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Wednesday,

May 30, 2007

Part III

Environmental
Protection Agency
40 CFR Part 82
Protection of Stratospheric Ozone: Listing
of Substitutes for Ozone-Depleting
Substances-n-Propyl Bromide in Solvent
Cleaning; Protection of Stratospheric
Ozone: Listing of Substitutes for Ozone-
DepletingSubstances-n-Propyl Bromide in
Adhesives, Coatings, and Aerosols; Final
Rule and Proposed Rule
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30142 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

ENVIRONMENTAL PROTECTION FOR FURTHER INFORMATION CONTACT: G. Executive Order 13045: Protection of
AGENCY Margaret Sheppard, Stratospheric Children from Environmental Health and
Protection Division, Office of Safety Risks
40 CFR Part 82 H. Executive Order 13211: Actions That
Atmospheric Programs, Mail Code
Significantly Affect Energy Supply,
6205J, Environmental Protection Distribution, or Use
[EPA–HQ–OAR–2002–0064; FRL–8316–8]
Agency, 1200 Pennsylvania Ave., NW., I. National Technology Transfer and
RIN 2060–AO10 Washington, DC 20460; telephone Advancement Act
number (202) 343–9163; fax number J. Congressional Review Act
Protection of Stratospheric Ozone: (202) 343–2362, e-mail address: VIII. References
Listing of Substitutes for Ozone- sheppard.margaret@epa.gov. Notices
Depleting Substances-n-Propyl I. General Information
and rulemakings under the SNAP
Bromide in Solvent Cleaning program are available on EPA’s A. Does this action apply to me?
Stratospheric Ozone World Wide Web
AGENCY: Environmental Protection This final rule lists n-propyl bromide
site at http://www.epa.gov/ozone/snap/
Agency. (nPB) as an acceptable substitute when
regs.
ACTION: Final Rule. used as a solvent in industrial
SUPPLEMENTARY INFORMATION: Table of equipment for metals cleaning,
SUMMARY: The Environmental Protection Contents: This action is divided into electronics cleaning, or precision
Agency (EPA) determines that n-propyl eight sections: cleaning. General metals, precision, and
bromide (nPB) is an acceptable I. General Information electronics cleaning includes cleaning
substitute for methyl chloroform and A. Does this action apply to me? with industrial cleaning equipment
chlorofluorocarbon (CFC)–113 in the B. What is n-propyl bromide? such as vapor degreasers, in-line
solvent cleaning sector under the C. What acronyms and abbreviations are cleaning systems, or automated
Significant New Alternatives Policy used in the preamble? equipment used for cleaning below the
(SNAP) program under section 612 of II. How does the Significant New
boiling point. We understand that nPB
Alternatives Policy (SNAP) Program
the Clean Air Act. The SNAP program work? is used primarily for cleaning in vapor
reviews alternatives to Class I and Class A. What are the statutory requirements and degreasers. Manual cleaning, such as
II ozone depleting substances and authority for the SNAP Program? pail-and-brush, hand wipe, recirculating
approves use of alternatives which do B. How do the regulations for the SNAP over-spray (‘‘sink-on-a-drum’’) parts
not present a substantially greater risk to Program work? washers, immersion cleaning into dip
public health and the environment than C. How does the SNAP Program list our tanks with manual parts handling, and
the substance they replace or than other decisions? use of squirt bottles, is not currently
available substitutes. D. Where can I get additional information regulated under the SNAP program.
about the SNAP Program?
DATES: This final rule is effective on July III. What is EPA’s final listing decision on
EPA also does not regulate the use of
30, 2007. nPB in solvent cleaning? solvents as carriers for flame retardants,
ADDRESSES: EPA has established a IV. What criteria did EPA use in making this dry cleaning, or paint stripping under
docket for this action under Docket ID Final Decision? the SNAP program.
No. EPA–HQ–OAR–2002–0064. All A. Availability of alternatives to ozone- This final action does not address the
documents in the docket are listed on depleting substances use of n-propyl bromide as an aerosol
B. Impacts on the Atmosphere and Local solvent or as a carrier solvent in
the http://www.regulations.gov Web Air Quality
site. Although listed in the index, some adhesives or coatings. We are issuing a
C. Ecosystem and Other Environmental
information is not publicly available, proposed rule addressing these end uses
Impacts
i.e., Confidential Business Information D. Flammability and Fire Safety in a separate Federal Register action.
(CBI) or other information whose E. Impact on Human Health Neither this final nor the proposed rule
disclosure is restricted by statute. V. How is EPA responding to comments on issue a decision on other end uses in
Certain other material, such as the June 2003 Notice of Proposed which nPB was submitted as an ozone-
copyrighted material, is not placed on Rulemaking? depleting substance (ODS) substitute,
the Internet and will be publicly A. EPA’s Acceptability Decision such as fire suppression or foam
B. Toxicity blowing, because of insufficient
available only in hard copy form. C. Ozone Depletion Potential
Publicly available docket materials are information.
D. Other Environmental Impacts
available either electronically in http:// E. Flammability
Affected users under this final rule
www.regulations.gov or in hard copy at F. Legal Authority to Set Exposure Limits could include:
the Air and Radiation Docket, EPA/DC, VI. How can I use nPB as safely as possible? • Businesses that clean metal parts,
EPA West, Room 3334, 1301 VII. Statutory and Executive Order Reviews such as automotive manufacturers,
Constitution Ave., NW., Washington, A. Executive Order 12866: Regulatory machine shops, machinery
DC. This docket facility is open from Planning and Review manufacturers, and electroplaters.
8:30 a.m. to 4:30 p.m., Monday through B. Paperwork Reduction Act • Businesses that manufacture
C. Regulatory Flexibility Act
Friday, excluding legal holidays. The electronics or computer equipment.
D. Unfunded Mandates Reform Act
telephone number for the Public E. Executive Order 13132: Federalism • Businesses that require a high level
Reading Room is (202) 566–1744, and F. Executive Order 13175: Consultation of cleanliness in removing oil, grease, or
the telephone number for the Air and and Coordination with Indian Tribal wax, such as for aerospace applications
Radiation Docket is (202) 566–1742. Governments or for manufacture of optical equipment.
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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations 30143

TABLE 1.—POTENTIALLY REGULATED ENTITIES, BY NORTH AMERICAN INDUSTRIAL CLASSIFICATION SYSTEM (NAICS)
CODE OR SUBSECTOR
NAICS code
Category Description of regulated entities
or subsector

Industry .......................................................................... 331 Primary Metal Manufacturing.


Industry .......................................................................... 332 Fabricated Metal Product Manufacturing.
Industry .......................................................................... 333 Machinery Manufacturing.
Industry .......................................................................... 334 Computer and Electronic Product Manufacturing.
Industry .......................................................................... 335 Equipment Appliance, and Component Manufacturing.
Industry .......................................................................... 336 Transportation Equipment Manufacturing.
Industry .......................................................................... 337 Furniture and Related Product Manufacturing.
Industry .......................................................................... 339 Miscellaneous Manufacturing.

This table is not intended to be CFC—chlorofluorocarbon NESHAP—National Emission Standard for


exhaustive, but rather a guide regarding cfm—cubic feet per minute Hazardous Air Pollutants
entities likely to be regulated by this CFR—Code of Federal Regulations NIOSH—National Institute for Occupational
CNS—central nervous system Safety and Health
action. If you have any questions about DNA—deoxyribonucleic acid NOAEL—No Observed Adverse Effect Level
whether this action applies to a EDSTAC—The Endocrine Disruptor NOEL—No Observed Effect Level
particular entity, consult the person Screening and Testing Advisory nPB-n-propyl bromide, C3H7Br, CAS Reg. No.
listed in the preceding section, FOR Committee 106–94–5; also called 1-bromopropane or
FURTHER INFORMATION CONTACT. EPA—the United States Environmental 1-BP
Protection Agency NPRM—Notice of Proposed Rulemaking
B. What is n-propyl bromide? FR—Federal Register NTP—National Toxicology Program
n-propyl bromide (nPB), also called 1- GWP—global warming potential NTTAA—National Technology Transfer and
HCFC-123—the ozone-depleting chemical Advancement Act
bromopropane, is a non-flammable
1,2-dichloro-1,1,2-trifluoroethane, CAS ODP—ozone depletion potential
organic solvent with a strong odor. Its Reg. No. 306–83–2 ODS—ozone-depleting substance
chemical formula is C3H7Br. Its HCFC-141b—the ozone-depleting chemical OEHHA—Office of Environmental Health
identification number in Chemical 1,1-dichloro-1-fluoroethane, CAS Reg. Hazard Assessment of the California
Abstracts Service’s registry (CAS Reg. No. 1717–00–6 Environmental Protection Agency
No.) is 106–94–5. nPB is used to remove HCFC-225ca/cb—the commercial mixture of OMB—U.S. Office of Management and
wax, oil, and grease from electronics, the two ozone-depleting chemicals 3,3- Budget
metal, and other materials. It also is dichloro-1,1,1,2,2-pentafluoropropane, OSHA—the United States Occupational
CAS Reg. No. 422–56–0 and 1,3- Safety and Health Administration
used as a carrier solvent in adhesives. dichloro-1,1,2,2,3-pentafluoropropane, PCBTF—parachlorobenzotrifluoride, CAS
Some brand names of products using CAS Reg. No. 507–55–1 Reg. No. 98–56–6
nPB are: Abzol, EnSolv, and Solvon HCFC—hydrochlorofluorocarbon PEL—Permissible Exposure Limit
cleaners; Pow-R-Wash NR Contact HEC—human equivalent concentration ppm—parts per million
Cleaner, Superkleen Flux Remover 2311 HFC-245fa—the chemical 1,1,3,3,3- RCRA—Resource Conservation and Recovery
and LPS NoFlash NU Electro Contact pentafluoropropane, CAS Reg. No. 460– Act
Cleaner aerosols; and Whisper Spray 73–1 RFA—Regulatory Flexibility Act
HFC-365mfc—the chemical 1,1,1,3,3- RfC—reference concentration
and Fire Retardant Soft Seam 6460 pentafluorobutane, CAS Reg. No. 405–
adhesives. SIP—state implementation plan
58–6 SNAP—Significant New Alternatives Policy
C. What acronyms and abbreviations are HFC-4310mee—the chemical STEL—Short term exposure limit
1,1,1,2,3,4,4,5,5,5-decafluoropentane, TCA—the ozone-depleting chemical 1,1,1-
used in the preamble? CAS Reg. No. 138495–42–8 trichloroethane, CAS Reg. No. 71–55–6;
Below is a list of acronyms and HFC—hydrofluorocarbon also called methyl chloroform, MCF, or
abbreviations used in this document. HFE—hydrofluoroether 1,1,1
HHE—health hazard evaluation TCE—the chemical 1,1,2-trichloroethene,
8-hr—eight hour ICF—ICF Consulting
ACGIH—American Conference of CAS Reg. No. 79–01–6, C2Cl3H; also call
ICR—Information Collection Request
Governmental Industrial Hygienists trichloroethylene
iPB—isopropyl bromide, C3H7Br, CAS Reg.
AEL—acceptable exposure limit TERA—Toxicological Excellence for Risk
No. 75–26–3, an isomer of n-propyl
ASTM—American Society for Testing and Assessment
bromide; also called 2-bromopropane or
Materials 2-BP TLV—Threshold Limit ValueTM
BMD—benchmark dose Koc—organic carbon partition coefficient, for TSCA—Toxic Substances Control Act
BMDL—benchmark dose lowerbound, the determining the tendency of a chemical TWA—time-weighted average
lower 95%-confidence level bound on to bind to organic carbon in soil UMRA—Unfunded Mandates Reform Act
the dose/exposure associated with the LC50—the concentration at which 50% of test U.S.C.—United States Code
benchmark response animals die VMSs—volatile methyl siloxanes
BSOC—Brominated Solvents Consortium LOAEL—Lowest Observed Adverse Effect VOC—volatile organic compound
CAA—Clean Air Act Level WEL—workplace exposure limit
CAS Reg. No.—Chemical Abstracts Service Log Kow—logarithm of the octanol-water II. How does the Significant New
Registry Identification Number partition coefficient, for determining the
CBI—Confidential Business Information
Alternatives Policy (SNAP) program
tendency of a chemical to accumulate in
work?
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CEG—community exposure guideline lipids or fats instead of remaining


CERHR—Center for the Evaluation of Risks to dissolved in water A. What are the statutory requirements
Human Reproduction mg/l—milligrams per liter and authority for the SNAP program?
CFC-113—the ozone-depleting chemical MSDS—Material Safety Data Sheet
1,1,2-trifluoro-1,2,2-trichloroethane, NAICS—North American Industrial Section 612 of the Clean Air Act
C2Cl3F3, CAS Reg. No. 76–13–1 Classification System (CAA) authorizes EPA to develop a

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30144 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

program for evaluating alternatives to that described the process for end uses are available for their specific
ozone-depleting substances, referred to administering the SNAP program and application. We describe these
as the Significant New Alternatives issued the first acceptability lists for substitutes as ‘‘acceptable subject to
Policy (SNAP) program. The major substitutes in the major industrial use narrowed use limits.’’ If you use a
provisions of section 612 are: sectors. These sectors include: substitute that is acceptable subject to
• Rulemaking—Section 612(c) Refrigeration and air conditioning; foam narrowed use limits, but use it in
requires EPA to promulgate rules blowing; solvents cleaning; fire applications and end-uses which are not
making it unlawful to replace any class suppression and explosion protection; consistent with the narrowed use limit,
I (chlorofluorocarbon, halon, carbon sterilants; aerosols; adhesives, coatings you are using these substitutes in an
tetrachloride, methyl chloroform, and and inks; and tobacco expansion. These unacceptable manner and you could be
hydrobromofluorocarbon) or class II sectors comprise the principal industrial subject to enforcement for violation of
(hydrochlorofluorocarbon) substance sectors that historically consumed large section 612 of the Clean Air Act.
with any substitute that the volumes of ozone-depleting substances. The Agency publishes its SNAP
Administrator determines may present Anyone who plans to market or program decisions in the Federal
adverse effects to human health or the produce a substitute for an ODS in one Register. For those substitutes that are
environment where the Administrator of the eight major industrial use sectors deemed acceptable subject to use
has identified an alternative that (1) must provide the Agency with health restrictions (use conditions and/or
reduces the overall risk to human health and safety studies on the substitute at narrowed use limits), or for substitutes
and the environment, and (2) is least 90 days before introducing it into deemed unacceptable, we first publish
currently or potentially available. interstate commerce for significant new these decisions as proposals to allow the
• Listing of Unacceptable/Acceptable use as an alternative. This requirement public opportunity to comment, and we
Substitutes—Section 612(c) also applies to the person planning to publish final decisions as final
requires EPA to publish a list of the introduce the substitute into interstate rulemakings. In contrast, we publish
substitutes unacceptable for specific commerce, typically chemical substitutes that are deemed acceptable
uses. We must publish a corresponding manufacturers, but may also include with no restrictions in ‘‘notices of
list of acceptable alternatives for importers, formulators or end-users acceptability,’’ rather than as proposed
specific uses. when they are responsible for and final rules. As described in the rule
• Petition Process—Section 612(d) introducing a substitute into commerce. implementing the SNAP program (59 FR
grants the right to any person to petition 13044), we do not believe that
C. How does the SNAP program list our
EPA to add a substitute to or delete a rulemaking procedures are necessary to
decisions?
substitute from the lists published in list alternatives that are acceptable
accordance with section 612(c). EPA has The Agency has identified four without restrictions because such
90 days to grant or deny a petition. possible decision categories for listings neither impose any sanction nor
Where the Agency grants the petition, substitutes: Acceptable; acceptable prevent anyone from using a substitute.
we must publish the revised lists within subject to use conditions; acceptable Many SNAP listings include
an additional six months. subject to narrowed use limits; and ‘‘comments’’ or ‘‘further information.’’
• 90-day Notification—Section 612(e) unacceptable. Use conditions and These statements provide additional
requires EPA to require any person who narrowed use limits are both considered information on substitutes that we
produces a chemical substitute for a ‘‘use restrictions’’ and are explained determine are either unacceptable,
class I substance to notify the Agency below. Substitutes that are deemed acceptable subject to narrowed use
not less than 90 days before new or acceptable with no use restrictions (no limits, or acceptable subject to use
existing chemicals are introduced into use conditions or narrowed use limits) conditions. Since this additional
interstate commerce for significant new can be used for all applications within information is not part of the regulatory
uses as substitutes for a class I the relevant sector end-use. Substitutes decision, these statements are not
substance. The producer must also that are acceptable subject to use binding for use of the substitute under
provide the Agency with the producer’s restrictions may be used only in the SNAP program. However, regulatory
health and safety studies on such accordance with those restrictions. It is requirements listed in this column are
substitutes. illegal to replace an ODS with a binding under other programs. The
• Outreach—Section 612(b)(1) states substitute listed as unacceptable. further information does not necessarily
that the Administrator shall seek to After reviewing a substitute, the include all other legal obligations
maximize the use of federal research Agency may make a determination that pertaining to the use of the substitute.
facilities and resources to assist users of a substitute is acceptable only if certain However, we encourage users of
class I and II substances in identifying conditions of use are met to minimize substitutes to apply all statements in the
and developing alternatives to the use of risks to human health and the FURTHER INFORMATION column in their
such substances in key commercial environment. We describe such use of these substitutes. In many
applications. substitutes as ‘‘acceptable subject to use instances, the information simply refers
• Clearinghouse—Section 612(b)(4) conditions.’’ If you use these substitutes to sound operating practices that have
requires the Agency to set up a public without meeting the associated use already been identified in existing
clearinghouse of alternative chemicals, conditions, you use these substitutes in industry and/or building-code
product substitutes, and alternative an unacceptable manner and you could standards. Thus, many of the comments,
manufacturing processes that are be subject to enforcement for violation if adopted, would not require the
available for products and of section 612 of the Clean Air Act. affected industry to make significant
manufacturing processes which use For some substitutes, the Agency may changes in existing operating practices.
class I and II substances. permit a narrowed range of use within
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a sector. For example, we may limit the D. Where can I get additional
B. How do the regulations for the SNAP use of a substitute to certain end-uses or information about the SNAP program?
program work? specific applications within an industry For copies of the comprehensive
On March 18, 1994, EPA published sector or may require a user to SNAP lists of substitutes or additional
the original rulemaking (59 FR 13044) demonstrate that no other acceptable information on SNAP, look at EPA’s

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Ozone Depletion World Wide Web site available or potentially available of the comment period on the June 2003
at http://www.epa.gov/ozone/snap/lists/ substitutes for ozone-depleting NPRM relevant to our proposed
index.html. For more information on the substances in these end uses. determinations for adhesive and aerosol
Agency’s process for administering the EPA is issuing today’s listing in the solvent end uses in that same proposal,
SNAP program or criteria for evaluation form of a final rule, rather than in a the Agency is issuing a new proposal for
of substitutes, refer to the SNAP final notice of acceptability, in order to those end uses in a separate Federal
rulemaking published in the Federal respond to the public comments Register action. The Agency is not
Register on March 18, 1994 (59 FR received on a Notice of Proposed including a recommended AEL in this
13044), codified at Code of Federal Rulemaking (NPRM) that we issued on final rule.
Regulations at 40 CFR part 82, subpart June 3, 2003 (68 FR 33284). In that rule,
we proposed listing n-propyl bromide Table 2 contains the text pertaining to
G. You can find a complete chronology
(nPB) as an acceptable substitute for use nPB use in solvent cleaning end-uses
of SNAP decisions and the appropriate
Federal Register citations at http:// in metals, precision, and electronics that will be added to EPA’s list of
www.epa.gov/ozone/snap/chron.html. cleaning, and in aerosols and adhesives acceptable substitutes located on the
end-uses, subject to the use condition SNAP Web site at http://www.epa.gov/
III. What is EPA’s final listing decision that nPB used in these applications ozone/snap/lists/index.html. This and
on nPB in solvent cleaning? contains no more than 0.05% by weight other listings for substitutes that are
The Agency is listing nPB as an of isopropyl bromide. In addition, in acceptable without restriction are not
acceptable substitute in metals, that proposed rule, EPA indicated that included in the Code of Federal
precision and electronics cleaning end we also would recommend that users Regulations because they are not
uses. Based on the available adhere to a voluntary acceptable regulatory requirements. The
information, we find that nPB can be exposure limit (AEL) of 25 parts per information contained in the ‘‘Further
used with no substantial increase in million averaged over an eight-hour Information’’ column of those tables are
overall risks to human health and the time-weighted average (TWA). Based on non-binding recommendations on the
environment, compared to other new information received after the close safe use of substitutes.

