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    ANNEX 4

        RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA
                                                                                               

    Substances                  Acceptable Daily           Recommended Maximum
                                Intake (ADI) for           Residue Limit (MRL)
                                human beings and
                                other
                                toxicological
                                recommendations
                                                                                               

    Anthelminthic agents
                                                                                               

    Closantel                   Not evaluated1             Muscle and liver
                                                           (sheep): 1500 g/kg2
                                                           Kidney (sheep): 5000 g/kg2
                                                           Fat (sheep): 2000 g/kg2
                                                           Muscle and liver
                                                           (cattle): 1000 g/kg2
                                                           Kidney and fat
                                                           (cattle): 3000 g/kg2
                                                                                               

    Flubendazole                0-12 g per kg             Muscle and liver
                                of body weight             (pigs): 10 g/kg2
                                                           Muscle (poultry): 200 g/kg2
                                                           Liver (poultry): 500 g/kg2
                                                           Eggs: 400 g/kg2
                                                                                               

    Ivermectin                  0-1 g per kg of           Liver (cattle): 100 g/kg3
                                body weight                Fat (cattle): 40 g/kg3
                                                                                               

    Tiabendazole                0-100 g per kg            Edible tissues4 (cattle, pigs,
    (Thiabendazole)             of body weight             goats and sheep) and milk
                                                           (cattle and goats):
                                                           100 g/kg5
                                                                                               

    RECOMMENDATIONS ON COMPOUNDS ON THE AGENDA
                                                                                               

    Substances                  Acceptable Daily           Recommended Maximum
                                Intake (ADI) for           Residue Limit (MRL)
                                human beings and
                                other
                                toxicological
                                recommendations
                                                                                               

    Triclabendazole             0-3 g per kg of           Muscle (cattle): 200 g/kg6
                                body weight                Liver and kidney (cattle):
                                                           300 g/kg6
                                                           Fat (cattle): 100 g/kg6
                                                           Edible tissues4 (sheep):
                                                           100 g/kg6
                                                                                               

    Antimicrobial agents
                                                                                               

    Furazolidone                Not allocated7             No MRLs allocated8
                                                                                               

    Nitrofural
    (Nitrofurazone)             Not allocated9             No MRLs allocated8
                                                                                               

    Production aids
                                                                                               

    Bovine                      Not specified10            Milk and edible
    somatotropins                                          tissues4
                                                           (cattle): Not specified11
                                                                                               

    Ractopamine                 Not allocated12            No MRLs allocated13
                                                                                               
                                                                                         
    Trypanocide
                                                                                               

    Isometamidium               0-100 g per kg of body    Muscle, fat, and milk
                                weight                     (cattle): 100 g/kg2
                                                           Liver (cattle): 500 g/kg2
                                                           Kidney (cattle): 1000 g/kg2
                                                                                               

    Notes to Annex 4

    1    An ADI of 0-30 g per kg of body weight was established at the
         thirty-sixth meeting of the Committee (WHO Technical Report
         Series 799, 1990).

    2    Expressed as parent drug.

    3    Expressed as 22,23-dilydroavermectin B1a (H2B1a)

    4    Edible tissues are defined as muscle, fat, liver, and kidney.

    5    Expressed as the sum of thiabendazole and 5-hydroxythiabendazole.

    6    Expressed as 5-chloro-6-(2',3'-dichlorophenoxy)-benzimadazole-2-one.

    7    An ADI could not be established because of evidence of genotoxicity
         and carcinogenicity and lack of information on the nature of the
         metabolites.

    8    MRLs were not allocated because:
         a.   No ADI was established;
         b.   Data on residues were not sufficient for the Committee to
              identify a marker residue; and
         c.   Insufficient information was available on the quantity and nature
              of the total residues.

    9    An ADI could not be established because no-effect levels were not
         observed for the tumorigenic effects.

    10   The ADI applies to somagrebove, sometribove, somavubove, and somidobove.
         ADI "not specified" means that available data on the toxicity and
         intake of the veterinary drug indicate a large margin of safety
         for the consumption of its 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 has 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.

    11   The MRLs apply to somagrebove, sometribove, somavubove, and somidobove.
         MRL "not specified" means that available data on the identity and
         concentration of residues of the veterinary drug in animal tissues
         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 has 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.

    12   An ADI could not be established because a clear no-effect level was
         observed for pharmacological effects and the issue of carcinogenicity has
         not been resolved.

    13   MRLs were not allocated because:
         a.   An ADI was not established, and
         b.   Sufficient information was not available for the Committee to
              establish a marker residue in animal tissues.
    





















    See Also:
       Toxicological Abbreviations