JMPR 2010 Contents

–
ISSN 0259-2517
200
Pesticide residues FAO
PLANT
PRODUCTION
in food 2010 AND PROTECTION
PAPER
Joint FAO/WHO Meeting
on Pesticide Residues 200
Pesticide residues in food 2010 – Joint FAO/WHO Meeting on Pesticide Residues

The annual Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the
Environment and the WHO Core Assessment Group on Pesticide Residues was held in Rome,
Italy, from 21 to 30 September 2010. The FAO Panel of Experts had met in Preparatory Sessions
from 16 to 20 September. The Meeting was held in pursuance of recommendations made by
previous meetings and accepted by the governing bodies of FAO and WHO that studies should
be undertaken jointly by experts to evaluate possible hazards to humans arising from the
occurrence of pesticide residues in foods. During the meeting the FAO Panel of Experts was
responsible for reviewing pesticide use patterns (use of good agricultural practices), data on
the chemistry and composition of the pesticides and methods of analysis for pesticide residues
and for estimating the maximum residue levels that might occur as a result of the use of the
pesticides according to good agricultural practices. The WHO Core Assessment Group was
responsible for reviewing toxicological and related data and for estimating, where possible and
appropriate, acceptable daily intakes (ADIs) and acute reference doses (ARfDs) of the pesticides
for humans. This report contains information on ADIs, ARfDs, maximum residue levels,
and general principles for the evaluation of pesticides. The recommendations of the
Joint Meeting, including further research and information, are proposed for use by
Member governments of the respective agencies and other interested parties.
REPORT
2010
ISBN 978-92-5-106735-2 ISSN 0259-2517
9 789251 067352 Food and Agriculture

I1949E/1/01.11 Organization of
the United Nations
FAO
Pesticide residues FAO
PLANT
in food 2010 PRODUCTION

AND PROTECTION
PAPER
Joint FAO/WHO Meeting
on Pesticide Residues 200
Report of the Joint Meeting of the FAO Panel of Experts on

Pesticide Residues in Food and the Environment and the
WHO Core Assessment Group on Pesticide Residues
Rome, Italy, 21–30 September 2010
WORLD HEALTH ORGANIZATION

FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS
Rome, 2011
The designations employed and the presentation of material in this information
product do not imply the expression of any opinion whatsoever on the part
of the Food and Agriculture Organization of the United Nations (FAO) concerning the
legal or development status of any country, territory, city or area or of its authorities,
or concerning the delimitation of its frontiers or boundaries. The mention of specific
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not imply that these have been endorsed or recommended by FAO in preference to
others of a similar nature that are not mentioned.
The views expressed in this information product are those of the author(s) and
do not necessarily reflect the views of FAO.
ISBN 978-92-5-106735-2
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© FAO 2011
CONTENTS
List of participants .................................................................................................................................. i
2010 Joint FAO/WHO Meeting on Pesticide Residues ........................................................................ i
Abbreviations ......................................................................................................................................... v
Use of JMPR reports and evaluations by registration authorities ................................................... ix
1. Introduction ....................................................................................................................... 1
Declaration of interests................................................................................................... 2
2. General considerations...................................................................................................... 3
2.1 Consideration regarding JMPR capacity and resources ................................................. 3
2.2 Dietary risk assessments conducted by the JMPR: need for appropriate consumption
data for further method development ............................................................................. 6
2.3 The needs of JMPR concerning food consumption data: Update on the activities of
the GEMS/Food programme .......................................................................................... 7
2.4 Information on the use of pesticides required for the estimation of residue levels in
minor crops..................................................................................................................... 8
2.5 Principles and guidance on the selection of representative crops for the extrapolation
of MRLs ....................................................................................................................... 11
2.6 Statistical calculation of MRLs .................................................................................... 12
2.7 Appropriate value from replicate samples from a supervised field trial for use in
statistical calculation of the MRL estimate .................................................................. 13
2.8 The application of proportionality in selecting data for MRL estimation .................... 14
2.9 Further consideration of expert judgement in evaluating residue trials ....................... 17
2.10 Use of the OECD Feed table ........................................................................................ 18
2.11 Training of scientists from developing countries for the establishment of pesticide
maximum residue levels in foods and assessment of the risk from dietary intake of
residues ......................................................................................................................... 20
3. Responses to specific concerns raised by the Codex Committee on Pesticide
Residues (CCPR) ............................................................................................................. 21
3.1 Bifenthrin (178) (T)...................................................................................................... 21
3.2 Cypermethrin (118) (R) ................................................................................................ 21
3.3 Fluopicolide (235) (T) .................................................................................................. 22
3.4 Paraquat (057) (R) ........................................................................................................ 24
4. Dietary risk assessment ................................................................................................... 27
5. Evaluation of data for acceptable daily intake and acute dietary intake for humans,
maximum residue levels and supervised triALS median residue values .................... 31
5.1 Bifenazate (219) (R) ..................................................................................................... 31
5.2 Bifenthrin (178) (R)** ................................................................................................. 37
5.3 Boscalid (221) (R) ........................................................................................................ 55
5.4 Cadusafos (174) (R)** ................................................................................................. 61
5.5 Chlorantraniliprole (230) (R) ....................................................................................... 67
5.6 Chlorothalonil (081) and metaboliteS R611965 and SDS-3701(T, R)** .................... 77
5.7 Clothianidin (238) (T, R)* ......................................................................................... 107
5.8 Cyproconazole (239) (T, R)* ..................................................................................... 149
5.9 Dicamba (240) (T, R)* ............................................................................................... 171
5.10 Difenoconazole (224) (R) .......................................................................................... 195
5.11 Dithianon (180) (T)** ................................................................................................ 201
5.12 Endosulfan (032) (R) ................................................................................................. 207
5.13 Etoxazole (241) (T, R)* ............................................................................................. 209
5.14 Fenpyroximate (193) (R)............................................................................................ 227
5.15 Flubendiamide (242) (T, R)* ..................................................................................... 235
5.16 Fludioxonil (211) (R) ................................................................................................. 259
5.17 Fluopyram (243) (T, R)* ............................................................................................ 263
5.18 Meptyldinocap (244) (T, R)* ..................................................................................... 283
5.19 Novaluron (217) (R)................................................................................................... 295
5.20 Spices (R) ................................................................................................................... 303
5.21 Tebuconazole (189) (T)** ......................................................................................... 307
5.22 Thiamethoxam (245) (T, R)* ..................................................................................... 313
5.23 Triazophos (143) (R) .................................................................................................. 365
6. Recommendations ......................................................................................................... 367
7. Future work ................................................................................................................... 369
Annex 1: Acceptable daily intakes, short-term dietary intakes, acute reference doses,
recommended maximum residue limits and supervised trials median residue values
recorded by the 2010 Meeting ...................................................................................... 373
Annex 2: Index of reports and evaluations of pesticides by the JMPR .................................... 391
Annex 3: International estimated daily intakes of pesticide residues ...................................... 403
Annex 4: International estimates of short-term dietary intakes of pesticide residues ........... 463
Annex 5: Reports and other documents resulting from previous Joint Meetings of the
FAO Panel of Experts on Pesticide Residues in Food and the Environment
and the WHO core assessment group on pesticide residues ..................................... 529
Annex 6: Livestock dietary burden ................................................................................................ 537
Corrigenda – Corrections to the report of the 2009 Meeting ........................................................ 571
D, dietary risk assessment; R, residue and analytical aspects; T, toxicological evaluation.

* New compound
** Evaluated within the periodic review programme of the Codex Committee on Pesticide
Residues
i
LIST OF PARTICIPANTS
2010 JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES
ROME, 21–30 SEPTEMBER 2010
FAO Members
Dr Ursula Banasiak, Federal Institute for Risk Assessment, Thielallee 88-92, D-14195 Berlin,
Germany
Mr Stephen Funk, Health Effects Division (7509P), United States Environmental Protection Agency,
1200 Pennsylvania Avenue NW, Washington, DC 20460, USA
Mr Denis J. Hamilton, Principal Scientific Officer Biosecurity, Department of Primary Industries and
Fisheries, PO Box 46, Brisbane, QLD 4001, Australia
Mr David Lunn, Senior Programme Manager (Residues–Plants), Export Standards Group, New
Zealand Food Safety Authority, PO Box 2835, Wellington, New Zealand (FAO Rapporteur)
Dr Dougal MacLachlan, Australian Quarantine and Inspection Service, Australian Government

Department of Agriculture, Fisheries and Forestry, GPO Box 858, Canberra, ACT 2601, Australia
Dr Bernadette Ossendorp, Centre for Substances and Integrated Risk Assessment, National Institute
of Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, PO Box 1, 3720
BA Bilthoven, Netherlands (FAO Chairman)
Dr Yukiko Yamada, Deputy Director-General, Food Safety and Consumer Affairs Bureau, Ministry
of Agriculture, Forestry and Fisheries, 1-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8950, Japan
WHO Members
Professor Alan R. Boobis, Experimental Medicine & Toxicology, Division of Investigative Science,
Faculty of Medicine, Imperial College London, Hammersmith Campus, Ducane Road, London
W12 0NN, England
Dr Les Davies, Chemical Review, Australian Pesticides and Veterinary Medicines Authority,
Kingston ACT, Australia
ii
Dr Vicki L. Dellarco, Office of Pesticide Programs (7501P), United States Environmental Protection
Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460, USA (WHO Rapporteur)
Professor Angelo Moretto, Department of Environmental and Occupational Health, University of

Milan, International Centre for Pesticides and Health Risk Prevention, Luigi Sacco Hospital, Via
Stephenson 94, 20157 Milan, Italy (WHO Chairman)
Dr Roland Solecki, Chemical Safety Division, Steering of Procedures and Overall Assessment,
Federal Institute for Risk Assessment, Thielallee 88-92, D-14195 Berlin, Germany
Dr Maria Tasheva, Consultant, National Service for Plant Protection, Ministry of Agriculture and
Food, 17 Hristo Botev Bul. 1040 Sofia, Bulgaria
Secretariat
Ms Catherine Adcock, Toxicological Evaluation Section 2, Health Effects Division II, Health
Evaluation Directorate, Pest Management Regulatory Agency, Ottawa, Ontario, Canada (WHO
Temporary Adviser)
Dr Árpád Ambrus, Hungarian Food Safety Office, Gyali ut 2-6, 1097 Budapest, Hungary (FAO
Temporary Adviser)
Mr Kevin Bodnaruk, 26/12 Phillip Mall, West Pymble, NSW 2073, Australia (FAO Editor)
Dr Ian Dewhurst, Chemicals Regulation Directorate, Mallard House, King’s Pool, 3 Peasholme
Green, York YO1 7PX, England (WHO Temporary Adviser)
Dr William Donovan, United States Environmental Protection Agency, MC 7509C, Washington, DC

20460, USA (FAO Temporary Adviser)
Mr Makoto Irie, Plant Product Safety Division, Food Safety and Consumer Affairs Bureau, Ministry
of Agriculture, Forestry and Fisheries, 1-2-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8950, Japan
(FAO Temporary Adviser)
Dr Debabrata Kanungo, Additional DG, Directorate General of Health Services, Ministry of Health
and Family Welfare, West, Block No. 1, R.K. Puram, New Delhi, India (WHO Temporary
Adviser)
Dr Douglas B. McGregor, Toxicity Evaluation Consultants, 38 Shore Road, Aberdour KY3 0TU,
Scotland (WHO Temporary Adviser)
iii
Dr Francesca Metruccio, International Centre for Pesticides and Health Risk Prevention (ICPS),
Luigi Sacco Hospital, Via Stephenson 94 20157, Milano, Italy (WHO Temporary Adviser)
Dr Rudolf Pfeil, Toxicology of Pesticides and Biocides, Federal Institute for Risk Assessment,
Thielallee 88-92, D-14195 Berlin, Germany (WHO Temporary Adviser)
Dr Xiongwu Qiao, Shanxi Academy of Agricultural Sciences, 2 Changfeng Street, Taiyuan, Shanxi
030006, China (FAO Temporary Adviser)
Ms Jeannie Richards, 15 bis rue Georges Musy, 71100 Saint Remy, France (FAO Temporary
Advisor)
Dr Prakashchandra V. Shah, United States Environmental Protection Agency, Mail Stop: 7505P,
1200 Pennsylvania Avenue NW, Washington, DC 20460, USA (WHO Temporary Adviser)
Dr Weili Shan, Residues Division, Institute for Control of Agrochemicals, Ministry of Agriculture,
Maizidian 22, Chaoyang District, Beijing 100125, China (FAO Temporary Adviser)
Ms Marla Sheffer, 1553 Marcoux Drive, Orleans, Ontario, Canada KIE 2K5 (WHO Temporary
Adviser)
Mr Christian Sieke, Federal Institute for Risk Assessment, Thielallee 88-92, D-14195 Berlin,
Germany (FAO Temporary Adviser)
Dr Angelika Tritscher, Dept of Food Safety and Zoonoses (FOS), World Health Organization, 1211
Geneva 27, Switzerland (WHO Joint Secretariat)
Ms Trijntje van der Velde, National Institute of Public Health and the Environment (RIVM), Antonie
van Leeuwenhoeklaan 9, PO Box 1, 3720 BA Bilthoven, Netherlands (FAO Temporary Adviser)
Dr Philippe Verger, GEMS/Food Programme, Dept of Food Safety and Zoonoses (FOS), World
Health Organization, 1211 Geneva 27, Switzerland (WHO Joint Secretariat)
Dr Gerrit Wolterink, Centre for Substances & Integrated Risk Assessment, National Institute of
Public Health and the Environment (RIVM), Antonie van Leeuwenhoeklaan 9, PO Box 1, 3720
BA Bilthoven, Netherlands (WHO Temporary Adviser)
Dr Midori Yoshida, Section Chief, Division of Pathology, Biological Safety Research Center,
National Institute of Health Sciences, Ministry of Health, Labour and Welfare, 1-18-1 Kamiyoga,
Setagaya-ku, Tokyo 158-8501, Japan (WHO Temporary Adviser)
iv
Ms Yong Zhen Yang, Plant Protection Service (AGPP), Food and Agriculture Organization of the
United Nations (FAO), Viale delle Terme di Caracalla, 00153 Rome, Italy (FAO Joint Secretary)
Dr Jürg Zarn, Swiss Federal Office of Public Health, Nutritional and Toxicological Risks Section,
Stauffacherstrasse 101, CH-8004 Zurich, Switzerland (WHO Temporary Adviser)
v
ABBREVIATIONS
ACN acetonitrile
ADI acceptable daily intake
ADME absorption, distribution, metabolism and excretion
ai active ingredient
AP alkaline phosphatase
AR applied radioactivity
ARfD acute reference dose
ATG-Ac N′-[amino(2-chlorothiazol-5-ylmethylamino)methylene] acetohydrazide
ATMG-Pyr N′-[(2-chlorothiazol-5-ylmethylamino)(methylamino)methylene]-2-
oxopropanohydrazide
AUC area under the curve for concentration–time
avg average
BrdU bromodeoxyuridine
BROD benzyloxyresorufin O-dealkylase
bw body weight
CAC Codex Alimentarius Commission
CAR constitutive androstane receptor
CAS Chemical Abstracts Service
CCCF Codex Committee on Contaminants in Foods
CCN Codex classification number (for compounds or commodities)
CCPR Codex Committee on Pesticide Residues
COLEACP Comité de Liaison Europe-Afrique-Caraïbes-Pacifique
COX-2 cyclooxygenase-2
CXL Codex MRL
CYP cytochrome P450
DAT days after treatment
DCGA 3,6-dichlorogentisic acid
DCSA 3,6-dichlorosalicylic acid
DT50 time required for 50% dissipation of the initial concentration
EC50 the concentration of agonist that elicits a response that is 50% of the possible
maximum
EFSA European Food Safety Authority
EROD ethoxyresorufin O-deethylase
EtOAc ethyl acetate
EU European Union
vi
F0 parental generation
F1 first filial generation
F2 second filial generation
FAO Food and Agriculture Organization of the United Nations
FOB functional observational battery
GAP good agricultural practice
GC gas chromatography
GC-FPD gas chromatography with flame photometric detection
GC-ECD gas chromatography with electron capture detection
GD gestation day
GEMS/Food Global Environment Monitoring System – Food Contamination Monitoring and
Assessment Programme
GLP good laboratory practice
HPLC high-pressure liquid chromatography
HR highest residue in the edible portion of a commodity found in trials used to
estimate a maximum residue level in the commodity
HR-P highest residue in a processed commodity calculated by multiplying the HR of the
raw commodity by the corresponding processing factor
IC50 concentration required to inhibit activity by 50%
IEDI international estimated daily intake
ILV independent laboratory validation
IESTI international estimate of short-term dietary intake
ISO International Organization for Standardization
IUPAC International Union of Pure and Applied Chemistry
JECFA Joint FAO/WHO Expert Committee on Food Additives
JMPM Joint FAO/WHO Meeting on Pesticide Management
JMPR Joint FAO/WHO Meeting on Pesticide Residues
JMPS Joint FAO/WHO Meeting on Pesticide Specifications
LC liquid chromatography
LC50 median lethal concentration
LD50 median lethal dose
LOAEL lowest-observed-adverse-effect level
LOD limit of detection
LOQ limit of quantification
MAI 3-methylamino-1H-imidazo[1,5-c]imidazole
MG methylguanidine
MNG N-methyl-N′-nitroguanidine
vii
MRL maximum residue limit

