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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 41





        Prepared by:
          The 50th meeting of the Joint FAO/WHO Expert
          Committee on Food Additives (JECFA)



        World Health Organization, Geneva 1998




    ANNEX 1

    Reports and other documents resulting from previous meetings of the
    Joint FAO/WHO Expert Committee on Food Additives

    1. General principles governing the use of food additives (First
    report of the Joint FAO/WHO Expert Committee on Food Additives). FAO
    Nutrition Meetings Report Series, No. 15, 1957; WHO Technical Report
    Series, No. 129, 1957 (out of print).

    2. Procedures for the testing of intentional food additives to
    establish their safety for use (Second report of the Joint FAO/WHO
    Expert Committee on Food Additives). FAO Nutrition Meetings Report
    Series, No. 17, 1958; WHO Technical Report Series, No. 144, 1958 (out
    of print).

    3. Specifications for identity and purity of food additives
    (antimicrobial preservatives and antioxidants) (Third report of the
    Joint FAO/WHO Expert Committee on Food Additives). These
    specifications were subsequently revised and published as
    Specifications for identity and purity of food additives, Vol. I.
    Antimicrobial preservatives and antioxidants, Rome, Food and
    Agriculture Organization of the United Nations, 1962 (out of print).

    4. Specifications for identity and purity of food additives (food
    colours) (Fourth report of the Joint FAO/WHO Expert Committee on Food
    Additives). These specifications were subsequently revised and
    published as Specifications for identity and purity of food additives,
    Vol. II. Food colours, Rome, Food and Agriculture Organization of the
    United Nations, 1963 (out of print).

    5. Evaluation of the carcinogenic hazards of food additives (Fifth
    report of the Joint FAO/WHO Expert Committee on Food Additives). FAO
    Nutrition Meetings Report Series, No. 29, 1961; WHO Technical Report
    Series, No. 220, 1961 (out of print).

    6. Evaluation of the toxicity of a number of antimicrobials and
    antioxidants (Sixth report of the Joint FAO/WHO Expert Committee on
    Food Additives). FAO Nutrition Meetings Report Series, No. 31, 1962;
    WHO Technical Report Series, No. 228, 1962 (out of print).

    7. Specifications for the identity and purity of food additives and
    their toxicological evaluation: emulsifiers, stabilizers, bleaching
    and maturing agents (Seventh report of the Joint FAO/WHO Expert
    Committee on Food Additives). FAO Nutrition Meetings Report Series,
    No. 35, 1964; WHO Technical Report Series, No. 281, 1964 (out of
    print).

    8. Specifications for the identity and purity of food additives and
    their toxicological evaluation: food colours and some antimicrobials
    and antioxidants (Eighth report of the Joint FAO/WHO Expert Committee
    on Food Additives). FAO Nutrition Meetings Report Series, No. 38,
    1965; WHO Technical Report Series, No. 309, 1965 (out of print).

    9. Specifications for identity and purity and toxicological evaluation
    of some antimicrobials and antioxidants. FAO Nutrition Meetings Report
    Series, No. 38A, 1965; WHO/Food Add/24.65 (out of print).

    10. Specifications for identity and purity and toxicological
    evaluation of food colours. FAO Nutrition Meetings Report Series, No.
    38B, 1966; WHO/Food Add/66.25.

    11. Specifications for the identity and purity of food additives and
    their toxicological evaluation: some antimicrobials, antioxidants,
    emulsifiers, stabilizers, flour-treatment agents, acids, and bases
    (Ninth report of the Joint FAO/WHO Expert Committee on Food
    Additives). FAO Nutrition Meetings Report Series, No. 40, 1966; WHO
    Technical Report Series, No. 339, 1966 (out of print).

    12. Toxicological evaluation of some antimicrobials, antioxidants,
    emulsifiers, stabilizers, flour-treatment agents, acids, and bases.
    FAO Nutrition Meetings Report Series, No. 40A, B, C; WHO/Food
    Add/67.29.

    13. Specifications for the identity and purity of food additives and
    their toxicological evaluation: some emulsifiers and stabilizers and
    certain other substances (Tenth report of the Joint FAO/WHO Expert
    Committee on Food Additives). FAO Nutrition Meetings Report Series,
    No. 43, 1967; WHO Technical Report Series, No. 373, 1967.

    14. Specifications for the identity and purity of food additives and
    their toxicological evaluation: some flavouring substances and
    non-nutritive sweetening agents (Eleventh report of the Joint FAO/WHO
    Expert Committee on Food Additives). FAO Nutrition Meetings Report
    Series, No. 44, 1968; WHO Technical Report Series, No. 383, 1968.

    15. Toxicological evaluation of some flavouring substances and
    non-nutritive sweetening agents. FAO Nutrition Meetings Report Series,
    No. 44A, 1968; WHO/Food Add/68.33.

    16. Specifications and criteria for identity and purity of some
    flavouring substances and non-nutritive sweetening agents. FAO
    Nutrition Meetings Report Series, No. 44B, 1969; WHO/Food Add/69.31.

