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Residues of Some Veterinary Drugs in Animals and Foods

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Residues of Some Veterinary Drugs in Animals and Foods Residues of some veterinary drugs in animals and foods > > v-,« / Albendazole Dimetridazole Diminazene aceturate . Ipronidazole Isometamidium chloride Metronidazole Rontdazole Sulfadimidine Sulfathiazole Trenbolone acetate FAO FOOD AND Residues of some NUTRITION veterinary drugs PAPER in animals and foods 41/2 Monographs prepared by the Thirty-Fourth Meeting of the Joint FAO/WHO Expert Committee on Food Additives Geneva, 30 January - 8 February 1989 FOOD AND AGRICULTURE ORGANIZATION OF THE UNITED NATIONS Rome, 1990 The designations employed and the presentation of material in this publication do not imply the expression of any opinion whatsoever on the part of the Food and Agriculture Organization of the United Nations concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. M-84 ISBN 92-5-102933-4 All rights reserved No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying or otherwise, without the prior permission of the copyright owner Applications for such permission, with a statement of the purpose and extent of the reproduction, should be addressed to the Director, Publications Division. Food and Agriculture Organization of the United Nations, Via delle Terme di Caracalla. 00100 Rome. Italy © FAO 1990 - i - TABLE OF CONTENTS Page List of participants ii - iii Abbreviations iv Introduction v - vi Monographs : Albendazole , 1 - 15 Dimetridazole 16 - 27 Diminazene aceturate 28 - 31 Ipronidazole 32 - 42 Isometamidium chloride 43 - 47 Metronidazole 48 - 52 Ronidazole 53 - 65 Sulfadimidine 66 - 81 Sulfathiazole 82 - 87 Trenbolone acetate 88 - 98 ANNEXES I. Recommendations on the compounds 99 - 100 II. General considerations for sulfadimidine and sulfathiazole 101 - 106 JOINT FAO/WBO EXPERT COMMITTEE ON FOOD ADDITIVES Geneva, 30 January - 8 February, 1989 List of Participants Members invited by EftO Dr. J. Boisseau, Director, National Laboratory of Veterinary Drugs, La Haute Marche, Javené, Fougères, France Dr. R. Ellis, Director, Chemistry Division, Food Safety and Inspection Service, United States Department of Agriculture, Washington, D.C. USA (Joint Rapporteur) Dr. D.P. Kariuki, Director, Veterinary Research Centre, Kenya Agricultural Research Institute, Kikuyu, Kenya (Vice-Chairman) Dr. R.R. MacKay, Consultant, Hallet Cove, South Australia, Australia Dr. J.L.R. Martinez, Chief, Toxicology Section, National Centre for Diagnosis and Research in Animal Health, San José, Costa Rica Dr. T. McEwan, Consulting Chemist, Brisbane, Queensland, Australia Members invited by WHO Dr. J. Juskevich, Consultant in Toxicology and Residues Chemistry, Halifax, Nova Scotia, Canada Dr. B.H. MacGibbon, Consultant in Environmental Health to the Department of Health, London, England (Chairman) Dr. J.G. McLean, Dean, Faculty of Applied Science, Swinburne Institute of Technology, Hawthorn, Victoria, Australia (Joint Rapporteur) Professor A. Somogyi, Head, Max von Pettenkofer Institute of the Federal Office of Public Health, Berlin (West) Dr. D.M. Pugh, Department of Veterinary Surgery and Companion Animal Medicine, Faculty of Veterinary Medicine, University College, Dublin, Ireland Professor F. Simon, Professor of Pharmacology, Department of Pharmacology and Toxicology, University of Veterinary Sciences, Budapest, Hungary Secretariat Dr. R. Benson, US Environmental Protection Agency, Denver, Co, USA (WHO Temporary Adviser) Dr. S. Brynes, office of New Animal Drug Evaluation, Center for Veterinary Medicine Food and Drug Administration, Rockville, MD, USA (FAO Consultant) Dr. G. Burin, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland (WHO Consultant) Mr. D. Byron, Joint FAO/WHO Food Standards Programme Group, Food Quality and Standards Service, Food Policy and Nutrition Division, FAO, Rome, Italy - iii - Dr. M. Elwell, National Institute of Environmental Health Sciences, Research Triangle Park, NC, USA (WHO Temporary Adviser) Dr. G. Gheorghiev, Joint FAO/WHO Food Standards Programme Group, Food Quality and Standards Service, Food Policy and Nutrition Division, FAO, Rome, Italy (Joint Secretary) Dr. G. Guest, Chairman, Codex Committee on Residues of Veterinary Drugs in Foods, Department of Health and Human Services, Food and Drug Administration, Rockville, MD, USA (WHO Temporary Adviser) Mr. R.A. Hankin, Administrator, Pharmaceuticals and Veterinary Medicines Division, Commission of the European Communities, Brussels, Belgium (WHO Temporary Adviser) Dr. Y. Hayashi, Director, Division of Pathology, National Institute of Hygienic Sciences, Tokyo, Japan (WHO Temporary Adviser) Dr. J.L. Herman, International Programme on