MS mass spectrometry
MSD mass selective detector
MS/MS tandem mass spectrometry
MTCA 2-methylthiothiazole-5-carboxylic acid
MTD maximum tolerated dose
NAFTA North American Free Trade Agreement
NOAEC no-observed-adverse-effect concentration
NOAEL no-observed-adverse-effect level
NTG nitroguanidine
OECD Organisation for Economic Co-operation and Development
PB phenobarbital
PBI plant-back interval
PCR polymerase chain reaction
PF processing factor
PFPD pulse flame photometric detection
PHI pre-harvest interval
ppm parts per million
PROD pentoxyresorufin O-dealkylase
RAC raw agricultural commodity
RTI re-treatment interval
S9 9000 × g rat liver supernatant
SDH succinate dehydrogenase
SFO single first order
SPE solid phase extraction
STMR supervised trials median residue
STMR-P supervised trials median residue in a processed commodity calculated by
multiplying the STMR of the raw commodity by the corresponding processing
factor
T3 triiodothyronine
T4 thyroxine
Tmax time to reach maximum concentration
TMG thiazolmethylguanidine
TRR total radioactive residues
TSH thyroid stimulating hormone
TZMU thiazolylmethylurea
TZNG thiazolylnitroguanidine
viii
UCL upper confidence limit

UDPGT uridine diphosphate–glucuronosyltransferase
USA United States of America
US/CAN United States and Canada
FDA PAM US Food and Drug Adminstration Pesticide Analytical Manual
VF variability factor
WHO World Health Organization
ix
USE OF JMPR REPORTS AND EVALUATIONS BY REGISTRATION AUTHORITIES
Most of the summaries and evaluations contained in this report are based on unpublished proprietary
data submitted for use by JMPR in making its assessments. A registration authority should not grant a
registration on the basis of an evaluation unless it has first received authorization for such use from
the owner of the data submitted for the JMPR review or has received the data on which the
summaries are based, either from the owner of the data or from a second party that has obtained
permission from the owner of the data for this purpose.
Introduction 1
PESTICIDE RESIDUES IN FOOD
REPORT OF THE 2010 JOINT FAO/WHO MEETING OF EXPERTS
1. INTRODUCTION
A Joint FAO/WHO Meeting on Pesticide Residues (JMPR) was held at the headquarters of the Food
and Agriculture Organization of the United Nations (FAO), Rome, Italy, from 21 to 30 September
2010. The Meeting brought together the FAO Panel of Experts on Pesticide Residues in Food and the
Environment and the World Health Organization (WHO) Core Assessment Group on Pesticide
Residues.
The Meeting was opened by Dr Peter Kenmore, Principal Officer, Plant Production and
Protection Division of FAO, on behalf of the Director-General of FAO and the Director-General of
the WHO.
Dr Kenmore welcomed the participants and gratefully acknowledged the contribution of the
two Expert groups for their hard work and valuable time in attending the meeting. He also thanked
the Experts’ national authorities, institutes and organizations for supporting their work with the
JMPR.
The JMPR has been operating for nearly 50 years, and its outputs are recognized as both
authoritative and invaluable in efforts to produce safe food and to facilitate international trade. The
value of JMPR is reflected in the continued support and commitment from governments of member
countries to this joint WHO/FAO activity.
At the Twenty-second session of the FAO Committee on Agriculture (COAG) held in June
2010, the members particularly stressed not only the importance of scientific advice from FAO and
WHO, but also the programme of capacity building in developing countries to facilitate greater
participation in the process of setting international standards.
The growing importance of the work of JMPR is also reflected in the recently adopted FAO
Strategic Programme which clearly recognised two Organisational Results that deal with crop
production and food safety. One of the FAO strategic objectives is entitled “Sustainable
intensification of crop production”, which integrates the range of activities required to assist
countries to produce more food in a sustainable manner. This includes development of technical
guidance, standards and providing assistance to developing countries in implementing the
international standards set up by the JMPR, JMPS and JMPM.
Dr Kenmore informed the Meeting that by mid-2009 the numbers of food insecure people
had exceeded one billion. By 2050 the world population is projected to exceed 9 billion, creating a
long-term challenge in food security. This population would require an estimated 70% more food,
and the resulting global demand for food, feed and fibre will require current crop production to
double, while conserving the natural resource-base that is the foundation of agricultural production.
Increasing crop productivity and quality through scientific sustainable practices is critical to
improved resource use efficiency, food security, rural development, livelihoods and environmental
quality.
The work of JMPR is an important element in the global effort to improve sustainable crop
production intensification and food safety in the world.
Dr Kenmore acknowledged the onerous workload to be accomplished by the present
Meeting, also noting the increasing demand for establishment of international MRLs in recent years.
He pointed out there are significant challenges facing the JMPR resource, and the issue will be
discussed at the next session of the CCPR. The Meeting needs to consider the practicability and
implications of new proposals.
2 Introduction
Dr Ezzeddine Boutrif, Director of Nutrition and Consumer Protection Division of FAO,

addressed the Meeting. He expressed gratitude at the great contribution by the JMPR to the Codex
MRLs, and highlighted that such a good collaboration between FAO and WHO in the joint
programme of food safety standards is extremely valuable and should be continued.
The Meeting was held as a result of recommendations made by previous Meetings and
accepted by the governing bodies of FAO and WHO that studies should be undertaken jointly by
experts to evaluate possible hazards to humans arising from the occurrence of residues of pesticides
in foods. The reports of previous Meetings (see Annex 5) contain information on acceptable daily
intakes (ADIs), acute reference doses (ARfDs), maximum residue levels (MRLs), and the general
principles that have been used for evaluating pesticides. The supporting documents (residue and
toxicological evaluations) contain detailed monographs on these pesticides and include evaluations of
analytical methods.
During the Meeting, the FAO Panel of Experts reviewed the pesticides under consideration,
and analysed their residues, including data on their metabolism, fate in the environment, and use
patterns. The Panel also estimated the maximum levels of residues that might occur as a result of use
of the pesticides according to good agricultural practice. The estimation of MRLs and supervised
trials median residues (STMR) values for commodities of animal origin was elaborated.
The WHO Core Assessment Group was responsible for reviewing toxicological and related
data in order to establish ADIs, and ARfDs, where necessary.
The Meeting evaluated a total of 23 pesticides, including 8 new compounds and 5 compounds
that were re-evaluated within the Code Committee on Pesticide Residues (CCPR) periodic review
programme for toxicity or residues, or both. The Meeting established ADIs and ARfDs, estimated
MRLs and recommended them for use by the CCPR, and estimated STMR and highest residue (HR)
levels as a basis for estimating dietary intakes.
The Meeting also estimated the dietary intakes (both short-term and long-term) of the
pesticides reviewed and, on this basis, performed a dietary risk assessment in relation to their ADIs or
ARfDs. Cases in which ADIs or ARfDs may be exceeded were clearly indicated in order to facilitate
the decision-making process of the CCPR. The rationale for methodologies for long- and short-term
dietary risk assessment are described in detail in the FAO Manual on the submission and evaluation
of pesticide residue data for the estimation of MRLs in food and feed (2009).
The Meeting considered a number of current issues related to the risk assessment of
chemicals, the evaluation of pesticide residues and the procedures used to recommend maximum
residue levels.
DECLARATION OF INTERESTS
The Secretariat informed the Committee that all experts participating in the 2010 JMPR had
completed declaration-of-interest forms, and that no conflicts had been identified.
General considerations 3
2. GENERAL CONSIDERATIONS
2.1 CONSIDERATION REGARDING JMPR CAPACITY AND RESOURCES

The Forty-second Session of the Codex Committee on Pesticide Residues (CCPR) held a discussion
about the limited resources of the Joint FAO/WHO Meeting on Pesticide Residues (JMPR), and
CCPR agreed that the United States of America (USA), with assistance from Cameroon and
CropLife, will prepare a discussion paper on how to address JMPR resource issues for consideration
by the next Session of CCPR in 2011. As this is an important subject for JMPR, this topic was
discussed at the current meeting to give a view from its perspective.
Requests to JMPR for pesticide assessments for new compounds and for compounds within
the periodic review programme of CCPR, as well as requests for assessments for additional maximum
residue level recommendations, have increased in recent years. Also, the complexity of questions, the
number of data provided per compound and the cost for meetings and publications have increased. In
contrast, financial and staff resources for the work of JMPR and for the JMPR Secretariat at FAO and
WHO have not increased, but rather have decreased. This has led to some backlog in the requested
evaluations.
JMPR is an independent international scientific expert group. It serves as a scientific
advisory body to FAO, WHO, FAO and WHO member governments, and the Codex Alimentarius
Commission (CAC). Advice to CAC on pesticides is provided via CCPR. The outcome of the JMPR
meetings feeds directly into national and international food standard setting, as well as into the
development of WHO recommendations and guidelines. The Meeting also plays an important role in
the continued improvement of risk assessment principles and methods, taking new scientific
developments into account.
Procedures and responsibilities for JMPR (as risk assessors) and CCPR (as risk managers)
are laid down in the risk analysis principles applied by CCPR 1.
Current JMPR working procedures

Procedural guidelines for JMPR have been published by WHO 2 and FAO 3. Key procedural aspects
are as follows:
• Preparation of meetings starts approximately 1 year before the meeting date with a public call
for data.
• Experts are selected according to FAO and WHO rules for expert meetings (from a standing
roster of experts), are invited as independent experts and do not represent their country or
organization.
• Tasks are assigned to experts who prepare, in advance of the meeting, draft evaluation
monographs, which also undergo an initial review.
• Final conclusions are reached at the meeting, and the final report is adopted before the close
of the meeting.
• Conclusions and recommendations are by consensus.
Operational aspects are as follows:
1
Codex Alimentarius Commission (2010) Section IV in: Procedural manual, 19th ed. Rome, Food and Agriculture
Organization of the United Nations, Joint FAO/WHO Food Standards Programme
(ftp://ftp.fao.org/codex/Publications/ProcManuals/Manual_19e.pdf).
2
http://www.who.int/ipcs/food/jmpr/guidelines/en/index.html
3
http://www.fao.org/docrep/012/i1216e/i1216e.pdf
4 General considerations
• In advance of the meeting, experts prepare and review working papers on a pro bono basis;
no consultancy fees or honoraria are provided.
• During the preparation period, extensive interactions via electronic means occur between
experts.
• The estimated average time investment for preparation of working papers is 2–3 months for
each expert doing the preparatory work.
• Experts often work on their own time; in other words, they perform this work to a large
degree in addition to their normal workload.
• Only the cost of participation at meetings (i.e., travel and per diem) is covered by FAO and
WHO.
• Original study reports (electronic format) are at hand and are consulted during the meeting as
needed.
• Frequent interactions and intense discussions within and between the groups (FAO and WHO
expert groups) are critical and impossible to be replaced by telephone or video conferencing,
in particular to resolve critical issues.
• Reports and evaluations (residue and toxicology) undergo technical editing to enhance
consistency and clarity.
• Over the course of 10 days (Joint Meeting, plus 5 days pre-meeting for the FAO panel), final
conclusions on safe intake levels, acceptable daily intakes (ADI) and acute reference doses
(ARfD) (compared with chronic and acute exposures) and recommendations on acceptable
maximum residue levels of pesticides in agricultural commodities are reached.
• For example, at the 2009 meeting, 31 experts evaluated a total of 24 pesticides for use in
many different crops (2008: 28 pesticides; 2007: 31 pesticides; 2006: 30 pesticides; 2005: 21
pesticides; 2004: 31 pesticides), and several hundred maximum residue level, highest
residues in edible portions of commodities found in trials used to estimate maximum residue
levels in the commodities (HRs) and supervised trials median residues (STMRs) were
recommended. The vast majority of these maximum residue level proposals have been
adopted as Codex maximum residue limits (CXLs).
• Currently, JMPR evaluates on average, within a 1-year time frame (from call for data until
final conclusion), between 25 and 30 pesticides and recommends several hundred maximum
residue level (and HRs and STMRs) for many pesticide/crop combinations.
• The overall direct cost to FAO and WHO per meeting is estimated at US$ 370 000, excluding
staff cost.
• With currently available resources, JMPR Secretariat and available experts, the meeting has
reached maximum capacity. For example, for the WHO group, a maximum of 10 full
evaluations per meeting are possible, considering one full evaluation per expert for preparing
the working paper and deliberations at the meeting.
Recent improvements of JMPR working procedures

• The transparency of the decisions taken has been increased.
• Work sharing has been implemented to build on existing national/regional evaluations to the
extent possible.
• Preparatory work via electronic means has increased.
• The FAO pre-meeting is working in two separate working groups to increase efficiency and
to be able to accommodate the evaluation of more compounds.
• The principles and methods for the risk assessment of chemicals in food, including pesticide
residues, have been consolidated and updated and were recently published as Environmental
Health Criteria 240 4.
• The FAO manual on the submission and evaluation of pesticide residue data was updated in
2009 5.
Factors affecting efficiency of the current JMPR work

• It is largely based on the goodwill of experts who work on a voluntary basis.
• The workload of experts in their regular jobs has increased, and less time can be allocated to
JMPR work.
• It is based to a large degree on employers’ willingness to let experts participate in JMPR
meetings.
• Extension of the current meeting (more experts, more compounds, longer time) is not
feasible.
• In the end, overall conclusions have to be agreed upon in all aspects by all experts.
• Longer meetings would require an even longer absence of experts from their offices.
• The effort to increase transparency of the decision-making process has led to very detailed
and lengthy reports and evaluations. The need for such detailed and lengthy reports and
evaluations could be reviewed and the guidance for preparatory work and reporting updated
accordingly.
• There is sometimes a lack of understanding by sponsors of the importance of submitting
complete data packages for JMPR evaluations in a timely manner.
Advantages of JMPR work and format

• It is an effective mechanism for problem solving and scientific consensus building.
• Recommendations are agreed upon and finalized within a specific time frame by an
independent international expert panel.
• Best practices are disseminated through involvement of participants from regulatory
authorities and academia from many different countries.
• It serves as capacity building and training for national evaluators.
• Decisions are based on scientific considerations only, using the latest scientific knowledge in
risk assessment.
• Maximum residue level recommendations serve as a basis for international safety-based
standards, Codex MRLs, which are applied to facilitate international trade.
4
FAO/WHO (2009) Principles and methods for the risk assessment of chemicals in food. Geneva, World Health
Organization; Rome, Food and Agriculture Organization of the United Nations (Environmental Health Criteria 240;
http://whqlibdoc.who.int/ehc/WHO_EHC_240_1_eng_front.pdf).
5
FAO (2009) Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and
feed, 2nd ed. Rome, Food and Agriculture Organization of the United Nations (FAO Plant Production and Protection Paper
197; http://www.fao.org/docrep/012/i1216e/i1216e.pdf).
Conclusions
• CCPR relies on the independent scientific advice of JMPR as providing the basis for
recommendation of international standards for pesticide residues in food and feed,
emphasizing the need for the continuing independence of this international expert meeting.
• JMPR/CCPR have improved and streamlined working procedures. This is now a very
efficient system within Codex, with a large number of standards recommended each year and
a short time frame between requests for scientific advice and establishment of global
standards.
• Globally harmonized international standards for pesticide residues are of increasing
importance, and experience from work-sharing exercises from previous JMPR meetings as
well as from registration authorities needs to be followed up. Recommendations designed to
improve efficiency should be implemented.
• Any changes to the current system, including increasing the frequency of JMPR meetings,
would have profound impacts, including a financial impact, and would need to be carefully
considered.
• In particular, implications for CCPR work also need to be considered with respect to timing
of meetings, but also regarding the number of recommendations coming from JMPR for
consideration by CCPR.
• The priority-setting process at CCPR needs to be strengthened, and existing criteria possibly
need to be reviewed and then enforced.
• It needs to be clarified whether the current increasing number of requests for evaluation is
only a temporary situation or is expected to be long term.
2.2 DIETARY RISK ASSESSMENTS CONDUCTED BY THE JMPR: NEED FOR