TABLE 2.—SOLVENT CLEANING ACCEPTABLE SUBSTITUTE


End use Substitute Decision Further information

Metals cleaning, electronics n-propyl bromide (nPB) as Acceptable ......................... EPA recommends the use of personal protective
cleaning, and precision a substitute for CFC–113 equipment, including chemical goggles, flexible lami-
cleaning. and methyl chloroform. nate protective gloves and chemical-resistant cloth-
ing.
EPA expects that all users of nPB would comply with
any final Permissible Exposure Limit that the Occu-
pational Safety and Health Administration issues in
the future under 42 U.S.C. 7610(a).
nPB, also known as 1-bromopropane, is Number 106–
94–5 in the Chemical Abstracts Service (CAS) Reg-
istry.

IV. What criteria did EPA consider in applications such as electronics Our evaluation is based on the end use;
making this final determination? cleaning. In those consumer products for example, we compared nPB as a
In the original rule implementing the made using nPB, such as a computer, metal cleaning solvent against other
SNAP program (March 18, 1994; 59 FR the nPB would have evaporated long available or potentially available metal
13044, at 40 CFR 82.180(a)(7)), the before a consumer would purchase the cleaning alternatives.
Agency identified the criteria we use in item. Therefore, we believe there is no Although EPA does not judge the
consumer exposure risk in the end uses effectiveness of an alternative for
determining whether a substitute is
we evaluated for this rule. purposes of determining whether it is
acceptable or unacceptable as a
Section 612(c) of the Clean Air Act acceptable, we consider effectiveness
replacement for class I or II compounds:
(i) Atmospheric effects and related directs EPA to publish a list of when determining whether alternatives
health and environmental impacts; [e.g., replacement substances (‘‘substitutes’’) that pose less risk are available in a
ozone depletion potential] for class I and class II ozone depleting particular application within an end
(ii) General population risks from substances based on whether the use. There are a wide variety of
ambient exposure to compounds with Administrator determines they are safe acceptable alternatives listed for solvent
direct toxicity and to increased ground- (when compared with other currently or cleaning, but not all are appropriate for
level ozone; potentially available substitutes) for a specific application because of
(iii) Ecosystem risks [e.g., specific uses or are to be prohibited for differences in soils, materials
bioaccumulation, impacts on surface specific uses. EPA must compare the compatibility, degree of cleanliness
and groundwater]; risks to human health and the required, local environmental
(iv) Occupational risks; environment of a substitute to the risks requirements, and other factors. For
(v) Consumer risks; associated with other substitutes that example, aqueous cleaners are effective
(vi) Flammability; and are currently or potentially available. In cleaners in many situations and are the
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(vii) Cost and availability of the addition, EPA also considers whether substitute of choice for many in the
substitute. the substitute for class I and class II metal cleaning end use. However, in
In this review, EPA considered all the ODSs ‘‘reduces the overall risk to some specific precision cleaning
criteria above. However, n-propyl human health and the environment’’ applications that require a high degree
bromide is used in industrial compared to the ODSs being replaced. of cleanliness and that have narrow

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spaces that may trap water used in cleanliness in precision cleaning. Of the developed to attain the National
rinsing, aqueous cleaners may not be available substitutes, aqueous cleaners Ambient Air Quality Standards for
appropriate and thus are not available in or solvents for vapor degreasing such as ground-level ozone, which is a
those specific applications. TCE, blends of alcohols or trans-1,2- respiratory irritant. Users located in
EPA evaluated each of the criteria dichloroethylene and HFCs or HFEs, ozone non-attainment areas may need to
separately and then considered overall and HCFC–225ca/cb are most likely to consider using a substitute for cleaning
risk to human health and the be used in the same applications as nPB. that is not a VOC or if they choose to
environment in comparison to other nPB is already commercially available use a substitute that is a VOC, they may
available or potentially available in solvent cleaning, and is used mostly need to control emissions in accordance
alternatives. We concluded that overall, for vapor degreasing in the electronics with the SIP. Companies have
while there are a number of alternatives and precision cleaning end uses (IBSA, petitioned EPA, requesting that we
that reduce the risks from ozone 2002). exempt nPB from regulation as a VOC.
depletion or from smog production 1 However, unless and until EPA issues a
slightly more than nPB when used in B. Impacts on the Atmosphere and
final rulemaking exempting a
industrial solvent cleaning equipment, Local Air Quality
compound from the definition of VOC
we found no single alternative that As discussed in the June 2003 and states change their SIPs to exclude
could work in all applications that proposal, nPB emissions from the such a compound from regulation, that
clearly would reduce overall risks to continental United States are estimated compound is still regulated as a VOC.
human health and the environment in to have an ozone depletion potential Other acceptable ODS-substitute
metals cleaning, electronics cleaning, (ODP) of approximately 0.013–0.018, solvents that are VOCs for state air
and precision cleaning. Balancing the (Wuebbles, 2002) 4, lower than that of quality planning purposes include most
different criteria discussed below, nPB the ozone depletion potential of the oxygenated solvents such as alcohols,
used in solvent cleaning end-uses does substances that nPB would replace— ketones, esters, and ethers;
not pose a significantly greater risk than CFC–113 (ODP=1.0), and methyl hydrocarbons and terpenes;
other substitutes or than the ODS it is chloroform and HCFC–141b (ODPs = trichloroethylene; trans-1,2-
replacing in these end uses. Thus, we 0.12) (WMO, 2002). Some other dichloroethylene; monochlorotoluenes;
are listing nPB as acceptable in metals acceptable alternatives for these ODSs and benzotrifluoride. Some VOC-
cleaning, electronics cleaning, and also have low ODPs. For example, exempt solvents that are acceptable ODS
precision cleaning. HCFC–225ca/cb has an ODP of 0.02– substitutes include HFC–245fa for
0.03 (WMO, 2002) and is acceptable in aerosol solvents; HCFC–225ca/cb, HFC–
A. Availability of Alternatives to Ozone- metals cleaning and aerosol solvents,
Depleting Substances 365mfc and HFC–4310mee for metals
and acceptable subject to use conditions electronics, and precision cleaning and
Other alternatives to methyl in precision cleaning and electronics aerosol solvents; and methylene
chloroform and CFC–113 are available cleaning. HCFC–123 has an ODP of 0.02 chloride, perchloroethylene, HFE–7100,
for metals, electronics, and precision (WMO, 2002), and is an acceptable HFE–7200, PCBTF, acetone, and methyl
cleaning that have already been found substitute in precision cleaning. There acetate for metals, electronics, and
acceptable or acceptable subject to use are other acceptable cleaners that precision cleaning, aerosol solvents,
conditions under the SNAP program essentially have no ODP—aqueous adhesives, and coatings.
including: Aqueous cleaners, semi- cleaners, HFEs, HFC–4310mee, HFC–
aqueous cleaners, alcohols, ketones, 365mfc, HFC–245fa, hydrocarbons, C. Ecosystem and Other Environmental
esters, ethers, terpenes, HCFC–225ca/cb, VMSs, methylene chloride, TCE, Impacts
hydrofluoroethers (HFEs), perchloroethylene, and PCBTF. EPA considered the possible impacts
hydrofluorocarbon (HFC)–4310mee, The global warming potential (GWP) of nPB if it were to pollute soil or water
HFC–365mfc, heptafluorocyclopentane, index is a means of quantifying the as a waste and compared these impacts
hydrocarbons, volatile methyl siloxanes potential integrated climate forcing of to screening criteria developed by the
(VMSs), trans-1,2-dichloroethylene, various greenhouse gases relative to Endocrine Disruptor Screening and
methylene chloride, trichloroethylene 2 carbon dioxide. Earlier data found a Testing Advisory Committee (EDSTAC,
(TCE), perchloroethylene,3 direct 100-year integrated GWP (100yr 1998) (see Table 3). Available data on
parachlorobenzotrifluoride (PCBTF), GWP) for nPB of 0.31 (Atmospheric and the organic carbon partition coefficient
and alternative technologies like Environmental Research, Inc., 1995). (Koc), the breakdown processes in water
supercritical fluids, plasma cleaning, More recent analysis that considers both and hydrolysis half-life, and the
and ultraviolet/ozone cleaning. Some the direct and the indirect GWP of nPB volatilization half-life indicate that nPB
alternatives are unlikely to be used in found a 100-yr GWP of 1.57 (ICF, 2003a; is less persistent in the environment
particular end uses because of ICF, 2006a). In either case, the GWP for than many solvents and would be of low
constraints such as cleaning nPB is comparable to or below that of to moderate concern for movement in
performance, materials compatibility, previously approved substitutes in these soil. Based on the LC50, the acute
cost, workplace exposure requirements, end uses. concentration at which 50% of tested
or flammability. For example, no-clean Use of nPB may be controlled as a animals die, nPB’s toxicity to aquatic
technology is used in electronics volatile organic compound (VOC) under life is moderate, being less than that for
cleaning and not in precision cleaning state implementation plans (SIPs) some acceptable cleaners (for example,
because of the need for a high degree of trichloroethylene, hexane, d-limonene,
4 nPB emissions in the tropics have an ODP of
and possibly some aqueous cleaners)
0.071 to 0.100; the portions of the U.S. outside the
1 Smog, also known as ground-level ozone, is continental U.S., such as Alaska, Hawaii, Guam,
and greater than that for some others
produced from emissions of volatile organic (methylene chloride, acetone, isopropyl
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and the U.S. Virgin Islands, contain less than 1


compounds that react under certain conditions of percent of the U.S.’s businesses in industries that alcohol, and some other aqueous
temperature and light. could use nPB. Thus, their potential impact on the
2 Also called trichlorethene or TCE, C Cl H, CAS
cleaners). The LC50 for nPB is 67 mg/l,
2 3 ozone layer must be significantly less than that of
Reg. No. 79–01–6. the already low impact from nPB emissions in the
which is greater than 10 mg/l. Based on
3 Also called PERC, tetrachloroethylene, or continental U.S. (U.S. Economic Census, 2002a EPA’s criteria for listing under the
tetrachloroethene, C2Cl4, CAS Reg. No. 172–18–4. through f). Toxics Release Inventory (U.S. EPA,

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1992), we believe that nPB would not be bioaccumulation. Table 3 summarizes a solvent used for metals, electronics,
sufficiently toxic to aquatic life to information on environmental impacts and precision cleaning; and methyl
warrant listing under the Toxics Release of nPB; trans-1,2-dichloroethylene, a chloroform, an ODS that nPB would
Inventory. Based on its relatively low commonly-used solvent in blends for replace.
bioconcentration factor and log Kow aerosol solvents, precision cleaning, and
value, nPB is not prone to electronics cleaning; trichloroethylene,

TABLE 3.—ECOSYSTEM AND OTHER ENVIRONMENTAL PROPERTIES OF NPB AND OTHER SOLVENTS
Value for trans- Value for trichloro- Value for methyl
Property Description of environmental property Value for nPB 1,2-dichloro-ethyl- ethylene chloroform
ene

Koc, organic-carbon Degree to which a substance tends to 330 (Source: ICF, 32 to 49 (Source: 106 to 460 152 (Source: U.S.
partition coeffi- stick to soil or move in soil. Lower 2004a). ATSDR, 1996). (Source: EPA, 1994a).
cient. values (< 300)* indicate great soil ATSDR, 1997).
mobility; values of 300 to 500 indi-
cate moderate mobility in soil.
Break down in Mechanism and speed with which a Hydrolysis is sig- Photolytic decom- Volatilization and Volatilization most
water. compound breaks down in the envi- nificant. Hydrol- position, biodegradation significant; bio-
ronment. (Hydrolysis half-life values ysis half-life of dechlorination most significant, degradation and
> 25 weeks* are of concern.) 26 days and biodegrada- with hydrolysis hydrolysis also
(Source: ICF, tion are signifi- relatively insig- occur (Source:
2004a). cant; hydrolysis nificant. Hydrol- ATSDR, 2004).
not significant ysis half-life of
(Source: 10.7 to 30
ATSDR, 1996). months (Source:
ATSDR, 1997).
Volatilization half- Tendency to volatilize and pass from 3.4 hours-4.4 days 3 to 6.2 hours 3.4 hours to 18 Hours to weeks
life from surface water into the air. (Source: ICF, (Source: days (Source: (Source: U.S.
waters. 2004a). ATSDR, 1996). ATSDR, 1997). EPA, 1994a).
LC50 (96 hours) for Concentration at which 50% of ani- 67 mg/L (Source: 108 mg/L (Source: 40.7 to 66.8 mg/L 52.8 to 105 mg/L
fathead minnows. mals die from toxicity after expo- Geiger, 1988). U.S. EPA, 1980). (Source: NPS, (Source: U.S.
sure for 4 days. 1997). EPA, 1994a).
log Kow .................. Logarithm of the octanol/water parti- 2.10 (Source: ICF, ¥0.48 (Source: 2.38 (Source: 2.50 (Source:
tion coefficient, a measure of tend- 2004a). LaGrega et al., LaGrega et al., LaGrega et al.,
ency to accumulate in fat. Log Kow 2001, p. 1119). 2001, p. 1127). 2001, p. 1127).
values >3* indicate high tendency
to accumulate.
Bioconcentration High factors (>1000)* indicate strong 23 (Source: 5 to 23 (Source: 10 to 100 (Source: <9 (Source: U.S.
factor. tendency for fish to absorb the HSDB, 2004). ATSDR, 1996). ATSDR, 1997). EPA, 1994a).
chemical from water into body tis-
sues.
*Criteria from EDSTAC, 1998.

nPB is not currently regulated as a D93 Pensky-Martens closed cup lower flammability limits, it could catch
hazardous air pollutant and is not listed methods (BSOC, 2000; Miller, 2003; fire in presence of a flame. Such a
as a hazardous waste under the Morford, 2003a, b and c; Shubkin, 2003; situation is unusual, but users should
Resource Conservation and Recovery Weiss Cohen, 2003). We agree with the take appropriate precautions in cases
Act (RCRA). nPB is not required to be commenters that by these standard test where the concentration of vapor could
reported as part of the Toxic Release methods, nPB displayed no flash point. fall between the flammability limits.
Inventory under Title III of the Thus under standard test conditions,
nPB is not flammable, and it should not E. Impact on Human Health
Superfund Amendments and
Reauthorization Act. Despite this, large be flammable under normal use In evaluating potential human health
amounts of nPB might be harmful if conditions. With its low potential for impacts of nPB, EPA considered
disposed of in water. We recommend flammability, nPB is comparable to impacts on both exposed workers and
that users dispose of nPB as they would chlorinated solvents, HCFCs, HFEs, on the general population because we
dispose of any spent halogenated HFC–245fa, HFC–4310mee, and identified these groups of people as the
solvent (F001 waste under RCRA). Users aqueous cleaners, and is less flammable ones likely to be exposed to nPB when
should not dump nPB into water, and than many acceptable substitutes, such it is used as a substitute for ozone-
should dispose of it by incineration. as ketones, alcohols, terpenes, and depleting substances. EPA evaluated the
hydrocarbons. nPB exhibits lower and available toxicity data using EPA
D. Flammability and Fire Safety upper flammability limits of guidelines to develop health-based
A number of commenters on the June approximately 3% to 8% (BSOC, 2000). criteria to characterize human health
2003 proposal provided additional A number of other solvents that are risks (U.S. EPA, 1994b. RfC Guidelines;
information on the flammability of nPB typically considered to be non- U.S. EPA, 1991. Guidelines for
rwilkins on PROD1PC63 with RULES_2

using standard test methods for flammable also have flammability limits Developmental Toxicity Risk
determining flash point, such as the (for example, methylene chloride, Assessment; U.S. EPA, 1995b.
American Society for Testing and HCFC–141b, and methyl chloroform). If Benchmark Dose guidelines; U.S. EPA,
Materials (ASTM) D 92 open cup, the concentration of vapor of such a 1996. Guidelines for Reproductive
ASTM D56 Tag closed cup, and ASTM solvent falls between the upper and Toxicity Risk Assessment).

