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    Annex 4

        Recommendations on compounds on the agenda
                                                                                              

    Substance                Acceptable daily          Recommended maximum
                             intake (ADI) and other    residue limit (MRL)
                             toxicological
                             recommendations
                                                                                              

    Anthelminthic agents

    Abamectin                0-0.2 g per kg of        No MRLs recommendedb
                             body weighta

    Doramectin               0-0.5 g per kg of        Muscle (cattle): 10 g/kgc,d
                             body weight               Liver (cattle): 100 g/kgc,d
                                                       Kidney (cattle): 30 g/kgc,d
                                                       Fat (cattle): 150 g/kgc,d

    Moxidectin               0-2 g per kg of          Muscle (cattle, sheep & deere)
                             body weight                 20 g/kgc,f
                                                       Liver (cattle, sheep & deere):
                                                         100 g/kgc,f
                                                       Kidney (cattle, sheep & deere):
                                                         50 g/kgc,f
                                                       Fat (cattle, sheep & deere):
                                                         500 g/kgc,f

    Febantel,                0-4 g per kg of          Muscle, kidney & fat (cattle, pigs
    fenbendazole, and        body weightg                & sheep): 100 g/kge,h
    oxfendazole                                        Liver (cattle, pigs & sheep):
                                                         500 g/kge,h
                                                       Milk (cattle): 100 g/le,h
                                                                                              

    Antimicrobial agents

    Ceftiofur                0-50 g per kg of         Muscle (cattle & pigs): 200 g/kgi
                             body weight               Liver (cattle & pigs): 2000 g/kgi
                                                       Kidney (cattle & pigs): 4000 g/kgi
                                                       Fat (cattle & pigs): 600 g/kgi
                                                       Milk (cattle): 100 g/li
                                                                                              

    Annex 4 (cont'd)

    Recommendations on compounds on the agenda
                                                                                              

    Substance                Acceptable daily          Recommended maximum
                             intake (ADI) and other    residue limit (MRL)
                             toxicological
                             recommendations
                                                                                              

    Chlortetracycline and    0-3 g per kg of          Muscle (cattle, pigs & poultry):
    tetracycline             body weightj                100 g/kgc,e
                                                       Liver (cattle, pigs, sheep &
                                                         poultry): 300 g/kgc,e
                                                       Kidney (cattle, pigs, sheep &
                                                         poultry): 600 g/kgc,e
                                                       Eggs (poultry): 200 g/kgc,e

    Oxytetracycline          0-3 g per kg of          Edible tissue (Penaeus
                             body weightj                monodon): 100 g/kgc,e

    Antiprotozoal agent

    Diclazuril               0-20 g per kg of         Muscle (sheep, rabbits & poultry):
                             body weightk                500 g/kgc,l
                                                       Liver (sheep, rabbits & poultry):
                                                         3000 g/kgc,l
                                                       Kidney (sheep, rabbits & poultry):
                                                         2000 g/kgc,l
                                                       Fat (sheep & rabbits):
                                                         1000 g/kgc,l
                                                       Skin/fat (poultry): 1000 g/kgc,l
                                                                                              
    
    Notes to Annex 4


    a.   The ADI for abamectin was established by the 1994 Joint FAO/WHO Meeting on
         Pesticide Residues (JMPR) (FAO Plant Production and Protection Paper
         No. 127, 1995; for the corresponding toxicological monograph, see Pesticide
         residues in food - 1994 evaluations. Part II Toxicology
         (WHO/PCS/95.2, 1995)).

    b.   Several issues relating to differences in the approaches adopted by the
         Joint FAO/WHO Expert Committee on Food Additives (JECFA) and JMPR in
         recommending MRLs in animal products arose at the meeting. In addition, the
         ADI established by JMPR for abamectin incorporated a safety factor of 500
         to take into account the teratogenicity of the Delta-8,9 isomer, a
         metabolite that does not occur when abamectin is used as a veterinary drug.
         For this reason, the Committee did not recommend MRLs for abamectin used as
         a veterinary drug but recommended that consultations should be held between
         representatives of JECFA and JMPR to resolve these differences.

    c.   Expressed as parent drug.

    d.   The Committee noted the high concentration of residues at the injection
         site 35 days after subcutaneous or intramuscular administration of the drug
         at the recommended dose.

    e.   Temporary MRL.

    f.   The Committee noted the very high concentrations and great variation in the
         level of residues at the injection site in cattle over a 49-day period.

    g.   Group temporary ADI for febantel, fenbendazole and oxfendazole, based on
         the no-observed-effect level (NOEL) for oxfendazole identified at the
         thirty-eighth meeting of the Committee (WHO Technical Report Series,
         No. 815, 1991).

    h.   Determined as the sum of fenbendazole, oxfendazole and oxfendazole sulfone,
         expressed as oxfendazole sulfone equivalents.

    i.   Expressed as desfuroylceftiofur.

    j.   Group ADI for chlortetracycline, oxytetracycline and tetracycline, based on
         the NOEL for oxytetracycline identified at the thirty-sixth meeting of the
         Committee (WHO Technical Report Series, No. 799, 1990).

    k.   Temporary ADI.

    l.   The MRL is temporary because the ADI is temporary.
    





















    See Also:
       Toxicological Abbreviations