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Residue Evaluation of Certain Veterinary Drugs

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Residue Evaluation of Certain Veterinary Drugs ISSN 1817-7077 F A O J E C F A M o n o g r a p h s 15 RESIDUE EVALUATION OF CERTAIN VETERINARY DRUGS Joint FAO/WHO Expert Committee on Food Additives 78th meeting 2013 ISSN 1817-7077 F A O J E C F A M o n o g r a p h s 15 RESIDUE EVALUATION OF CERTAIN VETERINARY DRUGS Joint FAO/WHO Expert Committee on Food Additives 78th Meeting 2013 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS Rome, 2014 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) or of the World Health Organization (WHO) concerning the legal 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 companies or products of manufacturers, whether or not these have been patented, does not imply that these are or have been endorsed or recommended by FAO or WHO in preference to others of a similar nature that are not mentioned. All reasonable precautions have been taken by FAO and WHO 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 FAO and WHO be liable for damages arising from its use. ISBN 978-92-5-108300-0 (print) E-ISBN 978-92-5-108301-7 (PDF) © FAO/WHO 2014 FAO and WHO encourage the use, reproduction and dissemination of material in this information product. Except where otherwise indicated, material may be copied, downloaded and printed for private study, research and teaching purposes, or for use in non-commercial products or services, provided that appropriate acknowledgement of FAO and WHO as the source and copyright holder is given and that their endorsement of users’ views, products or services is not implied in any way. All requests for translation and adaptation rights, and for resale and other commercial use rights should be made via www.fao.org/contact-us/licence- request or addressed to [email protected]. FAO information products are available on the FAO website (www.fao.org/ publications) and can be purchased through [email protected]. iii CONTENTS List of participants iv Abbreviations used vi 1. Introduction 1 2. General considerations 5 3. Derquantel 13 4. Emamectin Benzoate 23 5. Gentian violet 39 6. Ivermectin 61 7. Lasalocid sodium 65 8. Monepantel 89 9. Recombinant bovine somatotrophins 93 10. Zilpaterol hydrochloride 133 Annex 1 – Summary of JECFA evaluations of veterinary drug residues from the 32nd Meeting to the present 161 Annex 2 – Summary of Recommendations from the 78th JECFA on Compounds on the Agenda and Further Information Required 171 Annex 3 – Pilot of new approaches to estimate dietary exposure to veterinary drug residues 175 Annex 4 – Response from JECFA to nine questions posed by CCRVDF 20 205 Annex 5 – JECFA Guidelines for the Extrapolation of MRLs to Minor Species 211 Annex 6 – JECFA guidance for the establishment of MRLs in honey 229 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 granting 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. iv LIST OF PARTICIPANTS Seventy-eighth Meeting of the Joint FAO/WHO Expert Committee on Food Additives Geneva, 5–14 November 2013 Members Professor A. Anadón, Department of Toxicology and Pharmacology, Faculty of Veterinary Medicine, Universidad Complutense de Madrid, Madrid, Spain (Joint Rapporteur) Dr S. Barlow, Toxicologist, Brighton, East Sussex, England, United Kingdom Dr J.O. Boison, Centre for Veterinary Drug Residues, Canadian Food Inspection Agency, Saskatoon, Saskatchewan, Canada Professor A.R. Boobis, Centre for Pharmacology & Therapeutics, Department of Experimental Medicine, Division of Medicine, Faculty of Medicine, Imperial College London, London, England, United Kingdom (Chair) Dr L.G. Friedlander, Residue Chemistry Team, Division of Human Food Safety, Center for Veterinary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA (Joint Rapporteur) Professor S.H. Jeong, Department of Applied Biotoxicology, Hoseo University, Hoseo Toxicology Research Centre, Asan City, Chungnam, Republic of Korea Professor J. Palermo-Neto, Department of Pathology, Faculty of Veterinary Medicine, University of São Paulo, São