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30148 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

In the June 2003 NPRM, EPA al., 2002, NTP, 2003; Sohn et al. 2002, AEL. These documents assigned
proposed that an exposure limit of 25 Wang et al., 2003). uncertainty factors in a manner
ppm would be protective of a range of • Case reports of nPB exposure in the inconsistent with EPA’s guidance. This
effects observed in animal and human workplace indicate that severe, possibly would result in a higher AEL than we
studies, including reproductive and irreversible, neurological effects may would determine following the
developmental toxicity, neurotoxicity, occur at sustained concentrations of approach EPA has used on other
and hepatotoxicity. Reduction of sperm approximately 100 ppm or greater (Beck chemicals, as well as an AEL that in our
motility in rats, noted across multiple and Caravati, 2003; Majersik et al., 2004; view would not sufficiently protect
studies at relatively low exposures, was Majersik et al., 2005; Ichihara et al., human health from nPB’s effects
determined to be the most sensitive 2002; Miller, 2005; Raymond and Ford, because of multiple sources of
effect. The Agency derived an exposure 2005). In other cases, similar or higher uncertainty in available data (i.e.,
limit of 18 ppm from a dose response concentrations up to 170 ppm caused variability within the working
relationship in male rat offspring (‘‘F1 less severe nervous system effects population and differences between
generation’’) whose parents were (Nemhauser, 2005; NIOSH, 2003a; animals and humans in how nPB affects
exposed to nPB from prior to mating Ichihara, 2004a). Some neurological the reproductive system).
through birth and weaning of the litters effects occurred in workers at levels of • TERA (2004) reviews other AEL
(WIL Research Laboratories, 2001). We less than 50 ppm (Ichihara et al., 2004b). derivations for nPB, performs a
then proposed to adjust this value Because of design and methodological benchmark dose (BMD) analysis, and
upwards to 25 ppm based on principles limitations, such as small numbers of recommends an AEL of 20 ppm based
of risk management consistent with one subjects and limited exposure on live litter size. This document is
of the original ‘‘Guiding Principles’’ of information, these studies do not consistent with EPA guidance for BMD
the SNAP program (59 FR 13046, March provide a sufficient quantitative basis to modeling and for assigning uncertainty
18, 1994). As we discussed in the June derive an acceptable exposure limit. factors. A review of this document is
2003 NPRM, EPA noted that adhesives • Data on female rats indicate that available in the public docket (ICF,
users should be able to achieve an AEL nPB affects the maturation of ovarian 2004b).
of 25 ppm and that 25 ppm was between follicles and the ovarian cycle (Yamada • ICF (2004c, 2006b) derived an AEL
the level based on the most sensitive et al., 2003), consistent with previously for nPB based upon female reproductive
endpoint (sperm motility in the F1 reviewed data (WIL, 2001; Sekiguchi et effects. ICF (2004c, 2006b) discussed the
offspring generation) and the second al., 2002). relevant literature (Ichihara et al., 1999,
most sensitive endpoint (sperm motility • Some data on occupation exposure 2002, 2004a, 2004b; Sekiguchi, 2002;
in the F0 parental generation). suggest that workers exposed to nPB Yamada et al., 2003; WIL, 2001) and
calculated mean estrous cycle length
Following SNAP program principles, we may have experienced menstrual
and the mean number of estrous cycles
noted that ‘‘a slight adjustment of the disorders (Ichihara et al., 2002; Ichihara
occurring during a three-week period at
AEL may be warranted after applying et al., 2004b). However, the data are not
different exposure levels in the WIL,
judgment based on the available data statistically significant and are not
2001 2-generation study. ICF (2004c,
and after considering alternative sufficient to conclude that nPB exposure
2006a) found statistically significant
derivations’’ (69 FR 33295). We stated caused these female reproductive
reductions in the number of estrous
further that ‘‘18 ppm is a reasonable but effects.
cycles in a three-week period, both
possibly conservative starting point, and • Data on DNA damage in workers
including and excluding females that
that exposure to 25 ppm would not pose exposed to nPB was not statistically
had stopped their estrous cycles, at 250,
substantially greater risks, while still significant (Toraason et al., 2006). 500, and 750 ppm in the F0 parental
falling below an upper bound on the • Metabolic data on mice and rats generation and at 500 and 750 ppm in
occupation[al] exposure limit.’’ indicate some species differences. the F1 generation. ICF (2004c, 2006a)
As part of this final rulemaking, the Metabolism of nPB appears to be conducted BMD modeling and
Agency has reviewed both information primarily through cytochrome P450 calculated benchmark dose lowerbound
available at the time of the 2003 NPRM enzymes, particularly in mice; (BMDL) values of the number of estrous
related to the health risks associated glutathione conjugation also plays a cycles in a three-week period that varied
with nPB use, as well as more recent role, and a bigger role for rats than for from 102 to 208 ppm, depending upon
case studies of nPB exposures and mice (RTI, 2005). the model used and the benchmark
effects in the workplace, newly These more recent studies do not cause criteria selected. All data were
published toxicological studies, us to change our acceptability calculated based on the mean
comments to the NPRM, new risk determination for solvent cleaning. reductions in estrous cycle number
assessments on nPB, and a new In addition, we considered new calculated from the WIL, 2001 study.
threshold limit value (TLV) issued by evaluations of the toxicity of nPB from Values were calculated for the F0
the American Council of Government Stelljes and Wood (2004), Toxicological generation; the number of data for the
and Industrial Hygienists (ACGIH). The Excellence in Risk Assessment (TERA, F1 generation was too small for
new information is reviewed in greater 2004), ICF (2004a, 2006a), and the TLV statistical analysis. The BMDLs that ICF
detail in EPA’s proposal specific to the documentation from the ACGIH calculated for the number of estrous
use of nPB in aerosol solvents, (ACGIH, 2005). cycles in a three-week period were 162
adhesives, and coatings. • Stelljes and Wood (2004) is similar ppm and 208 ppm, depending on the
Some general conclusions we draw in its results to SLR International (2001), benchmark response criteria (10%
from the new studies include: a study by the same authors. EPA change in response vs. one standard
• New data from toxicological studies previously reviewed SLR International, deviation) and using a linear-
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on nervous system effects remain 2001 in developing the June 2003 heterogeneous model.
inconsistent and equivocal concerning NPRM. Both these studies concluded • The ACGIH issued a recommended
the level at which nervous system with a recommended AEL of 156 ppm, TLV of 10 ppm (time-weighted average)
effects occur (Fueta et al., 2002; Fueta et based on male reproductive effects and for nPB (ACGIH, 2005). ACGIH
al., 2004; Honma et al., 2003; Ishidao et uncertainty factors of 1 in driving the summarized numerous studies showing

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different effects of nPB and identified from one litter in this study and the complete body of literature as
no observed effect levels (NOELs) of 200 calculated a BMDL greater than 300 several studies discussing neurotoxicity
ppm for hepatotoxicity (ClinTrials, ppm for this endpoint after removing and female reproductive effects were
1997b) and less than 100 ppm for those outlier data (CERHR, 2002a, omitted from the list of references. A
developmental toxicity, as evidenced by 2003a, and 2004a). TERA calculated a number of reviews of this document are
decreased fetal weight (Huntingdon Life BMDL similar to that of the CERHR available in the public docket (ICF,
Sciences, 2001). expert panel when analyzing the same 2004d; O’Malley, 2004). Despite some
The Occupational Safety and Health data set (TERA, 2004). Further, the flaws in its derivation, the TLV of 10
Administration (OSHA) has not reference list in the documentation on ppm is less than two-fold lower than the
developed a permissible exposure limit the TLV indicates that ACGIH did not low end of the range of acceptable
(PEL) for nPB that EPA could use to review and evaluate all the studies exposure levels based on the most
evaluate toxicity risks 5 from workplace available prior to the development of sensitive reproductive endpoints (see
exposure. In prior SNAP reviews, EPA the recommended exposure limit. For below). This small difference is well
has used ACGIH TLVs where available example, key supporting articles that within the uncertainty we see when
in assessing a chemical’s risks and reported disruption of estrous cycles extrapolating a benchmark dose from an
determining its acceptability if OSHA (Yamada et al., 2003 and Sekiguchi et experimental study in rats to an
has not set a PEL. ACGIH is recognized al., 2002) were not discussed in the TLV occupational exposure limit in humans.
as an independent, scientifically documentation. Further, ACGIH did not We summarize the data for a number
knowledgeable organization with provide sufficient reasoning for the of end points found in these analyses in
expertise in issues of toxicity and selection of the chosen endpoint over Table 4 below. We examined these data
industrial hygiene. However, in this others (e.g., reproductive toxicity and/or to assess the acceptability of nPB use in
case, EPA believes that ACGIH’s TLV for neurotoxicity). The lack of discussion of the metals, electronics, and precision
nPB of 10 ppm has significant applied uncertainty factors also cleaning end uses reviewed in this final
limitations as a reliable basis for an prevents a determination of how ACGIH rule. These data indicate that, once
acceptable exposure limit, especially arrived at a TLV of 10 ppm. In uncertainty factors are applied
given the availability of other, more summary, EPA is not basing its consistent with EPA guidelines, the
comprehensive analyses described in proposed acceptability determination lowest levels for acceptable exposures
this preamble. First, according to the for nPB on the ACGIH TLV because: (1) would be derived for reproductive
authors of the Huntingdon Life Sciences Other scientists evaluating the database effects.6 The data also indicate that a
study, the decrease in fetal weight was for nPB did not find the reduced pup level sufficient to protect against male
an artifact of sampling procedure that weight to be the most sensitive reproductive effects (e.g., reduced sperm
biased the data (test animals were only endpoint; (2) BMD analysis of the motility) would be in a range from 18
sacrificed at the end of the day rather reduced pup weight data (CERHR, to 30 ppm, in the range of 17 to 22 ppm
than at random). The Center for the 2002a; TERA, 2004) results in a higher to protect against female reproductive
Evaluation of Risks to Human BMDL (roughly 300 ppm) than those for effects (e.g., estrous cycle length), and at
Reproduction (CERHR) expert panel sperm effects and estrous cycle changes; approximately 20 ppm for effects related
excluded ‘‘aberrantly low’’ fetal weights and (3) ACGIH may not have reviewed to reproductive success (live litter size).

TABLE 4.—SUMMARY OF ENDPOINTS USING BENCHMARK RESPONSE MODELING


Human
equivalent
BMDLb concentra-
Endpoint a Study (ppm) tion
(HEC)c
(ppm)

Liver Effects d

Liver vacuolation in males (F1 off- WIL, 2001 as analyzed in ICF, 2002 .............................................................. 110 116
spring generation).
Liver vacuolation in males (F0 parent WIL, 2001 as analyzed in ICF, 2002 .............................................................. 143 150
generation).
Liver vacuolation ................................ ClinTrials, 1997b as analyzed in ICF, 2002 and Stelljes & Wood, 2004 ....... 226 170

Reproductive Effects—Male

Sperm motility (F1 offspring genera- WIL, 2001 as analyzed in ICF, 2002 .............................................................. 169 177
tion).
WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 156 164
Sperm motility (F0 parent generation) WIL, 2001 as analyzed in ICF, 2002 .............................................................. 282 296
WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 263 276
Prostate weight (F0 parent genera- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 190 200
tion).
Sperm count ....................................... Ichihara et al., 2000b as analyzed in Stelljes & Wood, 2004 ........................ 232 325
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5 Vendors of nPB-based products have 6 By EPA guidelines, we would apply an necessarily screen out an individual from being able
recommended a wide range of exposure limits, from uncertainty factor of √10, or approximately 3, for to work, unlike for liver or nervous system effects.
5 ppm to 100 ppm (Albemarle, 2003; Chemtura, differences between species for all health effects. Therefore, for reproductive and developmental
2006; Docket A–2001–07, item II–D–19; Enviro We would also apply an uncertainty factor of √10 effects, we use a composite uncertainty factor of 10.
(3) for variability within the working population for
Tech International, 2006; Farr, 2003; Great Lakes See further discussion of uncertainty factors in
reproductive and developmental effects, because,
Chemical Company, 2001). among other reasons, these conditions would not section V.B.3 below.

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TABLE 4.—SUMMARY OF ENDPOINTS USING BENCHMARK RESPONSE MODELING—Continued


Human
equivalent
BMDLb concentra-
Endpoint a Study (ppm) tion
(HEC)c
(ppm)

Sperm deformities (F0 parent genera- WIL, 2001 as analyzed in Stelljes & Wood, 2004 .......................................... 296 311
tion).

Reproductive Effects—Female

Number of estrus cycles during a 3 WIL, 2001 as analyzed in ICF, 2006a ............................................................ 162 170
week period (F0 parent generation).
WIL, 2001 as analyzed in ICF, 2006a ............................................................ 208 218
Estrous cycle length (F1 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 400 420
generation) d.
Estrous cycle length (F0 parent gen- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 210 220
eration) e.
No estrous cycle incidence (F1 off- WIL, 2001 as analyzed in TERA, 2004 .......................................................... 180 189
spring generation).
No estrous cycle incidence (F0 parent WIL, 2001 as analyzed in TERA, 2004 .......................................................... 480 504
generation).

Reproductive Effects—Reproductive Success

Decreased live litter size (F1 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 190 200
generation).
Decreased live litter size (F2 offspring WIL, 2001 as analyzed in TERA, 2004 .......................................................... 170 179
generation).
Pup weight gain, post-natal days 21 WIL, 2001 as analyzed in TERA, 2004 .......................................................... 180 189
to 28 (F1 offspring generation).

Developmental Effects

Fetal body weight ............................... WIL, 2001 as analyzed in TERA, 2004 .......................................................... 310 326
Fetal body weight ............................... WIL, 2001 as analyzed in CERHR, 2002a ..................................................... 305 320

Nervous System Effects

Hindlimb strength ............................... Ichihara et. al., 2000a as analyzed in Stelljes and Wood, 2004 ................... 214 300
a Unless explicitly stated, data are from a parental generation. Of the studies analyzed, only the WIL, 2001 study has multiple generations to
be analyzed.
b The benchmark response value represents a specified level of excess risk above a control response.
c When considering workplace exposures, the human equivalent concentration is the BMDL, adjusted to apply to a 40-hour work week in which
workers are exposed for 8 hours a day for five days per week. Animals in the WIL, 2001 study were exposed for 6 hours a day, 7 days a week.
Animals in the Ichihara, 2000a and 2000b studies were exposed for 8 hours a day, 7 days a week. Animals in the ClinTrials, 1997b study were
exposed for 6 hours a day, 5 days a week.
d After applying an uncertainty factor of 3 for animal to human extrapolation, acceptable levels of exposure to protect against liver effects would
be in the range of 39 to 57 ppm.
e Omits data from those animals that have stopped estrous cycling altogether (TERA, 2004).

These more recent evaluations do not Based on review of the previously 1. Workplace Risks
change EPA’s acceptability available information and information
determination for solvent cleaning. As submitted in comments to the NPRM, EPA believes that the great majority of
discussed below, users of solvent the Agency believes that its derivation users of nPB in metals cleaning,
cleaning equipment are reliably able to of 18 ppm as a starting point in the electronics cleaning, and precision
achieve exposure levels well below our development of a recommended cleaning have been able to attain
acceptable exposure level is still valid. exposure levels of well below 25 ppm,
proposed AEL of 25 ppm in the June
For purposes of assessing the the proposed AEL in the 2003 NPRM,
2003 NPRM and therefore we expect
acceptability of nPB use in solvent with their existing equipment. Recently
nPB users in the metals, electronics, and
cleaning applications, the Agency measured exposure levels for nPB are
precision cleaning end uses to be able much lower than historic exposure data
evaluated whether exposure levels
to achieve acceptable exposure levels. from the 1970s and 1980s for metals
expected to result from solvent cleaning
Concentrations of nPB emitted from would approach either the 2003 cleaning and electronics cleaning (ICF,
industrial solvent cleaning equipment proposed recommended AEL of 25 ppm, 2006a); this reflects both improvements
were found to be below 25 ppm in or the more conservative starting point in industrial hygiene practices and
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roughly 88% of 500 samples on an 8-hr of 18 ppm which was derived from the improvements in cleaning equipment
time-weighted average, below 18 ppm in Agency’s original risk analysis. We also since 1994 spurred by the National
81% of these samples, and below 10 evaluated any potential risks to the Emission Standard for Hazardous Air
ppm in roughly 70% of these samples general population associated with nPB Pollutants for Halogenated Solvent
(U.S. EPA, 2003). use as a solvent. Cleaning (59 FR 61801). Concentrations

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of nPB emitted from industrial solvent adhesives would have exposures below uses. Another commenter stated that
cleaning equipment were found to be the community exposure guideline of nPB is dangerous to the ozone layer and
below 25 ppm in roughly 88% of 500 1 ppm (68 FR 33300–33301). The workers and urged EPA to find a safe
samples on an 8-hr time-weighted community exposure guideline was substitute.
average, below 18 ppm in 81% of these derived considering both sperm motility Response: EPA believes nPB may be
samples, and below 10 ppm in roughly and liver effects in the WIL (2001) 2- found acceptable under the SNAP
70% of these samples (U.S. EPA, 2003). generation study using EPA’s reference program only in those end uses where
One nPB supplier provided evidence concentrations (RfC) guidelines (U.S. it has been shown to be used safely, as
that on the few occasions when nPB EPA, 1994b). Since the general compared with other substitutes that are
concentrations from vapor degreasers population would not be exposed in currently or potentially available. We
were higher than the company’s excess of the community exposure find this to be the case for metals
recommended AEL of 25 ppm, users guideline from a highly emissive cleaning, electronics cleaning, and
were able to reduce exposure easily and application, the less emissive uses such precision cleaning.
inexpensively by changing work as metals, electronics, and precision Comment: Several commenters agreed
practices, such as reducing drafts near cleaning would create insignificant with EPA’s proposed approval for nPB
the cleaning equipment (Kassem, 2003). exposures (well below 1 ppm). Thus, we in metal cleaning, electronics cleaning,
The ability to meet the workplace believe that proper use of nPB in solvent and precision cleaning end uses. One
exposure limit depends on: (1) The cleaning would not pose measurable specifically reported that his company’s
features of the cleaning equipment used, risks to the general population. industrial hygiene program for nPB-
such as the presence of secondary based solvents in metal and electronics
cooling coils; and (2) the work practices, V. How is EPA responding to comments cleaning has conducted extensive air
such as avoiding drafts near cleaning on the June 2003 NPRM? sampling, and that the majority of the
equipment and lifting cleaned pieces In this section, EPA responds to samples have shown values well below
out slowly from the cleaning equipment. comments on the major issues in the 25 ppm. This commenter also noted
Workplace controls could include, but June 2003 NPRM. A complete response that, in those few workplaces where
are not limited to, the use of the to comments is in docket EPA–HQ– higher levels were found, adoption of
following: Covers on cold-cleaning and OAR–2002–0064. recommended workplace ventilation
vapor degreasing equipment when not and handling practices produced
A. EPA’s Acceptability Decision
in use; devices to limit air movement acceptable subsequent sample values.
over the degreaser; and/or a lip-vent There was no consensus among Thus, this commenter believes that
exhaust system to capture vapors and commenters about whether EPA should exposures can be controlled to
vent them out of the room. Training find nPB acceptable, acceptable subject protective levels.
workers in industrial hygiene practices to use conditions, or unacceptable in the One commenter expressed concerns
and in the proper use of cold cleaning various end uses listed in the proposal. over the approval of nPB as acceptable
and vapor degreasing equipment, as Some commenters raised concerns for use in solvent cleaning, maintaining
well as warning workers of the about specific end uses, particularly that toxicity data is insufficient to be
symptoms that may occur from over- aerosols and adhesives. Others convincing that long-term effects will
exposure to nPB, will also help reduce supported finding nPB acceptable in not be a concern. Two other
exposure. Therefore, we expect that solvents cleaning and in adhesives. We commenters did not support EPA’s
users of nPB in the solvent cleaning are not taking final action in this rule proposal to find nPB acceptable. One of
sector following typical industry with respect to nPB as a substitute in the commenters concurred with EPA
practices and using typical equipment aerosols or adhesives. We will respond that exposures from manual wipe
for vapor degreasing will continue to to any comments regarding those end cleaning will not be acceptable and that
meet acceptable exposure levels and to uses at the time we take final action for nPB should not be used in such
use nPB safely without regulatory aerosols and adhesives. operations. Another commenter
requirements. This is the approach the Comment: Several commenters opposed EPA’s proposed acceptability
SNAP program has taken with many supported EPA’s proposed approval of determination for solvent cleaning,
other solvents where users are readily nPB under the SNAP program in various stating that use of nPB in applications
able to meet workplace exposure limit end uses. In contrast, two commenters such as electronics and metals cleaning,
that will protect human health and there opposed EPA’s proposed acceptability label removal, and spray cleaning is not
is no enforceable OSHA PEL (e.g., HFC– determination in all end uses, including appropriate.
365mfc, HFC–245fa, solvent cleaning, citing concerns about Response: EPA agrees with those
heptafluorocyclopentane, ketones, exposure and the toxicity of nPB. commenters who said nPB should be
alcohols, esters, hydrocarbons, etc.). Another commenter stated that acceptable for use in metal cleaning,
Based on the available exposure data applications cited in the proposal (e.g., electronics cleaning, and precision
and current industry practices, EPA electronics and metals cleaning, label cleaning. By our definition of the
believes that users of nPB as an removal and spray cleaning) are not solvent cleaning sector, such users are
industrial solvent for metals cleaning, suitable for use of nPB. This commenter cleaning using industrial cleaning
electronics cleaning, and precision reasoned that if nPB provides unique equipment. For an organic solvent, this
cleaning are likely to be exposed to performance characteristics, its uses means a vapor degreaser or an
concentrations of nPB well below the should be limited to non-emissive and automated cold cleaning machine.
proposed AEL of 25 ppm from the 2003 low-volume applications. A commenter Emissions from vapor degreasers can be
NPRM. from a company that markets nPB as a controlled both through improving
chemical intermediate but not as a equipment (increasing the freeboard,
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2. General Population Risks solvent, noted that his company adding cooling coils, or adding a lift that
In the 2003 NPRM, the Agency recognizes the health concerns raises cleaned pieces slowly) and
provided analyses demonstrating that associated with nPB, and thus his through improved work practices
people living in the immediate vicinity company continues to prohibit the sale (leaving the vicinity of the vapor
of a facility using nPB in spray of nPB to customers with dispersive degreaser when done with work, tipping

