organs.
discipline and training curriculum is sepa- (c) Employee personal protective equipment.
rate and distinct from the others. A person Classes and characteristics of respirator
342
types; limitations of respirators; proper se- 2. CONTRACTOR/SUPERVISORS
lection, inspection; donning, use, mainte- A person must be accredited as a con-
nance, and storage procedures for res- tractor/supervisor to supervise any of the
pirators; methods for field testing of the following activities with respect to friable
facepiece-to-face seal (positive and negative- ACBM in a school or public and commercial
pressure fit checks); qualitative and quan- building: (1) A response action other than a
titative fit testing procedures; variability SSSD activity, (2) a maintenance activity
between field and laboratory protection fac- that disturbs friable ACBM other than a
tors that alter respiratory fit (e.g., facial SSSD activity, or (3) a response action for a
hair); the components of a proper respiratory major fiber release episode. All persons seek-
protection program; selection and use of per- ing accreditation as asbestos abatement con-
sonal protective clothing; use, storage, and tractor/supervisors shall complete at least a
handling of non-disposable clothing; and reg- 5–day training course as outlined below. The
ulations covering personal protective equip- training course must include lectures, dem-
ment. onstrations, at least 14 hours of hands-on
(d) State-of-the-art work practices. Proper training, individual respirator fit testing,
work practices for asbestos abatement ac- course review, and a written examination.
tivities, including descriptions of proper con- Hands-on training must permit supervisors
struction; maintenance of barriers and de- to have actual experience performing tasks
contamination enclosure systems; posi- associated with asbestos abatement.
tioning of warning signs; lock-out of elec- EPA recommends the use of audiovisual
trical and ventilation systems; proper work- materials to complement lectures, where ap-
ing techniques for minimizing fiber release; propriate.
use of wet methods; use of negative pressure Asbestos abatement supervisors include
those persons who provide supervision and
exhaust ventilation equipment; use of high-
direction to workers performing response ac-
efficiency particulate air (HEPA) vacuums;
tions. Supervisors may include those individ-
proper clean-up and disposal procedures;
uals with the position title of foreman,
work practices for removal, encapsulation,
working foreman, or leadman pursuant to
enclosure, and repair of ACM; emergency
collective bargaining agreements. At least
procedures for sudden releases; potential ex- one supervisor is required to be at the work-
posure situations; transport and disposal site at all times while response actions are
procedures; and recommended and prohibited being conducted. Asbestos workers must
work practices. have access to accredited supervisors
(e) Personal hygiene. Entry and exit proce- throughout the duration of the project.
dures for the work area; use of showers; The contractor/supervisor training course
avoidance of eating, drinking, smoking, and shall adequately address the following top-
chewing (gum or tobacco) in the work area; ics:
and potential exposures, such as family expo- (a) The physical characteristics of asbestos
sure. and asbestos-containing materials. Identifica-
(f) Additional safety hazards. Hazards en- tion of asbestos, aerodynamic characteris-
countered during abatement activities and tics, typical uses, physical appearance, a re-
how to deal with them, including electrical view of hazard assessment considerations,
hazards, heat stress, air contaminants other and a summary of abatement control op-
than asbestos, fire and explosion hazards, tions.
scaffold and ladder hazards, slips, trips, and (b) Potential health effects related to asbestos
falls, and confined spaces. exposure. The nature of asbestos-related dis-
(g) Medical monitoring. OSHA and EPA eases; routes of exposure; dose-response rela-
Worker Protection Rule requirements for tionships and the lack of a safe exposure
physical examinations, including a pul- level; synergism between cigarette smoking
monary function test, chest X-rays, and a and asbestos exposure; and latency period for
medical history for each employee. diseases.
(c) Employee personal protective equipment.
(h) Air monitoring. Procedures to determine
Classes and characteristics of respirator
airborne concentrations of asbestos fibers,
types; limitations of respirators; proper se-
focusing on how personal air sampling is per-
lection, inspection, donning, use, mainte-
formed and the reasons for it.
nance, and storage procedures for res-
(i) Relevant Federal, State, and local regu- pirators; methods for field testing of the
latory requirements, procedures, and standards. facepiece-to-face seal (positive and negative-
With particular attention directed at rel- pressure fit checks); qualitative and quan-
evant EPA, OSHA, and State regulations titative fit testing procedures; variability
concerning asbestos abatement workers. between field and laboratory protection fac-
(j) Establishment of respiratory protection
tors that alter respiratory fit (e.g., facial

programs. hair); the components of a proper respiratory
(k) Course review. A review of key aspects protection program; selection and use of per-
of the training course. sonal protective clothing; and use, storage,
343
and handling of non-disposable clothing; and (iv) OSHA Asbestos Construction Standard
regulations covering personal protective (29 CFR 1926.58). (v)EPA Worker Protection
equipment. Rule, (40 CFR part 763, subpart G).
(d) State-of-the-art work practices. Proper (j) Respiratory Protection Programs and Med-
work practices for asbestos abatement ac- ical Monitoring Programs.
tivities, including descriptions of proper con- (k) Insurance and liability issues. Contractor
struction and maintenance of barriers and issues; worker’s compensation coverage and
decontamination enclosure systems; posi- exclusions; third-party liabilities and de-
tioning of warning signs; lock-out of elec- fenses; insurance coverage and exclusions.
trical and ventilation systems; proper work- (l) Recordkeeping for asbestos abatement
ing techniques for minimizing fiber release; projects. Records required by Federal, State,
use of wet methods; use of negative pressure and local regulations; records recommended
exhaust ventilation equipment; use of HEPA for legal and insurance purposes.
vacuums; and proper clean-up and disposal (m) Supervisory techniques for asbestos abate-
procedures. Work practices for removal, en- ment activities. Supervisory practices to en-
capsulation, enclosure, and repair of ACM; force and reinforce the required work prac-
emergency procedures for unplanned re- tices and discourage unsafe work practices.
leases; potential exposure situations; trans- (n) Contract specifications. Discussions of
port and disposal procedures; and rec- key elements that are included in contract
ommended and prohibited work practices. specifications.
New abatement-related techniques and
(o) Course review. A review of key aspects
methodologies may be discussed.
of the training course.
(e) Personal hygiene. Entry and exit proce-
dures for the work area; use of showers; and 3. INSPECTOR
avoidance of eating, drinking, smoking, and
chewing (gum or tobacco) in the work area. All persons who inspect for ACBM in
Potential exposures, such as family expo- schools or public and commercial buildings
sure, shall also be included. must be accredited. All persons seeking ac-
(f) Additional safety hazards. Hazards en- creditation as an inspector shall complete at
countered during abatement activities and least a 3–day training course as outlined
how to deal with them, including electrical below. The course shall include lectures,
hazards, heat stress, air contaminants other demonstrations, 4 hours of hands-on train-
than asbestos, fire and explosion hazards, ing, individual respirator fit-testing, course
scaffold and ladder hazards, slips, trips, and review, and a written examination.
falls, and confined spaces. EPA recommends the use of audiovisual
(g) Medical monitoring. OSHA and EPA materials to complement lectures, where ap-
Worker Protection Rule requirements for propriate. Hands-on training should include
physical examinations, including a pul- conducting a simulated building walk-
monary function test, chest X-rays and a through inspection and respirator fit testing.
medical history for each employee. The inspector training course shall ade-
(h) Air monitoring. Procedures to determine quately address the following topics:
airborne concentrations of asbestos fibers, (a) Background information on asbestos.
including descriptions of aggressive air sam- Identification of asbestos, and examples and
pling, sampling equipment and methods, rea- discussion of the uses and locations of asbes-
sons for air monitoring, types of samples and tos in buildings; physical appearance of as-
interpretation of results. bestos.
EPA recommends that transmission elec- (b) Potential health effects related to asbestos
tron microscopy (TEM) be used for analysis exposure. The nature of asbestos-related dis-
of final air clearance samples, and that sam- eases; routes of exposure; dose-response rela-
ple analyses be performed by laboratories ac- tionships and the lack of a safe exposure
credited by the National Institute of Stand- level; the synergistic effect between ciga-
ards and Technology’s (NIST) National Vol- rette smoking and asbestos exposure; the la-
untary Laboratory Accreditation Program tency periods for asbestos-related diseases; a
(NVLAP). discussion of the relationship of asbestos ex-
(i) Relevant Federal, State, and local regu- posure to asbestosis, lung cancer, mesothe-
latory requirements, procedures, and standards, lioma, and cancers of other organs.
including: (c) Functions/qualifications and role of in-
(i) Requirements of TSCA Title II. spectors. Discussions of prior experience and
(ii) National Emission Standards for Haz- qualifications for inspectors and manage-
ardous Air Pollutants (40 CFR part 61), Sub- ment planners; discussions of the functions
parts A (General Provisions) and M (National of an accredited inspector as compared to
Emission Standard for Asbestos). those of an accredited management planner;
discussion of inspection process including in-
(iii) OSHA standards for permissible expo-

sure to airborne concentrations of asbestos ventory of ACM and physical assessment.
fibers and respiratory protection (29 CFR (d) Legal liabilities and defenses. Respon-
1910.134). sibilities of the inspector and management
344
planner; a discussion of comprehensive gen- surance procedures. EPA’s recommendation
eral liability policies, claims-made, and oc- that all bulk samples collected from school
currence policies, environmental and pollu- or public and commercial buildings be ana-
tion liability policy clauses; state liability lyzed by a laboratory accredited under the
insurance requirements; bonding and the re- NVLAP administered by NIST.
lationship of insurance availability to bond (j) Inspector respiratory protection and per-
availability. sonal protective equipment. Classes and char-
(e) Understanding building systems. The acteristics of respirator types; limitations of
interrelationship between building systems, respirators; proper selection, inspection;
including: an overview of common building donning, use, maintenance, and storage pro-
physical plan layout; heat, ventilation, and cedures for respirators; methods for field
air conditioning (HVAC) system types, phys- testing of the facepiece-to-face seal (positive
ical organization, and where asbestos is and negative-pressure fit checks); quali-
found on HVAC components; building me- tative and quantitative fit testing proce-
chanical systems, their types and organiza- dures; variability between field and labora-
tion, and where to look for asbestos on such tory protection factors that alter respiratory
systems; inspecting electrical systems, in- fit (e.g., facial hair); the components of a
cluding appropriate safety precautions; read- proper respiratory protection program; se-
ing blueprints and as-built drawings. lection and use of personal protective cloth-
(f) Public/employee/building occupant rela- ing; use, storage, and handling of non-dispos-
tions. Notifying employee organizations able clothing.
about the inspection; signs to warn building (k) Recordkeeping and writing the inspection
occupants; tact in dealing with occupants report. Labeling of samples and keying sam-
and the press; scheduling of inspections to ple identification to sampling location; rec-
minimize disruptions; and education of ommendations on sample labeling; detailing
building occupants about actions being of ACM inventory; photographs of selected
taken. sampling areas and examples of ACM condi-
(g) Pre-inspection planning and review of pre- tion; information required for inclusion in
vious inspection records. Scheduling the in- the management plan required for school
spection and obtaining access; building buildings under TSCA Title II, section 203
record review; identification of probable ho- (i)(1). EPA recommends that States develop
mogeneous areas from blueprints or as-built and require the use of standardized forms for
drawings; consultation with maintenance or recording the results of inspections in
building personnel; review of previous in- schools or public or commercial buildings,
spection, sampling, and abatement records of and that the use of these forms be incor-
a building; the role of the inspector in exclu- porated into the curriculum of training con-
sions for previously performed inspections. ducted for accreditation.
(h) Inspecting for friable and non-friable (l) Regulatory review. The following topics
ACM and assessing the condition of friable should be covered: National Emission Stand-
ACM. Procedures to follow in conducting vis- ards for Hazardous Air Pollutants (NESHAP;
ual inspections for friable and non-friable 40 CFR part 61, subparts A and M); EPA
ACM; types of building materials that may Worker Protection Rule (40 CFR part 763,
contain asbestos; touching materials to de- subpart G); OSHA Asbestos Construction
termine friability; open return air plenums Standard (29 CFR 1926.58); OSHA respirator
and their importance in HVAC systems; as- requirements (29 CFR 1910.134); the Asbestos-
sessing damage, significant damage, poten- Containing Materials in School Rule (40 CFR
tial damage, and potential significant dam- part 763, subpart E; applicable State and
age; amount of suspected ACM, both in total local regulations, and differences between
quantity and as a percentage of the total Federal and State requirements where they
area; type of damage; accessibility; mate- apply, and the effects, if any, on public and
rial’s potential for disturbance; known or nonpublic schools or commercial or public
suspected causes of damage or significant buildings.
damage; and deterioration as assessment fac- (m) Field trip. This includes a field exer-
tors. cise, including a walk-through inspection;
(i) Bulk sampling/documentation of asbestos. on-site discussion about information gath-
Detailed discussion of the ‘‘Simplified Sam- ering and the determination of sampling lo-
pling Scheme for Friable Surfacing Mate- cations; on-site practice in physical assess-
rials (EPA 560/5-85-030a October 1985)’’; tech- ment; classroom discussion of field exercise.
niques to ensure sampling in a randomly dis- (n) Course review. A review of key aspects
tributed manner for other than friable sur- of the training course.
facing materials; sampling of non-friable ma-
4. MANAGEMENT PLANNER
terials; techniques for bulk sampling; inspec-
tor’s sampling and repair equipment; All persons who prepare management plans
patching or repair of damage from sampling; for schools must be accredited. All persons
discussion of polarized light microscopy; seeking accreditation as management plan-
choosing an accredited laboratory to analyze ners shall complete a 3–day inspector train-
bulk samples; quality control and quality as- ing course as outlined above and a 2–day
345
management planner training course. Pos- proach to design of high-quality job speci-
session of current and valid inspector accred- fications.
itation shall be a prerequisite for admission (g) Developing an operations and mainte-
to the management planner training course. nance (O&M) plan. Purpose of the plan; dis-
The management planner course shall in- cussion of applicable EPA guidance docu-
clude lectures, demonstrations, course re- ments; what actions should be taken by cus-
view, and a written examination. todial staff; proper cleaning procedures;
EPA recommends the use of audiovisual steam cleaning and HEPA vacuuming; reduc-
materials to complement lectures, where ap- ing disturbance of ACM; scheduling O&M for
propriate. off-hours; rescheduling or canceling renova-
TSCA Title II does not require accreditation in areas with ACM; boiler room mainte-
tion for persons performing the management nance; disposal of ACM; in-house procedures
planner role in public and commercial build- for ACM—bridging and penetrating
ings. Nevertheless, such persons may find encapsulants; pipe fittings; metal sleeves;
this training and accreditation helpful in polyvinyl chloride (PVC), canvas, and wet
preparing them to design or administer as- wraps; muslin with straps, fiber mesh cloth;
bestos operations and maintenance programs mineral wool, and insulating cement; discus-
for public and commercial buildings. sion of employee protection programs and
The management planner training course staff training; case study in developing an
shall adequately address the following top- O&M plan (development, implementation
ics: process, and problems that have been experi-
(a) Course overview. The role and respon- enced).
sibilities of the management planner; oper- (h) Regulatory review. Focusing on the
ations and maintenance programs; setting OSHA Asbestos Construction Standard found
work priorities; protection of building occu- at 29 CFR 1926.58; the National Emission
pants. Standard for Hazardous Air Pollutants
(b) Evaluation/interpretation of survey re- (NESHAP) found at 40 CFR part 61, Subparts
sults. Review of TSCA Title II requirements A (General Provisions) and M (National
for inspection and management plans for Emission Standard for Asbestos); EPA Work-
school buildings as given in section 203(i)(1) er Protection Rule found at 40 CFR part 763,
of TSCA Title II; interpretation of field data subpart G; TSCA Title II; applicable State
and laboratory results; comparison of field regulations.
inspector’s data sheet with laboratory re- (i) Recordkeeping for the management plan-
sults and site survey. ner. Use of field inspector’s data sheet along
(c) Hazard assessment. Amplification of the with laboratory results; on-going record-
difference between physical assessment and keeping as a means to track asbestos dis-
hazard assessment; the role of the manage- turbance; procedures for recordkeeping. EPA
ment planner in hazard assessment; expla- recommends that States require the use of
nation of significant damage, damage, poten- standardized forms for purposes of manage-
tial damage, and potential significant dam- ment plans and incorporate the use of such
age; use of a description (or decision tree) forms into the initial training course for
code for assessment of ACM; assessment of management planners.
friable ACM; relationship of accessibility, vi- (j) Assembling and submitting the manage-
bration sources, use of adjoining space, and ment plan. Plan requirements for schools in
air plenums and other factors to hazard as- TSCA Title II section 203(i)(1); the manage-
sessment. ment plan as a planning tool.
(d) Legal implications. Liability; insurance (k) Financing abatement actions. Economic
issues specific to planners; liabilities associ- analysis and cost estimates; development of
ated with interim control measures, in-house cost estimates; present costs of abatement
maintenance, repair, and removal; use of re- versus future operation and maintenance
sults from previously performed inspections. costs; Asbestos School Hazard Abatement
(e) Evaluation and selection of control op- Act grants and loans.
tions. Overview of encapsulation, enclosure, (l) Course review. A review of key aspects of
interim operations and maintenance, and re- the training course.
moval; advantages and disadvantages of each
method; response actions described via a de- 5. PROJECT DESIGNER
cision tree or other appropriate method; A person must be accredited as a project
work practices for each response action; designer to design any of the following ac-
staging and prioritizing of work in both va- tivities with respect to friable ACBM in a
cant and occupied buildings; the need for school or public and commercial building: (1)
containment barriers and decontamination A response action other than a SSSD main-
in response actions. tenance activity, (2) a maintenance activity
(f) Role of other professionals. Use of indus- that disturbs friable ACBM other than a
trial hygienists, engineers, and architects in SSSD maintenance activity, or (3) a response
developing technical specifications for reaction for a major fiber release episode. All
sponse actions; any requirements that may persons seeking accreditation as a project
exist for architect sign-off of plans; team ap- designer shall complete at least a minimum
346
3–day training course as outlined below. The how to deal with them, including electrical
project designer course shall include lec- hazards, heat stress, air contaminants other
tures, demonstrations, a field trip, course re- than asbestos, fire, and explosion hazards.
view and a written examination. (h) Fiber aerodynamics and control. Aero-
EPA recommends the use of audiovisual dynamic characteristics of asbestos fibers;
materials to complement lectures, where ap- importance of proper containment barriers;
propriate. settling time for asbestos fibers; wet meth-
The abatement project designer training ods in abatement; aggressive air monitoring
course shall adequately address the following following abatement; aggressive air move-
topics: ment and negative-pressure exhaust ventila-
(a) Background information on asbestos. tion as a clean-up method.
Identification of asbestos; examples and dis-
(i) Designing abatement solutions. Discus-
cussion of the uses and locations of asbestos
sions of removal, enclosure, and encapsula-
in buildings; physical appearance of asbestos.
(b) Potential health effects related to asbestos tion methods; asbestos waste disposal.
exposure. Nature of asbestos-related diseases; (j) Final clearance process. Discussion of the
routes of exposure; dose-response relation- need for a written sampling rationale for ag-
ships and the lack of a safe exposure level; gressive final air clearance; requirements of
the synergistic effect between cigarette a complete visual inspection; and the rela-
smoking and asbestos exposure; the latency tionship of the visual inspection to final air
period of asbestos-related diseases; a discus- clearance.
sion of the relationship between asbestos ex- EPA recommends the use of TEM for anal-
posure and asbestosis, lung cancer, mesothe- ysis of final air clearance samples. These
lioma, and cancers of other organs. samples should be analyzed by laboratories
(c) Overview of abatement construction accredited under the NIST NVLAP.
projects. Abatement as a portion of a renova- (k) Budgeting/cost estimating. Development
tion project; OSHA requirements for notifi- of cost estimates; present costs of abatement
cation of other contractors on a multi-em- versus future operation and maintenance
ployer site (29 CFR 1926.58). costs; setting priorities for abatement jobs
(d) Safety system design specifications. De- to reduce costs.
sign, construction, and maintenance of con- (l) Writing abatement specifications. Prepara-
tainment barriers and decontamination en- tion of and need for a written project design;
closure systems; positioning of warning means and methods specifications versus
signs; electrical and ventilation system lock- performance specifications; design of abate-
out; proper working techniques for mini- ment in occupied buildings; modification of
mizing fiber release; entry and exit proce- guide specifications for a particular building;
dures for the work area; use of wet methods; worker and building occupant health/medical
proper techniques for initial cleaning; use of considerations; replacement of ACM with
negative-pressure exhaust ventilation equip- non-asbestos substitutes.
ment; use of HEPA vacuums; proper clean-up (m) Preparing abatement drawings. Signifi-
and disposal of asbestos; work practices as cance and need for drawings, use of as-built
they apply to encapsulation, enclosure, and drawings as base drawings; use of inspection
repair; use of glove bags and a demonstration photographs and on-site reports; methods of
of glove bag use. preparing abatement drawings; diagramming
(e) Field trip. A visit to an abatement site
containment barriers; relationship of draw-
or other suitable building site, including on-
ings to design specifications; particular
site discussions of abatement design and
problems related to abatement drawings.
building walk-through inspection. Include
(n) Contract preparation and administration.
discussion of rationale for the concept of
functional spaces during the walk-through. (o) Legal/liabilities/defenses. Insurance con-
(f) Employee personal protective equipment. siderations; bonding; hold-harmless clauses;
Classes and characteristics of respirator use of abatement contractor’s liability insur-
types; limitations of respirators; proper se- ance; claims made versus occurrence poli-
lection, inspection; donning, use, mainte- cies.
nance, and storage procedures for res- (p) Replacement. Replacement of asbestos
pirators; methods for field testing of the with asbestos-free substitutes.
facepiece-to-face seal (positive and negative- (q) Role of other consultants. Development
pressure fit checks); qualitative and quan- of technical specification sections by indus-
titative fit testing procedures; variability trial hygienists or engineers; the multi-dis-
between field and laboratory protection fac- ciplinary team approach to abatement de-
tors that alter respiratory fit (e.g., facial sign.
hair); the components of a proper respiratory (r) Occupied buildings. Special design proce-
protection program; selection and use of per- dures required in occupied buildings; edu-
sonal protective clothing; use, storage, and cation of occupants; extra monitoring rec-
handling of non-disposable clothing. ommendations; staging of work to minimize
(g) Additional safety hazards. Hazards en- occupant exposure; scheduling of renovation
countered during abatement activities and to minimize exposure.
347
(s) Relevant Federal, State, and local regu- EPA Worker Protection Rule, 40 CFR part
latory requirements, procedures and standards, 763, subpart G. Overview of pertinent OSHA
including, but not limited to: regulations, including: Construction Indus-
(i) Requirements of TSCA Title II. try Standard for Asbestos, 29 CFR 1926.58;
(ii) National Emission Standards for Haz- Respirator Standard, 29 CFR 1910.134; and the
ardous Air Pollutants, (40 CFR part 61) sub- Hazard Communication Standard, 29 CFR
parts A (General Provisions) and M (National 1926.59. Applicable State and local asbestos
Emission Standard for Asbestos). regulations; regulatory interrelationships.
(iii) OSHA Respirator Standard found at 29 (d) Understanding building construction and
CFR 1910.134. building systems. Building construction ba-
(iv) EPA Worker Protection Rule found at sics, building physical plan layout; under-
40 CFR part 763, subpart G. standing building systems (HVAC, electrical,
(v) OSHA Asbestos Construction Standard etc.); layout and organization, where asbes-
found at 29 CFR 1926.58. tos is likely to be found on building systems;
(vi) OSHA Hazard Communication Stand- renovations and the effect of asbestos abate-
ard found at 29 CFR 1926.59. ment on building systems.
(t) Course review. A review of key aspects of (e) Asbestos abatement contracts, specifica-
the training course. tions, and drawings. Basic provisions of the
contract; relationships between principle
6. PROJECT MONITOR parties, establishing chain of command;
EPA recommends that States adopt train- types of specifications, including means and
ing and accreditation requirements for per- methods, performance, and proprietary and
sons seeking to perform work as project nonproprietary; reading and interpreting
monitors. Project monitors observe abate- records and abatement drawings; discussion
ment activities performed by contractors of change orders; common enforcement re-
and generally serve as a building owner’s sponsibilities and authority of project mon-
representative to ensure that abatement itor.
work is completed according to specification (f) Response actions and abatement practices.
and in compliance with all relevant statutes Pre-work inspections; pre-work consider-
and regulations. They may also perform the ations, precleaning of the work area, re-
vital role of air monitoring for purposes of moval of furniture, fixtures, and equipment;
determining final clearance. EPA rec- shutdown/modification of building systems;
ommends that a State seeking to accredit in- construction and maintenance of contain-
dividuals as project monitors consider adopt- ment barriers, proper demarcation of work
ing a minimum 5–day training course cov- areas; work area entry/exit, hygiene prac-
ering the topics outlined below. The course tices; determining the effectiveness of air fil-
outlined below consists of lectures and dem- tration equipment; techniques for mini-
onstrations, at least 6 hours of hands-on mizing fiber release, wet methods, contin-
training, course review, and a written exam- uous cleaning; abatement methods other
ination. The hands-on training component than removal; abatement area clean-up pro-
might be satisfied by having the student cedures; waste transport and disposal proce-
simulate participation in or performance of dures; contingency planning for emergency
any of the relevant job functions or activi- response.
ties (or by incorporation of the workshop (g) Asbestos abatement equipment. Typical
component described in item ‘‘n’’ below of equipment found on an abatement project;
this unit). air filtration devices, vacuum systems, nega-
EPA recommends that the project monitor tive pressure differential monitoring; HEPA
training course adequately address the fol- filtration units, theory of filtration, design/
lowing topics: construction of HEPA filtration units, quali-
(a) Roles and responsibilities of the project tative and quantitative performance of
monitor. Definition and responsibilities of the HEPA filtration units, sizing the ventilation
project monitor, including regulatory/speci- requirements, location of HEPA filtration
fication compliance monitoring, air moni- units, qualitative and quantitative tests of
toring, conducting visual inspections, and containment barrier integrity; best available
final clearance monitoring. technology.
(b) Characteristics of asbestos and asbestos- (h) Personal protective equipment. Proper se-
containing materials. Typical uses of asbestos; lection of respiratory protection; classes and
physical appearance of asbestos; review of characteristics of respirator types, limita-
asbestos abatement and control techniques; tions of respirators; proper use of other safe-
presentation of the health effects of asbestos ty equipment, protective clothing selection,
exposure, including routes of exposure, dose- use, and proper handling, hard/bump hats,
response relationships, and latency periods safety shoes; breathing air systems, high
for asbestos-related diseases. pressure v. low pressure, testing for Grade D
(c) Federal asbestos regulations. Overview of air, determining proper backup air volumes.
pertinent EPA regulations, including: (i) Air monitoring strategies. Sampling
NESHAP, 40 CFR part 61, subparts A and M; equipment, sampling pumps (low v. high vol-
AHERA, 40 CFR part 763, subpart E; and the ume), flow regulating devices (critical and
348
limiting orifices), use of fibrous aerosol mon- the building owner based on given conditions
itors on abatement projects; sampling and these documents.
media, types of filters, types of cassettes, fil- Air monitoring strategies/asbestos abate-
ter orientation, storage and shipment of fil- ment equipment: This workshop could con-
ters; calibration techniques, primary cali- sist of simulated abatement sites for which
bration standards, secondary calibration sampling strategies would have to be devel-
standards, temperature/pressure effects, fre- oped (i.e., occupied buildings, industrial situ-
quency of calibration, recordkeeping and ations). Through demonstrations and exhi-
field work documentation, calculations; air
bition, the project monitor may also be able
sample analysis, techniques available and
to gain a better understanding of the func-
limitations of AHERA on their use, trans-
tion of various pieces of equipment used on
mission electron microscopy (background to
sample preparation and analysis, air sample abatement projects (air filtration units,
conditions which prohibit analysis, EPA’s water filtration units, negative pressure
recommended technique for analysis of final monitoring devices, sampling pump calibra-
air clearance samples), phase contrast mi- tion devices, etc.).
croscopy (background to sample preparation, Conducting visual inspections: This work-
and AHERA’s limits on the use of phase con- shop could consist, ideally, of an interactive
trast microscopy), what each technique video in which a participant is ‘‘taken
measures; analytical methodologies, AHERA through’’ a work area and asked to make
TEM protocol, NIOSH 7400, OSHA reference notes of what is seen. A series of questions
method (non clearance), EPA recommenda- will be asked which are designed to stimu-
tion for clearance (TEM); sampling strate- late a person’s recall of the area. This work-
gies for clearance monitoring, types of air shop could consist of a series of two or three
samples (personal breathing zone v. fixed- videos with different site conditions and dif-
station area) sampling location and objec- ferent degrees of cleanliness.
tives (pre-abatement, during abatement, and
clearance monitoring), number of samples to C. Examinations
be collected, minimum and maximum air
volumes, clearance monitoring (post-visual- 1. Each State shall administer a closed
inspection) (number of samples required, se- book examination or designate other entities
lection of sampling locations, period of sam- such as State-approved providers of training
pling, aggressive sampling, interpretations courses to administer the closed-book exam-
of sampling results, calculations), quality ination to persons seeking accreditation who
assurance; special sampling problems, crawl have completed an initial training course.
spaces, acceptable samples for laboratory Demonstration testing may also be included
analysis, sampling in occupied buildings as part of the examination. A person seeking
(barrier monitoring). initial accreditation in a specific discipline
(j) Safety and health issues other than asbes- must pass the examination for that dis-
tos. Confined-space entry, electrical hazards, cipline in order to receive accreditation. For
fire and explosion concerns, ladders and scaf- example, a person seeking accreditation as
folding, heat stress, air contaminants other an abatement project designer must pass the
than asbestos, fall hazards, hazardous mate- State’s examination for abatement project
rials on abatement projects. designer.
(k) Conducting visual inspections. Inspec- States may develop their own examina-
tions during abatement, visual inspections
tions, have providers of training courses de-
using the ASTM E1368 document; conducting
velop examinations, or use standardized ex-
inspections for completeness of removal; dis-
aminations developed for purposes of accred-
cussion of ‘‘how clean is clean?’’
itation under TSCA Title II. In addition,
(l) Legal responsibilities and liabilities of
States may supplement standardized exami-
project monitors. Specification enforcement
capabilities; regulatory enforcement; licens- nations with questions about State regula-
ing; powers delegated to project monitors tions. States may obtain commercially de-
through contract documents. veloped standardized examinations, develop
(m) Recordkeeping and report writing. Devel- standardized examinations independently, or
oping project logs/daily logs (what should be do so in cooperation with other States, or
included, who sees them); final report prepa- with commercial or non-profit providers on a
ration; recordkeeping under Federal regula- regional or national basis. EPA recommends
tions. the use of standardized, scientifically-vali-
(n) Workshops (6 hours spread over 3 days). dated testing instruments, which may be
Contracts, specifications, and drawings: This beneficial in terms of both promoting com-
workshop could consist of each participant petency and in fostering accreditation reci-
procity between States.
being issued a set of contracts, specifica-

tions, and drawings and then being asked to Each examination shall adequately cover
answer questions and make recommenda- the topics included in the training course for
tions to a project architect, engineer or to that discipline. Each person who completes a
349
training course, passes the required exam- D. Continuing Education
ination, and fulfills whatever other require-
ments the State imposes must receive an ac- For all disciplines, a State’s accreditation
creditation certificate in a specific dis- program shall include annual refresher train-
cipline. Whether a State directly issues ac- ing as a requirement for reaccreditation as
creditation certificates, or authorizes train- indicated below:
ing providers to issue accreditation certifi- 1. Workers: One full day of refresher train-
cates, each certificate issued to an accred- ing.
ited person must contain the following min- 2. Contractor/Supervisors: One full day of
imum information: refresher training.
a. A unique certificate number 3. Inspectors: One half-day of refresher
b. Name of accredited person training.
4. Management Planners: One half-day of
c. Discipline of the training course com-
inspector refresher training and one half-day
pleted.
of refresher training for management plan-
d. Dates of the training course.
ners.
e. Date of the examination. 5. Project Designers: One full day of re-
f. An expiration date of 1 year after the fresher training.
date upon which the person successfully The refresher courses shall be specific to
completed the course and examination. each discipline. Refresher courses shall be
g. The name, address, and telephone num- conducted as separate and distinct courses
ber of the training provider that issued the and not combined with any other training
certificate. during the period of the refresher course. For
h. A statement that the person receiving each discipline, the refresher course shall re-
the certificate has completed the requisite view and discuss changes in Federal, State,
training for asbestos accreditation under and local regulations, developments in state-
TSCA Title II. of-the-art procedures, and a review of key as-
States or training providers who reaccredit pects of the initial training course as deter-
persons based upon completion of required mined by the State. After completing the an-
refresher training must also provide accredi- nual refresher course, persons shall have
tation certificates with all of the above in- their accreditation extended for an addi-
formation, except the examination date may tional year from the date of the refresher
be omitted if a State does not require a re- course. A State may consider requiring per-
fresher examination for reaccreditation. sons to pass reaccreditation examinations at
Where a State licenses accredited persons specific intervals (for example, every 3
but has authorized training providers to years).
issue accreditation certificates, the State EPA recommends that States formally es-
may issue licenses in the form of photo-iden- tablish a 12-month grace period to enable
tification cards. Where this applies, EPA rec- formerly accredited persons with expired
ommends that the State licenses should in- certificates to complete refresher training
clude all of the same information required and have their accreditation status rein-
for the accreditation certificates. A State stated without having to re-take the initial
may also choose to issue photo-identifica- training course.
tion cards in addition to the required accred-
itation certificates. E. Qualifications
Accredited persons must have their initial In addition to requiring training and an ex-
and current accreditation certificates at the amination, a State may require candidates
location where they are conducting work. for accreditation to meet other qualification
2. The following are the requirements for and/or experience standards that the State
examination in each discipline: considers appropriate for some or all dis-
a. Worker: ciplines. States may choose to consider re-
i. 50 multiple-choice questions quiring qualifications similar to the exam-
ii. Passing score: 70 percent correct ples outlined below for inspectors, manage-
b. Contractor/Supervisor: ment planners and project designers. States
i. 100 multiple-choice questions may modify these examples as appropriate.
ii. Passing score: 70 percent correct In addition, States may want to include
c. Inspector: some requirements based on experience in
i. 50 Multiple-choice questions performing a task directly as a part of a job
or in an apprenticeship role. They may also
ii. Passing score: 70 percent correct
wish to consider additional criteria for the
d. Management Planner: approval of training course instructors be-
i. 50 Multiple-choice questions yond those prescribed by EPA.
ii. Passing score: 70 percent correct
1. Inspectors: Qualifications - possess a

e. Project Designer: high school diploma. States may want to re-
i. 100 multiple-choice questions quire an Associate’s Degree in specific fields
ii. Passing score: 70 percent correct (e.g., environmental or physical sciences).
350
2. Management Planners: Qualifications - 5. Verification of certificate information.
Registered architect, engineer, or certified EPA recommends that training providers of
industrial hygienist or related scientific refresher training courses confirm that their
field. students possess valid accreditation before
3. Project Designers: Qualifications - reg- granting course admission. EPA further rec-
istered architect, engineer, or certified in- ommends that training providers offering
dustrial hygienist. the initial management planner training
4. Asbestos Training Course Instructor: course verify that students have met the pre-
Qualifications - academic credentials and/or requisite of possessing valid inspector ac-
field experience in asbestos abatement. creditation at the time of course admission.
EPA recommends that States prescribe 6. Records retention and access. (a) The
minimum qualification standards for train- training provider shall maintain all required
ing instructors employed by training pro- records for a minimum of 3 years. The train-
viders. ing provider, however, may find it advan-
tageous to retain these records for a longer
F. Recordkeeping Requirements for Training period of time.
Providers (b) The training provider must allow rea-
sonable access to all of the records required
All approved providers of accredited asbes- by the MAP, and to any other records which
tos training courses must comply with the may be required by States for the approval
following minimum recordkeeping require- of asbestos training providers or the accredi-
ments. tation of asbestos training courses, to both
1. Training course materials. A training EPA and to State Agencies, on request. EPA
provider must retain copies of all instruc- encourages training providers to make this
tional materials used in the delivery of the information equally accessible to the general
classroom training such as student manuals, public.
instructor notebooks and handouts. (c) If a training provider ceases to conduct
2. Instructor qualifications. A training pro- training, the training provider shall notify
vider must retain copies of all instructors’ the approving government body (EPA or the
resumes, and the documents approving each State) and give it the opportunity to take
instructor issued by either EPA or a State. possession of that providers asbestos train-
Instructors must be approved by either EPA ing records.
or a State before teaching courses for accred-
itation purposes. A training provider must G. Deaccreditation
notify EPA or the State, as appropriate, in 1. States must establish criteria and proce-
advance whenever it changes course instruc- dures for deaccrediting persons accredited as
tors. Records must accurately identify the workers, contractor/supervisors, inspectors,
instructors that taught each particular management planners, and project designers.
course for each date that a course is offered. States must follow their own administrative
3. Examinations. A training provider must procedures in pursuing deaccreditation ac-
document that each person who receives an tions. At a minimum, the criteria shall in-
accreditation certificate for an initial train- clude:
ing course has achieved a passing score on (a) Performing work requiring accredita-
the examination. These records must clearly tion at a job site without being in physical
indicate the date upon which the exam was possession of initial and current accredita-
administered, the training course and dis- tion certificates;
cipline for which the exam was given, the (b) Permitting the duplication or use of
name of the person who proctored the exam, one’s own accreditation certificate by an-
a copy of the exam, and the name and test other;
score of each person taking the exam. The (c) Performing work for which accredita-
topic and dates of the training course must tion has not been received; or
correspond to those listed on that person’s (d) Obtaining accreditation from a training
accreditation certificate. States may choose provider that does not have approval to offer
to apply these same requirements to exami- training for the particular discipline from ei-
nations for refresher training courses. ther EPA or from a State that has a con-
4. Accreditation certificates. The training tractor accreditation plan at least as strin-
providers or States, whichever issues the ac- gent as the EPA MAP.
creditation certificate, shall maintain EPA may directly pursue deaccreditation
records that document the names of all per- actions without reliance on State
sons who have been awarded certificates, deaccreditation or enforcement authority or
their certificate numbers, the disciplines for actions. In addition to the above-listed situa-
which accreditation was conferred, training tions, the Administrator may suspend or re-
and expiration dates, and the training loca- voke the accreditation of persons who have
tion. The training provider or State shall been subject to a final order imposing a civil
maintain the records in a manner that al- penalty or convicted under section 16 of
lows verification by telephone of the re- TSCA, 15 U.S.C. 2615 or 2647, for violations of
quired information. 40 CFR part 763, or section 113 of the Clean
351
Air Act, 42 U.S.C. 7413, for violations of 40 possible. Any State that had an accredita-
CFR part 61, subpart M. tion program approved by EPA under an ear-
2. Any person who performs asbestos work lier version of the MAP may follow the same
requiring accreditation under section 206(a) procedures to obtain EPA approval of their
of TSCA, 15 U.S.C. 2646(a), without such ac- accreditation program under this MAP.
creditation is in violation of TSCA. The fol- B. Partial approval of a State Program for
lowing persons are not accredited for pur- the accreditation of one or more disciplines
poses of section 206(a) of TSCA: does not mean that the State is in full com-
(a) Any person who obtains accreditation pliance with TSCA where the deadline for
through fraudulent representation of train- that State to have adopted a State Plan no
ing or examination documents; less stringent than the MAP has already
(b) Any person who obtains training docu- passed. State Programs which are at least as
mentation through fraudulent means; stringent as the MAP for one or more of the
(c) Any person who gains admission to and accredited disciplines may, however, ac-
completes refresher training through fraudu- credit persons in those disciplines only.
lent representation of initial or previous re- C. States seeking EPA approval or re-
fresher training documentation; or approval of accreditation programs shall
(d) Any person who obtains accreditation submit the following information to the Re-
through fraudulent representation of accred- gional Asbestos Coordinator at their EPA
itation requirements such as education, Regional office:
training, professional registration, or experi- 1. A copy of the legislation establishing or
ence. upgrading the State’s accreditation program
(if applicable).
H. Reciprocity 2. A copy of the State’s accreditation regu-
EPA recommends that each State establish lations or revised regulations.
reciprocal arrangements with other States 3. A letter to the Regional Asbestos Coor-
that have established accreditation pro- dinator that clearly indicates how the State
grams that meet or exceed the requirements meets the program requirements of this
of the MAP. Such arrangements might ad- MAP. Addresses for each of the Regional As-
dress cooperation in licensing determina- bestos Coordinators are shown below:
tions, the review and approval of training EPA, Region I, (OES05–1) Asbestos Coordi-
programs and/or instructors, candidate test- nator, 5 Post Office Square—Suite 100, Bos-
ing and exam administration, curriculum de- ton, MA 02109–3912, (617) 918–1016.
velopment, policy formulation, compliance EPA, Region II, (MS-500), Asbestos Coordi-
monitoring, and the exchange of information nator, 2890 Woodbridge Ave., Edison, NJ
and data. The benefits to be derived from 08837-3679, (908) 321-6671.
these arrangements include a potential cost- EPA, Region III, (3AT-33), Asbestos Coordi-
savings from the reduction of duplicative ac- nator, 841 Chestnut Bldg., Philadelphia, PA
tivity and the attainment of a more profes- 19107, (215) 597-3160.
sional accredited workforce as States are EPA, Region IV, Asbestos Coordinator, 345
able to refine and improve the effectiveness Courtland St., N.E., Atlanta, GA 30365,
of their programs based upon the experience (404) 347-5014.
EPA, Region V, (SP-14J), Asbestos Coordi-
and methods of other States.
nator, 77 W. Jackson Blvd., Chicago, IL
I. Electronic Reporting 60604-3590, (312) 886-6003.
EPA, Region VI, (6T-PT), Asbestos Coordi-
States that choose to receive electronic nator, 1445 Ross Ave. Dallas, TX 75202-2744,
documents must include, at a minimum, the (214) 655-7244.
requirements of 40 CFR Part 3—(Electronic EPA, Region VII, (WWPD/TOPE), Asbestos
reporting) in their programs. Coordinator, U.S. Environmental Protec-
II. EPA Approval Process for State tion Agency, 11201 Renner Boulevard,
Accreditation Programs Lenexa, Kansas 66219. (800) 223–0425 or (913)
551–7122.
A. States may seek approval for a single EPA, Region VIII, (8AT-TS), Asbestos Coor-
discipline or all disciplines as specified in dinator, 1 Denver Place, Suite 500 999 - 18th
the MAP. For example, a State that cur- St., Denver, CO 80202-2405, (303) 293-1442.
rently only requires worker accreditation EPA, Region IX, Asbestos NESHAPs Con-
may receive EPA approval for that discipline tact, Air Division (A–5), 75 Hawthorne
alone. EPA encourages States that currently Street, San Francisco, CA 94105, (415) 972–
do not have accreditation requirements for 3989.
all disciplines required under section EPA, Region X, (AT-083), Asbestos Coordi-
206(b)(2) of TSCA, 15 U.S.C. 2646(b)(2), to seek nator, 1200 Sixth Ave., Seattle, WA 98101,
EPA approval for those disciplines the State (206) 553-4762.
does accredit. As States establish accredita- EPA maintains a listing of all those States
tion requirements for the remaining dis- that have applied for and received EPA ap-
ciplines, the requested information outlined proval for having accreditation requirements
below should be submitted to EPA as soon as that are at least as stringent as the MAP for
352
one or more disciplines. Any training courses 3. A copy of all course materials (student
approved by an EPA-approved State Pro- manuals, instructor notebooks, handouts,
gram are considered to be EPA-approved for etc.).
purposes of accreditation. 4. The names and qualifications of all
course instructors. Instructors must have
III. Approval of Training Courses
academic and/or field experience in asbestos
Individuals or groups wishing to sponsor abatement.
training courses for disciplines required to 5. A description of and an example of the
be accredited under section 206(b)(1)(A) of numbered certificates issued to students who
TSCA, 15 U.S.C. 2646(b)(1)(A), may apply for complete the refresher course and pass the
approval from States that have accreditation examination, if required.
program requirements that are at least as
stringent as this MAP. For a course to re- C. Withdrawal of Training Course Approval
ceive approval, it must meet the require-
ments for the course as outlined in this States must establish criteria and proce-
MAP, and any other requirements imposed dures for suspending or withdrawing ap-
by the State from which approval is being proval from accredited training programs.
sought. Courses that have been approved by States should follow their own administra-
a State with an accreditation program at tive procedures in pursuing actions for sus-
least as stringent as this MAP are approved pension or withdrawal of approval of train-
under section 206(a) of TSCA, 15 U.S.C. ing programs. At a minimum, the criteria
2646(a), for that particular State, and also for shall include:
any other State that does not have an ac- (1) Misrepresentation of the extent of a
creditation program as stringent as this training course’s approval by a State or
MAP. EPA;
(2) Failure to submit required information
A. Initial Training Course Approval or notifications in a timely manner;
A training provider must submit the fol- (3) Failure to maintain requisite records;
lowing minimum information to a State as (4) Falsification of accreditation records,
part of its application for the approval of instructor qualifications, or other accredita-
each training course: tion information; or
1. The course provider’s name, address, and (5) Failure to adhere to the training stand-
telephone number. ards and requirements of the EPA MAP or
2. A list of any other States that currently State Accreditation Program, as appro-
approve the training course. priate.
3. The course curriculum. In addition to the criteria listed above,
4. A letter from the provider of the train- EPA may also suspend or withdraw a train-
ing course that clearly indicates how the ing course’s approval where an approved
course meets the MAP requirements for: training course instructor, or other person
a. Length of training in days. with supervisory authority over the delivery
b. Amount and type of hands-on training. of training has been found in violation of
c. Examination (length, format, and pass- other asbestos regulations administered by
ing score). EPA. An administrative or judicial finding of
d. Topics covered in the course. violation, or execution of a consent agree-
5. A copy of all course materials (student ment and order under 40 CFR 22.18, con-
manuals, instructor notebooks, handouts, stitutes evidence of a failure to comply with
etc.). relevant statutes or regulations. States may
6. A detailed statement about the develop- wish to adopt this criterion modified to in-
ment of the examination used in the course. clude their own asbestos statutes or regula-
7. Names and qualifications of all course tions. EPA may also suspend or withdraw ap-
instructors. Instructors must have academic proval of training programs where a training
and/or field experience in asbestos abate- provider has submitted false information as
ment. a part of the self-certification required under
8. A description of and an example of the Unit V.B. of the revised MAP.
numbered certificates issued to students who Training course providers shall permit rep-
attend the course and pass the examination. resentatives of EPA or the State which ap-
proved their training courses to attend,
B. Refresher Training Course Approval
evaluate, and monitor any training course
The following minimum information is re- without charge. EPA or State compliance in-
quired for approval of refresher training spection staff are not required to give ad-
courses by States: vance notice of their inspections. EPA may
1. The length of training in half-days or suspend or withdraw State or EPA approval