Chemical Safety, World Health Organization, Geneva, Switzerland (Joint Secretary) Dr. R.J. Heitzman, Science Consultant and Technical Author, Berkshire, England (FAO Consultant) Dr. F.X.R. van Leeuwen, Laboratory for Toxicology, National Institute of Public Health and Environmental Protection, Bilthoven, Netherlands (WHO Temporary Adviser) Dr. R.C. Livingston, Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD, USA (FAO Consultant) Dr. E. Schlede, Max con Pettenkofer Institute of the Federal Office of Public Health, Berlin (West) (WHO Temporary Adviser Dr. K. Ueda, Director, Department of Veterinary Public Health, Institute of Public Health, Tokyo, Japan (WHO Temporary Adviser) Dr. J. Weatherwax, Food Quality and Consumer Protection Group, Food Quality and Standards Service, Food Policy and Nutrition Division, FAO, Rome, Italy Dr. K.N. Woodward, Department of Health and Social Security, London, England (WHO Temporary Adviser) Dr. M.S. Yong, Human Safety Division, Bureau of Veterinary Drugs, Ottawa, Ontario, Canada (WHO Temporary Adviser) - iv - ABBREVIATIONS USED IN THIS REPORT ABZ — Albendazole b.w. - body weight c - concentration by volume (g/100 ml), (optical rotation only) D.L. - detection limit EtQAc - ethyl acetate 14C - radiolabeled carbon - 14 g - gram GC - gas chromatography HPLC - High Performance Liquid Chromatography i .m. - intramuscular i.v. — intravenous kg - kilogram L - litre lbs. - pounds mCi - millicuries of radioactivity max — maximum M — molar mg - milligram ml - milliliter MS - mass spectrometry ND - not detected ng - nanogram nm — nanometer NMR - Nuclear magnetic resonance pg - picogram ppb - parts per billion ppm - parts per million ppt - parts per trillion RIA - Radioimmunoassay s.c. - subcutaneous SD — Standard deviation TBA - trenbolone acetate TBOH — trenbolone TLC - thin layer chromatography — tritium — ultraviolet WT — withdrawal time w/v - weight per unit volume vq - microgram (meg) < - less than > - greater than - v - INTRODUCTION The monographs on the residues of the ten compounds contained in this volume were prepared by the Thirty Fourth Meeting of the Joint FAO/WHO Expert Committee on Food Additives, (JECFA) which was held in Geneva, 30 January-8 February 1989. JECFA has evaluated some veterinary drugs at previous meetings: several antibiotics, including chloramphenicol at the 12th(l) and 32nd(2) meetings and tenbolone acetate and zeranol at the 26th(3), 27th(4) and 32nd(2) meetings. In response to growing concern about mass-medication of food producing animals and its implications for human health and international trade, a joint FAO/WHO Expert Consultation on Residues of Veterinary Drugs was convened in Rome, in November 1984(5). Among the main recommendations of this Consultation were the establishment of a specialized Codex Committee on Residues of Veterinary Drugs (CCRVD) and the periodic convening of an appropriate body to provide independent scientific advice to this Committee and to the member countries. At its first session in Washington in November 1986, the newly created CCRVD reaffirmed the need for such a scientific body and made a number of recommendations and suggestions to be considered by JECFA(6). In response to these recommendations, the Thirty-Second JECFA meeting was entirely devoted to the evaluation of residues of veterinary drugs in foods. The second and third sessions of the CCRVD were held in Washington, D.C. during December 1987 and November 1988 respectively. They revised the priority list of veterinary drugs requiring evaluation. Ten of these drugs were evaluated at the 34th JECFA, which was again devoted only to residues of veterinary drugs in foods. The present volume contains summary monographs of the residue data on all ten compounds on the agenda. The one anthelmintic was considered in ovine and bovine species including lactating dairy cows. Four 5-nitro-nidazoles were considered. None had been previously evaluated by the Committee. Three of the compounds were considered for turkeys and swine where they are used for treatment and prevention of histomaniasis and dysentery, respectively. The fourth compound, metronidazole, had no data regarding residue depletion studies in food animals and therefore no toxicological evaluation was made. The residue monograph for this substance was based on studies using bacteria, rats and dogs, as well as human data. Two antimicrobial sulfonamides were considered for swine and sheep with one (sulfadimidine) also considered for milk and eggs produced by treated animals. The growth promoter had been evaluated at three previous meetings of the Committee. The current meeting considered the substance for bovine species and reevaluated the results of three hormonal studies in
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