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work-pieces so they do not catch relevant. Other studies examining Others stated that sperm motility effects
solvent, or lifting cleaned pieces out neurological effects of nPB showed on the F1 generation are appropriate to
slowly). those effects to be transient and consider (Risotto, 2003; Farr, 2003),
In solvent cleaning equipment, reversible at and above 200 ppm particularly because of the potential for
exposure data show that nPB can meet (Ichihara et al., 2000a). Exposures of 200 in utero effects and because of the
an exposure level well below 25 ppm, ppm and above for three weeks had no consistent presence of these
even at levels of 5 ppm or less, the effect on memory, learning function, or reproductive effects in both generations
majority of the time (U.S. EPA 2003; coordination of limbs (Honma, 2003); and at multiple levels.
ICF, 2006a). Concentrations of nPB the effect of spontaneous locomotor Response: EPA is not finalizing a
emitted from industrial solvent cleaning activity seen in this study at 50 ppm specific AEL for the purposes of this
equipment were measure to be below 25 and above was not considered adverse final rule. EPA acknowledges that using
ppm in roughly 88% of more than 500 by the authors. In other studies, data from the F1 offspring generation
samples, below 18 ppm in 81% of these neurological effects were absent after may be conservative because the pups
samples, and at or below 5 ppm in 56% extended periods of exposure—after 28 in the F1generation were exposed to
of these samples (U.S. EPA, 2003). In days of exposure at concentrations > nPB between weaning and sexual
cases where exposure levels are higher, 400 ppm (ClinTrials, 1997a) and after 90 maturity (WIL, 2001). During
there are simple, cost-effective changes days of exposure at concentrations up to occupational exposure, this period of
that can be made to reduce emissions 600 ppm (ClinTrials, 1997b). Thus, exposure would not occur because
(Kassem, 2003). We agree that manual although neurological effects have been children under age 16 are not allowed
cleaning using nPB is inappropriate, associated with nPB exposure, the data to work in industrial settings. However,
because of the difficulty of controlling are currently insufficient to quantify EPA believes that because of the
emissions, but manual cleaning is and set an AEL based on this endpoint. potential for in utero effects that would
currently beyond the scope of the SNAP More recent data does not change EPA’s only be seen in the offspring generation,
Program. EPA plans to address spray acceptability determination for solvent looking only at the F0 parental
cleaning using aerosols in a new cleaning. generation could underestimate the
proposal. Comment: One commenter on the adverse health impacts of a chemical.
June 2003 NPRM requested that EPA Therefore, it was appropriate for us to
B. Toxicity evaluate a study by Yamada et al (2003), consider effects seen in both the F0
1. Health Endpoints a study published just prior to the June parental generation and the F1 offspring
2003 NPRM. generation. Further, effects on sperm
Comment: A number of commenters Response: EPA reexamined Yamada et motility in the parental and offspring
on the June 2003 NPRM suggested that al., 2003 and re-evaluated the literature generations are seen at levels generally
EPA should consider neurotoxicity as (Ichihara et al., 1999, 2002, 2004a,b; consistent with multiple reproductive
the endpoint in deriving the AEL for Sekiguchi, 2002, Yamada et al., 2003; effects seen in both generations and
nPB (Linnell, 2003; Werner, 2003; WIL, 2001). Multiple benchmark both sexes exposed to nPB, such as
Rusch and Bernhard, 2003; Rusch, analyses found a statistically significant estrous cycle length, lack of estrous
2003). In particular, they requested that decrease in the number of estrous cycles cycling, the number of estrous cycles in
EPA consider the study conducted by and increase in estrous cycle length a given period of time, fertility indices,
Wang (2003) and epidemiological data associated with nPB exposure, and the number of live pup births
on neurotoxic effects of nPB. consistent with other reproductive (TERA, 2004; ICF, 2006a; SLR
Response: Recent data collected from endpoints, namely reductions in sperm International, 2001).
occupational settings indicate that motility, decreased live litter size, and We also note that different substances
severe, possibly irreversible, change in prostate weight (ICF, 2002a; have different toxicological effects and
neurological effects may occur at ICF, 2006a; Stelljes and Wood, 2004; those effects must be considered based
sustained concentrations of TERA, 2004). These more recent on the best scientific information and
approximately 100 ppm or greater (Beck evaluations, which could lead to an methodologies available. It is incorrect
and Caravati, 2003; Majersik, 2004; HEC of 170 ppm and an AEL of 17 ppm, to claim that such reviews, which focus
Majersik, 2005), with variability in do not change EPA’s acceptability on the effects of different substances,
effects observed in different studies, determination for solvent cleaning, resulted in disparate treatment of nPB 7.
although in most cases exposures may since the evidence supports the ability
have been much higher. Other studies of users in this end use to consistently 2. Adjustments to Acceptable Exposure
with human data are discussed above in meet such a level. Level Based on Risk Management
section IV.E. Because of design and Comment: Some commenters stated Principles
methodological limitations, such as that data from the F1 generation is In the 2003 NPRM, EPA derived 18
small numbers of subjects and limited inappropriate for calculating ppm as the starting point for an
exposure information, none of the occupational exposure, citing acceptable exposure level based on
recent studies individually provides a statements from some toxicologists that reduced sperm motility in the offspring
sufficient quantitative basis to derive an use of effects on adult F1 generation generation of animals exposed to nPB
AEL. animals is inappropriate. They also (WIL, 2001). Following a SNAP program
In the study on rats by Wang et al. stated that EPA has not required this for principle that alternatives should be
(2003), measurements found a decrease other chemicals and that the resulting restricted only where it is ‘‘clearly more
in enzymes in the spinal cord and brain value is more conservative than what is harmful to human health and the
at 200, 400, and 800 ppm, but the normal and appropriate for industrial
animals displayed no physical or toxicology (Morford, 2003d and e;
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7 We interpret the commenter’s use of the term

behavioral changes. Because of the lack Ruckriegel, 2003). One commenter ‘‘equal protection’’ to mean that the commenter
of physical symptoms or behavioral claims that because EPA’s review of nPB beleives that EPA has performend a harsher review
of nPB than it has for other substitutes and not a
changes, EPA does not believe that the differed from EPA’s review of other claim that EPA has violated the 14th Amendment
decrease in enzyme levels in the central SNAP alternatives, the process violates of the Constitution, which applies only to the states
nervous system are toxicologically equal protection (Morford, 2003d and e). and not the Federal Government.

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environment than other alternatives,’’ uncertainty factors of up to 10 may be recommended with default dosimetric
we noted that ‘‘a slight adjustment of applied to the ‘‘human equivalent adjustments.’’ (U.S. EPA, 1994b, p. 4–
the AEL may be warranted after concentrations (which accounts for 73). By EPA RfC guidelines (US EPA,
applying judgment based on the worker exposure patterns of 8 hours per 1994b), no adjustment for differences in
available data and after considering day for 5 days a week), for each of the pharmacokinetics is necessary in this
alternative derivations’’(69 FR 33294, following conditions: instance because the blood/air partition
33295). The Agency proposed an (1) Data from animal studies are used coefficient 10 for nPB in the human (7.1)
upward adjustment of the AEL to 25 to estimate effects on humans; is less than in the rat (11.7), indicating
ppm based on principles of risk (2) Data on healthy people or animals that the delivered dose of nPB into the
management, and based, among other are adjusted to account for variations in bloodstream in rats is slightly higher
things, on a determination that 25 ppm sensitivity among members of the than in humans. EPA has seen no data
was between the level based on the most human population (inter-individual to indicate that (1) the toxicity is not
sensitive endpoint (sperm motility in variability); directly related to the inhaled parent
the F1 offspring generation) and the (3) Data from subchronic studies are compound in the arterial blood, or that
second most sensitive endpoint (sperm used to provide estimates for chronic (2) the critical metabolic pathways do
motility in the F0 parental generation). exposure; not scale across species, with respect to
We stated further that ‘‘18 ppm is a (4) Studies that only provide a LOAEL body weight, in the same way as the
reasonable but possibly conservative rather than a NOAEL or BMD; or ventilation rate. Consistent with
starting point, and that exposure to 25 (5) An incomplete database of toxicity Appendix J of EPA’s RfC guidelines for
ppm would not pose substantially information exists for the chemical. an inhaled compound that exerts its
greater risks, while still falling below an Comment: Some commenters on the effects through the bloodstream, EPA
upper bound on the occupation[al] June 2003 NPRM stated that EPA should applies an uncertainty factor of 1 for
exposure limit.’’ use an uncertainty factor of 1 or 2 to pharmacokinetics and an uncertainty
Comment: Commenters responded extrapolate from animals to humans factor of 3 for differences between
that: (1) The SNAP program does not (Weiss Cohen, 2003), while others animals and humans.
create a presumption in favor of suggested uncertainty factors of 2 or 3 Recent studies provide additional
substances that are already available on for pharmacokinetics, or an overall data regarding metabolism of nPB in rats
the market, especially where other uncertainty factor of 10 for rat to human and mice (RTI, 2005), but data on
alternatives exist (Linnell, 2003; extrapolation because of a lack of human metabolism are still lacking. One
Werner, 2003); (2) EPA’s AEL derivation information on the metabolism and analysis of these metabolic data
of 18 ppm is not conservative enough mode of action of nPB and because the suggested that mice are less sensitive to
(Werner, 2003; Risotto, 2003) and rat is an insensitive model for effects on the effects of nPB than rats and
further adjustment upward further male reproduction in humans (Werner, hypothesized that humans would also
reduces protection; (3) the data do not 2003; Rusch and Bernhardt, 2003). be less sensitive than rats (Stelljes,
support adjusting the AEL upward Response: EPA believes that two 2005). This analysis makes numerous
(EPA–HQ–OAR–2002–0064–0003); (4) uncertainty factors are appropriate for assumptions about toxic nPB
EPA should first use the same this database to account for (1) metabolites and metabolic activation
methodology in establishing an AEL as physiological differences between pathways that have not been confirmed
for other chemicals to ensure that the humans and rats; and (2) variability by experimental data. A review of this
program’s guiding principle in within the working population. EPA RfC analysis is available in the public docket
comparing risks is not compromised guidelines state that an uncertainty (ICF, 2006c). Despite the difference in
(Werner, 2003); and (5) EPA should factor of 10 may be used for potential metabolic pathways for nPB in mice and
reconsider whether industrial exposures differences between study animals and rats (RTI, 2005), EPA finds no
consistently occur or can be controlled humans. This factor of 10 consists in significant species-specific differences
at 25 ppm (Werner, 2003). No turn of two uncertainty factors of 3—the in toxicity exist between rats and mice
commenters specifically supported first to account for differences in at inhaled concentrations <500 ppm for
adjusting the AEL upward. pharmacodynamics8 and the second to 13 weeks (NTP, 2003; ICF, 2006c).
Response: EPA is not finalizing a account for differences in However, these metabolic and
specific AEL for the purposes of this pharmacokinetics9 between the study subchronic inhalation studies
final rule. In a separate proposed animal and humans. (The value of three conducted under the National
rulemaking for the aerosol, adhesive and is the square root of 10 rounded to one Toxicology Program did not specifically
coatings end uses, we will be providing digit, with 10 representing an order of examine for reproductive toxicity or
the public an opportunity to comment magnitude [EPA,1994a, pp. 1–6, 4–73]. nPB metabolism in target organs that
on a range of exposure level values that In practice, EPA uses the square root of control reproductive function. In
are comparable to the levels discussed 10 when there are two or four summary, there is little available data
in the June 2003 proposal (69 FR 33295) uncertainty factors of 3, yielding a total about the metabolic activation or
that the Agency would consider to be uncertainty factor of 10 or 100, and we reactive metabolites responsible for
acceptable. Because we have concluded use a value of 3 when multiplying by reproductive toxicity in rodents.
that end users in the solvent sector are other uncertainty factors.) In general, Similarly, for nPB, there is little
routinely able to meet even the lowest EPA’s RfC guidelines state that for the information available about differences
exposure level we considered uncertainty factor extrapolating from and similarities between rodents and
recommending (U.S. EPA, 2003), we do animal to human data, ‘‘Use of a 3 is humans. Given this circumstance, EPA
not need to make a final determination assumes, in the absence of evidence to
as to the appropriate level for purposes 8 Pharmacodynamics refers to the biochemical
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and physiological effects of chemicals in the body


the contrary, that nPB toxicity is
of this rulemaking. directly related to the inhaled parent
and the mechanism of their actions.
3. Uncertainty Factors 9 Pharmacokinetics refers to the activity or fate of

chemicals in the body, including the processes of 10 The blood/air partition coefficient is the ratio
According to EPA risk assessment absorption, distribution, localization in tissues, of a chemical’s concentration between blood and air
guidance for RfC (EPA 1994a), biotransformation, and excretion. when at equilibrium.

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30154 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

compound in the arterial blood and that factors in the past to protect sensitive default value for an uncertainty factor
the critical metabolic pathways scale subpopulations on other chemicals where there is indication that a value
across species in a manner similar to the reviewed under the SNAP program (e.g., less than an order of magnitude (10) but
ventilation rate (U.S. EPA, 1994b). trifluoroiodomethane at 60 FR 31092, 61 greater than one is appropriate, and
Therefore, the Agency applied an FR 25585 and IoGasTM Sterilant Blends where the available data are not
uncertainty factor of 1 to account for at 69 FR 58903). For deriving AELs from sufficiently quantified to select a
interspecies differences in health endpoints such as liver effects specific value.
pharmacokinetics. and neurotoxicity, the SNAP program
Given the available data on the blood/ 4. Other Analyses of nPB’s Toxicity
typically has assigned an uncertainty
air partition coefficient and EPA RfC factor of 1 for sensitive subpopulations Comment: One commenter stated that
guidance in the absence of other because we assume that individuals documents by Drs. Doull, Rozman,
information, EPA is applying the same who are especially susceptible to these Stelljes, Murray, Rodricks, and the KS
rationale used for other compounds effects will have greater difficulty Crump Group were not acknowledged
reviewed under EPA’s SNAP program working than most people. However, (Morford, 2003d,e, and f). Another
with a comparable amount of data there is no connection between the commenter requested that EPA take into
where an uncertainty factor of 1 for ability to reproduce and the ability to account the scientific presentations
pharmacokinetics was applied. To work in the industrial sectors discussed presented by Drs. Doull, Rozman and
account for uncertainty in in this rule. Thus, we find it appropriate Stelljes and mentions a review by Dr.
pharmacodynamics of nPB, EPA is to require an uncertainty factor greater Rodricks (Weiss Cohen, 2003).
applying the default uncertainty factor than 1 for reproductive effects for Response: EPA specifically mentioned
of 3. This follows the procedures in variability within the working and responded to the occupational
EPA’s RfC guidelines for situations population. exposure limit recommendations from
where there are no data to compare Comment: Some commenters said that Drs. Rozman, Doull, and Stelljes in the
pharmacodynamics in rats versus an uncertainty factor of 1 is appropriate preamble to the June 2003 NPRM at 68
humans (U.S. EPA, 1994b). Recently for variability within the working FR 33298–33299. In addition, EPA
published data on humans and rodents population because sensitive included more detailed written
do not decrease the uncertainty subpopulations will not be present in responses to these derivations and the
regarding the pharmacodynamics of the working population (Stelljes, 2003, evaluation by Dr. Rodricks in the online
nPB; therefore, modification of the Morford, 2003e). Other commenters docket prior to proposal (EPA–HQ–
uncertainty factor of 3 for differences stated that there will be very little OAR–2002–0064–0017, –0018, and
between species was not justified. difference in variability between the –0019). Here are abbreviated responses
Comment: One commenter stated that worker population and the general to the various documents cited by the
EPA did not cite any data that describes population and that it is unclear why commenter:
the size, condition, or existence of a EPA selected an uncertainty factor of 3 • Drs. Doull and Rozman’s letter
subpopulation of men especially instead of 10 (Werner, 2003). dated August 24, 2001, stating that a
sensitive to the effects of nPB. In Commenters suggested uncertainty two-generational reproductive study is
addition, this commenter asserted that factors for variability in the working not appropriate (Docket A–2001–07,
sensitive populations are not population of 1, 2, and 5 (Stelljes, 2003, item II–D–26)—Drs. Doull and Rozman
traditionally considered when deriving Weiss Cohen, 2003, Werner, 2003). do not provide a rationale for their
an OEL, and that EPA has never Response: EPA disagrees with the statement. Their statement is in conflict
mentioned a concern with sensitive commenters. EPA’s RfC guidelines with their AEL derivation, in which
subpopulations in previous SNAP recommend an uncertainty factor of 10 they consider use of the F1 generation
reviews. Another commenter said that to account for intraspecies variability of the WIL Laboratories two-generation
there is no evidence to support the within the general population. However, study. As discussed above in section
assertion that nPB exposure below a 100 in developing an AEL, EPA’s focus is on V.B.1, EPA believes that data from a
ppm average will further reduce sperm worker exposure, which excludes some two-generation reproductive study are
count or that the removal of nPB particularly vulnerable populations, appropriate in developing a guideline
exposure will improve sperm count. such as children, most adolescents, and for the workplace in order to assure that
Response: EPA disagrees with the the elderly. Thus, we believe that a full workers and their children are protected
comments. There are preexisting uncertainty factor of 10, as for the from any adverse health effects of
reproductive conditions as well as general population, may be higher than workplace exposure, including exposure
significant variability in fertility among necessary to protect workers. Certain in utero. We acknowledge that this
otherwise healthy adults in the individuals in the general population value may be more conservative than
workplace. Both male and female but not in the working population that considering data only from the parental
reproduction have been shown to be might be particularly vulnerable would generation.
adversely affected by aging, with effects include children and adolescents under • Drs. Doull and Rozman’s critique of
on the ovarian cycle and on sperm age 16 and individuals with immune ICF’s AEL derivation (II-D–41b)—Drs.
motility as major factors changing with deficiency disorders. However, because Doull and Rozman’s primary stated
increasing age for women and men, of variability in reproductive function reason for rejecting ICF Consulting’s
respectively (Dunson et al., 2002). due to factors present among workers, evaluation is that it does not reflect their
Adding damage from other factors, such such as aging, smoking, and sexually own AEL derivation. They reiterate that
as smoking or occupational exposure to transmitted disease (Dunson et al., they find neurotoxicity to be the
chemicals such as nPB, therefore, can 2002), and because there is no screening appropriate basis for an AEL without
potentially harm an individual’s ability of workers that would make workers addressing the reasons that ICF’s
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to reproduce further (Dunson, et al. more likely to have healthy derivation provides for finding
2002). EPA did not issue a proposal reproductive systems than non-workers reproductive toxicity to be of greater
based on sperm count, so that comment of the same age, we believe than an concern than neurotoxicity. We disagree
is not relevant to this rule. In addition, uncertainty factor of 1 is not sufficiently with Doull and Rozman’s conclusion
we note that EPA has used uncertainty protective. Under EPA guidelines, 3 is a that neurotoxicity is the more

