Other legitimate factors in the framework of risk analysis
5. The Committee noted matters arising from the 23rd Session of the Codex Alimentarius Commission[4] and the 14th Session of the Codex Committee on General Principles[5].
6. The Committee recalled that the Committee on General Principles (CCGP) was currently considering the role of “other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade” in relation to risk analysis. In order to facilitate the debate on general issues, the CCGP had requested the Committees involved in risk analysis to identify the relevant factors taken into account in their work. The Committee considered the other factors proposed in the comments of the United States and the EC (CRD 14 & 15) as a basis for discussion and came to the following conclusions.
7. The Committee considered the role of “Good Veterinary Practice” in the establishment of MRLs. The Observer from COMISA, supported by several delegations, proposed to refer to “Good Practice in the Use of Veterinary Drugs (GPVD)” as defined in the Procedural Manual. Other delegations expressed the view that the concept of “Good Veterinary Practice” went beyond the definition, which was too general and needed clarification, in particular to reflect that animal health and animal welfare were taken into account. It was noted that the current definition was the result of earlier consensus, and that the Committee had decided that it would only need to define good practices which were related to residues control. Some delegations pointed out that animal health and welfare and a number of other factors were taken into account in the registration of veterinary drugs at the national level but there should be no specific reference to such factors at the international level. The Committee agreed to refer to the current definition of GPVD and did not come to a consensus on the interpretation of this definition.
8. The Committee had an exchange of views on the relevance of Good Manufacturing Practice (GMP) for veterinary drugs. It was pointed out that GMP was considered as part of the risk assessment process whereas the Committee should concentrate on risk management aspects. The Committee however agreed that the question from the CCGP related to other factors in relation to the entire risk analysis process and that GMP was relevant in this context.
9. The Committee agreed that technical feasibility was taken into account in the decision process, for example, as regards the availability of methods of analysis; MRLs might need to be set at the limit of quntification of the method to facilitate monitoring programmes. The Committee also recalled that MRLs were not advanced beyond Step 7 unless there was a suitable analytical method to be used in monitoring and surveillance programmes (e.g. dexamethasone).
10. The Committee also recognized that it was necessary to minimize exposure by establishing MRLs only as high as required associated with the use in conformity with “Good Veterinary Practice” as identified by countries; food consumption estimates used by JECFA were very conservative; when establishing MRLs, consideration was also given to residues that occur in food of plant origin and/or the environment. The Committee agreed that the concept of ALARA (As Low As Reasonably Achievable) had been applied in the case of benzylpenicillin in view of potential for allergenic reactions associated with this compound and that it should be included as a legitimate factor.
11. The Committee concluded that the following factors had been or were taken into account in its work: Good Practices in the Use of Veterinary Drugs; Good Manufacturing Practices; technical feasibility; substantial changes in food composition and quality characteristics; the need to minimize exposure; the ALARA concept; food consumption estimates; and residues from other sources than animal products.
12. The Observer from Consumers International pointed out that several factors considered by the Committee reflected the importance of precaution in residue setting, since the general purpose of the process was to ensure health protection; this should not be considered as a separate factor but as an essential aspect of risk analysis as a whole. The Committee agreed that a precautionary approach to the establishment of MRLs that ensure the protection of public health was inherent to the deliberations of JECFA and the CCRVDF and that many of the factors identified and listed above reflected this approach.
13. The Committee considered the impact of residues on processing, especially as regards milk intended for cheese making. The JECFA Secretariat indicated that this had been considered in some cases in the evaluation process, but it had not affected the actual MRL for the raw material.
14. Some delegations and the Observer from Consumers International proposed that the Committee should consider additional factors in particular consumer information, consumer concerns, animal health and welfare, the technological need for veterinary drugs, and environmental aspects. The Committee could not come to a consensus on these aspects.
