ANNEX 4

    Recommendations on compounds on the agenda
                                                                        

                             Acceptable           Acceptable
    Substance                Daily                Residue
                             Intake for           Level
                             Human Beings
                                                                        

    Antimicrobial agent

      Chloramphenicol        Not allocated1       Not allocated1

    Growth promoters

      Endogenous

      Estradiol-17ß          Unnecessary2         Unnecessary2

      Progesterone           Unnecessary2         Unnecessary2

      Testosterone           Unnecessary2         Unnecessary2

      Xenobiotic

      Trenbolone             0-0.01 µg/kg of      1.4 µg/kg
      acetate                body weight3         (bovine
                                                  tissue) for ß-
                                                  trenbolone; 3,4
                                                  14 µg/kg (bovine
                                                  liver and kidney)
                                                  for alpha-
                                                  trenbolone3,5

      Zeranol                0-0.5 µg/kg of       10 µ/kg (bovine
                             body weight          liver;6
                                                  2 µg/kg (bovine
                                                  muscle)7
                                                                        

    1    No ADI or Acceptable Residue Level could be established because
         it was not possible to give an assurance that residues would be
         safe for sensitive subjects, who could develop aplastic anaemia.

    2    Establishing an ADI and an Acceptable Residue Level for a hormone
         that is produced endogenously at variable levels in human beings
         was considered unnecessary by the Committee. Residues resulting
         from the use of this substance as a growth promoter in accordance
         with good animal husbandry practice are unlikely to pose a hazard
         to human health.

    3    Temporary acceptance. The following information was requested,
         to be submitted by 1990: (a) the final reports, with supporting
         data, for the tissue residue studies in which trenbolone acetate
         was ministered to heifers and trenbolone acetate in combination
         with estradiol-17ß was administered to steers; (b) data on
         individual animals from the three hormonal studies in pigs that
         were reviewed by the Committee; and (c) results from a 90-day
         study in an appropriate species with orally administered
         alpha-trenbolone.

    4    Based on consumption of 500 g meat per day by a 70 kg person.

    5    Based on the finding that alpha-trenbolone had one-tenth of the
         hormonal activity of ß-trenbolone in a study in pigs.

    6    Based on a level consistent with good animal husbandry practice,
         as determined by studies with radiolabelled zeranol, since this
         level is lower than that calculated from the ADI as the maximum
         permissible on toxicological grounds.

    7    Based on the lowest level consistent with the practical
         analytical methods available for routine residue analysis.
    

    See Also:
       Toxicological Abbreviations