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appropriate endpoint for several survey, selecting an endpoint of 190 EPA disagrees in part with Dr. Stelljes’s
reasons: (1) The human data are ppm. However, the data in the final reasoning. Data from F0 animals may
insufficient to draw conclusions survey were not sufficient to detect any not be sufficiently protective because
because of a small number of subjects, dose-response with any statistical effects on the F0 animals will not reflect
limited exposure information, and lack significance (Custom Products HHE, II– effects of in utero exposure. However,
of statistical significance; (2) the animal A–49). Further, more recent studies on we agree that exposure during weaning
data on neurotoxicity are inconsistent human exposure to nPB have found is not reflective of workplace exposure,
and equivocal concerning the level at neurotoxic effects occurring at levels at and thus, data from F1 animals may be
which nervous system effects occur, and least as low as 86 ppm, and possibly conservative. EPA proposed 25 ppm
they indicate that neurotoxic effects lower than 60 ppm (Ichihara 2004a, instead of 18 ppm in part to take this
may be reversible; and (3) neurotoxicity Beck and Caravati 2003). These data conservatism into account.
is a less sensitive endpoint than would indicate that an AEL of 60 to 90 • Dr. Stelljes’s (SLR International’s)
reproductive effects. However, if we had ppm is not sufficiently protective AEL derivation (II–D–13)—EPA
used neurotoxicity as the endpoint for against neurotoxic effects. Drs. Rozman discussed this AEL derivation at length
an AEL, we would have reached the and Doull themselves now suggest that in the preamble to the proposed rule at
same acceptability determination for an AEL of 25 ppm may be more 68 FR 33298. We agreed with Dr.
solvent cleaning. appropriate for protecting against Stelljes’s BMD modeling and his
The basis of EPA’s June 2003 NPRM neurotoxic effects (Rozman and Doull, selection of reduced sperm motility in
is different from either one of these 2005). the F1 offspring generation of the WIL
documents because it uses a different • Dr. Rodricks’ AEL derivation and Laboratories study as the most sensitive
endpoint from Doull and Rozman’s comments on ICF’s derivation (II–D– endpoint. However, we disagree with
derivation (2001) and an uncertainty 65)—EPA reviewed Rodricks (2002) in Dr. Stelljes’s selection of uncertainty
factor of 3 instead of 2 to 3 for developing its June 2003 NPRM, factors. There is no information showing
variability within the working although the study was not explicitly that human sex cells are less sensitive
population (Doull and Rozman, 2001; mentioned in that preamble. Rodricks to nPB than rat sex cells, and there is
ICF, 2002a). According to EPA guidance (2002) suggests an AEL of 60 to 88 ppm considerable evidence that human
on establishing uncertainty factors, if a for nPB, based on male reproductive males have less reproductive capacity
uncertainty factor is between 1 and 10 effects. Dr. Rodricks says that the most than male rats (U.S. EPA, 1996).
and the data are not sufficient to sensitive endpoint that is relevant for Therefore, it is appropriate to add an
quantify the uncertainty between those occupational exposure is data from the uncertainty factor of at least 3 to
values, the default uncertainty factor to parent generation of the two-generation account for differences between rats and
be used is 3 (U.S. EPA, 1994b). reproductive study. Dr. Rodricks humans. Further, Stelljes dismisses the
• Drs. Rozman and Doull’s derivation suggests that an uncertainty factor of use of an uncertainty factor for
of an AEL (II–D–63)—EPA discussed only 1 to 2 is necessary for animal to differences within the human
our evaluation of this document at human extrapolation because one population. Although we agree that
length in the preamble of the June 2003 should consider animals and workers of children and the elderly would not be
NPRM at 68 FR 33298. In particular, we average sensitivity; although such an present in the workplace as sensitive
disagree with Rozman and Doull’s argument presumably could be made for subpopulations, there certainly is
selection of the most sensitive endpoint. any chemical used in the workplace, variability in the reproductive abilities
Rozman and Doull concluded that EPA has not seen other AEL derivations of different working-age people that
reproductive toxicity should not be that use this approach. Dr. Rodricks would have no impact on the
considered the most sensitive endpoint, appears to agree with ICF that an individual’s ability to be hired or to
stating that a National Institute for uncertainty factor for variability in work; therefore, EPA expects there is
Occupational Safety and Health reproductive function in the human some variability in the susceptibility of
(NIOSH) evaluation found that no population is reasonable, although he working individuals to the effects of
human beings at a facility using nPB- suggests a factor of 2 instead of the reproductive toxicants. EPA believes
based adhesives experienced range of 2 to 3 in ICF’s derivation. Dr. that male reproductive capacity is very
reproductive health effects from the Rodricks and colleagues previously susceptible to chemical insult (U.S.
nPB. However, the NIOSH study in fact recommended an AEL for nPB of less EPA, 1996).
concluded that the survey questions than 10 ppm, and at that time suggested • Dr. Murray’s opinion on parent and
would not be sufficient to determine if an uncertainty factor of 10 for variability offspring generations (II–D–58)—Dr.
there were reproductive health effects, in reproductive function in the human Murray says that because the offspring
which is significantly different from population (A–91–42, X–B–53). We generation will not yet have developed
saying that there was no health effect. discussed above the use of data from sperm while in utero, it is more
The expert panel for the CERHR looked both the F0 and F1 generations and the appropriate to use data from the parent
at the NIOSH report and a wide range use of an uncertainty factor of 3 for generation of the two-generation study.
of human and animal studies on nPB; in variability within the working However, Dr. Murray does not address
contrast to Rozman and Doull, the population. the possibility that nPB exposure during
expert panel concluded that there was • Dr. Stelljes’s critique of ICF’s AEL pregnancy could influence the
insufficient information on reproductive derivation (II–D–41a)—Dr. Stelljes states production of hormones that eventually
effects of nPB on humans and that the that ICF should have used data from the would result in sperm production.
results of tests on animals were parent generation rather than from the Further, Dr. Murray’s response does not
considered appropriate for evaluating offspring generation because ‘‘data from address potential effects on ova, which
potential reproductive health effects on F1 animals is not directly applicable to would be present while a fetus is still
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humans. a workplace exposure setting because in its mother’s womb.


Further, EPA disagrees with the both parents would not be exposed to • Report on uncertainty factors used
specific AEL value of 60 to 90 ppm that nPB on a daily basis over the by ACGIH from K.S. Crump Group (IV–
Rozman and Doull derived. They used reproductive cycle, and also have their D–26/OAR–2002–0064–0047 and –48)—
data on headaches from a draft NIOSH offspring exposed daily from weaning.’’ This report concluded that EPA’s

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approach to selecting uncertainty factors notation, and proposed that this was not 7. Iso-Propyl Bromide Limit
for use in risk assessment was more necessary (68 FR 33295). In the June 2003 proposed rule, we
transparent, with justification for each Comment: Several commenters on the proposed as a use condition that nPB
value selected, and was more consistent June 2003 proposal stated that a skin formulations contain no more than
than the values apparently used by the notation for nPB is appropriate, while 0.05% isopropyl bromide (iPB) 11 by
ACGIH in deriving TLVs. EPA agrees another commenter agreed with EPA’s weight because of potential health
with these conclusions. proposal that no skin notation was
Comment: A commenter states that effects associated with this isomer (68
necessary (Smith, 2003; HESIS, 2003; FR 33301–33302).
‘‘an uncertainty factor of 10 is NOT Werner, 2003, Weiss Cohen, 2003). One
‘generally’ used to derive occupational Comment: Two commenters said that
commenter said that EPA should require 0.05% iPB is an appropriate and
exposure limits and that in fact, manufacturers, distributors, and
uncertainty factors of 3 or less or more achievable limit. (Smith, 2003; Weiss
marketers of nPB-containing products to Cohen, 2003). One of these commenters
commonly used,’’ citing the K. S. Crump communicate such information on the
Group’s report. stated that industry test studies showed
Material Safety Data Sheets (MSDS) and that lower limits were neither
Response: In the case of the TLV that the product label.
ACGIH established for nPB, ACGIH toxicologically justified nor economical.
Response: We agree with the Another commenter opposed the
appears to set an AEL that is a factor of commenter that said a skin notation is
10 lower than the endpoint cited as implementation of the proposed use
not necessary. However, today’s restriction, stating that it places an
lowest (100 ppm for effects on pup decision includes a recommendation for
weight) (ACGIH, 2005). Thus, ACGIH undue legal burden on end users, rather
users to wear protective clothing and than the manufacturers of raw materials,
has used an approach for nPB consistent flexible laminate gloves when using nPB
with the total uncertainty factor of 10 and would not benefit worker safety.
to address the concerns about dermal This commenter also stated that this is
assigned by EPA. exposure. the only instance that SNAP has
5. Overall Stringency of the Acceptable Rat studies indicate that dermal regulated residual contaminants. This
Exposure Limit exposure to nPB results in neither commenter also suggested that EPA
Comment: Some commenters appreciable absorption through the skin defer to an AEL of 1 ppm for iPB
supported the proposed AEL of 25 ppm, (RTI, 2005) nor systemic toxicity (Elf established by the government of Korea
stating that it was derived using Atochem, 1995). Unlike methyl chloride and the Japan Society for Occupational
appropriate conservative and cautious and dichlorvos, which are absorbed Health. Moreover, this commenter said
scientific processes. Other commenters through the skin and could contribute to that the difference between the
said that the proposed AEL of 25 ppm systemic toxicity (ACGIH, 1991), EPA is acceptable iPB exposure determined by
was too high, citing uncertainties in the not including a skin notation for nPB in EPA and that determined by ASTM–
data, the inappropriateness of adjusting the information provided to users D6368–00 is very small and, thus, EPA’s
the AEL upward from 18 ppm, reports associated with this rulemaking because proposed regulation does not add any
of health effects on humans, and a need of the relatively low level of absorption. value to existing standards. Finally, this
for higher uncertainty factors. Other The ACGIH provides no skin notation in commenter noted that epidemiological
commenters said that the proposed AEL its TLV documentation for several data found no adverse effect on human
of 25 ppm was too low, citing higher solvents, including nPB (ACGIH, 2005), workers exposed to 110 ppm of iPB
AELs derived by Drs. Stelljes, Doull, methylene chloride, and (Ichihara, specific study not identified
Rozman, and Rodricks, NIOSH studies, perchloroethylene, and there is no by the commenter). (Morford, 2003g and
and a need for lower uncertainty factors. evidence that absorption through the h).
Commenters suggested alternate AEL skin is greater for nPB than for the other Response: We agree that industry has
values ranging from 1 ppm to 156 ppm. halogenated compounds. The TLV achieved this contamination limit for
Response: In this final rule, EPA is documentation for nPB states, ‘‘There is several years without regulation. We
not recommending an acceptable no basis for a skin notation because the also agree that the concentration of iPB
exposure limit. We have based our dermal LD50 of 1-BP was >2 g/kg.’’ likely to be breathed in by workers
determination of acceptability by Further, including a statement giving would be below 1 ppm even if workers
comparing measured exposure levels advice about how to reduce skin were exposed to concentrations of nPB
from workers using nPB in solvent exposure in the ‘‘Further Information’’ at 100 ppm or more, provided that the
cleaning to exposure levels discussed by column of listings is likely to be more iPB content meets the ASTM–D6368–00
EPA in the proposal (see section IV.E). informative to workers than a skin standard for nPB used in vapor
At the levels discussed in the NRPM or notation. degreasing. Further, even if iPB were
higher, we find nPB acceptable for Given the possibility that some nPB present in nPB formulations in
solvent cleaning. After considering the can be absorbed through the skin in concentrations as high as 1%, if
available scientific studies on toxicity, humans, and that the solvent can irritate industry meets the AEL for nPB
exposure data, and alternative the skin, EPA encourages users to wear proposed in 2003 of 25 ppm, or lower,
derivations of the acceptable exposure protective clothing and flexible laminate exposures still would be at most 0.25
limit, we find that the exposure levels gloves when using nPB and encourages ppm. This is below the level of 1 ppm
discussed in 2003 provide sufficient manufacturers, distributors, and established by the Korean government
protection for human health and are marketers of nPB-containing products to and by the Japan Society for
consistent with EPA’s derivations of include such precautions in their Occupational Health (Morford, 2003h).
AELs for other chemicals reviewed MSDSs. EPA believes that our Therefore, we are not adopting a use
under the SNAP program and EPA regulatory authority for the SNAP condition for iPB for the solvent
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guidance for risk assessment. program is over the substitution (use) of cleaning end uses.
ozone-depleting substances, and thus,
6. Skin Absorption we do not believe we have sufficient 11 iPB is also referred to as 2-bromopropane, 2-
In the June 2003 NPRM, EPA authority to regulate the manufacturers, propyl bromide, or 2-BP. Its CAS registry number
discussed listing nPB with a skin distributors and marketers of nPB. is 75–26–3.

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8. Short-Term Exposure Limit (STEL) larger if all emissions were to occur in Working Group for the consideration of
In the June 2003 NPRM, EPA the equatorial region. (Morford, 2003f). the Nineteenth Meeting of the Parties.
Response: EPA agrees that, based on (MOP 18, 2006)
recommended a short-term exposure
the current usage of nPB and its ODP in
limit of 75 ppm (three times the AEL). D. Other Environmental Impacts
Comment: One commenter noted that the U.S., there is not a significant
impact on the ozone layer. With respect to environmental effects
there was no indication in the various other than ozone depletion potential, we
Comment: Comments on the June
applications as to how the exposures stated in the June 2003 NPRM that users
2003 NPRM expressed concern that
from those operations compared to the should observe existing Federal, state,
other countries, particularly those in
EPA recommendation for a STEL at 75 and local regulations such as those
equatorial regions, might assume that
ppm. This commenter asserted that the under the Resource Conservation and
nPB does not pose a danger to the
potential for exceeding the STEL in Recovery Act or those for compliance
stratospheric ozone layer if the U.S.
solvent cleaning applications appears with the National Ambient Air Quality
EPA’s SNAP program finds nPB
high and should, therefore, be Standards (68 FR 33304).
acceptable (Linnell, 2003; Steminiski,
investigated by EPA. This commenter Comment: Commenters stated that,
2003).
also stated that, depending on the Response: Because the ODP for nPB is until the safety of nPB has been
results of this investigation, EPA may higher when used in the tropics (see demonstrated conclusively, more
choose to find nPB unacceptable in footnote 3 above in section IV.2), we stringent controls are necessary to
metals cleaning or restrict its use to recognize the concerns raised by these protect the public and the environment.
where ventilation is employed and/or commenters. However, EPA is In particular, these commenters said
personal protective equipment is worn. regulating use in the U.S. and cannot that the potential for cross-media
Response: EPA disagrees that it is dictate actions taken by other countries. impacts was not given adequate
necessary to use a short-term exposure For example, other countries could consideration in the proposed rule.
limit in determining the acceptability of choose to continue to use nPB even if They also stated that EPA did not
nPB in solvent cleaning. Acute, short- EPA were to find it unacceptable in the address the potential for nPB to
term exposures of nPB are not of U.S. We believe the more appropriate bioaccumulate in the environment or its
significant health concern, so long as forum to address this concern is through impact on sensitive species. One
long-term exposures are below the 8- the Parties to the Montreal Protocol. commenter said that he thought it was
hour TWA limit (ERG, 2004). EPA At the most recent Meeting of the appropriate to ensure that nPB be kept
provided the STEL recommendation in Parties to the Montreal Protocol, the out of wastewater, and an independent
the June 2003 proposal to give guidance Parties made the following decision contractor also mentioned concerns
to the user community, consistent with with regard to n-propyl bromide, in about water pollution. Another
the following recommendation of the order to ‘‘allow Parties to consider commenter said that nPB hydrolyzes
American Conference of Governmental further steps regarding n-propyl more quickly than the chlorinated
Industrial Hygienists (ACGIH): bromide, in the light of available solvents, and so would have less impact
‘‘Excursions in worker exposure levels alternatives’’ (Decision XVIII/11): on water quality. Currently, the
may exceed 3 times the [threshold limit 1. To request the Scientific representative’s company recommends
value] TLV–TWA for no more than a Assessment Panel to update existing that spent solvents be incinerated, and
total of 30 minutes during a workday’’ information on the ozone depletion offers free pickup and disposal of spent
(ACGIH 1999). We note that when the potential of n-propyl bromide, including solvent to its customers.
ACGIH developed a TLV for nPB, they ozone depleting potential depending on Response: EPA agrees that it should
said there were no data to support a the location of the emissions and the not be standard practice to dispose of
short-term exposure limit (ACGIH, season in the hemisphere at that spent nPB in water, and that nPB should
2005). location; be kept out of wastewater to the extent
2. To request the Technology and possible. This may be achieved by
C. Ozone Depletion Potential recycling or through incineration. These
Economic Assessment Panel to continue
We proposed that, since the ODP of its assessment of global emissions of n- also are good practices with other spent
nPB in the continental U.S. is only propyl bromide, * * * paying particular halogenated solvents, whether or not
0.013 to 0.018 relative to an ODP of 0.8 attention to: they are specifically listed as hazardous
for CFC-113, 0.1 for methyl chloroform, (a) Obtaining more complete data on wastes.
and 0.1 for HCFC-141b, nPB should not production and uses of n-propyl EPA’s PBT (persistence/
be found unacceptable because of its bromide as well as emissions of n- bioaccumulation/toxicity) profiler tool
ODP (68 FR 33303). The Agency propyl bromide from those sources; suggested that, based on its structure,
recognized that nPB’s ODP could be (b) Providing further information on nPB would not be considered persistent
much higher in tropical regions, as high the technological and economical in water or soil and that nPB would
as 0.071 to 0.100, but since EPA is availability of alternatives for the have a low tendency to bioaccumulate
regulating nPB used in the U.S., we different use categories of n-propyl (8.3, where 1000 is considered
made our decision based on the ODP in bromide and information on the toxicity bioaccumulative and greater than 5000
the continental U.S. of and regulations on the substitutes for is considered very bioaccumulative).
Comment: One commenter on the n-propyl bromide; Further, the calculated bioconcentration
June 2003 NPRM provided information (c) Presenting information on the factor for nPB is only in the range of 18
(Wuebbles, 2002) and stated that ‘‘even ozone depletion potential of the to 23 (HSDB, 2004; ICF, 2004a). Under
if the entire amount of nPB produced in substances for which n-propyl bromide EPA’s criteria for listing chemicals on
2002 was emitted across North is used as a replacement; the Toxics Release Inventory, this
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American, European and Asian 3. To request that the Technology and would not be a level of concern (ICF
latitudes, the resulting effects on ozone Economic Assessment Panel prepare a 2004a, EPA 1992). Therefore, we
depletion would be too small to report on the assessment referred to in conclude further testing for
measure.’’ The same commenter said paragraph 1 in time for the twenty- bioaccumulation of this chemical is not
that the effects on ozone would only be seventh meeting of the Open-ended needed before rendering a decision for

