Pesticide residues in food - 2003 - Joint FAO/WHO Meeting on Pesticide Residues
WHO/PCS/04.1
Toxicological evaluations
Sponsored jointly by FAO and WHO
With the support of the International Programme
on Chemical Safety (IPCS)
Joint Meeting of the
FAO Panel of Experts on Pesticide Residues
in Food and the Environment
and the
WHO Core Assessment Group
Geneva, Switzerland, 15-24 September 2003
The summaries and evaluations contained in this book are, in most cases, based on unpublished proprietary data submitted for the purpose of the JMPR assessment. 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 who submitted the data for 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.
WORLD HEALTH ORGANIZATION
WHO Library Cataloguing-in-Publication Data
Joint Meeting of the FAO Panel of Experts on Pesticides Residues in Food and the Environment and the WHO Core Assessment Group (2003: Geneva, Switzerland). Pesticide residues in food: 2003: toxicological evaluations/Joint Meeting of the FAO Panel of Experts on Pesticides Residues in Food and the Environment and the WHO Core Assessment Group, Geneva, 15-24 September 2003.
1.Pesticide residues—toxicity 2.Food contamination 3.No-observed-adverse-effect level
I. FAO Panel of Experts on Pesticides Residues in Food and the Environment
II.WHO Core Assessment Group on Pesticide Residues III.Title
ISBN 92 4 166519 X (NLM classification: WA 240)
This report contains the collective views of two international groups of experts and does not necessarily represent the decisions nor the stated policy of the Food and Agriculture Organization of the United Nations or the World Health Organization.
The preparatory work for the toxicological evaluations of pesticide residues carried out by the WHO Expert Group on Pesticide Residues for consideration by the FAO/WHO Joint Meeting on Pesticide Residues in Food and the Environment is actively supported by the International Programme on Chemical Safety within the framework of the Inter-Organization Programme for the Sound Management of Chemicals.
The International Programme on Chemical Safety (IPCS), established in 1980, is a joint venture of the United Nations Environment Programme (UNEP), the International Labour Organisation (ILO), and the World Health Organization (WHO). The overall objectives of the IPCS are to establish the scientific basis for assessing the risk to human health and the environment to exposure from chemicals, through international peer-review processes as a prerequisite for the promotion of chemical safety, and to provide technical assistance in strengthening national capacities for the sound management of chemicals.
The Inter-Organization Programme for the Sound Management of Chemicals (IOMC) was established in 1995 by UNEP, the Food and Agriculture Organization of the United Nations, WHO, the United Nations Industrial Development Organization, and the Organisation for Economic Co-operation and Development (Participating Organizations), following recommendations made by the 1992 United Nations Conference on the Environment and Development to strengthen cooperation and increase coordination in the field of chemical safety. The purpose of the IOMC is to promote coordination of the policies and activities pursued by the Participating Organizations, jointly or separately, to achieve the sound management of chemicals in relation to human health and the environment.
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List of participants |
Abbreviations |
Introduction |
Toxicological evaluations |
* First full evaluation
** Evaluated within the periodic review programme of the Code Committee on Pesticide Residues
2003 Joint Meeting of the FAO Panel of Experts on
Pesticide Residues in Food and the Environment
and the WHO Core Assessment Group
Geneva, 15-24 September 2003
PARTICIPANTS
FAO Panel of Experts on Pesticide Residues in Food and the Environment
Dr U. Banasiak, Federal Institute for Risk Assessment, Berlin, Germany
Dr E. Dutra Caldas, University of Brasilia, College of Health Sciences, Pharmaceutical Sciences Department, Brasilia/DF, Brazil (FAO Rapporteur)
Dr S. Funk, Health Effects Division, United States Environmental Protection Agency, Washington DC, USA (Vice-Chairman)
Mr D.J. Hamilton, Principal Scientific Officer, Animal & Plant Health Service, Department of Primary Industries, Brisbane, Australia
Dr B.C. Ossendorp, Centre for Substances and Integrated Risk Assessment, National Institute of Public Health and the Environment (RIVM), Bilthoven, Netherlands