    17. Specifications for the identity and purity of food additives and
    their toxicological evaluation: some antibiotics (Twelfth report of
    the Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition
    Meetings Report Series, No. 45, 1969; WHO Technical Report Series, No.
    430, 1969.

    18. Specifications for the identity and purity of some antibiotics.
    FAO Nutrition Meetings Report Series, No. 45A, 1969; WHO/Food
    Add/69.34.

    19. Specifications for the identity and purity of food additives and
    their toxicological evaluation: some food colours, emulsifiers,
    stabilizers, anticaking agents, and certain other substances
    (Thirteenth report of the Joint FAO/WHO Expert Committee on Food
    Additives). FAO Nutrition Meetings Report Series, No. 46, 1970; WHO
    Technical Report Series, No. 445, 1970.

    20. Toxicological evaluation of some food colours, emulsifiers,
    stabilizers, anticaking agents, and certain other substances. FAO
    Nutrition Meetings Report Series, No. 46A, 1970; WHO/Food Add/70.36.

    21. Specifications for the identity and purity of some food colours,
    emulsifiers, stabilizers, anticaking agents, and certain other food
    additives. FAO Nutrition Meetings Report Series, No. 46B, 1970;
    WHO/Food Add/70.37.

    22. Evaluation of food additives: specifications for the identity and
    purity of food additives and their toxicological evaluation: some
    extraction solvents and certain other substances; and a review of the
    technological efficacy of some antimicrobial agents. (Fourteenth
    report of the Joint FAO/WHO Expert Committee on Food Additives). FAO
    Nutrition Meetings Report Series, No. 48, 1971; WHO Technical Report
    Series, No. 462, 1971.

    23. Toxicological evaluation of some extraction solvents and certain
    other substances. FAO Nutrition Meetings Report Series, No. 48A, 1971;
    WHO/Food Add/70.39.

    24. Specifications for the identity and purity of some extraction
    solvents and certain other substances. FAO Nutrition Meetings Report
    Series, No. 48B, 1971; WHO/Food Add/70.40.

    25. A review of the technological efficacy of some antimicrobial
    agents. FAO Nutrition Meetings Report Series, No. 48C, 1971; WHO/Food
    Add/70.41.

    26. Evaluation of food additives: some enzymes, modified starches, and
    certain other substances: Toxicological evaluations and specifications
    and a review of the technological efficacy of some antioxidants
    (Fifteenth report of the Joint FAO/WHO Expert Committee on Food
    Additives). FAO Nutrition Meetings Report Series, No. 50, 1972; WHO
    Technical Report Series, No. 488, 1972.

    27. Toxicological evaluation of some enzymes, modified starches, and
    certain other substances. FAO Nutrition Meetings Report Series, No.
    50A, 1972; WHO Food Additives Series, No. 1, 1972.

    28. Specifications for the identity and purity of some enzymes and
    certain other substances. FAO Nutrition Meetings Report Series, No.
    50B, 1972; WHO Food Additives Series, No. 2, 1972.

    29. A review of the technological efficacy of some antioxidants and
    synergists. FAO Nutrition Meetings Report Series, No. 50C, 1972; WHO
    Food Additives Series, No. 3, 1972.

    30. Evaluation of certain food additives and the contaminants mercury,
    lead, and cadmium (Sixteenth report of the Joint FAO/WHO Expert
    Committee on Food Additives). FAO Nutrition Meetings Report Series,
    No. 51, 1972; WHO Technical Report Series, No. 505, 1972, and
    corrigendum.

    31. Evaluation of mercury, lead, cadmium and the food additives
    amaranth, diethylpyrocarbonate, and octyl gallate. FAO Nutrition
    Meetings Report Series, No. 51A, 1972; WHO Food Additives Series, No.
    4, 1972.

    32. Toxicological evaluation of certain food additives with a review
    of general principles and of specifications (Seventeenth report of the
    Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition
    Meetings Report Series, No. 53, 1974; WHO Technical Report Series, No.
    539, 1974, and corrigendum (out of print).

    33. Toxicological evaluation of some food additives including
    anticaking agents, antimicrobials, antioxidants, emulsifiers, and
    thickening agents. FAO Nutrition Meetings Report Series, No. 53A,
    1974; WHO Food Additives Series, No. 5, 1974.

    34. Specifications for identity and purity of thickening agents,
    anticaking agents, antimicrobials, antioxidants and emulsifiers. FAO
    Food and Nutrition Paper, No. 4, 1978.

    35. Evaluation of certain food additives (Eighteenth report of the
    Joint FAO/WHO Expert Committee on Food Additives). FAO Nutrition
    Meetings Report Series, No. 54, 1974; WHO Technical Report Series, No.
    557, 1974, and corrigendum.