days. of a training course based upon the criteria
2. The topics covered in the course. specified in this Unit III.C.
353
IV. EPA Procedures for Suspension or Revoca- itation or suspend or withdraw training
tion of Accreditation or Training Course Ap- course approval, as appropriate, in accord-
proval. ance with Unit IV.A. above. If such suspen-
sion, revocation, or withdrawal notice has
A. If the Administrator decides to suspend
not previously been issued, it will be issued
or revoke the accreditation of any person or
at the same time the emergency suspension
suspend or withdraw the approval of a train-
notice is issued.
ing course, the Administrator will notify the
E. Any notice, decision, or order issued by
affected entity of the following:
the Administrator under this section, and
1. The grounds upon which the suspension,
any documents filed by an accredited person
revocation, or withdrawal is based.
or approved training course provider in a
2. The time period during which the sus-
hearing under this section, shall be available
pension, revocation, or withdrawal is effec-
to the public except as otherwise provided by
tive, whether permanent or otherwise.
section 14 of TSCA or by 40 CFR part 2. Any
3. The conditions, if any, under which the
such hearing at which oral testimony is pre-
affected entity may receive accreditation or
sented shall be open to the public, except
approval in the future.
that the Presiding Officer may exclude the
4. Any additional conditions which the Ad-
public to the extent necessary to allow pres-
ministrator may impose.
5. The opportunity to request a hearing entation of information which may be enti-
prior to final Agency action to suspend or re- tled to confidential treatment under section
voke accreditation or suspend or withdraw 14 of TSCA or 40 CFR part 2.
approval. V. Implementation Schedule
B. If a hearing is requested by the accred-
ited person or training course provider pur- The various requirements of this MAP be-
suant to the preceding paragraph, the Ad- come effective in accordance with the fol-
ministrator will: lowing schedules:
1. Notify the affected entity of those asser-
A. Requirements applicable to State
tions of law and fact upon which the action
Programs
to suspend, revoke, or withdraw is based.
2. Provide the affected entity an oppor- 1. Each State shall adopt an accreditation
tunity to offer written statements of facts, plan that is at least as stringent as this MAP
explanations, comments, and arguments rel- within 180 days after the commencement of
evant to the proposed action. the first regular session of the legislature of
3. Provide the affected entity such other the State that is convened on or after April
procedural opportunities as the Adminis- 4, 1994.
trator may deem appropriate to ensure a fair 2. If a State has adopted an accreditation
and impartial hearing. plan at least as stringent as this MAP as of
4. Appoint an EPA attorney as Presiding April 4, 1994, the State may continue to:
Officer to conduct the hearing. No person a. Conduct TSCA training pursuant to this
shall serve as Presiding Officer if he or she MAP.
has had any prior connection with the spe- b. Approve training course providers to
cific case. conduct training and to issue accreditation
C. The Presiding Officer appointed pursu- that satisfies the requirements for TSCA ac-
ant to the preceding paragraph shall: creditation under this MAP.
1. Conduct a fair, orderly, and impartial c. Issue accreditation that satisfies the re-
hearing, without unnecessary delay. quirements for TSCA accreditation under
2. Consider all relevant evidence, expla- this MAP.
nation, comment, and argument submitted 3. A State that had complied with an ear-
pursuant to the preceding paragraph. lier version of the MAP, but has not adopted
3. Promptly notify the affected entity of an accreditation plan at least as stringent as
his or her decision and order. Such an order this MAP by April 4, 1994, may:
is a final Agency action. a. Conduct TSCA training which remains
D. If the Administrator determines that in compliance with the requirements of Unit
the public health, interest, or welfare war- V.B. of this MAP. After such training has
rants immediate action to suspend the ac- been self-certified in accordance with Unit
creditation of any person or the approval of V.B. of this MAP, the State may issue ac-
any training course provider, the Adminis- creditation that satisfies the requirement for
trator will: TSCA accreditation under this MAP.
1. Notify the affected entity of the grounds b. Sustain its approval for any training
upon which the emergency suspension is course providers to conduct training and
based; issue TSCA accreditation that the State had
2. Notify the affected entity of the time pe- approved before April 4, 1994, and that re-
riod during which the emergency suspension main in compliance with Unit V.B. of this
is effective. MAP.
3. Notify the affected entity of the Admin- c. Issue accreditation pursuant to an ear-
istrator’s intent to suspend or revoke accred- lier version of the MAP that provisionally
354
satisfies the requirement for TSCA accredi- this MAP and clearly state that the provider
tation until October 4, 1994. is also in compliance with all other require-
Such a State may not approve new TSCA ments of this MAP, including the new rec-
training course providers to conduct training ordkeeping and certificate provisions. Each
or to issue TSCA accreditation that satisfies submission must include the following state-
the requirements of this MAP until the ment signed by an authorized representative
State adopts an accreditation plan that is at of the training provider: ‘‘Under civil and
least as stringent as this MAP. criminal penalties of law for the making or
4. A State that had complied with an ear- submission of false or fraudulent statements
lier version of the MAP, but fails to adopt a or representations (18 U.S.C. 1001 and 15
plan as stringent as this MAP by the dead- U.S.C. 2615), I certify that the training de-
line established in Unit V.A.1., is subject to scribed in this submission complies with all
the following after that deadline date: applicable requirements of Title II of TSCA,
a. The State loses any status it may have 40 CFR part 763, Appendix C to subpart E, as
held as an EPA-approved State for accredita- revised, and any other applicable Federal,
tion purposes under section 206 of TSCA, 15 state, or local requirements.’’ A consolidated
U.S.C. 2646.
self-certification submission from each
b. All training course providers approved
training provider that addresses all of its ap-
by the State lose State approval to conduct
proved training courses is permissible and
training and issue accreditation that satis-
encouraged.
fies the requirements for TSCA accreditation
under this MAP. The self-certification must be sent via reg-
c. The State may not: istered mail, to EPA Headquarters at the fol-
i. Conduct training for accreditation pur- lowing address: Attn. Self-Certification Pro-
poses under section 206 of TSCA, 15 U.S.C. gram, Field Programs Branch, Chemical
2646. Management Division (7404), Office of Pollu-
ii. Approve training course providers to tion Prevention and Toxics, Environmental
conduct training or issue accreditation that Protection Agency, 1200 Pennsylvania Ave.,
satisfies the requirements for TSCA accredi- NW., Washington, DC 20460. A duplicate copy
tation; or of the complete submission must also be sent
iii. Issue accreditation that satisfies the to any States from which approval had been
requirement for TSCA accreditation. obtained.
EPA will extend EPA-approval to any The timely receipt of a complete self-cer-
training course provider that loses State ap- tification by EPA and all approving States
proval because the State does not comply shall have the effect of extending approval
with the deadline, so long as the provider is under this MAP to the training courses of-
in compliance with Unit V.B. of this MAP, fered by the submitting provider. If a self-
and the provider is approved by a State that certification is not received by the approving
had complied with an earlier version of the government bodies on or before the due date,
MAP as of the day before the State loses its the affected training course is not approved
EPA approval. under this MAP. Such training providers
5. A State that does not have an accredita- must then reapply for approval of these
tion program that satisfies the requirements training courses pursuant to the procedures
for TSCA accreditation under either an ear- outlined in Unit III.
lier version of the MAP or this MAP, may
not: C. Requirements applicable to Accredited
a. Conduct training for accreditation pur- Persons.
poses under section 206 of TSCA, 15 U.S.C.
2646; Persons accredited by a State with an ac-
b. Approve training course providers to creditation program no less stringent than
conduct training or issue accreditation that an earlier version of the MAP or by an EPA-
satisfies the requirements for TSCA accredi- approved training provider as of April 3, 1994,
tation; or are accredited in accordance with the re-
c. Issue accreditation that satisfies the requirements of this MAP, and are not re-
quirement for TSCA accreditation. quired to retake initial training. They must
continue to comply with the requirements
B. Requirements applicable to Training for annual refresher training in Unit I.D. of
Courses and Providers the revised MAP.
As of October 4, 1994, an approved training D. Requirements applicable to Non-
provider must certify to EPA and to any Accredited Persons.
State that has approved the provider for
TSCA accreditation, that each of the pro- In order to perform work requiring accredi-
vider’s training courses complies with the re- tation under TSCA Title II, persons who are
quirements of this MAP. The written sub- not accredited by a State with an accredita-
mission must document in specific detail the tion program no less stringent than an ear-
changes made to each training course in lier version of the MAP or by an EPA-ap-
order to comply with the requirements of proved training provider as of April 3, 1994,
355
Pt. 763, Subpt. E, App. D 40 CFR Ch. I (7–1–17 Edition)
must comply with the upgraded training re- Region I
quirements of this MAP by no later than Oc-
Asbestos NESHAPs Contact, Office of En-
tober 4, 1994. Non-accredited persons may ob-
vironmental Stewardship, USEPA, Region I,
tain initial accreditation on a provisional
5 Post Office Square—Suite 100, Boston, MA
basis by successfully completing any of the
02109–3912, (617) 918–1551.
training programs approved under an earlier
version of the MAP, and thereby perform Region II
work during the first 6 months after this
MAP takes effect. However, by October 4, Asbestos NESHAPs Contact, Air & Waste
1994, these persons must have successfully Management Division, USEPA, Region II, 26
completed an upgraded training program Federal Plaza, New York, NY 10007, (212) 264–
that fully complies with the requirements of 6770.
this MAP in order to continue to perform Region III
work requiring accreditation under section
206 of TSCA, 15 U.S.C. 2646. Asbestos NESHAPs Contact, Air Manage-
ment Division, USEPA, Region III, 841 Chest-
[59 FR 5251, Feb. 3, 1994, as amended at 60 FR nut Street, Philadelphia, PA 19107, (215) 597–
31922, June 19, 1995; 70 FR 59889, Oct. 13, 2005; 9325.
75 FR 69353, Nov. 12, 2010; 76 FR 49674, Aug. 11,
2011; 78 FR 37978, June 25, 2013] Region IV
Asbestos NESHAPs Contact, Air, Pesticide
APPENDIX D TO SUBPART E OF PART
& Toxic Management, USEPA, Region IV,
763—TRANSPORT AND DISPOSAL OF 345 Courtland Street, NE., Atlanta, GA 30365,
ASBESTOS WASTE (404) 347–4298.
For the purposes of this appendix, trans- Region V
port is defined as all activities from receipt
of the containerized asbestos waste at the Asbestos NESHAPs Contact, Air Manage-
generation site until it has been unloaded at ment Division, USEPA, Region V, 77 West
the disposal site. Current EPA regulations Jackson Boulevard, Chicago, IL 60604, (312)
state that there must be no visible emissions 353–6793.
to the outside air during waste transport.
Region VI
However, recognizing the potential hazards
and subsequent liabilities associated with Asbestos NESHAPs Contact, Air & Waste
exposure, the following additional pre- Management Division, USEPA, Region VI,
cautions are recommended. 1445 Ross Avenue, Dallas, TX 75202, (214) 655–
Recordkeeping. Before accepting wastes, a 7229.
transporter should determine if the waste is
properly wetted and containerized. The Region VII
transporter should then require a chain-of- Asbestos NESHAPs Contact, Air and Waste
custody form signed by the generator. A Management Division, U.S. Environmental
chain-of-custody form may include the name Protection Agency, Region 7, 11201 Renner
and address of the generator, the name and Boulevard, Lenexa, Kansas 66219. (800) 223–
address of the pickup site, the estimated 0425 or (913) 551–7122.
quantity of asbestos waste, types of con-
tainers used, and the destination of the Region VIII
waste. The chain-of-custody form should Asbestos NESHAPs Contact, Air & Waste
then be signed over to a disposal site oper- Management Division, USEPA, Region VIII,
ator to transfer responsibility for the asbes- 999 18th Street, Suite 500, Denver, CO 80202,
tos waste. A copy of the form signed by the (303) 293–1814.
disposal site operator should be maintained
by the transporter as evidence of receipt at Region IX
the disposal site.
Waste handling. A transporter should en- Asbestos NESHAPs Contact, Air Division,
sure that the asbestos waste is properly con- USEPA, Region IX, 75 Hawthorne Street,
tained in leak-tight containers with appro- San Francisco, CA 94105, (415) 972–3989.
priate labels, and that the outside surfaces of Region X
the containers are not contaminated with as-
bestos debris adhering to the containers. If Asbestos NESHAPs Contact, Air & Toxics
there is reason to believe that the condition Management Division, USEPA, Region X,
of the asbestos waste may allow significant 1200 Sixth Avenue, Seattle, WA 98101, (206)
fiber release, the transporter should not ac- 442–2724.
cept the waste. Improper containerization of Once the transporter is satisfied with the
wastes is a violation of the NESHAPs regula- condition of the asbestos waste and agrees to
tion and should be reported to the appro- handle it, the containers should be loaded
priate EPA Regional Asbestos NESHAPs into the transport vehicle in a careful man-
contact below: ner to prevent breaking of the containers.
356
Environmental Protection Agency Pt. 763, Subpt. E, App. D
Similarly, at the disposal site, the asbestos containers and labeled appropriately. The
waste containers should be transferred care- appropriate EPA Regional Asbestos
fully to avoid fiber release. NESHAPs Contact should be notified if the
Waste transport. Although there are no reg- landfill operator believes that the asbestos
ulatory specifications regarding the trans- waste is in a condition that may cause sig-
port vehicle, it is recommended that vehicles nificant fiber release during disposal. In situ-
used for transport of containerized asbestos ations when the wastes are not properly con-
waste have an enclosed carrying compart- tainerized, the landfill operator should thor-
ment or utilize a canvas covering sufficient oughly soak the asbestos with a water spray
to contain the transported waste, prevent prior to unloading, rinse out the truck, and
damage to containers, and prevent fiber re- immediately cover the wastes with non-
lease. Transport of large quantities of asbes- asbestos material prior to compacting the
tos waste is commonly conducted in a 20- waste in the landfill.
cubic-yard ‘‘roll off’’ box, which should also Waste deposition and covering. Recognizing
be covered. Vehicles that use compactors to the health dangers associated with asbestos
reduce waste volume should not be used be- exposure, the following procedures are rec-
cause these will cause the waste containers ommended to augment current federal re-
to rupture. Vacuum trucks used to transport quirements:
waste slurry must be inspected to ensure • Designate a separate area for asbestos
that water is not leaking from the truck. waste disposal. Provide a record for future
Disposal involves the isolation of asbestos landowners that asbestos waste has been bur-
waste material in order to prevent fiber re- ied there and that it would be hazardous to
lease to air or water. Landfilling is rec- attempt to excavate that area. (Future regu-
ommended as an environmentally sound iso- lations may require property deeds to iden-
lation method because asbestos fibers are tify the location of any asbestos wastes and
virtually immobile in soil. Other disposal warn against excavation.)
techniques such as incineration or chemical • Prepare a separate trench to receive as-
treatment are not feasible due to the unique bestos wastes. The size of the trench will de-
properties of asbestos. EPA has established pend upon the quantity and frequency of as-
asbestos disposal requirements for active and bestos waste delivered to the disposal site.
inactive disposal sites under NESHAPs (40 The trenching technique allows application
CFR Part 61, subpart M) and specifies gen- of soil cover without disturbing the asbestos
eral requirements for solid waste disposal waste containers. The trench should be
under RCRA (40 CFR Part 257). Advance EPA ramped to allow the transport vehicle to
notification of the intended disposal site is back into it, and the trench should be as nar-
required by NESHAPs. row as possible to reduce the amount of
Selecting a disposal facility. An acceptable cover required. If possible, the trench should
disposal facility for asbestos wastes must ad- be aligned perpendicular to prevailing winds.
here to EPA’s requirements of no visible • Place the asbestos waste containers into
emissions to the air during disposal, or mini- the trench carefully to avoid breaking them.
mizing emissions by covering the waste Be particularly careful with plastic bags be-
within 24 hours. The minimum required cause when they break under pressure asbes-
cover is 6 inches of nonasbestos material, tos particles can be emitted.
normally soil, or a dust-suppressing chem- • Completely cover the containerized
ical. In addition to these Federal require- waste within 24 hours with a minimum of 6
ments, many state or local government inches of nonasbestos material. Improperly
agencies require more stringent handling containerized waste is a violation of the
procedures. These agencies usually supply a NESHAPs and EPA should be notified.
list of ‘‘approved’’ or licensed asbestos dis- However, if improperly containerized
posal sites upon request. Solid waste control waste is received at the disposal site, it
agencies are listed in local telephone direc- should be covered immediately after unload-
tories under state, county, or city headings. ing. Only after the wastes, including prop-
A list of state solid waste agencies may be erly containerized wastes, are completely
obtained by calling the RCRA hotline: 1–800– covered, can the wastes be compacted or
424–9346 (382–3000 in Washington, DC). Some other heavy equipment run over it. During
landfill owners or operators place special re- compacting, avoid exposing wastes to the air
quirements on asbestos waste, such as plac- or tracking asbestos material away from the
ing all bagged waste into 55-gallon metal trench.
drums. Therefore, asbestos removal contrac- • For final closure of an area containing
tors should contact the intended landfill be- asbestos waste, cover with at least an addi-
fore arriving with the waste. tional 30 inches of compacted nonasbestos
Receiving asbestos waste. A landfill approved material to provide a 36-inch final cover. To
for receipt of asbestos waste should require control erosion of the final cover, it should
notification by the waste hauler that the be properly graded and vegetated. In areas of
load contains asbestos. The landfill operator the United States where excessive soil ero-
should inspect the loads to verify that asbes- sion may occur or the frost line exceeds 3
tos waste is properly contained in leak-tight feet, additional final cover is recommended.
357
Pt. 763, Subpt. E, App. E 40 CFR Ch. I (7–1–17 Edition)
In desert areas where vegetation would be analysis of subsamples with the polarized
difficult to maintain, 3–6 inches of well grad- light microscope.
ed crushed rock is recommended for place- The principles of optical mineralogy are
ment on top of the final cover. well established. 1 2 A light microscope
Controlling public access. Under the current equipped with two polarizing filters is used
NESHAPs regulation, EPA does not require to observe specific optical characteristics of
that a landfill used for asbestos disposal use a sample. The use of plane polarized light al-
warning signs or fencing if it meets the re- lows the determination of refractive indices
quirement to cover asbestos wastes. How- along specific crystallographic axes. Mor-
ever, under RCRA, EPA requires that access phology and color are also observed. A retar-
be controlled to prevent exposure of the pub-
dation plate is placed in the polarized light
lic to potential health and safety hazards at
path for determination of the sign of elon-
the disposal site. Therefore, for liability pro-
tection of operators of landfills that handle gation using orthoscopic illumination. Ori-
asbestos, fencing and warning signs are rec- entation of the two filters such that their vi-
ommended to control public access when bration planes are perpendicular (crossed
natural barriers do not exist. Access to a polars) allows observation of the
landfill should be limited to one or two en- birefringence and extinction characteristics
trances with gates that can be locked when of anisotropic particles.
left unattended. Fencing should be installed Quantitative analysis involves the use of
around the perimeter of the disposal site in point counting. Point counting is a standard
a manner adequate to deter access by the technique in petrography for determining
general public. Chain-link fencing, 6-ft high the relative areas occupied by separate min-
and topped with a barbed wire guard, should erals in thin sections of rock. Background
be used. More specific fencing requirements information on the use of point counting 2
may be specified by local regulations. Warn- and the interpretation of point count data 3
ing signs should be displayed at all entrances is available.
and at intervals of 330 feet or less along the This method is applicable to all bulk sam-
property line of the landfill or perimeter of ples of friable insulation materials sub-
the sections where asbestos waste is depos-
mitted for identification and quantitation of
ited. The sign should read as follows:
asbestos components.
ASBESTOS WASTE DISPOSAL SITE
BREATHING ASBESTOS DUST MAY 1.2 Range
CAUSE LUNG DISEASE AND CANCER The point counting method may be used
Recordkeeping. For protection from liabil- for analysis of samples containing from 0 to
ity, and considering possible future require- 100 percent asbestos. The upper detection
ments for notification on disposal site deeds, limit is 100 percent. The lower detection
a landfill owner should maintain documenta- limit is less than 1 percent.
tion of the specific location and quantity of
the buried asbestos wastes. In addition, the 1.3 Interferences
estimated depth of the waste below the sur-
Fibrous organic and inorganic constituents
face should be recorded whenever a landfill
of bulk samples may interfere with the iden-
section is closed. As mentioned previously,
tification and quantitation of the asbestos
such information should be recorded in the
land deed or other record along with a notice mineral content. Spray-on binder materials
warning against excavation of the area. may coat fibers and affect color or obscure
optical characteristics to the extent of
[52 FR 41897, Oct. 30, 1987, as amended at 62 masking fiber identity. Fine particles of
FR 1834, Jan. 14, 1997; 75 FR 69353, Nov. 12, other materials may also adhere to fibers to
2010; 76 FR 49674, Aug. 11, 2011; 78 FR 37978, an extent sufficient to cause confusion in
June 25, 2013] identification. Procedures that may be used
for the removal of interferences are pre-
APPENDIX E TO SUBPART E OF PART sented in Section 1.7.2.2.
763—INTERIM METHOD OF THE DE-
TERMINATION OF ASBESTOS IN BULK 1.4 Precision and Accuracy
INSULATION SAMPLES Adequate data for measuring the accuracy
SECTION 1. POLARIZED LIGHT MICROSCOPY and precision of the method for samples with
various matrices are not currently available.
1.1 Principle and Applicability Data obtained for samples containing a sin-
gle asbestos type in a simple matrix are
Bulk samples of building materials taken
available in the EPA report Bulk Sample
for asbestos identification are first examined

for homogeneity and preliminary fiber iden- Analysis for Asbestos Content: Evaluation of
tification at low magnification. Positive the Tentative Method.4
identification of suspect fibers is made by
358
Environmental Protection Agency Pt. 763, Subpt. E, App. E
1.5 Apparatus 1.7 Procedures
1.5.1 Sample Analysis NOTE: Exposure to airborne asbestos fibers
is a health hazard. Bulk samples submitted
A low-power binocular microscope, pref- for analysis are usually friable and may re-
erably stereoscopic, is used to examine the lease fibers during handling or matrix reduc-
bulk insulation sample as received. tion steps. All sample and slide preparations
• Microscope: binocular, 10–45X (approxi- should be carried out in a ventilated hood or
mate). glove box with continuous airflow (negative
• Light Source: incandescent or fluorescent. pressure). Handling of samples without these
• Forceps, Dissecting Needles, and Probes precautions may result in exposure of the
• Glassine Paper or Clean Glass Plate analyst and contamination of samples by
Compound microscope requirements: A po- airborne fibers.
larized light microscope complete with po-
larizer, analyzer, port for wave retardation 1.7.1 Sampling
plate, 360° graduated rotating stage, substage Samples for analysis of asbestos content
condenser, lamp, and lamp iris. shall be taken in the manner prescribed in
• Polarized Light Microscope: described above. Reference 5 and information on design of
• Objective Lenses: 10X, 20X, and 40X or near sampling and analysis programs may be
equivalent. found in Reference 6. If there are any ques-
• Dispersion Staining Objective Lens (optional) tions about the representative nature of the
• Ocular Lens: 10X minimum. sample, another sample should be requested
• Eyepiece Reticle: cross hair or 25 point before proceeding with the analysis.
Chalkley Point Array.
• Compensator Plate: 550 millimicron retarda- 1.7.2 Analysis
tion.
1.7.2.1 Gross Examination
1.5.2 Sample Preparation
Bulk samples of building materials taken
Sample preparation apparatus require- for the identification and quantitation of as-
ments will depend upon the type of insula- bestos are first examined for homogeneity at
tion sample under consideration. Various low magnification with the aid of a
physical and/or chemical means may be em- stereomicroscope. The core sample may be
ployed for an adequate sample assessment. examined in its container or carefully re-
• Ventilated Hood or negative pressure glove moved from the container onto a glassine
box. transfer paper or clean glass plate. If pos-
• Microscope Slides sible, note is made of the top and bottom ori-
• Coverslips entation. When discrete strata are identified,
• Mortar and Pestle: agate or porcelain. (op- each is treated as a separate material so that
tional) fibers are first identified and quantified in
• Wylie Mill (optional) that layer only, and then the results for each
• Beakers and Assorted Glassware (optional) layer are combined to yield an estimate of
• Certrifuge (optional) asbestos content for the whole sample.
• Filtration apparatus (optional)
• Low temperature asher (optional) 1.7.2.2 Sample Preparation
Bulk materials submitted for asbestos
1.6 Reagents
analysis involve a wide variety of matrix
1.6.1 Sample Preparation materials. Representative subsamples may
not be readily obtainable by simple means in
• Distilled Water (optional) heterogeneous materials, and various steps
• Dilute CH3COOH: ACS reagent grade (op- may be required to alleviate the difficulties
tional) encountered. In most cases, however, the
• Dilute HCl: ACS reagent grade (optional) best preparation is made by using forceps to
• Sodium metaphosphate (NaPO3)6 (optional) sample at several places from the bulk mate-
rial. Forcep samples are immersed in a re-
1.6.2 Analytical Reagents
fractive index liquid on a microscope slide,
Refractive Index Liquids: 1.490–1.570, 1.590– teased apart, covered with a cover glass, and
1.720 in increments of 0.002 or 0.004. observed with the polarized light micro-
• Refractive Index Liquids for Dispersion Stain- scope.
ing: high-dispersion series, 1.550, 1.605, 1.630 Alternatively, attempts may be made to
(optional). homogenize the sample or eliminate inter-
• UICC Asbestos Reference Sample Set: Avail- ferences before further characterization. The
able from: UICC MRC Pneumoconiosis selection of appropriate procedures is de-
Unit, Llandough Hospital, Penarth, pendent upon the samples encountered and
Glamorgan CF6 1XW, UK, and commercial personal preference. The following are pre-
distributors. sented as possible sample preparation steps.
• Tremolite-asbestos (source to be determined) A mortar and pestle can sometimes be used
• Actinolite-asbestos (source to be determined) in the size reduction of soft or loosely bound
359
materials though this may cause matting of to ash part of the sample and view the res-
some samples. Such samples may be reduced idue. Ashing should be performed in a low
in a Wylie mill. Apparatus should be clean temperature asher. Ashing may also be per-
and extreme care exercised to avoid cross- formed in a muffle furnace at temperatures
contamination of samples. Periodic checks of 500 °C or lower. Temperatures of 550 °C or
of the particle sizes should be made during higher will cause dehydroxylation of the as-
the grinding operation so as to preserve any bestos minerals, resulting in changes of the
fiber bundles present in an identifiable form. refractive index and other key parameters. If
These procedures are not recommended for a muffle furnace is to be used, the furnace
samples that contain amphibole minerals or thermostat should be checked and calibrated
vermiculite. Grinding of amphiboles may re- to ensure that samples will not be heated at
sult in the separation of fiber bundles or the temperatures greater than 550 °C.
production of cleavage fragments with as-
Ashing and acid treatment of samples
pect ratios greater than 3:1. Grinding of
vermiculite may also produce fragments should not be used as standard procedures. In
with aspect ratios greater than 3:1. order to monitor possible changes in fiber
Acid treatment may occasionally be re- characteristics, the material should be
quired to eliminate interferences. Calcium viewed microscopically before and after any
carbonate, gypsum, and bassanite (plaster) sample preparation procedure. Use of these
are frequently present in sprayed or procedures on samples to be used for quan-
trowelled insulations. These materials may titation requires a correction for percent
be removed by treatment with warm dilute weight loss.
acetic acid. Warm dilute hydrochloric acid
may also be used to remove the above mate- 1.7.2.3 Fiber Identification
rials. If acid treatment is required, wash the Positive identification of asbestos requires
sample at least twice with distilled water, the determination of the following optical
being careful not to lose the particulates properties.
during decanting steps. Centrifugation or fil-
• Morphology
tration of the suspension will prevent signifi-
cant fiber loss. The pore size of the filter • Color and pleochroism
should be 0.45 micron or less. Caution: pro- • Refractive indices
longed acid contact with the sample may • Birefringence
alter the optical characteristics of chrysotile • Extinction characteristics
fibers and should be avoided. • Sign of elongation
Coatings and binding materials adhering to
Table 1–1 lists the above properties for com-
fiber surfaces may also be removed by treat-
mercial asbestos fibers. Figure 1–1 presents a
ment with sodium metaphosphate.7 Add 10
flow diagram of the examination procedure.
mL of 10g/L sodium metaphosphate solution
to a small (0.1 to 0.5 mL) sample of bulk ma- Natural variations in the conditions under
terial in a 15-mL glass centrifuge tube. For which deposits of asbestiform minerals are
approximately 15 seconds each, stir the mix- formed will occasionally produce exceptions
ture on a vortex mixer, place in an ultra- to the published values and differences from
sonic bath and then shake by hand. Repeat the UICC standards. The sign of elongation is
the series. Collect the dispersed solids by determined by use of the compensator plate
centrifugation at 1000 rpm for 5 minutes. and crossed polars. Refractive indices may
Wash the sample three times by suspending be determined by the Becke line test. Alter-
in 10 mL distilled water and recentrifuging. natively, dispersion staining may be used.
After washing, resuspend the pellet in 5 mL Inexperienced operators may find that the
distilled water, place a drop of the suspen- dispersion staining technique is more easily
sion on a microscope slide, and dry the slide learned, and should consult Reference 9 for
at 110 °C. guidance. Central stop dispersion staining
In samples with a large portion of cellu- colors are presented in Table 1–2. Available
losic or other organic fibers, it may be useful high-dispersion (HD) liquids should be used.
TABLE 1–1—OPTICAL PROPERTIES OF ASBESTOC FIBERS

Refractive indices b Birefring- Sign of
Mineral Morphology, color a Extinction
ence elonation
a g
Chrysotile Wavy fibers. Fiber bundles have 1.493–1.560 1.517– .008 | to fiber +
(asbestiform splayed ends and ‘‘kinks’’. Aspect 1.562f length. (length
serpentine). ratio typically >10:1. Colorless 3, (nor- slow)
nonpleochroic. mally
1.556).
360
TABLE 1–1—OPTICAL PROPERTIES OF ASBESTOC FIBERS—Continued

Refractive indices b Birefring- Sign of
Mineral Morphology, color a Extinction
ence elonation
a g
Amosite Straight, rigid fibers. Aspect ratio typi- 1.635–1.696 1.655– .020–.033 | to fiber +
(asbestiform cally >10:1. Colorless to brown, 1.729 f length. (length
grunerite). nonpleochroic or weakly so. Opaque (nor- slow)
inclusions may be present. mally
1.696–
1.710.
Crocidolite Straight, rigid fibers. Thick fibers and 1.654–1.701 1.668– .014–.016 | to fiber ¥
(asbestiform bundles common, blue to purple- 1.7173e length. (length fast)
Riebeckite). blue in color. Pleochroic. (nor-
Birefringence is generally masked by mally
blue color. close to
1.700).
Anthophyllite- Straight fibers and acicular cleavage 1.596–1.652 1.615– .019–.024 | to fiber +
asbestos. fragments.d Some composite fibers. 1.676 f. length. (length
Aspect ratio <10:1. Colorless to light slow)
brown.
Tremolite-actin- Normally present as acicular or pris- 1.599–1.668 1.622– .023–.020 Oblique +
olite-asbes- matic cleavage fragments.d Single 1.688 f. extinc- (length
tos. crystals predominate, aspect ratio tion, 10– slow)
<10:1. Colorless to pale green. 20° for
frag-
ments.
Com-
posite fi-
bers
show |
extinc-
tion.
a From reference 5; colors cited are seen by observation with plane polarized light.
b From references 5 and 8.
c Fibers subjected to heating may be brownish.
d Fibers defined as having aspect ratio >3:1.
e to fiber length.
f |To fiber length.
361
362
EC01AP92.017</GPH>
TABLE 1–2—CENTRAL STOP DISPERSION • A reticle with 25 points (Chalkley Point

STAINING COLORS A Array) and counting at least 2 randomly
selected fields.
Mineral RI Liquid h h| For samples with mixtures of isotropic and
anisotropic materials present, viewing the
Chrysotile ..... 1.550 HD Blue ............. Blue-ma-
sample with slightly uncrossed polars or the
genta
Amosite ........ 1.680 Blue-ma- Golden-yel-
addition of the compensator plate to the po-
genta to low larized light path will allow simultaneous
pale blue. discrimination of both particle types. Quan-
1.550HD Yellow to Yellow to titation should be performed at 100X or at
white. white the lowest magnification of the polarized
Crocidolite b .. 1.700 Red magenta Blue-ma- light microscope that can effectively distin-
genta guish the sample components. Confirmation
1.550HD Yellow to Yellow to of the quantitation result by a second ana-
white. white lyst on some percentage of analyzed samples
Anthophyllite 1.605HD Blue ............. Gold to gold-
should be used as standard quality control
magenta
Tremolite ...... 1.605HD c Pale blue ..... Gold
procedure.
Actinolite ...... 1.605HD Gold-ma- Gold The percent asbestos is calculated as fol-
genta to lows:
blue. % asbestos = (a/n) 100%
1.630HD c Magenta ...... Golden-yel- where
low
a = number of asbestos counts,
a From reference 9. n = number of nonempty points counted
b Blue absorption color.
c Oblique
(400).
extinction view.
If a = 0, report ‘‘No asbestos detected.’’ If
1.7.2.4 Quantitation of Asbestos Content 0<a≤3, report ‘‘<1% asbestos’’.
The value reported should be rounded to
Asbestos quantitation is performed by a the nearest percent.
point-counting procedure or an equivalent
estimation method. An ocular reticle (cross- 1.8 References
hair or point array) is used to visually super- 1. Paul F. Kerr, Optical Mineralogy, 4th ed.,
impose a point or points on the microscope New York, McGraw-Hill, 1977.
field of view. Record the number of points 2. E. M. Chamot and C. W. Mason, Hand-
positioned directly above each kind of par- book of Chemical Microscopy, Volume One, 3rd
ticle or fiber of interest. Score only points ed., New York: John Wiley & Sons, 1958.
directly over asbestos fibers or nonasbestos 3. F. Chayes, Petrographic Modal Analysis:
matrix material. Do not score empty points An Elementary Statistical Appraisal, New
for the closest particle. If an asbestos fiber York: John Wiley & Sons, 1956.
and a matrix particle overlap so that a point 4. E. P. Brantly, Jr., K. W. Gold, L. E.
is superimposed on their visual intersection, Myers, and D. E. Lentzen, Bulk Sample Anal-
a point is scored for both categories. Point ysis for Asbestos Content: Evaluation of the
counting provides a determination of the Tentative Method, U.S. Environmental Pro-
area percent asbestos. Reliable conversion of tection Agency, October 1981.
area percent to percent of dry weight is not 5. U.S. Environmental Protection Agency,
currently feasible unless the specific Asbestos-Containing Materials in School Build-
gravities and relative volumes of the mate- ings: A Guidance Document, Parts 1 and 2,
rials are known. EPA/OPPT No. C00090, March 1979.
For the purpose of this method, ‘‘asbestos 6. D. Lucas, T. Hartwell, and A. V. Rao, As-
fibers’’ are defined as having an aspect ratio bestos-Containing Materials in School Build-
greater than 3:1 and being positively identi- ings: Guidance for Asbestos Analytical Pro-
fied as one of the minerals in Table 1–1. grams, EPA 560/13–80–017A, U.S. Environ-
A total of 400 points superimposed on ei- mental Protection Agency, December 1980, 96
ther asbestos fibers or nonasbestos matrix pp.
material must be counted over at least eight 7. D. H. Taylor and J. S. Bloom,
different preparations of representative sub- Hexametaphosphate pretreatment of insula-
samples. Take eight forcep samples and tion samples for identification of fibrous
mount each separately with the appropriate constituents, Microscope, 28, 1980.
refractive index liquid. The preparation 8. W. J. Campbell, R. L. Blake, L. L.
should not be heavily loaded. The sample Brown, E. E. Cather, and J. J. Sjoberg. Se-
should be uniformly dispersed to avoid over- lected Silicate Minerals and Their Asbestiform
lapping particles and allow 25–50 percent Varieties: Mineralogical Definitions and Identi-
empty area within the fields of view. Count fication-Characterization, U.S. Bureau of
50 nonempty points on each preparation,
Mines Information Circular 8751, 1977.

using either 9. Walter C. McCrone, Asbestos Particle
• A cross-hair reticle and mechanical stage; Atlas, Ann Arbor: Ann Arbor Science Pub-
or lishers, June 1980.
363
SECTION 2. X-RAY POWDER DIFFRACTION For qualitative analysis by XRD methods,
samples are initially scanned over limited
2.1 Principle and Applicability diagnostic peak regions for the serpentine
The principle of X-ray powder diffraction (∼7.4 Å) and amphibole (8.2–8.5 Å) minerals
(XRD) analysis is well established. 1 2 Any (Table 2–2). Standard slow-scanning methods
solid, crystalline material will diffract an for bulk sample analysis may be used for ma-
impingent beam of parallel, monochromatic terials shown by PLM to contain significant
X-rays whenever Bragg’s Law, amounts of asbestos (>5–10 percent). Detec-
λ = 2d sin q, tion of minor or trace amounts of asbestos
may require special sample preparation and
is satisfied for a particular set of planes in step-scanning analysis. All samples that ex-
the crystal lattice, where hibit diffraction peaks in the diagnostic re-
λ = the X-ray wavelength, Å; gions for asbestiform minerals are submitted
d = the interplanar spacing of the set of re- to a full (5°–60° 2q; 1° 2q/min) qualitative XRD
flecting lattice planes, Å; and scan, and their diffraction patterns are com-
q = the angle of incidence between the X-ray pared with standard reference powder dif-
beam and the reflecting lattice planes. fraction patterns 3 to verify initial peak as-
By appropriate orientation of a sample rel- signments and to identify possible matrix
ative to the incident X-ray beam, a diffrac- interferences when subsequent quantitative
tion pattern can be generated that, in most analysis will be performed.
cases, will be uniquely characteristic of both
the chemical composition and structure of TABLE 2–1—THE ASBESTOS MINERALS AND
the crystalline phases present. THEIR NONASBESTIFORM ANALOGS
Unlike optical methods of analysis, how-
ever, XRD cannot determine crystal mor- Asbestiform Nonasbestiform
phology. Therefore, in asbestos analysis,
XRD does not distinguish between fibrous SERPENTINE
and nonfibrous forms of the serpentine and Chrysotile Antigorite, lizardite
amphibole minerals (Table 2–1). However, AMPHIBOLE
when used in conjunction with optical meth- Anthophyllite asbestos Anthophyllite
ods such as polarized light microscopy Cummingtonite-grunerite Cummingtonite-grunerite
asbestos (‘‘Amosite’’)
(PLM), XRD techniques can provide a reli-
Crocidolite Riebeckite
able analytical method for the identification
Tremolite asbestos Tremolite
and characterization of asbestiform minerals Actinolite asbestos Actinolite
in bulk materials.
TABLE 2–2—PRINCIPAL LATTICE SPACINGS OF ASBESTIFORM MINERALS A
Principal d-spacings (Å) and relative inten-
sities
Minerals JCPDS Powder diffraction file 3 number
Chrysotile .................. 7.37100 3.6570 4.5750 21–543b

7.36100 .. 3.6680 2.4565 25–645
7.10100 .. 2.3380 3.5570 22–1162 (theoretical)
‘‘Amosite’’ .................. 8.33100 3.0670 2.75670 17–745 (nonfibrous)
8.22100 .. 3.06085 3.2570 27–1170 (UICC)
Anthophyllite .............. 3.05100 3.2460 8.2655 9–455
3.06100 .. 8.3370 3.2350 16–401 (synthetic)
Anthophyllite .............. 2.72100 2.54100 3.48080 25–157
Crocidolite ................. 8.35100 3.1055 2.72035 27–1415 (UICC)
Tremolite ................... 8.38100 3.12100 2.70590 13–437b
2.706100 3.1495 8.4340 20–1310b (synthetic)
3.13100 .. 2.70660 8.4440 23–666 (synthetic mixture with richterite)
a This information is intended as a guide, only. Complete powder diffraction data, including mineral type and source, should be
referred to, to ensure comparability of sample and reference materials where possible. Additional precision XRD data on
amosite, crocidolite, tremolite, and chrysotile are available from the U.S. Bureaus of Mines.4
b Fibrosity questionable.
Accurate quantitative analysis of asbestos qualitative XRD analysis is selected for

in bulk samples by XRD is critically depend- quantitation of each asbestiform mineral. A
ent on particle size distribution, crystallite ‘‘thin-layer’’ method of analysis 5 6 is rec-
size, preferred orientation and matrix ab- ommended in which, subsequent to
sorption effects, and comparability of stand- comminution of the bulk material to ∼10 μm
ard reference and sample materials. The by suitable cryogenic milling techniques, an
most intense diffraction peak that has been accurately known amount of the sample is
shown to be free from interference by prior deposited on a silver membrane filter. The
364
mass of asbestiform material is determined • Gypsum has a major peak at 7.5 Å that
by measuring the integrated area of the se- overlaps the 7.36 Å peak of chrysotile when
lected diffraction peak using a step-scanning present as a major sample constituent.
mode, correcting for matrix absorption ef- This may be removed by careful washing
fects, and comparing with suitable calibra- with distilled water, or be heating to 300 °C
tion standards. Alternative ‘‘thick-layer’’ or to convert gypsum to plaster of paris.
bulk methods, 7 8 may be used for semi- • Cellulose has a broad peak that partially
quantitative analysis. overlaps the secondary (3.66 Å) chrysotile
This XRD method is applicable as a con- peak.8
firmatory method for identification and • Overlap of major diagnostic peaks of the
quantitation of asbestos in bulk material amphibole asbestos minerals, amosite,
samples that have undergone prior analysis anthophyllite, crocidolite, and tremolite,
by PLM or other optical methods. at approximately 8.3 Å and 3.1 Å causes
mutual interference when these minerals
2.2 Range and Sensitivity occur in the presence of one another. In
The range of the method has not been de- some instances, adequate resolution may
termined. be attained by using step-scanning meth-
The sensitivity of the method has not been ods and/or by decreasing the collimator slit
determined. It will be variable and depend- width at the X-ray port.
ent upon many factors, including matrix ef- TABLE 2–3—COMMON CONSTITUENTS IN
fects (absoprtion and interferences), diag- INSULATION AND WALL MATERIALS
nostic reflections selected, and their relative
intensities. A. Insulation materials
Chrysotile
2.3 Limitations ‘‘Amosite’’
Crocidolite
2.3.1 Interferences
*Rock wool
Since the fibrous and nonfibrous forms of *Slag wool
the serpentine and amphibole minerals *Fiber glass
(Table 2–1) are indistinguishable by XRD Gypsum (CaSO4 · 2H2O)
techniques unless special sample preparation Vermiculite (micas)
techniques and instrumentation are used,9 *Perlite
the presence of nonasbestiform serpentines Clays (kaolin)
and amphiboles in a sample will pose severe *Wood pulp
interference problems in the identification *Paper fibers (talc, clay, carbonate fillers)
and quantitative analysis of their Calcium silicates (synthetic)
asbestiform analogs. Opaques (chromite, magnetite inclusions
The use of XRD for identification and in serpentine)
quantitation of asbestiform minerals in bulk Hematite (inclusions in ‘‘amosite’’)
samples may also be limited by the presence Magnesite
of other interfering materials in the sample. *Diatomaceous earth
For naturally occurring materials the com- B. Spray finishes or paints
monly associated asbestos-related mineral Bassanite
interferences can usually be anticipated. Carbonate minerals (calcite, dolomite,
However, for fabricated materials the nature vaterite)
of the interferences may vary greatly (Table Talc
2–3) and present more serious problems in Tremolite
identification and quantitation.10 Potential Anthophyllite
interferences are summarized in Table 2–4 Serpentine (including chrysotile)
and include the following: Amosite
• Chlorite has major peaks at 7.19 Å and 3.58 Crocidolite
Å That interfere with both the primary *Mineral wool
(7.36 Å) and secondary (3.66 Å) peaks for *Rock wool
chrysotile. Resolution of the primary peak *Slag wool
to give good quantitative results may be *Fiber glass
possible when a step-scanning mode of op- Clays (kaolin)
eration is employed. Micas
• Halloysite has a peak at 3.63 Å that inter- Chlorite
feres with the secondary (3.66 Å) peak for Gypsum (CaSO4 · 2H2O)
chrysotile. Quartz
• Kaolinite has a major peak at 7.15 Å that *Organic binders and thickeners
may interfere with the primary peak of Hyrdomagnesite
chrysotile at 7.36 Å when present at con- Wollastonite

centrations of >10 percent. However, the Opaques (chromite, magnetite inclusions
secondary chrysotile peak at 3.66 Å may be in serpentine)
used for quantitation. Hematite (inclusions in ‘‘amosite’’)
365
*Amorphous materialsllcontribute only orthorhombic anthophyllite separated by
to overall scattered radiation and increased less than 0.2 Å. 12
background radiation.
2.3.2 Matrix Effects
TABLE 2–4—INTERFERENCES IN XRD ANALYSIS If a copper X-ray source is used, the pres-
ASBESTIFORM MINERALS ence of iron at high concentrations in a sam-
ple will result in significant X-ray fluores-
Primary cence, leading to loss of peak intensity along
diag-
nostic with increased background intensity and an
Asbestiform min- peaks Interference overall decrease in sensitivity. This situa-
eral (approxi- tion may be corrected by choosing an X-ray
mate d-
spacings, source other than copper; however, this is
in Å) often accompanied both by loss of intensity
and by decreased resolution of closely spaced
Serpentine reflections. Alternatively, use of a diffracted
Chrysotile 7.4 Nonasbestiform serpentines
(antigorite, lizardite) beam monochromator will reduce back-
Chlorite ground fluorescent raditation, enabling
Kaolinite weaker diffraction peaks to be detected.
Gypsum X-ray absorption by the sample matrix will
3.7 Chlorite result in overall attenuation of the dif-
Halloysite fracted beam and may seriously interfere
Cellulose with quantitative analysis. Absorption ef-
Amphibole
‘‘Amosite’’ 3.1 Nonasbestiform amphiboles
fects may be minimized by using sufficiently
Anthophyllite " (cummingtonite-grunerite, ‘‘thin’’ samples for analysis. 5 13 14 However,
Crocidolite anthophyllite, riebeckite, unless absorption effects are known to be the
Tremolite tremolite) same for both samples and standards, appro-
Mutual interferences priate corrections should be made by ref-
Carbonates erencing diagnostic peak areas to an internal
Talc standard 7 8 or filter substrate (Ag) peak. 5 6
8.3 Mutual interferences
2.3.3 Particle Size Dependence
• Carbonates may also interfere with quan-
titative analysis of the amphibole asbestos Because the intensity of diffracted X-radi-
minerals, amosite, anthophyllite, crocid- ation is particle-size dependent, it is essen-
olite, and tremolite. Calcium carbonate tial for accurate quantitative analysis that
(CaCO3) has a peak at 3.035 Å that overlaps both sample and standard reference mate-
major amphibole peaks at approximately rials have similar particle size distributions.
3.1 Å when present in concentrations of >5 The optimum particle size range for quan-
percent. Removal of carbonates with a di- titative analysis of asbestos by XRD has
lute acid wash is possible; however, if been reported to be 1 to 10 μm.15 Com-
present, chrysotile may be partially dis- parability of sample and standard reference
solved by this treatment.11 material particle size distributions should be
• A major talc peak at 3.12 Å interferes with verified by optical microscopy (or another
the primary tremolite peak at this same suitable method) prior to analysis.
position and with secondary peaks of cro- 2.3.4 Preferred Orientation Effects
cidolite (3.10 Å), amosite (3.06 Å), and
anthophyllite (3.05 Å). In the presence of Preferred orientation of asbestiform min-
talc, the major diagnostic peak at approxi- erals during sample preparation often poses
mately 8.3 Å should be used for quantita- a serious problem in quantitative analysis by
tion of these asbestiform minerals. XRD. A number of techniques have been de-
The problem of intraspecies and matrix veloped for reducing preferred orientation ef-
interferences is further aggravated by the fects in ‘‘thick layer’’ samples. 7 8 15 However,
variability of the silicate mineral powder for ‘‘thin’’ samples on membrane filters, the
diffraction patterns themselves, which often preferred orientation effects seem to be both
makes definitive identification of the asbes- reproducible and favorable to enhancement
tos minerals by comparison with standard of the principal diagnostic reflections of as-
reference diffraction patterns difficult. This bestos minerals, actually increasing the
variability results from alterations in the overall sensitivity of the method. 12 14 (Fur-
crystal lattice associated with differences in ther investigation into preferred orientation
isomorphous substitution and degree of crys- effects in both thin layer and bulk samples is
tallinity. This is especially true for the required.)
amphiboles. These minerals exhibit a wide
2.3.5 Lack of Suitably Characterized
variety of very similar chemical composi-
Standard Materials
tions, with the result being that their dif-
fraction patterns are chracterized by having The problem of obtaining and character-
major (110) reflections of the monoclinic izing suitable reference materials for asbes-
amphiboles and (210) reflections of the tos analysis is clearly recognized. NIOSH has
366
recently directed a major research effort to- 2.5.2 Sample Analysis
ward the preparation and characterization of
analytical reference materials, including as- Sample analysis requirements include an
bestos standards; 16 17 however, these are not X-ray diffraction unit, equipped with:
available in large quantities for routine • Constant Potential Generator; Voltage and
analysis. mA Stabilizers
In addition, the problem of ensuring the • Automated Diffractometer with Step-Scanning
comparability of standard reference and Mode
sample materials, particularly regarding • Copper Target X-Ray Tube: High intensity,
crystallite size, particle size distribution, fine focus, preferably.
and degree of crystallinity, has yet to be • X-Ray Pulse Height Selector
adequately addressed. For example, Langer • X-Ray Detector (with high voltage power
et al. 18 have observed that in insulating mat- supply): Scintillation or proportional
rices, chrysotile tends to break open into counter.
bundles more frequently than amphiboles.
• Focusing Graphite Crystal Monochromator; or
This results in a line-broadening effect with
Nickel Filter (if copper source is used, and
a resultant decrease in sensitivity. Unless
iron fluorescence is not a serious problem).
this effect is the same for both standard and
sample materials, the amount of chrysotile • Data Output Accessories:
in the sample will be underestimated by • Strip Chart Recorder
XRD analysis. To minimize this problem, it • Decade Scaler/Timer
is recommended that standardized matrix re- • Digital Printer
duction procedures be used for both sample • Sample Spinner (optional).
and standard materials. • Instrument Calibration Reference Specimen:
a-quartz reference crystal (Arkansas
2.4 Precision and Accuracy quartz standard, #180–147–00, Philips Elec-
Precision of the method has not been de- tronics Instruments, Inc., 85 McKee Drive,
termined. Mahwah, NJ 07430) or equivalent.
Accuracy of the method has not been de-
termined. 2.6 Reagents
2.5 Apparatus 2.6.1 Standard Reference Materials
2.5.1 Sample Preparation The reference materials listed below are

intended to serve as a guide. Every attempt
Sample preparation apparatus require- should be made to acquire pure reference
ments will depend upon the sample type materials that are comparable to sample ma-
under consideration and the kind of XRD terials being analyzed.
analysis to be performed.
• Chrysotile: UICC Canadian, or NIEHS
• Mortar and Pestle: Agate or porcelain.
• Razor Blades Plastibest. (UICC reference materials
• Sample Mill: SPEX, Inc., freezer mill or available from: UICC, MRC Pneumo-
equivalent. coniosis Unit, Llandough Hospital,
• Bulk Sample Holders Penarth, Glamorgan, CF61XW, UK).
• Silver Membrane Filters: 25-mm diameter, • Crocidolite: UICC
0.45-μm pore size. Selas Corp. of America, • Amosite: UICC
Flotronics Div., 1957 Pioneer Road, Hun- • Anthophyllite: UICC
tington Valley, PA 19006. • Tremolite Asbestos: Wards Natural Science
• Microscope Slides Establishment, Rochester, N.Y.; Cyprus
• Vacuum Filtration Apparatus: Gelman No. Research Standard, Cyprus Research, 2435
1107 or equivalent, and side-arm vacuum Military Ave., Los Angeles, CA 90064
flask. (washed with dilute HCl to remove small
• Microbalance amount of calcite impurity); India
• Ultrasonic Bath or Probe: Model W140, tremolite, Rajasthan State, India.
Ultrasonics, Inc., operated at a power den- • Actinolite Asbestos
sity of approximately 0.1 W/mL, or equiva-
lent. 2.6.2 Adhesive
• Volumetric Flasks: 1–L volume.
• Assorted Pipettes Tape, petroleum jelly, etc. (for attaching
• Pipette Bulb silver membrane filters to sample holders).
• Nonserrated Forceps
• Polyethylene Wash Bottle 2.6.3 Surfactant
• Pyrex Beakers: 50-mL volume. 1 percent aerosol OT aqueous solution or
• Desiccator
equivalent.
• Filter Storage Cassettes
• Magnetic Stirring Plate and Bars 2.6.4 Isopropanol

