INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION TOXICOLOGICAL EVALUATION OF CERTAIN VETERINARY DRUG RESIDUES IN FOOD WHO FOOD ADDITIVES SERIES 38 Prepared by: The 47th meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) World Health Organization, Geneva 1996 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 assessment of the risk to human health and the environment from exposure to chemicals, through international peer-review processes, as a prerequisite for the 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, ILO, 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 UN Conference on Environment and Development to strengthen cooperation and increase 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. CONTENTS Preface Adrenoceptor agonists Clenbuterol Xylazine Antimicrobial agents Neomycin Thiamphenicol Tilmicosin Insecticides Cypermethrin and alpha-cypermethrin Annexes Annex 1 Reports and other documents resulting from previous meetings of the Joint FAO/WHO Expert Committee on Food Additives Annex 2 Abbreviations Annex 3 Participants in the forty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives Annex 4 Acceptable Daily Intakes, other toxicological information and information on specifications PREFACE The monographs contained in this volume were prepared at the forty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), which met in Rome, Italy, 4-13 June 1996. These monographs summarize the safety data on selected veterinary drug residues reviewed by the Committee. The data reviewed in these monographs form the basis for acceptable daily intakes (ADIs) established by the Committee. The forty-seventh report of JECFA will be published by the World Health Organization in the WHO Technical Report Series. Terms abbreviated in the monographs are listed in Annex 2. The participants in the meeting are listed in Annex 3 of the present publication and a summary of the conclusions of the Committee is included as Annex 4. Some of the substances listed in this annex were evaluated at the present meeting for residues only. Residue monographs on the veterinary drugs that were evaluated at the forty-seventh meeting of JECFA will be issued separately by FAO as Food and Nutrition Paper No. 41/9. These toxicological monographs should be read in conjunction with the residue monographs and the report. Reports and other documents resulting from previous meetings of JECFA are listed in Annex 1. JECFA serves as a scientific advisory body to FAO, WHO, their Member States, and the Codex Alimentarius Commission, primarily through the Codex Committee on Food Additives and Contaminants and the Codex Committee on Residues of Veterinary Drugs in Foods, regarding the safety of food additives, residues of veterinary drugs, naturally occurring toxicants, and contaminants in food. Committees accomplish this task by preparing reports of their meetings and publishing specifications or residue monographs and toxicological monographs, such as those contained in this volume, on substances that they have considered. The toxicological monographs contained in this volume are based upon working papers that were prepared by Temporary Advisers. A special acknowledgement is given at the beginning of each monograph to those who prepared these working papers. Many proprietary unpublished reports are referenced. These were voluntarily submitted to the Committee by various producers of the veterinary drugs under review and in many cases these reports represent the only safety data available on these substances. The Temporary Advisers based the working papers they developed on all the data that were submitted, and all these studies were available to the Committee when it made its evaluations. Special acknowledgement is made to these advisers. The monographs were edited by Dr P.G. Jenkins, International Programme on Chemical Safety. From 1972 to 1975 the toxicological monographs prepared by JECFA were published in the WHO Food Additives Series; after 1975 this series was available in the form of unpublished WHO documents provided upon request to the Organization. WHO Food Additives Series No. 20, which was prepared by the twenty-ninth Committee in 1985, through WHO Food Additives Series No. 24, which was prepared by the thirty-third Committee in 1988, were published by the Cambridge University Press. Beginning with WHO Food Additives Series No. 25, which was prepared by the thirty-fourth Committee, WHO has been producing these volumes as priced documents. The preparation and editing of the monographs included in this volume have been made possible through the technical and financial contributions of the Participating Institutions of the IPCS, which supports the activities of JECFA. IPCS is a joint venture of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization, which is the executing agency. One of the main objectives of the IPCS is to carry out and disseminate evaluations of the effects of chemicals on human health and the quality of the environment. 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 organizations participating in the IPCS concerning the legal status of any country, territory, city, or area or its authorities, or 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 those organizations in preference to others of a similar nature that are not mentioned. Any comments or new information on the biological or toxicological data on the compounds reported in this document should be addressed to: Joint WHO Secretary of the Joint FAO/WHO Expert Committee on Food Additives, International Programme on Chemical Safety, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland.
See Also: Toxicological Abbreviations