    36. Toxicological evaluation of some food colours, enzymes, flavour
    enhancers, thickening agents, and certain other food additives. FAO
    Nutrition Meetings Report Series, No. 54A, 1975; WHO Food Additives
    Series, No. 6, 1975.

    37. Specifications for the identity and purity of some food colours
    enhancers, thickening agents, and certain food flavour additives. FAO
    Nutrition Meetings Report Series, No. 54B, 1975; WHO Food Additives
    Series, No. 7, 1975.

    38. Evaluation of certain food additives: some food colours,
    thickening agents, smoke condensates, and certain other substances.
    (Nineteenth report of the Joint FAO/WHO Expert Committee on Food
    Additives). FAO Nutrition Meetings Report Series, No. 55, 1975; WHO
    Technical Report Series, No. 576, 1975.

    39. Toxicological evaluation of some food colours, thickening agents,
    and certain other substances. FAO Nutrition Meetings Report Series,
    No. 55A, 1975; WHO Food Additives Series, No. 8, 1975.

    40. Specifications for the identity and purity of certain food
    additives. FAO Nutrition Meetings Report Series, No. 55B, 1976; WHO
    Food Additives Series, No. 9, 1976.

    41. Evaluation of certain food additives (Twentieth report of the
    Joint FAO/WHO Expert Committee on Food Additives). FAO Food and
    Nutrition Meetings Series, No. 1, 1976; WHO Technical Report Series,
    No. 599, 1976.

    42. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 10, 1976.

    43. Specifications for the identity and purity of some food additives.
    FAO Food and Nutrition Series, No. 1B, 1977; WHO Food Additives
    Series, No. 11, 1977.

    44. Evaluation of certain food additives (Twenty-first report of the
    Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
    Report Series, No. 617, 1978.

    45. Summary of toxicological data of certain food additives. WHO Food
    Additives Series, No. 12, 1977.

    46. Specifications for identity and purity of some food additives,
    including antioxidants, food colours, thickeners, and others. FAO
    Nutrition Meetings Report Series, No. 57, 1977.

    47. Evaluation of certain food additives and contaminants
    (Twenty-second report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 631, 1978.

    48. Summary of toxicological data of certain food additives and
    contaminants. WHO Food Additives Series, No. 13, 1978.

    49.  Specifications for the identity and purity of certain food
    additives. FAO Food and Nutrition Paper, No. 7, 1978.

    50. Evaluation of certain food additives (Twenty-third report of the
    Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
    Report Series, No. 648, 1980, and corrigenda.

    51. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 14, 1980.

    52. Specifications for identity and purity of food colours, flavouring
    agents, and other food additives. FAO Food and Nutrition Paper, No.
    12, 1979.

    53. Evaluation of certain food additives (Twenty-fourth report of the
    Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
    Report Series, No. 653, 1980.

    54. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 15, 1980.

    55. Specifications for identity and purity of food additives
    (sweetening agents, emulsifying agents, and other food additives). FAO
    Food and Nutrition Paper, No. 17, 1980.

    56. Evaluation of certain food additives (Twenty-fifth report of the
    Joint FAO/WHO Expert Committee on Food Additives). WHO Technical
    Report Series, No. 669, 1981.

    57. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 16, 1981.

    58. Specifications for identity and purity of food additives (carrier
    solvents, emulsifiers and stabilizers, enzyme preparations, flavouring
    agents, food colours, sweetening agents, and other food additives).
    FAO Food and Nutrition Paper, No. 19, 1981.

    59. Evaluation of certain food additives and contaminants
    (Twenty-sixth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 683, 1982.

    60. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 17, 1982.

    61. Specifications for the identity and purity of certain food
    additives. FAO Food and Nutrition Paper, No. 25, 1982.

    62. Evaluation of certain food additives and contaminants
    (Twenty-seventh report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 696, 1983, and
    corrigenda.

    63. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 18, 1983.

    64. Specifications for the identity and purity of certain food
    additives. FAO Food and Nutrition Paper, No. 28, 1983.

    65. Guide to specifications--General notices, general methods,
    identification tests, test solutions, and other reference materials.
    FAO Food and Nutrition Paper, No. 5, Rev. 1, 1983.

    66. Evaluation of certain food additives and contaminants
    (Twenty-eighth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 710, 1984, and
    corrigendum.

    67. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 19, 1984.

    68. Specifications for the identity and purity of food colours. FAO
    Food and Nutrition Paper, No. 31/1, 1984.

    69. Specifications for the identity and purity of food additives. FAO
    Food and nutrition Paper, No. 31/2, 1984.

    70. Evaluation of certain food additives and contaminants
    (Twenty-ninth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 733, 1986, and
    corrigendum.

    71. Specifications for the identity and purity of certain food
    additives. FAO Food and nutrition Paper, No. 34, 1986.

    72. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 20. Cambridge University
    Press, 1987.

    73. Evaluation of certain food additives and contaminants (Thirtieth
    report of the Joint FAO/WHO Expert Committee on Food Additives). WHO
    Technical Report Series, No. 751, 1987.