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use of nPB in the solvent cleaning Pensky-Martens closed cup. Based on risks associated with other substitutes
sector. these data, we find that nPB is not that are currently or potentially
Currently, the estimated amount of flammable under standard test available.
nPB used in the U.S. in SNAP sectors conditions. EPA concludes that nPB Our long-standing interpretation is
is on the order of 10 to 12 million should not be considered unacceptable that worker safety is a factor we
pounds per year, which corresponds to on the basis of flammability risks. consider in determining whether a
roughly 1% of the organic solvent substitute poses significantly greater
cleaning market, a relatively small F. Legal Authority to Set Exposure
Limits risk than other available substitutes. In
amount. It is unlikely that very large the original SNAP rule, we promulgated
amounts of nPB will enter and remain Comment: Two commenters stated the criteria we would review for
in the nation’s water supply, because: that EPA has no jurisdiction to develop purposes of determining whether a
• nPB tends to evaporate quickly, any AEL designed to be applicable to a substitute posed more risk than other
with a calculated half-life of 3.4 hours workplace environment, and that this available substitutes. Specifically, 40
in a river or 4.4 days in a lake due to right belongs to OSHA. CFR 82.178(a) specifies the information
volatilization. Response: As an initial matter, EPA
we require as part of a SNAP
• nPB hydrolyzes readily, with a notes that it has not established an AEL
application and 40 CFR 82.180(a)(7)
measured hydrolysis half-life of 26 days applicable to the workplace in this rule.
identifies the criteria for review.
at 25° C and pH 7. Rather, EPA reviewed the available
• If released to the atmosphere, nPB Notably, we require submitters to
information to determine what a safe
will exist solely in the vapor phase provide information regarding the
workplace exposure might be in order to
based on its vapor pressure of 110.8 mm exposure data (40 CFR 82.178(a)(10))
determine whether use of nPB in the
Hg. Thus, it is unlikely to be and we identify ‘‘occupational risks’’ as
solvent cleaning sector poses
redeposited in rainwater in significant substantially more risk than use of other one of the criteria for review (40 CFR
amounts. (PBT Profiler, 2007; ICF, available substitutes. The analysis 82.180(a)(7)(iv)). In the preamble of the
2004a) performed by EPA imposes no binding original SNAP rule, we said that we
obligation on anyone, particularly in would use any available OSHA PELs,
Further, because nPB is short-lived
this case where EPA determined that EPA inhalation reference
compared to ODS and many ODS
nPB is acceptable for use in the solvent concentrations, or EPA cancer slope
substitutes, it is unlikely that nPB will
cleaning sector. factor data for a substitute together with
create a substantially greater impact
Although the Occupational Safety and exposure data to explore possible
than other acceptable cleaning solvents
Health Act (OSH Act) gives the concerns with toxicity (March 18, 1994;
and than the ODS it replaces. EPA is
Occupational Safety and Health 59 FR 13066). We have reviewed
required by the Clean Air Act to
Administration (OSHA) authority to substitutes based on existing OSHA
consider whether a replacement for an
issue a rule setting or revising an PELs, where available, and, where not
ODS is more harmful, overall, to human
occupational safety or health standard available, based on our own assessment
health and the environment than other
(29 U.S.C. 655(b)), it does not prohibit of what level is safe for workers. (See
available or potentially available
other Federal agencies from reviewing e.g., March 18, 1994, 59 FR 13044; Sept.
substitutes. The available information
the safe level of exposure under other 5, 1996, 61 FR 47012; June 8, 1999, 64
shows that nPB will not be more
statutes that require consideration of the FR 30410; June 19, 2000, 65 FR 37900;
hazardous than other available,
human health and environmental effects December 18, 2000, 65 FR 78977; March
acceptable solvents if it pollutes water
of a substance. Conversely, although 22, 2002, 67 FR 13272; August 21, 2003,
or soil.
section 4(b)(1) of the OSH Act prohibits 68 FR 50533). In making our own
E. Flammability OSHA from regulating a working assessment, we review any existing
In the June 2003 NPRM, we proposed condition addressed by another federal recommended exposure guidelines and
that nPB should not be restricted or agency’s regulations affecting available scientific studies and use
found unacceptable because of occupational safety or health, this EPA’s risk assessment guidelines (e.g.,
flammability (68 FR 33303). EPA provision is overridden with respect to U.S. EPA, 1994b).
specifically requested data concerning EPA’s exercise of authority under the In the case of EPA’s evaluation of
the flashpoint of pure nPB, including Clean Air Act by 42 U.S.C. 7610. That nPB, there is no final OSHA PEL for
the test method used to provide the provision states: ‘‘(a) Except as provided EPA to use in evaluating workplace
data. in subsection (b) of this section, this exposure risks. There is a wide
Comment: Several manufacturers of chapter shall not be construed as variability in the workplace exposure
nPB and nPB-based solvents and an superseding or limiting the authorities guidelines recommended by
independent contractor stated that nPB and responsibilities, under any other manufacturers of nPB-based products,
has no flash point under a number of provision of law, of the Administrator or ranging from 5 ppm to 100 ppm, thus
accepted consensus standards for flash any other Federal officer, department, or providing no definitive value for
point. In support of these statements, agency.’’ evaluating the human health risks of
the manufacturers of nPB and nPB- Section 612 of the Clean Air Act workplace exposure. The ACGIH has
based solvents provided flash point test expressly recognizes that some recently established a TLV for nPB of 10
data from a number of different test substitutes for ODS may pose more risk ppm; however, as discussed above in
methods (ASTM D 92 open cup, ASTM to human health and the environment section IV.E, EPA has concerns about
D56 Tag closed cup, and ASTM D93 than others and expressly requires EPA the scientific basis for this TLV. As
Pensky-Martens closed cup). to prohibit use of substitutes that pose provided in the original SNAP rule, in
Response: EPA agrees. The test results more risk than other substitutes that are the absence of a definitive workplace
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provided by the commenters indicates currently or potentially available. Thus, exposure limit set by OSHA, we
that nPB has no flash point using a in evaluating whether a substitute evaluated the available information to
number of standard test methods, should be found acceptable, we must establish our own health-based criteria
including ASTM D 92 open cup, ASTM compare the risks to human health and for evaluating nPB’s human health risks
D56 Tag closed cup, and ASTM D93 the environment of that substitute to the to workers.

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Comment: A commenter said that Report, S–Prt 103–38 at 1337. The under the CAA only when the
EPA’s authority for the SNAP program legislative history cited by the complaint concerned substances
is under section 615 of the Clean Air commenter is not pertinent. The emitted to the ambient air. Claims
Act and that the SNAP program only legislative history for Part B of Title I of regarding air quality within the
has authority to take action based on the Act is not relevant because that workplace are brought under the
effects on the stratosphere. Specifically, section was repealed in 1990. Public whistleblower provisions of the OSH
the commenter claims section 615 of the Law 101–549, section 601. Nor is the Act.
CAA limits EPA’s authority under title legislative history for other statutes, Response: The commenter overstates
VI to regulating for purposes of such as TSCA, relevant for determining the import of the decisions issued by the
protecting the stratospheric ozone layer. what authority Congress granted to EPA Administrative Review Board. In each of
Citing section 618, the commenter also under the CAA. the cited decisions, the Board examined
contends that section 618 identified The commenter incorrectly states that the specific circumstances before it to
SNAP requirements as ‘‘requirements sections 615 and 618 of the CAA place determine which statutory
for the control and abatement of air limits on EPA’s authority under section whistleblower provision provided the
pollution’’ and cites the CAA and EPA 612 of the Act. These provisions basis for the claimed action. While
policy documents as identifying expand, rather than restrict, the making general pronouncements that
ambient air as air external to buildings. Administrator’s authority. Section 615 the CAA regulates ambient air and
The commenter also notes that title VI is a separate provision of the statute and OSHA regulates air within the
was intended to implement the provides general authority for the workplace, none of these opinions
Montreal Protocol and that it replaced Administrator to regulate for purposes specifically addressed the scope of
former Part B. The commenter cites of addressing adverse effects to the EPA’s authority under section 612, the
legislative history from the enactment of stratosphere. This provision does not SNAP provisions of the Act.
Part B that indicated EPA’s authority explicitly or implicitly purport to limit Comment: A commenter stated that
under Part B was not intended to pre- the Administrator’s authority under even if ventilation or other measures
empt authority of other agencies to take other provisions of the Act. Rather, it is could reduce exposures to below 25
action with respect to hazards in their a general provision authorizing the ppm, there is nothing to ensure that
areas of jurisdiction and that EPA’s Administrator to regulate for protecting companies will take such measures.
authority under Part B was only to fill against adverse effects to the This commenter also stated that he is
regulatory gaps and not to supersede stratospheric ozone layer. aware of nPB formulators that have
existing authority of other agencies. With respect to section 618, we first already announced they will not adhere
With respect to the legislative history of note that the commenter appears to to this voluntary standard. Three
equate the stratospheric ozone layer commenters, all representing local
the 1990 Amendments, the commenter
with ‘‘ambient air.’’ In fact, they are two environmental regulators, stated that a
argues that there is no suggestion that
different things. Ambient air is defined recommendation that worker exposure
‘‘EPA has authority to set workplace
as ‘‘that portion of the atmosphere, be limited to 25 ppm will not carry the
worker-exposure standards.’’ The
external to buildings, to which the enforcement powers of an OSHA
commenter also cites legislative history
general public has access.’’ 40 CFR standard, and that this lack of control
from the Toxic Substances Control Act
50.1(e). The stratospheric level generally will encourage the use of nPB in
in which Congress indicated EPA’s
extends from 10 to 50 kilometers above applications beyond those envisioned
authority under that statute does not
the earth and is not considered air to by EPA. Another commenter asserted
extend to setting workplace standards.
which the public has access. [See that the proposed exposure limits (both
Response: While many provisions in http://www.epa.gov/ozone/defns.html]. the AEL and the STEL) should be
title VI address the regulation of The definition of ‘‘air pollutant’’ under established as use conditions, citing
substances that deplete the stratospheric the CAA is defined in terms of Section 612 as the basis for EPA’s
ozone layer, section 612 which governs substances emitted to the ‘‘ambient air.’’ authority to do so. This commenter
the SNAP program is broader. The The purpose of section 618 is to make stated that a precedent has already been
purpose of Section 612 is to review clear that for purposes of sections 116 set for EPA to accept an alternative
substitutes for ODS and Section 612 of (retention of state authority) and 118 chemical subject to use conditions—
the Clean Air Act clearly requires EPA (control of pollution from federal including that observance of workplace
to consider both the environmental facilities), the provisions in Title VI concentration limits—in the adhesives,
effects as well as human health, which governing protection of the stratospheric aerosols, and solvent cleaning sectors
includes both the health of the general ozone layer shall be treated the same as (e.g., HCFC–225 ca/cb, HFC–4310mee,
population and workers. EPA believes if they were for the purpose of monochlorotoluenes, benzotrifluorides;
there is no doubt that the statutory controlling and abating ‘‘air pollution’’ 40 CFR part 82, subpart G, appendices
language requires EPA to consider (i.e., pollution to the ambient air). A, B, and D).
effects beyond those on the Again, this is not for the purpose of Response: EPA agrees that a
stratospheric ozone layer. In addition, restricting the Administrator’s authority recommended AEL from EPA does not
the legislative history makes clear that under any provision of the Act. Rather, provide the same level of protection as
this language is to be interpreted it is for the purpose of extending the an enforceable standard from OSHA. We
broadly. Specifically, the report of protections of Title VI to programs that also agree that EPA has the authority
House Debate on the Clean Air Act otherwise only address air pollution under section 612 to require use
Amendments provides ‘‘the (i.e., ambient air, which does not conditions in those circumstances
Administrator shall base risk estimates include the stratospheric ozone layer). where use of a potentially promising
on the total environmental risk (toxicity, Comment: A commenter stated that substitute would otherwise be
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flammability, atmospheric, etc.) that is EPA’s claim to authority conflicts with unacceptable unless those use
perceived to exist, not just the risk as it the Department of Labor’s conditions are met and there are
relates to ozone depletion.’’ House administrative ‘‘whistleblower’’ case significant concerns about the ability of
Debate on the Clean Air Act law. These cases hold that a industry to meet a safe level for use. In
Amendments of 1990 Conference whistleblower action may proceed the preamble to the original SNAP rule,

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we recognized that there may be cases nPB will pose significantly greater risk VI. How can I use nPB as safely as
where OSHA has not regulated worker than other substitutes that are available possible?
exposure to a substitute. We went on to in the same end use. The range of levels Below are actions that will help nPB
say that ‘‘EPA anticipates applying use EPA used for its analysis is not binding. users minimize exposure levels:
conditions only in the rare instances Moreover, as explained above in section
where clear regulatory gaps exist, and V.B.2, EPA has concluded that for All End Uses
where an unreasonable risk would exist purposes of finding nPB acceptable in • All users of nPB should wear
in the absence of any conditions.’’ For the solvent cleaning end use, it is not appropriate personal protective
the solvent cleaning end use, we do not necessary to provide a non-binding equipment, including chemical goggles,
believe that there is an unreasonable recommended workplace exposure limit flexible laminate protective gloves (e.g.,
risk in the absence of a use condition. because these users in the solvent Viton, Silvershield) and chemical-
Available exposure data show that cleaning sector are regularly able to resistant clothing. Special care should
roughly 88% of samples from nPB users be taken to avoid contact with the skin
comply with even the lowest level EPA
in solvent cleaning met an exposure since nPB, like many halogenated
considered in performing its evaluation.
level of 25 ppm, 81% met an exposure solvents, can be absorbed through the
level of 18 ppm, and 70% met an For standards covering hazardous
skin. Refer to OSHA’s standard for the
exposure level of 10 ppm (U.S. EPA, chemicals in the workplace, the OSH
selection and use of Personal Protective
2003). One nPB supplier provided Act requires OSHA to set standards that,
Equipment, 29 CFR 1910.132.
evidence that on the few occasions to the extent feasible, ensure that
• Limit worker exposure to solvents
when nPB concentrations from vapor workers do not suffer material to minimize any potential adverse
degreasers were higher than the impairments of health. Standards health effects. Workers should avoid
company’s recommended AEL of 25 established by OSHA under their statute staying for long periods of time in areas
ppm, users were able to reduce have not typically prohibited the use of near where they have been using the
exposure easily and inexpensively by the chemical in any particular solvent. Where possible, shorten the
changing work practices, such as application, but instead establish period during each day when a worker
reducing drafts near the cleaning performance goals for the use and is exposed. Where respiratory protection
equipment (Kassem, 2003). Therefore, handling of hazardous chemicals that is necessary to limit worker exposures,
we expect that users of nPB in the reduce such risks to the extent feasible. respirators must be selected and used in
solvent cleaning sector following typical The available information on health accordance with OSHA’s Respiratory
industry practices and using typical effects of nPB on workers is not
equipment for vapor degreasing will Protection standard, 29 CFR 1910.134.
continue to use nPB at levels considered
sufficiently well-characterized to • Use less solvent, or use a different
develop a standard based on avoiding solvent, either alone or in a mixture
safe for workers. As noted above, this is
material impairments of health in with nPB.
the approach we indicated we would
follow at the time of the original SNAP workers. Most manufacturers and • Follow all recommended safety
rule and we have taken this same organizations that set workplace precautions specified in the
approach for many other solvents where exposure limits such as ACGIH and the manufacturer’s MSDS.
users are readily able to meet a American Industrial Hygiene • Workers should receive safety
workplace exposure limit that will Association use an approach similar to training and education that includes
protect human health and there is no EPA’s and do not base exposure limits potential health effects of exposure to
enforceable OSHA PEL (e.g., HFC– on avoiding material impairments of nPB, covering information included on
365mfc and heptafluorocyclopentane at health in workers. Because of the need the appropriate MSDSs, as required by
65 FR 78977, ketones, alcohols, esters, for large amounts of well-characterized OSHA’s Hazard Communication
and hydrocarbons at 59 FR 13044). data from the workplace on exposures Standard (29 CFR 1910.1200).
Comment: One commenter claims that and associated health effects to prepare • Request a confidential consultation
section 6 of the Occupational Safety and an AEL to prevent material impairment, from your State government on all
Health Act requires OSHA to make if EPA were to develop AELs for nPB aspects of occupational safety and
certain legal findings before and other chemicals based on the health. You can contact the appropriate
promulgating a standard and that state agency that participates in OSHA’s
approach required by section 6 of the
therefore EPA has no authority to consultation program. These contacts
OSH Act, EPA would effectively be
develop any AEL applicable to a are on OSHA’s Web site at http://
unable to assess the human health
workplace environment. Furthermore, www.osha.gov/oshdir/consult.html. For
effects of ODS alternatives in time to
since OSHA is the only agency that can further information on OSHA’s
assist industry in transitioning away confidential consultancy program, visit
make standards applicable in the from ODS. In order to provide for a
workplace, any level developed by EPA OSHA’s web page at http://
more timely assessment of human www.osha.gov/html/consultation.html.
is misleading. The same commenter said
health effects, as well as one that is • Use the employee exposure
that EPA offers no reasoning as to why
consistent with federal guidelines of the monitoring programs and product
a different methodology for setting an
AEL (from that of OSHA) is necessary or National Academies of Science (NAS, stewardship programs where offered by
advisable. Therefore, this commenter 1983), we have considered exposure manufacturers and formulators of nPB-
believes that the Agency’s process levels following EPA guidance (U.S. based products.
violates equal protection unless EPA is EPA, 1994b). Different substances have • If the manufacturer or formulator of
publishing a new standard for chemical different toxicological effects and those your nPB-based product does not have
review under SNAP. effects must be considered based on the an exposure monitoring program, we
rwilkins on PROD1PC63 with RULES_2

Response: In this rulemaking, EPA best scientific information and recommend that you start your own
has not developed an AEL that is methodologies available. It is incorrect exposure monitoring program, and/or
applicable in any workplace. Rather, to claim that such reviews, which focus request a confidential consultation from
EPA looked at a range of possible AELs on the effects of different substances, your State government. A medical
for purposes of determining whether resulted in disparate treatment of nPB. monitoring program should be