APPROPRIATE CONSUMPTION DATA FOR FURTHER METHOD
DEVELOPMENT
In the Codex Procedural Manual (19 ed., section IV, Working Principles for Risk Analysis for
Application in the Framework of the Codex Alimentarius, para 23), the following is stated:
‘Constraints, uncertainties and assumptions having an impact on the risk assessment should be
explicitly considered at each step in the risk assessment and documented in a transparent manner.
Expression of uncertainty or variability in risk estimates may be qualitative or quantitative, but should
be quantified to the extent that is scientifically achievable.’
The Meeting recognizes that evaluation of uncertainties in a risk assessment increases
transparency and, therefore, the credibility of the process. Consequently, reliance on worst-case
assumptions can be reduced and decision support improved. Uncertainty analysis can also identify
important data gaps, which can be filled to improve the accuracy of the estimation 6.
JMPR performs both long-term (chronic) and short-term (acute) dietary risk assessments. In
the majority of cases where there is an exceedance of a toxicological reference value, it is the ARfD
that is exceeded, by the short-term exposure assessment. In 2006 and 2007 (Report 2006, General
consideration item 2.4, and Report 2007, General consideration item 2.1), the Meeting discussed in
detail the uncertainties in the calculation of the international estimated short-term intake (IESTI), as
well as the interpretation of the outcome. Ways in which the dietary risk assessments could be
refined, both for hazard and for exposure assessment, are provided in the JMPR Report at the end of
each compound’s evaluation, in the section named ‘Dietary risk assessment’. From 2009 onwards, to
6
IPCS ‘Guidance Document on Characterizing and Communicating Uncertainty in Exposure Assessment’ (WHO 2008)
improve dissemination, this information has also been listed at the end of Chapter 4, where the results
of the dietary risk assessments are summarized.
However, it should be noted that the uncertainties addressed in these evaluations are
compound specific, relating, e.g., to the derivation of the ADI, the ARfD, the MRL, the HR, STMR
and processing factors. Generic uncertainties arising from the use of default parameters in the IESTI
model, such as consumption values, are not addressed. Nor is the conservativeness of the model as
used.
IESTI calculations are performed per pesticide × commodity combination with the outcomes
compared to the ARfD. It is a routine screening assessment that does not require an analysis of
uncertainty on every occasion, provided that appropriately conservative assumptions or safety factors
are included to take into account uncertainty. The EFSA PPR panel in its Opinion on acute dietary
intake assessment has shown that the IESTI methodology is, in general, sufficiently conservative
when applied in the MRL setting process 7. However in several fora (among others, JMPR) changes to
the IESTI methodology are under discussion, e.g., the possible replacement of HR by MRL in the
IESTI calculations. To ensure international harmonisation of methodology, changes cannot be
implemented by JMPR alone, to address this, a FAO/WHO consultation is recommended, as the
Meeting noted in 2006 and 2007.
In addition, whilst risk assessments by JMPR are aimed at the global population, the Meeting
uses Large Portion data collected by WHO/GEMS/Food from only a limited number of countries.
Moreover the GEMS/Food data are sometimes older than those used for the same country in regional
assessments, e.g., Europe. The Meeting concluded that the IESTI calculations should be based on the
best available data and therefore, in view of these potential limitations, the WHO/GEMS/Food Large
Portion database and its related unit weight database should be updated (see also General
consideration item 2.3).
In conclusion, that in order to strengthen its dietary risk assessments, the Meeting strongly
recommends that:
FAO and WHO host a consultation, the main objectives of which would be the continued refinement
of the estimation of the short-term dietary intake of pesticides and the interpretation of the outcomes
of short-term dietary risk assessment conducted by JMPR, including characterization of uncertainties.
Codex Member States prioritize the submission of their most recent data on Large Portions and unit
weights to WHO/GEMS/Food, to ensure that the JMPR uses the best available information in its
dietary exposure assessments.
2.3 THE NEEDS OF JMPR CONCERNING FOOD CONSUMPTION DATA: UPDATE

ON THE ACTIVITIES OF THE GEMS/FOOD PROGRAMME
For its dietary risk assessment, the JMPR relies on food consumption data as collected by the WHO
GEMS/Food Programme. Although most parameters in the dietary risk assessment are dependent on
the compound, the food consumption data are generic, and play a key role in the assessment and its
related uncertainties (see General consideration item 2.2). It is therefore very important that the food
consumption data are reliable and as current as practicable.
The chronic (long-term) dietary risk assessment (IEDI) is based on the 13 GEMS/Food
Cluster diets, which were introduced in the JMPR automated spreadsheets at the 2006 Meeting (see
General consideration item 2.3, JMPR 2006). The 13 clusters are globally representative and, as a
7
Opinion of the Scientific Panel on Plant protection products and their Residues on a request from the Commission on acute
dietary intake assessment of pesticide residues in fruit and vegetables (Question N° EFSA-Q-2006-114) adopted on 19 April
2007. The EFSA Journal (2007) 538, 1-88
http://www.efsa.europa.eu/en/scdocs/scdoc/538.htm
consequence, are appropriate for use in Codex standard setting. The mean consumption values in the
cluster diets are derived from FAO Food Balance Sheets (FBS). The cluster diets were last updated in
2006 and as new FAO FBS are now available the cluster diets should be updated.
In contrast, the acute (short-term) dietary risk assessment (IESTI) is based on national food
consumption survey data. Individual countries have supplied their so-called ‘Large Portions’ (97.5th
percentile of the consumption distribution, “consumers only” to GEMS/Food. Existing data need to
be updated based on the latest national surveys available. Member States which have recently
performed food consumption surveys should be encouraged to submit data in order to ensure a
broader coverage of regions.
The current Meeting was informed of renewed activities in GEMS/Food programme. In order
to improve the networking, the national contact points are in the process of becoming National
Institutions recognized by the WHO. These institutions will then be able to develop multilateral
collaborations with other data providers, as well as with the WHO GEMS/Food Collaborating
Centres that also deal with methodological developments and training.
The structure of the GEMS/Food database will be improved with a new food classification
for data exchange compatible with the Codex Alimentarius and through the inclusion of both raw
agricultural commodities and processed foods. A new web-based system for data submission (OPAL-
web) will also soon be implemented.
Recently, the WHO set up two expert groups; one considering occurrence data, the other,
food consumption data. The conclusions and recommendations of these working groups will be used
to improve the GEMS/Food programme with regard to data submission and data interchange.
The collection of data on the food consumption of individuals, with a particular focus on
consumption by children, has become one of the major objectives of the GEMS/Food programme.
This in addition to the collection of data for the cluster diets will enable the use of probabilistic
modelling and, for pesticide risk assessment, the derivation of Large Portions in a harmonized while
providing improved representation of the global population.
The current Meeting welcomed these recent developments in the GEMS/Food programme
and also recommends consideration be given to collecting harmonised food consumption data for
specific groups of the population in addition to children.
2.4 INFORMATION ON THE USE OF PESTICIDES REQUIRED FOR THE

ESTIMATION OF RESIDUE LEVELS IN MINOR CROPS
The Forty-second Session of the CCPR recommended that when residue data on minor crops are
submitted by developing countries, the application of pesticides should match the critical GAP and
that an official letter would be acceptable if labels were not available.
As a follow-up to the discussions at the CCPR, reports of field trials on mango, okra and
papaya were provided by the Pesticides Initiative Programme for evaluation by the current Meeting.
However, no approved label or an official letter was provided from the responsible government
agency. The general rules, as outlined in the FAO Manual, precludes the evaluation of residue data
for estimation of maximum residue levels, STMR and HR values when critical information is
missing.
However, the Meeting in acknowledging the need for Codex MRLs to be established for
minor crops and the diverging practices in developing countries, evaluated the submitted residue data,
and conditionally made recommendations for maximum residue levels, STMR and HR values for
bifenthrin (mango, papaya and okra) and difenoconazole (papaya). The acceptability, or otherwise, of
these recommendations can therefore be decided by the CCPR, noting the lack of information on
official use patterns.
The Meeting emphasised that this exception should not be a general practice and that data
submitters should comply with the requirements as specified in the FAO Manual 8.
Chapter 3 of the FAO Manual 9 on the submission and evaluation of pesticide residue data
provides detailed information on the data requirements for the estimation of maximum residue levels.
GAP summaries are intended as an aid to the evaluation of submitted data and are to be provided in
addition to certified labels. It is emphasised that copies of original labels have to be provided by the
manufacturer(s), or other data submitters, in addition to the summary information.
The most essential information, which could be provided for the registered/authorised use of
a pesticide includes:
• Exact description of crops and use situations with English name and the commodity
description given in the Codex Classification of Foods and Animal Feeds;
• The formulation of the pesticide product using the two-letter coding system used in FAO
pesticide specifications and given in Appendix III of the FAO Manual;
• The concentration of active ingredient in the formulated product expressed in g/L for liquids
and w/w basis as g/kg or % of active ingredient in the solid product;
• The type of treatment such as ULV or high volume spraying and the crop growth stage at the
final application;
• Maximum application rate expressed as kg ai/ha or kg ai/hL, number of applications, interval
between applications and pre-harvest interval corresponding to specified application rate, if
relevant, and maximum total application rate per season where specified;
In cases where use details are given in g/hL or kg/hL (spray concentration), state the spray
concentration but do not calculate the kg ai/ha equivalent with the average amount of spray liquid
used per hectare.
Estimation of group maximum residue levels for plant commodities

The estimation of maximum residue levels for a commodity group, as opposed to individual
commodities, is common practice by the JMPR. The aim of this approach is to cover minor and very
minor crops by a group maximum residue level.
Many factors can influence the proposal of a group maximum residue level or an individual
maximum residue level with the final decision being made on case by case basis. For support and
comparability, the JMPR developed 14 (a – n) general principles to estimating group maximum
residue levels which are described in detail in Chapter 6 of the FAO Manual (2009) 10.
In general, the 2010 JMPR confirmed these rules but discussed a revision of principle (a)
which requires “The use pattern...... should be the same and applicable for the whole group.”
The Meeting noted that a group maximum residue level can also be recommended for some
cases where the GAP for the individual commodities is not identical and that principle (a) should be
revised as follows:
“In general, the use pattern should be similar and applicable for the whole crop group. If the
use patterns are different for the individual crops but produce similar residues, a group maximum
residue level might be recommended.”
8
FAO Manual (2009), Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in
food and feed. FAO plant production and protection paper 197
9
ibid. Chapter 3 Data and information required for JMPR evaluations.
10
FAO Manual (2009), Submission and evaluation of pesticide residues data for the estimation of maximum residue levels
in food and feed. 6.7 Estimation of group maximum residue levels STMR and HR values for plant commodities. FAO plant
production and protection paper 197, p 97–101
For acute dietary intake purposes, the highest residue (HR) value of the commodity on which
the maximum residue level is based, should be applied to the single commodities of the whole crop
group. In cases when the ARfD is exceeded when using the group HR, a group maximum residue
level cannot be recommended.
The examples below are based on evaluations of the 2010 JMPR and are explained in detail
in the Report (5.2 and 5.22). Example 1 illustrates the derivation of a group maximum residue level
and example 2 shows a case where no group maximum residue level could be recommended because
of short-term intake concerns in one commodity.
Example 1: Thiamethoxam in berry fruits
Information on GAP and residue data

Cranberry
US GAP: WG formulation, foliar sprays at 0.070 kg ai/ha, 30 days PHI.
Six cranberry trials at GAP, where residues found were all < 0.01 mg/kg.
Blueberries
Nine blueberry trials at GAP, where residues found were: < 0.01, 0.05, 0.06, 0.06, 0.07, 0.07, 0.07,
0.07 and 0.11 mg/kg.
Caneberries
Six caneberry trials at GAP, where residues were: 0.01, 0.06, 0.10, 0.12, 0.19 and 0.20 mg/kg
Strawberry
Eight strawberry trials at GAP, where residues were: 0.02, 0.02, 0.05, 0.05, 0.06, 0.14, 0.22 and
0.26 mg/kg.
Grapes
Spain and Italy GAP: WG formulation, foliar sprays at 0.050 kg ai/ha, 21 days PHI.
Eleven grape trials at GAP, where residues were: < 0.02 (2), 0.02, 0.02, 0.02, 0.04, 0.04, 0.07, 0.13,
0.17 and 0.21 mg/kg
Recommendation
Residue data with suitable GAP were available for strawberry, cranberries, blueberries, caneberries
and grapes. The Meeting noted that thiamethoxam residues were highest in strawberries.
On the basis of the foliar applications on strawberries in eight US trials, the Meeting
estimated a maximum residue level of 0.5 mg/kg for thiamethoxam in berries and other small fruits.
Grapes are often evaluated separately because the crop is rarely included in a berries crop
group as GAP and specific data are needed for its important processed commodities. However, the
estimated maximum residue level for grapes closely agrees with that estimated for the other berry
fruits, so the Meeting agreed to include the grapes with the berry fruits proposals.
Example 2: Bifenthrin residues in fruiting vegetables, other than cucurbits
Information on GAP and residue data

Peppers
US GAP 0.022–0.11 kg ai/ha, PHI of 7 days
Eleven pepper trials at US GAP, where bifenthrin residues were: < 0.055, 0.07, 0.09, 0.10, 0.11, 0.14,
0.17, 0.21, 0.23, 0.24 and 0.31 mg/kg.
Okra
Ivory Coast GAP: 2 × 0.04 kg ai/ha, PHI of 2 days
Four okra trials at the Ivory Coast GAP, where bifenthrin residues were: 0.04, 0.05, 0.09 and
0.11 mg/kg.
Tomato
US GAP 0.022–0.11 kg ai/ha, PHI of 1 day; Mexican GAP 0.06 kg ai/ha, PHI of 1 day
No residue trials at the US GAP were available
Seven trials at the Mexican GAP, where residues were: 0.03, 0.04, 0.06, 0.06, 0.09, 0.15 and 0.15
mg/kg.
Egg plant
US GAP 0.034–0.11 kg ai/ha, PHI 7 days
Three trials on egg plant at the US GAP: residues < 0.05 mg/kg (3)
Six trials on tomato at the US GAP for egg plant, where residues found were: < 0.05 (4), 0.07 and
0.10 mg/kg.
Recommendation
Residue data with suitable GAP were available for peppers, tomatoes, egg plant and okra to enable
the estimation of a group maximum residue level for fruiting vegetables, other than cucurbits (except
mushrooms and sweet corn) to be considered. The Meeting noted that bifenthrin residues were
highest in peppers. The ARfD of 0.01 mg/kg bw was exceeded if the estimated group HR of 0.31
mg/kg based on the data on pepper was applied for egg plant (130% of the ARfD for children). Using
the HR of 0.10 mg/kg for eggplant to calculate the short-term intake there was no exceedance of the
ARfD. Therefore the Meeting concluded to estimate maximum residue levels for the individual crops
as follows: peppers 0.5 mg/kg, tomatoes 0.3 mg/kg, egg plant 0.3 mg/kg, okra 0.2 mg/kg.
2.5 PRINCIPLES AND GUIDANCE ON THE SELECTION OF REPRESENTATIVE

CROPS FOR THE EXTRAPOLATION OF MRLS
The Forty-second Session of the CCPR agreed to ask the 2010 JMPR for an opinion on the text of the
proposed principles and guidance on the selection of representative crops for the extrapolation of
MRLs to commodity groups. At previous meetings the JMPR has provided advice on the topic of the
use of extrapolation of residues trials on crops to establish commodity group MRLs (General
consideration item 2.8 2007, General consideration item 2.10 2008). The current Meeting has
provided further guidance on how it estimates group maximum residue levels (General consideration
item 2.5). The proposed draft “Principles and guidance on the selection of representative crops for the
extrapolation of MRLs” (ALINORM 10/33/24 Appendix XI) is generally in agreement with the
opinions expressed previously by the 2007 and 2008 Meetings of the JMPR. The Meeting especially
welcome the recognition by CCPR that there will be, from time to time, the need to consider
alternative representative crops for use in extrapolation of residues in one crop to estimate a group
maximum residue level.
The guidance will be particularly useful during the planning stages of supervised trials that
will produce data suitable for support of group MRLs.
The JMPR looks forward to the finalisation of this document.
2.6 STATISTICAL CALCULATION OF MRLS