    74. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 21. Cambridge University
    Press, 1987.

    75. Specifications for the identity and purity of certain food
    additives. FAO Food and Nutrition Paper, No. 37, 1986.

    76. Principles for the safety assessment of food additives and
    contaminants in food. WHO Environmental Health Criteria, No. 70.
    Geneva, World Health Organization, 1987.

    77. Evaluation of certain food additives and contaminants
    (Thirty-first report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 759, 1987, and
    corrigendum.

    78. Toxicological evaluation of certain food additives. WHO Food
    Additives Series, No. 22. Cambridge University Press, 1988.

    79. Specifications for the identity and purity of certain food
    additives. FAO Food and Nutrition Paper, No. 38, 1988.

    80. Evaluation of certain veterinary drug residues in food
    (Thirty-second report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 763, 1988.

    81. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 23. Cambridge University Press,
    1988.

    82. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition paper, No. 41, 1988.

    83. Evaluation of certain food additives and contaminants
    (Thirty-third report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 776, 1989.

    84. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 24. Cambridge University
    Press, 1989.

    85. Evaluation of certain veterinary drug residues in food
    (Thirty-fourth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 788, 1989.

    86. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 25, 1990.

    87. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/2, 1990.

    88. Evaluation of certain food additives and contaminants
    (Thirty-fifth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 789, 1990, and
    corrigenda.

    89. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 26, 1990.

    90. Specifications for identity and purity of certain food additives.
    FAO Food and Nutrition Paper, No. 49, 1990.

    91. Evaluation of certain veterinary drug residues in food
    (Thirty-sixth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 799, 1990.

    92. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 27, 1991.

    93. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/3, 1991.

    94. Evaluation of certain food additives and contaminants
    (Thirty-seventh report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 806, 1991, and
    corrigenda.

    95. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 28, 1991.

    96. Compendium of Food Additive Specifications. Joint FAO/WHO Expert
    Committee on Food Additives (JECFA). Combined specifications from 1st
    through the 37th Meetings, 1956-1990. FAO, 1992 (2 volumes).

    97. Evaluation of certain veterinary drug residues in food
    (Thirty-eighth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 815, 1991.

    98. Toxicological evaluation of certain veterinary residues in food.
    WHO Food Additives Series, No. 29, 1991.

    99. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/4, 1991.

    100. Guide to specifications - General notices, general analytical
    techniques, identification tests, test solutions, and other reference
    materials. FAO Food and Nutrition Paper, No. 5, Ref. 2, 1991.

    101. Evaluation of certain food additives and naturally occurring
    toxicants (Thirty-ninth report of the Joint FAO/WHO Expert Committee
    on Food Additives). WHO Technical Report Series No. 828, 1992.

    102. Toxicological evaluation of certain food additives and naturally
    occurring toxicants. WHO Food Additive Series, No. 30, 1993.

    103. Compendium of food additive specifications: Addendum 1. FAO Food
    and Nutrition Paper, No. 52, 1992.

    104. Evaluation of certain veterinary drug residues in food (Fortieth
    report of the Joint FAO/WHO Expert Committee on Food Additives). WHO
    Technical Report Series, No. 832, 1993.

    105. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 31, 1993.

    106. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/5, 1993.

    107. Evaluation of certain food additives and contaminants
    (Forty-first report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 837, 1993.

    108. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 32, 1993.

    109. Compendium of food additive specifications, addendum 2. FAO Food
    and Nutrition Paper, No. 52, Add. 2, 1993.

    110. Evaluation of certain veterinary drug residues in food
    (Forty-second report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 851, 1995.

    111. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 33, 1994.

    112. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/6, 1994.

    113. Evaluation of certain veterinary drug residues in food
    (Forty-third report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 855, 1995, and
    corrigendum.

    114. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 34, 1995.

    115. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/7, 1995.

    116. Evaluation of certain food additives and contaminants
    (Forty-fourth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 859, 1995.

    117. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 35, 1996.

    118. Compendium of food additive specifications, addendum 3. FAO Food
    and Nutrition Paper, No. 52, Add. 3, 1995.

    119. Evaluation of certain veterinary drug residues in food
    (Forty-fifth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 864, 1996.

    120. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 36, 1996.

    121. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/8, 1996.

    122. Evaluation of certain food additives and contaminants
    (Forty-sixth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 868, 1997.

    123. Toxicological evaluation of certain food additives and
    contaminants. WHO Food Additives Series, No. 37, 1996.

    124. Compendium of food additives specifications, addendum 4. FAO Food
    and Nutrition Paper, No. 52, Add. 4, 1996.

    125. Evaluation of certain veterinary drug residues in food
    (Forty-seventh report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, No. 876, in press.

    126. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 38, 1996.

    127. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/9, 1997.

    128. Evaluation of certain veterinary drug residues in food
    (Forty-eighth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series, in press.

