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CONSIDERATION OF PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS (MRLVDs) AT STEP 4[9] (Agenda Item 8)

33. The representative of the European Union reiterated its previous general reservation that in principle the final report of JECFA should be available before advancing the relevant MRLs. However, the representative agreed to be flexible and did not oppose the advancement of the MRLs on this occasion.

34. The Committee agreed that temporary MRLs could be advanced for adoption by the Commission at step 8, with the understanding that full MRLs could be recommended at a later date on the basis of data submitted to JECFA in a subsequent review. A specific time frame during which the temporary MRLs would remain valid would be specified, and at the expiration of this time period the temporary MRLs would need to be reconsidered by the Committee.

Abamectin

35. The Committee advanced the proposed draft MRLs for cattle (liver, kidney, fat) to Step 5. Azaperone

36. The Committee advanced the proposed draft temporary MRLs for pigs (muscle, fat, liver, kidney) to Step 5.

Chlorotetracycline/Oxytetracycline/Tetracycline

37. The Committee noted that methods of analysis had been recommended for chlortetracycline/oxytetracycline (pig and cattle muscle/kidney and cattle milk) and tetracycline (cattle muscle, kidney and milk). The Committee advanced the proposed draft MRLs for cattle, pigs, sheep, poultry (muscle, liver, kidney), cattle, sheep (milk) and poultry (eggs) to Step 5. In view of the biological relevance of low levels of antimicrobials on human intestinal microflora, the JECFA Secretariat agreed to consider its previous evaluation of these substances (tetracycline group) in the context of its overall assessment of antmicrobials.

Oxytetracycline (only)

38. The Committee advanced the proposed draft MRL for giant prawn to Step 5/8, by omitting Steps 6 and 7, as there were no toxicological concerns. The Committee withdrew previously adopted MRLs for fat (cattle, sheep, pigs, chickens, turkeys) on the basis of the 47th JECFA recommendation that the elaboration of MRLs for fat were unnecessary. As the previously adopted MRL for fish muscle was not recommended for withdrawal by the 47th JECFA, the Committee maintained the MRL at Step 8.

Clenbuterol

39. The Committee retained the proposed draft MRLs for cattle, horses (muscle, liver, kidney, fat) and cattle (milk) at Step 4 in view of the extremely low ADI, MRLs and absence of the final JECFA report. In response to a comment, the JECFA Secretariat noted that the compound had been evaluated for certain therapeutic applications (propylisis in cows and propylisis and respiratory diseases in horses) and was not evaluated for growth promotion purposes.

Cypermethrin

40. The Committee advanced the proposed draft temporary MRLs for cattle, sheep, chickens (muscle, liver, kidney, fat), chickens (eggs) and cattle (milk) to Step 5.

a-Cypermethrin

41. The Committee advanced the proposed draft temporary MRLs for cattle, sheep, chickens (muscle, liver, kidney, fat), chickens (eggs) and cattle (milk) to Step 5.

Dexamethasone

42. The Committee advanced the proposed draft temporary MRLs for cattle, pigs, horses (muscle, kidney, liver) and cattle (milk) to Step 5.

Diclazuril

43. The Committee advanced the proposed draft temporary MRLs for sheep, rabbits, poultry (muscle, liver, kidney, fat) to Step 5.

Dihydrostreptomycin and Streptomycin

44. The Committee advanced the proposed draft temporary MRLs for cattle, pigs, chicken, sheep

(muscle, liver, fat, kidney) and cattle (milk) to Step 5.

Febantel/Febendazole/Oxfendazole

45. The Committee advanced the proposed draft temporary MRLs for cattle, pigs, sheep (muscle, kidney, fat, liver) and cattle (milk) to Step 5.

Gentamicin

46. The Committee advanced the proposed draft temporary MRLs for cattle, pigs (muscle, fat, liver, kidney) and cattle (milk) to Step 5.

Moxidectin

47. The Committee advanced the proposed draft temporary MRLs for deer (muscle, liver, kidney, fat) to Step 5/8, omitting Steps 6 and 7, for adoption as Temporary MRLs for the period 1997-1999. It was noted that these uses were scheduled for JECFA review in 1998, after which the status of the Temporary MRL would be reviewed by the Committee and the Commission.

Neomycin

48. The Committee advanced proposed draft MRLs for cattle, goats, pigs, sheep, chickens, ducks, turkeys (muscle, liver, fat, kidney), chickens (eggs) and cattle (milk) to Step 5.

Spectinomycin

49. The Committee advanced the proposed draft temporary MRLs for cattle, pigs, chickens (muscle, liver, kidney, fat) and cattle (milk) to Step 5.

Spiramycin

50. The Committee advanced the proposed draft MRLs for pigs (liver, kidney, fat) to Step 5/8, by omitting Steps 6 and 7, as these were modifications of previous assessments which presented no additional toxicological concerns.

Thiamphenicol

51. The Committee advanced the proposed draft temporary MRLs for cattle and chickens (muscle, liver, kidney, fat) to Step 5.

Tilmicosin

52. The Committee advanced the proposed draft MRLs for cattle, pigs, sheep (muscle, liver, kidney, fat) and the proposed draft temporary MRL for sheep (milk) to Step 5.

STATUS OF THE PROPOSED DRAFT MAXIMUM RESIDUE LIMITS FOR VETERINARY DRUGS

53. The proposed draft maximum residue limits for veterinary drugs are contained in Appendix IV (advanced to Step 5/8), Appendix V (advanced to Step 5) and Appendix VI (retained at Step 4).


[9] ALINORM 97/31, Appendix V and government comments submitted by Germany, Malaysia, Norway, Poland and the United States in response to CL 1996/27-RVDF (CX/RVDF 96/6).

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