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Evaluation of Certain Veterinary Drug Residues in Food

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Evaluation of Certain Veterinary Drug Residues in Food WHO Technical Report Series 969 Evaluation of certain veterinary drug residues in food Seventy-fifth report of the Joint FAO/WHO Expert Committee on Food Additives Food and Agriculture Organization of the United Nations WHO Library Cataloguing-in-Publication Data Evaluation of certain veterinary drug residues in food : seventy-fifth report of the Joint FAO/WHO Expert Committee on Food Additives. (WHO technical report series ; no. 969) 1.Food contamination. 2.Drug residues - analysis. 3.Drug residues - toxicity. 4.Veterinary drugs - toxicity. 5.Veterinary drugs - pharmacology. 6.Risk assessment. 7.Maximum allowable concentrations - standards. 8.No-observed-adverse-effect level. I.World Health Organization. II.Food and Agriculture Organization of the United Nations. III.Joint FAO/ WHO Expert Committee on Food Additives. IV.Series. ISBN 978 92 4 120969 4 (NLM classification: WA 712) ISSN 0512-3054 © World Health Organization 2012 All rights reserved. Publications of the World Health Organization are available on the WHO web site (www.who.int) or can be purchased from WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzerland (tel.: +41 22 791 3264; fax: +41 22 791 4857; e-mail: [email protected]). Requests for permission to reproduce or translate WHO publications—whether for sale or for non- commercial distribution—should be addressed to WHO Press through the WHO web site (www. who.int/about/licensing/copyright_form/en/index.html). 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 World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication contains the collective views of an international group of experts and does not necessarily represent the decisions or the policies of the World Health Organization. Typeset in India Printed in Malta Contents 1. Introduction 1 1.1 Declarations of interest 2 2. General considerations 3 2.1 Report from the Eighteenth and Nineteenth Sessions of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) 3 2.2 Comments on documents under elaboration for CCRVDF 4 2.3 Information on registration/approval status of veterinary drugs 5 2.4 Extrapolation of MRLs 5 2.5 Dietary exposure assessment methodologies 6 2.6 Decision-tree approach to the evaluation of residues of veterinary drugs 8 2.7 Guidance for JECFA experts 8 3. Comments on residues of specific veterinary drugs 11 3.1 Amoxicillin 11 3.2 Apramycin 23 3.3 Derquantel 35 3.4 Ivermectin 52 3.5 Monensin 54 3.6 Monepantel 58 3.7 Narasin 68 3.8 Triclabendazole 71 4. Future work 73 5. Recommendations 75 Acknowledgement 77 References 79 Annex 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives 81 Annex 2 Recommendations on compounds on the agenda and further information required 97 iii Seventy-fifth meeting of the Joint FAO/WHO Expert Committee on Food Additives Rome, 8–17 November 2011 Members Professor A. Anadón, Department of Toxicology and Pharmacology, Faculty of Veterinary Medicine, Universidad Complutense de Madrid, Madrid, Spain Dr D. Arnold, Consultant, Berlin, Germany (Vice-Chairman) Professor A.R. Boobis, Centre for Pharmacology & Therapeutics, Department of Experimental Medicine, Division of Medicine, Faculty of Medicine, Imper- ial College London, London, England (Chairman) Dr R. Ellis, Consultant, Myrtle Beach, SC, United States of America (USA) (Joint Rapporteur) Dr A. Fernández Suárez, Ciencias Veterinarias, Universidad del Salvador, Buenos Aires, Argentina Dr L.G. Friedlander, Office of New Animal Drug Evaluation, Center for Veter- inary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA Dr K.J. Greenlees, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA (Joint Rapporteur) Professor J. Palermo-Neto, Department of Pathology, Faculty of Veterinary Medicine, University of São Paulo, São Paulo, Brazil Dr L. Ritter, Canadian Network of Toxicology Centres, Professor Emeritus, School of Environmental Sciences, University of Guelph, Guelph, Ontario, Canada Dr P. Sanders, National Reference Laboratory for Veterinary