    129. Toxicological evaluation of certain veterinary drug residues in
    food. WHO Food Additives Series, No. 39, 1997.

    130. Residues of some veterinary drugs in animals and foods. FAO Food
    and Nutrition Paper, No. 41/10, in press.

    131. Evaluation of certain food additives and contaminants
    (Forty-ninth report of the Joint FAO/WHO Expert Committee on Food
    Additives). WHO Technical Report Series,  in preparation.

    132. Safety evaluation of certain food additives and contaminants. WHO
    Food Additives Series, No. 40, 1998.

    133. Compendium of food additive specifications: Addendum 5.  FAO Food
    and Nutrition Paper, No. 52, Add. 5, 1997.

    134. Evaluation of certain veterinary drug residues in food (Fiftieth
    report of the Joint FAO/WHO Expert Committee on Food Additives).  WHO
    Technical Report Series, in preparation.

    ANNEX 2

    ABBREVIATIONS USED IN THE MONOGRAPHS

    ADI       acceptable daily intake
    ATCC      American Tissue Culture Collection
    AUC       area under the concentrationtime curve
    BLV       bovine leukaemia virus
    BSE       bovine spongiform encephalopathy
    bw        body weight
    CAEV      caprine arthritis encephalitis virus
    CCFA      D-cycloserine, cefotoxin, and fructose agar
    CFU       colony-forming units
    CYP       cytochrome P450 isoenzyme
    d         day
    DNA       deoxyribonucleic acid
    ED        Euclidian distance
    EEC       European Economic Community
    EPA       Environmental Protection Agency (USA)
    F1        first filial generation
    F2        second filial generation
    FAO       Food and Agricultural Organization of the United Nations
    FDA       Food and Drug Administration (USA)
    GABA      gamma-aminobutyric acid
    GLP       good laboratory practice
    GST-P+    gluathione  S-transferase placental form-positive
    HIV       human immunodeficiency virus
    HPLC      high-performance liquid chromatography
    ID50      median inhibitory dose
    IDDM      insulin-dependent type I diabetes mellitus
    IGF-I     insulin-like growth factor
    JECFA     Joint FAO/WHO Expert Committee on Food Additives
    LD50      median lethal dose
    MIC       minimal inhibitory concentration
    MRL       maximum residue limit
    NCCLS     National Committee for Clinical Laboratory Standards
    ND        not determined
    NDEA       N-nitrosodiethylamine
    NOEL      no-observed-effect level
    OECD      Organisation for Economic Co-operation and Developoment
    PEG       polyethylene glycol
    QA        quality assurance
    rbST      recombinant bovine somatotropin
    RIA       radioimmunoassay
    S9        9000   g fraction of rat liver
    SD        standard deviation
    SPF       specific pathogen-free
    T3        triiodothyronine
    T4        thyroxine
    TSH       thyroid-stimulating hormone
    VPI       Virginia Polytechnic Institute and State University
    WHO       World Health Organization
    w/w       weight for weight

    ANNEX 3

    Joint FAO/WHO Expert Committee On Food Additives

    Rome, 17-26 February 1998

    Members

    Dr L.-E. Appelgren, Professor of Pharmacology, Department of
    Pharmacology and Toxicology, Faculty of Veterinary Medicine, The
    Swedish University of Agricultual Sciences, Biomedical Centre,
    Uppsala, Sweden

    Dr D. Arnold, Deputy Director, Federal Institute for Health,
    Protection of Consumers and Veterinary Medicine, Berlin, Germany

    Dr J. Boisseau, Director, National Agency for Veterinary Medicines,
    National Centre of Veterinary and Food Studies, Fougres, France
     (Chairman)

    Professor A.R. Boobis, Section on Clinical Pharmacology, Division of
    Medicine, Imperial College School of Medicine, Hammersmith Campus,
    London, United Kingdom

    Dr R. Ellis, Director, Scientific Research and Oversight, Office of
    Public Health and Science, US Department of Agriculture, Washington
    DC, USA  (Rapporteur)

    Dr R. Livingston, Center for Veterinary Medicine, Food and Drug
    Administration, Rockville, MD, USA

    Professor J.G. McLean, South Melbourne, Victoria, Australia
     (Vice-Chairman)

    Dr J. MacNeil, Head, Center for Veterinary Drug Residues, Health of
    Animals Laboratory, Canadian Food Inspection Agency, Saskatoon,
    Saskatchewan, Canada

    Dr J. Rojas Martinez, Chief, Toxicology and Residue Section, National
    Laboratory of Veterinary Sciences, Ministry of Agriculture and Animal
    Husbandry, San Jos, Costa Rica

    Dr M.A. Miller, Deputy Director for Human Food Safety, Office of New
    Animal Drug Evaluation, Center for Veterinary Medicine, Food and Drug
    Administration, Rockville, MD, USA  (Rapporteur)

    Professor E.S. Mitema, Department of Public Health, Pharmacology and
    Toxicology, Faculty of Veterinary Medicine, College of Agriculture and
    Veterinary Sciences, University of Nairobi, Kabete, Kenya

