• better delineation of the respective roles of the Committee and Joint FAO/WHO Expert Committee on Food Additives (JECFA);
  
  

• improvement of transparency of the process;
  
  

• recognition that the application of safety factors and other conventions to address uncertainty were not strictly scientifically based and therefore, introduced an element of risk management into the risk assessment process;
  
  

• consideration of the benefits of the use of veterinary drugs as well as risks, for animals as well as humans;
  
  

• problems in relation to animal studies and the potential of using in vitro studies as alternatives for such studies;
  
  

• problems related to the generation of residue data for minor species;
  
  

• problems related to old substances which had not been evaluated under modern criteria, but which were still in use in many countries, and substances on the so-called "inactive list."

The recommendations of the Joint Expert Committee on Food Additives (JECFA) for thirteen veterinary drugs were evaluated. Acceptable Daily Intakes (ADI's) and Maximum Residue Limits (MRL's) were allocated/confirmed for clenbuterol, abamectin, moxidectin, chlortetracycline, oxytetracycline, tetracycline, neomycin, spiramycin, cypermethrin and -cypermethrin, and tilmicosin. MRL's for cypermethrin, -cypermethrin, and tilmicosin in sheep milk were made temporary pending further information. A temporary ADI and temporary MRL's were established for thiamphenicol. The JECFA could recommend neither an ADI nor MRL's for xylazine.

A working paper on procedures for assessing the effects of antimicrobial veterinary drug residues in food on the human intestinal microflora was reviewed.

The International Office of Epizootics reported on the progress of the "International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products" (known as VICH). In the short term, it was decided to establish five working groups which would consider the following topics: Guidelines on Quality, Safety, Good Clinical Practice, Efficacy of Anthelmintics, and Ecotoxicology.

Another important issue discussed was Guidelines on Residues at Injection Sites. The intention of the proposed guidelines was to ensure consumer safety, enhance residue monitoring practices, and to assist in trade facilitation. There was general support that the calculation of risk from consumption of residues at the injection site should be based on the principles of acute reference dose. The Committee invited JECFA to examine the issues raised in the paper and in the present discussion. It also requested that the paper be revised in light of this advice and be circulated for comments prior to submission for consideration at its next Session.

There was an extensive discussion regarding the methods of analysis and sampling for residues of veterinary drugs at the Ninth Session held in 1995. The Committee recalled the decision that if no method of analysis acceptable to the Committee was available to monitor an MRL, that the MRL should not be advanced beyond Step 7 to full acceptance by the Committee. Noting that its Terms of Reference required the Committee "to determine criteria for analytical methods used for the control of veterinary drug residues in foods" but did not extend to the consideration of methods of analysis, the Committee agreed that all MRL's currently retained at Step 7 should be considered for acceptance by advancement to Step 8.

The Committee also discussed a paper prepared by the Delegation of Australia and other delegations on the validation of analytical methods. Many of the issues raised in the paper were of potential concern in other areas of the Commission's work, including pesticide residues, contaminants, and microbiological analysis. The Committee proposed that the Commission request FAO, together with WHO, to give consideration to convening an Expert Consultation on the question of methods validation for food control purposes.

The delegation of the United States, with assistance from other delegations, presented a paper on the evaluation of residues of veterinary drugs in milk and milk products. The Committee noted that the proposals contained in the document were directed towards the prevention and monitoring of veterinary drug residues. Drug monitoring programs should be undertaken at an early point in the milk collection system. Problems such as the dilution of affected milk from individual cows or herds with other milk could be addressed this way. It was proposed that an integrated test system, drawing on the principles of the Hazard Analysis/Critical Control Point (HACCP) System, would be effective in combining screening and more investigatory tests at Critical Control Points.

The Committee noted the need for more data on the fate of residues during milk processing, e.g., pasteurization, spray drying, and cheese-making. The Committee also suggested the need for further data on the distribution of residues between different milk components (milk fat, whey, protein) following the administration of veterinary drugs by different routes (e.g., intramuscular use compared to intramammary use).