• Porcelain Crucibles
• Muffle Furnace or Low Temperature Asher ACS Reagent Grade.
367
2.7 Procedure ples may be reduced by cutting with a razor
blade in a mortar, or by grinding in a suit-
2.7.1 Sampling able mill (e.g., a microhammer mill or equiv-
Samples for analysis of asbestos content alent). When using a mortar for grinding or
shall be collected as specified in EPA Guid- cutting, the sample should be moistened
ance Document #C0090, Asbestos-Containing with ethanol, or some other suitable wetting
Materials in School Buildings.10 agent, to minimize exposures.
For accurate, reproducible quantitative
2.7.2 Analysis analysis, the particle size of both sample and
standard materials should be reduced to ∼10
All samples must be analyzed initially for μm (see Section 2.3.3). Dry ball milling at liq-
asbestos content by PLM. XRD should be uid nitrogen temperatures (e.g., Spex Freezer
used as an auxiliary method when a second, Mill, or equivalent) for a maximum time of
independent analysis is requested. 10 min. is recommended to obtain satisfac-
NOTE: Asbestos is a toxic substance. All tory particle size distributions while pro-
handling of dry materials should be per- tecting the integrity of the crystal lattice. 5
formed in an operating fume hood. Bulk samples of very large particle size may
require grinding in two stages for full matrix
2.7.2.1 Sample Preparation reduction to <10 μm. 8 16
The method of sample preparation required Final particle size distributions should al-
for XRD analysis will depend on: (1) The con- ways be verified by optical microscopy or an-
dition of the sample received (sample size, other suitable method.
homogeneity, particle size distribution, and 2.7.2.1.2 Low temperature ashing—For ma-
overall composition as determined by PLM); terials shown by PLM to contain large
and (2) the type of XRD analysis to be per- amounts of gypsum, cellulosic, or other or-
formed (qualitative, quantitative, thin layer ganic materials, it may be desirable to ash
or bulk). the samples prior to analysis to reduce back-
Bulk materials are usually received as ground radiation or matrix interference.
inhomogeneous mixtures of complex com- Since chrysotile undergoes dehydroxylation
position with very wide particle size dis- at temperatures between 550 °C and 650 °C,
tributions. Preparation of a homogeneous, with subsequent transformation to
representative sample from asbestos-con- forsterite,23 24 ashing temperatures should be
taining materials is particularly difficult be- kept below 500 °C. Use of a low temperature
cause the fibrous nature of the asbestos min- asher is recommended. In all cases, calibra-
erals inhibits mechanical mixing and stir- tion of the oven is essential to ensure that a
ring, and because milling procedures may maximum ashing temperature of 500 °C is not
cause adverse lattice alterations. exceeded.
A discussion of specific matrix reduction 2.7.2.1.3 Acid leaching—Because of the in-
procedures is given below. Complete methods terference caused by gypsum and some car-
of sample preparation are detailed in Sec- bonates in the detection of asbestiform min-
erals by XRD (see Section 2.3.1), it may be
tions 2.7.2.2 and 2.7.2.3.
necessary to remove these interferents by a
NOTE: All samples should be examined mi- simple acid leaching procedure prior to anal-
croscopically before and after each matrix ysis (see Section 1.7.2.2).
reduction step to monitor changes in sample
particle size, composition, and crystallinity, 2.7.2.2 Qualitative Analysis
and to ensure sample representativeness and
2.7.2.2.1 Initial screening of bulk material—
homogeneity for analysis.
Qualitative analysis should be performed on
2.7.2.1.1 Milling— Mechanical milling of a representative, homogeneous portion of the
asbestos materials has been shown to de- sample with a minimum of sample treat-
crease fiber crystallinity, with a resultant ment.
decrease in diffraction intensity of the speci- 1. Grind and mix the sample with a mortar
men; the degree of lattice alteration is re- and pestle (or equivalent method, see Sec-
lated to the duration and type of milling tion 2.7.2.1.1.) to a final particle size suffi-
process. 19 22 Therefore, all milling times ciently small (∼100 μm) to allow adequate
should be kept to a minimum. packing into the sample holder.
For qualitative analysis, particle size is not 2. Pack the sample into a standard bulk
usually of critical importance and initial sample holder. Care should be taken to en-
characterization of the material with a min- sure that a representative portion of the
imum of matrix reduction is often desirable milled sample is selected for analysis. Par-
to document the composition of the sample ticular care should be taken to avoid pos-
as received. Bulk samples of very large par- sible size segregation of the sample. (Note:
ticle size (>2–3 mm) should be comminuted Use of a back-packing method 25 of bulk sam-
to ∼100 μm. A mortar and pestle can some-
ple preparation may reduce preferred ori-

times be used in size reduction of soft or entation effects.)
loosely bound materials though this may 3. Mount the sample on the diffractometer
cause matting of some samples. Such sam- and scan over the diagnostic peak regions for
368
the serpentine (∼67.4 Å) and amphibole (8.2– 2. Dry at 100 °C for 2 hr; cool in a desic-
8.5 Å) minerals (see Table 2–2). The X-ray dif- cator.
fraction equipment should be optimized for 3. Weigh accurately to the nearest 0.01 mg.
intensity. A slow scanning speed of 1° 2q/min 4. Samples shown by PLM to contain large
is recommended for adequate resolution. Use amounts of cellulosic or other organic mate-
of a sample spinner is recommended. rials, gypsum, or carbonates, should be sub-
4. Submit all samples that exhibit diffrac- mitted to appropriate matrix reduction pro-
tion peaks in the diagnostic regions for cedures described in Sections 2.7.2.1.2 and
asbestiform minerals to a full qualitative 2.7.2.1.3. After ashing and/or acid treatment,
XRD scan (5°–60° 2q; 1°2q/min) to verify initial repeat the drying and weighing procedures
peak assignments and to identify potential described above, and determine the percent
matrix interferences when subsequent quan- weight loss; L.
titative analysis is to be performed. 5. Quantitatively transfer an accurately
5. Compare the sample XRD pattern with weighed amount (50–100 mg) of the sample to
standard reference powder diffraction pat- a 1–L volumetric flask with approximately
terns (i.e., JCPDS powder diffraction data 3 200 mL isopropanol to which 3 to 4 drops of
or those of other well-characterized ref- surfactant have been added.
erence materials). Principal lattice spacings 6. Ultrasonicate for 10 min at a power den-
of asbestiform minerals are given in Table 2– sity of approximately 0.1 W/mL, to disperse
2; common constituents of bulk insulation the sample material.
and wall materials are listed in Table 2–3. 7. Dilute to volume with isopropanol.
2.7.2.2.2 Detection of minor or trace constitu- 8. Place flask on a magnetic stirring plate.
ents— Routine screening of bulk materials Stir.
9. Place a silver membrane filter on the fil-
by XRD may fail to detect small concentra-
tration apparatus, apply a vacuum, and at-
tions (<5 percent) of asbestos. The limits of
tach the reservoir. Release the vacuum and
detection will, in general, be improved if ma-
add several milliliters of isopropanol to the
trix absorption effects are minimized, and if
reservoir. Vigorously hand shake the asbes-
the sample particle size is reduced to the op-
tos suspension and immediately withdraw an
timal 1 to 10 μm range, provided that the
aliquot from the center of the suspension so
crystal lattice is not degraded in the milling
that total sample weight, WT, on the filter
process. Therefore, in those instances where
will be approximately 1 mg. Do not adjust
confirmation of the presence of an the volume in the pipet by expelling part of
asbestiform mineral at very low levels is re- the suspension; if more than the desired ali-
quired, or where a negative result from ini- quot is withdrawn, discard the aliquot and
tial screening of the bulk material by XRD resume the procedure with a clean pipet.
(see Section 2.7.2.2.1) is in conflict with pre- Transfer the aliquot to the reservoir. Filter
vious PLM results, it may be desirable to rapidly under vacuum. Do not wash the res-
prepare the sample as described for quan- ervoir walls. Leave the filter apparatus
titative analysis (see Section 2.7.2.3) and under vacuum until dry. Remove the res-
step-scan over appropriate 2q ranges of se- ervoir, release the vacuum, and remove the
lected diagnostic peaks (Table 2–2). Accurate filter with forceps. (Note: Water-soluble ma-
transfer of the sample to the silver mem- trix interferences such as gypsum may be re-
brane filter is not necessary unless subse- moved at this time by careful washing of the
quent quantitative analysis is to be per- filtrate with distilled water. Extreme care
formed. should be taken not to disturb the sample.)
2.7.2.3 Quantitative Analysis 10. Attach the filter to a flat holder with a
suitable adhesive and place on the diffrac-
The proposed method for quantitation of tometer. Use of a sample spinner is rec-
asbestos in bulk samples is a modification of ommended.
the NIOSH-recommended thin-layer method 11. For each asbestos mineral to be
for chrysotile in air. 5 A thick-layer or bulk quantitated select a reflection (or reflec-
method involving pelletizing the sample may tions) that has been shown to be free from
be used for semiquantitative analysis; 7 8 interferences by prior PLM or qualitative
however, this method requires the addition XRD analysis and that can be used unambig-
of an internal standard, use of a specially uously as an index of the amount of material
fabricated sample press, and relatively large present in the sample (see Table 2–2).
amounts of standard reference materials. Ad- 12. Analyze the selected diagnostic reflec-
ditional research is required to evaluate the tion(s) by step scanning in increments of
comparability of thin- and thick-layer meth- 0.02° 2q for an appropriate fixed time and in-
ods for quantitative asbestos analysis. tegrating the counts. (A fixed count scan
For quantitative analysis by thin-layer may be used alternatively; however, the
methods, the following procedure is rec- method chosen should be used consistently
ommended: for all samples and standards.) An appro-

1. Mill and size all or a substantial rep- priate scanning interval should be selected
resentative portion of the sample as outlined for each peak, and background corrections
in Section 2.7.2.1.1. made. For a fixed time scan, measure the
369
background on each side of the peak for one- the aliquot to the reservoir. Keep the tip of
half the peak-scanning time. The net inten- the pipet near the surface of the isopropanol.
sity, Ia, is the difference between the peak in- Filter rapidly under vacuum. Do not wash
tegrated count and the total background the sides of the reservoir. Leave the vacuum
count. on for a time sufficient to dry the filter. Re-
13. Determine the net count, IAg, of the fil- lease the vacuum and remove the filter with
ter 2.36 Å silver peak following the procedure forceps.
in step 12. Remove the filter from the holder,
reverse it, and reattach it to the holder. De- 2.8.2 Analysis of Calibration Standards
termine the net count for the unattenuated 1. Mount each filter on a flat holder. Per-
silver peak, IA˚g. Scan times may be less for form step scans on selected diagnostic reflec-
measurement of silver peaks than for sample tions of the standards and reference speci-
peaks; however, they should be constant
men using the procedure outlined in Section
throughout the analysis.
2.7.2.3, step 12, and the same conditions as
14. Normalize all raw, net intensities (to
those used for the samples.
correct for instrument instabilities) by ref-
2. Determine the normalized intensity for
erencing them to an external standard (e.g.,
each peak measured, Îs̊td, as outlined in Sec-
the 3.34 Å peak of an a-quartz reference crys-
tion 2.7.2.3, step 14.
tal). After each unknown is scanned, deter-
mine the net count, Ir̊, of the reference speci- 2.9 Calculations
men following the procedure in step 12. De-
termine the normalized intensities by divid- For each asbestos reference material, cal-
ing the peak intensities by Ir̊: culate the exact weight deposited on each
standard filter from the concentrations of
the standard suspensions and aliquot vol-
umes. Record the weight, w, of each stand-
ard. Prepare a calibration curve by regress-
ing Î2s̊td on w. Poor reproducibility (±15 per-
cent RSD) at any given level indicates prob-
2.8 Calibration lems in the sample preparation technique,
and a need for new standards. The data
2.8.1 Preparation of Calibration Standards should fit a straight line equation.
1. Mill and size standard asbestos materials Determine the slope, m, of the calibration
according to the procedure outlined in Sec- curve in counts/microgram. The intercept, b,
tion 2.7.2.1.1. Equivalent, standardized matrix of the line with the Îs̊td axis should be ap-
reduction and sizing techniques should be used proximately zero. A large negative intercept
for both standard and sample materials. indicates an error in determining the back-
2. Dry at 100 °C for 2 hr; cool in a desic- ground. This may arise from incorrectly
cator. measuring the baseline or from interference
3. Prepare two suspensions of each standby another phase at the angle of background
ard in isopropanol by weighing approxi- measurement. A large positive intercept in-
mately 10 and 50 mg of the dry material to dicates an error in determining the baseline
the nearest 0.01 mg. Quantitatively transfer or that an impurity is included in the meas-
each to a 1–L volumetric flask with approxi- ured peak.
mately 200 mL isopropanol to which a few Using the normalized intensity, ÎAg, for the
drops of surfactant have been added. attenuated silver peak of a sample, and the
4. Ultrasonicate for 10 min at a power den- corresponding normalized intensity from the
sity of approximately 0.1 W/mL, to disperse unattenuated silver peak, ÎA˚g, of the sample
the asbestos material. filter, calculate the transmittance, T, for
5. Dilute to volume with isopropanol. each sample as follows: 26 27
6. Place the flask on a magnetic stirring
plate. Stir.
7. Prepare, in triplicate, a series of at least
five standard filters to cover the desired ana-
lytical range, using appropriate aliquots of
the 10 and 50 mg/L suspensions and the fol-
lowing procedure.
Mount a silver membrane filter on the fil-
tration apparatus. Place a few milliliters of
isopropanol in the reservoir. Vigorously
hand shake the asbestos suspension and im- Determine the correction factor, f(T), for
mediately withdraw an aliquot from the cen- each sample according to the formula:
ter of the suspension. Do not adjust the vol-
-R (ln T)
ume in the pipet by expelling part of the sus-

f (T) = llll
EC01AP92.019</MATH>
pension; if more than the desired aliquot is

l-TR
withdrawn, discard the aliquot and resume
the procedure with a clean pipet. Transfer where
370
EC01AP92.018</GPH>
sin QAg 7. H. Dunn and J. H. Stewart, Jr., Quan-

R= llll titative determination of chrysotile in build-
sin Qa ing materials, The Microscope, 29(1), 1981.
8. M. Taylor, Methods for the quantitative
qAg = angular position of the measured silver determination of asbestos and quartz in bulk
peak (from Bragg’s Law), and samples using X-ray diffraction, The Analyst,
qa = angular position of the diagnostic asbes- 103(1231):1009–1020, 1978.
tos peak. 9. L. Birks, M. Fatemi, J. V. Gilfrich, and
Calculate the weight, Wa, in micrograms, E. T. Johnson, Quantitative Analysis of Air-
of the asbestos material analyzed for in each borne Asbestos by X-ray Diffraction, Naval Re-
sample, using the appropriate calibration search Laboratory Report 7879, Naval Re-
data and absorption corrections: search Laboratory, Washington, DC, 1975.
10. U.S. Environmental Protection Agency,
Asbestos-Containing Materials in School Build-
ings: A Guidance Document, Parts 1 and 2,
EPA/OPPT No. C00090, March 1979.
11. J. B. Krause and W. H. Ashton,
Misidentification of asbestos in talc, pp. 339–
353, in: Proceedings of Workshop on Asbestos:
Definitions and Measurement Methods (NBS
Calculate the percent composition, Pa, of Special Publication 506), C. C. Gravatt, P. D.
each asbestos mineral analyzed for in the LaFleur, and K. F. Heinrich (eds.), Wash-
parent material, from the total sample ington, DC: National Measurement Labora-
weight, WT, on the filter: tory, National Bureau of Standards, 1977
Wa(1-.01L) (issued 1978).
Pa = llll— x 100 12. H. D. Stanley, The detection and identi-
WT fication of asbestos and asbesti-form min-
erals in talc, pp. 325–337, in Proceedings of
where Workshop on Asbestos: Definitions and Meas-
Pa = percent asbestos mineral in parent ma- urement Methods (NBS Special Publication
terial; 506), C. C. Gravatt, P. D. LaFleur, and K. F.
Wa = mass of asbestos mineral on filter, in Heinrich (eds.), Washington, DC, National
μg; Measurement Laboratory, National Bureau
WT = total sample weight on filter, in μg; of Standards, 1977 (issued 1978).
L = percent weight loss of parent material on 13. A. L. Rickards, Estimation of trace
ashing and/or acid treatment (see Sec- amounts of chrysotile asbestos by X-ray dif-
tion 2.7.2.3). fraction, Anal. Chem., 44(11):1872–3, 1972.
14. P. M. Cook, P. L. Smith, and D. G. Wil-
2.10 References son, Amphibole fiber concentration and de-
1. H. P. Klug and L. E. Alexander, X-ray termination for a series of community air
Diffraction Procedures for Polycrystalline and samples: use of X-ray diffraction to supple-
Amorphous Materials, 2nd ed., New York: ment electron microscope analysis, in: Elec-
John Wiley and Sons, 1979. tron Microscopy and X-ray Applications to En-
2. L. V. Azaroff and M. J. Buerger, The vironmental and Occupation Health Analysis,
Powder Method of X-ray Crystallography, New P. A. Russell and A. E. Hutchings (eds.), Ann
York: McGraw-Hill, 1958. Arbor: Ann Arbor Science Publications, 1977.
3. JCPDS-International Center for Diffraction 15. A. N. Rohl and A. M. Langer, Identifica-
Data Powder Diffraction File, U.S. Depart- tion and quantitation of asbestos in talc, En-
ment of Commerce, National Bureau of viron. Health Perspectives, 9:95–109, 1974.
Standards, and Joint Committee on Powder 16. J. L. Graf, P. K. Ase, and R. G. Draftz,
Diffraction Studies, Swarthmore, PA. Preparation and Characterization of Analytical
4. W. J. Campbell, C. W. Huggins, and A. G. Reference Minerals, DHEW (NIOSH) Publica-
Wylie, Chemical and Physical Characterization tion No. 79–139, June 1979.
of Amosite, Chrysotile, Crocidolite, and Non- 17. J. C. Haartz, B. A. Lange, R. G. Draftz,
fibrous Tremolite for National Institute of Envi- and R. F. Scholl, Selection and characteriza-
ronmental Health Sciences Oral Ingestion Stud- tion of fibrous and nonfibrous amphiboles for
ies, U.S. Bureau of Mines Report of Inves- analytical methods development, pp. 295–312,
tigation RI8452, 1980. in: Proceedings of Workshop on Asbestos: Defi-
5. B. A. Lange and J. C. Haartz, Determina- nitions and Measurement Methods (NBS Spe-
tion of microgram quantities of asbestos by cial Publication 506), C. C. Gravatt, P. D. La-
X-ray diffraction: Chrysotile in thin dust Fleur, and K. F. Heinrich (eds.), Washington,
layers of matrix material, Anal. Chem., DC: National Measurement Laboratory, Na-
51(4):520–525, 1979. tional Bureau of Standards, 1977 (issued

6. NIOSH Manual of Analytical Methods, 1978).
Volume 5, U.S. Dept. HEW, August 1979, pp. 18. Personal communication, A. M. Langer,
309–1 to 309–9. Environmental Sciences Laboratory, Mount
371
EC01AP92.020</MATH>
§ 763.120 40 CFR Ch. I (7–1–17 Edition)
Sinai School of Medicine of the City Univer- has exempted from the requirements of
sity of New York, New York, New York. this subpart under § 763.123, you must
19. A. M. Langer, M. S. Wolff, A. N. Rohl, follow the requirements of this subpart
and I. J. Selikoff, Variation of properties of
chrysotile asbestos subjected to milling, J.
to protect your employees from occu-
Toxicol. and Environ. Health, 4:173–188, 1978. pational exposure to asbestos.
20. A. M. Langer, A. D. Mackler, and F. D.
Pooley, Electron microscopical investigation § 763.122 What does this subpart re-
of asbestos fibers, Environ. Health Perspect., quire me to do?
9:63–80, 1974. If you are a State or local govern-
21. E. Occella and G. Maddalon, X-ray dif- ment employer whose employees per-
fraction characteristics of some types of as-
form:
bestos in relation to different techniques of
comminution, Med. Lavoro, 54(10):628–636, (a) Construction activities identified
1963. in 29 CFR 1926.1101(a), you must:
22. K. R. Spurny, W. Stöber, H. Opiela, and (1) Comply with the OSHA standards
G. Weiss, On the problem of milling and ul- in 29 CFR 1926.1101.
trasonic treatment of asbestos and glass fi- (2) Submit notifications required for
bers in biological and analytical applica- alternative control methods to the Di-
tions, Am. Ind. Hyg. Assoc. J., 41:198–203, 1980. rector, National Program Chemicals
23. L. G. Berry and B. Mason, Mineralogy,
San Francisco: W. H. Greeman & Co., 1959.
Division (7404), Office of Pollution Pre-
24. J. P. Schelz, The detection of chrysotile vention and Toxics, Environmental
asbestos at low levels in talc by differential Protection Agency, 1200 Pennsylvania
thermal analysis, Thermochimica Acta, 8:197– Ave., NW., Washington, DC 20460.
204, 1974. (b) Custodial activities not associ-
25. Reference 1, pp. 372–374. ated with the construction activities
26. J. Leroux, Staub-Reinhalt Luft, 29:26 identified in 29 CFR 1926.1101(a), you
(English), 1969.
27. J. A. Leroux, B. C. Davey, and A.
must comply with the OSHA standards
Paillard, Am. Ind. Hyg. Assoc. J., 34:409, 1973. in 29 CFR 1910.1001.
(c) Repair, cleaning, or replacement
[47 FR 23369, May 27, 1982; 47 FR 38535, Sept.
of asbestos-containing clutch plates
1, 1982; Redesignated at 60 FR 31922, June 19,
1995] and brake pads, shoes, and linings, or
removal of asbestos-containing residue
from brake drums or clutch housings,
Subpart F [Reserved] you must comply with the OSHA
standards in 29 CFR 1910.1001.
Subpart G—Asbestos Worker
Protection § 763.123 May a State implement its
own asbestos worker protection
plan?
SOURCE: 65 FR 69216, Nov. 15, 2000, unless
otherwise noted. This section describes the process
under which a State may be exempted
§ 763.120 What is the purpose of this from the requirements of this subpart.
subpart? (a) States seeking an exemption. If your
This subpart protects certain State State wishes to implement its own as-
and local government employees who bestos worker protection plan, rather
are not protected by the Asbestos than complying with the requirements
Standards of the Occupational Safety of this subpart, your State must apply
and Health Administration (OSHA). for and receive an exemption from
This subpart applies the OSHA Asbes- EPA.
tos Standards in 29 CFR 1910.1001 and 29 (1) What must my State do to apply for
CFR 1926.1101 to these employees. an exemption? To apply for an exemp-
tion from the requirements of this sub-
§ 763.121 Does this subpart apply to part, your State must send to the Di-
me? rector of EPA’s Office of Pollution Pre-
If you are a State or local govern- vention and Toxics (OPPT) a copy of
ment employer and you are not subject its asbestos worker protection regula-
to a State asbestos standard that tions and a detailed explanation of how
OSHA has approved under section 18 of your State’s asbestos worker protec-
the Occupational Safety and Health tion plan meets the requirements of
Act or a State asbestos plan that EPA TSCA section 18 (15 U.S.C. 2617).
372
(2) What action will EPA take on my State’s updated asbestos worker pro-
State’s application for an exemption? tection plan meets the requirements of
EPA will review your State’s applica- TSCA section 18.
tion and make a preliminary deter- (i) If EPA determines that the up-
mination whether your State’s asbes- dated State plan does meet the require-
tos worker protection plan meets the ments of TSCA section 18, EPA will
requirements of TSCA section 18. issue your State an amended exemp-
(i) If EPA’s preliminary determination.
tion is that your State’s plan does (ii) If EPA determines that the up-
meet the requirements of TSCA section dated State plan does not meet the re-
18, EPA will initiate a rulemaking, in- quirements of TSCA section 18, EPA
cluding an opportunity for public com- will notify your State in writing and
ment, to exempt your State from the will give your State a reasonable op-
requirements of this subpart. After portunity to respond to that deter-
considering any comments, EPA will mination.
issue a final rule granting or denying
(iii) If EPA does not grant your State
the exemption.
an amended exemption, or if your
(ii) If EPA’s preliminary determina-
tion is that the State plan does not State does not submit a timely request
meet the requirements of TSCA section for amended exemption, then the State
18, EPA will notify your State in writ- and local government employers in
ing and will give your State a reason- your State are subject to the require-
able opportunity to respond to that de- ments of this subpart.
termination.
(iii) If EPA does not grant your State Subpart H [Reserved]
an exemption, then the State and local
government employers in your State Subpart I—Prohibition of the Man-
are subject to the requirements of this ufacture, Importation, Proc-
subpart.
(b) States that have been granted an ex-
essing, and Distribution in
emption. If EPA has exempted your Commerce of Certain Asbes-
State from the requirements of this tos-Containing Products; La-
subpart, your State must update its as- beling Requirements
bestos worker protection regulations
as necessary to implement changes to SOURCE: 54 FR 29507, July 12, 1989, unless
meet the requirements of this subpart, otherwise noted.
and must apply to EPA for an amend-
ment to its exemption. § 763.160 Scope.
(1) What must my State do to apply for This subpart prohibits the manufac-
an amendment to its exemption? To apply ture, importation, processing, and dis-
for an amendment to its exemption, tribution in commerce of the asbestos-
your State must send to the Director containing products identified and at
of OPPT a copy of its updated asbestos the dates indicated in §§ 763.165, 763.167,
worker protection regulations and a and 763.169. This subpart requires that
detailed explanation of how your products subject to this rule’s bans,
State’s updated asbestos worker pro-
but not yet subject to a ban on dis-
tection plan meets the requirements of
tribution in commerce, be labeled. This
TSCA section 18. Your State must sub-
subpart also includes general exemp-
mit its application for an amendment
tions and procedures for requesting ex-
within 6 months of the effective date of
emptions from the provisions of this
any changes to the requirements of
subpart.
this subpart, or within a reasonable
time agreed upon by your State and § 763.163 Definitions.
OPPT.
(2) What action will EPA take on my For purposes of this subpart:
State’s application for an amendment? Act means the Toxic Substances Con-
EPA will review your State’s applica- trol Act, 15 U.S.C. 2601 et seq.
tion for an amendment and make a pre- Agency means the United States En-
liminary determination whether your vironmental Protection Agency.
373
§ 763.163 40 CFR Ch. I (7–1–17 Edition)
Asbestos means the asbestiform vari- toms territory of the United States for
eties of: chrysotile (serpentine); crocid- export without any use, processing, or
olite (riebeckite); amosite disposal within the customs territory
(cummingtonite-grunerite); tremolite; of the United States; or (2) entering the
anthophyllite; and actinolite. customs territory of the United States
Asbestos-containing product means any as a component of a product during
product to which asbestos is delib- normal personal or business activities
erately added in any concentration or involving use of the product.
which contains more than 1.0 percent Importer means anyone who imports a
asbestos by weight or area. chemical substance, including a chem-
Chemical substance, has the same ical substance as part of a mixture or
meaning as in section 3 of the Act. article, into the customs territory of
Commerce has the same meaning as in the United States. Importer includes
section 3 of the Act. the person primarily liable for the pay-
Commercial paper means an asbestos- ment of any duties on the merchandise
containing product which is made of or an authorized agent acting on his or
paper intended for use as general insu- her behalf. The term includes as appro-
lation paper or muffler paper. Major priate:
applications of commercial papers are (1) The consignee.
insulation against fire, heat transfer, (2) The importer of record.
and corrosion in circumstances that re- (3) The actual owner if an actual
quire a thin, but durable, barrier. owner’s declaration and superseding
Corrugated paper means an asbestos- bond has been filed in accordance with
containing product made of corrugated 19 CFR 141.20.
paper, which is often cemented to a flat (4) The transferee, if the right to
backing, may be laminated with foils withdraw merchandise in a bonded
or other materials, and has a cor- warehouse has been transferred in ac-
rugated surface. Major applications of cordance with subpart C of 19 CFR part
asbestos corrugated paper include: 144.
thermal insulation for pipe coverings; Manufacture means to produce or
block insulation; panel insulation in manufacture in the United States.
elevators; insulation in appliances; and Manufacturer means a person who
insulation in low-pressure steam, hot produces or manufactures in the
water, and process lines. United States.
Customs territory of the United States New uses of asbestos means commer-
means the 50 States, Puerto Rico, and cial uses of asbestos not identified in
the District of Columbia. § 763.165 the manufacture, importation
Distribute in commerce has the same or processing of which would be initi-
meaning as in section 3 of the Act, but ated for the first time after August 25,
the term does not include actions 1989.
taken with respect to an asbestos-con- Person means any natural person,
taining product (to sell, resale, deliver, firm, company, corporation, joint-ven-
or hold) in connection with the end use ture, partnership, sole proprietorship,
of the product by persons who are users association, or any other business enti-
(persons who use the product for its in- ty; any State or political subdivision
tended purpose after it is manufactured thereof, or any municipality; any
or processed). The term also does not interstate body and any department,
include distribution by manufacturers, agency, or instrumentality of the Fed-
importers, and processors, and other eral Government.
persons solely for purposes of disposal Process has the same meaning as in
of an asbestos-containing product. section 3 of the Act.
Flooring felt means an asbestos-con- Processor has the same meaning as in
taining product which is made of paper section 3 of the Act.
felt intended for use as an underlayer Rollboard means an asbestos-con-
for floor coverings, or to be bonded to taining product made of paper that is
the underside of vinyl sheet flooring. produced in a continuous sheet, is
Import means to bring into the cus- flexible, and is rolled to achieve a de-
toms territory of the United States, ex- sired thickness. Asbestos rollboard
cept for: (1) Shipment through the cus- consists of two sheets of asbestos paper
374
laminated together. Major applications § 763.167 Processing prohibitions.

of this product include: office parti- (a) After August 27, 1990, no person
tioning; garage paneling; linings for shall process for any use, either in the
stoves and electric switch boxes; and United States or for export, any of the
fire-proofing agent for security boxes, asbestos-containing products listed at
safes, and files. § 763.165(a).
Specialty paper means an asbestos- (b) After August 26, 1996, no person
containing product that is made of shall process for any use, either in the
paper intended for use as filters for United States or for export, any of the
beverages or other fluids or as paper asbestos-containing products listed at
fill for cooling towers. Cooling tower § 763.165(b).
fill consists of asbestos paper that is [59 FR 33209, June 28, 1994]
used as a cooling agent for liquids from
industrial processes and air condi- § 763.169 Distribution in commerce
tioning systems. prohibitions.
State has the same meaning as in sec- (a) After August 25, 1992, no person
tion 3 of the Act. shall distribute in commerce, either for
Stock-on-hand means the products use in the United States or for export,
which are in the possession, direction, any of the asbestos-containing prod-
or control of a person and are intended ucts listed at § 763.165(a).
for distribution in commerce. (b) After August 25, 1997, no person
shall distribute in commerce, either for
United States has the same meaning
use in the United States or for export,
as in section 3 of the Act. any of the asbestos-containing prod-
[59 FR 33208, June 28, 1994] ucts listed at § 763.165(b).
(c) A manufacturer, importer, proc-
§ 763.165 Manufacture and importation essor, or any other person who is sub-
prohibitions. ject to a ban on distribution in com-
(a) After August 27, 1990, no person merce in paragraph (a) or (b) of this
shall manufacture or import the fol- section must, within 6 months of the
effective date of the ban of a specific
lowing asbestos-containing products,
asbestos-containing product from dis-
either for use in the United States or
tribution in commerce, dispose of all
for export: flooring felt and new uses of their remaining stock-on-hand of that
asbestos. product, by means that are in compli-
(b) After August 26, 1996, no person ance with applicable local, State, and
shall manufacture or import the fol- Federal restrictions which are current
lowing asbestos-containing products, at that time.
either for use in the United States or
[59 FR 33209, June 28, 1994]
for export: commercial paper, cor-
rugated paper, rollboard, and specialty § 763.171 Labeling requirements.
paper.
(a) After August 27, 1990, manufactur-
(c) The import prohibitions of this ers, importers, and processors of all as-
subpart do not prohibit: bestos-containing products that are
(1) The import into the customs ter- identified in § 763.165(a) shall label the
ritory of the United States of products products as specified in this subpart at
imported solely for shipment outside the time of manufacture, import, or
the customs territory of the United processing. This requirement includes
States, unless further repackaging or labeling all manufacturers’, importers’,
processing of the product is performed and processors’ stock-on-hand as of Au-
in the United States; or gust 27, 1990.
(2) Activities involving purchases or (b) After August 25, 1995, manufactur-
acquisitions of small quantities of ers, importers, and processors of all as-
products made outside the customs ter- bestos-containing products that are
ritory of the United States for personal identified in § 763.165(b), shall label the
use in the United States. products as specified in this subpart at

the time of manufacture, import, or
[59 FR 33209, June 28, 1994] processing. This requirement includes
375
§ 763.173 40 CFR Ch. I (7–1–17 Edition)
labeling all manufacturers’, importers’, NOTICE

and processors’ stock-on-hand as of Au- This product contains ASBESTOS. The U.S.
gust 25, 1995. Environmental Protection Agency has
(c) The label shall be placed directly banned the distribution in U.S. commerce of
on the visible exterior of the wrappings this product under section 6 of the Toxic
Substances Control Act (15 U.S.C. 2605) as of
and packaging in which the product is (insert effective date of ban on distribution
placed for sale, shipment, or storage. If in commerce). Distribution of this product in
the product has more than one layer of commerce after this date and intentionally
external wrapping or packaging, the removing or tampering with this label are
label must be attached to the inner- violations of Federal law.
most layer adjacent to the product. If (e) No one may intentionally remove,
the innermost layer of product wrap- deface, cover, or otherwise obscure or
ping or packaging does not have a visi- tamper with a label or sticker that has
ble exterior surface larger than 5 been applied in compliance with this
square inches, either a tag meeting the section, except when the product is
requirements of paragraph (d) of this used or disposed of.
section must be securely attached to [59 FR 33209, June 28, 1994]
the product’s innermost layer of prod-
uct wrapping or packaging, or a label § 763.173 Exemptions.
must be attached to the next outer (a) Persons who are subject to the
layer of product packaging or wrap- prohibitions imposed by § 763.165,
ping. Any products that are distributed § 763.167, or § 763.169 may file an applica-
in commerce to someone other than tion for an exemption. Persons whose
the end user, shipped, or stored with- exemption applications are approved
out packaging or wrapping must be la- by the Agency may manufacture, im-
beled or tagged directly on a visible export, process, or distribute in com-
terior surface of the product as de- merce the banned product as specified
scribed in paragraph (d) of this section. in the Agency’s approval of the appli-
(d)(1) Labels must be either printed cation. No applicant for an exemption
directly on product packaging or in the may continue the banned activity that
form of a sticker or tag made of plas- is the subject of an exemption applica-
tic, paper, metal, or other durable sub- tion after the effective date of the ban
unless the Agency has granted the ex-
stances. Labels must be attached in
emption or the applicant receives an
such a manner that they cannot be re-
extension under paragraph (b)(4) or (5)
moved without defacing or destroying
of this section.
them. Product labels shall appear as in (b) Application filing dates. (1) Appli-
paragraph (d)(2) of this section and cations for products affected by the
consist of block letters and numerals of prohibitions under §§ 763.165(a) and
color that contrasts with the back- 763.167(a) may be submitted at any
ground of the label or tag. Labels shall time and will be either granted or de-
be sufficiently durable to equal or ex- nied by EPA as soon as is feasible.
ceed the life, including storage and dis- (2) Applications for products affected
posal, of the product packaging or by the ban under § 763.169(a) may be
wrapping. The size of the label or tag submitted at any time and will be ei-
must be at least 15.25 cm (6 inches) on ther granted or denied by EPA as soon
each side. If the product packaging is as is feasible.
too small to accommodate a label of (3) Applications for products affected
this size, the label may be reduced in by the ban under §§ 763.165(b) and
size proportionately to the size of the 763.167(b) may not be submitted prior
product packaging or wrapping down to to February 27, 1995. Complete applica-
a minimum 2.5 cm (1 inch) on each side tions received after that date, but be-
if the product wrapping or packaging fore August 25, 1995, will be either
has a visible exterior surface larger granted or denied by the Agency prior
to the effective date of the ban for the
than 5 square inches.

product. Applications received after
(2) Products subject to this subpart
August 25, 1995, will be either granted
shall be labeled in English as follows: or denied by EPA as soon as is feasible.
376
(4) Applications for products affected 20460, ATTENTION: Asbestos Exemp-

by the ban under § 763.169(b) may not be tion. For information regarding the
submitted prior to February 26, 1996. submission of exemptions containing
Complete applications received after information claimed as confidential
that date, but before August 26, 1996, business information (CBI), see
will be either granted or denied by the § 763.179.
Agency prior to the effective date of (d) Content of application and cri-
the ban for the product. Applications teria for decisionmaking.
received after August 26, 1996, will be (1) Content of application. Each ap-
either granted or denied by EPA as plication must contain the following:
soon as is feasible. (i) Name, address, and telephone
(5) The Agency will consider an appli- number of the applicant.
cation for an exemption from a ban (ii) Description of the manufacturing,
under § 763.169 for a product at the same import, processing, and/or distribution
time the applicant submits an applica- in commerce activity for which an ex-
tion for an exemption from a ban under emption is requested, including a de-
§ 763.165 or § 763.167 for that product. scription of the asbestos-containing
EPA will grant an exemption at that product to be manufactured, imported,
time from a ban under § 763.169 if the processed, or distributed in commerce.
Agency determines it appropriate to do (iii) Identification of locations at
so. which the exempted activity would
(6) If the Agency denies an applica- take place.
tion less than 30 days before the effec- (iv) Length of time requested for ex-
tive date of a ban for a product, the ap- emption (maximum length of an ex-
plicant can continue the activity for 30 emption is 4 years).
days after receipt of the denial from (v) Estimated amount of asbestos to
the Agency. be used in the activity that is the sub-
(7) If the Agency fails to meet the ject of the exemption application.
deadlines stated in paragraphs (b)(3) (vi) Data demonstrating the exposure
and (b)(4) of this section for granting or level over the life cycle of the product
denying a complete application in in- that is the subject of the application.
stances in which the deadline is before (vii) Data concerning:
the effective date of the ban to which (A) The extent to which non-asbestos
the application applies, the applicant substitutes for the product that is the
will be granted an extension of 1 year subject of the application fall signifi-
from the Agency’s deadline date. Dur- cantly short in performance under nec-
ing this extension period the applicant essary product standards or require-
may continue the activity that is the ments, including laws or ordinances
subject of the exemption application. mandating product safety standards.
The Agency will either grant or deny (B) The costs of non-asbestos sub-
the application during the extension stitutes relative to the costs of the as-
period. The extension period will ter- bestos-containing product and, in the
minate either on the date the Agency case in which the product is a compo-
grants the application or 30 days after nent of another product, the effect on
the applicant receives the Agency’s de- the cost of the end use product of using
nial of the application. However, no ex- the substitute component.
tension will be granted if the Agency is (C) The extent to which the product
scheduled to grant or deny an applica- or use serves a high-valued use.
tion at some date after the effective (viii) Evidence of demonstrable good
date of the ban, pursuant to the dead- faith attempts by the applicant to de-
lines stated in paragraphs (b)(3) and velop and use a non-asbestos substance
(b)(4) of this section. or product which may be substituted
(c) Where to file. All applications for the asbestos-containing product or
must be submitted to the following lo- the asbestos in the product or use that
cation: TSCA Docket Receipts Office is the subject to the application.
(7407), Office of Pollution Prevention (ix) Evidence, in addition to that pro-
and Toxics, U.S. Environmental Pro- vided in the other information required
tection Agency, Rm E-G99, 1200 Penn- with the application, showing that the
sylvania Ave., NW., Washington, DC continued manufacture, importation,
377
§ 763.175 40 CFR Ch. I (7–1–17 Edition)
processing, distribution in commerce, mine that an extension period provided

and use, as applicable, of the product for in paragraph (b)(5) of this section is
will not present an unreasonable risk unavailable to the applicant.
of injury to human health. (h) When denying an application, the
(2) Criteria for decision (existing Agency will notify the applicant by
products). After considering all the in- registered mail of its decision and ra-
formation provided by an applicant tionale. Whenever possible, the Agency
under paragraphs (d)(1) and (e) of this will send this letter prior to the appro-
section, and any other information priate ban. This letter will be consid-
available to EPA, EPA will grant an ered a final Agency action for purposes
exemption from the prohibitions in of judicial review. A notice announcing
§ 763.165, § 763.167, or § 763.169 for an ap- the Agency’s denial of the application
plicant’s asbestos-containing product will be published in the FEDERAL REG-
only if EPA determines both of the fol- ISTER.
lowing: (i) If the Agency proposes to approve
(i) The applicant has made good faith an exemption, it will issue a notice in
attempts to develop and use a non-as- the FEDERAL REGISTER announcing this
bestos substance or product which may intent and invite public comments. If,
be substituted for the asbestos-con- after considering any timely comments
taining product or the asbestos in the received, the Agency approves an ex-
product or use, and those attempts emption, its decision will be published
have failed to produce a substitute or a in the FEDERAL REGISTER. This notice
substitute that results in a product will be considered a final Agency ac-
that can be economically produced. tion for purposes of judicial review.
(ii) Continued manufacturing, proc- (j) The length of an exemption period
essing, distribution in commerce, and will be specified by the agency when it
use, as applicable, of the product will approves the exemption. To extend an
not present an unreasonable risk of in- exemption period beyond the period
jury to human health. stipulated by EPA, applicants must
(3) Criteria for decision (new prod- submit a new application to the Agen-
ucts). Requests to develop and use an cy, following the application proce-
asbestos substance or product will be dures described in this section. Appli-
treated as a petition pursuant to sec- cations may not be submitted prior to
tion 21 of TSCA. 15 months before the expiration of the
(e) The Agency reserves the right to exemption period, unless stated other-
request further information from an wise in the notice granting the exemp-
exemption applicant if necessary to tion. Applications received between 15
complete the Agency’s evaluation of an months and 1 year before the end of the
application. exemption period will be either granted
(f) Upon receipt of a complete appli- or denied by the Agency before the end
cation, the Agency will issue a notice of the exemption period. Applications
in the FEDERAL REGISTER announcing received after the date 1 year prior to
its receipt and invite public comments the end of the exemption period will be
on the merits of the application. either granted or denied by the Agency
(g) If the application does not include as soon as is feasible. Applicants may
all of the information required in para- not continue the activity that is the
graph (d) of this section, the Agency subject of the renewal application after
will return it to the applicant as in- the date of the end of the exemption
complete and any resubmission of the period.
application will be considered a new [54 FR 29507, July 12, 1989; 54 FR 37531, Sept.
application for purposes of the avail- 11, 1989, as amended at 54 FR 46898, Nov. 8,
ability of any extension period. If the 1989; 59 FR 33210, June 28, 1994]
application is substantially inadequate
to allow the Agency to make a rea- § 763.175 Enforcement.
soned judgment on any of the informa- (a) Failure to comply with any provi-
tion required in paragraph (d) of this sion of this subpart is a violation of
section and the Agency chooses to re- section 15 of the Act (15 U.S.C. 2614).
quest additional information from the (b) Failure or refusal to establish and
applicant, the Agency may also deter- maintain records, or to permit access
378
to or copying of records as required by and sales and the quantities purchased

section 11 of the Act (15 U.S.C. 2610) is or sold. These records must be main-
a violation of section 15 of the Act (15 tained for 3 years after the effective
U.S.C. 2614). date of the § 763.169 ban for the product.
(c) Failure or refusal to permit entry (2) Each person who is subject to the
or inspection as required by section 11 requirements of § 763.171 must, for each
of the Act (15 U.S.C. 2610) is a violation product required to be labeled, main-
of section 15 of the Act (15 U.S.C. 2614). tain a copy of the label used in compli-
(d) Violators may be subject to the ance with § 763.171. These records must
civil and criminal penalties in section be maintained for 3 years after the ef-
16 of the Act (15 U.S.C. 2615) for each fective date of the ban on distribution
violation. in commerce for the product for which
(e) The Agency may seek to enjoin the § 763.171 requirements apply.
the manufacture, import, processing, [54 FR 29507, July 12, 1989, as amended at 54
or distribution in commerce of asbes- FR 46898, Nov. 8, 1989; 58 FR 34205, June 23,
tos-containing products in violation of 1993]
this subpart, or act to seize any asbes-
tos-containing products manufactured, § 763.179 Confidential business infor-
imported, processed, or distributed in mation claims.
commerce in violation of this subpart, (a) Applicants for exemptions under
or take any other actions under the au- § 763.173 may assert a Confidential Busi-
thority of section 7 or 17 of the Act (15 ness Information (CBI) claim for infor-
U.S.C. 2606 or 2616) that are appro- mation in an exemption application or
priate. supplement submitted to the Agency
under this subpart only if the claim is
§ 763.176 Inspections. asserted in accordance with this sec-
The Agency will conduct inspections tion, and release of the information
under section 11 of the Act (15 U.S.C. would reveal trade secrets or confiden-
2610) to ensure compliance with this tial commercial or financial informa-
subpart. tion, as provided in section 14(a) of the
Act. Information covered by a CBI
§ 763.178 Recordkeeping. claim will be treated in accordance
(a) Inventory. (1) Each person who is with the procedures set forth in 40 CFR
subject to the prohibitions imposed by part 2, subpart B. The Agency will
§§ 763.165 and 763.167 must perform an place all information not claimed as
inventory of the stock-on-hand of each CBI in the manner described in this
banned product as of the effective date section in a public file without further
of the ban for that product for the ap- notice to the applicant.
plicable activity. (b) Applicants may assert CBI claims
(2) The inventory shall be in writing only at the time they submit a com-
and shall include the type of product, pleted exemption application and only
the number of product units currently in the specified manner. If no such
in the stock-on-hand of the person per- claim accompanies the information
forming the inventory, and the loca- when it is received by the Agency, the
tion of the stock. information may be made available to
(3) Results of the inventory for a the public without further notice to
banned product must be maintained by the applicant. Submitters that claim
the person for 3 years after the effec- information as business confidential
tive date of the § 763.165 or § 763.167 ban must do so by writing the word ‘‘Con-
on the product. fidential’’ at the top of the page on
(b) Records. (1) Each person whose ac- which the information appears and by
tivities are subject to the bans imposed underlining, circling, or placing brack-
by §§ 763.165, 763.167, and 763.169 for a ets ([ ]) around the information
product must, between the effective claimed CBI.
date of the § 763.165 or § 763.167 ban on (c) Applicants who assert a CBI claim
the product and the § 763.169 ban on the for submitted information must pro-
product, keep records of all commer- vide the Agency with two copies of
cial transactions regarding the prod- their exemption application. The first
uct, including the dates of purchases copy must be complete and contain all
379
information being claimed as CBI. The (5) Does the information claimed as
second copy must contain only infor- confidential appear or is it referred to
mation not claimed as CBI. The Agen- in advertising or promotional mate-
cy will place the second copy of the rials for the product or the resulting
submission in a public file. Failure to end product, safety data sheets or
furnish a second copy of the submission other similar materials for the product
when information is claimed as CBI in or the resulting end product, profes-
the first copy will be considered a pre- sional or trade publications, or any
sumptive waiver of the claim of con- other media available to the public or
fidentiality. The Agency will notify the to your competitors? If you answered
applicant by certified mail that a find- yes, indicate where the information ap-
ing of a presumptive waiver of the pears.
claim of confidentiality has been made. (6) If the Agency disclosed the infor-
The applicant has 30 days from the mation you are claiming as confiden-
date of receipt of notification to sub- tial to the public, how difficult would
mit the required second copy. Failure it be for the competitor to enter the
to submit the second copy will cause market for your product? Consider in
the Agency to place the first copy in a your answer such constraints as cap-
public file. ital and marketing cost, specialized
technical expertise, or unusual proc-
(d) Applicants must substantiate all
esses.
claims of CBI at the time the applicant
(7) Has the Agency, another Federal
asserts the claim, i.e., when the exemp- agency, or a Federal court made any
tion application or supplement is sub- confidentiality determination regard-
mitted, by responding to the questions ing this information? If so, provide cop-
in paragraph (e) of this section. Failure ies of such determinations.
to provide substantiation of a claim at (8) How would your company’s com-
the time the applicant submits the ap- petitive position be harmed if the
plication will result in a waiver of the Agency disclosed this information?
CBI claim, and the information may be Why should such harm be considered
disclosed to the public without further substantial? Describe the causal rela-
notice to the applicant. tionship between the disclosure and
(e) Applicants who assert any CBI harm.
claims must substantiate all claims by (9) In light of section 14(b) of TSCA,
providing detailed responses to the fol- if you have claimed information from a
lowing: health and safety study as confidential,
(1) Is this information subject to a do you assert that disclosure of this in-
patent or patent application in the formation would disclose a process
United States or elsewhere? If so, why used in the manufacturing or proc-
is confidentiality necessary? essing of a product or information un-
(2) For what period do you assert a related to the effects of asbestos on
claim of confidentiality? If the claim is human health and the environment? If
to extend until a certain event or point your answer is yes, explain.
in time, please indicate that event or
time period. Explain why such informa- PART 766—DIBENZO-PARA-
tion should remain confidential until DIOXINS/DIBENZOFURANS
such point.
(3) Has the information that you are Subpart A—General Provisions
claiming as confidential been disclosed
Sec.
to persons outside of your company? 766.1 Scope and purpose.
Will it be disclosed to such persons in 766.2 Applicability and duration of this
the future? If so, what restrictions, if part.
any, apply to use or further disclosure 766.3 Definitions.
of the information? 766.5 Compliance.
(4) Briefly describe measures taken 766.7 Submission of information.
766.10 Test standards.
by your company to guard against
766.12 Testing guidelines.

