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        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