Dr Y. Yamada, Research Planning and Coordination Division, National Food Research Institute, Tsukuba, Japan
WHO Toxicological Core Assessment Group
Professor A.R. Boobis, Experimental Medicine and Toxicology, Division of Medicine, Faculty of Medicine, Imperial College London, England (WHO Chairman)
Dr L. Davies, Science Strategy—Pesticides, Office of Chemical Safety, Australian Department of Health and Ageing, Woden, Australia
Dr V.L. Dellarco, United States Environmental Protection Agency, Office of Pesticide Programs, Health Effects Division, Washington DC, USA (WHO Rapporteur)
Dr H. Hakansson, Institute of Environmental Medicine, Karolinska Institute, Unit of Environmental Health Risk Assessment, Stockholm, Sweden
Dr A. Moretto, Dipartimento Medicina Ambientale e Sanità Pubblica, Università di Padova, Padova, Italy
Dr R. Solecki, Pesticides and Biocides Division, Federal Institute for Risk Assessment Thielallee, Berlin
Dr M. Tasheva, Laboratory of Toxicology, National Centre of Hygiene, Medical Ecology and Nutrition, Sofia, Bulgaria
Secretariat
Dr A. Ambrus, Head, Agrochemicals Unit, Joint FAO/IAEA Division of Nuclear Techniques in Food and Agriculture, International Atomic Energy Agency, Vienna, Austria (FAO Consultant)
Dr A. Bartholomaeus, Therapeutic Goods Administration, Australian Department of Health and Ageing, Woden, Australia (WHO Temporary Adviser)
Mr B. Declercq, Ministère de l'Economie et des Finances, Laboratoire interrégional de la DGCCRF, Massy, France (FAO Consultant)
Dr I.C. Dewhurst, Pesticides Safety Directorate, King's Pool, York, England (WHO Temporary Adviser)
Dr S. Dogheim, Agriculture Research Centre, Ministry of Agriculture, Heliopolis, Cairo, Egypt (FAO Consultant)
Dr K. Hamernik, Office of Science Coordination and Policy, United States Environmental Protection Agency, Washington DC, USA (WHO Temporary Adviser)
Mr A.R.C. Hill, Department for Environment, Food and Rural Affairs, Central Science Laboratory, Sand Hutton, York, England (FAO Consultant)
Dr H. Jeuring, Chairman, Codex Committee on Pesticide Residues, Senior Public Health Officer Food, Food and Consumer Product Safety Authority, The Hague, Netherlands (WHO Temporary Adviser)
Mr D. Lunn, Programme Manager (Residues-Plants), Dairy and Plant Products Group, New Zealand Food Safety Authority, Wellington, New Zealand (FAO Consultant)
Dr D. MacLachlan, Australian Quarantine and Inspection Service, Australian Department of Agriculture, Fisheries and Forestry, Edmond Barton Building, Kingston, Australia (FAO Consultant)
Ms S. Malezieux, Ministère de l'agriculture, de la pêche, de l'alimentation et des affairs rurales, Direction Genérale de l'Alimentation, Paris, France (FAO Consultant)
Dr T.C. Marrs, Food Standards Agency, London, England (WHO Temporary Adviser)
Dr J. Maskeliunas, Food Standards Officer, Joint FAO/WHO Food Standards Programme, Food and Nutrition Division, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Staff Member)
Dr D.B. McGregor, Lyon, France (WHO Temporary Adviser)
Dr G. Moy, Food Safety Programme, World Health Organization, Geneva, Switzerland (WHO Staff Member)
Dr S. Page, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland (WHO Staff Member)
Dr R. Pfeil, Pesticides and Biocides Division, Federal Institute for Risk Assessment, Berlin, Germany (WHO Temporary Adviser)
Dr P.V. Shah, US Environmental Protection Agency, Washington DC, USA (WHO Temporary Adviser)
Dr A. Takagi, Division of Toxicology, National Institute of Health Sciences, 1-18-1 Kamiyoga, Setaga-ku, Tokyo, Japan (WHO Temporary Adviser)
Dr A. Tejada, FAO Joint Secretary to JMPR Pesticide Management Group, Plant Protection Service, Plant Production and Protection Division, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Joint Secretary)
Dr A. Tritscher, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland (WHO Joint Secretary)
Dr G. Vaagt, Senior Officer, Pesticide Management Group, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Staff Member)
Dr Gerrit Wolterink, Centre for Substances and Risk Assessment, National Institute of Public Health and the Environment (RIVM), Bilthoven, Netherlands (WHO Temporary Adviser)
Abbreviations used
ADI |
acceptable daily intake |
ai |
active ingredient |
AUC |
area under the curve for concentration-time |
bw |
body weight |
CCN |
Codex classification number (for compounds or commodities) |
CCPR |
Codex Committee on Pesticide Residues |
CYP |
cytochrome P450 |
CXL |
Codex level |
DMSO |
dimethyl sulfoxide |
ECD |
electron capture detection |
F0 |
parental generation |
F1 |
first filial generation |
F2 |