undesired disclosure of the information 766.14 Contents of protocols.
you are claiming as confidential to 766.16 Developing the analytical test meth-
others. od.
380
766.18 Method sensitivity. in part 790 of this chapter and any
modifications to such procedures con-
Subpart B—Specific Chemical Testing/ tained in this part.
Reporting Requirements
(d) Section 766.32 specifies conditions
766.20 Who must test. under which persons required to test
766.25 Chemical substances for testing. may request an exclusion or waiver
766.27 Congeners and LOQs for which quan- from testing.
titation is required.
(e) Deadlines for submission to EPA
766.28 Expert review of protocols.
766.32 Exclusions and waivers. of protocols, reports, studies, and test
766.35 Reporting requirements. results are specified in part 790, sub-
766.38 Reporting on precursor chemical subpart C and § 766.35.
stances. (f) Sections 766.10, 766.12, 766.14,
AUTHORITY: 15 U.S.C. 2603 and 2607. 766.16, and 766.18 prescribe analytical
methods required; § 766.27 prescribes
otherwise noted. target levels of quantitation (LOQ) for
each congener for which quantitation
is required.
Subpart A—General Provisions (g) If results of existing tests or tests
§ 766.1 Scope and purpose. performed under this part indicate the
presence of HDDs/HDFs in the identi-
(a) This part identifies requirements
fied chemical substance above the LOQ
for testing under section 4 of the Toxic
specified in § 766.27, § 766.35(c) requires
Substances Control Act (TSCA), 15
the following additional reporting on
U.S.C. 2603, to ascertain whether cer-
the specified chemicals: production,
tain specified chemical substances may
process, use, exposure and disposal
be contaminated with halogenated
data under section 8(a) of TSCA; health
dibenzodioxins (HDDs)/dibenzofurans
(HDFs) as defined in § 766.3, and re- and safety studies under section 8(d) of
quirements for reporting under section TSCA; and reports of allegations of sig-
8 of TSCA, 15 U.S.C. 2607. nificant adverse reactions under sec-
(b) Section 766.35(b) requires manu- tion 8(c) of TSCA. In some cases, addi-
facturers and processors of chemical tional reporting may be required of
substances identified in § 766.25 to sub- manufacturers reporting no contami-
mit to EPA: nation of the identified chemical sub-
(1) Any existing test data showing stances under § 766.35(c)(2).
analysis of the chemical substances for (h) Section 766.38 requires manufac-
concentrations of HDDs/HDFs, applica- turers of chemical substances produced
ble protocols, and the results of the from chemical substances identified as
analysis for HDDs/HDFs, (2) allegations possible precursors to HDD/HDF forma-
of significant adverse reactions to tion, to report on chemical substances
HDDs/HDFs, compiled in accordance produced from such precursors.
with part 717 of this chapter, and (3)
health and safety studies on the HDDs/ § 766.2 Applicability and duration of
this part.
HDFs, in accordance with applicable
provisions of part 716 of this chapter. (a) Chemical substances subject to test-
(c) Section 766.35(a) requires manu- ing. (1) This part is applicable to each
facturers and, under certain cir- person who, at any time during the du-
cumstances, processors of chemical ration of this part, manufactures (and/
substances identified in § 766.25 to sub- or imports), or processes, a chemical
mit letters of intent to test and proto- substance identified under § 766.25.
cols for the analysis of the chemical (2) The duration of this part for any
substances for the presence of HDDs/ testing requirement for any chemical
HDFs. Section 766.20 requires these substance is the period commencing
manufacturers and processors to test with the effective date of this part to
their chemical substances for the pres- the end of the reimbursement period,
ence of HDDs/HDFs. Any submissions as defined in § 766.3, for each chemical
must be in accordance with the EPA substance. All reporting requirements

Procedures Governing Testing Consent for any chemical substance listed
Agreements and Test Rules contained under § 766.25 shall be in effect for the
381
§ 766.3 40 CFR Ch. I (7–1–17 Edition)
same period as the testing require- or totally brominated at the following

ment. positions on the molecular structure:
(b) Precursor chemical substances. (1) 2,3,7,8; 1,2,3,7,8; 1,2,3,4,7,8; 1,2,3,6,7,8;
This part is applicable to each person 1,2,3,7,8,9; and 1,2,3,4,7,8,9.
who manufactures (and/or imports) a HDF or 2,3,7,8-HDF means any of the
chemical substance from any precursor dibenzofurans totally chlorinated or
chemical substance identified in totally brominated at the following po-
§ 766.38. sitions on the molecular structure:
(2) The requirement for precursor re- 2,3,7,8; 1,2,3,7,8; 2,3,4,7,8; 1,2,3,4,7,8;
porting under § 766.38 shall be in effect 1,2,3,6,7,8; 1,2,3,7,8,9; 2,3,4,6,7,8;
until three years after the effective 1,2,3,4,6,7,8; and 1,2,3,4,7,8,9.
date of this part. Homolog means a group of isomers
(3) Small manufacturers are exempt that have the same degree of halo-
from reporting process and reaction genation. For example, the homologous
condition data on chemical substances class of tetrachlorodibenzo-p-dioxins
made from precursor chemical sub- consists of all dibenzo-p-dioxins con-
stances listed under § 766.38. taining four chlorine atoms. When the
homologous classes discussed in this
§ 766.3 Definitions. part are referred to, the following ab-
The definitions in section 3 of TSCA breviations for the prefix denoting the
and the definitions of §§ 704.3, 716.3, number of halogens are used:
717.3, and 790.3 of this chapter also tetra-, T (4 atoms)
apply to this part. penta-, Pe (5 atoms)
Central Data Exchange or CDX means hexa-, Hx (6 atoms)
hepta-, Hp (7 atoms)
EPA’s centralized electronic submis-
sion receiving system. HRGC means high resolution gas
Chemical Information Submission Sys- chromatography.
tem or CISS means EPA’s electronic, HRMS means high resolution mass
web-based reporting tool for the com- spectrometry.
pletion and submission of data, reports, Level of quantitation or LOQ means
and other information, or its succes- the lowest concentration at which
sors. HDDs/HDFs can be reproducibly meas-
Congener means any one particular ured in a specific chemical substance
member of a class of chemical sub- within specified confidence limits, as
stances. A specific congener is denoted described in this part.
by unique chemical structure, for ex- Polybrominated dibenzofurans refers to
ample 2,3,7,8-tetrachlorodibenzofuran. any member of a class of dibenzofurans
Dibenzofuran means any of a family with two to eight bromine
of compounds which has as a nucleus a substituents.
triple-ring structure consisting of two Polybrominated dibenzo-p-dioxin or
benzene rings connected through a pair PBDD means to any member of a class
of bridges between the benzene rings. of dibenzo-p-dioxins with two to eight
The bridges are a carbon-carbon bridge bromine substituents.
and a carbon-oxygen-carbon bridge at Polychlorinated dibenzofuran means
both substitution positions. any member of a class of dibenzofurans
Dibenzo-p-dioxin or dioxin means any with two to eight chlorine
of a family of compounds which has as substituents.
a nucleus a triple-ring structure con- Polychlorinated dibenzo-p-dioxin or
sisting of two benzene rings connected PCDD means any member of a class of
through a pair of oxygen atoms. dibenzo-p-dioxins with two to eight
Guidelines means the Midwest Re- chlorine substituents.
search Institute (MRI) publication Polyhalogenated dibenzofuran or
Guidelines for the Determination of PHDF means any member of a class of
Polyhalogenated Dioxins and dibenzofurans containing two to eight
Dibenzofurans in Commercial Products, chlorine, bromine, or a combination of
EPA contract No. 68–02–3938; MRI chlorine and bromine substituents.
Project No. 8201–A(41), 1985. Polyhalogenated dibenzo-p-dioxin or

HDD or 2,3,7,8-HDD means any of the PHDD means any member of a class of
dibenzo-p-dioxins totally chlorinated dibenzo-p-dioxins containing two to
382
eight chlorine substituents or two to (b) You must use the CISS tool to
eight bromine substituents. complete and submit all data, reports,
Positive test result means: (1) Any re- and other information required under
solvable gas chromatographic peak for this part except for records and reports
any 2,3,7,8-HDD or HDF which exceeds of allegations of significant adverse re-
the LOQ listed under § 766.27 for that actions, which must be submitted in
congener, or (2) exceeds LOQs approved accordance with paragraph (c) of this
by EPA under § 766.28. section.
Precursor means a chemical sub- (1) Submissions must be submitted to
stance which is not contaminated due EPA via CDX.
to the process conditions under which (2) To access the CISS tool go to
it is manufactured, but because of its https://cdx.epa.gov/ssl/CSPP/
molecular structure, and under favor- PrimaryAuthorizedOfficial/Home.aspx
able process conditions, it may cause and follow the appropriate links and
or aid the formation of HDDs/HDFs in for further instructions to go http://
other chemicals in which it is used as www.epa.gov/oppt/chemtest/ereporting/
a feedstock or intermediate. index.html.
QA means quality assurance. (c) You must submit records and re-
QC means quality control. ports of allegations of significant ad-
Reimbursement period means the pe- verse reactions and the accompanying
riod that begins when the data from cover letters by one of the following
the last test to be completed under this methods:
part for a specific chemical substance (1) Mail, preferably certified, to the
listed in § 766.25 is submitted to EPA, Document Control Office (DCO)
and ends after an amount of time equal (7407M), Office of Pollution Prevention
to that which had been required to de- and Toxics (OPPT), Environmental
velop that data or 5 years, whichever is Protection Agency, 1200 Pennsylvania
later. Ave. NW., Washington, DC 20460–0001,
TSCA means the Toxic Substances ATTN: Dioxin/Furan report part 766,
Control Act, 15 U.S.C. 2601 et seq. Allegations of significant adverse reac-
tions.
FR 72828, Dec. 4, 2013] (2) Hand delivery to OPPT Document
Control Office (DCO), EPA East, Rm.
§ 766.5 Compliance. 6428, 1201 Constitution Ave. NW., Wash-
ington, DC, ATTN: Dioxin/Furan report
Any person who fails or refuses to
part 766, Allegations of significant ad-
comply with any aspect of this part is
verse reactions. The DCO is open from
in violation of section 15 of TSCA. Sec-
8 a.m. to 4 p.m., Monday through Fri-
tion 15(1) makes it unlawful for any
day, excluding legal holidays. The tele-
person to fail or refuse to comply with
phone number for the DCO is (202) 564–
any rule or order issued under section
8930. Such deliveries are only accepted
4. Section 15(3) makes it unlawful for
during the DCO’s normal hours of oper-
any person to fail or refuse to submit
ation.
information required under this part.
Section 16 provides that a violation of [78 FR 72828, Dec. 4, 2013]
section 15 renders a person liable to the
United States for a civil penalty and § 766.10 Test standards.
possible criminal prosecution. Under Testing required under subpart B of
section 17 of TSCA, the district courts this part must be performed using the
of the United States have jurisdiction protocols submitted to and reviewed by
to restrain any violation of section 15. the EPA expert panel established under
§ 766.28. All new data, documentation,
§ 766.7 Submission of information. records, protocols, specimens, and re-
(a) All information (including letters ports generated as a result of testing
of intent, protocols, data, forms, stud- under subpart B of this part must be
ies, and allegations) submitted to EPA fully developed and retained in accord-
under this part must bear the applica- ance with part 792 of this chapter.
ble Code of Federal Regulations (CFR) These items must be made available
section number (e.g., § 766.20). during an inspection or submitted to
383
§ 766.12 40 CFR Ch. I (7–1–17 Edition)
EPA upon request by EPA or its au- and HDD/HDF-reinforced control sam-
thorized representative. Laboratories ples, or isotopically labeled compounds
conducting testing for submission to (standards) and duplicate samples will
EPA in response to a test rule promul- be handled; a description of the chem-
gated under section 4 of TSCA must ad- ical extraction and clean up procedures
here to the TSCA Good Laboratory to be used; how extraction efficiency
Practices (GLPs) published in part 792 and measurement efficiency will be es-
of this chapter. Sponsors must notify tablished; and a description of instru-
the laboratory that the testing is being ment hardware and operating condi-
conducted pursuant to TSCA section 4. tions, including type and source of col-
Sponsors are also responsible for ensur- umns, carrier gas and flow rate, oper-
ing that laboratories conducting the
ating temperature range, and ion
testing abide by the TSCA GLP stand-
source temperature.
ards. At the time test data are sub-
mitted, manufacturers must submit a § 766.16 Developing the analytical test
certification to EPA that the labora- method.
tory performing the testing adhered to
the TSCA GLPs. Because of the matrix differences of
the chemicals listed for testing, no one
§ 766.12 Testing guidelines. method for sample selection, prepara-
Analytical test methods must be de- tion, extraction and clean up is pre-
veloped using methods equivalent to scribed. For analysis, High Resolution
those described or reviewed in Guide- Gas Chromatography (HRGC) with
lines for the Determination of High Resolution Mass Spectrometry
Polyhalogenated Dibenzo-p-dioxins and (HRMS) is the method of choice, but
Dibenzofurans in Commercial Products. other methods may be used if they can
Copies are available from the Director, be demonstrated to reach the target
Environmental Assistance Division LOQs as well as HRGC/HRMS.
(7408), Office of Pollution Prevention (a) Sample selection. The chemical
and Toxics, U.S.Environmental Protec- product to be tested should be sampled
tion Agency, Room E–543B, 1200 Penn- so that the specimens collected for
sylvania Ave., NW., Washington, DC analysis are representative of the
20460, Telephone: (202) 554–1404, TDD: whole. Additional guidance for sample
(202) 544–0551. Publicly available docket
selection is provided under § 766.12.
materials are available at the address-
es in § 700.17(b)(1) and (2) of this chap- (b) Sample preparation. The sample
ter. must be mechanically homogenized
and subsampled as necessary. Subsam-
[60 FR 34466, July 3, 1995, as amended at 77 ples must be spiked or reinforced with
FR 46292, Aug. 3, 2012]
surrogate compounds or with standard
§ 766.14 Contents of protocols. stock solutions, and the surrogates or
standards must be thoroughly incor-
Protocols should include all parts of
porated by mechanical agitation. Addi-
the Quality Assurance Plan for Measure-
tional guidance is provided under
ment of Brominated or Chlorinated
Dibenzofurans and Dibenzodioxins, as § 766.12.
stated in the Guidelines. For each (c) Sample extraction and cleanup. The
chemical substance and each process, spiked samples must be treated to sep-
the manufacturer must submit a state- arate the HDDs/HDFs from the sample
ment of how many grades of the chem- matrix. Methods are reviewed in the
ical substance it produces, a justifica- Guidelines under § 766.12, but the final
tion for selection of the specific grade method or methods are left to the dis-
of chemical substance for testing, spe- cretion of the analyst, provided the in-
cific plans for collection of samples strumental response of the surrogates
from the process stream, naming the meets the criteria listed in the Quality
point of collection, the method of col- Assurance Plan for Measurement of
lecting the sample, and an estimate of Brominated or Chlorinated Dibenzofurans
how well the samples will represent the and Dibenzodioxins, Appendixes B and C
material to be characterized; a descrip- of the Guidelines. Cleanup techniques
tion of how control samples (blanks) are described in the Guidelines. These
384
are chosen at the discretion of the ana- that the cost of testing will be passed
lyst to meet the requirements of the on to processors through the pricing
chemical matrix. mechanism, thereby enabling them to
(d) Analysis. The method of choice is share in the cost of testing. However,
High Resolution Gas Chromatographic/ processors will be called upon to spon-
High Resolution Mass Spectrometric sor testing should manufacturers and
Determination, (HRGC/HRMS) but al- importers fail to do so. A processor
ternate methods may be used if the may apply for an exemption from test-
manufacturer can demonstrate that ing upon certification to EPA that a
the method will reach the target LOQs manufacturer or importer is testing
as well as HRGC/HRMS. Specific oper- the chemical substance which that per-
ating requirements are found in the son processes.
Guidelines. (b) If no manufacturer or importer
described in § 766.20 submits a letter of
§ 766.18 Method sensitivity. intent to perform testing within the
The target level of quantitation re- period described under § 766.35(a), or an
quired under § 766.27 for each HDD/HDF exemption application under § 790.45(a),
congener is the level which must be at- or a request for an exclusion or waiver
tempted for each resolved HRGC peak under § 766.32, EPA will issue a notice
for that congener. For at least one in the FEDERAL REGISTER to notify all
product sample, at least two analyses processors of that chemical substance.
of the same isotopically labeled HDD/ The notice will state that EPA has not
HDF internal calibration standards received any of the documents de-
spiked to a final product concentration scribed in the previous sentence, and
equal to the LOQ for that congener that current processors will have 30
must be reproducibly extracted, days to submit either a letter of intent
cleaned up, and quantified to within to perform the test or submit an ex-
±20 percent of each other. For each emption application.
spiked product sample, the signal to (c) If no manufacturer, importer or
noise ratio for the calibration standard processor submits a letter of intent to
peaks after complete extraction and perform testing of a specific chemical
cleanup must be 10:1 or greater. The re- substance produced by a specific proc-
covery of the internal calibration ess, EPA will notify all manufacturers,
standards in the extracted and cleaned importers, and processors, either by
up product samples must be within 50 notice in the FEDERAL REGISTER or by
to 150 percent of the amount spiked, letter, that all exemption applications
and the results must be corrected for will be denied and that within 30 days
recovery. all manufacturers, importers, and proc-
essors will be in violation of this part
Subpart B—Specific Chemical until a proposed study plan is sub-
Testing/Reporting Requirements mitted for required testing.
(d) Manufacturers, importers, and
§ 766.20 Who must test. processors who are subject to this part
(a) Any person who manufactures, must comply with the test rule devel-
imports, or processes a chemical sub- opment and exemption procedures in
stance listed in § 766.25 must test that part 790 of this chapter, except as
chemical substance and must submit modified in this part.
appropriate information to EPA ac-
cording to the schedules described in § 766.25 Chemical substances for test-
ing.
§ 766.35. Chemical substances manufac-
tured, imported or processed between (a) Listing of chemical substances.
January 1, 1984 and the date of promul- Chemical substances required to be
gation of this part are subject to test- tested for HDDs/HDFs under this rule
ing upon the effective date of this part. are listed in this section. The listing is
All other chemical substances are sub- by Chemical Abstracts Service (CAS)
ject to testing immediately upon man- Number and common name.
ufacture, import or processing. EPA NOTE: For purposes of guidance only, EPA
expects that only manufacturers and lists the chemical substances subject to test-
importers will perform testing, and ing under this part in two classes—those
385
§ 766.27 40 CFR Ch. I (7–1–17 Edition)
known to be manufactured or imported be- § 766.27 Congeners and LOQs for
tween January 1, 1984, and promulgation of which quantitation is required.
this part, and those not known to be manu-
factured or imported at the time of promul- Quantitation at the target LOQ
gation of this part. shown for each of the following HDDs/
(1) Chemicals substances known to be HDFs which may be present in the
manufactured between January 1, 1984 chemical substances is required for the
and date of promulgation of this part. chemical substances listed under
CAS No. Chemical name
§ 766.25. Analysis must take place for
either chlorinated or brominated
79–94–7 Tetrabromobisphenol-A. dibenzodioxins or dibenzofurans,
118–75–2 2,3,5,6-Tetrachloro-2,5-cyclohexadiene-1,4-
dione.
whichever is predominantly expected
118–79–6 2,4,6-Tribromophenol. to occur in the chemical substance to
120–83–2 2,4-Dichlorophenol. be tested. Only chlorinated and
1163–19–5 Decabromodiphenyloxide. brominated congeners need be quan-
4162–45–2 Tetrabromobisphenol-A-bisethoxylate.
21850–44–2 Tetrabromobisphenol-A-bis-2,3-dibromopropyl
tified; for chemical substances con-
ether. taining predominantly chlorine atoms,
25327–89–3 Allyl ether of tetrabromobisphenol-A. only congeners totally chlorinated at
32534–81–9 Pentabromodiphenyloxide.
the numbered positions need be quan-
32536–52–0 Octabromodiphenyloxide.
37853–59–1 1,2-Bis(tribromophenoxy)-ethane. tified; for chemical substances con-
55205–38–4 Tetrabromobisphenol-A diacrylate. taining predominantly bromine atoms,
only congeners totally brominated at
(2) Chemicals not known to be manufac- the numbered positions need be quan-
tured between January 1, 1984 and the tified.
date of promulgation of this part.
Chlorinated dioxins Brominated dioxins LOQ
2,3,7,8-TCDD .............. 2,3,7,8-TBDD .............. 0.1 ppb.
79–95–8 Tetrachlorobisphenol-A. 1,2,3,7,8-PeCDD ......... 1,2,3,7,8-PeBDD ......... 0.5 ppb.
87–10–5 3,4′,5-Tribromosalicylanilide. 1,2,3,4,7.8-HxCDD ...... 1,2,3,4,7,8-HxBDD ...... 2.5 ppb.
87–65–0 2,6-Dichlorophenol. 1,2,3,6,7,8-HxCDD ...... 1,2,3,6,7,8-HxBDD ...... 2.5 ppb.
95–77–2 3,4-Dichlorophenol. 1,2,3,7,8,9-HxCDD ...... 1,2,3,7,8,9-HxBDD ...... 2.5 ppb.
95–95–4 2,4,5-Trichlorophenol. 1,2,3,4,6,7,8-HpCDD ... 1,2,3,4,6,7,8-HpBDD ... 100 ppb.
99–28–5 2,6-Dibromo-4-nitrophenol. 2,3,7,8-TCDF ............... 2,3,7,8-TBDF ............... 1 ppb.
120–36–5 2[2,4-(Dichlorophenoxy)]-propionic acid.
1,2,3,7,8-PeCDF ......... 1,2,3,7,8-PeBDF ......... 5 ppb.
320–72–9 3,5-Dichlorosalicyclic acid.
2,3,4,7,8-PeCDF ......... 2,3,4,7,8-PeBDF ......... 5 ppb.
488–47–1 Tetrabromocatechol.
1,2,3,4,7,8-HxCDF ...... 1,2,3,4,7,8-HxBDF ...... 25 ppb.
576–24–9 2,3-Dichlorophenol.
1,2,3,6,7,8-HxCDF ...... 1,2,3,6,7,8-HxBDF ...... 25 ppb.
583–78–8 2,5-Dichlorophenol.
608–71–9 Pentabromophenol. 1,2,3,7,8,9-HxCDF ...... 1,2,3,7,8,9-HxBDF ...... 25 ppb.
615–58–7 2,4-Dibromophenol. 2,3,4,6,7,8-HxCDF ...... 2,3,4,6,7,8-HxBDF ...... 25 ppb.
933–75–5 2,3,6-Trichlorophenol. 1,2,3,4,6,7,8-HpCDF ... 1,2,3,4,6,7,8-HpBDF ... 1 ppm.
1940–42–7 4-Bromo-2,5-dichlorophenol. 1,2,3,4,7,8,9-HpCDF ... 1,2,3,4,7,8,9-HpBDF ... 1 ppm.
2577–72–2 3,5-Dibromosalicylanilide.
3772–94–9 Pentachlorophenyl laurate.
37853–61–5 Bismethylether of tetrabromobisphenol-A. § 766.28 Expert review of protocols.
Alkylamine tetrachlorophenate. EPA will gather a panel of experts in
Tetrabromobisphenol-B.
analysis of chemical matrices for
(b) Grade to be tested. If the same HDDs/HDFs to review the protocols for
process is used to manufacture all testing submitted to EPA. The panel
grades of the same chemical substance, members will be employees of EPA
only one grade need be tested. The and/or of other U.S. Government agen-
grade to be tested must be the grade cies who have had experience in anal-
subject to the most intense heat and ysis of chemical matrices and/or chem-
alkalinity for the longest duration of ical wastes for HDDs/HDFs. The panel
time, manufactured under each dif- will recommend to the Director, EPA
ferent process. If the heat, alkalinity Office of Pollution Prevention and
and duration of reaction do not differ Toxics, whether the protocol submitted
for various grades, the test substance is likely to allow analysis down to the
must be the grade of chemical sub- target LOQs, or if not, whether the pro-
stance with the highest volume of tocol represents a good faith effort on
sales. the part of the tester to achieve the
386
lowest possible LOQs. The final deter- bioassay on that chemical is excluded
mination to accept or reject the pro- from the testing requirement under
tocol will be made by the Director, Of- this part. Provided, however, that this
fice of Pollution Prevention and exclusion will not apply if Dow fails to
Toxics. EPA will review the submitted supply to EPA within 60 days of the ef-
protocols as rapidly as possible and fective date of this section evidence
will complete the review within 90 days showing which grade was used for the
after receipt. EPA may require submis- NTP bioassay.
sion of revised protocols. Comments (b) Timing. Exclusion or waiver re-
and recommendations will be trans- quests and detailed supporting data
mitted to the submitter, and if revi- must be submitted to EPA within 60
sions are required, a final protocol days from the effective date of this
must be submitted to EPA within 90 part for persons manufacturing, im-
days after EPA transmits such rec- porting or processing a chemical sub-
ommendations. stance as of the date of promulgation,
or 60 days prior to the date of resump-
§ 766.32 Exclusions and waivers. tion of manufacture or import for a
(a) Reasons for exclusions and waivers. chemical substance produced by a spe-
Any person subject to the testing re- cific process if the chemical substance
quirements of this part may request an is not manufactured, imported or proc-
exclusion or waiver from testing for essed as of the date of promulgation.
any one of the following reasons: (c) Publication. Within 10 days of re-
(1) Exclusions may be granted if. (i) ceipt of any exclusion or waiver re-
Testing of the appropriate grade of the quest, EPA will issue in the FEDERAL
chemical substance has already been REGISTER a notice of such receipt. EPA
carried out, either analytical testing at will also issue a notice of its decision
the lowest LOQ possible, with appro- on each exclusion or waiver request
priate QA/QC, or a well-designed bio- within 60 days of receipt.
assay with appropriate QA/QC or; (d) Decision. The EPA Director of the
(ii) Process and reaction conditions Office of Pollution Prevention and
of the chemical substance such that no Toxics will make the decision to grant
HDDs/HDFs could be produced under or deny waivers or exclusions.
those conditions;
(2) Waivers may be granted if. (i) A re- § 766.35 Reporting requirements.
sponsible company official certifies (a) Letters of intent, exemption applica-
that the chemical substance is pro- tions, and protocols—(1) Letters of intent.
duced only in quantities of 100 kilo- (i) Persons who have manufactured or
grams or less per year, only for re- imported chemical substances listed
search and development purposes; or under § 766.25 between January 1, 1984,
(ii) In the judgement of EPA, the cost and the effective date of this part are
of testing would drive the chemical required to submit under § 790.45 of this
substance off the market, or prevent chapter a letter of intent to test or an
resumption of manufacture or import exemption application. These letters
of the chemical substance, if it is not must be submitted no later than Sep-
currently manufactured, and the chem- tember 3, 1987.
ical substance will be produced so that (ii) Persons who commence manufac-
no unreasonable risk will occur due to ture, import or processing of a chem-
its manufacture, import, processing, ical substance listed under § 766.25 that
distribution, use, or disposal. (In this has not been manufactured, imported
case, the manufacturer must submit to or processed between January 1, 1984
EPA all data supporting the deter- and the effective date of this part must
mination.) submit under § 790.45 of this chapter,
(iii) Waivers may be appropriately within 60 days after the commence-
conditioned with respect to such fac- ment of manufacture, import, or proc-
tors as time and conditions of manu- essing of the chemical substance, a let-
facture or use. The grade of ter of intent to test or an exemption
decabromodiphenyl oxide produced by application.

Dow Chemical Company (Dow) for the (iii) Persons who commence manu-
National Toxicology Program (NTP) facture, import or processing of a
387
§ 766.35 40 CFR Ch. I (7–1–17 Edition)
chemical substance listed under § 766.25 (CAS. No. 118–79–6);

between the effective date of this part decabromodiphenyloxide (CAS No.
and the end of the reimbursement pe- 1163–19–5); and 1,2-
riod for that particular chemical sub- bis(tribromophenoxy)-ethane (CAS No.
stance produced by a specific process 37853–59–1) is January 31, 1991.
must submit under § 790.45 of this chap- (2) The deadline for submitting proto-
ter, within 60 days after the commence- cols for octabromodiphenyloxide (CAS
ment of manufacture, import or proc- No. 32536–52–0) and allyl ether of
essing of the chemical substance, a let- tetrabromobisphenol-A (CAS No. 25327–
ter of intent to test or an exemption 89–3) is January 31, 1991.
application. (3) The deadline for submitting proto-
(2) Protocols. (i) Each person who is cols for pentabromodiphenyloxide (CAS
manufacturing or processing a chem- No. 32534–81–9) is February 6, 1995. The
ical substance listed in § 766.25 as of the
deadline for submitting
effective date of this part who submits
tetrabromobisphenol-A-bisethoxylate
a notice of intent to test under
(CAS No. 4126–45–2) is January 31, 1991.
§ 766.35(a)(1) must submit a protocol for
the test as follows: (4) The deadline for submitting proto-
(A) The protocols for each cols for 3,4′,5-tribromosalicylanilide
chlorinated chemical substance pro- (CAS No. 87–10–5) is September 5, 1990.
duced by each process to be tested (ii) For chemical substances pro-
must be submitted to EPA no later duced by a specific process not manu-
than 12 months after the effective date factured or processed as of the effective
of this part. date of this part, a person who begins
(B) The protocol for each brominated manufacture and submits a notice of
chemical substance produced by each intent to test must submit protocols
process to be tested must be submitted for the test as follows:
to EPA no later than 24 months after (A) Except as noted for the submitter
the effective date of this part except and substance specified in the fol-
for the following chemicals. lowing table, protocols for testing
(1) The deadline for submitting the must be submitted 12 months after
protocols for tetrabromobisphenol-A manufacture or importation begins for
(CAS No. 79–94–7); 2,4,6 tribromophenol chlorinated chemical substances.
CAS No. Submitter Chemical Due date
118–75–2 Rhone-Poulenc ............................................ 2,3,5,6-tetrachloro-2,5-cyclohexaniene-1,4-dione ............. March 4,

1994
(B) Protocols for testing must be sub- the results of all existing test data
mitted 24 months after manufacture which show that chemical substance
begins for brominated chemical sub- has been tested for the presence of
stances. HDDs/HDFs.
(iii) For persons who have been (2) Any manufacturer or importer of
granted exemptions, waivers or exclu- a chemical substance listed in § 766.25
sions from testing, protocols must be in possession of unpublished health and
submitted 12 months after expiration safety studies on HDDs/HDFs is re-
of the exemption, waiver or exclusion quired to submit copies of such studies
for chlorinated chemical substances, to EPA no later than October 5, 1987 or
and 24 months after expiration of the 90 days after the person first manufac-
exemption, waiver or exclusion for tures or imports the chemical sub-
brominated chemical substances. stance, whichever is later. The fol-
(b) Information that must be submitted lowing provisions of part 716 of this
to EPA. (1) Persons who manufacture or chapter apply to submission of these
import a chemical substance listed studies: §§ 716.3, 716.10(a) (1) and (4);
under § 766.25 must report no later than 716.20(a) (1), (2), (3), (4), (7), (8) and (10);
October 5, 1987 or 90 days after the per- 716.25; 716.30; 716.35(a) (1), (2), and (4) [if
son first manufactures or imports the applicable]; 716.35 (b) and (c); 716.40 (a)
chemical substance, whichever is later, and (b); 716.50; 716.55; and 716.60(a)(2).
388
(3) No later than October 5, 1987 or 90 (4) Test results. (i) Test results must
days after the person first manufac- be submitted to EPA not later than 270
tures or imports the substance listed in days after EPA’s transmission of com-
§ 766.25, any manufacturer or importer ments or 180 days after a final protocol
of a chemical substance listed in is submitted to EPA, whichever is
§ 766.25 must submit records required to shorter, except as noted for the submit-
be held under part 717 of this chapter ters and substances specified in the fol-
on any HDDs/HDFs. lowing table:
CAS No. Submitter Chemical Due Date Effective Date
79–94–7 Great Lakes Tetrabromobisphenol-A May 26, 1992 May 28, 1993
79–94–7 Ethyl Tetrabromobisphenol-A August 10, 1992 May 28, 1993
79–94–7 Ameribrom Tetrabromobisphenol-A April 15, 1994 September 29,
1995
87–10–5 Pfister 3,4′,5-tribromosalicylanilide 45 days after protocol ap- May 28, 1993
proval
118–75–2 Rhone-Poulenc Inc. 2,3,5,6-tetrachloro-2,5- July 5, 1996 June 30, 1997
cyclohexadiene-1,4-dione
118–79–6 Great Lakes 2,4,6-Tribromophenol May 26, 1992 May 28, 1993
1163–19–5 Ameribrom Decabromodiphenyloxide April 15, 1994 September 29,
1995
1163–19–5 Ethyl Decabromodiphenyloxide May 26, 1992 May 28, 1993
1163–19–5 Great Lakes Decabromodiphenyloxide May 26, 1992 May 28, 1993
4162–45–2 Great Lakes Tetrabromobisphenol-A- June 2, 1993 September 8, 1994
bisethoxylate
25327–89–3 Great Lakes Allyl Ether of August 10, 1992 May 28, 1993
Tetrabromobisphenol-A
32534–81–9 Great Lakes Pentabromodiphenyloxide March 22, 1993 September 8, 1994
32534–81–9 Akzo Chemicals Pentabromodiphenyloxide February 6, 1995 September 29,
Inc. 1995
32534–81–9 Ameribrom Pentabromodiphenyloxide March 22, 1993 September 8, 1994
32536–52–0 Ameribrom Octabromodiphenyloxide January 8, 1993 September 29,
1995
32536–52–0 Ethyl Octabromodiphenyloxide May 15, 1994 May 28, 1993
32536–52–0 Great Lakes Octabromodiphenyloxide May 26, 1992 May 28, 1993
37853–59–1 Great Lakes 1,2-bis(tribromophenoxy)ethane January 24, 1995 September 29,
1995
(ii) For purposes of reporting test re- (ii) Health and safety studies for the
sults to EPA, and for further reporting chemical substance for which a posi-
triggered by a positive test result tive test result has been reported. The
under § 766.35(c), a positive test result following provisions of part 716 of this
is defined at § 766.3. chapter apply to submission of these
(iii) Reporting of test results must studies: §§ 716.3; 716.10 (a) (1), (2), (3) and
follow procedures set out in part 790 of (4); 716.20; 716.25; 716.30; 716.35(a) (1), (2),
this chapter, except as modified in this and (4), [if applicable]; 716.35 (b) and (c);
part. 716.40 (a) and (b); 716.50; 716.55;
(c) Information required to be submitted 716.60(a)(2).
to EPA after submission of a positive test (iii) Copies of records on the chem-
result. (1) Any person who submits a ical substances required to be held
positive test result for a specific chem- under part 717 of this chapter.
ical substance listed under § 766.25 must (2) If a positive test result on a chem-
submit to EPA no later than 90 days ical substance is received from one per-
after the date of submission of the son but not from others, EPA may
positive test result the following: issue a notice in the FEDERAL REGISTER
(i) A completed form (EPA 7710–51) listing that chemical substance and re-
for that chemical substance. The form quiring any person manufacturing, im-
and instructions are available online at porting or processing that chemical
http://www.epa.gov/oppt/chemtest/ substance who has not submitted a
ereporting/index.html. One form must be positive test result to submit the infor-
submitted for each chemical substance mation required in Part II of EPA

for which a positive test result has Form 7710–51. Such a notice will be
been submitted. published only if EPA needs additional
389
§ 766.38 40 CFR Ch. I (7–1–17 Edition)
process data to make a determination CAS No. Chemical name

of unreasonable risk.
95–57–8 ... o-Chlorophenol.
(d)–(e) [Reserved] 95–88–5 ... 4-Chlororesorcinol.
(f) Effective date. (1) The effective 95–94–3 ... 1,2,4,5-Tetrachlorobenzene.
date of this final rule is July 6, 1987, ex- 97–50–7 ... 5-Chloro-2,4-dimethoxyaniline.
cept for paragraphs (a)(2)(i)(B) intro- 99–30–9 ... 2,6-Dichloro-4-nitroaniline.
99–54–7 ... 1,2-Dichloro-4-nitrobenzene.
ductory text, (a)(2)(i)(B)(1),
106–46–7 p-Dichlorobenzene.
(a)(2)(i)(B)(2), (a)(2)(i)(B)(3), 108–70–3 1,3,5-Trichlorobenzene.
(a)(2)(i)(B)(4), the table in paragraph 108–86–1 Bromobenzene.
(a)(2)(ii)(A), and the table in paragraph 108–90–7 Chlorobenzene.
(b)(4)(i) of this section. 117–18–0 1,2,4,5-Tetrachloro-3-nitrobenzene.
120–82–1 1,2,4-Trichlorobenzene.
(2) The effective date for paragraph 348–51–6 o-Chorofluorobenzene.
(a)(2)(i)(B) introductory text, 350–30–1 3-Chloro-4-fluoronitrobenzene.
(a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and 615–67–8 Chlorohydroquinone.
(a)(2)(i)(B)(4), is May 21, 1991. The effec- 626–39–1 1,3,5-Tribromobenzene.
tive date of paragraphs (a)(2)(i)(B)(3), 827–94–1 2,6-Dibromo-4-nitroaniline.
and the table in paragraph (a)(2)(ii)(A)
is September 29, 1995. The effective (b) Persons required to report. All per-
date of paragraph (b)(4)(i) introductory sons who manufacture or import a
text is May 28, 1993, and the effective chemical product produced using any
date of the entries in the table in para- of the chemical substances listed in
graph (b)(4)(i) is shown in the effective paragraph (a) of this section as feed-
dates column of the table. stocks or intermediates must report no
(3) The guidelines and other test later than September 29, 1987. Small
methods cited in this rule are ref- manufacturers and those manufactur-
erenced as they exist on the effective ers and importers who produce the pre-
date of the final rule. cursor chemical substances in quan-
tities of 100 kilograms or less per year
[52 FR 21437, June 5, 1987, as amended at 56 only for research and development pur-
FR 23229, May 21, 1991; 57 FR 24960, June 12,
poses are not required to report under
1992; 58 FR 30991, May 28, 1993, 58 FR 34205,
June 23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR this section
31922, June 19, 1995; 60 FR 50433, Sept. 29, 1995; (c) Data to be reported. Manufacturers
60 FR 56955, Nov. 13, 1995; 62 FR 35105, June and importers of chemical products
30, 1997; 78 FR 72829, Dec. 4, 2013] made from precursor chemical sub-
stances identified in paragraph (a) of
§ 766.38 Reporting on precursor chem- this section must report process and
ical substances. reaction condition data on Part II of
(a) Identification of precursor chemical EPA Form 7710–51 for each chemical
substances. Precursor chemical sub- product. A separate EPA Form 7710–51
stances are produced under conditions must be submitted for each chemical
that will not yield HDDs and HDFs, but product reported, and the precursor
their molecular structure is conducive chemical substance used must be iden-
to HDD/HDF formation under favorable tified. All forms must be submitted to
reaction conditions when they are used EPA no later than September 29, 1987.
to produce other chemicals or prod-
ucts. The following precursor chemical FR 31922, June 19, 1995]
substances are identified by Chemical
Abstract Service (CAS) number and
name. PARTS 767–769 [RESERVED]
PART 770—FORMALDEHYDE
85–22–3 ... Pentabromoethylbenzene. STANDARDS FOR COMPOSITE
87–61–6 ... 1,2,3-Trichlorobenzene.
87–84–3 ... 1,2,3,4,5-Pentabromo-6-chloro-cyclohexane.
WOOD PRODUCTS
89–61–2 ... 1,4-Dichloro-2-nitrobenzene.
89–64–5 ... 4-Chloro-2-nitrophenol. Subpart A—General Provisions
89–69–0 ... 2,4,5-Trichloronitrobenzene.
92–04–6 ... 2-Chloro-4-phenylphenol. Sec.
94–74–6 ... 4-Chloro-o-toloxy acetic acid.