    Professor J. Palermo-Neto, Dean, Department of Pathology, Faculty of
    Veterinary Medicine, University of Sao Paulo, Sao Paulo, Brazil

    Dr A. Pintr, National Institute of Environmental Health, Budapest,
    Hungary

    Dr P. Sinhaseni, Deputy Director for Research, Institute of Health
    Research, Chulalongkorn University, Bangkok, Thailand

    Dr S. Soback, Head, National Residue Laboratory, Kimron Veterinary
    Institute, Ministry of Agriculture, Beit Dagan, Israel

    Dr R. Wells, Gordon, NSW, Australia
    Secretariat

    Dr C. E. Cerniglia, Director, Division of Microbiology and Chemistry,
    National Center for Toxicological Research, Food and Drug
    Administration, Jefferson, AR, USA  (WHO Temporary Adviser)

    Dr P. Chamberlain, Toxicologist, Division of Human Food Safety, Office
    of New Animal Drug Evaluation, Center for Veterinary Medicine, Food
    and Drug Administration, Rockville, MD, USA  (WHO Temporary Adviser)

    Dr S.D. Chernausek, Endocrinology, Childrens Hospital Medical Center,
    Cincinnati, OH, USA  (WHO Temporary Adviser)

    Dr R. Fuchs, Head, Department of Experimental Toxicology and
    Ecotoxicology, Institute for Medical Research and Occupational Health,
    Zagreb, Croatia  (WHO Temporary Adviser)

    Dr E.A.M. Good, Veterinary Medicines Directorate, Addlestone, Surrey,
    United Kingdom  (WHO Temporary Adviser)

    Dr M.K. Hansen, Consumer Policy Institute, Consumers Union, Yonkers,
    NY, USA  (WHO Temporary Adviser)

    Dr R. Heitzman, Compton, Newbury, Berks, United Kingdom  (FAO 
     Consultant)

    Dr J.L. Herrman, Scientist, Assessment of Risk and Methodologies,
    International Programme on Chemical Safety, World Health Organization,
    Geneva, Switzerland  (Joint Secretary)

    Mrs E. Heseltine, Communication in Science, Lajarthe,
    Saint-Lon-sur-Vzre, France  (Editor)

    Dr K. Mitsumori, Chief, Third Section, Division of Pathology,
    Biological Safety Research Centre, National Institute of Health
    Sciences, Tokyo, Japan  (WHO Temporary Adviser)

    Professor C.E. Nord, Chairman, Department of Immunology, Microbiology,
    Pathology and Infection Diseases, Karolinska Institutet, Huddinge
    University Hospital, Huddinge, Sweden  (WHO Temporary Adviser)

    Dr P. Olsen, Head, Pathology Section, Institute of Food Safety and
    Toxicology, Danish Veterinary and Food Administration, Sborg, Denmark
     (WHO Temporary Adviser)

    Dr J. Paakkanen, Food Quality Liaison Group, Food Quality and
    Standards Service, Food and Nutrition Division, Rome, Italy
     (Joint Secretary)

    Dr M. Pronk, Centre for Substances and Risk Assessment, National
    Institute of Public Health and the Environment, Bilthoven, Netherlands
     (WHO Temporary Adviser)

    Dr L. Ritter, Executive Director, Canadian Network of Toxicology
    Centres, Professor, Department of Environmental Biology, University of
    Guelph, Guelph, Ontario, Canada  (WHO Temporary Adviser)

    Dr G. Roberts, Head, Chemical Products Assessment Section, Therapeutic
    Goods Administration, Commonwealth Department of Health and Family
    Services, Woden, ACT, Australia  (WHO Temporary Adviser)

    Dr B. Roestel, National Agency for Veterinary Medicines, National
    Centre of Veterinary and Food Studies, Fougres, France  (FAO 
     Consultant)

    Dr R.C. Sills, Head, Molecular Pathology, National Institute of
    Environmental Health Sciences, Research Triangle Park, NC, USA  (WHO 
     Temporary Adviser)

    Dr S. Sundlof, Director, Center for Veterinary Medicine, Food and Drug
    Administration, Rockville, MD, USA  (WHO Temporary Adviser)

    Professor F.R. Ungemach, Institute of Pharmacology, Pharmacy and
    Toxicology, Faculty of Veterinary Medicine, University of Leipzig,
    Leipzig, Germany  (WHO Temporary Adviser)

    Dr N. Weber, Leader, Residue Chemistry Team, Office of New Animal Drug
    Evaluation, Center for Veterinary Medicine, Food and Drug
    Administration, Rockville, MD, USA  (FAO Consultant)

    ANNEX 4

    Recommendations on compounds on the agenda and further toxicological
    studies and other information required

     Anthelminthic agents

    Eprinomectin

    Acceptable daily intake:      0-10 g/kg bw
    Residue definition:           Eprinomectin B1a

     Recommended maximum residue limits (MRLs)