The Meeting recalled that the 2009 CCPR had invited JMPR to provide input into the development of
the “OECD MRL Calculator” and to test it when once available (ALINORM 09/32/24, para 34–40).
The Meeting recalled that during 2009 and early 2010 the Draft OECD MRL Calculator had
gone through a series of modifications, and that the March 2010 version (2010-03-30), circulated to
interested parties for testing, was close to being finalised. In this version, a new paradigm has been
adopted, to use a non-distributional approach to propose an MRL value based on the highest result
selected from:
• the highest residue of the data set (HR),
• the mean of the selected data set plus 4 times the standard deviation of the data set (“Mean +
4*SD”)
• 3 times the mean value (3*mean) and including a correction factor to accommodate the
frequency of residue values below the LOQ.
A copy of this version was provided to JMPR for use at this Meeting (in conjunction with the
current NAFTA Calculator) so that comments could be provided to CCPR on JMPR experiences in
using the calculator.
The Meeting noted that the goals of the calculator are (1) to provide national regulators with
a tool to estimate MRLs that reflect at least the 95th percentile of the underlying residue distribution
and thus reduce the chance of non-compliance from pesticide use according to GAP and (2) to
provide a mechanism for arriving at a harmonized MRL estimate when the same data are considered
by different authorities and organizations.
The calculator was used by the Meeting when considering maximum residue levels for a
number of compounds, and the proposed maximum residue level values were compared with the
levels recommended using expert judgement 11. The Meeting observed that the two estimates were
generally in agreement. There was a tendency for the calculator to propose higher values, not
unexpected due the higher levels of uncertainty associated with the small data sets often available to
the Meeting.
The experiences of the Meeting when using the calculator were:
• The calculator is easy to use and the draft User Guide 12 provides clear and comprehensive
information on the calculations used to propose maximum residue level values and on how to
enter the data and retrieve the results. The warning messages relating to small data sets and
high levels of left-censored data are particularly useful.
• Selection of the appropriate data set is a critical first step when using the calculator.
• The opportunity to compile multiple output columns for different commodities and for the
output to display the derivation of the proposed value would be of particular help to JMPR.
11
See Section 2.1 of the 2009 JMPR Report “Transparency in Maximum residue level estimation process: further
considerations”
12
OECD MRL Draft Calculator User Guide – 13th March 2010
• In both the Users Guide and the related draft White Paper 13, considerable detail is provided
on how to deal with data sets with a high proportion of left-censored data. The opinion of
JMPR is that in most instances, the current JMPR practices 14 adequately deal with this
matter.
The Meeting concluded that the tested version of the OECD Calculator is a helpful tool to
supplement expert judgement and to promote consistency in the elaboration of MRLs. The Meeting
looks forward to the publication of the final version and would be pleased to contribute to any further
refinements of the current version, noting that several JMPR members have been actively engaged
with the OECD calculator working group over the past two years.
2.7 APPROPRIATE VALUE FROM REPLICATE SAMPLES FROM A SUPERVISED

FIELD TRIAL FOR USE IN STATISTICAL CALCULATION OF THE MRL
ESTIMATE
Appropriate value from replicate samples from a supervised field trial for use in statistical calculation
of the maximum residue level estimate
The Meeting noted that the instructions/background to the OECD statistical calculation of maximum
residue levels spreadsheet recommends the input of the average result from each independent field
trial. If more than one replicate composite sample is collected, the average result from the analyses of
the replicates should be used. The OECD work group states that the average is the best estimate of
the ‘true’ value of the residue level for the particular trial. The more replicates available, the more
robust is the estimate.
The JMPR documented its practice in 2007 (General consideration item 2.5, JMPR Report
2007). It was recommended to use the highest value from replicate samples of a given field trial. This
was intended to include a reflection of the intra-trial variability of trial results and to provide a
sufficient maximum residue level estimate.
The current Meeting reconsidered the situation. The inter-trial variability is the value being
measured for entry into the calculation. For a given pesticide, supervised trials conducted under the
same use patterns in different locations will yield a range of residue concentrations on the crop
commodity, and it is this range of results that are needed to derive a maximum residue level estimate.
The range is reflected in the set of average values. The use of the high value from each trial will skew
the estimate somewhat higher.
Replicate trial results are normally provided from only the NAFTA region, and then there are
only two values. Two values do not provide a good measure of intra-trial variability for statistical
calculations. Moreover, trials from the majority of countries/regions consist of one result, and there is
no possibility of determining an average or a highest value. The single value may be higher, lower, or
the same as a hypothetical replicate.
The Meeting therefore concluded to use the average of replicate field trial residue values in
establishing the data set for statistical calculation of maximum residue level estimates. However, the
interpretation of the estimate must take into account individual replicate values contributing to the
data set that exceed the estimate. This practice will be implemented with the 2011 JMPR.
13
Draft OECD MRL Calculator White Paper. 14th July 2010
14
JMPR Manual, Chapter 6.5
2.8 THE APPLICATION OF PROPORTIONALITY IN SELECTING DATA FOR MRL

ESTIMATION
At the 2010 CCPR delegations suggested that JMPR could have recommended maximum residue
level for a number of commodities when the supporting residue data were from trials involving
treatments more than 25% higher than the authorized GAP maximum application rates in situations
where there were no dietary intake risks (CCPR, Report of the Forty-second Session, April 2010,
ALINORM 10/33/24, paragraph 72).
In the estimation of maximum residue levels, JMPR accepts that the nominal rate of
application in a trial would normally be considered consistent with GAP when it is within
approximately ± 25 % of the GAP rate, which includes the probable variation in commercial practice
(2009 FAO Manual, Second Edition, available on the web 15.
The policy is similar to that adopted by regulators, for instance the OECD crop field trial
guideline states “to date there are no definitive analyses that would allow trials with widely varying
application rates or PHIs to be combined. However, variation of ± 25% of application rate is
currently deemed acceptable (i.e., 25% rule)”.
A proportional relationship between pesticide application rate and residues on the harvested
commodity would imply that residues from field trials with higher or lower application rates could be
proportionately adjusted (or “scaled”) allowing estimates to be made of residues that would have
been present if the application rate matched the maximum on the product label. Use of such a
procedure would often increase the size of the residue database supporting an MRL and potentially
allow better results from statistical methods for MRL estimation.
In the current Meeting residue trial evaluation reports of the JMPR for the period 2000
through 2009 were used to investigate the effect of application rates on residues, where side-by-side
sets of field trials were available. A total of 1146 sets of trials were located where crops were treated
in side-by-side trials with application rate or spray concentration being the only parameter varied.
Data were located for 52 different active ingredients encompassing herbicides, insecticides and
fungicides. Pre-harvest intervals (PHIs) ranged from 0 to 294 days.
The analysis of residue trial data confirms the assumption that residues of insecticides and
fungicides in plant commodities do indeed scale with application rate, allowing prognosis on residue
levels resulting from field trials conducted using deviating application rates. Proportionality was
found to be independent of the ratio of application rates, at least for the range 1.3× to 10× or their
reciprocal, formulation type, application type (foliar spray, soil spray and seed treatment) , PHI,
residue concentration, crop or pesticide (except herbicides or growth regulators).
The Meeting decided it would only consider the method of proportionality in cases, where
residue data according to GAP are not sufficient for a recommendation or where additional
information on residues in treated commodities useful for the evaluation may be achieved. When
considering proportionality, the following aspects need to be taken into account:
General aspects
Active substances: Proportionality of application rates to the residue concentration was investigated
mainly for insecticides and fungicides. For herbicides and growth regulators proportionality of
residues is not probable, since changes in application rates may strongly interfere the plant
development itself and thus with the resulting residue concentration remaining. The Meeting decided
that the principle of proportionality may not be used in cases, where application of a pesticide may
affect crop growth.
15
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-docs/en/
Commodity type: Proportionality may not apply to residues in commodities intended for
trade, human consumption or animal feed purposes resulting from unpredictable residue transfer
(e.g., as a side effect following mechanical harvesting or shuck-splitting).
Special consideration is required for scaling of residues in protected edible parts of the
commodities for dietary intake purposes. While residues are generally proportional in the whole
commodity (e.g., citrus fruit), careful application of scaling factors is required for the corresponding
protected parts.
Type of application: Proportionality of residues was investigated for spray (foliar and soil)
and seed treatments only. Based on the characteristics of the use as soil spray treatment,
proportionality may also be assumed for related modes of application like drenching, drip irrigation
or hydroponic application. For other forms of treatment (e.g., granular application) the effect on the
proportionality has, as yet not been investigated.
Scaling of residue data

Guidance is required for the use of scaling in residue evaluation and for the selection of residue
values from trials, where data for a range of application rates are available. As a general approach the
scaling of individual trial results should be calculated according to the following equation:
GAP rate
Scaled residue = Measured residue ×
Trial application rate
In the data investigated the differences in the ratios of application rates ranged up to a factor
of ×10 for the field trials analysed. Due to the structure of the data a satisfying number of individual
results were reported for a ratio of application rates of 1.15 to 4.4 only.
Under consideration of the likely larger relative uncertainty of low residues the Meeting
decided to limit the up-scaling of residues to a factor of 3. On the other hand more reliable results
obtained from overdosed field trials might be down-scaled by a factor of up to 5 (multiplication by a
factor of 0.2), normally providing a more reliable data basis in comparison to measured low residues.
This approach results in an acceptable range of scaling factors of 0.2 to 3. A general example for the
scaling of residues is presented below:
Example 1: Application rate < GAP rate

kg ai/ha Commodities Scaling factor Pesticide A residue (mg/kg)
Trial 0.045 Gin trash 0.32
Example 2: Application rate > GAP rate

Trial 0.225 Gin trash 1.9
Special consideration is required for field trial results below the LOQ of the analytical
method. In general the LOQ represents the minimum amount of residue still being quantifiable with
an acceptable certainty of measurement and identification. Normally this situation requires an
appropriate substitution method for these results followed by sensitivity analysis to describe the
impact of the respective trial on the overall assessment. It is proposed to not apply the method of
scaling to residue data below the LOQ.
In cases of up-scaling the elevated uncertainty within multiplying non-detects to levels,

where finite results may be possible, was considered no appropriate. Therefore data below the LOQ
should be taken into account for up-scaling.
On the other hand down-scaling of residue data below the LOQ would result in even lower
residues. For these cases the Meeting agreed that, as a conservative approach, the LOQ may also be
used in the scaled dataset for an assessment.
Example 3: Application rate < GAP rate, residue below the LOQ
Trial 0.045 Gin trash < 0.01
Scaled residue 0.07 No scaling possible Do not use value
according to GAP
Example 4: Application rate > GAP rate, residue below the LOQ
Trial 0.225 Gin trash < 0.01
Scaled residue 0.07 No scaling factor used < 0.01
according to GAP
Reporting of scaled residues within the JMPR evaluation

The application of scaling is part of a part of the assessment process and should be reported in the
appraisal. It is therefore proposed to separate the scaling into up to three steps, which include the
reporting of the unadjusted data, the application of scaling factors and finally the combination of data
generated with different application rates. For a better understanding one simple example (requiring
only 2 steps) from the 2010 JMPR Report for chlorantraniliprole and an artificial consideration are
presented below:
Example 1
Chlorantraniliprole field trials on alfalfa were made available to the Meeting from the USA (GAP:
73 g ai/ha, 1 application/cutting, PHI of 0 days and a maximum application per season of 224 g
ai/ha).
Chlorantraniliprole residues on alfalfa forage treated at 1.5× the maximum rate were 2.0, 2.1,
3.0, 3.0, 3.2, 3.7, 4.1, 4.6, 4.8, 5.2, 5.3, 5.4, 5.7, 5.7, 5.7, 5.9, 5.9, 6.2, 6.2, 6.3, 6.7, 6.8, 6.9, 6.9, 7.5,
7.6, 7.6, 7.8, 8.3, 11 mg/kg (fresh weight basis). When corrected for reported moisture contents the
residues were 9.5, 9.7, 11, 13, 14, 16, 19, 19, 20, 23, 23, 23, 24, 24, 25, 26, 26, 27, 29, 29, 30, 30, 31,
32, 33, 34, 34, 36, 42, 43 mg/kg (dry weight basis).
The residues scaled to the same application rate as GAP were calculated by dividing by 1.5
and are (n = 30): 6.3, 6.5, 7.3, 8.7, 9.3, 10.7, 12.7, 12.7, 13.3, 15.3, 15.3, 15.3, 16, 16, 16.7, 17.3,
17.3, 18, 19.3, 19.3, 20, 20, 20.7, 21.3, 22, 22.7, 22.7, 24, 28, 28.7 mg/kg. Using the data scaled for
application rate, the Meeting estimated an STMR value for chlorantraniliprole in alfalfa forage of
17 mg/kg (dry weight basis).
Example 2
Pesticide A is registered on green beans with one spray application of 0.073 kg ai/ha with a PHI of 0
days.
Supervised field trials conducted at different application rates are available resulting in the
following residues in green beans after a PHI of 0 days:
Application rate 0.03 kg ai/ha: < 0.01, < 0.01, 0.05, 0.07, 0.08 mg/kg
Application rate 0.06 kg ai/ha: 0.02, 0.03, 0.09, 0.15 mg/kg
Application rate 0.12 kg ai/ha: < 0.01, 0.11, 0.19, 0.19 and 0.2 mg/kg
Additional supervised trial data were available on green beans treated at rates of 0.02 kg
ai/ha, which would require scaling higher than the maximum factor of 3 for up-scaling to comply
with GAP.
Scaled residues of Pesticide A in green beans after a PHI of 0 days were:
Application rate 0.03 kg ai/ha scaled to GAP (scaling factor: 0.073 kg ai/ha / 0.03 kg ai/ha =
2.4): 0.12, 0.17, 0.19 mg/kg
Application rate 0.06 kg ai/ha (± 25% GAP, no scaling required): 0.02, 0.03, 0.09,
0.15 mg/kg
Application rate 0.12 kg ai/ha scaled to GAP (scaling factor: 0.073 kg ai/ha / 0.12 kg ai/ha =
0.61): < 0.01, 0.067, 0.12, 0.12, 0.12 mg/kg
The Meeting concluded that scaled residues in green beans treated at different application
rates are not significantly different and may be combined for a recommendation. The combined
scaled residues of Pesticide A in green beans were: < 0.01, 0.02, 0.03, 0.067, 0.09, 0.12(4), 0.15, 0.17
and 0.19 mg/kg.
The Meeting estimated a maximum residue level, and STMR and an HR for Pesticide A
based on scaled residue data on green beans of 0.3, 0.12 and 0.19 mg/kg, respectively.
2.9 FURTHER CONSIDERATION OF EXPERT JUDGEMENT IN EVALUATING

RESIDUE TRIALS
The Meeting considered the use of expert judgment in evaluating supervised residue trials at the 2009
Meeting and provided an item describing in general terms how this occurs. A paper has recently been
published that contains information that may be of use in informing expert judgment (MacLachlan
and Hamilton 2010 16). The authors have assembled a database of residues on crops receiving a single
foliar spray application normalized to an application rate of one kg ai/ha (or one kg ai/hL for spray
concentrations). The approach is similar to that used for many years in the estimation of residues on
vegetation used in initial tiers of environmental risk assessment (Hoerger and Kenaga 1972 17;
Fletcher et al. 1994 18; Pfleeger et al. 1996 19). It is assumed that provided the interval between
application and measurement is short, the measured residues provide a good measure of the volume
of spray intercepted by the part of the plant that is of interest when normalized for application rate.
It is anticipated that the crop specific information on residues at day of application can be
used in two ways to assist the work of the JMPR:
• to derive expected median and highest residues on the day of a spray application; and
• to predict likely median and high residues following multiple applications at various intervals
after the last spray. The latter is only possible for those pesticides for which the decline of
16
Maclachlan DJ and Hamilton D. 2010. A new tool for the evaluation of crop residue trial data (day zero-plus decline),
Food Additives & Contaminants: Part A, 27:347 — 364
17
Hoerger FD, Kenaga EE. 1972. Pesticide residues on plants, correlation of representative data as a basis for estimation of
their magnitude in the environment. Environ Qual. 1:9–28.
18
Fletcher JS, Nellessen JE, Pfleeger TG. 1994. Literature review and evaluation of the EPA food-chain (Kenaga)
nomogram, an instrument for estimating pesticide residues on plants. Environ Toxicol Chem. 13:1383–1391
19
Pfleeger TG, Fong A, Hayes R, Ratsch H, Wickliff C. 1996. Field evaluation of the EPA (Kenaga) nomogram, a method
for estimating wildlife exposure to pesticide residues on plants. Environ Toxicol Chem. 15:535–543
residues in supervised trials follow simple first order kinetics and for which information is
available on DT50 values.
The likely median and high residues can be compared with results from actual supervised
residue trials and estimates provided by statistical calculators to support recommendations for
maximum residue levels.
It was generally felt the tool might be suitable for use in 20% of cases. The day 0 residue
database only applies to foliar application of pesticides.
The paper provides details of how the information may be used.
At the present Meeting the approach was as an adjunct to other considerations and statistical
calculations in estimating maximum residue levels used in the evaluation of chlorantraniliprole
residues in oranges and cabbages.
2.10 USE OF THE OECD FEED TABLE