94–81–5 ... 4-(2-Methyl-4-chlorophenoxy) butyric acid.
770.1 Scope and applicability.
95–50–1 ... o-Dichlorobenzene. 770.2 Effective dates.
95–56–7 ... o-Bromophenol. 770.3 Definitions.
390
770.4 Exemption from the hardwood ply- products for TSCA Title VI compli-
wood definition for certain laminated ance.
products. (3) Any composite wood products, and
770.5 Prohibited acts.
component parts or finished goods con-
Subpart B—EPA TSCA Title VI Third-Party taining these materials, that are sold,
Certification Program supplied, offered for sale, or manufac-
tured (including imported) in the
770.7 Third-party certification. United States, including composite
770.8 Applications, notifications, and re- wood products used or installed in
ports. manufactured housing.
(c) Subparts B, C, and D of this part
Subpart C—Composite Wood Products do not apply to the following:
770.10 Formaldehyde emission standards. (1) Any finished good that has pre-
770.12 Stockpiling. viously been sold or supplied to an end
770.15 Composite wood product certifi- user, an individual or entity that pur-
cation. chased or acquired the finished good in
770.17 No-added formaldehyde-based resins. good faith for purposes other than re-
770.18 Ultra low-emitting formaldehyde res- sale. For example, subparts B, C, and D
ins.
of this part do not apply to antiques or
770.20 Testing requirements.
770.21 Quality control manual, facilities, secondhand furniture.
and personnel. (2) Hardboard.
770.22 Non-complying lots. (3) Structural plywood, as specified
770.24 Samples for testing. in PS 1–07, Voluntary Product Stand-
770.30 Importers, fabricators, distributors, ard—Structural Plywood (incorporated
and retailers. by reference, see § 770.99).
770.40 Reporting and recordkeeping. (4) Structural panels, as specified in
770.45 Labeling. PS 2–04, Voluntary Product Standard—
Performance Standard for Wood-Based
Subpart D—Incorporation by Reference
Structural-Use Panels (incorporated by
770.99 Incorporation by reference. reference, see § 770.99).
AUTHORITY: 15 U.S.C. 2697(d). (5) Structural composite lumber, as
specified in ASTM D5456–06, Standard
SOURCE: 81 FR 89724, Dec. 12, 2016, unless Specification for Evaluation of Struc-
otherwise noted.
tural Composite Lumber Products (in-
corporated by reference, see § 770.99).
Subpart A—General Provisions (6) Oriented strand board.
(7) Glued laminated lumber, as speci-
§ 770.1 Scope and applicability. fied in ANSI/AITC A190.1–2002, Struc-
(a) This part contains formaldehyde tural Glued Laminated Timber (incor-
emission standards, testing and certifi- porated by reference, see § 770.99).
cation provisions, and other require- (8) Prefabricated wood I-joists, as
ments for the manufacture (including specified in ASTM D5055–05, Standard
import), distribution, and sale of com- Specification for Establishing and
posite wood products, component parts Monitoring Structural Capacities of
that contain composite wood products, Prefabricated Wood I-Joists (incor-
and finished goods that contain com- porated by reference, see § 770.99).
posite wood products. (9) Finger-jointed lumber.
(b) This part applies to: (10) Wood packaging, including pal-
(1) Laboratory Accreditation Bodies lets, crates, spools, and dunnage.
(ABs) and Product ABs that are accred- (11) Composite wood products used
iting third-party certifiers (TPCs) for inside the following:
TSCA Title VI (15 U.S.C. 2697(d)) pur- (i) New vehicles (other than rec-
poses and those that wish to commence reational vehicles) that are con-
accrediting TPCs for TSCA Title VI structed entirely from new parts and
purposes. that have never been the subject of a
(2) TPCs that are certifying com- retail sale or registered with the appli-
posite wood products for TSCA Title VI cable State or other governmental
compliance and those that wish to agency.
commence certifying composite wood (ii) New rail cars.
391
§ 770.2 40 CFR Ch. I (7–1–17 Edition)
(iii) New boats. under TSCA Title VI, provided that

(iv) New aerospace craft. they remain approved by CARB and
(v) New aircraft. comply with all aspects of this part
(d) The emission standards in § 770.10 other than the requirements of
do not apply to windows that contain § 770.7(c)(1)(i) and (ii) and (c)(2)(iii) and
composite wood products, if the win- (iv). After the two-year transition pe-
dows contain less than five percent by riod, CARB-approved TPCs may con-
volume of composite wood products, tinue to certify composite wood prod-
combined, in relation to the total vol- ucts under TSCA Title VI provided the
ume of the finished window. TPC maintains its CARB approval, fol-
(e) The emission standards in § 770.10 lows the requirements under this part,
do not apply to exterior doors and ga- submits to EPA documentation from
rage doors that contain composite CARB supporting their eligibility for
wood products, if: reciprocity and has received EPA rec-
(1) The doors are made from com- ognition as an EPA TSCA Title VI
posite wood products manufactured TPC. All TPCs that are certifying prod-
with no-added formaldehyde-based res- ucts as compliant with TSCA Title VI,
ins or ultra low-emitting formaldehyde both during and after the transition pe-
resins; or riod, are subject to enforcement ac-
(2) The doors contain less than three tions for any violations of TSCA Title
percent by volume of composite wood VI or these regulations.
products, combined, in relation to the (e) After December 12, 2017, all manu-
total volume of the finished exterior facturers (including importers), fab-
door or garage door. ricators, suppliers, distributors, and re-
§ 770.2 Effective dates. tailers of composite wood products, and
component parts or finished goods con-
(a) This rule is effective February 10, taining these materials, must comply
2017. with this part, subject to the following:
(b) Laboratory and Product ABs that
(1) After December 12, 2017, laminated
wish to accredit TPCs for TSCA Title
product producers must comply with
VI purposes may apply to EPA begin-
the requirements of this part that are
ning February 10, 2017 to become recog-
applicable to fabricators.
nized. Laboratory and Product ABs
must be recognized by EPA before they (2) After December 12, 2023, producers
begin to provide and at all times while of laminated products must comply
providing TSCA Title VI accreditation with the requirements of this part that
services. are applicable to hardwood plywood
(c) TPCs that are not approved by the panel producers (in addition to the re-
California Air Resources Board (CARB) quirements of this part that are appli-
that wish to provide TSCA Title VI cable to fabricators) except as provided
certification services may apply to at § 770.4.
EPA beginning February 10, 2017 to be- (3) After December 12, 2023, producers
come recognized. TPCs must be recog- of laminated products that, as provided
nized by EPA and comply with all of at § 770.4, are exempt from the defini-
the applicable requirements of this tion of ‘‘hardwood plywood’’ must com-
part before they begin to provide and ply with the recordkeeping require-
at all times while providing TSCA ments in § 770.40(c) and (d) (in addition
Title VI certification services. to the requirements of this part that
(d) Notwithstanding any other provi- are applicable to fabricators).
sion of this part, TPCs that are ap- (4) Composite wood products manu-
proved by CARB to certify composite factured (including imported) before
wood products have until December 12, December 12, 2017 may be sold, sup-
2018 to become accredited by an EPA plied, offered for sale, or used to fab-
TSCA Title VI AB(s) pursuant to the ricate component parts or finished
requirements of this part. During this goods at any time.
two-year transition period, existing
EFFECTIVE DATE NOTE: At 82 FR 23737, May

CARB-approved TPCs and CARB TPCs 24, 2017, § 770.2 was revised, effective July 10,
approved during this transition period 2017. For the convenience of the user, the re-
may carry out certification activities vised text is set forth as follows:
392
§ 770.2 Effective dates. § 770.4, are exempt from the definition of
(a) This part is effective as of May 22, 2017. ‘‘hardwood plywood’’ must comply with the
(b) Laboratory and Product ABs that wish recordkeeping requirements in § 770.40(c) and
to accredit TPCs for TSCA Title VI purposes (d) (in addition to the requirements of this
may apply to EPA beginning May 22, 2017 to part that are applicable to fabricators)
become recognized. Laboratory and Product (4) Composite wood products manufactured
ABs must be recognized by EPA before they (including imported) before March 22, 2018
begin to provide and at all times while pro- may be sold, supplied, offered for sale, or
viding TSCA Title VI accreditation services. used to fabricate component parts or fin-
(c) TPCs that are not approved by the Cali- ished goods at any time.
fornia Air Resources Board (CARB) that wish
to provide TSCA Title VI certification serv- § 770.3 Definitions.
ices may apply to EPA beginning May 22,
2017 to become recognized. TPCs must be rec- For the purposes of this part, the fol-
ognized by EPA and comply with all of the lowing definitions apply:
applicable requirements of this part before Accreditation Body or AB means an
they begin to provide and at all times while organization that provides an impar-
providing TSCA Title VI certification serv- tial verification of the competency of
ices.
(d) Notwithstanding any other provision of
conformity assessment bodies or TPCs.
this part, TPCs that are approved by CARB Agent for Service means an entity des-
to certify composite wood products have ignated by a TPC or AB to receive legal
until March 22, 2019 to become accredited by documents on their behalf.
an EPA TSCA Title VI AB(s) pursuant to the Article means a manufactured item
requirements of this part. During this two- which:
year transition period, existing CARB-ap-
proved TPCs and CARB TPCs approved dur- (1) Is formed to a specific shape or de-
ing this transition period may carry out cer- sign during manufacture;
tification activities under TSCA Title VI, (2) Has end use functions dependent
provided that they remain approved by in whole or in part upon its shape or
CARB and comply with all aspects of this design during the end use; and
part other than the requirements of
(3) Has either no change of chemical
§ 770.7(c)(1)(i) and (ii) and (c)(2)(iii) and (iv).
After the two-year transition period, CARB- composition during its end use or only
approved TPCs may continue to certify com- those changes of composition which
posite wood products under TSCA Title VI have no commercial purpose separate
provided the TPC maintains its CARB ap- from that of the article and that may
proval, follows the requirements under this occur as described in 19 CFR
part, submits to EPA documentation from 12.120(a)(2), except that fluids and par-
CARB supporting their eligibility for reci-
ticles are not considered articles re-
procity and has received EPA recognition as
an EPA TSCA Title VI TPC. All TPCs that gardless of shape or design.
are certifying products as compliant with Assessment means a process to include
TSCA Title VI, both during and after the an on-site review undertaken by an AB
transition period, are subject to enforcement to assess the competence of all oper-
actions for any violations of TSCA Title VI ations of a conformity assessment body
or these regulations. and TPC, based on particular stand-
(e) Beginning March 22, 2018, all manufac-
turers (including importers), fabricators,
ard(s) and/or other normative docu-
suppliers, distributors, and retailers of comments for a defined scope of accredita-
posite wood products, and component parts tion, as defined in ISO/IEC 17011:2004(E)
or finished goods containing these materials, (incorporated by reference, see § 770.99).
must comply with this part, subject to the Bundle means more than one com-
following: posite wood product, component part,
(1) Beginning March 22, 2018, laminated
or finished good fastened together for
product producers must comply with the re-
quirements of this part that are applicable transportation or sale.
to fabricators. Combination core means a platform
(2) Beginning March 22, 2024, producers of for making hardwood plywood or lami-
laminated products must comply with the nated products that consists of a com-
requirements of this part that are applicable bination of layers of veneer and
to hardwood plywood panel producers (in ad- particleboard or medium density fiber-
dition to the requirements of this part that
board.
are applicable to fabricators) except as pro-

vided at § 770.4. Component part means an object other
(3) Beginning March 22, 2024, producers of than a panel that contains one or more
laminated products that, as provided at composite wood products and is used in
393
§ 770.3 40 CFR Ch. I (7–1–17 Edition)
the construction or assembly of fin- EPA TSCA Title VI Third-Party Cer-

ished goods. Component parts that are tifier or EPA TSCA Title VI TPC means
sold directly to consumers are consid- a conformity assessment body that
ered finished goods. provides both product certification
Composite core means a platform for services and laboratory testing services
making hardwood plywood or lami- (either directly or through contracted
nated products that consists of services), is accredited by an EPA
particleboard and/or medium density TSCA Title VI Product AB and an EPA
fiberboard, or combination core. TSCA Title VI Laboratory AB (unless
Composite wood product means hard- the laboratory testing services are con-
wood plywood made with a veneer or tracted to a laboratory accredited by
composite core, medium-density fiber- an EPA TSCA Title VI Laboratory
board, and particleboard. AB), and is recognized by EPA pursu-
Distributor means any person or enti- ant to § 770.7(c).
ty to whom a composite wood product, Fabricator means a person or entity
component part, or finished good is who incorporates composite wood prod-
sold or supplied for the purposes of re- ucts into component parts or into fin-
sale or distribution in commerce, ex- ished goods. This includes laminated
cept that manufacturers and retailers product producers, but persons or enti-
are not distributors. ties in the construction trades are not
Engineered veneer means a type of ve- fabricators by renovating or remod-
neer that is created by dyeing and glu- eling buildings.
ing together leaves of veneer in a mold Finished good means any good or
to produce a block. The block is then product, other than a panel, that con-
sliced into leaves of veneer with a de- tains hardwood plywood (with a veneer
signed appearance that is highly re- or composite core), particleboard, or
peatable. medium-density fiberboard and that is
EPA TSCA Title VI Laboratory Accredi- not a component part or other part
tation Body or EPA TSCA Title VI Lab- used in the assembly of a finished good.
oratory AB means an AB that has a rec- Site-built buildings or other site-built
ognition agreement with EPA under real property improvements are not
the EPA TSCA Title VI Third-Party considered finished goods.
Certification Program, accredits a Hardboard means a composite panel
TPC’s testing laboratory or contract composed of cellulosic fibers, consoli-
testing laboratory to ISO/IEC dated under heat and pressure in a hot
17025:2005(E) (incorporated by ref- press by: A wet process; or a dry proc-
erence, see § 770.99) with a scope of ac- ess that uses a phenolic resin, or a
creditation to include this part and the resin system in which there is no form-
formaldehyde test methods used to aldehyde as part of the resin cross-
comply with this part, and assesses the linking structure; or a wet formed/dry
testing laboratory’s conformance to pressed process; and that is commonly
ISO/IEC 17020:2012(E) (incorporated by or commercially known, or sold, as
reference, see § 770.99) in order to per- hardboard, including any product con-
form laboratory testing services. forming to one of the following ANSI
EPA TSCA Title VI Product Accredita- standards: Basic Hardboard (ANSI
tion Body or EPA TSCA Title VI Product A135.4–2012) (incorporated by reference,
AB means an AB that has a recognition see § 770.99), Prefinished Hardboard
agreement with EPA under the EPA Paneling (ANSI A135.5–2012) (incor-
TSCA Title VI Third-Party Certifi- porated by reference, see § 770.99), Engi-
cation Program, accredits a TPC to neered Wood Siding (ANSI A135.6–2012)
ISO/IEC 17065:2012(E) (incorporated by (incorporated by reference, see § 770.99),
reference, see § 770.99) with a scope of or Engineered Wood Trim (ANSI
accreditation to include composite A135.7–2012) (incorporated by reference,
wood products and this part, and as- see § 770.99). There is a rebuttable pre-
sesses the TPC’s conformance to ISO/ sumption that products emitting more
IEC 17020:1998(E) (incorporated by ref- than 0.06 ppm formaldehyde as meas-

erence, see § 770.99) in order to perform ured by ASTM E1333–10 (incorporated
product certification. by reference, see § 770.99) or ASTM
394
D6007–02 (incorporated by reference, see addition, a laminated product is pro-

§ 770.99) are not hardboard. duced by either the fabricator of the
Hardwood plywood means a hardwood finished good in which the product is
or decorative panel that is intended for incorporated or a fabricator who uses
interior use and composed of (as deter- the laminated product in the further
mined under ANSI/HPVA HP–1–2009 (in- construction or assembly of a compo-
corporated by reference, see § 770.99)) an nent part.
assembly of layers or plies of veneer, Laminated product producer means a
joined by an adhesive with a lumber manufacturing plant or other facility
core, a particleboard core, a medium- that manufactures (excluding facilities
density fiberboard core, a hardboard that solely import products) laminated
core, a veneer core, or any other spe- products on the premises. Laminated
cial core or special back material. product producers are fabricators and,
Hardwood plywood does not include after December 12, 2023, laminated
military-specified plywood, curved ply- product producers are also hardwood
wood, or any plywood specified in PS 1– plywood panel producers except as pro-
07, Voluntary Product Standard— vided at § 770.4.
Structural Plywood (incorporated by Lot means the panels produced from
reference, see § 770.99), or PS 2–04, Vol- the beginning of production of a prod-
untary Product Standard—Perform- uct type until the first quality control
ance Standard for Wood-Based Struc- test; between one quality control test
tural-Use Panels (incorporated by ref- and the next; or from the last quality
erence, see § 770.99). In addition, hard- control test to the end of production
wood plywood includes laminated prod- for a particular product type.
ucts except as provided at § 770.4. Medium-density fiberboard means a
Importer means any person or entity panel composed of cellulosic fibers
who imports composite wood products, made by dry forming and pressing a
component parts, or finished goods into resinated fiber mat (as determined
the customs territory of the United under ANSI A208.2–2009 (incorporated
States (as defined in general note 2 of by reference, see § 770.99)).
the Harmonized Tariff Schedules of the No-added formaldehyde-based resin
United States pursuant to 15 U.S.C. means a resin formulated with no
2612(a)(1)). Importer includes: added formaldehyde as part of the resin
(1) The entity primarily liable for the crosslinking structure in a composite
payment of any duties on the products; wood product that meets the emission
or standards in § 770.17(c).
(2) An authorized agent acting on the Non-complying lot means any lot of
entity’s behalf. composite wood product represented by
Intended for interior use means in- a quarterly test value or quality con-
tended for use or storage inside a build- trol test result that indicates that the
ing or recreational vehicle, or con- lot exceeds the applicable standard for
structed in such a way that it is not the particular composite wood product
suitable for long-term use in a location in § 770.10(b). A quality control test re-
exposed to the elements. Windows, sult that exceeds the QCL is considered
doors, and garage doors with at least a test result that indicates that the lot
one interior-facing side are intended exceeds the applicable standard. Fu-
for interior use. ture production of the product type(s)
Laboratory Accreditation Body or Lab- represented by a failed quarterly test
oratory AB means an AB that accredits are not considered certified and must
conformity assessment body testing be treated as a non-complying lot until
laboratories. the product type(s) are re-qualified
Laminated product means a product in through a successful quarterly test.
which a wood or woody grass veneer is Panel means a thin (usually less than
affixed to a particleboard core or plat- two inches thick), flat, usually rectan-
form, a medium-density fiberboard gular piece of particleboard, medium-
core or platform, or a veneer core or density fiberboard or hardwood ply-
platform. A laminated product is a wood. Embossing or imparting of an ir-

component part used in the construc- regular surface on the composite wood
tion or assembly of a finished good. In products by the original panel producer
395
§ 770.3 40 CFR Ch. I (7–1–17 Edition)
during pressing does not remove the Quality control limit or QCL means the
product from this definition. Cutting a value from the quality control method
panel into smaller pieces, without ad- test that is the correlative equivalent
ditional fabrication, does not make the to the applicable emission standard
panel into a component part or finished based on the ASTM E1333–10 method
good. This does not include items made (incorporated by reference, see § 770.99).
for the purpose of research and devel- Reassessment means an assessment, as
opment, provided such items are not described in sections 7.5 to 7.11 of ISO/
sold, supplied, or offered for sale. IEC 17011:2004(E) (incorporated by ref-
Panel producer means a manufac- erence, see § 770.99), except that experi-
turing plant or other facility that man- ence gained during previous assess-
ufactures (excluding facilities that ments shall be taken into account.
solely import products) composite Recreational vehicle means a vehicle
wood products on the premises. which is:
Particleboard means a panel composed (1) Built on a single chassis;
of cellulosic material in the form of (2) Four hundred square feet or less
discrete particles (as distinguished when measured at the largest hori-
from fibers, flakes, or strands) that are zontal projections;
pressed together with resin (as deter- (3) Self-propelled or permanently
mined under ANSI A208.1–2009 (incor- towable by a light duty truck; and
porated by reference, see § 770.99)). (4) Designed primarily not for use as
Particleboard does not include any a permanent dwelling but as temporary
product specified in PS 2–04, Perform- living quarters for recreational, camp-
ance Standard for Wood-Based Struc- ing, travel, or seasonal use.
tural-Use Panels (incorporated by ref- Resin system means type of resin used,
erence, see § 770.99). including but not limited to urea-form-
Phenol-formaldehyde resin means a aldehyde, soy, phenol-formaldehyde, or
resin that consists primarily of phenol melamine-urea-formaldehyde.
and formaldehyde and does not contain Retailer means any person or entity
urea-formaldehyde. that sells, offers for sale, or supplies di-
Product Accreditation Body or Product rectly to consumers composite wood
AB means an AB that accredits con- products, component parts or finished
formity assessment bodies who perform goods that contain composite wood
product certification. products, except that persons or enti-
Product type means a type of com- ties in the construction trades are not
posite wood product, or group of com- considered retailers by selling, ren-
posite wood products, made by the ovating, or remodeling buildings.
same panel producer with the same Scavenger means a chemical or
resin system that differs from another chemicals that can be applied to resins
product type based on panel composi- or composite wood products either dur-
tion and formaldehyde emission char- ing or after manufacture and that
acteristics. Grouped products must react with residual or excess formalde-
have similar formaldehyde emission hyde to reduce the amount of formalde-
characteristics and their emissions hyde that can be emitted from com-
must fit the same correlation curve or posite wood products.
linear regression. Shipping quality control limit means a
Production line means a set of oper- quality control limit that is developed
ations and physical industrial or me- in conjunction with an EPA TSCA
chanical equipment used to produce a Title VI TPC that is based on panels
composite wood product in one facility prior to shipment rather than imme-
utilizing the same or similar equip- diately after manufacturing.
ment and quality assurance and qual- Stockpiling means manufacturing or
ity control procedures. purchasing composite wood products,
Purchaser means any panel producer, whether in the form of panels or incor-
importer, fabricator, distributor, or re- porated into component parts or fin-
tailer that acquires composite wood ished goods, between July 7, 2010 and
products, component parts, or finished June 12, 2017 at an average rate at least
goods for purposes of resale in ex- 20% greater than the average rate of
change for money or its equivalent. manufacture or purchase during the
396
2009 calendar year for the purpose of factures (excluding facilities that solely im-
circumventing the emission standards port products) laminated products on the
and other requirements of this subpart. premises. Laminated product producers are
fabricators and, beginning March 22, 2024,
Thin medium-density fiberboard means
laminated product producers are also hard-
medium-density fiberboard that has a wood plywood panel producers except as pro-
thickness less than or equal to 8 milli- vided at § 770.4.
meters or 0.315 inches.
Third-party certifier or TPC means a
* * * * *
conformity assessment body that pro-
vides both product certification serv- § 770.4 Exemption from the hardwood
ices and laboratory testing services (ei- plywood definition for certain lami-
ther directly or through contracted nated products.
services).
TPC laboratory means a laboratory or (a) Current exemptions. The definition
contract laboratory of an EPA TSCA of the term ‘‘hardwood plywood’’ in
Title VI TPC that is accredited by an § 770.3 does not include:
EPA TSCA Title VI Laboratory AB to (1) Laminated products made by at-
ISO/IEC 17025:2005(E) (incorporated by taching a wood or woody grass veneer
reference, see § 770.99), and whose in- with a phenol-formaldehyde resin to a
spection activities are in conformance platform that has been manufactured
with ISO/IEC 17020:1998(E) (incor- in compliance with this part (including
porated by reference, see § 770.99). either certified in accordance with
Surveillance On-Site Assessment means § 770.15, manufactured with no-added
a set of on-site activities that are less formaldehyde-based resins under
comprehensive than reassessment, to § 770.17, or manufactured with ultra
monitor the continued fulfilment by low-emitting formaldehyde-based res-
accredited conformance assessment ins under § 770.18).
bodies of requirements for accredita- (2) Laminated products made by at-
tion, as described in sections 7.5 to 7.11 taching a wood or woody grass veneer
of ISO/IEC 17011:2004(E) (incorporated with a resin formulated with no-added
by reference, see § 770.99). formaldehyde as part of the resin cross-
Ultra low-emitting formaldehyde resin linking structure to a platform that
means a resin in a composite wood has been manufactured in compliance
product that meets the emission stand- with this part (including either cer-
ards in § 770.18(c). tified in accordance with § 770.15, manu-
Veneer means a sheet of wood or factured with no-added formaldehyde-
woody grass with a maximum thick- based resins under § 770.17, or manufac-
ness of 6.4 millimeters (1⁄4 inch) that is tured with ultra low-emitting form-
rotary cut, sliced, or sawed from a log, aldehyde-based resins under § 770.18).
bolt, flitch, block, or culm; including (b) Rulemaking petitions for exemption.
engineered veneer. (1) Any person may petition the Agen-
Veneer core means a platform for cy to initiate a rulemaking for addi-
making hardwood plywood or lami- tional exemptions for laminated prod-
nated products that consists of veneer. ucts from the definition of the term
Woody grass means a plant of the ‘‘hardwood plywood,’’ pursuant to 15
family Poaceae (formerly Gramineae) U.S.C. 2697(a)(3)(C)(i)(I).
with hard lignified tissues or woody (2) Each petition should provide all
parts. available and relevant information, in-
cluding studies conducted and form-
24, 2017, in § 770.3, the term ‘‘laminated prod-
aldehyde emissions data, and should be
uct producer’’ was revised, effective July 10, submitted to: Director, National Pro-
2017. For the convenience of the user, the re- gram Chemicals Division, Office of Pol-
vised text is set forth as follows: lution Prevention and Toxics (MC
7404T), U.S. Environmental Protection
§ 770.3 Definitions. Agency, 1200 Pennsylvania Ave NW.,
Washington, DC 20460–001.
* * * * * (3) EPA will promptly review each

Laminated product producer means a manu- submitted petition and, where appro-
facturing plant or other facility that manu- priate, publish a proposed rule in the
397
§ 770.5 40 CFR Ch. I (7–1–17 Edition)
FEDERAL REGISTER based on the peti- (iii) Be competent to perform accred-

tion and provide a public comment pe- itation activities for product certifi-
riod of generally 30 days before taking cation according to ISO/IEC
a final action. 17065:2012(E) (incorporated by ref-
erence, see § 770.99).
§ 770.5 Prohibited acts. (2) Application. To be recognized by
(a) Failure or refusal to comply with EPA under the EPA TSCA Title VI
any requirement of TSCA section 601 Third-Party Certification Program, a
(15 U.S.C. 2697) or this part is a viola- Product AB must submit an applica-
tion of TSCA section 15 (15 U.S.C. 2614). tion to EPA in accordance with § 770.8
(b) Failure or refusal to establish and that contains the following:
maintain records or to make available (i) Name, address, telephone number,
or permit access to or copying of and email address of the organization
records, as required by this part, is a or primary contact;
violation of TSCA section 15 (15 U.S.C. (ii) Documentation of IAF MLA sig-
2614). natory status, membership in one of
(c) Making false or misleading state- the IAF recognized regional accredita-
ments in any statement, certification, tion cooperations, or an equivalent or-
or record required by this part is a vio- ganization as determined by EPA;
lation of TSCA section 15 (15 U.S.C. (iii) Description of any other quali-
2614). fications related to the Product AB’s
(d) Violators may be subject to civil experience in performing product ac-
and criminal sanctions pursuant to creditation of TPCs for manufactured
TSCA section 16 (15 U.S.C. 2615) for products including an affirmation that
each violation. assessors will be technically competent
to assess a TPC’s ability to perform
Subpart B—EPA TSCA Title VI Third- their activities under paragraph (c)(4)
Party Certification Program of this section; and
(iv) If not a domestic entity, name
§ 770.7 Third-party certification. and address of an agent for service lo-
(a) EPA TSCA Title VI Product ABs. To cated in the United States. Service on
participate in the EPA TSCA Title VI this agent constitutes service on the
Third-Party Certification Program as AB or any of its officers or employees
an EPA TSCA Title VI Product AB, a for any action by EPA or otherwise by
Product AB must have the qualifica- the United States related to the re-
tions described in this section, submit quirements of this part. ABs may share
an application and enter into a rec- an agent for service.
ognition agreement with EPA as de- (3) Recognition agreement. To be recog-
scribed in this section, and, upon rec- nized by EPA under the EPA TSCA
ognition from EPA, impartially per- Title VI Third-Party Certification Pro-
form the responsibilities described in gram, a Product AB must enter into a
this section. recognition agreement with EPA that
(1) Qualifications. To qualify for rec- describes the EPA TSCA Title VI Prod-
ognition by EPA in the EPA TSCA uct AB’s responsibilities under this
Title VI Third-Party Certification Pro- subpart.
gram as an EPA TSCA Title VI Prod- (i) Each recognition agreement will
uct AB, an applicant Product AB must: be valid for three years.
(i) Be a signatory to the Inter- (ii) Each recognition agreement will
national Accreditation Forum, Inc.’s identify an EPA Recognition Agree-
(IAF) Multilateral Recognition Ar- ment Implementation Officer and an
rangement (MLA) through level three, EPA TSCA Title VI Product AB Imple-
or have membership in one of the IAF mentation Officer that will serve as the
recognized regional accreditation co- point of contact for the EPA TSCA
operations, or an equivalent organiza- Title VI Third-Party Certification Pro-
tion as determined by EPA; gram.
(ii) Be in conformance with ISO/IEC (iii) To renew a recognition agree-

17011:2004(E) (incorporated by ref- ment for an additional three-year pe-
erence, see § 770.99); and riod, the EPA TSCA Title VI Product
398
AB must submit an application for requirements of ISO/IEC 17065:2012(E), is

newal in accordance with § 770.8 before in conformance with ISO/IEC
the three-year period of the recogni- 17020:1998(E) as required under ISO/IEC
tion agreement lapses. The application 17065:2012(E) section 6.2.1 (incorporated
must indicate any changes from the by reference, see § 770.99) and the EPA
EPA TSCA Title VI Product AB’s ini- TSCA Title VI TPC requirements under
tial application or most recent renewal this part. In performing the on-site as-
application. sessment, the EPA TSCA Title VI
(iv) If an EPA TSCA Title VI Product Product AB must:
AB fails to submit an application for (1) Develop a checklist of the EPA
renewal prior to the expiration of the TSCA Title VI TPC requirements under
previous recognition agreement, its paragraph (c)(4) of this section and the
recognition will lapse and the EPA key accreditation elements of ISO/IEC
TSCA Title VI Product AB may not 17065:2012(E) (incorporated by ref-
provide accreditation services under erence, see § 770.99); and
TSCA Title VI. (2) Use the checklist for each on-site
(v) If an EPA TSCA Title VI Product assessment.
AB does submit an application for re- (B) A review of the approach that the
newal prior to the expiration of the TPC will use to verify the accuracy of
previous recognition agreement, it may the formaldehyde emissions tests con-
continue to provide TSCA Title VI ac- ducted by the TPC laboratory and the
creditation services under the terms of formaldehyde quality control tests
its previous recognition agreement conducted by or for the panel producers
until EPA has taken action on its ap- producing composite wood products
plication for renewal of the recognition that are subject to the requirements of
agreement. TSCA Title VI.
(4) Impartiality. EPA TSCA Title VI (C) A review of the approach that the
Product ABs must act impartially TPC will use for evaluating a panel
when performing activities under the producer’s quality assurance and qual-
EPA TSCA Title VI Third-Party Cer- ity control processes, the proficiency of
tification Program. To demonstrate the panel producer’s quality assurance
impartiality, Product ABs must: and quality control personnel, the re-
(i) Ensure that an accreditation deci- quired elements of a panel producer’s
sion regarding a TPC is made by per- quality assurance and quality control
sons different from those who con- manual, and sufficiency of on-site test-
ducted the assessment of the TPC; and ing facilities as applicable.
(ii) Ensure that the AB’s personnel (D) A review of the approach that the
who assess TPCs or make decisions re- TPC laboratory will use for estab-
garding accreditation do not receive fi- lishing correlation or equivalence be-
nancial benefit from the outcome of an tween ASTM E1333–10 and ASTM D6007–
accreditation decision. 02, if used, (incorporated by reference,
(5) Responsibilities. Each EPA TSCA see § 770.99) or allowable formaldehyde
Title VI Product AB has the following test methods listed under § 770.20.
responsibilities under the EPA TSCA (E) A review of the approach that the
Title VI Third-Party Certification Pro- TPC will use for evaluating the process
gram: for sample selection, handling, and
(i) Accreditation. EPA TSCA Title VI shipping procedures that the panel pro-
Product ABs must determine the ac- ducer will use for quality control test-
creditation eligibility, and accredit if ing as applicable.
appropriate, each TPC seeking recogni- (F) A review of the accreditation cre-
tion under the EPA TSCA Title VI dentials of the TPC laboratory, includ-
Third-Party Certification Program by ing a verification that the laboratory
performing an assessment of each TPC has been accredited to ISO/IEC
as described in this section. The assess- 17025:2005(E) (incorporated by ref-
ment must include all of the following erence, see § 770.99) with a scope of ac-
components: creditation to include this part—Form-
(A) An on-site assessment by the aldehyde Standards for Composite

EPA TSCA Title VI Product AB to de- Wood Products and the formaldehyde
termine whether the TPC meets the retest methods ASTM E1333–10 and
399
§ 770.7 40 CFR Ch. I (7–1–17 Edition)
ASTM D6007–02, if used, by an EPA (vi) Annual report. Each EPA TSCA
TSCA Title VI Laboratory AB (incor- Title VI Product AB must provide, in
porated by reference, see § 770.99). accordance with § 770.8, an annual re-
(ii) Reassessment. Each EPA TSCA port on or before March 1st of each
Title VI Product AB must, in accord- year for the AB services performed dur-
ance with ISO/IEC 17011:2004(E) section ing the previous calendar year includ-
7.11 (incorporated by reference, see ing the number and locations of assess-
§ 770.99), conduct an on-site reassessment, reassessment, and surveillance
ment or surveillance on-site assess- on-site assessments performed for each
ment at least every two years of each EPA TSCA Title VI TPC.
EPA TSCA Title VI TPC that the AB (vii) EPA meetings. Each EPA TSCA
has accredited. Title VI Product AB must meet with
(iii) Suspension, reduction, withdrawal. EPA at least once every two years in
Each EPA TSCA Title VI Product AB person, via teleconference, or through
must suspend, reduce, or withdraw the other virtual methods to discuss the
accreditation of an EPA TSCA Title VI implementation of the EPA TSCA
TPC that the AB has accredited when Title VI Third-Party Certification Pro-
circumstances warrant. gram.
(iv) Notifications. Each EPA TSCA (viii) Inspections. Each EPA TSCA
Title VI Product AB must provide, in Title VI Product AB must allow inspec-
accordance with § 770.8, the following tions of the AB’s facilities by EPA, at
notifications to EPA, as applicable: reasonable times, within reasonable
(A) Notification of the loss of its sta- limits, and in a reasonable manner,
tus as a signatory to the IAF MLA, or upon the presentation of appropriate
loss of membership in one of the IAF credentials and a written notification
recognized regional accreditation co- to the AB.
operations, or an equivalent organiza- (b) EPA TSCA Title VI Laboratory ABs.
tion as determined by EPA must be To participate in the EPA TSCA Title
provided within five calendar days of VI Third-Party Certification Program
the date that the body receives notifi- as an EPA TSCA Title VI Laboratory
cation of the loss of its signatory or AB, a Laboratory AB must have the
membership status. qualifications described in this section,
(B) Notification that an EPA TSCA submit an application and enter into a
Title VI TPC has failed to comply with recognition agreement with EPA as de-
any provision of this part must be pro- scribed in this section, and, upon rec-
vided within 72 hours of the time the ognition from EPA, impartially per-
Product AB identifies the deficiency. form the responsibilities described in
The notice must include a description this section.
of the steps taken to address the defi- (1) Qualifications. To qualify for rec-
ciency. ognition by EPA under the EPA TSCA
(C) Notification of suspension, reduc- Title VI Third-Party Certification Pro-
tion or withdrawal of an EPA TSCA gram as an EPA TSCA Title VI Labora-
Title VI TPC’s accreditation must be tory AB, an applicant Laboratory AB
provided within 72 hours of the time must:
that the suspension, reduction or with- (i) Be a signatory to the Inter-
drawal takes effect. national Laboratory Accreditation Co-
(D) Notification of a change in a non- operation (ILAC) Mutual Recognition
domestic Product AB’s agent for serv- Arrangement (MRA), or have member-
ice must be provided within five cal- ship in one of the ILAC recognized re-
endar days. gional accreditation cooperations, or
(v) Records. Each EPA TSCA Title VI an equivalent organization as deter-
Product AB must maintain, in elec- mined by EPA;
tronic form, the checklists and other (ii) Be in conformance with ISO/IEC
records documenting compliance with 17011:2004(E) (incorporated by ref-
the requirements for assessment, reas- erence, see § 770.99);
sessment, and surveillance on-site as- (iii) Be competent to perform accred-

sessments of EPA TSCA Title VI TPCs itation activities for laboratory ac-
for three years. creditation according to ISO/IEC
400
17025:2005(E) (incorporated by ref- Title VI Third-Party Certification Pro-

erence, see § 770.99); and gram.
(iv) Be competent to ensure EPA (iii) To renew a recognition agree-
TSCA Title VI TPC inspection activi- ment for an additional three-year pe-
ties are in conformance with ISO/IEC riod, the EPA TSCA Title VI Labora-
17020:1998(E) (incorporated by ref- tory AB must submit an application
erence, see § 770.99). for renewal in accordance with § 770.8
(2) Application. To be recognized by before the three-year period of the rec-
EPA under the EPA TSCA Title VI ognition agreement lapses. The appli-
Third-Party Certification Program, a cation must indicate any changes from
Laboratory AB must submit an appli- the EPA TSCA Title VI Laboratory
cation to EPA, which may be sub- AB’s initial application or most recent
mitted in conjunction with a Product renewal application.
AB application. For recognition, a Lab- (iv) If an EPA TSCA Title VI Labora-
oratory AB must submit an application tory AB fails to submit an application
in accordance with § 770.8 that contains for renewal prior to the expiration of
the following: the previous recognition agreement, its
(i) Name, address, telephone number, recognition will lapse and the EPA
and email address of the organization TSCA Title VI Laboratory AB may not
or primary contact; provide accreditation services under
(ii) Documentation of ILAC MRA sig- TSCA Title VI.
natory status, membership in one of (v) If an EPA TSCA Title VI Labora-
the ILAC recognized regional accredi- tory AB does submit an application for
tation cooperations, or an equivalent renewal prior to the expiration of the
organization as determined by EPA; previous recognition agreement, it may
(iii) Description of any other quali- continue to provide TSCA Title VI ac-
fications related to the Laboratory creditation services under the terms of
AB’s experience in performing labora- its previous recognition agreement
tory accreditation and inspection cer- until EPA has taken action on its ap-
tification of TPCs including an affir- plication for renewal of the recognition
mation that assessors will be tech- agreement.
nically competent to assess TPCs abil- (4) Impartiality. EPA TSCA Title VI
ity to perform their activities under Laboratory ABs must act impartially
paragraph (c)(4) of this section; and when performing activities under the
(iv) If not a domestic entity, name EPA TSCA Title VI Third-Party Cer-
and address of an agent for service lo- tification Program. To demonstrate
cated in the United States. Service on impartiality, Laboratory ABs must:
this agent constitutes service on the (i) Ensure that an accreditation deci-
AB or any of its officers or employees sion regarding a TPC is made by per-
for any action by EPA or otherwise by sons different from those who con-
the United States related to the re- ducted the assessment of the TPC; and
quirements of this part. ABs may share (ii) Ensure that the AB’s personnel
an agent for service. who assess TPCs or make decisions re-
(3) Recognition agreement. To be recog- garding accreditation do not receive fi-
nized by EPA under the EPA TSCA nancial benefit from the outcome of an
Title VI Third-Party Certification Pro- accreditation decision.
gram, a Laboratory AB must enter into (5) Responsibilities. Each EPA TSCA
a recognition agreement with EPA Title VI Laboratory AB has the fol-
that describes the EPA TSCA Title VI lowing responsibilities under the EPA
Laboratory AB’s responsibilities under TSCA Title VI Third-Party Certifi-
this subpart. cation Program:
(i) Each recognition agreement will (i) Accreditation. EPA TSCA Title VI
be valid for three years. Laboratory ABs must determine the
(ii) Each recognition agreement will accreditation eligibility, and accredit
identify an EPA Recognition Agree- if appropriate, each TPC seeking rec-
ment Implementation Officer and an ognition under the EPA TSCA Title VI
EPA TSCA Title VI Laboratory AB Im- Third-Party Certification Program by

plementation Officer that will serve as performing an assessment of each TPC.
the point of contact for the EPA TSCA The assessment must include an on-
401
§ 770.7 40 CFR Ch. I (7–1–17 Edition)
site assessment by the EPA TSCA Title tion as determined by EPA, within five
VI Laboratory AB to determine wheth- calendar days of the date that the body
er the laboratory meets the require- receives notice of the loss of its signa-
ments of ISO/IEC 17025:2005(E) (incor- tory or membership status.
porated by reference, see § 770.99), is in (B) Notification that a TPC labora-
conformance with ISO/IEC 17020:1998(E) tory has failed to comply with any pro-
(incorporated by reference, see § 770.99) vision of this part within 72 hours of
and the EPA TSCA Title VI TPC re- the time the Laboratory AB identifies
quirements under this part including the deficiency. The notice must include
the formaldehyde test methods ASTM a description of the steps taken to ad-
E1333–10 and ASTM D6007–02 (incor- dress the deficiency.
porated by reference, see § 770.99), if (C) Notification of suspension, reduc-
used. In performing the on-site assess- tion or withdrawal of a TPC labora-
ment, the EPA TSCA Title VI Labora- tory’s accreditation within 72 hours of
tory AB must: the time that the suspension, reduction
(A) Develop a checklist of the TPC or withdrawal takes effect.
requirements under paragraph (c)(4) of (D) Notification of a change in a non-
this section and the key conformity domestic Laboratory AB’s agent for
elements of ISO/IEC 17025:2005(E) (inservice within five calendar days.
corporated by reference, see § 770.99); (vi) Records. Each EPA TSCA Title VI
and Laboratory AB must maintain, in elec-
(B) Use the checklist for each on-site tronic form, the checklists and other
assessment. records documenting compliance with
(ii) Reassessment. Each EPA TSCA the requirements for assessment, reas-
Title VI Laboratory AB must, in ac- sessment, and surveillance on-site as-
cordance with ISO/IEC 17011:2004(E) sessments of TPC laboratories for three
section 7.11 (incorporated by reference, years.
see § 770.99), conduct a follow-up reas- (vii) Annual report. Each EPA TSCA
sessment or surveillance on-site assess- Title VI Laboratory AB must provide,
ment of each TPC laboratory that the in accordance with § 770.8, an annual re-
AB has accredited. port to EPA on or before March 1st of
(iii) Proficiency. Each EPA TSCA each year for AB services performed
Title VI Laboratory AB must verify during the previous calendar year in-
the accuracy of the formaldehyde emis- cluding the number and locations of as-
sions tests conducted by the TPC lab- sessment, reassessment, and surveil-
oratory by ensuring the TPC labora- lance on-site assessments performed
tory participates in the CARB interlab- for each TPC laboratory.
oratory comparison for formaldehyde (viii) EPA meetings. Each EPA TSCA
emissions when offered. In lieu of par- Title VI Laboratory AB must meet
ticipation in the CARB interlaboratory with EPA at least once every two years
comparison ensure that the TPC lab- in person, via teleconference, or
oratory participates in an EPA-recog- through other virtual methods to dis-
nized proficiency testing program, if cuss the implementation of the EPA
available. TSCA Title VI Third-Party Certifi-
(iv) Suspension, reduction, withdrawal. cation Program.
Each EPA TSCA Title VI Laboratory (ix) Inspections. Each EPA TSCA
AB must suspend, reduce, or withdraw Title VI Laboratory AB must allow in-
the accreditation of a TPC laboratory spections of the AB’s facilities by EPA,
that the AB has accredited when cir- at reasonable times, within reasonable
cumstances warrant. limits, and in a reasonable manner,
(v) Notifications. Each EPA TSCA upon the presentation of appropriate
Title VI Laboratory AB must provide, credentials and a written notification
in accordance with § 770.8, the following to the AB.
notifications to EPA as applicable: (c) EPA TSCA Title VI Third-Party
(A) Notification of the loss of its sta- Certifiers. To participate in the EPA
tus as a signatory to the ILAC MRA, or TSCA Title VI Third-Party Certifi-
loss of membership in one of the ILAC cation Program as an EPA TSCA Title
recognized regional accreditation co- VI TPC, a TPC must be accredited by
operations, or an equivalent organiza- an EPA TSCA Title VI Product AB, use
402
a laboratory that is accredited by an evaluating correlation between test