                                                                   
    Species     Muscle     Liver      Kidney    Fat       Milk
                (g/kg)    (g/kg)    (g/kg)   (g/kg)   (g/L)
                                                                   

    Cattle      100        2000       300       250       20
                                                                   

    Febantel, fenbendazole, and oxfendazole

    Acceptable daily intake: 0-7 g/kg bw (group ADI for febantel,
                             fenbendazole, and oxfendazole)

    Residue definition:      Determined as the sum of fenbendazole,
                             oxfendazole, and oxfendazole sulfone,
                             expressed as oxfendazole sulfone equivalents

     Recommended maximum residue limits (MRLs)

                                                                    

    Species     Muscle     Liver      Kidney    Fat       Milk
                (g/kg)    (g/kg)    (g/kg)   (g/kg)   (g/L)
                                                                    

    Cattle      100        500        100       100       100
    Horses      100        500        100       100
    Pigs        100        500        100       100
    Goats       100        500        100       100
    Sheep       100        500        100       100       100
                                                                    

    Moxidectin

    Acceptable daily intake: 0-2 g/kg bw (established at the forty-fifth
                             meeting of the Committee (Annex 1, reference
                             119))

    Residue definition:      Moxidectin

     Recommended maximum residue limits (MRLs)

                                                                    

    Species        Muscle     Liver       Kidney       Fat
                   (g/kg)    (g/kg)     (g/kg)      (g/kg)
                                                                    

    Cattlea        20b        100         50           500
    Sheepa         50         100         50           500
    Deer           20         100         50           500
                                                                    

    a    Recommended at the forty-fifth meeting of the Committee (Annex
         1, reference 119), except for sheep muscle, which was recommended
         at the forty-seventh meeting (Annex 1, reference 125)
    b    At the forty-fifth meeting (Annex 1, reference 119), the
         Committee noted the very high concentration and great variation
         in the level of residues at the injection site in cattle over a
         49-day period after dosing.

     Antimicrobial agents

    Gentamicin

    Acceptable daily intake:      0-20 g/kg bw
    Residue definition:           Gentamicin

     Recommended maximum residue limits (MRLs)

                                                                     

    Species     Muscle     Liver      Kidney    Fat       Milk
                (g/kg)    (g/kg)    (g/kg)   (g/kg)   (g/L)
                                                                     

    Cattle      100        2000       5000      100       200
    Pigs        100        2000       5000      100
                                                                     

    Procaine benzylpenicillin

    Acceptable daily intake: Residues of benzylpenicillin and procaine
                             benzylpenicillin should be less than 30 g of
                             penicillin per person per day.
    Residue definition:      Benzylpenicillin

     Recommended maximum residue limits (MRLs)

                                                                

    Speciesa       Muscle     Liver       Kidney       Milk
                   (g/kg)    (g/kg)     (g/kg)      (g/L)
                                                                

    Cattle         50         50          50           4
    Pigs           50         50          50           
    Chickens       50         50          50           
                                                                

    a    Procaine benzylpenicillin is also used in horses, sheep,
         turkeys, rabbits, quail, and pheasants. Owing to lack of
         information, MRLs could not be established for those species.


    Sarafloxacin

    Acceptable daily intake: 0-0.3 g/kg bw
    Residue definition:      Sarafloxacin

     Recommended maximum residue limits (MRLs)

                                                                

    Species        Muscle     Liver       Kidney       Fat
                   (g/kg)    (g/kg)     (g/kg)      (g/kg)
                                                                

    Chickens       10         80          80           20
    Turkeys        10         80          80           20
                                                                

    Spectinomycin

    Acceptable daily intake: 0-40 g/kg bw (established at the
                             forty-second meeting of the Committee (Annex
                             1, reference 110))
    Residue definition:      Spectinomycin


     Recommended maximum residue limits (MRLs)

                                                                     

    Species    Muscle    Liver     Kidney    Fat      Milk    Eggs
               (g/kg)   (g/kg)   (g/kg)   (g/kg)  (g/L)  (g/kg)
                                                                     

    Cattle     500       2000      5000      2000     200
    Pigs       500       2000      5000      2000
    Sheep      500       2000      5000      2000
    Chickens   500       2000      5000      2000             2000
                                                                     

    Chlortetracycline, oxytetracycline, and tetracycline

    Acceptable daily intake: 0-30 g/kg bw (group ADI for oxytetracycline,
                             chlortetracycline, and tetracycline)
    Residue definition:      Parent drug

     Recommended maximum residue limits (MRLs)a

                                                                     

    Species           Muscle    Liver     Kidney     Milk     Eggs
                      (g/kg)   (g/kg)   (g/kg)    (g/L)   (g/kg)
                                                                     

    Cattle            200       600       1200       100
    Pigs              200       600       1200
    Sheep             200       600       1200       100
    Poultry           200       600       1200                400
    Fishb,c           200
    Giant prawnb      200
    (Penaeus monodon)
                                                                     


    a Singly or in combination
    b Applies only to oxytetracycline
    c Temporary, pending evaluation of use pattern of oxytetracycline
      in aquaculture