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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations 30161

established for the early detection and emissions controls (e.g., secondary Ave., NW., Washington, DC 20460 or by
prevention of acute and chronic effects cooling coils, automated lifts or hoists) calling (202) 566–1672.
of exposure to nPB. The workers’ within a year of installation. Based on Burden means the total time, effort, or
physician(s) should be given evidence from solvent suppliers, EPA financial resources expended by persons
information about the adverse health believes that some of those users would to generate, maintain, retain, or disclose
effects of exposure to nPB and the have chosen to use nPB in order to or provide information to or for a
workers’ potential for exposure. avoid meeting requirements of the Federal agency. This includes the time
• For non-aerosol solvent cleaning, national emission standard for needed to review instructions; develop,
follow guidelines in the National halogenated solvents cleaning and that acquire, install, and utilize technology
Emissions Standards for Hazardous Air they would only become aware of the and systems for the purposes of
Pollutant (NESHAP) for halogenated potential savings due to reduced solvent collecting, validating, and verifying
solvents cleaning if you are using nPB. usage as a result of this proposal information, processing and
The equipment and procedural changes (Ultronix, 2001; Kassem, 2003; maintaining information, and disclosing
described in the halogenated solvents Tattersall, 2004). Based on available and providing information; adjust the
NESHAP can reduce emissions, reduce exposure data for each sector, we existing ways to comply with any
solvent losses and lower the cost of assumed that 81% of nPB users in the previously applicable instructions and
cleaning with organic solvents. For non-aerosol solvent cleaning sector requirements; train personnel to be able
more information on the halogenated already achieve exposure levels at the to respond to a collection of
solvents NESHAP, visit http:// lowest level that we considered, i.e., 18 information; search data sources;
www.epa.gov/ttn/atw/eparules.html and ppm (U.S. EPA, 2003). Of those nPB complete and review the collection of
http://www.epa.gov/ttn/atw/degrea/ solvent users with exposure levels information; and transmit or otherwise
halopg.html. We note that these steps above that, we examined the cost disclose the information.
are useful for reducing exposure to any associated with reducing emissions on An agency may not conduct or
industrial solvent, and not just nPB. average by 60%. sponsor, and a person is not required to
If all nPB users in solvent cleaning respond to a collection of information
VII. Statutory and Executive Order reduced exposures to 18 ppm, EPA unless it displays a currently valid OMB
Reviews estimates that users would save up to $2 control number. The OMB control
A. Executive Order 12866: Regulatory million dollars per year, overall (U.S. numbers for EPA’s regulations in 40
Planning and Review EPA, 2007). The value will depend on CFR are listed in 40 CFR part 9.
the number of users that attempt to meet C. Regulatory Flexibility Act
Under Executive Order (EO) 12866 an acceptable exposure level which is
(58 FR 51735, October 4, 1993), this already being achieved with existing The Regulatory Flexibility Act (RFA)
action is a ‘‘significant regulatory equipment, the initial exposure level of generally requires an agency to prepare
action.’’ It raises novel legal or policy cleaning solvent users, the price of nPB, a regulatory flexibility analysis of any
issues arising out of legal mandates, the and the amount of emission control rule subject to notice and comment
President’s priorities, or the principles equipment installed. rulemaking requirements under the
set forth in the Executive Order. Administrative Procedure Act or any
Accordingly, EPA submitted this action B. Paperwork Reduction Act other statute unless the agency certifies
to the Office of Management and Budget There are no new requirements for that the rule will not have a significant
(OMB) for review under EO 12866 and reporting or recordkeeping or economic impact on a substantial
any changes made in response to OMB information collection associated with number of small entities. Small entities
recommendations have been this final rule. The final rule merely include small businesses, small
documented in the docket for this allows the use of substitutes for ozone- organizations, and small governmental
action. depleting substances, without requiring jurisdictions. The RFA provides default
In addition, EPA prepared an analysis the collection, keeping, or reporting of definitions for each type of small entity.
of the potential costs and benefits information. OMB has previously Small entities are defined as: (1) A small
associated with this action. This approved the information collection business as defined by the Small
analysis is contained in the document requirements contained in the existing Business Administration’s (SBA)
‘‘Analysis of Economic Impacts of nPB regulations in subpart G of 40 CFR part regulations at 13 CFR 121.201; (2) a
Rulemaking.’’ A copy of the analysis is 82 under the provisions of the small governmental jurisdiction that is a
available in the docket for this action Paperwork Reduction Act, 44 U.S.C. government of a city, county, town,
(Ref. EPA–HQ–OAR–2002–0064) and 3501 et seq. and has assigned OMB school district or special district with a
the analysis is briefly summarized here. control number 2060–0226 (EPA ICR population of less than 50,000; and (3)
In our analysis, we assumed that No. 1596.06). This ICR included five a small organization that is any not-for-
capital costs are annualized over 15 types of respondent reporting and profit enterprise which is independently
years or less using a discount rate for record-keeping activities pursuant to owned and operated and is not
determining net present value of 7.0%. SNAP regulations: submission of a dominant in its field. However, the RFA
The acceptability determination for SNAP petition, filing a SNAP//Toxic also authorizes an agency to use
solvents cleaning imposes no Substance Control Act (TSCA) alternate definitions for each category of
requirements and thus creates no Addendum, notification for test small entity, ‘‘which are appropriate to
additional cost to users. marketing activity, record-keeping for the activities of the agency’’ after
EPA also considered potential costs substitutes acceptable subject to use proposing the alternate definition(s) in
end users could incur to meet restrictions, and record-keeping for the Federal Register and taking
acceptable exposure levels if they are small volume uses. A copy of the OMB comment. 5 U.S.C. 601(3)—(5). In
rwilkins on PROD1PC63 with RULES_2

not already achieving it. EPA found that approved Information Collection addition, to establish an alternate small
those users using nPB-based solvents in Request (ICR) may be obtained from business definition, agencies must
a vapor degreaser would save money by Susan Auby, Collection Strategies consult with SBA’s Office of Advocacy.
reducing solvent losses, and that the Division; U.S. Environmental Protection For purposes of assessing the impacts
savings would recover the costs of Agency (2822T); 1200 Pennsylvania of EPA’s June 2003 proposed rule on

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30162 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

small entities, EPA proposed to define believes businesses using nPB-based rule on the private sector is less than
‘‘small business’’ as a small business cleaning solvents for metals cleaning, $100 million per year. Thus, this rule is
with less than 500 employees, rather electronics cleaning, or precision not subject to the requirements of
than use the individual SBA size cleaning would experience significant sections 202 and 205 of the UMRA. EPA
standards for the numerous NAICS cost benefits by reducing spending on has determined that this rule contains
subsectors and codes to simplify the solvent. no regulatory requirements that might
economic analysis. We solicited significantly or uniquely affect small
D. Unfunded Mandates Reform Act
comments on the use of this alternate governments. This regulation applies
definition for this analysis in the June Title II of the Unfunded Mandates directly to facilities that use these
2003 NPRM and received no public Reform Act of 1995 (UMRA), Public substances and not to governmental
comments. EPA also consulted with the Law 104–4, establishes requirements for entities.
SBA’s Office of Advocacy on the use of Federal agencies to assess the effects of
their regulatory actions on State, local, E. Executive Order 13132: Federalism
an alternate small business definition of
500 employees. The Office of Advocacy and tribal governments and the private Executive Order 13132, entitled
concurred with EPA’s use of this sector. Under section 202 of the UMRA, ‘‘Federalism’’ (64 FR 43255, August 10,
alternate definition to analysis the EPA generally must prepare a written 1999), requires EPA to develop an
economic impacts on small businesses statement, including a cost-benefit accountable process to ensure
from the use of n-propyl bromide as an analysis, for proposed and final rules ‘‘meaningful and timely input by State
acceptable substitute for use in metals, with ‘‘Federal mandates’’ that may and local officials in the development of
precision, and electronics cleaning, and result in expenditures to State, local, regulatory policies that have federalism
in aerosols and adhesives end-uses. and tribal governments, in the aggregate, implications.’’ ‘‘Policies that have
Therefore, EPA used this alternate or to the private sector, of $100 million federalism implications’’ is defined in
definition for this final rule. We believe or more in any one year. Before the Executive Order to include
that no small governments or small promulgating an EPA rule for which a regulations that have ‘‘substantial direct
organizations are affected by this rule. written statement is needed, section 205 effects on the States, on the relationship
This approach slightly reduced the of the UMRA generally requires EPA to between the national government and
number of small businesses included in identify and consider a reasonable the States, or on the distribution of
our analysis and slightly increased the number of regulatory alternatives and power and responsibilities among the
adopt the least costly, most cost- various levels of government.’’
percentage of small businesses for
effective or least burdensome alternative This final rule does not have
whom the analysis indicated the use of
that achieves the objectives of the rule. federalism implications. It will not have
nPB in metals, precision, and
The provisions of section 205 do not substantial direct effects on the States,
electronics cleaning may have an
apply when they are inconsistent with on the relationship between the national
economically significant impact. The
applicable law. Moreover, section 205 government and the States, or on the
number and types of small businesses
allows EPA to adopt an alternative other distribution of power and
that are subject to this rule have not
than the least costly, most cost-effective responsibilities among the various
changed significantly since the June
or least burdensome alternative if the levels of government, as specified in
2003 proposal. EPA intends to use this
Administrator publishes with the final Executive Order 13132. This regulation
alternate definition of ‘‘small business’’ rule an explanation why that alternative applies directly to facilities that use
for regulatory flexibility analyses under was not adopted. Before EPA establishes these substances and not to
the RFA for any other rule related to the any regulatory requirements that may governmental entities. Thus, Executive
use of nPB as a chemical alternative to significantly or uniquely affect small Order 13132 does not apply to this rule.
ozone-depleting substances (ODS) for governments, including tribal
the same end uses in the June 2003 governments, it must have developed F. Executive Order 13175: Consultation
NPRM (e.g., adhesives and aerosol under section 203 of the UMRA a small and Coordination With Indian Tribal
solvents). government agency plan. The plan must Governments
After considering the economic provide for notifying potentially Executive Order 13175, entitled
impacts of this rule on small entities, I affected small governments, enabling ‘‘Consultation and Coordination with
certify that this action will not have a officials of affected small governments Indian Tribal Governments’’ (65 FR
significant economic impact on a to have meaningful and timely input in 67249, November 6, 2000), requires EPA
substantial number of small entities. the development of EPA regulatory to develop an accountable process to
EPA estimates that approximately 1470 proposals with significant Federal ensure ‘‘meaningful and timely input by
users of nPB industrial cleaning intergovernmental mandates, and tribal officials in the development of
solvents (e.g., cleaning with vapor informing, educating, and advising regulatory policies that have tribal
degreasers) would be subject to this small governments on compliance with implications.’’ ‘‘Policies that have tribal
rule. This rule lists nPB as an acceptable the regulatory requirements. EPA has implications’’ is defined in the
substitute for ODS. This rule itself does determined that this rule does not Executive Order to include regulations
not impose any binding requirements on contain a Federal mandate that may that have ‘‘substantial direct effects on
users of nPB, and therefore will not result in expenditures of $100 million or one or more Indian tribes, on the
have a significant economic impact on more for State, local, and tribal relationship between the Federal
a substantial number of small entities. governments, in the aggregate, or the government and the Indian tribes, or on
EPA did however analyze the potential private sector in any one year. This final the distribution of power and
economic impacts on small businesses rule does not affect State, local, or tribal responsibilities between the Federal
that use nPB for cleaning solvents for governments. This rule contains no government and Indian tribes.’’
rwilkins on PROD1PC63 with RULES_2

metals cleaning, electronics cleaning, or enforceable requirements. The impact of This final rule does not have tribal
precision cleaning. The details of EPA’s users meeting the AEL range discussed implications. It will not have substantial
analysis are described in the supporting in the preamble is from a savings of $2 direct effects on tribal governments, on
materials for this rulemaking (U.S. EPA, million per year to a cost of $0 million the relationship between the Federal
2007). Based on its analysis, EPA per year. Therefore, the impact of this government and Indian tribes, or on the

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Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations 30163

distribution of power and likely to have any adverse energy Availability


responsibilities between the Federal effects. IBSA, 2002. Record of September 5, 2002
government and Indian tribes, as Meeting with the International
I. National Technology Transfer and
specified in Executive Order 13175. Brominated Solvents Association Inc.
Advancement Act
This final rule would not significantly (A–2001–07, II–D–60)
or uniquely affect the communities of Section 12(d) of the National
Technology Transfer and Advancement Ozone-Depletion Potential and Other
Indian tribal governments, because this Environmental Impacts
regulation applies directly to facilities Act of 1995 (‘‘NTTAA’’), Public Law
104–113, section 12(d) (15 U.S.C. 272 ATSDR, 1994. Toxicological Profile For
that use these substances and not to
note) directs EPA to use voluntary Acetone. Agency for Toxic Substances
governmental entities. Thus, Executive and Disease Registry. May, 1994.
Order 13175 does not apply to this final consensus standards in its regulatory
activities unless to do so would be Available at http://www.atsdr.cdc.gov/
rule. toxprofiles/tp21-c5.pdf (EPA–HQ–OAR–
inconsistent with applicable law or
G. Executive Order 13045: Protection of 2002–0064–0118)
otherwise impractical. Voluntary ATSDR, 1996. Toxicological Profile For 1,2-
Children From Environmental Health consensus standards are technical Dichloroethene. Agency for Toxic
and Safety Risks standards (e.g., materials specifications, Substances and Disease Registry. August,
Executive Order 13045: ‘‘Protection of test methods, sampling procedures, and 1996. Available at http://
Children from Environmental Health business practices) that are developed or www.atsdr.cdc.gov/toxprofiles/tp87-
Risks and Safety Risks’’ (62 FR 19885, adopted by voluntary consensus c5.pdf (EPA–HQ–OAR–2002–0064–
standards bodies. The NTTAA directs 0113)
April 23, 1997) applies to any rule that: ATSDR, 1997. Toxicological Profile For
(1) Is determined to be ‘‘economically EPA to provide Congress, through OMB,
explanations when the Agency decides Trichloroethylene. Agency for Toxic
significant’’ as defined under Executive Substances and Disease Registry.
Order 12866, and (2) concerns an not to use available and applicable
September, 1997. Available at http://
environmental health or safety risk that voluntary consensus standards. www.atsdr.cdc.gov/toxprofiles/tp19-
This action does not involve technical c5.pdf (EPA–HQ–OAR–2002–0064–
EPA has reason to believe may have a
standards. Therefore, EPA did not 0123)
disproportionate effect on children. If
consider the use of any voluntary ATSDR, 2004. Draft Toxicological Profile For
the regulatory action meets both criteria,
consensus standards. 1,1,1-Trichloroethane. Agency for Toxic
the Agency must evaluate the
Substances and Disease Registry.
environmental health or safety effects of J. Congressional Review Act September, 2004. Updated draft for
the planned rule on children, and The Congressional Review Act, 5 comment. Available at http://
explain why the planned regulation is U.S.C. 801 et seq., as added by the Small www.atsdr.cdc.gov/toxprofiles/tp70-
preferable to other potentially effective Business Regulatory Enforcement c6.pdf (EPA–HQ–OAR–2002–0064–
and reasonably feasible alternatives Fairness Act of 1996, generally provides 0132)
considered by the Agency. that before a rule may take effect, the EDSTAC, 1998. Final Report of the Endocrine
This final rule is not subject to the Disruptor Screening and Testing
agency promulgating the rule must Advisory Committee. August, 1998.
Executive Order because it is not submit a rule report, which includes a (EPA–HQ–OAR–2002–0064–0136)
economically significant as defined in copy of the rule, to each House of the Geiger et al., 1998. Geiger, D.L., Call, D.J.,
Executive Order 12866, and because the Congress and to the Comptroller General and Brooke, L.T. 1988. Acute Toxicities
Agency does not have reason to believe of the United States. EPA will submit a of Organic Chemicals to Fathead
the environmental health or safety risks report containing this rule and other Minnows (Pimephales promelas), Vol. 4.
addressed by this action present a required information to the U.S. Senate, In: Center for Lake Superior
disproportionate risk to children. The the U.S. House of Representatives, and Environmental Stud., Univ. of
exposure limits and acceptability the Comptroller General of the United Wisconsin-Superior, Superior, WI I:355.
listings in this final rule apply to the (Summarized in ICF, 2004a)
States prior to publication of the rule in HSDB, 2004. Hazardous Substances Databank
workplace. These are areas where we the Federal Register. A major rule File for 1-Bromopropane. Accessed 1/
expect adults are more likely to be cannot take effect until 60 days after it 2004 from the World Wide Web at http://
present than children, and thus, the is published in the Federal Register. toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./
agents do not put children at risk This action is not a ‘‘major rule’’ as temp/∼dLwM9e:1 (Summarized in ICF,
disproportionately. defined by 5 U.S.C. 804(2). This rule 2004a)
will be effective July 30, 2007. ICF, 2004a. ICF Consulting. Memo to E.
H. Executive Order 13211: Actions That Birgfeld, EPA, re: nPB Aquatic Toxicity.
Significantly Affect Energy Supply, VIII. References January 19, 2004. (EPA–HQ–OAR–2002–
Distribution, or Use 0064–0193)
The documents below are referenced
This rule is not a ‘‘significant energy in the preamble. All documents are LaGrega, M., Buckingham, P., Evans, J., and
Environmental Resources Management,
action’’ as defined in Executive Order located in the Air Docket at the address 2001. Hazardous Waste Management.
13211, ‘‘Actions Concerning Regulations listed in section I.B.1 at the beginning Second Edition. McGraw-Hill, New
That Significantly Affect Energy Supply, of this document. Unless specified York, NY. 2001. (EPA–HQ–OAR–2002–
Distribution, or Use’’ (66 FR 28355 (May otherwise, all documents are available 0064–0112)
22, 2001)) because it is not likely to electronically through the Federal Linnell, 2003. Comments from the
have a significant adverse effect on the Docket Management System, Docket # Electronics Industry Alliance. (EPA–HQ–
supply, distribution, or use of energy. EPA–HQ–OAR–2002–0064. Some OAR–2002–0064 items –0043, –0044,
This action would impact specific items are available only in hard and –0045)
manufacturing of various metal, copy in dockets A–2001–07 or A–92–42 NPS, 1997. Irwin, R.J., M. VanMouwerik, L.
rwilkins on PROD1PC63 with RULES_2

Stevens, M.S. Seese, and W. Basham.


electronic, medical, and optical (legacy docket numbers for SNAP nPB 1997. Environmental Contaminants
products cleaned with solvents rule and for SNAP program and Encyclopedia. National Park Service,
containing nPB and products made with submissions). Numbers listed after the Water Resources Division, Fort Collins,
adhesives containing nPB. Further, we reference indicate the docket and item Colorado. (EPA–HQ–OAR–2002–0064–
have concluded that this rule is not numbers. 0086)

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30164 Federal Register / Vol. 72, No. 103 / Wednesday, May 30, 2007 / Rules and Regulations