EPA TSCA Title VI Laboratory AB, methods. Applicant TPCs that have
have the other qualifications described demonstrated experience with test
in this subsection, submit an applica- method ASTM D6007–02 only, must be
tion and be recognized by EPA, and, contracting testing with a laboratory
upon recognition from EPA, impar- that has a large chamber and dem-
tially perform the responsibilities de- onstrate its experience with ASTM
scribed in this section. Alternatively, E1333–10.
CARB-approved TPCs must meet the (2) Application. Before certifying any
criteria for reciprocity in paragraph (d) products under this part, a TPC must
of this section and comply with the re- be recognized by EPA under the EPA
quirements of this part in order to be TSCA Title VI Third-Party Certifi-
recognized by EPA as an EPA TSCA cation Program. To be recognized by
Title VI TPC. EPA, a TPC must submit an applica-
(1) Qualifications. To qualify for rec- tion in accordance with § 770.8 and
ognition by EPA in the EPA TSCA renew that application every two
Title VI Third-Party Certification Pro- years. The application must contain
gram as an EPA TSCA Title VI TPC, the following:
an applicant TPC must: (i) Email address of the organization
(i) Be accredited by an EPA TSCA or primary contact, organization name,
Title VI Product AB to ISO/IEC organization telephone number, and or-
17065:2012(E) (incorporated by ref- ganization address;
erence, see § 770.99), with a scope of ac-
(ii) Type of composite wood products
creditation that includes include com-
that the applicant intends to certify;
posite wood products and this part—
Formaldehyde Standards for Com- (iii) A copy of the TPC’s certificate
posite Wood Products; of accreditation from an EPA TSCA
(ii) Be, or have a contract with a lab- Title VI Product AB to ISO/IEC
oratory that is, accredited by an EPA 17065:2012(E) (incorporated by ref-
TSCA Title VI Laboratory AB to ISO/ erence, see § 770.99) with a scope of ac-
IEC 17025:2005(E) (incorporated by ref- creditation that includes composite
erence, see § 770.99) with a scope of ac- wood products and this part—Form-
creditation to include this part—Form- aldehyde Standards for Composite
aldehyde Standards for Composite Wood Products;
Wood Products and the formaldehyde (iv) A copy of the TPC laboratory’s
test methods ASTM E1333–10 and certificate of accreditation from an
ASTM D6007–02, if used (incorporated EPA TSCA Title VI Laboratory AB to
by reference, see § 770.99); ISO/IEC 17025:2005(E) (incorporated by
(iii) Have the ability to conduct in- reference, see § 770.99) with a scope of
spections of composite wood products accreditation to include this part—
and properly train and supervise in- Formaldehyde Standards for Com-
spectors to inspect composite wood posite Wood Products and the form-
products in conformance with ISO/IEC aldehyde test methods ASTM E1333–10
17020:1998(E) as required under ISO/IEC and ASTM D6007–02 (incorporated by
17065:2012(E) section 6.2.1 (incorporated reference, see § 770.99), if used;
by reference, see § 770.99); (v) An affirmation of the TPC’s abil-
(iv) Have demonstrated experience in ity to conduct inspections of composite
the composite wood product industry wood products and properly train and
with at least one type of composite supervise inspectors to inspect com-
wood product and indicated the specific posite wood products in conformance
product(s) the applicant intends to cer- with ISO/IEC 17020:1998(E) as required
tify; and under ISO/IEC 17065:2012(E) section 6.2.1
(v) Have demonstrated experience in (incorporated by reference, see § 770.99);
performing or verifying formaldehyde (vi) A description of the TPC’s expe-
emissions testing on composite wood rience in the composite wood product
products, including experience with industry with at least one type of com-
test method ASTM E1333–10 and ASTM posite wood product and indicate the
D6007–02, if used, (incorporated by ref- specific product(s) the applicant in-
erence, see § 770.99), and experience tends to certify;
403
§ 770.7 40 CFR Ch. I (7–1–17 Edition)
(vii) A description of the TPC’s expe- (4) Responsibilities. Each EPA TSCA
rience in performing or verifying form- Title VI TPC has the following respon-
aldehyde emissions testing on com- sibilities under the EPA TSCA Title VI
posite wood products; Third-Party Certification Program:
(viii) A description of the TPC’s expe- (i) Certification. EPA TSCA Title VI
rience with test method ASTM E1333–10 TPCs certify composite wood products
and/or ASTM D6007–02, if used, (incor- that are produced in accordance with
porated by reference, see § 770.99), and this part and that comply with the
experience evaluating correlation be- emission standards of TSCA Title VI
tween test methods. Applicant TPCs and this part, in accordance with ISO/
that have experience with test method IEC 17065:2012(E) (incorporated by ref-
ASTM D6007–02 only, must be con- erence, see § 770.99). For each panel pro-
tracting testing with a laboratory that ducer making composite wood products
has a large chamber and describe its certified by the TPC, the EPA TSCA
experience with ASTM E1333–10; and Title VI TPC must:
(ix) If not a domestic entity, the (A) Verify that each panel producer
name and address of an agent for serv- has adequate quality assurance and
ice located in the United States. Serv- quality control procedures and is com-
ice on this agent constitutes service on plying with the applicable quality as-
the TPC or any of its officers or em- surance and quality control require-
ployees for any action by EPA or oth- ments of this part;
erwise by the United States related to
(B) Verify each panel producer’s qual-
the requirements of this part. TPCs
ity control test results compared with
may share an agent for service.
test results from ASTM E1333–10 and
(3) Impartiality. EPA TSCA Title VI
ASTM D6007–02, if used, (incorporated
TPCs must act impartially in accord-
by reference, see § 770.99) by having the
ance with their accreditation when per-
TPC laboratory conduct quarterly
forming activities under the EPA
tests and evaluate test method equiva-
TSCA Title VI Third-Party Certifi-
lence and correlation as required under
cation Program. To demonstrate im-
§ 770.20;
partiality, TPCs must:
(i) Not also be, or have a financial in- (C) In consultation with the panel
terest in a panel producer, fabricator, producer, establish quality control lim-
laminated product producer, importer, its (QCLs) for formaldehyde emissions,
designer, distributor or retailer of com- and, if applicable, shipping quality con-
posite wood products; trol limits or other formaldehyde emis-
(ii) Ensure that TPC management sion limits, for each panel producer and
personnel and TPC personnel involved product type;
in the review and certification deci- (D) Establish, for each panel pro-
sion-making process for composite ducer, the process that will be used to
wood products are not involved in ac- determine if products are exceeding the
tivities within the same or separate applicable QCL;
legal entity that may compromise the (E) Provide its CARB or EPA TPC
impartiality of its certification deci- number to each panel producer for la-
sion-making process, such as advocacy beling and recordkeeping; and
or consulting activities; (F) Inspect each panel producer, its
(iii) Ensure that TPC management products, and its records at least quar-
personnel and TPC personnel of the terly in conformance with ISO/IEC
same or separate legal entity involved 17020:1998(E) as required under ISO/IEC
in activities such as advocacy or con- 17065:2012(E) section 6.2.1 (incorporated
sulting are not involved in the manage- by reference, see § 770.99).
ment of the certification body, the re- (ii) Laboratories. For quarterly test-
view, or the certification decisions; and ing, each EPA TSCA Title VI TPC
(iv) Ensure that TPC management must use only laboratories that have
personnel and TPC personnel certifying been accredited by an EPA TSCA Title
composite wood products sign a con- VI Laboratory AB and that either par-
flict of interest statement attesting ticipate in the CARB interlaboratory

that they will receive no financial ben- comparison for formaldehyde emissions
efit from the outcome of certification. when offered or in an EPA-recognized
404
proficiency or interlaboratory pro- E1333–10 (incorporated by reference, see

gram, if available. § 770.99) correlative equivalent values,
(iii) NAF and ULEF. For panel pro- the established QCL value(s) and the
ducers that do not receive approval for quality control method used.
NAF or ULEF third-party certification (D) Notification of each failed quar-
exemptions or ULEF reduced testing terly test, that is any sample that ex-
from CARB, EPA TSCA Title VI TPCs ceeds the applicable formaldehyde
must review applications for NAF or emission standard in § 770.10, within 72
ULEF third-party certification exemp- hours. Information in this notification
tions or ULEF reduced testing. Each is not eligible for treatment as con-
EPA TSCA Title VI TPC must approve fidential business information.
these applications within 90 calendar (E) Notification of a change in a non-
days of receipt if the panel producer domestic TPC’s agent for service with-
demonstrates that the requirements in five calendar days.
for third-party certification exemption (F) Notification of a loss of accredi-
under § 770.17 or § 770.18 or reduced test- tation or notification that the TPC has
ing under § 770.18 are met. discontinued its participation in the
(iv) Reduced testing for medium-density EPA TSCA Title VI Third-Party Cer-
fiberboard or fiberboard. EPA TSCA tification Program must be provided
Title VI TPCs must review applications within 72 hours.
from panel producers to reduce the
(vi) Other notifications. Each EPA
number of quality control tests for
TSCA Title VI TPC must provide the
particleboard and medium-density fi-
following notifications, if applicable:
berboard, and approve these applica-
(A) Notification of each failed quar-
tions within 90 calendar days of receipt
terly test, that is any sample that ex-
if the panel producer demonstrates
ceeds the applicable formaldehyde
that the requirements for reduced test-
emission standard in § 770.10, to the
ing under § 770.20(b)(2)(ii) are met.
panel producer in writing within 72
(v) Notifications to EPA. Each EPA
hours. Information in this notification
TSCA Title VI TPC must provide, in
is not eligible for treatment as con-
accordance with § 770.8, the following
fidential business information.
notifications to EPA, as applicable:
(A) Notification of an approved or re- (B) Notification of a loss of accredi-
jected application, including a renewal tation or notification that the TPC has
application, for a NAF or ULEF third- discontinued its participation in the
party certification exemption or ULEF EPA TSCA Title VI Third-Party Cer-
reduced testing within five calendar tification Program within 72 hours to
days of the approval or rejection with all panel producers for which it pro-
copies of all approved applications for- vides EPA TSCA Title VI certification
warded to EPA within 30 calendar days services.
of approval. (C) Notification of any changes in
(B) Notification of an approved or re- personnel qualifications, procedures, or
jected application, including a renewal laboratories used, to the TPC’s EPA
application, for reduced testing for me- TSCA Title VI ABs within 30 calendar
dium-density fiberboard or days.
particleboard within five calendar days (vii) Records. Each EPA TSCA Title
of the approval or rejection with copies VI TPC must maintain, in electronic
of all approved applications forwarded form, the following records for three
to EPA within 30 calendar days of ap- years from the date the record is cre-
proval. ated, and provide them to EPA within
(C) Notification of a panel producer 30 calendar days of a request from
exceeding its established QCL for more EPA:
than two consecutive quality control (A) A list of panel producers and
tests within 72 hours of the time that their respective products and product
the TPC becomes aware of the second types, including type of resin systems
exceedance. The notice must include used, that the EPA TSCA Title VI TPC
the product type, dates of the quality has certified;

control tests that exceeded the QCL, (B) Results of inspections and form-
quality control test results, ASTM aldehyde emissions tests conducted for
405
§ 770.7 40 CFR Ch. I (7–1–17 Edition)
and linked to each panel producer and cluding how the non-complying lot was
product type; addressed;
(C) A list of laboratories used by the (6) For each non-complying lot re-
EPA TSCA Title VI TPC, as well as all sulting from a failed quality control
test methods used, including test con- test, the test date, method, product
ditions and conditioning time, and type, volume of product affected, lot
quarterly test results; numbers, the results of retesting, and a
(D) Methods and results for estab- description of the final disposition of
lishing test method correlations and the affected product, including how the
equivalence; non-complying lot was addressed; and
(E) Documentation for NAF or ULEF (7) Any corrective actions that re-
third-party certification exemptions or sulted from quarterly tests and inspec-
ULEF reduced testing approvals, in- tions.
cluding the name of the panel pro- (B) A list of laboratories and test
ducer, facility, products approved, type methods used by the TPC, number and
of resin systems used and dates of ap- volume (cubic meters) of large and
proval; small chambers, date of equivalence
(F) Documentation of reduced testing determination and equivalence data.
approval for panel producers of me- (C) Any non-conformities identified
dium-density fiberboard or by its EPA TSCA Title VI AB(s) and
particleboard, including the name of how they were addressed.
the panel producer, products approved (D) The results compared with the
and dates of approval; and mean of the interlaboratory compari-
(G) A copy of the most recent assess- son for all formaldehyde emissions
ment, reassessment, and/or surveil- interlaboratory comparison tests other
lance on-site assessment report pro- than the CARB interlaboratory com-
vided by its EPA TSCA Title VI ABs. parison or, if available, the results of
(viii) Annual report. Each EPA TSCA an EPA-recognized proficiency testing
Title VI TPC must provide, in accord- program.
ance with § 770.8, an annual report on or (ix) Assessments and inspections. Upon
before March 1st of each year for the request, each EPA TSCA Title VI TPC
TPC services performed during the pre- must allow EPA representatives to:
vious calendar year. Quarterly test re- (A) Accompany the TPC’s staff dur-
sults, the test method, date of test, and ing an assessment, reassessment or
product tested (including the product surveillance on-site assessment of the
name or description and panel producer TPC by its AB(s); and
name) are not eligible for treatment as (B) Inspect the TPC’s facilities, at
confidential business information. The reasonable times, within reasonable
report must contain all of the fol- limits, and in a reasonable manner,
lowing elements, as applicable: upon the presentation of appropriate
(A) The following information for credentials and a written notification
each panel producer making composite to the TPC.
wood products certified by the TPC, (d) Reciprocity for third-party certifiers
the EPA TSCA Title VI TPC: approved by the California Air Resources
(1) Composite wood products that the Board (CARB)—(1) During transitional
EPA TSCA Title VI TPC has certified period. The transitional period is de-
during the previous calendar year; fined as the two-year period beginning
(2) Types of resin systems used for on December 12, 2016 and ending on De-
the composite wood products certified; cember 12, 2018. TPCs already approved
(3) Dates of quarterly inspections; by CARB and TPCs subsequently ap-
(4) For each quarterly test, the date, proved by CARB during the transition
result, test method, and whether a con- period must apply for EPA recognition
tract laboratory was used; in accordance with § 770.8 before they
(5) For each failed quarterly test, the can certify any products under this
product type, the volume of product af- part. Once recognized by EPA, CARB-
fected, the results of recertification approved TPCs become EPA TSCA

testing, and a description of the final Title VI TPCs and may certify com-
disposition of the affected product, in- posite wood products under TSCA Title
406
VI until December 12, 2018 as long as (i) No longer maintains signatory

they: status to the IAF MLA or ILAC MRA,
(i) Remain approved by CARB; and membership in one of the IAF/ILAC
(ii) Comply with all aspects of this recognized regional accreditation co-
part other than the requirements of operations, or an equivalent organiza-
paragraphs (c)(1)(i) and (ii) and tion as determined by EPA;
(c)(2)(iii) and (iv) of this section. This (ii) Fails to comply with any require-
includes: ment of TSCA Title VI or this part;
(A) Provide panel producers with the (iii) Makes any false or misleading
TPC number issued by CARB; and statements on its application, records,
(B) Provide the annual report re- or reports; or
quired by paragraph (c)(4)(viii) of this (iv) Makes substantial changes to
section to CARB and EPA during the personnel qualifications or procedures
two-year transitional period. that make the AB, TPC and/or TPC
(C) Provide notifications required by laboratory unable to comply with any
paragraph (c)(4)(v) to EPA. applicable requirements of this part.
(2) After transition period. (i) TPCs ap- (3) Process for suspending, revoking or
proved by CARB may continue to cer- modifying recognition. (i) Prior to tak-
tify composite wood products under ing action to suspend, revoke or modify
TSCA Title VI after the two-year tran- recognition, EPA will notify the par-
sitional period if the TPC: ticipant AB or the participant TPC in
(A) Maintains its CARB approval; writing of the following:
(B) Complies with the requirements (A) The legal and factual basis for
of this part; the proposed suspension, revocation or
(C) Submits to EPA, in accordance modification;
with § 770.8: (B) The anticipated commencement
(1) Documentation from CARB that date and duration of the suspension,
specifies eligibility for reciprocity; and revocation or modification;
(2) A copy of the application sub- (C) Actions, if any, which the af-
mitted to CARB to be recognized as a fected AB or TPC may take to avoid
TPC under the CARB ATCM. suspension, revocation or modification,
(D) Receives EPA recognition as an or to receive recognition in the future;
EPA TSCA Title VI TPC. and
(ii) EPA retains the authority to (D) The opportunity and method for
deny recognition of CARB-approved requesting a hearing with EPA prior to
TPCs who seek recognition through final suspension, revocation or modi-
reciprocity in the EPA TSCA Title VI fication.
Third-Party Certification Program if (ii) If the affected AB or TPC re-
EPA has information indicating that quests a hearing in writing to EPA
the TPC is not qualified. within 30 calendar days of receipt of
(e) Suspension, revocation or modifica- the notification, EPA will:
tion of recognition—(1) Third-party cer- (A) Provide the affected AB or TPC
tifiers. EPA may suspend, revoke or an opportunity to offer written state-
modify the recognition of a TPC, if the ments in response to EPA’s assertions
TPC: of the legal and factual basis for the
(i) Fails to comply with any require- proposed action; and
ment of TSCA Title VI or this part; (B) Appoint an impartial EPA official
(ii) Makes any false or misleading as Presiding Officer to conduct the
statements on its application, records, hearing. The Presiding Officer will:
or reports; or (1) Conduct a fair, orderly, and im-
(iii) Makes substantial changes to partial hearing within 90 calendar days
personnel qualifications, procedures, or of the request for a hearing;
laboratories that make the TPC or (2) Consider all relevant evidence, ex-
TPC laboratory unable to comply with planations, comments, and arguments
any applicable requirements of this submitted; and
part. (3) Notify the affected AB or TPC in
(2) ABs. EPA may suspend, revoke or writing within calendar 90 days of com-
modify the recognition of an AB if the pletion of the hearing of his or her de-
AB: cision and order. Such an order is a
407
§ 770.7 40 CFR Ch. I (7–1–17 Edition)
final EPA action which may be subject (i) For reasons other than fraud or
to judicial review. The order must con- providing false or misleading state-
tain the basis, commencement date, ments, and other than a reason that
and duration of the suspension, revoca- implicates a particular TPC in a viola-
tion or modification. tion of TSCA Title VI, TPCs accredited
(iii) If EPA determines that the pub- by that AB can continue to certify
lic health, interest, or welfare warrants products under TSCA Title VI for 180
immediate action to revoke the rec- calendar days, after which the TPCs
ognition of an AB or TPC prior to the must be accredited again by another
opportunity for a hearing, it will notify EPA TSCA Title VI AB and re-recog-
the affected AB or TPC of its right to nized by EPA.
request a hearing on the immediate (ii) Due to fraud or providing false or
revocation within 15 calendar days of misleading statements with respect to
the revocation taking place and the a particular TPC, or for any other rea-
procedures for the conduct of such a son that implicates a particular TPC in
hearing. a violation of TSCA Title VI, that TPC
(iv) Any notification, decision, or may not provide any TSCA Title VI
order issued by EPA under this section, certification services until it has been
any transcript or other verbatim accredited again by another EPA TSCA
record of oral testimony, and any docu- Title VI AB and re-recognized by EPA.
ments filed by a certified individual or (2) If a TPC loses its accreditation, or
firm in a hearing under this section if TPC is removed or withdraws from
will be available to the public, except the EPA TSCA Title VI Third-Party
as otherwise provided by TSCA section Certification Program:
14. Any such hearing at which oral tes- (i) For reasons other than fraud or
timony is presented will be open to the providing false or misleading state-
public, except that the Presiding Offi- ments, and other than a reason that
cer may exclude the public to the ex- implicates a particular panel producer
tent necessary to allow presentation of in a violation of TSCA Title VI, the
information which may be entitled to panel producers that used the TPC to
confidential treatment under TSCA certify their products must enlist an-
section 14. other EPA TSCA Title VI TPC to cer-
(v) EPA will maintain a publicly tify their products within 90 calendar
available list of ABs on its Web site days. If the panel producer is not able
whose recognition has been suspended, to obtain the services of another EPA
revoked or modified, or reinstated and TSCA Title VI TPC within 90 days, the
a publicly available list of TPCs whose panel producer may request from EPA
recognition has been suspended, re- a 90 calendar day extension. During the
voked, modified, or reinstated. time a panel producer is seeking a new
(vi) Unless the decision and order TPC, it must continue to comply with
issued under paragraph (e)(3) of this all other requirements of TSCA Title
section specify otherwise, an AB or a VI, including quality control testing.
TPC whose recognition has been re- (ii) Due to fraud or providing false or
voked must reapply for recognition in misleading statements with respect to
order to become recognized under this a particular panel producer, or for any
part again. other reason that implicates a par-
(vii) Unless the decision and order ticular panel producer in a violation of
issued under paragraph (e)(3) of this TSCA Title VI, that panel producer
section specify otherwise, an AB whose may not sell, supply, offer for sale, or
recognition has been revoked or a TPC manufacture composite wood products
whose recognition has been revoked, for sale in the United States until its
must immediately notify all TPCs or composite wood products have been re-
panel producers to which it provides certified by another EPA TSCA Title
TSCA Title VI accreditation or certifi- VI TPC.
cation services of the revocation. (g) Process for denying EPA TSCA Title
(f) Effect of the loss of recognition or VI recognition. (1) Upon EPA denying a
accreditation. (1) If an AB is removed or request for recognition of an AB or

withdraws from the EPA TSCA Title TPC, EPA will notify the AB or TPC in
VI Third-Party Certification Program: writing of the following:
408
(i) The legal and factual basis for the (i) My company has taken measures
denial; and to protect the confidentiality of the in-
(ii) Actions, if any, which the af- formation.
fected AB or TPC may take to receive (ii) I have determined that the infor-
recognition in the future. mation is not required to be disclosed
(2) [Reserved] or otherwise made available to the pub-
lic under any other Federal law.
EFFECTIVE DATE NOTE: At 82 FR 23738, May (iii) I have a reasonable basis to con-
24, 2017, in § 770.7, paragraph (d)(1) introduc- clude that disclosure of the informa-
tory text was revised, effective July 10, 2017.
tion is likely to cause substantial harm
For the convenience of the user, the revised
text is set forth as follows:
to the competitive position of the per-
son.
§ 770.7 Third-party certification. (iv) I have a reasonable basis to be-
lieve that the information is not read-
* * * * * ily discoverable through reverse engi-
neering.
(d) * * *
(1) During transitional period. The transi-
tional period is defined as the period begin-
Subpart C—Composite Wood
ning on December 12, 2016 and ending on Products
March 22, 2019. TPCs already approved by
CARB and TPCs subsequently approved by § 770.10 Formaldehyde emission stand-
CARB during the transition period must ards.
apply for EPA recognition in accordance (a) Except as otherwise provided in
with § 770.8 before they can certify any prod- this part, the emission standards in
ucts under this part. Once recognized by
this section apply to composite wood
EPA, CARB-approved TPCs become EPA
TSCA Title VI TPCs and may certify com-
products sold, supplied, offered for sale,
posite wood products under TSCA Title VI or manufactured (including imported)
until March 22, 2019 as long as they: on or after December 12, 2017 in the
United States. These emission stand-
ards apply regardless of whether the
* * * * *
composite wood product is in the form
§ 770.8 Applications, notifications, and of a panel, a component part, or incor-
reports. porated into a finished good.
(b) The emission standards are based
(a) All applications, notifications, on test method ASTM E1333–10 (incor-
and reports that are required to be sub- porated by reference, see § 770.99), and
mitted to EPA under this subpart must are as follows:
be submitted via the EPA Central Data (1) For hardwood plywood made with
Exchange (CDX) found at https:// a veneer core or a composite core, 0.05
cdx.epa.gov. parts per million (ppm) of formalde-
(b) If the EPA CDX is unavailable, hyde.
EPA will so inform EPA TSCA Title VI (2) For medium-density fiberboard,
ABs and TPCs and will make electronic 0.11 ppm of formaldehyde.
applications and reporting forms avail- (3) For thin medium-density fiber-
able online at http://www.epa.gov/form- board, 0.13 ppm of formaldehyde.
aldehyde. (4) For particleboard, 0.09 ppm of
(c)(1) Persons submitting a notice formaldehyde.
under this rule are subject to EPA con-
fidentiality regulations at 40 CFR part 24, 2017, in § 770.10, paragraph (a) was revised,
2, subpart B, except that the certifi- effective July 10, 2017. For the convenience of
cation in paragraph (c)(2) of this sec- the user, the revised text is set forth as fol-
tion must also be provided when assert- lows:
ing a claim of confidentiality.
§ 770.10 Formaldehyde emission standards.
(2) In submitting a claim of confiden-
(a) Except as otherwise provided in this
tiality, a person must certify the truth
part, the emission standards in this section

of the following four statements con- apply to composite wood products sold, sup-
cerning all information which is plied, offered for sale, or manufactured (in-
claimed as confidential: cluding imported) beginning March 22, 2018
409
§ 770.12 40 CFR Ch. I (7–1–17 Edition)
in the United States. These emission stand- § 770.12 Stockpiling.
ards apply regardless of whether the com- (a) The sale of stockpiled inventory of
posite wood product is in the form of a panel, composite wood products, whether in the
a component part, or incorporated into a fin- form of panels or incorporated into compo-
ished good. nent parts or finished goods, is prohibited be-
ginning March 22, 2018.
* * * * *
* * * * *
§ 770.12 Stockpiling.
(a) The sale of stockpiled inventory § 770.15 Composite wood product cer-
tification.
of composite wood products, whether in
the form of panels or incorporated into (a) After December 12, 2017, only cer-
component parts or finished goods, is tified composite wood products, wheth-
prohibited after December 12, 2017. er in the form of panels or incorporated
(b) To determine whether stockpiling into component parts or finished goods,
has occurred, the rate of manufacture are permitted to be sold, supplied, of-
or purchase is measured as follows: fered for sale, or manufactured (includ-
(1) For composite wood products in ing imported) in the United States, un-
less the product is specifically exempt-
the form of panels, the rate is meas-
ed by this part.
ured in terms of square footage of pan-
els produced. (b) Certified composite wood prod-
ucts are those that are produced or fab-
(2) For composite wood products in-
ricated in accordance with all of the
corporated into component parts or provisions of this part.
finished goods, the rate is measured in
(c) To obtain product certification, a
terms of the square footage of com-
panel producer must apply to an EPA
posite wood product panels purchased
TSCA Title VI TPC.
for the purpose of incorporating them
(1) For panel producers that do not
into component parts or finished goods.
have any previous product certifi-
(c) Manufacturers or purchasers who cations from a CARB-approved TPC or
have, in an annual year, a greater than an EPA TSCA Title VI TPC, the appli-
20% increase in manufacturing or pur- cation must contain the following:
chasing composite wood products rel-
(i) The panel producer’s name, ad-
ative to annual year 2009 for some rea- dress, telephone number, and other
son other than circumventing the contact information;
emission standards would not be in vio-
(ii) A copy of the panel producer’s
lation of this section. Such reasons
quality control manual as required by
may include, but are not limited to: § 770.21(a);
(1) A quantifiable immediate increase (iii) Name and contact information
in customer demand or sales. for the panel producer’s quality control
(2) A documented and planned busi- manager;
ness expansion. (iv) An identification of the specific
(3) The manufacturer or purchaser products for which certification is re-
was not in business at the beginning of quested, and the resin system used in
calendar year 2009. panel production;
(4) An increase in production to meet (v) At least five tests conducted
increased demand resulting from an under the supervision of an EPA TSCA
emergency event or natural disaster. Title VI TPC pursuant to test method
(d) In order to be found to be stock- ASTM E1333–10 or ASTM D6007–02 (in-
piling an entity must be increasing the corporated by reference, see § 770.99).
rate of manufacturing or purchasing Test results obtained by ASTM D6007–
for the purpose of circumventing the 02 must include a showing of equiva-
emission standards. lence in accordance with § 770.20(d)(1);
(vi) At least five quality control tests
24, 2017, in § 770.12, paragraph (a) was revised, conducted in accordance with
effective July 10, 2017. For the convenience of § 770.20(b)(1);

the user, the revised text is set forth as fol- (vii) Linear regression equation and
lows: correlation data; and
410
(viii) Results of an initial, on-site in- submitted for the candidate product at
spection by the TPC of the panel pro- any time.
ducer. (e) If a product is certified by a
(2) For panel producers applying for CARB-approved TPC, it will also be
certification of a new product type but considered certified under TSCA Title
that have previous product certifi- VI until December 12, 2018 after which
cations from a CARB-approved TPC or the TPC needs to receive recognition as
an EPA TSCA Title VI TPC, the appli- an EPA TSCA Title VI TPC under
cation must contain the following: § 770.7(d) in order for the product to re-
(i) The panel producer’s name, ad- main certified.
dress, and telephone number; (f) To maintain certification, the
(ii) An identification of the specific panel producer making the certified
products for which certification is re- product must get inspected by its EPA
quested, and the resin system used in TSCA Title VI TPC quarterly as well
panel production; as meet the testing requirements under
(iii) At least five tests conducted § 770.20.
under the supervision of an EPA TSCA (g) If the certified product fails a
Title VI TPC pursuant to test method quarterly test, certification for any
ASTM E1333–10 or ASTM D6007–02 (in- product types represented by the sam-
corporated by reference, see § 770.99). ple is suspended until a compliant
Test results obtained by ASTM D6007– quarterly test result is obtained in ac-
02 must include a showing of equiva- cordance with § 770.22.
lence in accordance with § 770.20(d)(1);
(iv) At least five quality control tests
24, 2017, in § 770.15, paragraphs (a) and (e)
conducted in accordance with were revised, effective July 10, 2017. For the
§ 770.20(b)(1); convenience of the user, the revised text is
(v) Linear regression equation and set forth as follows:
correlation data; and
(vi) Description of any changes in the § 770.15 Composite wood product certifi-
cation.
panel producer’s quality control man-
ual and a copy of those changes. (a) Beginning March 22, 2018, only certified
composite wood products, whether in the
(d) The EPA TSCA Title VI TPC form of panels or incorporated into compo-
must act on a panel producer’s com- nent parts or finished goods, are permitted
plete application within 90 calendar to be sold, supplied, offered for sale, or man-
days of receipt by reviewing all of the ufactured (including imported) in the United
components of the application. States, unless the product is specifically ex-
(1) If the application indicates that empted by this part.
the candidate product achieves the ap-
plicable emission standards described * * * * *
in § 770.10, adequate correlation as de-
(e) If a product is certified by a CARB-ap-
scribed in § 770.20(d)(2), and that the proved TPC that is also recognized by EPA,
panel producer is meeting the require- the product will also be considered certified
ments in § 770.21, the EPA TSCA Title under TSCA Title VI until March 22, 2019
VI TPC will approve the application. after which the TPC needs to comply with
(2) If the application is from a panel all the requirements of this part as an EPA
producer that did not previously have TSCA Title VI TPC under Section 770.7(d) in
products certified by a CARB-approved order for the product to remain certified.
TPC or an EPA TSCA Title VI TPC,
the EPA TSCA Title VI TPC will re- * * * * *
view the quality control manual and
results of the on-site initial inspection § 770.17 No-added formaldehyde-based
and approve or disapprove the quality resins.
control manual. (a) Producers of composite wood
(3) If the application does not dem- product panels made with no-added
onstrate that the candidate product formaldehyde-based resins may apply
achieves the applicable emission stand- to an EPA TSCA Title VI TPC or to
ards described in § 770.10, the EPA CARB for a two-year exemption from
TSCA Title VI TPC will disapprove the the testing requirements in § 770.20 and
application. A new application may be certification requirements in §§ 770.15
411
§ 770.18 40 CFR Ch. I (7–1–17 Edition)
and 770.40(b). The application must accordance with paragraph (a)(3) of

contain the following: this section that complies with the
(1) The panel producer’s name, ad- emission standards in paragraph (c)(1)
dress, and telephone number; of this section.
(2) An identification of the specific (f) Any time there is an operational
product and the resin system; or process change that is likely to af-
(3) At least one test conducted under fect formaldehyde emissions, such as a
the supervision of an EPA TSCA Title change in resin formulation, press
VI TPC pursuant to test method ASTM cycle duration, temperature, or
E1333–10 or ASTM D6007–02 (incor- amount of resin used per panel, at least
porated by reference, see § 770.99). Test one quality control test under § 770.20
results obtained by ASTM D6007–02 and at least one test result in accord-
must include a showing of equivalence ance with paragraph (a)(3) of this sec-
in accordance with § 770.20(d)(1); and tion that indicate compliance with the
(4) Three months of routine quality emission standards in paragraph (c)(1)
control tests under § 770.20, including a of this section are required.
showing of correlation in accordance (g) A change in the resin system in-
with § 770.20(d)(2), totaling not less validates the exemption for any prod-
than five quality control tests. uct produced with the different resin
(b) The EPA TSCA Title VI TPC will after such a change.
approve a panel producer’s application
within 90 calendar days of receipt if the § 770.18 Ultra low-emitting formalde-
application is complete and dem- hyde resins.
onstrates that the candidate product (a) Producers of composite wood
achieves the emission standards de- product panels made with ultra low-
scribed in paragraph (c) of this section. emitting formaldehyde resins may
(c) As measured according to para- apply to an EPA TSCA Title VI TPC or
graphs (a)(3) and (4) of this section, the CARB for approval either to conduct
emission standards for composite wood less frequent testing than is specified
products made with no-added formalde- in § 770.20 or approval for a two-year ex-
hyde-based resins are as follows: emption from the testing requirements
(1) No test result higher than 0.05 in § 770.20 and certification require-
parts per million (ppm) of formalde- ments in §§ 770.15 and 770.40(b). The ap-
hyde for hardwood plywood and 0.06 plication must contain the following:
ppm for particleboard, medium-density (1) The panel producer’s name, ad-
fiberboard, and thin medium-density fi- dress, and telephone number;
berboard. (2) An identification of the specific
(2) No higher than 0.04 ppm of form- product type, including resin system;
aldehyde for 90% of the three months (3) At least two tests conducted
of routine quality control testing data under the supervision of an EPA TSCA
required under paragraph (a)(4) of this Title VI TPC pursuant to test method
section. ASTM E1333–10 or ASTM D6007–02 (in-
(d) Products that meet the require- corporated by reference, see § 770.99).
ments specified under § 770.17(c)(1) and Test results obtained by ASTM D6007–
(2) and have obtained exemption from 02 must include a showing of equiva-
the California Air Resources Board will lence in accordance with § 770.20(d)(1);
also be exempt from the requirements and
in §§ 770.15, 770.20, and 770.40(b), as long (4) Six months of routine quality con-
as the requirements of the California trol tests under § 770.20, including a
Air Resources Board remain as strin- showing of correlation in accordance
gent as EPA’s requirements. with § 770.20(d)(2), totaling not less
(e) After the two-year period of the than ten quality control tests.
initial exemption, and every two years (b) The EPA TSCA Title VI TPC will
thereafter, in order to continue to approve a panel producer’s application
qualify for the exemption from the within 90 calendar days of receipt if the
testing and certification requirements, application is complete and dem-
the panel producer must reapply to an onstrates that the candidate product
EPA TSCA Title VI TPC or to CARB achieves the emission standards re-
and obtain at least one test result in quired for reduced testing as described
412
in paragraph (c) of this section or the of the California Air Resources Board
emission standards required for a two- remain as stringent as EPA’s require-
year exemption as described in para- ments.
graph (d) of this section. (f) Products that are represented by a
(c) As measured according to para- quarterly test result that exceeds the
graphs (a)(3) and (4) of this section, the applicable emission standard in this
emission standards for reduced testing section or a quality control test that
for composite wood products made with indicates that the product exceeds the
ultra low-emitting formaldehyde resins applicable emission standard in this
are as follows: section lose their reduced testing ap-
(1) No test result higher than 0.05 proval and must reapply as specified
parts per million (ppm) of formalde- under § 770.18(a).
hyde for hardwood plywood, 0.08 ppm (g) After the two-year period of the
for particleboard, 0.09 ppm for medium- initial exemption, and every two years
density fiberboard, and 0.11 ppm for thereafter, in order to continue to
thin medium-density fiberboard. qualify for the exemption from the
(2) For 90% of the six months of rou- testing and certification requirements,
tine quality control testing data re- the panel producer must reapply to an
quired under paragraph (a)(4) of this EPA TSCA Title VI TPC or CARB and
section, no higher than 0.05 ppm of obtain at least two test results in ac-
formaldehyde for particleboard, no cordance with paragraph (a)(3) of this
higher than 0.06 ppm of formaldehyde section that comply with the emission
for medium-density fiberboard, and no standards in paragraph (d)(1) of this
higher than 0.08 ppm of formaldehyde section.
for thin medium-density fiberboard. (h) Any time there is an operational
(d) As measured according to para- or process change such as a change in
graphs (a)(3) and (4) of this section, the resin formulation, press cycle duration,
emission standards for an exemption temperature, or amount of resin used
from the testing and certification re- per panel, at least five quality control
quirements of § 770.20 for composite tests under § 770.20 and at least one test
wood products made with ultra low- result in accordance with paragraph
emitting formaldehyde resins are as (a)(3) of this section that indicate com-
follows: pliance with the emission standards in
(1) No test result higher than 0.05 paragraph (d)(1) of this section are re-
ppm of formaldehyde for hardwood ply- quired.
wood or 0.06 ppm of formaldehyde for (i) A change in the resin system in-
particleboard, medium-density fiber- validates the exemption or reduced
board, and thin medium-density fiber- testing approval for any product type
board. produced after such a change.
(2) For 90% of the six months of rou-
tine quality control testing data re- § 770.20 Testing requirements.
quired under paragraph (a)(4) of this (a) General requirements. (1) All panels
section, no higher than 0.04 parts per must be tested in an unfinished condi-
million of formaldehyde. tion, prior to the application of a fin-
(e) Products that have obtained an ishing or topcoat, as soon as possible
exemption from the California Air Re- after their production but no later
sources Board will also be exempt from than 30 calendar days after production.
the requirements in §§ 770.15, 770.20, and (2) Facilities that conduct the form-
770.40(b) if they meet the requirements aldehyde testing required by this sec-
under § 770.18(d) and the requirements tion must follow the procedures and
of the California Air Resources Board specifications, such as testing condi-
remain as stringent as EPA’s require- tions and loading ratios, of the test
ments. Products that have obtained ap- method being used.
proval for reduced testing from the (3) All equipment used in the form-
California Air Resources Board will be aldehyde testing required by this sec-
granted approval to conduct less fre- tion must be calibrated and otherwise
quent testing than is specified in maintained and used in accordance

§ 770.20 if they meet the requirements with the equipment manufacturer’s in-
under § 770.18(c) and the requirements structions.
413
§ 770.20 40 CFR Ch. I (7–1–17 Edition)
(b) Quality control testing—(1) Allow- (2) Maintain a 30 panel running aver-
able methods. Quality control testing age.
must be performed using any of the fol- (B) With respect to reduced quality
lowing methods, with a showing of cor- control testing, EPA TSCA Title VI
relation for each method pursuant to TPCs:
paragraph (d) of this section: (1) May approve a reduction to one
(i) ASTM D6007–02 (incorporated by quality control test per 24-hour produc-
reference, see § 770.99). tion period if the 30 panel running av-
(ii) ASTM D5582–00 (incorporated by erage remains two standard deviations
reference, see § 770.99). below the designated QCL for the pre-
(iii) BS EN 717–2:1995 (Gas Analysis vious 60 consecutive calendar days or
Method) (incorporated by reference, see more;
§ 770.99). (2) May approve a reduction to one
(iv) DMC 2007 User’s Manual (incor- quality control test per 48-hour produc-
porated by reference, see § 770.99). tion period if the 30 panel running av-
(v) DMC 2012 GP User’s Manual (in- erage remains three standard devi-
corporated by reference, see § 770.99). ations below the designated QCL for
(vi) BS EN 120:1992 (Perforator Meth- the previous 60 consecutive calendar
od) (incorporated by reference, see days or more;
§ 770.99). (3) Will approve a request for reduced
quality control testing as long as the
(vii) JIS A 1460:2001(E) (24-hr Desic-
data submitted by the panel producer
cator Method) (incorporated by ref-
demonstrate compliance with the cri-
erence, see § 770.99).
teria and the EPA TSCA Title VI TPC
(2) Frequency of testing. (i)
does not otherwise have reason to be-
Particleboard and medium-density fi-
lieve that the data are inaccurate or
berboard must be tested at least once
the panel producer’s production proc-
per shift (eight or twelve hours, plus or
esses are inadequate to ensure contin-
minus one hour of production) for each
ued compliance with the emission
production line for each product type.
standards; and
Quality control tests must also be con-
(4) Will revoke approval for reduced
ducted whenever:
quality control testing if testing or in-
(A) A product type production ends, spections indicate a panel producer no
even if eight hours of production has longer demonstrates consistent oper-
not been reached; ations and low variability of test val-
(B) The resin formulation is changed ues.
so that the formaldehyde to urea ratio (iii) Hardwood plywood must be test-
is increased; ed as follows:
(C) There is an increase by more than (A) At least one test per week per
ten percent in the amount of formalde- product type if the weekly hardwood
hyde resin used, by square foot or by plywood production at the panel pro-
panel; ducer is more than 100,000 but less than
(D) There is a decrease in the des- 200,000 square feet.
ignated press time by more than 20%; (B) At least two tests per week per
or product type if the weekly hardwood
(E) The quality control manager or plywood production at the panel pro-
quality control employee has reason to ducer is 200,000 square feet or more, but
believe that the panel being produced less than 400,000 square feet.
may not meet the requirements of the (C) At least four tests per week per
applicable standards. product type if the weekly hardwood
(ii) Particleboard and medium-den- plywood production at the panel pro-
sity fiberboard panel producers are eli- ducer is 400,000 square feet or more.
gible for reduced quality control test- (D) If weekly production of hardwood
ing if they demonstrate consistent op- plywood at the panel producer is 100,000
erations and low variability of test val- square feet or less, at least one test per
ues. 100,000 square feet for each product
(A) To qualify, panel producers must: type produced; or, if less than 100,000
(1) Apply in writing to an EPA TSCA square feet of a particular product type
Title VI TPC; and is produced, one quality control test of
414
that product type every month that it (2) Sample selection. (i) Samples must
is produced. be randomly chosen by an EPA TSCA
(E) Quality control tests must also be Title VI TPC.
conducted whenever: (ii) Samples must be selected from
(1) The resin formulation is changed each certified product type for quar-
so that the formaldehyde to urea ratio terly testing purposes. For hardwood
is increased; plywood samples, the samples must be
(2) There is an increase by more than randomly selected from products that
ten percent in the amount of formalde- represent the range of formaldehyde
hyde resin used, by square foot or by emissions of products produced by the
panel; panel producer.
(3) There is an increase by more than (iii) Samples must not include the
top or the bottom composite wood
20% in the adhesive application rate;
product of a bundle.
(4) There is a decrease in the des-
(3) Sample handling. Samples must be
ignated press time by more than 20%;
closely stacked or air-tight wrapped
or between the time of sample selection
(5) The quality control manager or and the start of test conditioning.
quality control employee has reason to Samples must be labeled as such,
believe that the panel being produced signed by the EPA TSCA Title VI TPC,
may not meet the requirements of the bundled air-tight, wrapped in poly-
applicable standard. ethylene, protected by cover sheets,
(iv) Composite wood products that and promptly shipped to the TPC lab-
have been approved by an EPA TSCA oratory. Conditioning must begin as
Title VI TPC or CARB for reduced test- soon as possible, but no later than 30
ing under § 770.18(b) through (c) must be calendar days after the samples were
tested at least once per week per prod- produced.
uct type and, for particle board and (4) Results. Any sample that exceeds
medium-density fiberboard, per produc- the applicable formaldehyde emission
tion line, for products produced that standard in § 770.10 must be reported by
week, except that hardwood plywood the EPA TSCA Title VI TPC to the
panel producers who qualify for less panel producer in writing and to EPA,
frequent testing under paragraph in accordance with § 770.8, within 72
(b)(2)(iii)(D) of this section may con- hours. The panel producer must comply
tinue to perform quality control test- with § 770.22 with respect to any lot rep-
ing under that provision. resented by a sample result that ex-
(3) Results. Any test result that exceeds the applicable formaldehyde
ceeds the QCL established pursuant to emission standard. Where multiple
§ 770.7(c)(4)(i)(C) must be reported to products are grouped in a single prod-
the EPA TSCA Title VI TPC in writing uct type for testing, this includes all
within 72 hours. The panel producer products in the group represented by
must comply with § 770.22 with respect the sample.
to any lot represented by a quality (5) Reduced testing frequency. Com-
control sample that exceeds the QCL. posite wood products that have been
Where multiple products are grouped in approved by an EPA TSCA Title VI
a single product type for testing, this TPC or CARB for reduced testing under
includes all products in the group rep- § 770.18(c) need only undergo quarterly
resented by the sample. testing every six months.
(c) Quarterly testing. Quarterly test- (d) Equivalence or correlation. Equiva-
ing must be supervised by EPA TSCA lence or correlation between ASTM
Title VI TPCs and performed by TPC E1333–10 (incorporated by reference, see
laboratories. § 770.99) and any other test method used
(1) Allowable methods. Quarterly test- for quarterly or quality control testing
ing must be performed using ASTM must be demonstrated by EPA TSCA
E1333–10 (incorporated by reference, see Title VI TPCs or panel producers, re-
§ 770.99) or, with a showing of equiva- spectively, at least once each year for
lence pursuant to paragraph (d) of this each testing apparatus or whenever

section, ASTM D6007–02 (incorporated there is a significant change in equip-
by reference, see § 770.99). ment, procedure, or the qualifications
415
§ 770.20 40 CFR Ch. I (7–1–17 Edition)
of testing personnel. Once equivalence D6007–02 method (incorporated by ref-

or correlation have been established erence, see § 770.99).
for three consecutive years, equiva- (B) For the ASTM D6007–02 method
lence or correlation must be dem- (incorporated by reference, see § 770.99),
onstrated every two years or whenever each comparison sample shall consist
there is a significant change in equip- of testing specimens representing por-
ment, procedure, or the qualifications tions of panels similar to the panels
of testing personnel. tested in the ASTM E1333–10 method
(1) Equivalence between ASTM E1333–10 (incorporated by reference, see § 770.99)
and ASTM D6007–02 when used by the and matched to their respective ASTM
TPC for quarterly testing. Equivalence E1333–10 method (incorporated by ref-
must be demonstrated for at least five
erence, see § 770.99) comparison sample
comparison sample sets, which com-
result. The ratio of air flow to sample
pare the results of the two methods.
surface area specified in ASTM D6007–
Equivalence must be demonstrated for
each small chamber used and for the 02 (incorporated by reference, see
ranges of emissions of composite wood § 770.99) must be used.
products tested by the TPC. (C) The five comparison sample—
(i) Samples. (A) For the ASTM E1333– must consist of testing a minimum of
10 method (incorporated by reference, five sample sets as measured by the
see § 770.99), each comparison sample ASTM E1333–10 method (incorporated
must consist of the result of testing by reference, see § 770.99).
panels, using the applicable loading ra- (ii) Average and standard deviation.
tios specified in the ASTM E1333–10 The arithmetic mean, x, and standard
method (incorporated by reference, see deviation, S, of the difference of all
§ 770.99), from similar panels of the comparison sets must be calculated as
same product type tested by the ASTM follows:
Where x̄ = arithmetic mean; S = standard de- (iii) Equivalence determination. The

viation; n = number of sets; Di = dif- ASTM D6007–02 method (incorporated
ference between the ASTM E1333–10 and by reference, see § 770.99) is considered
ASTM D6007–02 method (incorporated by equivalent to the ASTM E1333–10 meth-
reference, see § 770.99) values for the ith od (incorporated by reference, see
set; and i ranges from 1 to n.
§ 770.99) if the following condition is
met:
Where C is equal to 0.026. (i) Correlation. The correlation must

(2) Correlation between ASTM E1333–10 be based on a minimum sample size of
and any quality control test method. Cor- five data pairs and a simple linear re-
gression where the dependent variable
relation must be demonstrated by es-