     Antiprotozoal agents

    Diclazuril

    Acceptable daily intake:    0-30 g/kg bw
    Residue definition:         Diclazuril

     Recommended maximum residue limits (MRLs)

                                                                

    Species           Muscle    Liver     Kidney     Fat
                      (g/kg)   (g/kg)   (g/kg)    (g/kg)
                                                                

    Sheep             500       3000      2000       1000
    Poultry           500       3000      2000       1000a
    Rabbits           500       3000      2000       1000
                                                                

    a Skin or fat

    Imidocarb

    Acceptable daily intake:    0-10 g/kg bw
    Residue definition:         Imidocarb

     Recommended maximum residue limits (MRLs)a

                                                                     

    Species       Muscle     Liver      Kidney     Fat      Milk
                  (g/kg)    (g/kg)    (g/kg)    (g/kg)  (g/L)
                                                                     

    Cattle        300        2000       1500       50       50
                                                                     

    a    Temporary. Studies of residue depletion in lactating and non-
         lactating cattle given recommended subcutaneous doses of
         unlabelled imidocarb and analysis of samples by the proposed
         regulatory method with enzymatic digestion are required for
         evaluation in 2001. If MRLs are to be recommended for sheep, a
         study of residue depletion with the recommended dose and route of
         administration is required.

    Nicarbazin

    Acceptable daily intake: 0-400 g/kg bw
    Residue definition:       N,N'-Bis(4-nitrophenyl)urea

     Recommended maximum residue limits (MRLs)

                                                                     

    Species                Muscle    Liver     Kidney    Fat or skin
                           (g/kg)   (g/kg)   (g/kg)   (g/kg)
                                                                     

    Chickens (broilers)    200       200       200       200 
                                                                     

     Glucocorticosteroid

    Dexamethasone

    Acceptable daily intake:      0-0.015 g/kg bw (established at the
                                  forty-second meeting of the Committee
                                  (Annex 1, reference 110))
    Maximum residue limits:       The forty-second and forty-third
                                  meetings of the Committee recommended
                                  temporary MRLs of 0.5 g/kg in muscle,
                                  0.5 g/kg in kidney, and 2.5 g/kg in
                                  liver of cattle, horses, and pigs and
                                  0.3 g/L in cattle milk based on an ADI
                                  of 0-0.015 g/kg bw. The MRLs were
                                  temporary because there was no adequate
                                  method to determine compliance with the
                                  MRLs. The Committee requested data on
                                  the performance of the analytical method
                                  for evaluation at its forty-eight
                                  meeting, but no data were received. The
                                  Committee decided to withdraw the
                                  temporary MRLs for dexamethasone because
                                  of lack of an adequate analytical method
                                  for enforcement of the MRLs. The present
                                  Committee reviewed the documentation for
                                  a high-performance liquid
                                  chromatography-mass spectrometry method
                                  for measuring dexamethasone residues in
                                  tissues and milk. The Committee
                                  concluded that the proposed method does
                                  not meet the required performance
                                  characteristics for identification and
                                  quantification of residues in incurred
                                  tissues. MRLs could not be recommended
                                  because a suitable method for residue
                                  analysis was not available.

     Production aid

    Bovine somatotropins

    Acceptable daily intake:      Not specifieda (applies to
                                  somagrebove, sometribove, somavubove,
                                  and somidobove)

    Maximum residue limits:       Not specified in cattle milk and edible
                                  tissuesb (applies to somagrebove,
                                  sometribove, somavubove, and somidobove)

    a    ADI 'not specified' means that available data on the toxicity
         and intake of the veterinary drug indicate a large margin of
         safety for consumption of residues in food when the drug is used
         according to good practice in the use of veterinary drugs. For
         that reason and for the reasons stated in the individual
         evaluation, the Committee concluded that use of the veterinary
         drug does not represent a hazard to human health and that there
         is no need to specify a numerical ADI.
    b    MRL 'not specified' means that available data on the identity
         and concentration of residues of the veterinary drug in animal
         tissues indicate a wide margin of safety for consumption of
         residues in food when the drug is used according to good practice
         in the use of veterinary drugs. For that reason and for the
         reasons stated in the individual evaluation, the Committee
         concluded that the presence of drug residues in the named animal
         product does not present a health concern and that there is no
         need to specify a numerical MRL.

     Tranquilizing agent

    Azaperone

    Acceptable daily intake:      0-6 g/kg bw
    Residue definition:           Sum of concentrations of azaperone and
                                  azaperol

     Recommended maximum residue limits (MRLs)

                                                                     

    Species       Muscle      Liver       Kidney        Fat
                  (g/kg)     (g/kg)     (g/kg)       (g/kg)
                                                                     

    Pigs          60          100         100           60
                                                                     
    






















    See Also:
       Toxicological Abbreviations