Steminiski, 2003. July 27, 2003 Comment Morford, 2003a, b. Enviro Tech International mitogen-activated protein kinase in the
from J. Steminiski, PhD. (EPA–HQ– Comment re Section IV D Flammability hippocampus of rats exposed to 1-
OAR–2002–0064–0035 and –0043) with Exhibits (7/25/03) (EPA–HQ–OAR– bromopropane. 2002. Life Sciences 72
U.S. Economic Census, 2002a. General 2002–0064–0030 and EPA–HQ–OAR– (2002) 521–529. (EPA–HQ–OAR–2002–
Summary: 2002. Subject Series. Report 2002–0064–0031) 0064–0115)
No. EC02–31SG–1, October, 2005. U.S. Morford, 2003c. Enviro Tech Int. Fueta et al., 2004. Y. Fueta, T. Fukuda, T.
Census Bureau. (EPA–HQ–OAR–2002– Flammability of nPB & Comparison With Ishidao, H. Hori. Electrophysiology and
0064–0133) Methylene Chloride-Additional immunohistochemistry in the
U.S. Economic Census, 2002b. U.S. Economic Comments on Flammability (7/29/03) hippocampal CA1 and the Dentate Gyrus
Census for Island Areas, 2002. Report for (EPA–HQ–OAR–2002–0064–0036) of Rats Chronically exposed to 1–
Northern Marianas Islands, Rpt. No. Shubkin, 2003. R. Shubkin, Poly Systems, Bromopropane, a Substitute for Specific
IA02–00A–NMI, May, 2004. U.S. Census EPA received 7/23/03 Re: Comment on Chlorofluorocarbons. Neuroscience 124
Bureau. (EPA–HQ–OAR–2002–0064– Flammability of n-Propyl Bromide as (2004) 593–603. (EPA–HQ–OAR–2002–
0091) Discussed in Proposed Rule Published in 0064–0142)
U.S. Economic Census, 2002c. U.S. Economic Federal Register (EPA–HQ–OAR–2002– Honma et al., 2003. Honma, T, Suda M,
Census for Island Areas, 2002. Report for 0064–0025) Miyagawa M. ‘‘Inhalation of 1-
Guam, Rpt. No. IA02–00A–GUAM, Weiss Cohen, 2003. T. Weiss Cohen, Dead bromopropane causes excitation in the
March, 2005. U.S. Census Bureau. (EPA– Sea Bromine Group, 7/31/2003 Comment central nervous system of male F344
HQ–OAR–2002–0064–0102) to Federal Register Proposed Rules of rats.’’ Neurotoxicology. 2003 Aug; 24 (4–
U.S. Economic Census, 2002d. U.S. June 3, 2003, on Protection of 5):563–75. (EPA–HQ–OAR–2002–0064–
Economic Census for Island Areas, 2002. Stratospheric Ozone: Listing of 0138)
Report for Virgin Islands, Rpt. No. IA02– Substitutes for Ozone-Depleting ICF, 2002. Risk Screen for Use of N-Propyl
00A–VI , April, 2005. U.S. Census Substances—n-Propyl Bromide (EPA– Bromide. ICF Consulting. Prepared for
Bureau. (EPA–HQ–OAR–2002–0064– HQ–OAR–2002–0064–0053) U.S. EPA, May, 2002. (EPA–HQ–OAR–
0131) 2002–0064–0006 through –0012)
U.S. Economic Census, 2002e. U.S. Economic Human Health ICF, 2004b. ICF Consulting. ICF Consulting
Census for Island Areas, 2002. Report for Review of the TERA Report. December
ACGIH, 1991. Skin Notation Documentation
American Samoa, Rpt. No. IA02–00A– 13, 2004
for Methyl Chloride. Available online at
AS, April, 2005. U.S. Census Bureau. ICF, 2004c. ICF Consulting. External Expert
(EPA–HQ–OAR–2002–0064–0103) http://www.acgih.org.
ACGIH, 2005. Documentation for Threshold Review Panel on n-Propyl Bromide.
U.S. Economic Census, 2002f. U.S. Economic
Limit Value for 1-Bromopropane. 2005. December 13, 2004
Census for Island Areas, 2002. Report for
Available online at http://www.acgih.org. ICF, 2004d. ICF Consulting. Review of
Puerto Rico: Manufacturing, Rpt. No.
Albemarle, 2003. Product Description for ACGIH’s Proposed Threshold Limit
IA02–00I–PRM, October, 2005. U.S.
Census Bureau. (EPA–HQ–OAR–2002– Abzol() Cleaners. 2003. (EPA–HQ– Value for 1-Bromopropane. April 26,
0064–0107) OAR–2002–0064–0148) 2004
U.S. EPA, 1980. Ambient Water Quality Beck and Caravati, 2003. Neurotoxicity ICF, 2006a. ICF Consulting. Risk Screen on
Criteria for Dichloroethylenes. EPA 440/ associated with 1-bromopropane Substitutes for Ozone-Depleting
5–80–041 October, 1980. Available at exposure. Utah Poison Control Center, Substances for Adhesive, Aerosol
http://www.epa.gov/waterscience/pc/ University of Utah, Salt Lake City, UT. Solvent, and Solvent Cleaning
ambientwqc/dichloroethylenes80.pdf J Toxicology Clinical Toxicology Applications. Proposed Substitute: n-
U.S. EPA, 1992. Hazard Assessment 41(5):729. (Abstract from conference). Propyl Bromide. April 18, 2006.
Guidelines for Listing Chemicals on the 2003. (EPA–HQ–OAR–2002–0064–0111) Attachments: A, Determination of an
Toxic Release Inventory, Revised Draft. CERHR, 2002a. NTP-Center for the AEL; B, Derivation of an RfC; C,
Washington, DC: Office of Pollution, Evaluation of Risks to Human Evaluation of the Global Warming
Prevention and Toxics. As referenced in Reproduction Expert Panel Report on the Potential; D, Occupational Exposure
ICF, 2004a. Reproductive and Developmental Analysis for Adhesive Applications; E,
U.S. EPA, 1994a. Chemical Summary for Toxicity of 1–Bromopropane [nPB]. Occupational Exposure Analysis for
Methyl Chloroform, prepared by Office March 2002. (EPA–HQ–OAR–2002– Aerosol Solvent Applications; F, General
of Pollution Prevention and Toxics, 0064–0096) Population Exposure Assessment for n-
August, 1994. (EPA–HQ–OAR–2002– ClinTrials, 1997a. A 28-Day Inhalation Study Propyl Bromide
0064–0121) of a VaporFormulation of ALBTA1 in the ICF, 2006b. ICF Consulting. Revised
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Steffens at the North American Congress bromopropane, and 1,2-dichloropropane NIOSH. (EPA–HQ–OAR–2002–0064–
of Clinical Toxicologists. September 14, on the estrous cycle and ovulation in 0015 and EPA–HQ–OAR–2002–0064–
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Miller, 2005. ‘‘1-Bromopropane: A Private 126(1):41–9 (A–2001–07, II–D–39) Wang et al., 2003. H. Wang, G. Ichihara, H.
Neurological Practice Experience in SLR International, 2001. ‘‘Inhalation Ito, K. Kato, J. Kitoh, T. Yamada, X. Yu,
2000,’’ Presentation by Dr. J.M. Miller, at Occupational Exposure Limit for n- S. Tsuboi, Y. Moriyama, and Y.
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Toxicologists. September 14, 2005 (EPA– Tech International, Inc. 2001. (A–2001– Biochemical Changes in RateCentral
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Nemhauser, 2005. ‘‘Bromopropane: A Health Sohn et al., 2002. Sohn, Y.K., Suh, J.S., Kim, to 1-Bromopropane’’ NeuroToxicology
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NIOSH, 2003a. NIOSH Health Hazard Stelljes and Wood, 2004. Stelljes, M., Wood, toxicity study of 1-bromopropane in
Evaluation Report #99–0260–2906 Marx R. Development of an occupational rats.’’ Sponsored by the Brominated
Industries, Inc. Sawmills, NC. Available exposure limit for n-propylbromide Solvent Consortium. May 24, 2001.
online at http://www.cdc.gov/niosh/hhe/ using benchmark dose methods. (A–2001–07, II–D–10)
reports/pdfs/1999-0260-2906.pdf. (EPA– Regulatory Toxicology and Yamada T. et al., 2003. Exposure to
HQ–OAR–2002–0064–0094) Pharmacology 40 (2004) 136–150 (EPA– 1-Bromopropane Causes Ovarian
NTP, 2003. Results of 13-week Inhalation HQ–OAR–2002–0064–0087) Dysfunction in Rats. Toxicol Sci 71:96–
Testing by the National Toxicology Stelljes, ME, 2005. Mechanistic Hypothesis 103 (EPA–HQ–OAR–2002–0064–0097)
Program. Available at http://ntp- for n-Propylbromide and Ramifications How Is EPA Responding to Comments?
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index.cfm?fuseaction= United States. Technical Memorandum ACGIH, 1991. Full citation above in ‘‘Human
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ntpsearch.searchresults&searchterm= to EnviroTech International. 7 Health’’ section.


106-94-5 September, 2005. (EPA–HQ–OAR–2002– ACGIH, 2004. TLVs and BEIs: Threshold
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Toxicology Advisor, Albemarle TERA, 2004. Toxicological Excellence for and Physical Agents, Biological
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Cincinnati, OH. Available online at Linnell, 2003. Full citation above in ‘‘Ozone- Clinical Toxicologists. September 14,
http://www.acgih.org. Depletion Potential and Other 2005. (EPA–HQ–OAR–2002–0064–0126)
ACGIH, 2005. Full citation above in ‘‘Human Environmental Impacts’’ section. RTI, 2005. Full citation above in ‘‘Human
Health’’ section. Majersik, 2004. Full citation above in Health’’ section.
Beck and Caravati, 2003. Full citation above ‘‘Human Health’’ section. Ruckriegel, 2003. Comment on n-Propyl
in ‘‘Human Health’’ section. Majersik, 2005. Full citation above in Bromide Recommended Workplace
Chemtura, 2006. Material Safety Data Sheet ‘‘Human Health’’ section. Exposure Level in Proposed Rule
for n-propyl bromide. April, 2006. (EPA– MOP 18, 2006. Report of the Eighteenth Published in Federal Register Vol. 68,
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ClinTrials, 1997a. Full citation above in Protocol on Substances that Deplete the (EPA–HQ–OAR–2002–0064–0055)
‘‘Human Health’’ section. Ozone Layer. November 16, 2006. (EPA- Rusch and Bernhard, 2003. Comments on
ClinTrials, 1997b. Full citation above in HQ–OAR–2002–0064–0163) proposed regulation of n-propyl bromide
‘‘Human Health’’ section. Morford, 2003a. Full citation above in from Steven Bernhardt and George
Doull and Rozman, 2001. Doull and Rozman, ‘‘Flammability’’ section. Rusch, Honeywell. August 1, 2003.
2001. Derivation of an Occupational Morford, 2003b. Full citation above in (EPA–HQ–OAR–2002–0064–0059)
Exposure Limit for n-Propyl Bromide, ‘‘Flammability’’ section. Rusch, 2003. Late comments on proposed
prepared by John Doull, Ph.D., M.D., and Morford, 2003c. Full citation above in regulation of n-propyl bromide from
Karl K. Rozman, Ph.D., D.A.B.T. ‘‘Flammability’’ section. George Rusch, Honeywell. (EPA–HQ–
submitted by Envirotech International, Morford, 2003d. Support for EPA Proposal to OAR–2002–0064–0068)
Inc. (A–2001–07, II–D–14) Approve n propyl bromide and Sekiguchi, 2002. Full citation above in
Dunson et al., 2002. Full citation above in Comments Pursuant to Section D. ‘‘Human Health’’ section.
Flammability of Protection of SLR International, 2001. Full citation above
‘‘Human Health’’ section.
Stratospheric Ozone: Listing of in ‘‘Human Health’’ section.
Elf Atochem, 1995. Elf Atochem, 1995.
Substitutes for Ozone Depleting Smith, 2003. Comments on Protection of
Micronucleus Test by Intraperitoneal
Substances—n-Propyl Bromide: Stratospheric Ozone: Listing of
Route in Mice. n-Propyl Bromide. Study
Proposed Rule Federal Register Vol. 68 Substitutes for Ozone-Depleting
No. 12122 MAS. Study Director, Brigitte Substances—n-Propyl Bromide, FR Vol.
No. 106, June 3, 2003. Enviro Tech
Molinier. Study performed by Centre 68, No. 106, June 3, 2003. R.L. Smith,
International, Inc. Comments Regarding
International de Toxoicologie, Misery, Albemarle Corporation. July 23, 2003.
Proposed Rule & Exhibit A Richard
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Morford, Enviro Tech International.
X–A–9) Stelljes, 2003. Comments from Dr. Marc
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ERG, 2004. Analysis of Health and Stelljes, SLR International, on proposed
0064–0047)
Environmental Impacts of ODS Morford, 2003e. Enviro Tech International, rule on n-propyl bromide. (HQ–EPA–
Substitutes—Evaluating the need to set a Inc. Combined Exhibits to Comment OAR–2002–0064–0022)
short-term exposure or ceiling limit for 0047/Morford, 2003e on Proposed Rule Stelljes and Wood, 2004. Full citation above
n-propyl bromide. ERG. June 8, 2004. Richard Morford, Enviro Tech in ‘‘Human Health’’ section.
Farr, 2003. Comment on proposed rule on n- International. August 3, 2003. (EPA–HQ– Stelljes, 2005. Full citation above in ‘‘Human
propyl bromide from Craig Farr, Atofina. OAR–2002–0064–0048) Health’’ section.
July 31, 2003. (EPA–HQ–OAR–2002– Morford, 2003f. Initial Comments to TERA, 2004. Full citation above in ‘‘Human
0064–0060) Protection of Stratospheric Ozone: Health’’ section.
HDSB, 2004. Full citation above in ‘‘Ozone- Listing of Substitutes for Ozone U.S. EPA, 1994b. Full citation above in
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Environmental Impacts’’ section. bromide: Proposed Rule Federal Register U.S. EPA, 1996. Full citation above in
HESIS, 2003. California Department of Health Vol. 68 No. 106, June 3, 2003. Richard ‘‘Human Health’’ section.
Services—HESIS 1-Bromopropane Morford, Enviro Tech International. June U.S. EPA, 2003. Summary of Data on
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(EPA–HQ–OAR–2002–0064–0039) 0002) Bromide, May 21, 2003. EPA’s summary
Honma, 2003. Full citation above in ‘‘Human Morford, 2003g. Comment regarding of exposure data from nPB suppliers and
Health’’ section. proposed restriction on isopropyl NIOSH. (EPA–HQ–OAR–2002–0064–
ICF, 2002a. Full citation above in ‘‘Human bromide Richard Morford, Enviro Tech 0015 and –0016)
Health’’ section. International. August 3, 2003. (EPA–HQ– Weiss Cohen, 2003. Comments from Tammi
ICF, 2004a. Full citation above in ‘‘Ozone- OAR–2002–0064–0042) Weiss Cohen, Dead Sea Bromine Group.
Depletion Potential and Other Morford, 2003h. Enviro Tech International Comments To Federal Register Proposed
Environmental Impacts’’ section. Inc Comment Regarding iPB Content Rules Of June 3, 2003, On Protection Of
ICF, 2006a. Full citation above in ‘‘Human Restriction Exhibit A 04–Aug–2003 Stratospheric Ozone: Listing Of
Health’’ section. (EPA–HQ–OAR–2002–0064–0046) Substitutes For Ozone-Depleting
ICF, 2006b. Full citation above in ‘‘Human Morford, 2003i. White Paper: ‘‘EPA Is Substances—N Propyl Bromide. (EPA–
Health’’ section. Unlawfully Regulating Occupational HQ–OAR–2002–0064–0038)
ICF, 2006c. ICF Consulting. Evaluation of Exposures’’ Attachment to public Werner, 2003. Full citation above in ‘‘Human
Memorandum from Dr. M. Stelljes. May, comments. (EPA–HQ–OAR–2003–0064– Health’’ section.
2006. 0049) WIL, 2001. Full citation above in ‘‘Human
Ichihara, 1999. Full citation above in NTP, 2003. Full citation above in ‘‘Human Health’’ section.
‘‘Human Health’’ section. Health’’ section. Yamada et al., 2003. Full citation above in
Ichihara, 2000a. Full citation above in PBT Profiler, 2007. Results from the PBT ‘‘Human Health’’ section.
‘‘Human Health’’ section. Profiler Tool for 1-bromopropane, CAS
Ichihara, 2002. Full citation above in
Executive Orders and Statutes
No. 106–94–5. Downloaded on February
‘‘Human Health’’ section. 9, 2007 from http://www.pbtprofiler.net/ Kassem, 2003. Full citation above for
Ichihara, 2004a. Full citation above in default.asp. (EPA–HQ–OAR–2002– ‘‘Decisions for Each Sector and End Use’’
‘‘Human Health’’ section. 0064–0168) section.
Ichihara, 2004b. Full citation above in Risotto, 2003. Full citation above in ‘‘Human Ultronix, 2001. Response to questionnaire
rwilkins on PROD1PC63 with RULES_2

‘‘Human Health’’ section. Health’’ section. from EPA by C. Wolf, Ultronix, 2001.
Kassem, 2003. January 10, 2003 Letter from Rodricks, 2002. Full citation above in (A–2001–07, II–D–76)
O.M. Kassem, Albemarle Corporation to ‘‘Human Health’’ section. Tattersall, 2004. Conversation between M.
K. Bromberg, Small Business Rozman and Doull, 2005. Rozman and Doull, Sheppard, EPA, and Tom Tattersall,
Administration Re: n propyl bromide 2005. Presentation by Drs. Rozman and MicroCare Corporation. (EPA–HQ–OAR–
SNAP. (A–2001–07, II–D–78) Doull at the North American Congress of 2002–0064–0171)

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U.S. EPA, 2003. Full citation above for List of Subjects in 40 CFR Part 82 Dated: May 15, 2007.
‘‘Human Health’’ section. Stephen L. Johnson,
Environmental protection,
U.S. EPA, 2007. Analysis of Economic
Administrative practice and procedure, Administrator.
Impacts of Final nPB Rulemaking for
Air pollution control, Reporting and
Cleaning Solvent Sector. 2007. Appendix A: Summary of Decision
recordkeeping requirements.
SOLVENT CLEANING ACCEPTABLE SUBSTITUTE
End uses Substitute Decision Further information

Metals cleaning, electronics n-propyl bromide (nPB) as Acceptable ......................... EPA recommends the use of personal protective
cleaning, and precision a substitute for CFC–113 equipment, including chemical goggles, flexible lami-
cleaning. and methyl chloroform. nate protective gloves and chemical-resistant cloth-
ing.
EPA expects that all users of nPB would comply with
any final Permissible Exposure Limit that the Occu-
pational Safety and Health Administration issues in
the future under 42 U.S.C. 7610(a).
nPB, also known as 1-bromopropane, is Number 106–
94–5 in the Chemical Abstracts Service (CAS) Reg-
istry.

[FR Doc. E7–9707 Filed 5–29–07; 8:45 am]


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