ER12DE16.003</GPH>
tablishing an acceptable correlation (Y-axis) is the quality control test

coefficient (‘‘r’’ value). value and the independent variable (X-
416
ER12DE16.002</GPH>
axis) is the ASTM E1333–10 (incor- (iv) A description of the frequency of

porated by reference, see § 770.99) test quality control testing;
value. Either composite wood products (v) A description of the procedures
or formaldehyde emissions reference used to identify changes in formalde-
materials can be used to establish the hyde emissions resulting from produc-
correlation. tion changes (e.g., increase in the per-
(ii) Minimum acceptable correlation co- centage of resin, increase in formalde-
efficients (‘‘r’’ values). The minimum ac- hyde/urea molar ratio in the resin, or
ceptable correlation coefficients are as decrease in press time);
follows, where ‘‘n’’ is equal to the num- (vi) A description of provisions for
ber of data pairs, and ‘‘r’’ is the cor- additional testing;
relation coefficient: (vii) A description of recordkeeping
procedures;
Degrees of freedom
(n-2) ‘‘r’’ value (viii) A description of labeling proce-
dures;
3 ..................................................................... 0.878 (ix) The average percentage of resin
4 ..................................................................... 0.811
5 ..................................................................... 0.754 and press time for each product type;
6 ..................................................................... 0.707 (x) A description of product types,
7 ..................................................................... 0.666 and if applicable, a description of prod-
8 ..................................................................... 0.632
9 ..................................................................... 0.602 uct variables covered under each prod-
10 or more ..................................................... 0.576 uct type;
(xi) Procedures for reduced quality
(iii) Variation from previous results. If control testing, if applicable; and
data from an EPA TSCA Title VI TPC’s (xii) Procedures for handling non-
quarterly test results and a panel pro- complying lots, including a description
ducer’s quality control test results do of how the panel producer will ensure
not fit the previously established cor- compliance with the notification re-
relation, the panel producer must have quirements of § 770.22(d)(1).
its TPC establish a new correlation and (2) The quality control manual must
new QCLs. be approved by an EPA TSCA Title VI
(iv) Failed quarterly tests. If a panel TPC.
producer fails two quarterly tests in a (b) Quality control facilities. Each
row for the same product type, the panel producer must designate a qual-
panel producer must have its TPC es- ity control facility for conducting
tablish a new correlation curve. quality control formaldehyde testing.
(e) Quality assurance and quality con- (1) The quality control facility must
trol requirements for panel producers. be an EPA TSCA Title VI TPC, a con-
Panel producers are responsible for tract laboratory, or a laboratory owned
product compliance with the applicable and operated by the panel producer.
emission standards. (2) Each quality control facility must
have quality control employees with
§ 770.21 Quality control manual, facili- adequate experience and/or training to
ties, and personnel. conduct accurate chemical quan-
(a) Quality control manual. (1) Each titative analytical tests. The quality
panel producer must have a written control manager must identify each
quality control manual. The manual person conducting formaldehyde qual-
must contain, at a minimum, the fol- ity control testing to the EPA TSCA
lowing: Title VI TPC.
(i) A description of the organiza- (c) Quality control manager. Each
tional structure of the quality control panel producer must designate a person
department, including the names of the as quality control manager with ade-
quality control manager and quality quate experience and/or training to be
control employees; responsible for formaldehyde emissions
(ii) A description of the sampling quality control. The quality control
procedures to be followed; manager must:
(iii) A description of the method of (1) Have the authority to take ac-
handling samples, including a specific tions necessary to ensure that applica-

maximum time period for analyzing ble formaldehyde emission standards
quality control samples; are being met on an ongoing basis;
417
§ 770.22 40 CFR Ch. I (7–1–17 Edition)
(2) Be identified to the EPA TSCA samples set aside by the panel producer
Title VI TPC that will be overseeing for retest in the event of a failure.
the quality control testing. The panel (ii) The sample must test at or below
producer must notify the EPA TSCA the applicable emission standards in
Title VI TPC in writing within ten cal- § 770.10.
endar days of any change in the iden- (d) If composite wood products be-
tity of the quality control manager and longing to a non-complying lot have
provide the EPA TSCA Title VI TPC been shipped to a fabricator, importer,
with the new quality control manager’s distributor, or retailer before the test
qualifications; results are received, the panel producer
(3) Review and approve all reports of must:
quality control testing conducted on (1) Ensure that the composite wood
the production of the panel producer; products are not distributed further by
(4) Ensure that the samples are col- notifying, within 72 hours of the time
lected, packaged, and shipped accord- that the panel producer is made aware
ing to the procedures specified in the of the failing test result, the fabrica-
quality control manual; and tors, importers, distributors, and re-
(5) Inform the EPA TSCA Title VI tailers that received the composite
TPC in writing of any significant wood products. The notification must
changes in production that could affect include the following:
formaldehyde emissions within 72 (i) Panel producer name, contact in-
hours of making those changes. formation, and date of notice;
(ii) A description of the composite
§ 770.22 Non-complying lots. wood products that belong to the non-
complying lot that is sufficient to
(a) Non-complying lots are not cer- allow the fabricator, importer, dis-
tified composite wood products and tributor, or retailer to identify the
they may not be sold, supplied or of- products;
fered for sale in the United States ex- (iii) Whether the failed test result
cept in accordance with this section. was of a quarterly test, a quality con-
(b) Non-complying lots must be iso- trol test, or a retest of composite wood
lated from certified lots. products belonging to a non-complying
(c) Non-complying lots must either lot;
be disposed of or retested and certified (iv) A statement that composite
using the same test method, if each wood products belonging to the non-
panel is treated with a scavenger or complying lot must be isolated from
handled by other means of reducing other composite wood products and
formaldehyde emissions, such as aging. cannot be further distributed in com-
Tests must be performed as follows: merce; and
(1) Quality control tests. (i) At least (v) A description of the steps the
one test panel must be selected from panel producer intends to take to ei-
each of three separate bundles. The ther recall the composite wood prod-
panels must be selected so that they ucts belonging to the non-complying
are representative of the entire non- lot or to treat and retest the products
complying lot and they are not the top and certify the lot.
or bottom panel of a bundle. The panels (2) Do one of the following:
may be selected from properly stored (i) Recall the composite wood prod-
samples set aside by the panel producer ucts belonging to the non-complying
for retest in the event of a failure. lot and either treat and retest products
(ii) All samples must test at or below belonging to the non-complying lot or
the level that indicates that the prod- dispose of them; or
uct is in compliance with the applica- (ii) Treat and retest composite wood
ble emission standards in § 770.10. products belonging to the non-com-
(2) Quarterly tests. (i) At least one test plying lot while they remain in posses-
panel must be randomly selected so sion of a fabricator, importer, dis-
that it is representative of the entire tributor, or retailer.
non-complying lot and is not the top or (e) Information on the disposition of
bottom panel of a bundle. The panel non-complying lots, including product
may be selected from properly stored type and amount of composite wood
418
products affected, lot numbers, mitiga- Title VI compliant or were produced

tion measures used, results of re- before December 12, 2017 and by ensur-
testing, and final disposition, must be ing the following records are made
provided to the EPA TSCA Title VI available to EPA within 30 calendar
TPC within seven calendar days of days of request:
final disposition. (1) Records identifying the panel pro-
(f) Fabricators, importers, distribu- ducer and the date the composite wood
tors, or retailers who are notified that products were produced; and
they have received composite wood (2) Records identifying the supplier,
products belonging to a non-complying if different, and the date the composite
lot and who have further distributed
wood products, component parts, or
the composite wood products are re-
finished goods were purchased.
sponsible for notifying the purchasers
of the composite wood products in ac- (c) Fabricators, distributors, and re-
cordance with paragraph (d)(1) of this tailers must demonstrate that they
section. have taken reasonable precautions by
obtaining bills of lading, invoices, or
§ 770.24 Samples for testing. comparable documents that include a
(a) Composite wood products may be written statement from the supplier
shipped into and transported across the that the composite wood products,
United States for quality control or component parts, or finished goods are
quarterly tests. TPCs that ship com- TSCA Title VI compliant or that the
posite panels into or across the United composite wood products were pro-
States solely for quality control or duced before December 12, 2017.
quarterly tests are not considered im- (d) On and after December 12, 2018,
porters or distributors or importers for importers of articles that are regulated
the purposes of § 770.7(c)(3)(i). composite wood products, or articles
(1) Such panels must not be sold, of- that contain regulated composite wood
fered for sale or supplied to any entity products, must comply with the import
other than a TPC laboratory before certification regulations for ‘‘Chemical
testing in accordance with § 770.17, Substances in Bulk and As Part of Mix-
§ 770.18, or § 770.20. tures and Articles,’’ as found at 19 CFR
(2) If test results for such products 12.118 through 12.127.
demonstrate compliance with the emis- (e) Records required by this section
sion standards in this subpart, the pan- must be maintained in accordance with
els may be relabeled in accordance § 770.40(d).
with § 770.45 and sold, offered for sale,
or supplied. EFFECTIVE DATE NOTE: At 82 FR 23738, May
(b) [Reserved] 24, 2017, in § 770.30, paragraphs (b) introduc-
tory text, (c) and (d) were revised, effective
§ 770.30 Importers, fabricators, dis- July 10, 2017. For the convenience of the
tributors, and retailers. user, the revised text is set forth as follows:
(a) Importers, fabricators, distribu- § 770.30 Importers, fabricators, distributors,

tors, and retailers must take reason- and retailers.
able precautions to ensure that the
composite wood products they sell, * * * * *
supply, offer for sale, or hold for sale,
(b) Importers must demonstrate that they
whether in the form of panels, compo-
have taken reasonable precautions by main-
nent parts, or finished goods, comply taining, for three years, bills of lading, in-
with the emission standards and other voices, or comparable documents that in-
requirements of this subpart. clude a written statement from the supplier
(b) Importers must demonstrate that that the composite wood products, compo-
they have taken reasonable pre- nent parts, or finished goods are TSCA Title
cautions by maintaining, for three VI compliant or were produced before March
years, bills of lading, invoices, or com- 22, 2018 and by ensuring the following records
parable documents that include a writ- are made available to EPA within 30 cal-
ten statement from the supplier that endar days of request:

the composite wood products, compo-
nent parts, or finished goods are TSCA * * * * *
419
§ 770.40 40 CFR Ch. I (7–1–17 Edition)
(c) Fabricators, distributors, and retailers the lot number that the tested mate-
must demonstrate that they have taken rea- rial represents, the test method used,
sonable precautions by obtaining bills of lad- and the test results.
ing, invoices, or comparable documents that
include a written statement from the sup- (3) Production records, including a
plier that the composite wood products, com- description of the composite wood
ponent parts, or finished goods are TSCA product(s), the date of manufacture, lot
Title VI compliant or that the composite numbers, and tracking information al-
wood products were produced before March lowing each product to be traced to a
22, 2018. specific lot produced.
(4) Records of changes in production,
* * * * * including changes of more than ten
(d) Beginning March 22, 2019, importers of percent in the resin use percentage,
articles that are regulated composite wood changes in resin composition that re-
products, or articles that contain regulated sult in a higher ratio of formaldehyde
composite wood products, must comply with to other resin components, and changes
the import certification regulations for in the process, such as changes in press
‘‘Chemical Substances in Bulk and As Part time by more than 20%.
of Mixtures and Articles,’’ as found at 19
CFR 12.118 through 12.127. (5) Records demonstrating initial and
continued eligibility for the reduced
testing provisions in §§ 770.17 and 770.18,
* * * * * if applicable. These records must in-
§ 770.40 Reporting and recordkeeping. clude:
(i) Approval for reduced testing from
(a) Panel producers must maintain an EPA TSCA Title VI TPC or CARB;
the following records for a period of
(ii) Amount of resin use reported by
three years, except that records dem-
volume and weight;
onstrating initial eligibility for re-
(iii) Production volume reported as
duced testing or third-party certifi-
square feet per product type;
cation exemption under § 770.17 or
§ 770.18 must be kept for as long as the (iv) Resin trade name, resin manufac-
panel producer is producing composite turer contact information (name, ad-
wood products with reduced testing or dress, phone number, and email), and
under a third-party certification ex- resin supplier contact information
emption. The following records must (name, address, phone number, and
also be made available to the panel email); and
producers’ EPA TSCA Title VI TPCs. (v) Any changes in the formulation of
Panel producers must make the records the resin.
described in paragraph (a)(1) of this (6) Purchaser information for each
section available to direct purchasers composite wood product, if applicable,
of their composite wood products. This including the name, contact person if
information may not be withheld from available, address, telephone number,
direct purchasers as confidential busi- email address if available, purchase
ness information. order or invoice number, and amount
(1) Records of all quarterly emissions purchased.
testing. These records must identify (7) Transporter information for each
the EPA TSCA Title VI TPC con- composite wood product, if applicable,
ducting or overseeing the testing. including name, contact person, ad-
These records must also include the dress, telephone number, email address
date, the product type tested, the lot if available, and shipping invoice num-
number that the tested material rep- ber.
resents, the test method used, and the (8) Information on the disposition of
test results. non-complying lots, including product
(2) Records of all ongoing quality type and amount of composite wood
control testing. These records must products affected, lot numbers, pur-
identify the EPA TSCA Title VI TPC chasers who received product belonging
conducting or overseeing the testing to non-complying lots (if any), copies
and the facility actually performing of purchaser notifications used (if any),
the testing. These records must also in- mitigation measures used, results of
clude the date, the product type tested, retesting, and final disposition.
420
(9) Representative copies of labels products are TSCA Title VI certified. If

used. a composite wood panel is not individ-
(b) Panel producers must provide ually labeled, the panel producer, im-
their EPA TSCA Title VI TPC with porter, distributor, fabricator, or re-
monthly product data reports for each tailer must have a method (e.g., color-
production facility, production line, coded edge marking) sufficient to iden-
and product type, maintain copies of tify the supplier of the panel and link-
the reports for a minimum of three ing the information on the label to the
years from the date that they are pro- products. This information must be
duced. Monthly product data reports made available to potential customers
must contain a data sheet for each spe- upon request. The label may be applied
cific product type with test and pro- as a stamp, tag, or sticker.
duction information, and a quality con- (1) A panel producer number may be
trol graph containing the following: used instead of a name to protect iden-
(1) QCL; tity, so long as the identity of the
(2) Shipping QCL (if applicable); panel producer can be determined at
(3) Results of quality control tests; the request of EPA.
and (2) Only panels or bundles of panels
(4) Retest values. manufactured in accordance with
(c) Laminated product producers § 770.17 may also be labeled that they
whose products are exempt from the were made with no-added formalde-
definition of hardwood plywood must
hyde-based resins in addition to the
keep records demonstrating eligibility
other information required by this sec-
for the exemption. These records must
tion.
be kept for a minimum of three years
from the date they are produced and (3) Only panels or bundles of panels
must include: manufactured in accordance with
(1) Resin trade name, resin manufac- § 770.18 may also be labeled that they
turer contact information (name, ad- were made with ultra low-emitting
dress, phone number, and email), resin formaldehyde resins in addition to the
supplier contact information (name, other information required by this sec-
address, phone number, and email), and tion.
resin purchase records; (b) Panels imported into or trans-
(2) Panel producer contact informa- ported across the United States for
tion and panel purchase records; quarterly or quality control testing
(3) For panels produced in-house, purposes in accordance with § 770.20
records demonstrating that the panels must be labeled ‘‘For TSCA Title VI
have been certified by an EPA TSCA testing only, not for sale in the United
Title VI TPC; and States.’’ The panels may be re-labeled
(4) For resins produced in-house, if test results are below the applicable
records demonstrating the production emission standards in this subpart.
of phenol-formaldehyde resins or resins (c) Fabricators of finished goods con-
formulated with no added formalde- taining composite wood products must
hyde as part of the resin cross-linking label every finished good they produce
structure. or every box or bundle containing fin-
(d) Importers, fabricators, distribu- ished goods. If a finished good (includ-
tors, and retailers must maintain the ing component parts sold separately to
records described in § 770.30 for a min- end users) is not individually labeled,
imum of three years from the import the importer, distributor, or retailer
date or the date of the purchases or must retain a copy of the label, be able
shipments described therein. to identify the products associated
with that label, and make the label in-
§ 770.45 Labeling. formation available to potential cus-
(a) Panels or bundles of panels that tomers upon request.
are sold, supplied, or offered for sale in (1) The label may be applied as a
the United States must be labeled with stamp, tag, or sticker.
the panel producer’s name, the lot (2) The label must include, at a min-
number, the number of the EPA TSCA imum, in legible English text, the fab-
Title VI TPC, and a statement that the ricator’s name, the date the finished
421
§ 770.99 40 CFR Ch. I (7–1–17 Edition)
good was produced (in month/year for- any edition other than that specified in
mat), and a statement that the finished this section, a document must be pub-
goods are TSCA Title VI compliant. lished in the FEDERAL REGISTER and
(3) Finished goods made from panels the material must be available to the
manufactured in accordance with public. All approved materials are
§ 770.17 and/or § 770.18 may also be la- available for inspection at the OPPT
beled that they were made with no- Docket in the Environmental Protec-
added formaldehyde-based resins, or tion Agency Docket Center (EPA/DC),
ultra low-emitting formaldehyde resins West William Jefferson Clinton Bldg.,
in addition to the other information re- Rm. 3334, 1301 Constitution Ave. NW.,
quired by this section. They may be la- Washington, DC. The EPA/DC Public
beled as being made with a combina- Reading Room hours of operation are
tion of compliant composite wood, no- 8:30 a.m. to 4:30 p.m., Monday through
added formaldehyde-based resins, and Friday, excluding legal holidays. The
ultra low-emitting formaldehyde res- telephone number of the EPA/DC Pub-
ins, if this is accurate. lic Reading room is (202) 566–1744, and
(4) Fabricators may substitute the the telephone number for the OPPT
name of a responsible downstream fab- Docket is (202) 566–0280. In addition,
ricator, importer, distributor, or re- these materials are also available for
tailer for their name on the label if inspection at the National Archives
they obtain and maintain written con-
and Records Administration (NARA).
sent from the downstream entity.
For information on the availability of
(d) Importers, distributors, and re-
this material at NARA, call (202) 741–
tailers must leave intact labels on fin-
6030 or go to http://www.archives.gov/
ished goods, including component parts
sold separately to end users. federallregister/
(e) Finished goods, including compo- codeloflfederallregulations/
nent parts sold separately to end users, ibrllocations.html. These materials
containing only a de minimis amount of may also be obtained from the sources
regulated composite wood product are listed in this section.
excepted from the labeling require- (a) CPA, AITC, and HPVA material.
ments. A finished good, including com- Copies of these materials may be ob-
ponent parts sold directly to contained from the specific publisher, as
sumers, contains a de minimis amount noted below, or from the American Na-
of regulated composite wood product if tional Standards Institute, 1899 L
its regulated composite wood product Street NW., 11th Floor, Washington,
content does not exceed 144 square DC 20036, or by calling (202) 293–8020, or
inches, based on the surface area of its at http://ansi.org/. Note that ANSI/AITC
largest face. The exception does not A190.1–2002 is published by the Amer-
apply to finished goods or component ican Institute of Timber Construction;
parts that are designed to be used in ANSI A135.4–2012, ANSI A135.5–2012,
combination or in multiples to create ANSI A135.6–2012, ANSI A135.7–2012,
larger surfaces, finished goods, or com- ANSI A208.1–2009, and ANSI A208.2–2009
ponent parts. are published by the Composite Panel
(f) Composite wood products and fin- Association; and ANSI ANSI/HPVA–
ished goods made entirely of composite HP–1–2009 is published by the Hardwood
wood products manufactured before the Plywood Veneer Association.
manufactured-by date must not be la- (1) ANSI A135.4–2012, Basic Hard-
beled as TSCA Title VI compliant. board, Approved June 8, 2012, IBR ap-
proved for § 770.3.
Subpart D—Incorporation by (2) ANSI A135.5–2012, Prefinished
Reference Hardboard Paneling, Approved March
29, 2012, IBR approved for § 770.3.
§ 770.99 Incorporation by reference. (3) ANSI A135.6–2012, Engineered
The materials listed in this section Wood Siding, Approved June 5, 2012,
are incorporated by reference into this IBR approved for § 770.3.
part with the approval of the Director (4) ANSI A135.7–2012, Engineered
of the Federal Register under 5 U.S.C. Wood Trim, Approved July 17, 2012, IBR
552(a) and 1 CFR part 51. To enforce approved for § 770.3.
422
(5) ANSI A208.1–2009, Particleboard, ard, go to CEN’s Web site, http://

Approved February 2, 2009, IBR ap- www.cen.eu, and select ‘‘Products’’ for
proved for § 770.3. more detailed information.
(6) ANSI A208.2–2009, Medium Density (1) BS EN 120:1992, Wood based pan-
Fiberboard (MDF) for Interior Applica- els—Determination of formaldehyde
tions, Approved February 2, 2009, IBR content—Extraction method called the
approved for § 770.3. perforator method, incorporating
(7) ANSI/AITC A190.1–2002, American Amendment No. 1, English Version,
National Standard for Wood Products— copyright BSI 1997, IBR approved for
Structural Glued Laminated Timber, § 770.20(b).
Approved October 10, 2002, IBR ap- (2) BS EN 717–2:1995, Wood-based pan-
proved for § 770.1(c). els—Determination of formaldehyde re-
(8) ANSI/HPVA HP–1–2009, American lease—Part 2: Formaldehyde release by
National Standard for Hardwood and the gas analysis method, incorporating
Decorative Plywood, Approved January Corrigendum No. 1, English Version,
26, 2010, IBR approved for § 770.3. copyright BSI 9 December 2002, IBR ap-
(b) ASTM material. Copies of these proved for § 770.20(b).
materials may be obtained from ASTM (d) Georgia Pacific material. Copies of
International, 100 Barr Harbor Dr., P.O. this material may be obtained from
Box C700, West Conshohocken, PA Georgia-Pacific Chemicals LLC, 133
19428–2959, or by calling (877) 909–ASTM,
Peachtree Street, Atlanta, GA 30303, or
or at http://www.astm.org.
by calling (877) 377–2737, or at http://
(1) ASTM D5055–05, Standard Speci-
www.gp-dmc.com/default.aspx.
fication for Establishing and Moni-
(1) The Dynamic Microchamber com-
toring Structural Capacities of Prefab-
puter integrated formaldehyde test
ricated Wood I-Joists, Approved Octo-
system, User Manual, revised March
ber 1, 2005, IBR approved for § 770.1(c).
2007 (DMC 2007 User’s Manual) IBR ap-
(2) ASTM D5456–06, Standard Speci-
proved for § 770.20(b).
fication for Evaluation of Structural
Composite Lumber Products, Approved (2) The GP Dynamic Microchamber
March 1, 2006, IBR approved for Computer-integrated formaldehyde
§ 770.1(c). test system, User Manual, copyright
(3) ASTM D5582–00 (Reapproved 2006), 2012 (DMC 2012 GP User’s Manual), IBR
Standard Test Method for Determining approved for § 770.20(b).
Formaldehyde Levels from Wood Prod- (e) ISO material. Copies of these mate-
ucts Using a Desiccator, October 1, rials may be obtained from the Inter-
2006, IBR approved for § 770.20(b). national Organization for Standardiza-
(4) ASTM D6007–02, Standard Test tion, 1, ch. de la Voie- Creuse, CP 56,
Method for Determining Formaldehyde CH–1211, Geneve 20, Switzerland, or by
Concentrations in Air from Wood Prod- calling +41–22–749–01–11, or at http://
ucts Using a Small Scale Chamber, Ap- www.iso.org.
proved April 10, 2002, IBR approved for (1) ISO/IEC 17011:2004(E), Conformity
§§ 770.3, 770.7(a) through (c), 770.15(c), assessments—General requirements for
770.17(a), 770.18(a) and 770.20(b) through accreditation bodies accrediting con-
(d). formity assessments bodies, First edi-
(5) ASTM E1333–10, Standard Test tion, Corrected version, 2005–02–15, IBR
Method for Determining Formaldehyde approved for §§ 770.3 and 770.7(a)
Concentrations in Air and Emission through (b).
Rates from Wood Products Using a (2) ISO/IEC 17020:2012(E), Conformity
Large Chamber, Approved May 1, 2010, assessment–Requirements for the oper-
IBR approved for §§ 770.3, 770.7(a) ation of various bodies performing in-
through (c), 770.10(b), 770.15(c), 770.17(a), spection, Second edition, 2012–03–01 IBR
770.18(a) and 770.20(c) through (d). approved for §§ 770.3 and 770.7(a)
(c) CEN materials. Copies of these ma- through (c).
terials are not directly available from (3) ISO/IEC 17025:2005(E), General re-
the European Committee for Standard- quirements for the competence of test-
ization, but from one of CEN’s National ing and calibration laboratories, Sec-
Members, Affiliates, or Partner Stand- ond edition, 2005–05–15, IBR approved
ardization Bodies. To purchase a stand- for §§ 770.3 and 770.7(a) through (c).
423
§ 770.99 40 CFR Ch. I (7–1–17 Edition)
(4) ISO/IEC 17065:2012(E), Conformity ber. Order numbers may be obtained

assessment—Requirements for bodies from the Public Inquiries Unit at (301)
certifying products, processes and serv- 975–NIST. Mailing address: Public In-
ices, First edition, 2012–09–15, IBR ap- quiries Unit, NIST, 100 Bureau Dr.,
proved for §§ 770.3 and 770.7(a) and (c). Stop 1070, Gaithersburg, MD 20899–1070.
(f) Japanese Standards Association. If you have a GPO stock number, you
Copies of this material may be ob- can purchase printed copies of NIST
tained from Japanese Industrial Stand- publications from GPO. GPO orders
ards, 1–24, Akasaka 4, Minatoku, Tokyo may be mailed to: U.S. Government
107– 8440, Japan, or by calling +81–3– Printing Office, P.O. Box 979050, St.
3583–8000, or at http://www.jsa.or.jp/. Louis, MO 63197–9000, placed by tele-
(1) JIS A 1460:2001(E), Building boards phone at (866) 512–1800 (DC Area only:
Determination of formaldehyde emis- (202) 512–1800), or faxed to (202) 512–2104.
sion—Desiccator method, First English Additional information is available on-
edition, published 2003–07 IBR approved line at: http://www.nist.gov.
for § 770.20(b). (1) PS 1–07, Structural Plywood, May
(2) [Reserved] 2007, IBR approved for §§ 770.1(c) and
(g) NIST material. Copies of these ma- 770.3.
terials may be obtained from the Na- (2) PS 2–04, Performance Standard for
tional Institute of Standards and Tech- Wood-Based Structural-Use Panels, De-
nology (NIST) by calling (800) 553–6847 cember 2004, IBR approved for §§ 770.1(c)
or from the U.S. Government Printing and 770.3.
Office (GPO). To purchase a NIST pub-
lication you must have the order num- PARTS 771–789 [RESERVED]
424
FINDING AIDS
A list of CFR titles, subtitles, chapters, subchapters and parts and an alphabet-
ical list of agencies publishing in the CFR are included in the CFR Index and
Finding Aids volume to the Code of Federal Regulations which is published sepa-
rately and revised annually.
Table of CFR Titles and Chapters
Alphabetical List of Agencies Appearing in the CFR
List of CFR Sections Affected
425
Table of CFR Titles and Chapters
(Revised as of July 1, 2017)
Title 1—General Provisions
I Administrative Committee of the Federal Register (Parts 1—49)

II Office of the Federal Register (Parts 50—299)
III Administrative Conference of the United States (Parts 300—399)
IV Miscellaneous Agencies (Parts 400—500)
Title 2—Grants and Agreements
SUBTITLE A—OFFICE OF MANAGEMENT AND BUDGET GUIDANCE FOR

GRANTS AND AGREEMENTS
I Office of Management and Budget Governmentwide Guidance for
Grants and Agreements (Parts 2—199)
II Office of Management and Budget Guidance (Parts 200—299)
SUBTITLE B—FEDERAL AGENCY REGULATIONS FOR GRANTS AND
AGREEMENTS
III Department of Health and Human Services (Parts 300—399)
IV Department of Agriculture (Parts 400—499)
VI Department of State (Parts 600—699)
VII Agency for International Development (Parts 700—799)
VIII Department of Veterans Affairs (Parts 800—899)
IX Department of Energy (Parts 900—999)
X Department of the Treasury (Parts 1000—1099)
XI Department of Defense (Parts 1100—1199)
XII Department of Transportation (Parts 1200—1299)
XIII Department of Commerce (Parts 1300—1399)
XIV Department of the Interior (Parts 1400—1499)
XV Environmental Protection Agency (Parts 1500—1599)
XVIII National Aeronautics and Space Administration (Parts 1800—
1899)
XX United States Nuclear Regulatory Commission (Parts 2000—2099)
XXII Corporation for National and Community Service (Parts 2200—
2299)
XXIII Social Security Administration (Parts 2300—2399)
XXIV Housing and Urban Development (Parts 2400—2499)
XXV National Science Foundation (Parts 2500—2599)
XXVI National Archives and Records Administration (Parts 2600—2699)

XXVII Small Business Administration (Parts 2700—2799)
427
Title 2—Grants and Agreements—Continued
Chap.
XXVIII Department of Justice (Parts 2800—2899)

XXIX Department of Labor (Parts 2900—2999)
XXX Department of Homeland Security (Parts 3000—3099)
XXXI Institute of Museum and Library Services (Parts 3100—3199)
XXXII National Endowment for the Arts (Parts 3200—3299)
XXXIII National Endowment for the Humanities (Parts 3300—3399)
XXXIV Department of Education (Parts 3400—3499)
XXXV Export-Import Bank of the United States (Parts 3500—3599)
XXXVI Office of National Drug Control Policy, Executive Office of the
President (Parts 3600—3699)
XXXVII Peace Corps (Parts 3700—3799)
LVIII Election Assistance Commission (Parts 5800—5899)
LIX Gulf Coast Ecosystem Restoration Council (Parts 5900—5999)
Title 3—The President
I Executive Office of the President (Parts 100—199)
Title 4—Accounts
I Government Accountability Office (Parts 1—199)
Title 5—Administrative Personnel
I Office of Personnel Management (Parts 1—1199)

II Merit Systems Protection Board (Parts 1200—1299)
III Office of Management and Budget (Parts 1300—1399)
IV Office of Personnel Management and Office of the Director of
National Intelligence (Parts 1400—1499)
V The International Organizations Employees Loyalty Board
(Parts 1500—1599)
VI Federal Retirement Thrift Investment Board (Parts 1600—1699)
VIII Office of Special Counsel (Parts 1800—1899)
IX Appalachian Regional Commission (Parts 1900—1999)
XI Armed Forces Retirement Home (Parts 2100—2199)
XIV Federal Labor Relations Authority, General Counsel of the Fed-
eral Labor Relations Authority and Federal Service Impasses
Panel (Parts 2400—2499)
XVI Office of Government Ethics (Parts 2600—2699)
XXI Department of the Treasury (Parts 3100—3199)
XXII Federal Deposit Insurance Corporation (Parts 3200—3299)
XXIII Department of Energy (Parts 3300—3399)
XXIV Federal Energy Regulatory Commission (Parts 3400—3499)
XXV Department of the Interior (Parts 3500—3599)
XXVI Department of Defense (Parts 3600—3699)

XXVIII Department of Justice (Parts 3800—3899)
428
Title 5—Administrative Personnel—Continued
Chap.
XXIX Federal Communications Commission (Parts 3900—3999)

XXX Farm Credit System Insurance Corporation (Parts 4000—4099)
XXXI Farm Credit Administration (Parts 4100—4199)
XXXIII Overseas Private Investment Corporation (Parts 4300—4399)
XXXIV Securities and Exchange Commission (Parts 4400—4499)
XXXV Office of Personnel Management (Parts 4500—4599)
XXXVI Department of Homeland Security (Parts 4600—4699)
XXXVII Federal Election Commission (Parts 4700—4799)
XL Interstate Commerce Commission (Parts 5000—5099)
XLI Commodity Futures Trading Commission (Parts 5100—5199)
XLII Department of Labor (Parts 5200—5299)
XLIII National Science Foundation (Parts 5300—5399)
XLV Department of Health and Human Services (Parts 5500—5599)
XLVI Postal Rate Commission (Parts 5600—5699)
XLVII Federal Trade Commission (Parts 5700—5799)
XLVIII Nuclear Regulatory Commission (Parts 5800—5899)
XLIX Federal Labor Relations Authority (Parts 5900—5999)
L Department of Transportation (Parts 6000—6099)
LII Export-Import Bank of the United States (Parts 6200—6299)
LIII Department of Education (Parts 6300—6399)
LIV Environmental Protection Agency (Parts 6400—6499)
LV National Endowment for the Arts (Parts 6500—6599)
LVI National Endowment for the Humanities (Parts 6600—6699)
LVII General Services Administration (Parts 6700—6799)
LVIII Board of Governors of the Federal Reserve System (Parts 6800—
6899)
LIX National Aeronautics and Space Administration (Parts 6900—
6999)
LX United States Postal Service (Parts 7000—7099)
LXI National Labor Relations Board (Parts 7100—7199)
LXII Equal Employment Opportunity Commission (Parts 7200—7299)
LXIII Inter-American Foundation (Parts 7300—7399)
LXIV Merit Systems Protection Board (Parts 7400—7499)
LXV Department of Housing and Urban Development (Parts 7500—
7599)
LXVI National Archives and Records Administration (Parts 7600—7699)
LXVII Institute of Museum and Library Services (Parts 7700—7799)
LXVIII Commission on Civil Rights (Parts 7800—7899)
LXIX Tennessee Valley Authority (Parts 7900—7999)
LXX Court Services and Offender Supervision Agency for the District
of Columbia (Parts 8000—8099)
LXXI Consumer Product Safety Commission (Parts 8100—8199)
LXXIII Department of Agriculture (Parts 8300—8399)

LXXIV Federal Mine Safety and Health Review Commission (Parts
8400—8499)
429
Title 5—Administrative Personnel—Continued
Chap.
LXXVI Federal Retirement Thrift Investment Board (Parts 8600—8699)

LXXVII Office of Management and Budget (Parts 8700—8799)
LXXX Federal Housing Finance Agency (Parts 9000—9099)
LXXXIII Special Inspector General for Afghanistan Reconstruction (Parts
9300—9399)
LXXXIV Bureau of Consumer Financial Protection (Parts 9400—9499)
LXXXVI National Credit Union Administration (Parts 9600—9699)
XCVII Department of Homeland Security Human Resources Manage-
ment System (Department of Homeland Security—Office of
Personnel Management) (Parts 9700—9799)
XCVIII Council of the Inspectors General on Integrity and Efficiency
(Parts 9800—9899)
XCIX Military Compensation and Retirement Modernization Commis-
sion (Parts 9900—9999)
C National Council on Disability (Partys 10000—10049)
Title 6—Domestic Security
I Department of Homeland Security, Office of the Secretary

(Parts 1—199)
X Privacy and Civil Liberties Oversight Board (Parts 1000—1099)
Title 7—Agriculture
SUBTITLE A—OFFICE OF THE SECRETARY OF AGRICULTURE (PARTS

0—26)
SUBTITLE B—REGULATIONS OF THE DEPARTMENT OF AGRICULTURE
I Agricultural Marketing Service (Standards, Inspections, Mar-
keting Practices), Department of Agriculture (Parts 27—209)
II Food and Nutrition Service, Department of Agriculture (Parts
210—299)
III Animal and Plant Health Inspection Service, Department of Ag-
riculture (Parts 300—399)
IV Federal Crop Insurance Corporation, Department of Agriculture
(Parts 400—499)
V Agricultural Research Service, Department of Agriculture
(Parts 500—599)
VI Natural Resources Conservation Service, Department of Agri-
culture (Parts 600—699)
VII Farm Service Agency, Department of Agriculture (Parts 700—
799)
VIII Grain Inspection, Packers and Stockyards Administration (Fed-
eral Grain Inspection Service), Department of Agriculture
(Parts 800—899)
IX Agricultural Marketing Service (Marketing Agreements and Or-
ders; Fruits, Vegetables, Nuts), Department of Agriculture
(Parts 900—999)
X Agricultural Marketing Service (Marketing Agreements and Or-
ders; Milk), Department of Agriculture (Parts 1000—1199)
430
Title 7—Agriculture—Continued
Chap.
XI Agricultural Marketing Service (Marketing Agreements and Or-

ders; Miscellaneous Commodities), Department of Agriculture
(Parts 1200—1299)
XIV Commodity Credit Corporation, Department of Agriculture
(Parts 1400—1499)
XV Foreign Agricultural Service, Department of Agriculture (Parts
1500—1599)
XVI Rural Telephone Bank, Department of Agriculture (Parts 1600—
1699)
XVII Rural Utilities Service, Department of Agriculture (Parts 1700—
1799)
XVIII Rural Housing Service, Rural Business-Cooperative Service,
Rural Utilities Service, and Farm Service Agency, Depart-
ment of Agriculture (Parts 1800—2099)
XX Local Television Loan Guarantee Board (Parts 2200—2299)
XXV Office of Advocacy and Outreach, Department of Agriculture
(Parts 2500—2599)
XXVI Office of Inspector General, Department of Agriculture (Parts
2600—2699)
XXVII Office of Information Resources Management, Department of
Agriculture (Parts 2700—2799)
XXVIII Office of Operations, Department of Agriculture (Parts 2800—
2899)
XXIX Office of Energy Policy and New Uses, Department of Agri-
XXX Office of the Chief Financial Officer, Department of Agriculture
(Parts 3000—3099)
XXXI Office of Environmental Quality, Department of Agriculture
(Parts 3100—3199)
XXXII Office of Procurement and Property Management, Department
of Agriculture (Parts 3200—3299)
XXXIII Office of Transportation, Department of Agriculture (Parts
3300—3399)
XXXIV National Institute of Food and Agriculture (Parts 3400—3499)
XXXV Rural Housing Service, Department of Agriculture (Parts 3500—
3599)
XXXVI National Agricultural Statistics Service, Department of Agri-
XXXVII Economic Research Service, Department of Agriculture (Parts
3700—3799)
XXXVIII World Agricultural Outlook Board, Department of Agriculture
(Parts 3800—3899)
XLI [Reserved]
XLII Rural Business-Cooperative Service and Rural Utilities Service,
Department of Agriculture (Parts 4200—4299)
Title 8—Aliens and Nationality

I Department of Homeland Security (Immigration and Naturaliza-

tion) (Parts 1—499)
431
Title 8—Aliens and Nationality—Continued
Chap.
V Executive Office for Immigration Review, Department of Justice

(Parts 1000—1399)
Title 9—Animals and Animal Products
I Animal and Plant Health Inspection Service, Department of Ag-

riculture (Parts 1—199)
II Grain Inspection, Packers and Stockyards Administration
(Packers and Stockyards Programs), Department of Agri-
III Food Safety and Inspection Service, Department of Agriculture
(Parts 300—599)
Title 10—Energy
I Nuclear Regulatory Commission (Parts 0—199)

II Department of Energy (Parts 200—699)
III Department of Energy (Parts 700—999)
X Department of Energy (General Provisions) (Parts 1000—1099)
XIII Nuclear Waste Technical Review Board (Parts 1300—1399)
XVII Defense Nuclear Facilities Safety Board (Parts 1700—1799)
XVIII Northeast Interstate Low-Level Radioactive Waste Commission
(Parts 1800—1899)
Title 11—Federal Elections
I Federal Election Commission (Parts 1—9099)

II Election Assistance Commission (Parts 9400—9499)
Title 12—Banks and Banking
I Comptroller of the Currency, Department of the Treasury (Parts

1—199)
II Federal Reserve System (Parts 200—299)
III Federal Deposit Insurance Corporation (Parts 300—399)
IV Export-Import Bank of the United States (Parts 400—499)
V Office of Thrift Supervision, Department of the Treasury (Parts
500—599)
VI Farm Credit Administration (Parts 600—699)
VII National Credit Union Administration (Parts 700—799)
VIII Federal Financing Bank (Parts 800—899)
IX Federal Housing Finance Board (Parts 900—999)
X Bureau of Consumer Financial Protection (Parts 1000—1099)
XI Federal Financial Institutions Examination Council (Parts
1100—1199)
XII Federal Housing Finance Agency (Parts 1200—1299)
XIII Financial Stability Oversight Council (Parts 1300—1399)

XIV Farm Credit System Insurance Corporation (Parts 1400—1499)
432
Title 12—Banks and Banking—Continued
Chap.
XV Department of the Treasury (Parts 1500—1599)

XVI Office of Financial Research (Parts 1600—1699)
XVII Office of Federal Housing Enterprise Oversight, Department of
Housing and Urban Development (Parts 1700—1799)
XVIII Community Development Financial Institutions Fund, Depart-
ment of the Treasury (Parts 1800—1899)
Title 13—Business Credit and Assistance
I Small Business Administration (Parts 1—199)

III Economic Development Administration, Department of Com-
merce (Parts 300—399)
IV Emergency Steel Guarantee Loan Board (Parts 400—499)
V Emergency Oil and Gas Guaranteed Loan Board (Parts 500—599)
Title 14—Aeronautics and Space
I Federal Aviation Administration, Department of Transportation

(Parts 1—199)
II Office of the Secretary, Department of Transportation (Aviation
Proceedings) (Parts 200—399)
III Commercial Space Transportation, Federal Aviation Adminis-
tration, Department of Transportation (Parts 400—1199)
V National Aeronautics and Space Administration (Parts 1200—
1299)
VI Air Transportation System Stabilization (Parts 1300—1399)
Title 15—Commerce and Foreign Trade
SUBTITLE A—OFFICE OF THE SECRETARY OF COMMERCE (PARTS 0—

29)
SUBTITLE B—REGULATIONS RELATING TO COMMERCE AND FOREIGN
TRADE
I Bureau of the Census, Department of Commerce (Parts 30—199)
II National Institute of Standards and Technology, Department of
Commerce (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV Foreign-Trade Zones Board, Department of Commerce (Parts
400—499)
VII Bureau of Industry and Security, Department of Commerce
(Parts 700—799)
VIII Bureau of Economic Analysis, Department of Commerce (Parts
800—899)
IX National Oceanic and Atmospheric Administration, Department
of Commerce (Parts 900—999)
XI Technology Administration, Department of Commerce (Parts

1100—1199)
XIII East-West Foreign Trade Board (Parts 1300—1399)
433
Title 15—Commerce and Foreign Trade—Continued
Chap.
XIV Minority Business Development Agency (Parts 1400—1499)

SUBTITLE C—REGULATIONS RELATING TO FOREIGN TRADE AGREE-
MENTS
XX Office of the United States Trade Representative (Parts 2000—
2099)
SUBTITLE D—REGULATIONS RELATING TO TELECOMMUNICATIONS
AND INFORMATION
XXIII National Telecommunications and Information Administration,
Department of Commerce (Parts 2300—2399)
Title 16—Commercial Practices
I Federal Trade Commission (Parts 0—999)

II Consumer Product Safety Commission (Parts 1000—1799)
Title 17—Commodity and Securities Exchanges
I Commodity Futures Trading Commission (Parts 1—199)

II Securities and Exchange Commission (Parts 200—399)
IV Department of the Treasury (Parts 400—499)
Title 18—Conservation of Power and Water Resources
I Federal Energy Regulatory Commission, Department of Energy

(Parts 1—399)
III Delaware River Basin Commission (Parts 400—499)
VI Water Resources Council (Parts 700—799)
VIII Susquehanna River Basin Commission (Parts 800—899)
XIII Tennessee Valley Authority (Parts 1300—1399)
Title 19—Customs Duties
I U.S. Customs and Border Protection, Department of Homeland

Security; Department of the Treasury (Parts 0—199)
II United States International Trade Commission (Parts 200—299)
III International Trade Administration, Department of Commerce
(Parts 300—399)
IV U.S. Immigration and Customs Enforcement, Department of
Homeland Security (Parts 400—599)
Title 20—Employees’ Benefits
I Office of Workers’ Compensation Programs, Department of

Labor (Parts 1—199)
II Railroad Retirement Board (Parts 200—399)
III Social Security Administration (Parts 400—499)

IV Employees’ Compensation Appeals Board, Department of Labor
(Parts 500—599)
434
Title 20—Employees’ Benefits—Continued
Chap.
V Employment and Training Administration, Department of Labor

(Parts 600—699)
VI Office of Workers’ Compensation Programs, Department of
VII Benefits Review Board, Department of Labor (Parts 800—899)
VIII Joint Board for the Enrollment of Actuaries (Parts 900—999)
IX Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 1000—1099)
Title 21—Food and Drugs
I Food and Drug Administration, Department of Health and

Human Services (Parts 1—1299)
II Drug Enforcement Administration, Department of Justice (Parts
1300—1399)
III Office of National Drug Control Policy (Parts 1400—1499)
Title 22—Foreign Relations
I Department of State (Parts 1—199)

II Agency for International Development (Parts 200—299)
III Peace Corps (Parts 300—399)
IV International Joint Commission, United States and Canada
(Parts 400—499)
V Broadcasting Board of Governors (Parts 500—599)
VII Overseas Private Investment Corporation (Parts 700—799)
IX Foreign Service Grievance Board (Parts 900—999)
X Inter-American Foundation (Parts 1000—1099)
XI International Boundary and Water Commission, United States
and Mexico, United States Section (Parts 1100—1199)
XII United States International Development Cooperation Agency
(Parts 1200—1299)
XIII Millennium Challenge Corporation (Parts 1300—1399)
XIV Foreign Service Labor Relations Board; Federal Labor Relations
Authority; General Counsel of the Federal Labor Relations
Authority; and the Foreign Service Impasse Disputes Panel
(Parts 1400—1499)
XV African Development Foundation (Parts 1500—1599)
XVI Japan-United States Friendship Commission (Parts 1600—1699)
XVII United States Institute of Peace (Parts 1700—1799)
Title 23—Highways
I Federal Highway Administration, Department of Transportation

(Parts 1—999)
II National Highway Traffic Safety Administration and Federal

Highway Administration, Department of Transportation
(Parts 1200—1299)
435
Title 23—Highways—Continued
Chap.
III National Highway Traffic Safety Administration, Department of

Transportation (Parts 1300—1399)
Title 24—Housing and Urban Development
SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF HOUSING

AND URBAN DEVELOPMENT (PARTS 0—99)
SUBTITLE B—REGULATIONS RELATING TO HOUSING AND URBAN DE-
VELOPMENT
I Office of Assistant Secretary for Equal Opportunity, Department
of Housing and Urban Development (Parts 100—199)
II Office of Assistant Secretary for Housing-Federal Housing Com-
missioner, Department of Housing and Urban Development
(Parts 200—299)
III Government National Mortgage Association, Department of
Housing and Urban Development (Parts 300—399)
IV Office of Housing and Office of Multifamily Housing Assistance
Restructuring, Department of Housing and Urban Develop-
ment (Parts 400—499)
V Office of Assistant Secretary for Community Planning and De-
velopment, Department of Housing and Urban Development
(Parts 500—599)
VI Office of Assistant Secretary for Community Planning and De-
velopment, Department of Housing and Urban Development
(Parts 600—699) [Reserved]
VII Office of the Secretary, Department of Housing and Urban Devel-
opment (Housing Assistance Programs and Public and Indian
Housing Programs) (Parts 700—799)
VIII Office of the Assistant Secretary for Housing—Federal Housing
Commissioner, Department of Housing and Urban Develop-
ment (Section 8 Housing Assistance Programs, Section 202 Di-
rect Loan Program, Section 202 Supportive Housing for the El-
derly Program and Section 811 Supportive Housing for Persons
With Disabilities Program) (Parts 800—899)
IX Office of Assistant Secretary for Public and Indian Housing, De-
partment of Housing and Urban Development (Parts 900—1699)
X Office of Assistant Secretary for Housing—Federal Housing
ment (Interstate Land Sales Registration Program) (Parts
1700—1799)
XII Office of Inspector General, Department of Housing and Urban
Development (Parts 2000—2099)
XV Emergency Mortgage Insurance and Loan Programs, Depart-
ment of Housing and Urban Development (Parts 2700—2799)
[Reserved]
XX Office of Assistant Secretary for Housing—Federal Housing
ment (Parts 3200—3899)
XXIV Board of Directors of the HOPE for Homeowners Program (Parts

4000—4099) [Reserved]
XXV Neighborhood Reinvestment Corporation (Parts 4100—4199)
436
Title 25—Indians
Chap.
I Bureau of Indian Affairs, Department of the Interior (Parts 1—

299)
II Indian Arts and Crafts Board, Department of the Interior (Parts
300—399)
III National Indian Gaming Commission, Department of the Inte-
rior (Parts 500—599)
IV Office of Navajo and Hopi Indian Relocation (Parts 700—799)
V Bureau of Indian Affairs, Department of the Interior, and Indian
Health Service, Department of Health and Human Services
(Part 900)
VI Office of the Assistant Secretary-Indian Affairs, Department of
the Interior (Parts 1000—1199)
VII Office of the Special Trustee for American Indians, Department
of the Interior (Parts 1200—1299)
Title 26—Internal Revenue
I Internal Revenue Service, Department of the Treasury (Parts 1—

End)
Title 27—Alcohol, Tobacco Products and Firearms
I Alcohol and Tobacco Tax and Trade Bureau, Department of the

Treasury (Parts 1—399)
II Bureau of Alcohol, Tobacco, Firearms, and Explosives, Depart-
ment of Justice (Parts 400—699)
Title 28—Judicial Administration
I Department of Justice (Parts 0—299)

III Federal Prison Industries, Inc., Department of Justice (Parts
300—399)
V Bureau of Prisons, Department of Justice (Parts 500—599)
VI Offices of Independent Counsel, Department of Justice (Parts
600—699)
VII Office of Independent Counsel (Parts 700—799)
VIII Court Services and Offender Supervision Agency for the District
of Columbia (Parts 800—899)
IX National Crime Prevention and Privacy Compact Council (Parts
900—999)
XI Department of Justice and Department of State (Parts 1100—
1199)
Title 29—Labor
SUBTITLE A—OFFICE OF THE SECRETARY OF LABOR (PARTS 0—99)

SUBTITLE B—REGULATIONS RELATING TO LABOR

I National Labor Relations Board (Parts 100—199)
437
Title 29—Labor—Continued
Chap.
II Office of Labor-Management Standards, Department of Labor

(Parts 200—299)
III National Railroad Adjustment Board (Parts 300—399)
IV Office of Labor-Management Standards, Department of Labor
(Parts 400—499)
V Wage and Hour Division, Department of Labor (Parts 500—899)
IX Construction Industry Collective Bargaining Commission (Parts
900—999)
X National Mediation Board (Parts 1200—1299)
XII Federal Mediation and Conciliation Service (Parts 1400—1499)
XIV Equal Employment Opportunity Commission (Parts 1600—1699)
XVII Occupational Safety and Health Administration, Department of
XX Occupational Safety and Health Review Commission (Parts
2200—2499)
XXV Employee Benefits Security Administration, Department of
XXVII Federal Mine Safety and Health Review Commission (Parts
2700—2799)
XL Pension Benefit Guaranty Corporation (Parts 4000—4999)
Title 30—Mineral Resources
I Mine Safety and Health Administration, Department of Labor

(Parts 1—199)
II Bureau of Safety and Environmental Enforcement, Department
of the Interior (Parts 200—299)
IV Geological Survey, Department of the Interior (Parts 400—499)
V Bureau of Ocean Energy Management, Department of the Inte-
VII Office of Surface Mining Reclamation and Enforcement, Depart-
ment of the Interior (Parts 700—999)
XII Office of Natural Resources Revenue, Department of the Interior
(Parts 1200—1299)
Title 31—Money and Finance: Treasury
SUBTITLE A—OFFICE OF THE SECRETARY OF THE TREASURY (PARTS

0—50)
SUBTITLE B—REGULATIONS RELATING TO MONEY AND FINANCE
I Monetary Offices, Department of the Treasury (Parts 51—199)
II Fiscal Service, Department of the Treasury (Parts 200—399)
IV Secret Service, Department of the Treasury (Parts 400—499)
V Office of Foreign Assets Control, Department of the Treasury
(Parts 500—599)
VI Bureau of Engraving and Printing, Department of the Treasury
(Parts 600—699)
VII Federal Law Enforcement Training Center, Department of the
438
Title 31—Money and Finance: Treasury—Continued
Chap.
VIII Office of International Investment, Department of the Treasury