The OECD feed table from the OECD Overview Guidance 20 is currently used by JMPR to calculate
the dietary burdens for the purpose of interpreting the results of feeding studies. The latest available
version of the OECD feed table is included in the 2009 FAO Manual, Second Edition (Appendix IX)
and is available on the web 21.
The consumption information from the OECD feed table is combined with estimates of
residues on the feed items (STMR or HR values, as appropriate) to arrive at estimates of the total
dietary burden of beef cattle, dairy cattle, broilers, and laying poultry for the pesticide under
consideration. These values are then compared to the results of feeding studies to arrive at estimates
of the levels of pesticides in milk, eggs, meat, fat, and edible offal. Results for cattle and poultry will
be extrapolated to all relevant livestock. The detailed procedure is described in the 2009 FAO
manual.
The JMPR procedure maximizes livestock dietary-intake burdens of the pesticide by taking
into account the feed items from different Codex classes, e.g., forage, grain and byproducts, and
emphasizes the use of diverse feed items with maximum pesticide residues. This calculation is
performed for every region for which information on livestock burden is available, the intention
being to arrive at estimates that are inclusive of livestock burdens worldwide.
The 2009 JMPR decided that some modification to the OECD feed table would be needed for
the version placed in the FAO Manual. The OECD had grouped feed items into four broad categories:
forages; roots and tubers; cereal grains/crop seeds; byproducts of processing. The category “forages”
as used by OECD includes virtually all plant commodities other than grains and roots and tubers
(forage, fodder, silage, hay, straw, leaves and tops, and grasses), and thus encompasses a much wider
selection of commodities than the Codex definition.
The 2009 JMPR modified the OECD feed table to denote the Codex Commodity Code for
each feed item listed in the OECD table and if such a code was not available the Codex Group Code
(Appendix IX, 2009 FAO manual, Second Edition). This is important because in performing the
calculation of livestock dietary burden, the total burden for the group is considered as well as the
burden coming from each individual commodity. For example, if residues occurred in clover, alfalfa
fodder, and bean fodder (the group of legume animal feeds), they should be considered in sequence,
20 OECD Environment, Health and Safety Publications. Guidance Document on overview of residue chemistry studies.
Series on Testing and Assessment No. 64 and Series on Pesticides No. 32. Revised February 2009, Environment Directorate,
Paris.
21
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-docs/en/
beginning with the calculated highest residue in the dry-weight feed. The detailed procedure is
described in the 2009 FAO Manual.
The Meeting of the 2010 JMPR decided that some further modifications in the OECD feed
table are needed to avoid situations where commodities with unique codes might be treated as
separate feed items. The 2010 JMPR replaced the Codex Commodity Codes allocated to the OECD
feed items in 2009 by the more general Codex Group Codes and corrected some of the Codex Group
Codes allocated by the 2009 JMPR. The Codex Group Code allocation is only for the benefit of
dietary burden calculations conducted by JMPR. The allocation of Codex Group Codes to OECD
feed items does not have any impact on the existing Codex Classification System, nor does it have an
impact on the OECD feed table.
The OECD feed table “FORAGES” group corresponds to the Codex Group numbers 050,
051 and 052 (see the table below) for forage and fodder crops. The individual commodities in the
OECD feed table were assigned to Codex Group Codes AL, AF/AS, AM/AV as appropriate. For the
purpose of dietary burden calculation the AF and AS (forage/straw) and AM and AV (fodder/forage)
were taken as one group. Commodities having a different Codex Group Code like VB (head
cabbages) or VL (rape greens) were reallocated as AM/AV.
The OECD feed table “ROOTS & TUBERS” group corresponds to the Codex Group number
016 (see the table below). The individual commodities in the OECD feed table were given the Codex
Group Code VR as appropriate.
The OECD feed table “CEREAL GRAINS/CROPS SEEDS” corresponds to the Codex
Group numbers 015 and 020 (see table) for pulses and cereal grains. The Meeting of the 2010 JMPR
decided that oilseeds (Codex number 023), should also be allocated to this group. The individual
commodities in the OECD feed table were given the Codex Group Code VD, GC and SO as
appropriate.
The OECD feed table “BYPRODUCTS” group corresponds to the Codex Group numbers
058, 059, 065, 069 and 071 (see table) for processing by-products. The individual commodities in the
OECD feed table were assigned to Codex Group Codes AB, CM/CF, DM, or SM as appropriate. For
the purpose of dietary burden calculation the CM and CF (cereal milling fractions) were taken as one
group.
The Meeting decided that sweet corn cannery waste better fitted with the forages group,
while the alfalfa meal better fitted in the byproducts group.
For dietary burden calculations there are 11 groups to consider: AB, AF/AS, AL, AM/AV,
CM/CF, DM, GC, SM, SO, VD, VR. A revised version of the OECD feed table is to be made
available on the web. The 2010 JMPR already used the revised allocation groups in the calculation of
livestock dietary burden.
OECD Codex Group Codex Group name Codex Group Code

No
Forages 050 Legume animal feeds AL
051 Straw, fodder and forage of cereal grains and AF (forage)
grasses (including buckwheat fodder) AS (straws and fodder, dry)
052 Miscellaneous Fodder and Forage crops AV (forage)
AM (fodder)
Roots & Tubers 016 Root and tuber vegetables VR
Cereal Grains/ 015 Pulses VD
Crop Seeds
020 Cereal Grains GC
023 Oilseed SO
Byproducts 058 Milled cereal products (early milling stages) CM
065 Cereal grain milling fractions CF
059 Miscellaneous secondary food commodities of plant SM
origin
OECD Codex Group Codex Group name Codex Group Code

No
069 Miscellaneous derived edible products of plant DM
origin
071 By-products, used for animal feeding purposes, AB
derived from fruit and vegetable processing
2.11 TRAINING OF SCIENTISTS FROM DEVELOPING COUNTRIES FOR THE

ESTABLISHMENT OF PESTICIDE MAXIMUM RESIDUE LEVELS IN FOODS
AND ASSESSMENT OF THE RISK FROM DIETARY INTAKE OF RESIDUES
The need for training in the evaluation of pesticide residues has become apparent in recent years as
procedures have become more complex and the interest in the operations of JMPR and the Codex
Committee on Pesticide Residues have increased.
FAO has received requests for a training manual and the FAO Secretary of the JMPR
initiated a project to produce a JMPR Training Manual and for its use in a training course in 2010.
The Training Manual is intended to be suitable for use in training workshops and also for
self-guided study. The FAO/WHO Training Manual on Pesticide Specifications, first issued in 2008,
was also an inspiration to produce a training manual on pesticide residues.
The main objectives of the training programme are:
• To train scientists to become potential members for the FAO Panel of Experts. Participants
will be trained in the process of evaluation of residue data for estimation of maximum residue
levels and estimation of dietary exposure.
• To respond to the requests of developing countries to play a greater role in establishing Good
Agricultural Practices (GAP) and health-based pesticide criteria for their own countries
which are more reflective of local diets.
• To augment the experience of developing countries in the working procedures of the JMPR
and thereby increase their effective participation in the international forums which regulate
pesticide residues in international trade.
The contents of the Training Manual reflect the sections of a typical residue evaluation,
including pesticide identity and properties, metabolism, supervised residue trials, food processing and
consumer exposure to residues.
The Training Manual chapters:
• specify the purpose of the particular step in the evaluation process;
• make reference to the relevant chapters and sections of the FAO Manual;
• explain the process with practical examples illustrating the usual procedure and give
examples for ‘difficult’ cases which require special consideration;
• Case studies are designed for exercises by the participants of training programmes under the
guidance of the trainers.
The Training Manual will be published on the FAO web site after practical experience in the
first training course.
Responses to specific concerns raised by CCPR 21
3. RESPONSES TO SPECIFIC CONCERNS RAISED BY THE CODEX COMMITTEE

ON PESTICIDE RESIDUES (CCPR)
The Meeting noted that the information supplied on some of the concern forms submitted by CCPR
Members was inadequate to permit JMPR to clearly identify the critical issues underlying the
concerns. Consequently, the Meeting had great difficulty in determining the issues involved, raising
the possibility that the response provided by the Meeting might not actually address the true concern.
The Meeting requested that any future concerns submitted to JMPR should be accompanied by
comprehensive and transparent supporting information. If such information is not provided, the
Meeting might be forced to conclude that it is not able to provide a meaningful response.
3.1 BIFENTHRIN (178)
Background
At the Forty-second Session of the Codex Committee on Pesticide Residues (CCPR), concern was
raised by the European Union, France and CropLife International regarding the acute reference dose
(ARfD) for bifenthrin established by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR) in
2009. A concern form was submitted to the JMPR Secretariat by Kenya on 15 September 2010.
Comments by JMPR
The concern form was submitted long after the deadline established by CCPR and only a few days
before the start of the JMPR meeting. Nevertheless, JMPR considered the concern and the points
raised. However, the information provided in the concern form was very limited, and the short time
available did not allow a thorough consideration of the concerns raised. The Meeting therefore
decided to defer consideration of this item to the next meeting.
3.2 CYPERMETHRIN (118)
Background
On the request of Forty-second Session of the CCPR (ALINORM 10/33/24, para 43-44), the EU
submitted a concern form to the present Meeting. The concern form stated that using the CXL MRLs
on plant and animal commodities as inputs in the EFSA PRIMo rev. 2A, a chronic dietary intake
concern was identified with up to 176 % of the ADI (NL child) as well as acute intake concerns with
regards to the following crops: citrus (Oranges: 479% ARfD-VF = 5; Grapefruit: 446% ARfD-VF =
5; Mandarins: 209% ARfD-VF = 5; Lemons: 127% ARfD-VF=5), scarole (broad- leaf endive) (153%
ARfD-VF=5)-covered by leafy vegetables, apples (126% ARfD-VF = 5), pears (114% ARfD-VF
= 5)-covered by pome fruits, apricots (123% ARfD-VF = 5), plums (133% ARfD-VF = 5), peaches
(217% ARfD-VF = 5)-covered by stone fruits, cauliflower (165% ARfD-VF = 5) and broccoli (104%
ARfD-VF = 5)-covered by brassica vegetables.
The EU requested revocation of these Codex MRLs.
Evaluation of cypermethrin(s) by the JMPR and CCPR

Cypermethrin, alpha-cypermethrin and zeta-cypermethrin (pyrethroid compounds), are non-systemic
broad spectrum insecticides acting by ingestion and contact. Cypermethrin was first evaluated by the
1979 JMPR and a number of times subsequently. It was reviewed for toxicology by the 2006 JMPR
within the periodic review programme of the CCPR; the review included alpha-cypermethrin and
zeta-cypermethrin, which had not previously been considered by the JMPR. A group ADI of 0–
22 Responses to specific concerns raised by CCPR
0.02 mg/kg bw and a group ARfD of 0.04 mg/kg bw was established for cypermethrins (including
alpha- and zeta-cypermethrin). The periodic review for residues was scheduled for 2008. Three
manufacturers submitted residue data to JMPR on cypermethrins (including alpha and zeta
cypermethrin) for consideration by the 2008 JMPR. The 2008 Meeting agreed that metabolism
studies, environmental fate studies, methods of analysis and freezer storage stability studies of the
cypermethrins were mutually supportive and should be considered together. Separate monographs
were prepared for each of the three compounds, but they were considered together in a single
appraisal. Definition of the residue (for plants and animals; for compliance with the MRL and for
estimation of dietary intake): cypermethrin (sum of isomers). The residue is fat soluble. The 2008
Meeting estimated a large number of maximum residue levels. In 2009, an additional evaluation was
performed on the use of cypermethrin as grain protectant.
The Forty-first Session of CCPR in 2009 decided to advance the draft MRLs for all
commodities (as proposed by 2009 JMPR) except asparagus for adoption at Step 5/8, noting the EU
and Norway reservations on the MRLs for cauliflower; scarole (broad-leaf); apple (covered by pome
fruits) and peach (covered by stone fruits) because of their acute intake concerns (ALINORM
09/32/24, para 90–94). Later in 2009, the CAC adopted all draft MRLs at step 5/8 as CXLs.
The Forty-second Session of CCPR invited the EU to submit a concern form clearly outlining
their acute intake concerns. (ALINORM 10/33/24, para 43–44).
Comments by JMPR
The Meeting noted that for the long-term intake, it is unrealistic to assume that person will for his
whole lifetime consume commodities with on all of them the pesticide present at the level of the
CXL. Using the STMRs in the IEDI calculation revealed no exceedance of the ADI.
In addition the Meeting noted that also for the short-term dietary intake calculations the CXL
values were used, not the HR values for the edible portion. For example, the intake of the residue
from citrus fruits is largely overestimated when the calculation is based on the residue in whole fruit.
In addition, a variability factor of 5 was used where JMPR employs a variability factor of 3.
Based on the above, the present Meeting confirmed that the short-term dietary intake of
cypermethrin(s) from its use on citrus, scarole, apples, pears, apricots, plums, peaches, cauliflower
and broccoli, as based on the results presented by the 2009 Meeting, is unlikely to present a public
health concern.
3.3 FLUOPICOLIDE (235)
Background
At the Forty-second Session of the CCPR, the Delegation of Switzerland raised concerns regarding
the acute reference dose (ARfD) for fluopicolide that had been established by the Joint FAO/WHO
Meeting on Pesticide Residues (JMPR) in 2009. The JMPR was requested to reconsider the
derivation of the ARfD for fluopicolide.
Evaluation of fluopicolide by the JMPR

Fluopicolide was reviewed for the first time by the JMPR in 2009 at the request of the CCPR. The
JMPR established an ARfD for fluopicolide of 0.6 mg/kg body weight (bw) for women of child-
bearing age on the basis of a no-observed-adverse-effect level (NOAEL) of 60 mg/kg bw per day to
which a safety factor of 100 was applied. This NOAEL was identified based on a marginally
increased incidence of skeletal defects of the vertebrae and sternebrae, which might be attributable to
a single exposure to fluopicolide at 700 mg/kg bw per day in a study of developmental toxicity in
rats.
The Meeting concluded that the establishment of an ARfD for the general population was not
necessary for fluopicolide on the basis of its low acute toxicity, the lack of evidence for any acute
neurotoxicity and the absence of any other toxicologically relevant effect that might be attributable to
a single dose.
Concern submitted by Switzerland

The JMPR was requested to reconsider the rabbit developmental studies as an alternative basis for
the derivation of the ARfD for fluopicolide:
In the rabbit range-finding (4 animals per group) and the definitive developmental toxicity study (23
animals per group), 60 mg/kg bw per day, the level of the rat maternal and fetal NOAEL, proved to be
lethal for 3/23 dams within three weeks of treatment and for 3/4 dams at 100 mg/kg bw per day (and 4/4
dams at higher doses). Additionally, 15/23 dams aborted at 60 mg/kg bw per day, one dam at the next
lower dose level of 20 mg/kg bw per day, and none at 5 mg/kg bw per day and in the control group,
respectively. The high incidence of abortions at 60 mg/kg bw per day are treatment-related and the
abortion seen in one dam at a dose level only three fold lower should not be ignored as this might also
be treatment related. Mortality and abortions could be seen as either an acute effect or as the final
severe manifestation of not yet evident effects accumulating in the study period before.
In view of the severe effects at 60 mg/kg bw per day, possibly being an acute effect or a final
manifestation of sub-clinical effects accumulating in the study period before, the identification of the
relevant NOAEL as the basis for an ARfD should be reconsidered as well as the relevance of these
effects for the general population.
Switzerland proposed the use of 20 mg/kg bw per day as the basis for an ARfD with
application of a safety factor of 200.
Comments by the JMPR

After consideration of the concerns from Switzerland and after reviewing the conclusions of the 2009
JMPR, which included a reassessment of the original report from the rabbit range-finding study and
the main developmental study in rabbits, the present Meeting highlighted the following points:
• In the rabbit range-finding study (four animals per group), dosing was on days 6–28 of
gestation. All rabbits from the 100, 250, 500 and 1000 mg/kg bw per day dose groups were
found dead, killed while in a moribund condition or killed after abortion from day 13 to day
23 of the study. The dose of 100 mg/kg bw per day was lethal after at least 10 days of dosing
for four of four dams (days 16, 20, 22, 22). Nonspecific symptoms, including impaired
motility and consciousness, respiratory sounds, decreased defecation and hay consumption,
hyperactivity, hypoactivity and discoloured urine, were observed from day 13 to day 23 of
the study. At 50 mg/kg bw per day, one of four dams showed decreased defecation and
discoloured tray and aborted on day 29. Therefore, it was killed on day 29. The other animals
at this dose did not show any clinical signs. The dose of 50 mg/kg bw per day was considered
to be a suitable high dose for the main study.
• In the main study, dosing was on days 6–28 of gestation (0, 5, 20 and 60 mg/kg bw per day).
At 60 mg/kg bw per day, 15 of 23 dams aborted from days 22 to 29; 1 dam at the next lower
dose level of 20 mg/kg bw per day was killed after premature delivery on day 28.
• The high incidence of abortions at 60 mg/kg bw per day was treatment related, and the
abortion seen in one dam at a dose level only 3-fold lower might also be treatment related.
However, mortality and abortions cannot be seen as an acute effect. The affected animals
showed decreased defecation, reduced hay consumption, hypoactivity, bristling coat,
pultaceous faeces and discoloured urine between days 22 and 29. This is considered as a
manifestation of subchronic effects. The mean food consumption in the 60 mg/kg bw per day
group, expressed as a percentage of food consumption per unit body weight before treatment,
24 Responses to specific concerns raised by CCPR
was statistically significantly decreased between days 23–26 and days 26–29 and not
immediately after treatment began on day 6 of gestation. This decrease was only slight in the
first week but prominent thereafter. With an obvious delay, the body weights in the 60 mg/kg
bw per day group were also lower between days 26 and 29. No teratogenic effects were
observed in the fetuses.
• Because the severe effects at 60 mg/kg bw per day occurred in the latter part of the treatment
period, they are considered a manifestation of the subchronic effects of the prior dosing
period. The NOAEL for these findings is not a relevant basis for an ARfD.
In conclusion, the JMPR does not agree with the proposal to use the effects observed in the
developmental study in the rabbit at 20 mg/kg bw per day as the basis for an ARfD. The Meeting
reaffirmed the ARfD for fluopicolide of 0.6 mg/kg bw for women of child-bearing age based on a
NOAEL of 60 mg/kg bw per day and a safety factor of 100.
3.4 PARAQUAT (057)
Background
On the request of the Forty-second Session of the CCPR (ALINORM 10/33/24, para 33–34), the EU
submitted a concern form to the present Meeting. The concern form stated that using EU endpoints
(ARfD 0.005 mg/kg bw/day) and risk assessment methodologies (PRIMo rev2) for children, dried
beans are 150% and potatoes are 154% of the ARfD, using HR values of 0.41 mg/kg (39 trials) and
0.05 mg/kg (25 trials) for pulses and root and tuber vegetables, respectively. It was acknowledged
that a higher ARfD of 0.006 mg/kg bw/day is accepted by JMPR, but indicated that EU risk
assessment methodologies using these endpoints still indicate 125% and 128% of the ARfD using the
JMPR HR values.
Evaluation of paraquat by the JMPR and CCPR