Drug Residues and Antimicrobial Resistance, Agence nationale de sécurité sanitaire de l’alimentation, de l’environnement et du travail (ANSES), Fougères, France Professor G.E. Swan, Faculty of Veterinary Science, University of Pretoria, Onderstepoort, South Africa1 Secretariat Dr J. Boison, Centre for Veterinary Drug Residues, Canadian Food Inspection Agency, Saskatoon, Saskatchewan, Canada (FAO Expert) Dr A. Bruno, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Codex Secretariat) 1 Dr Swan was invited but unable to attend the meeting. v Dr C.E. Cerniglia, Division of Microbiology, National Center for Toxicological Re- search, Food and Drug Administration, Department of Health and Human Services, Jefferson, AR, USA (WHO Temporary Adviser) Dr P.L. Chamberlain, Office of the Chief/Office of the Chief Scientist/Office of Counterterrorism and Emerging Threats, Food and Drug Administration, Department of Health and Human Services, Silver Spring, MD, USA (WHO Temporary Adviser) Dr S. Ghimire, Veterinary Drugs Directorate, Health Canada, Ottawa, Ontario, Canada (WHO Temporary Adviser) Dr N. Jarrett, European Medicines Agency, London, England (WHO Temporary Adviser) Professor S.H. Jeong, Department of Applied Biotoxicology, Hoseo University, Hoseo Toxicology Research Centre, Asan City, Chungnam, Republic of Korea (WHO Temporary Adviser) Professor B. Le Bizec, Laboratoire d’Étude des Résidus et des contaminants dans les aliments (LABERCA), École Nationale Vétérinaire, Agroalimentaire et de l’Alimentation Nantes Atlantique (ONIRIS), Nantes, France (FAO Expert) Dr K. Ogawa, Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences, Tokyo, Japan (WHO Temporary Adviser) Dr F. Ramos, Bromatology, Pharmacognosy and Analytical Sciences Group, Pharmacy Faculty, Coimbra University, Coimbra, Portugal (FAO Expert) Dr G. Roberts, Consultant, Preston, Victoria, Australia (WHO Temporary Adviser) Ms M. Sheffer, Orleans, Ontario, Canada (FAO/WHO Editor) Dr A. Tritscher, Department of Food Safety and Zoonoses, World Health Organ- ization, Geneva, Switzerland (WHO Joint Secretary) Dr P. Verger, Department of Food Safety and Zoonoses, World Health Organiza- tion, Geneva, Switzerland (WHO Joint Secretary to JMPR) Dr A. Wennberg, Nutrition and Consumer Protection Division, Food and Agricul- ture Organization of the United Nations, Rome, Italy (FAO Joint Secretary) vi Monographs containing summaries of relevant data and toxicological evalu- ations are available from WHO under the title: Toxicological evaluation of certain veterinary drug residues in food. WHO Food Additives Series, No. 66, 2012, in press. Specifications are issued separately by FAO under the title: Compendium of food additive specifications. FAO JECFA Monographs 12, 2012, in press. Use of JECFA reports and evaluations by registration authorities Most of the evaluations and summaries contained in this publication are based on unpublished proprietary data submitted to JECFA for use when making its assessment. A registration authority should not consider grant- ing a registration based on an evaluation published herein unless it has first received authorization for such use from the owner of the data or any second party that has received permission from the owner for using the data. vii 1. Introduction The Joint FAO/WHO Expert Committee on Food Additives (JECFA) met in Rome from 8 to 17 November 2011. The meeting was opened by Mr Berhe Tekola, Director of the Animal Production and Health Division of the Agri- culture and Consumer Protection Department of the Food and Agriculture Organization of the United Nations (FAO), on behalf of the Directors-General of the World Health Organization (WHO) and FAO. Mr Tekola provided information to the Committee on the reform process in FAO, in particular in relation to the introduction of a corporate results-based approach to pro- gramme planning and measuring achievements to better meet the demands of countries for improved efficiency. The current medium-term plan of pro- grammes and resources has been aligned with defined strategic objectives and outcomes. The provision of scientific advice on food safety
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