Paulo, Brazil Professor Emeritus L. Ritter, 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 (Vice-Chair) Professor G.E. Swan, Faculty of Veterinary Science, University of Pretoria, Onderstepoort, South Africa Secretariat Ms A. Bruno, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organization of the United Nations, Rome, Italy (Codex Secretariat) Dr C.E. Cerniglia, Division of Microbiology, National Center for Toxicological Research, Food and Drug Administration, Department of Health and Human Services, Jefferson, AR, USA (WHO Expert) Mr S.J. Crossley, Provision of Scientific Advice, Agriculture and Consumer Protection Department, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Joint Secretary) Dr H. Erdely, Residue Chemistry Team, Division of Human Food Safety, Center for Veterinary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA (FAO Expert) Dr V. Fattori, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Secretariat) Dr S. Ghimire, Veterinary Drugs Directorate, Health Canada, Ottawa, Ontario, Canada (WHO Expert) v Dr N. Jarrett, European Medicines Agency, London, England, United Kingdom (WHO Expert) Dr K.M. Kang, Joint FAO/WHO Food Standards Programme, Food and Agriculture Organization of the United Nations, Rome, Italy (Codex Secretariat) Mr J. Kim, Risk Assessment and Risk Management, Department of Food Safety and Zoonoses, World Health Organization, Geneva, Switzerland (WHO Secretariat) 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 J. MacNeil, Consultant, Food and Agriculture Organization of the United Nations, Rome, Italy (FAO Secretariat) Dr K. Ogawa, Division of Pathology, Biological Safety Research Center, National Institute of Health Sciences, Tokyo, Japan (WHO Expert) Professor F. Ramos, Bromatology, Pharmacognosy and Analytical Sciences Group, Pharmacy Faculty, Coimbra University, Coimbra, Portugal (FAO Expert) Mr J. Reeve, Science and Risk Assessment Directorate, Standards Branch, Ministry for Primary Industries, Wellington, New Zealand (WHO Expert) Dr R. Reuss, Food Standards Australia New Zealand, Barton, ACT, Australia (FAO Expert) Ms M. Sheffer, Orleans, Ontario, Canada (WHO Editor) Dr A. Tritscher, Risk Assessment and Management, Department of Food Safety and Zoonoses, World Health Organization, Geneva, Switzerland (WHO Joint Secretary) Dr S. Vaughn, Chair, Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF), Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA (CCRVDF) Dr P. Verger, Department of Food Safety and Zoonoses, World Health Organization, Geneva, Switzerland (WHO Joint Secretary to JMPR) Dr Z. Yuan, Department of Veterinary Basic Medicine, College of Veterinary Medicine, Huazhong Agricultural University, Hubei, China (FAO Expert) Dr T. Zhou, Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug Administration, Department of Health and Human Services, Rockville, MD, USA (WHO Expert) vi Abbreviations ADI Acceptable daily intake ADME Absorption, distribution, metabolism and excretion APCI atmospheric pressure chemical ionization [in LC/MS and LC-MS/MS] ARfD acute reference dose AUC area under the curve bST bovine somatotrophin bw bodyweight CAC Codex Alimentarius Commission CAS Chemical Abstracts Service CCRVDF Codex Committee on Residues of Veterinary Drugs in Foods ClT total body clearance Cmax maximum concentration (plasma) CR clearance (renal) CV coefficient of variation CVMP Committee for Medicinal Products for Veterinary Use [of EMEA] DAD diode array detector [in HPLC] EC electrochemical detection [in liquid chromatography] ECLIA electrochemiluminescent immunoassay EDI estimated daily intake EHC Environmental Health Criteria EINECS European Inventory of Existing Commercial Chemical Substances ELISA enzyme-linked immunosorbent assay EMEA European Agency for the Evaluation of Medicinal Products ESI electrospray interface [in LC/MS and LC-MS/MS] FAO Food and Agriculture Organization of the United Nations GC gas chromatography GC/MS gas chromatography/mass spectrometry GEADE global estimate of acute dietary exposure GECDE global estimate of chronic
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