Paraquat, a non-selective contact herbicide, is usually available as the dichloride salt or the
bis(methylsulfate) salt but is determined as paraquat ion in analysis. It can be used for pre-plant and
pre-emergence weed control, resulting in little or no residues in the harvested crop, but also for post-
emergence weed control and as a harvest aid desiccant. When used for pre-plant and pre-emergence
weed control, paraquat is not sprayed directly onto crops and is strongly adsorbed to soil.
Paraquat was first evaluated by the JMPR for toxicology and residues in 1970. The Meeting
reviewed paraquat toxicologically within the Periodic Review Programme in 2003 and established an
ADI of 0–0.005 mg/kg bw and an ARfD of 0.006 mg/kg bw as paraquat cation. The 2004 JMPR
evaluated paraquat for residues under the Periodic Review Programme and concluded that the
definition of residue for compliance with MRLs and for estimation of dietary intake was paraquat
cation. Maximum residue levels were recommended for several fruits, several vegetables, maize,
sorghum, cotton-seed, sunflower, hops, tea and animal commodities. In addition, the 2009 JMPR
estimated a maximum residue level for rice.
The Thirty-seventh Session of CCPR in 2005 decided to advance all MRLs as proposed by
the 2004 JMPR to Step 5. The Committee decided to consider for withdrawal at its next Session all
existing CXLs (ALINORM 05/28/24, para 99–100).
The Thirty-eighth Session of CCPR in 2006 decided to revoke most existing CXLs as
recommended by the 2004 JMPR (except the CXL for rice, because new data would become
available). The Committee decided to advance all draft MRLs except those for animal forage to Step
8 (ALINORM 06/29/24, para 67-68). Later in 2006, the CAC adopted all draft MRLs at step 8 as
CXLs.
The Forty-second Session of CCPR in 2010, when considering a new maximum residue level
on rice, as proposed by the 2009 JMPR, noted the acute dietary intake concern of the EU for pulses
and potatoes, and invited the EU to submit a concern form clearly outlining their concern
(ALINORM 10/33/24, para 33–34).
Comments by JMPR
The Meeting noted that the current CXLs are generally in the range of 0.01(*) to 0.05 mg/kg, except
for animal feed commodities and oil seeds. However, a CXL for pulses (VD 0070) of 0.5 mg/kg is in
place. For Root and tuber vegetables (VR 0075; includes potatoes) the CXL is 0.05 mg/kg. Currently,
all EU MRLs are set at the LOQ (either 0.02 mg/kg or 0.05 mg/kg).
The 2004 JMPR reported that the levels of residues arising from the use of paraquat as a
harvest desiccant on legume vegetables and pulses were higher than those from pre-emergence or
post-emergence application. The 2004 Meeting combined the results of trials on field peas and chick
peas in Australia and on soya beans in Brazil and the USA in which paraquat was used as a desiccant
harvest aid to estimate a group maximum residue level for pulses. The combined residue levels in
seeds, in ranked order, were: < 0.01 (2), < 0.02, 0.02 (4), 0.03 (4), 0.04 (2), < 0.05 (2), 0.05 (2), 0.06,
0.07 (2), 0.08 (3), 0.09 (2), 0.10, 0.11 (2), 0.12, 0.13 (2), 0.15, 0.16 (2), 0.23, 0.25, 0.28 (3), 0.31 and
0.41 mg/kg.
The present Meeting noted that the EU dietary intake calculations for beans employed the
IESTI equation case 1 (based on the HR value and no variability factor). The 2004 JMPR employed
case 3, which is based on the STMR value (also with no variability factor). Case 3 is used where
processed commodities are bulked or blended so that the STMR-P represents the likely highest
residue level. The case 1 equation would only apply to pulse commodities when the estimates are
based on post-harvest use of the pesticide. The Meeting noted that pre-harvest desiccant use can not
be considered a post-harvest use. A post-harvest use is defined as a use where harvested commodities
from different farms are combined and treated as one, resulting in a batch or lot containing the same
residue and marketed to the same location. In a pre-harvest use crops from different farms that are
treated differently can be combined, thereby averaging out a possible high residue coming from one
of the farms.
The use patterns of paraquat on root and tuber vegetables as considered by the 2004 JMPR
concerned pre-plant, pre-emergence treatments in Japan and the USA. Since paraquat binds strongly
to soil, limited uptake by the roots and tubers is expected. This is in line with the residue levels in
potato trials of pre and post-emergence application: < 0.01 (8) and 0.02 mg/kg. The Meeting noted
that the combined results from trials on beetroot, sugar-beet, carrot, turnip and potato on which the
2004 JMPR recommendations were based were, in ranked order: < 0.01 (12), 0.02, < 0.03 (4), 0.03
(2) and < 0.05 (6) mg/kg. The HR for the group of Root and tuber vegetables (including potatoes) is
therefore based on the highest LOQ of 0.05 mg/kg as reported for six trials on sugar-beet root. The
actual HR for potatoes is probably lower, as the highest residue found in potato trials was 0.02
mg/kg. Furthermore, the dietary risk assessments are based on the consumption of raw potatoes.
Processing information for potato, as reported by the 2004 JMPR, shows that most of the residue is
in/on the peel (PF for peeled potato is 0.27). Furthermore, the EU dietary intake model employed a
variability factor of 7 in the IESTI calculation, whereas the JMPR dietary intake model employs a
variability factor of 3.
Based on the above, the present Meeting confirmed that the short-term dietary intake of
paraquat from its use on pulses and potato, based on the results presented by the 2004 Meeting, is
unlikely to present a public health concern.
Dietary risk assessment 27
4. DIETARY RISK ASSESSMENT
Assessment of risk from long-term dietary intake

At the present Meeting risks associated with long-term dietary intake were assessed for compounds
for which MRLs were recommended and STMRs estimated. International estimated daily intakes
(IEDIs) were calculated by multiplying the concentrations of residues (STMRs and STMR-Ps) by the
average daily per capita consumption estimated for each commodity on the basis of the 13
GEMS/Food Consumption cluster diets. 22 IEDIs are expressed as a percentage of the maximum ADI
for a 55 kg or 60 kg person, depending on the cluster diet.
New Evaluations
Clothianidin, cyproconazole, dicamba, etoxazole, flubendiamide, fluopyram, meptyldinocap and
thiamethoxam were evaluated for toxicology and/or residues for the first time and the Meeting
established ADIs and conducted long-term dietary risk assessments for these compounds.
Periodic Evaluations
Bifenthrin, cadusafos and chlorothalonil were evaluated for toxicology and/or residues under the
Periodic Re-evaluation Programme and previous Meetings have established ADIs for these
compounds. Long-term dietary risk assessments were conducted for these compounds.
Dithianon and tebuconazole were evaluated for toxicology under the Periodic Re-evaluation
Programme and the Meeting established ADIs for these compounds. Long-term dietary risk
assessments will be considered during the periodic review for residues at subsequent Meetings.
Evaluations
Bifenazate, boscalid, chlorantraniliprole, difenoconazole, endosulfan, fenpyroximate, fludioxonil,
novaluron and triazophos were considered for residues and the Meeting conducted long-term dietary
risk assessments for these compounds.
The outcome of the evaluation of a range of compounds on spices, performed at this Meeting,
was such that the long-term dietary intake assessment was not necessary.
A summary of the long-term dietary risk assessments conducted by the present meeting is
shown on Table 1. The detailed calculations of long-term dietary intakes are given in Annex 3. The
upper bound percentages are rounded to one significant decimal up to 0.4, to the whole number up to
9 and nearest 10 above that. Percentages above 100 should not necessarily be interpreted as giving
rise to a health concern because of the conservative assumptions used in the assessments.
Calculations of dietary intake can be further refined at the national level by taking into account more
detailed information, as described in the Guidelines for predicting intake of pesticide residues. 23
Table 1 Summary of long-term dietary of risk assessments conducted by the 2010 JMPR
CCPR code Compound Name ADI Range of IEDI, as % of maximum ADI
(mg/kg bw)
219 Bifenazate 0–0.01 3–20
178 Bifenthrin 0–0.01 8–20
221 Boscalid 0–0.04 10–40
22
http://www.who.int/foodsafety/chem/gems/en/index1.html
23
WHO (1997) Guidelines for predicting dietary intake of pesticide residues. 2nd Revised Edition, GEMS/Food Document
WHO/FSF/FOS/97.7, Geneva
28 Dietary risk assessment
CCPR code Compound Name ADI Range of IEDI, as % of maximum ADI

(mg/kg bw)
174 Cadusafos 0–0.0005 0–1
230 Chlorantraniliprole 0–2 0–0 [0.1–0.4]
081 Chlorothalonil 0–0.02 9–40
SDS-3701 0–0.008 5–10
238 Clothianidin 0–0.1 1–2
239 Cyproconazole 0–0.02 1–2
142 Dicamba 0–0.3 0–1
224 Difenoconazole 0–0.01 0–10
180 Dithianon 0–0.01
032 Endosulfan 0–0.006 2–20
241 Etoxazole 0–0.05 0–1
193 Fenpyroximate 0–0.01 0–6
242 Flubendiamide 0–0.02 3–20
211 Fludioxonil 0–0.4 1–2
243 Fluopyram 0–0.01 0–6
224 Meptyldinocap 0–0.02
217 Novaluron 0–0.01 7–50
189 Tebuconazole 0–0.03
245 Thiamethoxam 0–0.08 1–4
143 Triazophos 0–0.001 0–50
Assessment of risk from short-term dietary intake

Consumption data of large portions from the GEMS/Food database were used at the present Meeting
to assess the risks associated with short term dietary intake for compounds with STMR and HR
estimated values and established acute reference doses (ARfDs). The procedures for calculating the
short-term intake were defined primarily in 1997 at an FAO/WHO Geneva Consultation 24 refined at
the International Conference on Pesticide Residues Variability and Acute Dietary Risk Assessment
sponsored by the Pesticide Safety Directorate and at subsequent JMPR Meetings.
Data on the consumption of large portions were provided to GEMS/Food by the governments
of Australia, France, The Netherlands, Japan, South Africa, Thailand, the UK and the USA. Data on
unit weights and per cent edible portions were provided to GEMS/Food by the governments of
Belgium, France, Japan, Sweden, the UK and the USA. The body weights of adults and children aged
≤ 6 years were provided to GEMS/Food by the governments of Australia, France, the Netherlands,
South Africa, Thailand, the UK and the USA. The consumption, unit weight and body weight data
used for the short-term intake calculation were compiled by GEMS/Food 25. The documents are dated
April, 2008 (large portions and body weights) and May, 2003 (unit weights). The procedures used for
calculating the International estimated short-term intake (IESTI) are described in detail in Chapter 3
of the 2003 JMPR report. Detailed guidance on setting ARfD is described in Section 2.1 of the 2004
JMPR report 26.
On the basis of data received by the present or previous Meetings, the establishment of an
ARfD was considered to be unnecessary for bifenazate boscalid, chlorantraniliprole, etoxazole,
fludioxonil, meptyldinocap and novaluron. Therefore, it was not necessary to estimate the short-term
intakes for these compounds.
24
WHO (1997) Food consumption and exposure assessment of chemicals. Report of a FAO/WHO Consultation. Geneva,
Switzerland, 10–14 February 1997, Geneva
25
http://www.who.int/foodsafety/chem/acute_data/en/
26
Pesticide Residues in Food–2004. Report of the JMPR 2004, FAO Plant Production and Protection Paper 178. Rome,
Italy, 20–29 September 2004
Dietary risk assessment 29
Clothianidin, cyproconazole, dicamba, flubendiamide, fluopyram and thiamethoxam were