(Parts 800—899)
IX Federal Claims Collection Standards (Department of the Treas-
ury—Department of Justice) (Parts 900—999)
X Financial Crimes Enforcement Network, Department of the
Title 32—National Defense
SUBTITLE A—DEPARTMENT OF DEFENSE

I Office of the Secretary of Defense (Parts 1—399)
V Department of the Army (Parts 400—699)
VI Department of the Navy (Parts 700—799)
VII Department of the Air Force (Parts 800—1099)
SUBTITLE B—OTHER REGULATIONS RELATING TO NATIONAL DE-
FENSE
XII Defense Logistics Agency (Parts 1200—1299)
XVI Selective Service System (Parts 1600—1699)
XVII Office of the Director of National Intelligence (Parts 1700—1799)
XVIII National Counterintelligence Center (Parts 1800—1899)
XIX Central Intelligence Agency (Parts 1900—1999)
XX Information Security Oversight Office, National Archives and
Records Administration (Parts 2000—2099)
XXI National Security Council (Parts 2100—2199)
XXIV Office of Science and Technology Policy (Parts 2400—2499)
XXVII Office for Micronesian Status Negotiations (Parts 2700—2799)
XXVIII Office of the Vice President of the United States (Parts 2800—
2899)
Title 33—Navigation and Navigable Waters
I Coast Guard, Department of Homeland Security (Parts 1—199)

II Corps of Engineers, Department of the Army (Parts 200—399)
IV Saint Lawrence Seaway Development Corporation, Department
of Transportation (Parts 400—499)
Title 34—Education
SUBTITLE A—OFFICE OF THE SECRETARY, DEPARTMENT OF EDU-

CATION (PARTS 1—99)
SUBTITLE B—REGULATIONS OF THE OFFICES OF THE DEPARTMENT
OF EDUCATION
I Office for Civil Rights, Department of Education (Parts 100—199)
II Office of Elementary and Secondary Education, Department of
Education (Parts 200—299)

III Office of Special Education and Rehabilitative Services, Depart-
ment of Education (Parts 300—399)
439
Title 34—Education—Continued
Chap.
IV Office of Career, Technical and Adult Education, Department of

Education (Parts 400—499)
V Office of Bilingual Education and Minority Languages Affairs,
Department of Education (Parts 500—599) [Reserved]
VI Office of Postsecondary Education, Department of Education
(Parts 600—699)
VII Office of Educational Research and Improvement, Department of
Education (Parts 700—799) [Reserved]
SUBTITLE C—REGULATIONS RELATING TO EDUCATION
XI [Reserved]
XII National Council on Disability (Parts 1200—1299)
Title 35 [Reserved]
Title 36—Parks, Forests, and Public Property
I National Park Service, Department of the Interior (Parts 1—199)

II Forest Service, Department of Agriculture (Parts 200—299)
III Corps of Engineers, Department of the Army (Parts 300—399)
IV American Battle Monuments Commission (Parts 400—499)
V Smithsonian Institution (Parts 500—599)
VI [Reserved]
VII Library of Congress (Parts 700—799)
VIII Advisory Council on Historic Preservation (Parts 800—899)
IX Pennsylvania Avenue Development Corporation (Parts 900—999)
X Presidio Trust (Parts 1000—1099)
XI Architectural and Transportation Barriers Compliance Board
(Parts 1100—1199)
XII National Archives and Records Administration (Parts 1200—1299)
XV Oklahoma City National Memorial Trust (Parts 1500—1599)
XVI Morris K. Udall Scholarship and Excellence in National Environ-
mental Policy Foundation (Parts 1600—1699)
Title 37—Patents, Trademarks, and Copyrights
I United States Patent and Trademark Office, Department of

Commerce (Parts 1—199)
II U.S. Copyright Office, Library of Congress (Parts 200—299)
III Copyright Royalty Board, Library of Congress (Parts 300—399)
IV Assistant Secretary for Technology Policy, Department of Com-
merce (Parts 400—599)
Title 38—Pensions, Bonuses, and Veterans’ Relief

I Department of Veterans Affairs (Parts 0—199)

II Armed Forces Retirement Home (Parts 200—299)
440
Title 39—Postal Service
Chap.
I United States Postal Service (Parts 1—999)

III Postal Regulatory Commission (Parts 3000—3099)
Title 40—Protection of Environment
I Environmental Protection Agency (Parts 1—1099)

IV Environmental Protection Agency and Department of Justice
(Parts 1400—1499)
V Council on Environmental Quality (Parts 1500—1599)
VI Chemical Safety and Hazard Investigation Board (Parts 1600—
1699)
VII Environmental Protection Agency and Department of Defense;
Uniform National Discharge Standards for Vessels of the
Armed Forces (Parts 1700—1799)
VIII Gulf Coast Ecosystem Restoration Council (Parts 1800—1899)
Title 41—Public Contracts and Property Management
SUBTITLE A—FEDERAL PROCUREMENT REGULATIONS SYSTEM

[NOTE]
SUBTITLE B—OTHER PROVISIONS RELATING TO PUBLIC CONTRACTS
50 Public Contracts, Department of Labor (Parts 50–1—50–999)
51 Committee for Purchase From People Who Are Blind or Severely
Disabled (Parts 51–1—51–99)
60 Office of Federal Contract Compliance Programs, Equal Employ-
ment Opportunity, Department of Labor (Parts 60–1—60–999)
61 Office of the Assistant Secretary for Veterans’ Employment and
Training Service, Department of Labor (Parts 61–1—61–999)
62—100 [Reserved]
SUBTITLE C—FEDERAL PROPERTY MANAGEMENT REGULATIONS
SYSTEM
101 Federal Property Management Regulations (Parts 101–1—101–99)
102 Federal Management Regulation (Parts 102–1—102–299)
103—104 [Reserved]
105 General Services Administration (Parts 105–1—105–999)
109 Department of Energy Property Management Regulations (Parts
109–1—109–99)
114 Department of the Interior (Parts 114–1—114–99)
115 Environmental Protection Agency (Parts 115–1—115–99)
128 Department of Justice (Parts 128–1—128–99)
129—200 [Reserved]
SUBTITLE D—OTHER PROVISIONS RELATING TO PROPERTY MANAGE-
MENT [RESERVED]
SUBTITLE E—FEDERAL INFORMATION RESOURCES MANAGEMENT
REGULATIONS SYSTEM [RESERVED]
SUBTITLE F—FEDERAL TRAVEL REGULATION SYSTEM
300 General (Parts 300–1—300–99)

301 Temporary Duty (TDY) Travel Allowances (Parts 301–1—301–99)
441
Title 41—Public Contracts and Property Management—Continued
Chap.
302 Relocation Allowances (Parts 302–1—302–99)

303 Payment of Expenses Connected with the Death of Certain Em-
ployees (Part 303–1—303–99)
304 Payment of Travel Expenses from a Non-Federal Source (Parts
304–1—304–99)
Title 42—Public Health
I Public Health Service, Department of Health and Human Serv-

ices (Parts 1—199)
IV Centers for Medicare & Medicaid Services, Department of Health
and Human Services (Parts 400—599)
V Office of Inspector General-Health Care, Department of Health
Title 43—Public Lands: Interior
SUBTITLE A—OFFICE OF THE SECRETARY OF THE INTERIOR (PARTS

1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC LANDS
I Bureau of Reclamation, Department of the Interior (Parts 400—
999)
II Bureau of Land Management, Department of the Interior (Parts
1000—9999)
III Utah Reclamation Mitigation and Conservation Commission
(Parts 10000—10099)
Title 44—Emergency Management and Assistance
I Federal Emergency Management Agency, Department of Home-

land Security (Parts 0—399)
IV Department of Commerce and Department of Transportation
(Parts 400—499)
Title 45—Public Welfare
SUBTITLE A—DEPARTMENT OF HEALTH AND HUMAN SERVICES

(PARTS 1—199)
SUBTITLE B—REGULATIONS RELATING TO PUBLIC WELFARE
II Office of Family Assistance (Assistance Programs), Administra-
tion for Children and Families, Department of Health and
Human Services (Parts 200—299)
III Office of Child Support Enforcement (Child Support Enforce-
ment Program), Administration for Children and Families,
Department of Health and Human Services (Parts 300—399)
IV Office of Refugee Resettlement, Administration for Children and
Families, Department of Health and Human Services (Parts
400—499)
V Foreign Claims Settlement Commission of the United States,
Department of Justice (Parts 500—599)
442
Title 45—Public Welfare—Continued
Chap.
VI National Science Foundation (Parts 600—699)

VII Commission on Civil Rights (Parts 700—799)
VIII Office of Personnel Management (Parts 800—899)
IX Denali Commission (Parts 900—999)
X Office of Community Services, Administration for Children and
Families, Department of Health and Human Services (Parts
1000—1099)
XI National Foundation on the Arts and the Humanities (Parts
1100—1199)
XII Corporation for National and Community Service (Parts 1200—
1299)
XIII Administration for Children and Families, Department of Health
XVI Legal Services Corporation (Parts 1600—1699)
XVII National Commission on Libraries and Information Science
(Parts 1700—1799)
XVIII Harry S. Truman Scholarship Foundation (Parts 1800—1899)
XXI Commission on Fine Arts (Parts 2100—2199)
XXIII Arctic Research Commission (Part 2301)
XXIV James Madison Memorial Fellowship Foundation (Parts 2400—
2499)
XXV Corporation for National and Community Service (Parts 2500—
2599)
Title 46—Shipping
I Coast Guard, Department of Homeland Security (Parts 1—199)

II Maritime Administration, Department of Transportation (Parts
200—399)
III Coast Guard (Great Lakes Pilotage), Department of Homeland
Security (Parts 400—499)
IV Federal Maritime Commission (Parts 500—599)
Title 47—Telecommunication
I Federal Communications Commission (Parts 0—199)

II Office of Science and Technology Policy and National Security
Council (Parts 200—299)
III National Telecommunications and Information Administration,
Department of Commerce (Parts 300—399)
IV National Telecommunications and Information Administration,
Department of Commerce, and National Highway Traffic Safe-
ty Administration, Department of Transportation (Parts 400—
499)
Title 48—Federal Acquisition Regulations System

1 Federal Acquisition Regulation (Parts 1—99)
443
Title 48—Federal Acquisition Regulations System—Continued
Chap.
2 Defense Acquisition Regulations System, Department of Defense

(Parts 200—299)
3 Health and Human Services (Parts 300—399)
4 Department of Agriculture (Parts 400—499)
5 General Services Administration (Parts 500—599)
6 Department of State (Parts 600—699)
7 Agency for International Development (Parts 700—799)
8 Department of Veterans Affairs (Parts 800—899)
9 Department of Energy (Parts 900—999)
10 Department of the Treasury (Parts 1000—1099)
12 Department of Transportation (Parts 1200—1299)
13 Department of Commerce (Parts 1300—1399)
14 Department of the Interior (Parts 1400—1499)
15 Environmental Protection Agency (Parts 1500—1599)
16 Office of Personnel Management, Federal Employees Health
Benefits Acquisition Regulation (Parts 1600—1699)
17 Office of Personnel Management (Parts 1700—1799)
18 National Aeronautics and Space Administration (Parts 1800—
1899)
19 Broadcasting Board of Governors (Parts 1900—1999)
20 Nuclear Regulatory Commission (Parts 2000—2099)
21 Office of Personnel Management, Federal Employees Group Life
Insurance Federal Acquisition Regulation (Parts 2100—2199)
23 Social Security Administration (Parts 2300—2399)
24 Department of Housing and Urban Development (Parts 2400—
2499)
25 National Science Foundation (Parts 2500—2599)
28 Department of Justice (Parts 2800—2899)
29 Department of Labor (Parts 2900—2999)
30 Department of Homeland Security, Homeland Security Acquisi-
tion Regulation (HSAR) (Parts 3000—3099)
34 Department of Education Acquisition Regulation (Parts 3400—
3499)
51 Department of the Army Acquisition Regulations (Parts 5100—
5199)
52 Department of the Navy Acquisition Regulations (Parts 5200—
5299)
53 Department of the Air Force Federal Acquisition Regulation
Supplement (Parts 5300—5399) [Reserved]
54 Defense Logistics Agency, Department of Defense (Parts 5400—
5499)
57 African Development Foundation (Parts 5700—5799)
61 Civilian Board of Contract Appeals, General Services Adminis-
tration (Parts 6100—6199)

63 Department of Transportation Board of Contract Appeals (Parts
6300—6399)
444
Title 48—Federal Acquisition Regulations System—Continued
Chap.
99 Cost Accounting Standards Board, Office of Federal Procure-

ment Policy, Office of Management and Budget (Parts 9900—
9999)
Title 49—Transportation
SUBTITLE A—OFFICE OF THE SECRETARY OF TRANSPORTATION

(PARTS 1—99)
SUBTITLE B—OTHER REGULATIONS RELATING TO TRANSPORTATION
I Pipeline and Hazardous Materials Safety Administration, De-
partment of Transportation (Parts 100—199)
II Federal Railroad Administration, Department of Transportation
(Parts 200—299)
III Federal Motor Carrier Safety Administration, Department of
IV Coast Guard, Department of Homeland Security (Parts 400—499)
V National Highway Traffic Safety Administration, Department of
VI Federal Transit Administration, Department of Transportation
(Parts 600—699)
VII National Railroad Passenger Corporation (AMTRAK) (Parts
700—799)
VIII National Transportation Safety Board (Parts 800—999)
X Surface Transportation Board (Parts 1000—1399)
XI Research and Innovative Technology Administration, Depart-
ment of Transportation (Parts 1400—1499) [Reserved]
XII Transportation Security Administration, Department of Home-
land Security (Parts 1500—1699)
Title 50—Wildlife and Fisheries
I United States Fish and Wildlife Service, Department of the Inte-

II National Marine Fisheries Service, National Oceanic and Atmos-
pheric Administration, Department of Commerce (Parts 200—
299)
III International Fishing and Related Activities (Parts 300—399)
IV Joint Regulations (United States Fish and Wildlife Service, De-
partment of the Interior and National Marine Fisheries Serv-
ice, National Oceanic and Atmospheric Administration, De-
partment of Commerce); Endangered Species Committee Reg-
ulations (Parts 400—499)
V Marine Mammal Commission (Parts 500—599)
VI Fishery Conservation and Management, National Oceanic and
Atmospheric Administration, Department of Commerce (Parts
600—699)
445
Alphabetical List of Agencies Appearing in the CFR
(Revised as of July 1, 2017)
CFR Title, Subtitle or

Agency Chapter
Administrative Committee of the Federal Register 1, I
Administrative Conference of the United States 1, III
Advisory Council on Historic Preservation 36, VIII
Advocacy and Outreach, Office of 7, XXV
Afghanistan Reconstruction, Special Inspector General for 5, LXXXIII
African Development Foundation 22, XV
Federal Acquisition Regulation 48, 57
Agency for International Development 2, VII; 22, II
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Agriculture Department 2, IV; 5, LXXIII
Advocacy and Outreach, Office of 7, XXV
Agricultural Marketing Service 7, I, IX, X, XI
Agricultural Research Service 7, V
Animal and Plant Health Inspection Service 7, III; 9, I
Chief Financial Officer, Office of 7, XXX
Commodity Credit Corporation 7, XIV
Economic Research Service 7, XXXVII
Energy Policy and New Uses, Office of 2, IX; 7, XXIX
Environmental Quality, Office of 7, XXXI
Farm Service Agency 7, VII, XVIII
Federal Crop Insurance Corporation 7, IV
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Forest Service 36, II
Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II
Information Resources Management, Office of 7, XXVII
Inspector General, Office of 7, XXVI
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National Institute of Food and Agriculture 7, XXXIV
Natural Resources Conservation Service 7, VI
Operations, Office of 7, XXVIII
Procurement and Property Management, Office of 7, XXXII
Rural Business-Cooperative Service 7, XVIII, XLII
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV
Rural Telephone Bank 7, XVI
Rural Utilities Service 7, XVII, XVIII, XLII
Secretary of Agriculture, Office of 7, Subtitle A
Transportation, Office of 7, XXXIII
World Agricultural Outlook Board 7, XXXVIII
Air Force Department 32, VII
Federal Acquisition Regulation Supplement 48, 53
Air Transportation Stabilization Board 14, VI
Alcohol and Tobacco Tax and Trade Bureau 27, I
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II

AMTRAK 49, VII
American Battle Monuments Commission 36, IV
American Indians, Office of the Special Trustee 25, VII
447
Agency Chapter
Animal and Plant Health Inspection Service 7, III; 9, I
Appalachian Regional Commission 5, IX
Architectural and Transportation Barriers Compliance Board 36, XI
Arctic Research Commission 45, XXIII
Armed Forces Retirement Home 5, XI
Army Department 32, V
Engineers, Corps of 33, II; 36, III
Bilingual Education and Minority Languages Affairs, Office of 34, V
Blind or Severely Disabled, Committee for Purchase from 41, 51
People Who Are
Broadcasting Board of Governors 22, V
Career, Technical and Adult Education, Office of 34, IV
Census Bureau 15, I
Centers for Medicare & Medicaid Services 42, IV
Central Intelligence Agency 32, XIX
Chemical Safety and Hazardous Investigation Board 40, VI
Chief Financial Officer, Office of 7, XXX
Child Support Enforcement, Office of 45, III
Children and Families, Administration for 45, II, III, IV, X, XIII
Civil Rights, Commission on 5, LXVIII; 45, VII
Civil Rights, Office for 34, I
Council of the Inspectors General on Integrity and Efficiency 5, XCVIII
Court Services and Offender Supervision Agency for the 5, LXX
District of Columbia
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Commerce Department 2, XIII; 44, IV; 50, VI
Census Bureau 15, I
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Emergency Management and Assistance 44, IV
Foreign-Trade Zones Board 15, IV
Industry and Security, Bureau of 15, VII
International Trade Administration 15, III; 19, III
National Institute of Standards and Technology 15, II
National Marine Fisheries Service 50, II, IV
National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Weather Service 15, IX
Patent and Trademark Office, United States 37, I
Productivity, Technology and Innovation, Assistant 37, IV
Secretary for
Secretary of Commerce, Office of 15, Subtitle A
Technology Administration 15, XI
Technology Policy, Assistant Secretary for 37, IV
Commercial Space Transportation 14, III
Commodity Credit Corporation 7, XIV
Commodity Futures Trading Commission 5, XLI; 17, I
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Community Services, Office of 45, X
Comptroller of the Currency 12, I
Construction Industry Collective Bargaining Commission 29, IX
Consumer Financial Protection Bureau 5, LXXXIV; 12, X
Consumer Product Safety Commission 5, LXXI; 16, II
Copyright Royalty Board 37, III
Corporation for National and Community Service 2, XXII; 45, XII, XXV
Cost Accounting Standards Board 48, 99
Council on Environmental Quality 40, V
Court Services and Offender Supervision Agency for the 5, LXX; 28, VIII
District of Columbia
Customs and Border Protection 19, I
Defense Contract Audit Agency 32, I
448
Agency Chapter
Defense Department 2, XI; 5, XXVI; 32,
Subtitle A; 40, VII
Advanced Research Projects Agency 32, I
Air Force Department 32, VII
Army Department 32, V; 33, II; 36, III; 48,
51
Defense Acquisition Regulations System 48, 2
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, I, XII; 48, 54
National Imagery and Mapping Agency 32, I
Navy Department 32, VI; 48, 52
Secretary of Defense, Office of 2, XI; 32, I
Defense Contract Audit Agency 32, I
Defense Intelligence Agency 32, I
Defense Logistics Agency 32, XII; 48, 54
Defense Nuclear Facilities Safety Board 10, XVII
Delaware River Basin Commission 18, III
Denali Commission 45, IX
District of Columbia, Court Services and Offender Supervision 5, LXX; 28, VIII
Agency for the
Drug Enforcement Administration 21, II
East-West Foreign Trade Board 15, XIII
Economic Analysis, Bureau of 15, VIII
Economic Development Administration 13, III
Economic Research Service 7, XXXVII
Education, Department of 2, XXXIV; 5, LIII
Bilingual Education and Minority Languages Affairs, Office 34, V
of
Career, Technical and Adult Education, Office of 34, IV
Civil Rights, Office for 34, I
Educational Research and Improvement, Office of 34, VII
Elementary and Secondary Education, Office of 34, II
Postsecondary Education, Office of 34, VI
Secretary of Education, Office of 34, Subtitle A
Special Education and Rehabilitative Services, Office of 34, III
Career, Technical, and Adult Education, Office of 34, IV
Educational Research and Improvement, Office of 34, VII
Election Assistance Commission 2, LVIII; 11, II
Elementary and Secondary Education, Office of 34, II
Emergency Oil and Gas Guaranteed Loan Board 13, V
Emergency Steel Guarantee Loan Board 13, IV
Employee Benefits Security Administration 29, XXV
Employees’ Compensation Appeals Board 20, IV
Employees Loyalty Board 5, V
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
Endangered Species Committee 50, IV
Energy, Department of 2, IX; 5, XXIII; 10, II,
III, X
Federal Energy Regulatory Commission 5, XXIV; 18, I
Property Management Regulations 41, 109
Energy, Office of 7, XXIX
Engraving and Printing, Bureau of 31, VI
Environmental Protection Agency 2, XV; 5, LIV; 40, I, IV,
VII
Environmental Quality, Office of 7, XXXI
Equal Employment Opportunity Commission 5, LXII; 29, XIV
Equal Opportunity, Office of Assistant Secretary for 24, I
Executive Office of the President 3, I

Environmental Quality, Council on 40, V
Management and Budget, Office of 2, Subtitle A; 5, III,
LXXVII; 14, VI; 48, 99
449
Agency Chapter
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Security Council 32, XXI; 47, 2
Presidential Documents 3
Science and Technology Policy, Office of 32, XXIV; 47, II
Trade Representative, Office of the United States 15, XX
Export-Import Bank of the United States 2, XXXV; 5, LII; 12, IV
Family Assistance, Office of 45, II
Farm Credit Administration 5, XXXI; 12, VI
Farm Credit System Insurance Corporation 5, XXX; 12, XIV
Farm Service Agency 7, VII, XVIII
Federal Aviation Administration 14, I
Federal Claims Collection Standards 31, IX
Federal Communications Commission 5, XXIX; 47, I
Federal Contract Compliance Programs, Office of 41, 60
Federal Crop Insurance Corporation 7, IV
Federal Deposit Insurance Corporation 5, XXII; 12, III
Federal Election Commission 5, XXXVII; 11, I
Federal Emergency Management Agency 44, I
Federal Employees Group Life Insurance Federal Acquisition 48, 21
Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Federal Energy Regulatory Commission 5, XXIV; 18, I
Federal Financial Institutions Examination Council 12, XI
Federal Financing Bank 12, VIII
Federal Highway Administration 23, I, II
Federal Home Loan Mortgage Corporation 1, IV
Federal Housing Enterprise Oversight Office 12, XVII
Federal Housing Finance Agency 5, LXXX; 12, XII
Federal Housing Finance Board 12, IX
Federal Labor Relations Authority 5, XIV, XLIX; 22, XIV
Federal Law Enforcement Training Center 31, VII
Federal Management Regulation 41, 102
Federal Maritime Commission 46, IV
Federal Mediation and Conciliation Service 29, XII
Federal Mine Safety and Health Review Commission 5, LXXIV; 29, XXVII
Federal Motor Carrier Safety Administration 49, III
Federal Prison Industries, Inc. 28, III
Federal Procurement Policy Office 48, 99
Federal Property Management Regulations 41, 101
Federal Railroad Administration 49, II
Federal Register, Administrative Committee of 1, I
Federal Register, Office of 1, II
Federal Reserve System 12, II
Board of Governors 5, LVIII
Federal Retirement Thrift Investment Board 5, VI, LXXVI
Federal Service Impasses Panel 5, XIV
Federal Trade Commission 5, XLVII; 16, I
Federal Transit Administration 49, VI
Federal Travel Regulation System 41, Subtitle F
Financial Crimes Enforcement Network 31, X
Financial Research Office 12, XVI
Financial Stability Oversight Council 12, XIII
Fine Arts, Commission on 45, XXI
Fiscal Service 31, II
Fish and Wildlife Service, United States 50, I, IV
Food and Drug Administration 21, I
Food and Nutrition Service 7, II
Food Safety and Inspection Service 9, III
Foreign Agricultural Service 7, XV
Foreign Assets Control, Office of 31, V
Foreign Claims Settlement Commission of the United States 45, V
Foreign Service Grievance Board 22, IX

Foreign Service Impasse Disputes Panel 22, XIV
Foreign Service Labor Relations Board 22, XIV
Foreign-Trade Zones Board 15, IV
450
Agency Chapter
Forest Service 36, II
General Services Administration 5, LVII; 41, 105
Contract Appeals, Board of 48, 61
Federal Management Regulation 41, 102
Federal Property Management Regulations 41, 101
Federal Travel Regulation System 41, Subtitle F
General 41, 300
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Relocation Allowances 41, 302
Temporary Duty (TDY) Travel Allowances 41, 301
Geological Survey 30, IV
Government Accountability Office 4, I
Government Ethics, Office of 5, XVI
Government National Mortgage Association 24, III
Grain Inspection, Packers and Stockyards Administration 7, VIII; 9, II
Gulf Coast Ecosystem Restoration Council 2, LIX; 40, VIII
Harry S. Truman Scholarship Foundation 45, XVIII
Health and Human Services, Department of 2, III; 5, XLV; 45,
Subtitle A
Centers for Medicare & Medicaid Services 42, IV
Child Support Enforcement, Office of 45, III
Children and Families, Administration for 45, II, III, IV, X, XIII
Community Services, Office of 45, X
Family Assistance, Office of 45, II
Food and Drug Administration 21, I
Indian Health Service 25, V
Inspector General (Health Care), Office of 42, V
Public Health Service 42, I
Refugee Resettlement, Office of 45, IV
Homeland Security, Department of 2, XXX; 5, XXXVI; 6, I;
8, I
Coast Guard 33, I; 46, I; 49, IV
Coast Guard (Great Lakes Pilotage) 46, III
Federal Emergency Management Agency 44, I
Human Resources Management and Labor Relations 5, XCVII
Systems
Immigration and Customs Enforcement Bureau 19, IV
Transportation Security Administration 49, XII
HOPE for Homeowners Program, Board of Directors of 24, XXIV
Housing and Urban Development, Department of 2, XXIV; 5, LXV; 24,
Subtitle B
Community Planning and Development, Office of Assistant 24, V, VI
Secretary for
Equal Opportunity, Office of Assistant Secretary for 24, I
Federal Housing Enterprise Oversight, Office of 12, XVII
Government National Mortgage Association 24, III
Housing—Federal Housing Commissioner, Office of 24, II, VIII, X, XX
Assistant Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Inspector General, Office of 24, XII
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Secretary, Office of 24, Subtitle A, VII
Housing—Federal Housing Commissioner, Office of Assistant 24, II, VIII, X, XX
Secretary for
Housing, Office of, and Multifamily Housing Assistance 24, IV
Restructuring, Office of
Immigration and Customs Enforcement Bureau 19, IV

Immigration Review, Executive Office for 8, V
Independent Counsel, Office of 28, VII
Independent Counsel, Offices of 28, VI
451
Agency Chapter
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Indian Health Service 25, V
Industry and Security, Bureau of 15, VII
Information Resources Management, Office of 7, XXVII
Information Security Oversight Office, National Archives and 32, XX
Records Administration
Inspector General
Agriculture Department 7, XXVI
Health and Human Services Department 42, V
Housing and Urban Development Department 24, XII, XV
Institute of Peace, United States 22, XVII
Inter-American Foundation 5, LXIII; 22, X
Interior Department 2, XIV
American Indians, Office of the Special Trustee 25, VII
Endangered Species Committee 50, IV
Federal Property Management Regulations System 41, 114
Fish and Wildlife Service, United States 50, I, IV
Geological Survey 30, IV
Indian Affairs, Bureau of 25, I, V
Indian Affairs, Office of the Assistant Secretary 25, VI
Indian Arts and Crafts Board 25, II
Land Management, Bureau of 43, II
National Indian Gaming Commission 25, III
National Park Service 36, I
Natural Resource Revenue, Office of 30, XII
Ocean Energy Management, Bureau of 30, V
Reclamation, Bureau of 43, I
Safety and Enforcement Bureau, Bureau of 30, II
Secretary of the Interior, Office of 2, XIV; 43, Subtitle A
Surface Mining Reclamation and Enforcement, Office of 30, VII
Internal Revenue Service 26, I
International Boundary and Water Commission, United States 22, XI
and Mexico, United States Section
International Development, United States Agency for 22, II
International Development Cooperation Agency, United 22, XII
States
International Joint Commission, United States and Canada 22, IV
International Organizations Employees Loyalty Board 5, V
International Trade Administration 15, III; 19, III
International Trade Commission, United States 19, II
Interstate Commerce Commission 5, XL
Investment Security, Office of 31, VIII
James Madison Memorial Fellowship Foundation 45, XXIV
Japan–United States Friendship Commission 22, XVI
Joint Board for the Enrollment of Actuaries 20, VIII
Justice Department 2, XXVIII; 5, XXVIII;
28, I, XI; 40, IV
Alcohol, Tobacco, Firearms, and Explosives, Bureau of 27, II
Drug Enforcement Administration 21, II
Federal Prison Industries, Inc. 28, III
Foreign Claims Settlement Commission of the United 45, V
States
Immigration Review, Executive Office for 8, V
Independent Counsel, Offices of 28, VI
Prisons, Bureau of 28, V
Labor Department 2, XXIX; 5, XLII
Employee Benefits Security Administration 29, XXV

Employees’ Compensation Appeals Board 20, IV
Employment and Training Administration 20, V
Employment Standards Administration 20, VI
452
Agency Chapter
Federal Contract Compliance Programs, Office of 41, 60
Federal Procurement Regulations System 41, 50
Labor-Management Standards, Office of 29, II, IV
Mine Safety and Health Administration 30, I
Occupational Safety and Health Administration 29, XVII
Public Contracts 41, 50
Secretary of Labor, Office of 29, Subtitle A
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Wage and Hour Division 29, V
Workers’ Compensation Programs, Office of 20, I, VII
Labor-Management Standards, Office of 29, II, IV
Land Management, Bureau of 43, II
Legal Services Corporation 45, XVI
Library of Congress 36, VII
Copyright Royalty Board 37, III
U.S. Copyright Office 37, II
Local Television Loan Guarantee Board 7, XX
Management and Budget, Office of 5, III, LXXVII; 14, VI;
48, 99
Marine Mammal Commission 50, V
Maritime Administration 46, II
Merit Systems Protection Board 5, II, LXIV
Micronesian Status Negotiations, Office for 32, XXVII
Military Compensation and Retirement Modernization 5, XCIX
Commission
Millennium Challenge Corporation 22, XIII
Mine Safety and Health Administration 30, I
Minority Business Development Agency 15, XIV
Miscellaneous Agencies 1, IV
Monetary Offices 31, I
Morris K. Udall Scholarship and Excellence in National 36, XVI
Environmental Policy Foundation
Museum and Library Services, Institute of 2, XXXI
National Aeronautics and Space Administration 2, XVIII; 5, LIX; 14, V
National Agricultural Library 7, XLI
National Agricultural Statistics Service 7, XXXVI
National and Community Service, Corporation for 2, XXII; 45, XII, XXV
National Archives and Records Administration 2, XXVI; 5, LXVI; 36,
XII
Information Security Oversight Office 32, XX
National Capital Planning Commission 1, IV
National Commission for Employment Policy 1, IV
National Commission on Libraries and Information Science 45, XVII
National Council on Disability 5, C; 34, XII
National Counterintelligence Center 32, XVIII
National Credit Union Administration 5, LXXXVI; 12, VII
National Crime Prevention and Privacy Compact Council 28, IX
National Drug Control Policy, Office of 2, XXXVI; 21, III
National Endowment for the Arts 2, XXXII
National Endowment for the Humanities 2, XXXIII
National Foundation on the Arts and the Humanities 45, XI
National Geospatial-Intelligence Agency 32, I
National Highway Traffic Safety Administration 23, II, III; 47, VI; 49, V
National Imagery and Mapping Agency 32, I
National Indian Gaming Commission 25, III
National Institute of Food and Agriculture 7, XXXIV
National Institute of Standards and Technology 15, II
National Intelligence, Office of Director of 5, IV; 32, XVII
National Labor Relations Board 5, LXI; 29, I
National Marine Fisheries Service 50, II, IV
National Mediation Board 29, X

National Oceanic and Atmospheric Administration 15, IX; 50, II, III, IV, VI
National Park Service 36, I
National Railroad Adjustment Board 29, III
453
Agency Chapter
National Railroad Passenger Corporation (AMTRAK) 49, VII
National Science Foundation 2, XXV; 5, XLIII; 45, VI
National Security Council 32, XXI
National Security Council and Office of Science and 47, II
Technology Policy
National Telecommunications and Information 15, XXIII; 47, III, IV
Administration
National Transportation Safety Board 49, VIII
Natural Resources Conservation Service 7, VI
Natural Resource Revenue, Office of 30, XII
Navajo and Hopi Indian Relocation, Office of 25, IV
Navy Department 32, VI
Neighborhood Reinvestment Corporation 24, XXV
Northeast Interstate Low-Level Radioactive Waste 10, XVIII
Commission
Nuclear Regulatory Commission 2, XX; 5, XLVIII; 10, I
Occupational Safety and Health Administration 29, XVII
Occupational Safety and Health Review Commission 29, XX
Ocean Energy Management, Bureau of 30, V
Oklahoma City National Memorial Trust 36, XV
Operations Office 7, XXVIII
Overseas Private Investment Corporation 5, XXXIII; 22, VII
Patent and Trademark Office, United States 37, I
Payment From a Non-Federal Source for Travel Expenses 41, 304
Payment of Expenses Connected With the Death of Certain 41, 303
Employees
Peace Corps 2, XXXVII; 22, III
Pennsylvania Avenue Development Corporation 36, IX
Pension Benefit Guaranty Corporation 29, XL
Personnel Management, Office of 5, I, XXXV; 5, IV; 45,
VIII
Human Resources Management and Labor Relations 5, XCVII
Systems, Department of Homeland Security
Federal Employees Group Life Insurance Federal 48, 21
Acquisition Regulation
Federal Employees Health Benefits Acquisition Regulation 48, 16
Pipeline and Hazardous Materials Safety Administration 49, I
Postal Regulatory Commission 5, XLVI; 39, III
Postal Service, United States 5, LX; 39, I
Postsecondary Education, Office of 34, VI
President’s Commission on White House Fellowships 1, IV
Presidential Documents 3
Presidio Trust 36, X
Prisons, Bureau of 28, V
Privacy and Civil Liberties Oversight Board 6, X
Procurement and Property Management, Office of 7, XXXII
Productivity, Technology and Innovation, Assistant 37, IV
Secretary
Public Contracts, Department of Labor 41, 50
Public and Indian Housing, Office of Assistant Secretary for 24, IX
Public Health Service 42, I
Railroad Retirement Board 20, II
Reclamation, Bureau of 43, I
Refugee Resettlement, Office of 45, IV
Relocation Allowances 41, 302
Research and Innovative Technology Administration 49, XI
Rural Business-Cooperative Service 7, XVIII, XLII
Rural Development Administration 7, XLII
Rural Housing Service 7, XVIII, XXXV
Rural Telephone Bank 7, XVI

Rural Utilities Service 7, XVII, XVIII, XLII
Safety and Environmental Enforcement, Bureau of 30, II
Saint Lawrence Seaway Development Corporation 33, IV
454
Agency Chapter
Science and Technology Policy, Office of 32, XXIV
Science and Technology Policy, Office of, and National 47, II
Security Council
Secret Service 31, IV
Securities and Exchange Commission 5, XXXIV; 17, II
Selective Service System 32, XVI
Small Business Administration 2, XXVII; 13, I
Smithsonian Institution 36, V
Social Security Administration 2, XXIII; 20, III; 48, 23
Soldiers’ and Airmen’s Home, United States 5, XI
Special Counsel, Office of 5, VIII
Special Education and Rehabilitative Services, Office of 34, III
State Department 2, VI; 22, I; 28, XI
Surface Mining Reclamation and Enforcement, Office of 30, VII
Surface Transportation Board 49, X
Susquehanna River Basin Commission 18, VIII
Technology Administration 15, XI
Technology Policy, Assistant Secretary for 37, IV
Tennessee Valley Authority 5, LXIX; 18, XIII
Thrift Supervision Office, Department of the Treasury 12, V
Trade Representative, United States, Office of 15, XX
Transportation, Department of 2, XII; 5, L
Contract Appeals, Board of 48, 63
Emergency Management and Assistance 44, IV
Federal Aviation Administration 14, I
Federal Highway Administration 23, I, II
Federal Motor Carrier Safety Administration 49, III
Federal Railroad Administration 49, II
Federal Transit Administration 49, VI
Maritime Administration 46, II
National Highway Traffic Safety Administration 23, II, III; 47, IV; 49, V
Pipeline and Hazardous Materials Safety Administration 49, I
Saint Lawrence Seaway Development Corporation 33, IV
Secretary of Transportation, Office of 14, II; 49, Subtitle A
Transportation Statistics Bureau 49, XI
Transportation, Office of 7, XXXIII
Transportation Security Administration 49, XII
Transportation Statistics Bureau 49, XI
Travel Allowances, Temporary Duty (TDY) 41, 301
Treasury Department 2, X;5, XXI; 12, XV; 17,
IV; 31, IX
Alcohol and Tobacco Tax and Trade Bureau 27, I
Community Development Financial Institutions Fund 12, XVIII
Comptroller of the Currency 12, I
Engraving and Printing, Bureau of 31, VI
Federal Law Enforcement Training Center 31, VII
Financial Crimes Enforcement Network 31, X
Fiscal Service 31, II
Foreign Assets Control, Office of 31, V
Internal Revenue Service 26, I
Investment Security, Office of 31, VIII
Monetary Offices 31, I
Secret Service 31, IV
Secretary of the Treasury, Office of 31, Subtitle A
Thrift Supervision, Office of 12, V
Truman, Harry S. Scholarship Foundation 45, XVIII
United States and Canada, International Joint Commission 22, IV
United States and Mexico, International Boundary and Water 22, XI

Commission, United States Section
U.S. Copyright Office 37, II
Utah Reclamation Mitigation and Conservation Commission 43, III
455
Agency Chapter
Veterans Affairs Department 2, VIII; 38, I
Veterans’ Employment and Training Service, Office of the 41, 61; 20, IX
Vice President of the United States, Office of 32, XXVIII
Wage and Hour Division 29, V
Water Resources Council 18, VI
Workers’ Compensation Programs, Office of 20, I, VII
World Agricultural Outlook Board 7, XXXVIII
456
List of CFR Sections Affected
All changes in this volume of the Code of Federal Regulations (CFR)
that were made by documents published in the FEDERAL REGISTER since
January 1, 2012 are enumerated in the following list. Entries indicate the
nature of the changes effected. Page numbers refer to FEDERAL REGISTER
pages. The user should consult the entries for chapters, parts and sub-
parts as well as sections for revisions.
For changes to this volume of the CFR prior to this listing, consult
the annual edition of the monthly List of CFR Sections Affected (LSA).
The LSA is available at www.fdsys.gov. For changes to this volume of
the CFR prior to 2001, see the ‘‘List of CFR Sections Affected, 1949–1963,
1964–1972, 1973–1985, and 1986–2000’’ published in 11 separate volumes. The
‘‘List of CFR Sections Affected 1986–2000’’ is available at www.fdsys.gov.
2012 40 CFR—Continued 78 FR
Page
40 CFR 77 FR Chapter I—Continued
Page
725.54 (b) and (d) revised ................ 72828
Chapter I 725.60 (a) revised ........................... 72828
723.50 (h)(2)(i)(A) amended ............ 46293 725.190 (d) revised.......................... 72828
725.67 (b)(1) amended..................... 46293 725.975 (b) introductory text re-
725.95 Amended............................. 46293 vised......................................... 72828
761.19 Revised ................................ 2463 725.984 (b)(1) revised ...................... 72828
761.30 (i)(1)(iii)(A)(1) amended....... 46293 763.80—763.99 (Subpart E) Appen-
761.60 (j)(1)(vii) revised ................. 54830 dices C and D amended .............. 37978
761.65 (i)(2) and (4) revised ............. 54830 766.3 Amended .............................. 72828
761.71 (b)(2)(vi) revised ................... 2464 766.7 Revised ................................ 72828
761.75 (b)(8)(iii) revised ................... 2464 766.35 (c)(1)(i) revised .................... 72829
761.180 (a)(2)(viii) removed ............ 54830
761.207 Revised ............................. 54830 2014
761.208 Revised ............................. 54831
761.209 Revised ............................. 54831 40 CFR 79 FR
Page
761.210 Revised ............................. 54831
761.211 Revised ............................. 54832 Chapter I
761.212 Added ................................ 54832 761.80 (j) revised ................... 18477, 58270
761.213 Added ................................ 54833 Regulation at 79 FR 18477 with-
761.214 Added ................................ 54833 drawn .......................................33867
761.215 Revised ............................. 54833 766 Waiver denied ......................... 72984
761.216 Added ................................ 54834
761.217 Added ................................ 54835 2015
761.219 Added ................................ 54835
763.90 (i)(5) amended................... 46293 40 CFR 80 FR
Page
766.12 Amended............................. 46293
Chapter I
723.50 (j)(6)(ii)(B) revised;
2013 (j)(6)(ii)(C) removed .................. 42746
40 CFR 78 FR 725.15 (a)(2), (b)(2) introductory
Page text, (ii), (iii) and (d) through
Chapter I (g) revised................................. 42747

723.50 (e)(1) revised ....................... 72828 745.90 (a)(4) revised ....................... 20446
725.25 (c) revised ........................... 72828 761.60 (i)(1) revised ........................ 77578
457
40 CFR (7–1–17 Edition)
40 CFR—Continued 80 FR 40 CFR—Continued 81 FR
Page Page
Chapter I—Continued Chapter I—Continued
761.207 (a)(1), (2) and (3) re- 750.34 Removed; redesignated
vised......................................... 37995 from 750.36 ................................ 93636
750.35 Removed; redesignated
2016 from 750.41 and revised .............. 93636
40 CFR 81 FR
750.36 Redesignated as 750.34 ......... 93636
Page 750.37 Removed............................. 93636
Chapter I 750.38 Removed............................. 93636
745.90 (a)(2) and (4) revised .............. 7995 750.39 Removed............................. 93636
745.225 (a)(4), (c)(8)(viii) and 750.40 Removed............................. 93636
(14)(ii)(D)(7) added; (c) intro- 750.41 Redesignated as 750.35 ......... 93636
ductory text, (13)(i), (14)(i), (d) 770 Added ..................................... 89724
introductory text, (e) intro-
ductory text, (2), (3), (4) and 2017
(5)(viii) revised........................... 7995
745.238 (c)(3) removed; (c)(4) and (Regulations published from January 1,
(5) redesignated as new (c)(3) 2017, through July 1, 2017)
and (4); (d)(1) heading, (2) head- 40 CFR 82 FR
ing and (e)(2) revised................... 7996 Page
750.1—750.9 (Subpart A) Re- Chapter I
moved ...................................... 93636
770 Regulation at 81 FR 89724 eff.
750.10 Revised ............................... 93636
date delayed to 3-21-17 ................ 8499
750.13 Revised ............................... 93636
Regulation at 81 FR 89724 eff.
750.14 Removed; redesignated
from 750.16 ................................ 93636 date further delayed to 5-22-17
750.15 Removed; redesignated ................................................. 14324
from 750.21 and revised .............. 93636 770.2 Revised ................................ 23737
750.16 Redesignated as 750.14 ......... 93636 770.3 Amended .............................. 23738
750.17 Removed............................. 93636 770.7 (d)(1) introductory text re-
750.18 Removed............................. 93636 vised......................................... 23738
750.19 Removed............................. 93636 770.10 (a) revised ........................... 23738
750.20 Removed............................. 93636 770.12 (a) revised ........................... 23738
750.21 Redesignated as 750.15 ......... 93636 770.15 (a) and (e) revised ................ 23738
750.30 Revised ............................... 93636 770.30 (b) introductiory text, (c)
750.33 Revised ............................... 93636 and (d) revised........................... 23738
Æ
458

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Title 40

Revised as of July 1, 2017

Containing a codification of documents

Published by the Office of the Federal Register

Legal Status and Use of Seals and Logos

Use of ISBN Prefix

U.S. GOVERNMENT PUBLISHING OFFICE

U.S. Superintendent of Documents • Washington, DC 20402–0001

Phone: toll-free (866) 512-1800; DC area (202) 512-1800

Chapter I—Environmental Protection Agency (Continued) ............ 3

Table of CFR Titles and Chapters ....................................................... 427

Alphabetical List of Agencies Appearing in the CFR ......................... 447

List of CFR Sections Affected ............................................................. 457

To cite the regulations in

Title 40—PROTECTION OF ENVIRONMENT is composed of thirty-seven volumes.

Chapter I—Environmental Protection Agency appears in all thirty-seven vol-

CHAPTER I—Environmental Protection Agency (Continued) 723

EDITORIAL NOTE: Nomenclature changes to chapter I appear at 65 FR 47324, 47325, Aug. 2,

SUBCHAPTER R—TOXIC SUBSTANCES CONTROL ACT

PART 723—PREMANUFACTURE (1) Act means the Toxic Substances

this chapter. (ii) Any reversible damage to biologi-

higher concentration authorized by manufactured under this section, not-

complete by EPA. When a submission in the prescribed time period, EPA

provisions of paragraph (h)(2) of this (B) The manufacturer may continue

(ii) Manufacturing the new chemical substance at the manufacturing site

users of any controls specified in the under what conditions, distribution of

(3) The terms byproduct, EPA, impuri- of an instant photographic or peel-

opment of the film. for that new chemical substance sub-

(3) Comply with the requirements of excursion of 50 percent above these

stance in manufacturing, processing, or practices, and personal protective de-

substance’s physical-chemical prop- diagram, if available. The notice must

monomer); the maximum residual of (x) Certification. The manufacturer

turer must maintain a record of the enlarge the exemption category or to

(2) As required by section 5(h)(4) of (i) Determine that the substance

(2) To manufacture a new chemical depending on the telogen used produces

(c) Applicability. This section applies polymer is designed or is reasonably

Monobasic Acids and Natural Oils

Fatty acids, coco ............................................................................................................................................ 61788–47–4*

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

Fatty acids, soya ............................................................................................................................................ 68308–53–2*

1,2,3-Propanetriol, homopolymer ................................................................................................................... 25618–55–7

TABLE 1—LIST OF REACTANTS FROM WHICH POLYESTER MAY BE MADE—Continued

1-Butanol ........................................................................................................................................................ 71–36–3**

than two weight percent according to seded regulations. Manufacturers grant-

725.15 Determining applicability when 725.238 Activities conducted outside a struc-

Subpart M—Significant New Uses for

means quantities of a microorganism § 725.8 Coverage of this part.

rial including linkers, homopolymers, required by paragraph (b) of this sec-

unambiguously identified on the Inven- (1) Confidential identity or use. In

to access the e-PMN software. A bona the microorganism is subject to this

ficient information has been provided, § 725.20 Scope and purpose.

be submitted in a manner set forth in required, which the submitter indicates

must submit to EPA data described in (a) Requirements specific to MCANs

(b) Requirements specific to TERAs (4) Ambiguous statements or infor-

data to be misleading or answers to (9) For MCANs, the submitter does

review period will be deemed suspended new information.

review period under § 725.56. The review exemption requests.

(b) If a manufacturer, importer, or L of this part are set forth in § 725.850.

genotypic and phenotypic information; able economic and social consequences

national economy, small business, connection with the requirements of

(2) If any information is claimed con- microorganism identity at the time of

(1) The information would disclose organism identity confidential in the

(MCAN). It is expected that MCANs (b) Importers of new microorganisms. (1)