second filial generation |
FAO |
Food and Agricultural Organization of the United Nations |
FOB |
functional observational battery |
GC |
gas chromatography |
GCP |
good clinical practice |
GLC |
gas-liquid chromatography |
GLP |
good laboratory practice |
GPC |
gel-permeation chromatography |
GEMS/Food |
Global Environment Monitoring System-Food Contamination Monitoring and Assessment Programme |
GSH |
glutathione |
HPLC |
high-performance liquid chromatography |
IARC |
International Agency for Research on Cancer |
IEDI |
international estimated daily intake |
IESTI |
international estimate of short-term dietary intake |
ISO |
International Standards Organization |
JECFA |
Joint Expert Committee on Food Additives |
JMPR |
Joint Meeting on Pesticide Residues |
LC |
liquid chromatography |
LC50 |
median lethal concentration |
LD50 |
median lethal dose |
LOAEL |
lowest-observed-adverse-effect level |
LOAEC |
lowest-observed-adverse-effect concentration |
LOD |
limit of detection |
LOQ |
limit of quantification |
MDL |
method detection limit |
MLD |
minimum level of detection |
MRL |
maximum residue limit |
MS |
mass spectrometry |
MS/MS |
tandem mass spectrometry |
NAD |
nicotinamide adenine dinucleotide |
NADP |
nicotinamide adenine dinucleotide phosphate |
NADPH |
nicotinamide adenine dinucleotide phosphate, reduced form |
NOAEL |
no-observed-adverse-effect level |
NOEL |
no-observed-effect level |
OECD |
Organization for Economic Co-operation and Development |
RfD |
reference dose |
TMDI |
theoretical maximum daily intake |
UV |
ultraviolet radiation |
WHO |
World Health Organization |
Introduction
The toxicological monographs and monograph addenda contained in this volume were prepared by a WHO Core Assessment Group that met with the FAO Panel of Experts on Pesticide Residues in Food and the Environment in a Joint Meeting on Pesticide Residues (JMPR) in Geneva, Switzerland, on 15-24 September 2003.
Four of the compounds evaluated by the Core Assessment Group at the Meeting, cyprodinil, famoxadone, methoxyfenozide and pyraclostrobin, were evaluated for the first time. The other eight substances had been evaluated at previous meetings. For five of these, only information received since the previous evaluations is summarized in "monograph addenda". Of these, dimethoate, malathion, phosmet and tebufenozide were evaluated for establishment of an acute reference dose. The appropriate earlier documents on the five compounds should be consulted in order to obtain full toxicological profiles. Toxicological monographs were prepared on carbosulfan, paraquat and terbufos, summarizing new data and, where relevant, incorporating information from previous monographs and addenda. Reports and other documents resulting from previous Joint Meetings on Pesticide Residues are listed in Annex 1.
The report of the Joint Meeting has been published by the FAO as FAO Plant Production and Protection Paper 176. That report contains comments on the compounds considered, acceptable daily intakes established by the WHO Core Assessment Group, and maximum residue limits established by the FAO Panel of Experts. Monographs on residues prepared by the FAO Panel of Experts are published as a companion volume, as Evaluations 2003, Part I, Residues, in the FAO Plant Production and Protection Paper series.
The toxicological monographs and addenda contained in this volume are based on working papers that were prepared by temporary advisers before the 2003 Joint Meeting. A special acknowledgement is made to those advisers. The monographs were edited by Dr H. Mattock, St Jean d'Ardières, France.
The preparation and editing of this volume was made possible by the technical and financial contributions of the lead institutions of the International Programme on Chemical Safety (IPCS), which supports the activities of the JMPR. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the Central Unit of the IPCS concerning the legal status of any country, territory, city or area or of its authorities, nor concerning the delimitation of its frontiers or boundaries. The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by the IPCS in preference to others of a similar nature that are not mentioned.
Any comments or new information on the biological properties or toxicity of the compounds included in this volume should be addressed to: Joint WHO Secretary of the Joint FAO/WHO Meeting on Pesticide Residues, International Programme on Chemical Safety, World Health Organization, 20 Avenue Appia, 1211 Geneva, Switzerland.
See Also: Toxicological Abbreviations