evaluated for toxicology at this Meeting for the first time and ARfDs were allocated. Short-term
dietary risk assessments for these compounds were also conducted for these compounds.
Bifenthrin, cadusafos, chlorothalonil were evaluated for toxicology at previous Meetings
under the Periodic Re-evaluation Programme and ARfDs were allocated. The current Meeting
conducted short-term dietary risk assessments for these compounds.
Dithianon and tebuconazole were evaluated for toxicology at this Meeting under the Periodic
Re-evaluation Programme and ARfDs were allocated. The short-term dietary risk assessment for
these compounds will be considered during the periodic review for residues at subsequent Meetings.
The short-term intakes as percentages of the ARfDs for the general population and for
children are summarized in Table 2. The upper bound percentages are rounded to one significant
decimal up to 0.4, to the whole number up to 9 and nearest 10 above that. Percentages above 100
should not necessarily be interpreted as giving rise to a health concern because of the conservative
assumptions used in the assessments. The detailed calculations of short-term dietary intakes are given
in Annex 4.
Table 2 Summary of short-term dietary risk assessments conducted by the 2010 JMPR
CCPR code Compound Name ARfD Commodity Percentage of ARfD
(mg/kg bw) General Children
population aged ≤ 6
years
219 Bifenazate Unnecessary
178 Bifenthrin 0.01 strawberries 230 430
other commodities 0–50 0–90
221 Boscalid Unnecessary
174 Cadusafos 0.001 all 0–20 0–40
230 Chlorantraniliprole Unnecessary
081 Chlorothalonil 0.6 all 0–20 0–100
SDS-3701 0.03 0–20 0–50
238 Clothianidin 0.6 all 0–3 0–10
239 Cyproconazole 0.06 all 0–5 0–4
142 Dicamba 0.5 all 0–4 0–9
224 Difenoconazole 0.3
180 Dithianon 0.1
032 Endosulfan 0.02 tea infusion 1 1
241 Etoxazole Unnecessary
193 Fenpyroximate 0.02 all 0–20 0–60
242 Flubendiamide 0.2 all 0–40 0–60
211 Fludioxonil Unnecessary
243 Fluopyram 0.5 all 0–4 0.10
224 Meptyldinocap Unnecessary
217 Novaluron Unnecessary
189 Tebuconazole 0.3
245 Thiamethoxam 1 all 0–4 0–10
143 Triazophos 0.001 rice 0–260 0–270
other commodities 0–40 0–60
Possible risk assessment refinement when IESTI exceeds the ARfD
Bifenthrin on strawberries
The Meeting noted that the short-term dietary risk assessment of strawberries could be refined if
alternative GAP was available.
30 Dietary risk assessment
A concern form regarding the ARfD was received late and with limited information and will
be considered at the next meeting.
Triazophos in rice
The Meeting noted that the short-term dietary risk assessment of rice was based on residue data for
brown rice and could be refined if additional processing information were available on rice as
consumed.
In the current evaluation short-term intakes were estimated for 4 commodities (cotton seed,
edible cottonseed oil, immature soya been seed and rice) for which STMR values have been
recommended by the 2007 and present JMPR Meetings. The estimated short-term intake derived from
residues in soya bean (immature), cotton seed and cotton seed oil for general population and children
ranged from 0–40% and 0–60% of the acute reference dose, respectively. However, the short-term
intake from residues in rice was 270% and 260% of the ARfD for children and general population,
respectively. The results are shown in Annex 4.
The meeting noted that the ARfD of 0.001 mg/kg of body weight is based on a 3 week study
in human volunteers with a NOAEL of 0.0125 mg/kg bw, supported by a 52 week study on dogs. The
meeting also noted that the NOAEL in the human volunteer study was the highest dose tested and
that the LOAEL in the dog study was 30-fold the NOAEL. In addition, limited data from preliminary
studies in human volunteers suggest that the NOAEL might indeed be higher than 0.125 mg/kg bw.
Consequently, the ARfD is likely to be conservative and it might be refined (e.g., by conducting an
acute oral toxicity study in rats) 27.
There was no alternative GAP to be considered.
Studies on the effect of processing (polishing, cooking, frying) are desirable to obtain more
realistic information on residue levels in food actually consumed.
27
Acute Oral Toxicity (OECD Test Guideline 420)
Recommendations 367
6. RECOMMENDATIONS
1. The issue of JMPR resources was discussed at the current meeting and the conclusions were
given as follows:
• CCPR relies on the independent scientific advice of JMPR as providing the basis for
recommendation of international standards for pesticide residues in food and feed,
emphasizing the need for the continuing independence of this international expert meeting.
• JMPR/CCPR have improved and streamlined working procedures. This is now a very
efficient system within Codex, with a large number of standards recommended each year and
a short time frame between requests for scientific advice and establishment of global
standards.
• Globally harmonized international standards for pesticide residues are of increasing
importance, and experience from work-sharing exercises from previous JMPR meetings as
well as from registration authorities needs to be followed up. Recommendations designed to
improve efficiency should be implemented.
• Any changes to the current system, including increasing the frequency of JMPR meetings,
would have profound impacts, including a financial impact, and would need to be carefully
considered.
• In particular, implications for CCPR work also need to be considered with respect to timing
of meetings, but also regarding the number of recommendations coming from JMPR for
consideration by CCPR.
• The priority-setting process at CCPR needs to be strengthened, and existing criteria possibly
need to be reviewed and then enforced.
• It needs to be clarified whether the current increasing number of requests for evaluation is
only a temporary situation or is expected to be long term.
2. In order to strengthen its dietary risk assessments, the Meeting strongly recommends that:
• FAO and WHO host a consultation, the main objectives of which would be the continued
refinement of the estimation of the short-term dietary intake of pesticides and the
interpretation of the outcomes of short-term dietary risk assessment conducted by JMPR,
including characterization of uncertainties.
• Codex Member States prioritize the submission of their most recent data on Large Portions
and unit weights to WHO/GEMS/Food, to ensure that the JMPR uses the best available
information in its dietary exposure assessments.
3. The Meeting in acknowledging the need for Codex MRLs to be established for minor crops and
the diverging practices in developing countries and noted the lack of information on official use
patterns.
368 Recommendations
The Meeting emphasised that the data submitters should comply with the requirements as
specified in the FAO Manual 31.
Chapter 3 of the FAO Manual 32 on the submission and evaluation of pesticide residue data
provides detailed information on the data requirements for the estimation of maximum residue levels.
GAP summaries are intended as an aid to the evaluation of submitted data and are to be provided in
addition to certified labels. It is emphasised that copies of original labels have to be provided by the
manufacturer(s), or other data submitters, in addition to the summary information.
The most essential information, which could be provided for the registered/authorised use of
a pesticide includes:
• Exact description of crops and use situations with English name and the commodity
description given in the Codex Classification of Foods and Animal Feeds;
• The formulation of the pesticide product using the two-letter coding system used in FAO
pesticide specifications and given in Appendix III of the FAO Manual;
• The concentration of active ingredient in the formulated product expressed in g/L for liquids
and w/w basis as g/kg or % of active ingredient in the solid product;
• The type of treatment such as ULV or high volume spraying and the crop growth stage at the
final application;
• Maximum application rate expressed as kg ai/ha or kg ai/hL, number of applications, interval
between applications and pre-harvest interval corresponding to specified application rate, if
relevant, and maximum total application rate per season where specified;
31
FAO Manual (2009), Submission and evaluation of pesticide residues data for the estimation of maximum residue levels
in food and feed. FAO plant production and protection paper 197
32
ibid. Chapter 3 Data and information required for JMPR evaluations.
Future work 369
7. FUTURE WORK
The items listed below are tentatively scheduled to be considered by the Meeting in 2012 and 2013.
The compounds listed include those recommended as priorities by the CCPR at its Forty-first and
earlier sessions and compounds scheduled for re-evaluation within the CCPR periodic review
programme.
Updated calls for data are available at least ten months before each JMPR meeting from the
web pages of the Joint Secretariat:
http://www.fao.org/agriculture/crops/core-themes/theme/pests/pm/jmpr/jmpr-meet/en/
http://www.who.int/ipcs/food/en/
2012 JMPR
TOXICOLOGICAL EVALUATIONS RESIDUE EVALUATIONS
NEW COMPOUNDS NEW COMPOUNDS
ametoctradin (BASF) – USA ametoctradin - potato, cucumber, zucchini, melon,
tomato, peppers, table and wine grapes, lettuce and
PRIORITY 1
lamb’s lettuce, brassica vegetables, bulb vegetables
and hops
chlorfenapyr - cotton seed, beans, papaya, peppers,
cabbage, tomato, garlic, onion, corn, melon, tea and
potato.)
toxicological evaluation in 2011
clopyralid (Dow AgroSciences) - USA – PRIORITY 1 clopyralid - Hops, pome fruits, stone fruits, cranberry,
strawberry, spinach, sugar beets, barley, corn, oats,
sorghum, wheat, linseed, rape seed, grass forage
cyantraniliprole (Dupont) – USA cyantraniliprole - pome fruit, stone fruit, brassica
vegetables, cucurbit vegetables, fruiting vegetables,
PRIORITY 1
leafy vegetables, bulb vegetables, green/long beans,
grape, potato, sweet potato, rice, cotton, canola, citrus,
tree nuts
dinotefuran (Mitsui Chemicals Agro) – Japan - dinotefuran - apple, cabbage, chinese cabbage, citrus,
PRIORITY 1 cotton seeds, cruciferous vegetables, cucurbits, egg
plant, grape, green soybeans, lettuce, mango, melon,
okra, peach, pear, persimmon, potato, rice, soy bean,
spinach, sweet peppers, tea, tomato, meat from
mammals (other than marine mammals), edible offals
(mammalian), milks,
fluxapyroxad (BASF) – USA fluxapyroxad – Cereal grains (barley, corn, rice,
sorghum and wheat), oilseeds (canola, sunflower, and
PRIORITY 1
cottonseed), root and tuber vegetables (potato, carrot,
sugar beet), legume vegetables (dry and succulent
peas, beans and soya bean), Brassica stem and leafy
vegetables (broccoli, cauliflower, cabbage), fruiting
vegetables (peppers, tomatoes), pome fruit (apple and
pear), citrus (orange, grapefruit, lemon), stone fruits
(cherry, peach, plum), cucurbits (cucumber, melon,
pumpkin, squash), bulb vegetables (onion, garlic),
coffee, banana, grapes, mango, papaya and peanuts.
370 Future work
PERIODIC RE-EVALUATIONS PERIODIC RE-EVALUATIONS

aldicarb (117) – Bayer CropScience)
bentazone (172) (BASF) bentazone (172) - beans (green and dried), peas (green
and dried), cereals, maize, sorghum, onion, peanuts,
potato, linseed, meat, milk, eggs.
cycloxydim (179) (BASF) - Beans (green and dried),
brassicae, carrot, grape, leek, lettuce (head and leafy),
peas (fresh and dried), potato, rapeseed, strawberry,
sugarbeet
dichlorvos (025) – (AMVAC Chemical UK) - cattle
(fat, meat, meat byproducts), eggs, goat (fat, meat,
meat byproducts), horse (fat, meat, meat byproducts),
milk, mushroom, poultry ( fat, meat, meat byproducts),
post-harvest, raw agricultural commodities
nonperishable, packaged or bagged, containing 6
percent fat or less, post-harvest, raw agricultural
commodities, nonperishable, packaged or bagged,
containing more than 6 percent fat, postharvest, sheep
(fat, meat, meat byproducts), tomato
diquat (031) (Syngenta) diquat (031) – Cereal grains (including barley, wheat,
maize, oats, rice, sorghum), Oilseeds (including
linseed, oilseed rape, soya bean, sunflower, cotton,
poppy), Legume vegetable group (including peas,
beans, lentils), Head brassica group (including
cabbage), Flowering brassica group, Leafy brassica
group, Fruiting vegetable group (including tomato,
pepper), Root and tuber group (including carrot,
radish, beetroot, sugarbeet, potato), Stem vegetable
group (including asparagus, celery, leek), Cucurbits
(edible and inedible peel), Bulb vegetables (including
onion), Citrus fruit, Lettuce group, spinach, canary,
lupine, mustard, apple, banana, chicory witloof, coffee,
sweet corn, grape, herbs (including parsley and sage),
hop, kohlrabi, lucerne, olive, peach, strawberry,
clover, grass, alfalfa, sugarcane,
dithianon (028) (BASF) - pome fruit, cherry, grapes,
hops, mandarin
fenbutatin oxide (109) (BASF) fenbutatin oxide (109) - Tree nuts, pome fruit, banana,
cherry, citrus fruit, cucumber, grapes, raisins, stone
fruit, strawberry, tomato, meat, milk, eggs
fenpropathrin (185) (Sumitomo Chemical) fenpropathrin (185) - cattle meat, cattle milk, cattle
edible offal, cotton seed, cotton seed oil, egg plant,
eggs, gherkin, grapes, chilli pepper, sweet pepper,
pome fruits, poutry meat, poutry edible offal, tea,
tomato
fenvalerate (119) – (Sumitomo Chemical) – support fenvalerate (119) - reviews are available from the USA
unknown
Future work 371
glufosinate-ammonium (175) – (Bayer CropScience) glufosinate-ammonium (175) - Citrus fruits, Tree nuts,
Almonds hulls, Pome fruits, Stone fruits, Berries and
other small fruits (except currants), Currants (Black,
Red, White), Banana, Assorted tropical and sub-
tropical fruits - inedible peel, Potato, Carrot, Bulb
onion, Corn salad, Common bean (pods and/or
immature seeds), Asparagus, Broad bean (dry),
Common bean (dry), Peas (dry), Rape seed and crude
Rape seed oil, Crude, Soya bean (dry), Sunflower seed
and crude Sunflower seed oil, Maize grain, Maize
fodder, Sugar beet, Tea, Palm oil, Meat (from
mammals other than marine mammals), Poultry meat,
Edible offal (mammalian), Edible offal of Poultry,
Eggs, Milks.
EVALUATIONS EVALUATIONS
buprofezin (173) (Nihon Nohyaku) – coffee (USA) –
awaiting confirmation
captan (7) (Arysta) - Pesticide Initiative Project -
mango
carbofuran (96) (FMC ) – banana
chlorpyrifos-methyl (090) (DOW)- alternative GAP
for cereal commodities (wheat, barley, oat, sorghum,
wheat germ, wheat bran – unprocessed – excluding
maize)
cyfluthrin (157) - (Bayer CropScience) soybean,
cabbage
2013 JMPR
NEW COMPOUNDS NEW COMPOUNDS
PERIODIC RE-EVALUATIONS PERIODIC RE-EVALUATIONS

aldicarb (117) – (Bayer CropScience) - citrus fruits
amitraz (122) – (Arysta Lifesciences) amitraz (122) – (awaiting advice on commodities)
bromide ion (47) – no Croplife manufacturer bromide ion (47) – support unknown
responsible - support unknown
disulfoton (74) – [Bayer CropScience] support from disulfoton (74)
USA
dichlofluanid (82) – (Bayer CropScience) - not dichlofluanid (82) – not supported by the manufacturer
supported by the manufacturer
dinocap (87) – (Dow AgroSciences) - not supported by dinocap (87) – not supported by the manufacturer
the manufacturer
metalaxyl (138) – (Syngenta) - no longer supported by metalaxyl (138) (Syngenta)– no longer supported by
the manufacturer the manufacturer - Field trials (Thailand), reviews are
available from USA.
372 Future work

methidathion (51) (Syngenta)– no longer supported by methidathion (51) (Syngenta)– no longer supported by
the manufacturer the manufacturer
tecnazene (115) – (no croplife manufacturer listed as tecnazene (115) – support unknown
responsible - support unknown)
triforine (116) (Sumitomo Corp) triforine (116) –(Sumitomo Corp) Apple, Blueberries,
Brussels sprouts, Cereal grains, Cherries, Common
bean, Currants (Black, Red, White), Fruiting
vegetables, Cucurbits, Gooseberry, Peach, Plums
(including prunes), Strawberry, Tomato
EVALUATIONS EVALUATIONS
FAO TECHNICAL PAPERS
FAO PLANT PRODUCTION AND PROTECTION PAPERS
1 Horticulture: a select bibliography, 1976 (E) 26 Pesticide residues in food 1980 – Report, 1981 (E F S)
2 Cotton specialists and research institutions in 26 Sup. Pesticide residues in food 1980 – Evaluations,
selected countries, 1976 (E) 1981 (E)
3 Food legumes: distribution, adaptability and biology 27 Small‑scale cash crop farming in South Asia, 1981 (E)
of yield, 1977 (E F S) 28 Second expert consultation on environmental
4 Soybean production in the tropics, 1977 (C E F S) criteria for registration of pesticides, 1981 (E F S)
4 Rev.1 Soybean production in the tropics (first revision), 29 Sesame: status and improvement, 1981 (E)
1982 (E) 30 Palm tissue culture, 1981 (C E)
5 Les systèmes pastoraux sahéliens, 1977 (F) 31 An eco‑climatic classification of intertropical Africa,
6 Pest resistance to pesticides and crop loss assessment 1981 (E)
– Vol. 1, 1977 (E F S) 32 Weeds in tropical crops: selected abstracts, 1981 (E)
6/2 Pest resistance to pesticides and crop loss assessment 32 Sup.1 Weeds in tropical crops: review of abstracts, 1982 (E)
– Vol. 2, 1979 (E F S) 33 Plant collecting and herbarium development,
6/3 Pest resistance to pesticides and crop loss assessment 1981 (E)
– Vol. 3, 1981 (E F S) 34 Improvement of nutritional quality of food crops,
7 Rodent pest biology and control – Bibliography 1981 (C E)
1970-74, 1977 (E) 35 Date production and protection, 1982 (Ar E)
8 Tropical pasture seed production, 1979 (E F** S**) 36 El cultivo y la utilización del tarwi – Lupinus
9 Food legume crops: improvement and production, mutabilis Sweet, 1982 (S)
1977 (E) 37 Pesticide residues in food 1981 – Report, 1982 (E F S)
10 Pesticide residues in food, 1977 – Report, 1978 (E F S) 38 Winged bean production in the tropics, 1982 (E)
10 Rev. Pesticide residues in food 1977 – Report, 1978 (E) 39 Seeds, 1982 (E/F/S)
10 Sup. Pesticide residues in food 1977 – Evaluations, 40 Rodent control in agriculture, 1982 (Ar C E F S)
1978 (E) 41 Rice development and rainfed rice production,
11 Pesticide residues in food 1965‑78 – Index and 1982 (E)
summary, 1978 (E F S) 42 Pesticide residues in food 1981 – Evaluations,
12 Crop calendars, 1978 (E/F/S) 1982 (E)
13 The use of FAO specifications for plant protection 43 Manual on mushroom cultivation, 1983 (E F)
products, 1979 (E F S) 44 Improving weed management, 1984 (E F S)
14 Guidelines for integrated control of rice insect pests, 45 Pocket computers in agrometeorology, 1983 (E)
1979 (Ar C E F S) 46 Pesticide residues in food 1982 – Report, 1983 (E F S)
15 Pesticide residues in food 1978 – Report, 1979 (E F S) 47 The sago palm, 1983 (E F)
15 Sup. Pesticide residues in food 1978 – Evaluations, 48 Guidelines for integrated control of cotton pests,
1979 (E) 1983 (Ar E F S)
16 Rodenticides: analyses, specifications, formulations, 49 Pesticide residues in food 1982 – Evaluations,
1979 (E F S) 1983 (E)
17 Agrometeorological crop monitoring and 50 International plant quarantine treatment manual,
forecasting, 1979 (C E F S) 1983 (C E)
18 Guidelines for integrated control of maize pests, 51 Handbook on jute, 1983 (E)
1979 (C E) 52 The palmyrah palm: potential and perspectives,
19 Elements of integrated control of sorghum pests, 1983 (E)
1979 (E F S) 53/1 Selected medicinal plants, 1983 (E)
20 Pesticide residues in food 1979 – Report, 1980 (E F S) 54 Manual of fumigation for insect control,
20 Sup. Pesticide residues in food 1979 – Evaluations, 1984 (C E F S)
1980 (E) 55 Breeding for durable disease and pest resistance,
21 Recommended methods for measurement of pest 1984 (C E)
resistance to pesticides, 1980 (E F) 56 Pesticide residues in food 1983 – Report, 1984 (E F S)
22 China: multiple cropping and related crop 57 Coconut, tree of life, 1984 (E S)
production technology, 1980 (E) 58 Economic guidelines for crop pest control,
23 China: development of olive production, 1980 (E) 1984 (E F S)
24/1 Improvement and production of maize, sorghum 59 Micropropagation of selected rootcrops, palms,
and millet – Vol. 1. General principles, 1980 (E F) citrus and ornamental species, 1984 (E)
24/2 Improvement and production of maize, sorghum 60 Minimum requirements for receiving and
and millet – Vol. 2. Breeding, agronomy and seed maintaining tissue culture propagating material,
production, 1980 (E F) 1985 (E F S)
25 Prosopis tamarugo: fodder tree for arid zones, 61 Pesticide residues in food 1983 – Evaluations,
1981 (E F S) 1985 (E)
62 Pesticide residues in food 1984 – Report, 1985 (E F S) 93/1 Pesticide residues in food 1988 – Evaluations – Part I:
63 Manual of pest control for food security reserve Residues, 1988 (E)
grain stocks, 1985 (C E) 93/2 Pesticide residues in food 1988 – Evaluations – Part II:
64 Contribution à l’écologie des aphides africains, Toxicology, 1989 (E)
1985 (F) 94 Utilization of genetic resources: suitable approaches,
65 Amélioration de la culture irriguée du riz des petits agronomical evaluation and use, 1989 (E)
fermiers, 1985 (F) 95 Rodent pests and their control in the Near East,
66 Sesame and safflower: status and potentials, 1985 (E) 1989 (E)
67 Pesticide residues in food 1984 – Evaluations, 96 Striga – Improved management in Africa, 1989 (E)
1985 (E) 97/1 Fodders for the Near East: alfalfa, 1989 (Ar E)
68 Pesticide residues in food 1985 – Report, 1986 (E F S) 97/2 Fodders for the Near East: annual medic pastures,
69 Breeding for horizontal resistance to wheat diseases, 1989 (Ar E F)
1986 (E) 98 An annotated bibliography on rodent research in
70 Breeding for durable resistance in perennial crops, Latin America 1960‑1985, 1989 (E)
1986 (E) 99 Pesticide residues in food 1989 – Report, 1989 (E F S)
71 Technical guideline on seed potato 100 Pesticide residues in food 1989 – Evaluations – Part I:
micropropagation and multiplication, 1986 (E) Residues, 1990 (E)
72/1 Pesticide residues in food 1985 – Evaluations – Part I: 100/2 Pesticide residues in food 1989 – Evaluations – Part II:
Residues, 1986 (E) Toxicology, 1990 (E)
72/2 Pesticide residues in food 1985 – Evaluations – Part II: 101 Soilless culture for horticultural crop production,
Toxicology, 1986 (E) 1990 (E)
73 Early agrometeorological crop yield assessment, 102 Pesticide residues in food 1990 – Report, 1990 (E F S)
1986 (E F S) 103/1 Pesticide residues in food 1990 – Evaluations – Part I:
74 Ecology and control of perennial weeds in Latin Residues, 1990 (E)
America, 1986 (E S) 104 Major weeds of the Near East, 1991 (E)
75 Technical guidelines for field variety trials, 105 Fundamentos teórico‑prácticos del cultivo de tejidos
1993 (E F S) vegetales, 1990 (S)
76 Guidelines for seed exchange and plant introduction 106 Technical guidelines for mushroom growing in the
in tropical crops, 1986 (E) tropics, 1990 (E)
77 Pesticide residues in food 1986 – Report, 1986 (E F S) 107 Gynandropsis gynandra (L.) Briq. – a tropical leafy
78 Pesticide residues in food 1986 – Evaluations – Part I: vegetable – its cultivation and utilization, 1991 (E)
Residues, 1986 (E) 108 Carambola cultivation, 1993 (E S)
78/2 Pesticide residues in food 1986 – Evaluations – Part II: 109 Soil solarization, 1991 (E)
Toxicology, 1987 (E) 110 Potato production and consumption in developing
79 Tissue culture of selected tropical fruit plants, countries, 1991 (E)
1987 (E) 111 Pesticide residues in food 1991 – Report, 1991 (E)
80 Improved weed management in the Near East, 112 Cocoa pest and disease management in Southeast
1987 (E) Asia and Australasia, 1992 (E)
81 Weed science and weed control in Southeast Asia, 113/1 Pesticide residues in food 1991 – Evaluations – Part I:
1987 (E) Residues, 1991 (E)
82 Hybrid seed production of selected cereal, oil and 114 Integrated pest management for protected
vegetable crops, 1987 (E) vegetable cultivation in the Near East, 1992 (E)
83 Litchi cultivation, 1989 (E S) 115 Olive pests and their control in the Near East,
84 Pesticide residues in food 1987 – Report, 1987 (E F S) 1992 (E)
85 Manual on the development and use of FAO 116 Pesticide residues in food 1992 – Report, 1993 (E F S)
specifications for plant protection products, 117 Quality declared seed, 1993 (E F S)
1987 (E** F S) 118 Pesticide residues in food 1992 – Evaluations –
86/1 Pesticide residues in food 1987 – Evaluations – Part I: Part I: Residues, 1993 (E)
Residues, 1988 (E) 119 Quarantine for seed, 1993 (E)
86/2 Pesticide residues in food 1987 – Evaluations – Part II: 120 Weed management for developing countries,
Toxicology, 1988 (E) 1993 (E S)
87 Root and tuber crops, plantains and bananas in 120/1 Weed management for developing countries,
developing countries – challenges and opportunities, Addendum 1, 2004 (E F S)
1988 (E) 121 Rambutan cultivation, 1993 (E)
88 Jessenia and Oenocarpus: neotropical oil palms 122 Pesticide residues in food 1993 – Report,
worthy of domestication, 1988 (E S) 1993 (E F S)
89 Vegetable production under arid and semi‑arid 123 Rodent pest management in eastern Africa, 1994 (E)
conditions in tropical Africa, 1988 (E F) 124 Pesticide residues in food 1993 – Evaluations – Part I:
90 Protected cultivation in the Mediterranean climate, Residues, 1994 (E)
1990 (E F S) 125 Plant quarantine: theory and practice, 1994 (Ar)
91 Pastures and cattle under coconuts, 1988 (E S) 126 Tropical root and tuber crops – Production,
92 Pesticide residues in food 1988 – Report, perspectives and future prospects, 1994 (E)
1988 (E F S) 127 Pesticide residues in food 1994 – Report, 1994 (E)
128 Manual on the development and use of FAO 162 Grassland resource assessment for pastoral systems,
specifications for plant protection products – Fourth 2001, (E)
edition, 1995 (E F S) 163 Pesticide residues in food 2000 – Report, 2001 (E)
129 Mangosteen cultivation, 1995 (E) 164 Seed policy and programmes in Latin America and
130 Post-harvest deterioration of cassava – the Caribbean, 2001 (E S)
A biotechnology perspective, 1995 (E) 165 Pesticide residues in food 2000 – Evaluations –
131/1 Pesticide residues in food 1994 – Evaluations – Part I: Part I, 2001 (E)
Residues, Volume 1, 1995 (E) 166 Global report on validated alternatives to the use of
131/2 Pesticide residues in food 1994 – Evaluations – Part I: methyl bromide for soil fumigation, 2001 (E)
Residues, Volume 2, 1995 (E) 167 Pesticide residues in food 2001 – Report, 2001 (E)
132 Agro-ecology, cultivation and uses of cactus pear, 168 Seed policy and programmes for the Central and
1995 (E) Eastern European countries, Commonwealth of
133 Pesticide residues in food 1995 – Report, 1996 (E) Independent States and other countries in transition,
134 (Number not assigned) 2001 (E)
135 Citrus pest problems and their control in the Near 169 Cactus (Opuntia spp.) as forage, 2003 (E S)
East, 1996 (E) 170 Submission and evaluation of pesticide residues data
136 El pepino dulce y su cultivo, 1996 (S) for the estimation of maximum residue levels in
137 Pesticide residues in food 1995 – Evaluations – Part I: food and feed, 2002 (E)
Residues, 1996 (E) 171 Pesticide residues in food 2001 – Evaluations –
138 Sunn pests and their control in the Near East, Part I, 2002 (E)
1996 (E) 172 Pesticide residues in food, 2002 – Report, 2002 (E)
139 Weed management in rice, 1996 (E) 173 Manual on development and use of FAO and WHO
140 Pesticide residues in food 1996 – Report, 1997 (E) specifications for pesticides, 2002 (E S)
141 Cotton pests and their control in the Near East, 174 Genotype x environment interaction – Challenges
1997 (E) and opportunities for plant breeding and cultivar
142 Pesticide residues in food 1996 – Evaluations – Part I recommendations, 2002 (E)
Residues, 1997 (E) 175/1 Pesticide residues in food 2002 – Evaluations –
143 Management of the whitefly-virus complex, 1997 (E) Part 1: Residues – Volume 1 (E)
144 Plant nematode problems and their control in the 175/2 Pesticide residues in food 2002 – Evaluations –
Near East region, 1997 (E) Part 1: Residues – Volume 2 (E)
145 Pesticide residues in food 1997 – Report, 1998 (E) 176 Pesticide residues in food 2003 – Report, 2004 (E)
146 Pesticide residues in food 1997 – Evaluations – Part I: 177 Pesticide residues in food 2003 – Evaluations –
Residues, 1998 (E) Part 1: Residues, 2004 (E)
147 Soil solarization and integrated management of 178 Pesticide residues in food 2004 – Report, 2004 (E)
soilborne pests, 1998 (E) 179 Triticale improvement and production, 2004 (E)
148 Pesticide residues in food 1998 – Report, 1999 (E) 180 Seed multiplication by resource-limited farmers
149 Manual on the development and use of FAO - Proceedings of the Latin American workshop,
specifications for plant protection products – Fifth 2004 (E)
edition, including the new procedure, 1999 (E) 181 Towards effective and sustainable seed-relief
150 Restoring farmers’ seed systems in disaster activities, 2004 (E)
situations, 1999 (E) 182/1 Pesticide residues in food 2004 – Evaluations –
151 Seed policy and programmes for sub-Saharan Africa, Part 1: Residues, Volume 1 (E)
1999 (E F) 182/2 Pesticide residues in food 2004 – Evaluations –
152/1 Pesticide residues in food 1998 – Evaluations – Part I: Part 1: Residues, Volume 2 (E)
Residues, Volume 1, 1999 (E) 183 Pesticide residues in food 2005 – Report, 2005 (E)
152/2 Pesticide residues in food 1998 – Evaluations – 184/1 Pesticide residues in food 2005 – Evaluations –
Part I: Residues, Volume 2, 1999 (E) Part 1: Residues, Volume 1 (E)
153 Pesticide residues in food 1999 – Report, 1999 (E) 184/2 Pesticide residues in food 2005 – Evaluations –
154 Greenhouses and shelter structures for tropical Part 1: Residues, Volume 2 (E)
regions, 1999 (E) 185 Quality declared seed system, 2006 (E F S)
155 Vegetable seedling production manual, 1999 (E) 186 Calendario de cultivos – América Latina y el Caribe,
156 Date palm cultivation, 1999 (E) 2006 (S)
156 Rev.1 Date palm cultivation, 2002 (E) 187 Pesticide residues in food 2006 – Report, 2006 (E)
157 Pesticide residues in food 1999 – Evaluations – 188 Weedy rices – origin, biology, ecology and control,
Part I: Residues, 2000 (E) 2006 (E S)\
158 Ornamental plant propagation in the tropics, 189/1 Pesticide residues in food 2006 – Evaluations –
2000 (E) Part 1: Residues, Volume 1 (E)
159 Seed policy and programmes in the Near East and 189/2 Pesticide residues in food 2006 – Evaluations –
North Africa, 2000 Part 1: Residues, Volume 2 (E)
160 Seed policy and programmes for Asia and the Pacific, 190 Guidance for packing, shipping, holding
2000 (E) and release of sterile flies in area-wide
161 Silage making in the tropics with particular emphasis fruit fly control programmes,
on smallholders, 2000 (E S) 2007 (E)
191 Pesticide residues in food 2007 – Report, 2007 (E)
192 Pesticide residues in food 2007 – Evaluations –
Part 1: Residues, 2008 (E)
194 Pesticide residues in food 2008 – Evaluations,
2008 (E)
195 Quality declared planting material – Protocols and
standards for vegetatively propagated crops,
2009 (E)
197 Submission and evaluation of pesticide residues
data for the estimation of maximum residue levels
in food and feed, 2009 (E)
198 Pesticide residues in food 2009 – Evaluations –
Part 1: Residues, 2010 (E)
199 Rearing codling moth for the sterile insect
technique, 2010 (E)
200 Pesticide residues in food 2010 − Report, 2011 (E)
Availability: January 2011
Ar – Arabic Multil – Multilingual

C – Chinese * Out of print
E – English ** In preparation
F – French
P – Portuguese
S – Spanish
The FAO Technical Papers are available through the

authorized FAO Sales Agents or directly from Sales and
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Rome, Italy.

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Pesticide residues in food 2010 – Joint FAO/WHO Meeting on Pesticide Residues

9 789251 067352 Food and Agriculture

in food 2010 PRODUCTION

Report of the Joint Meeting of the FAO Panel of Experts on

WORLD HEALTH ORGANIZATION

D, dietary risk assessment; R, residue and analytical aspects; T, toxicological evaluation.

2010 JOINT FAO/WHO MEETING ON PESTICIDE RESIDUES

ROME, 21–30 SEPTEMBER 2010

Dr Dougal MacLachlan, Australian Quarantine and Inspection Service, Australian Government

Professor Angelo Moretto, Department of Environmental and Occupational Health, University of

Dr William Donovan, United States Environmental Protection Agency, MC 7509C, Washington, DC

MRL maximum residue limit

UCL upper confidence limit

USE OF JMPR REPORTS AND EVALUATIONS BY REGISTRATION AUTHORITIES

PESTICIDE RESIDUES IN FOOD

REPORT OF THE 2010 JOINT FAO/WHO MEETING OF EXPERTS

Dr Ezzeddine Boutrif, Director of Nutrition and Consumer Protection Division of FAO,

2.1 CONSIDERATION REGARDING JMPR CAPACITY AND RESOURCES

Current JMPR working procedures

Recent improvements of JMPR working procedures

Factors affecting efficiency of the current JMPR work

Advantages of JMPR work and format

2.2 DIETARY RISK ASSESSMENTS CONDUCTED BY THE JMPR: NEED FOR

2.3 THE NEEDS OF JMPR CONCERNING FOOD CONSUMPTION DATA: UPDATE

2.4 INFORMATION ON THE USE OF PESTICIDES REQUIRED FOR THE

Estimation of group maximum residue levels for plant commodities

Example 1: Thiamethoxam in berry fruits

Information on GAP and residue data

Example 2: Bifenthrin residues in fruiting vegetables, other than cucurbits

Information on GAP and residue data

2.5 PRINCIPLES AND GUIDANCE ON THE SELECTION OF REPRESENTATIVE

2.6 STATISTICAL CALCULATION OF MRLS

2.7 APPROPRIATE VALUE FROM REPLICATE SAMPLES FROM A SUPERVISED

2.8 THE APPLICATION OF PROPORTIONALITY IN SELECTING DATA FOR MRL

Scaling of residue data

Example 1: Application rate < GAP rate

Example 2: Application rate > GAP rate

In cases of up-scaling the elevated uncertainty within multiplying non-detects to levels,

Reporting of scaled residues within the JMPR evaluation

2.9 FURTHER CONSIDERATION OF EXPERT JUDGEMENT IN EVALUATING

2.10 USE OF THE OECD FEED TABLE

OECD Codex Group Codex Group name Codex Group Code

OECD Codex Group Codex Group name Codex Group Code

2.11 TRAINING OF SCIENTISTS FROM DEVELOPING COUNTRIES FOR THE

3. RESPONSES TO SPECIFIC CONCERNS RAISED BY THE CODEX COMMITTEE

3.1 BIFENTHRIN (178)

3.2 CYPERMETHRIN (118)

Evaluation of cypermethrin(s) by the JMPR and CCPR

3.3 FLUOPICOLIDE (235)

Evaluation of fluopicolide by the JMPR

Concern submitted by Switzerland

Comments by the JMPR

3.4 PARAQUAT (057)

Evaluation of paraquat by the JMPR and CCPR

4. DIETARY RISK ASSESSMENT

Assessment of risk from long-term dietary intake

CCPR code Compound Name ADI Range of IEDI, as % of maximum ADI

Assessment of risk from short-term dietary intake

Clothianidin, cyproconazole, dicamba, flubendiamide, fluopyram and thiamethoxam were

Possible risk assessment refinement when IESTI exceeds the ARfD

PERIODIC RE-EVALUATIONS PERIODIC RE-EVALUATIONS

PERIODIC RE-EVALUATIONS PERIODIC RE-EVALUATIONS

TOXICOLOGICAL EVALUATIONS RESIDUE EVALUATIONS