59. The Committee recalled that the Commission at its 22nd Session had decided to suspend consideration of the adoption of the MRLs for Bovine Somatotropin pending re-evaluation of scientific data by JECFA and the CCRVDF and examination of the application of "other legitimate factors" in relation with BST by the CCGP. In reply to a question concerning the re-evaluation of the data by the 50th Session of JECFA, the Committee was informed that the Summary report of this meeting, which included the complete section on BST evaluation had been published and distributed and was available on the Internet. However, the supporting toxicological monographs were not yet available and the final report, following editing, would be published by WHO in the coming months. Since PST had not been evaluated by JECFA, the Committee could not consider this specific case.
60. The Committee reasserted the primary role of science in health related issues, as reflected in the current work on risk analysis in relation to food safety. It had an extensive discussion on the application of the second statement of principle concerning "other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in the food trade".
61. Several delegations and the Observer from the EC expressed the view that Codex Committees were not expert groups and that their role was not limited to systematic integration of JECFA recommendations in standards and other texts. They expressed policy choices consistent with the overall responsibility of Codex committees in carrying out risk management, whereas risk assessment was the role of expert groups. As representatives of governments, member countries had to take political decisions which integrated a number of factors in addition to risk assessment. They pointed out that Codex standards aimed at both protecting consumer health and ensuring fair practices in the food trade, and that the distinction between safety and quality aspects was not always clear.
62. In this perspective, these Delegations stated that the consideration of other legitimate factors in the decision process was essential and several elements should be considered in the case of BST. Toxicological evaluation was not the only element to be considered; as in the case of additives with an ADI not specified, technological justification and need had to be considered and these did not exist in the case of BST. In addition they stated that only intensive production systems allowed its use, which was contrary to the agricultural policy followed by many countries and generally detrimental to the environment, while it would not be generally accessible to developing countries. Reference was also made to a potential reduction of animal immune defences and the risk of increased antibiotics use as a consequence. These delegations, recalling the opposition of some consumers to the use of BST,emphasized the importance of consumer concerns as a legitimate factor, in order to ensure that Codex standards were based on consensus and were largely accepted. The Observer from CSPI stated that the wider acceptance of standards in world trade depended on recognition of societal values. The Observer of the WVA asked the Committee to consider animal health and animal welfare in the case of BST as a legitimate factor to be considered in the discussion process.
63. Other delegations and the Observer from COMISA supported the recommendations of the document and stressed that science-based risk assessment should be the determining factor when addressing a food safety issue such as the setting ofMRLs for veterinary drugs. They recognized that while other factors were integrated in the definition of policy at the national level, the purpose of international standards was to provide a reference for the protection of health, as defined under the SPS Agreement, when sanitary measures were concerned. The factors mentioned by those delegations opposing the MRL for BST might be considered at the national level but were not relevant in the framework of Codex; especially matters such as animal health and environment were outside its competence. In addition, no objective criteria had been put forward to justify specific economic or other problems related to BST, and the prohibition of BST appeared to be more restrictive to trade than necessary.
64. These Delegations were of the opinion that the application of factors such as environmental concerns, consumer choice, animal welfare greatly differed from one country to another and should be addressed at the national level; some delegations also pointed out that consumer concerns or preferences were different between developed and developing countries.
65. The Observer from the European Community wished to clarify an erroneous impression that the EC had prohibited the import of milk and milk products derived from animals treated with BST. In fact, no such prohibition had been introduced: there was a moratorium on the use of BST in the European Union until the end of 1999. Therefore no trade problems existed.
66. Attention was also drawn to the fact that in the Codex Statements of Principle, the term "other legitimate factors" was not open-ended but was limited to those relevant to the health protection of the consumer and ensuring fair practices in the food trade. It was considered important to work within the terms of reference of these principles. Other Delegations believed that even though animal welfare and the environment were not part of Codex objectives, states should legitimately ensure consistency in their actions by refusing decisions taken in the area of Codex work which would have negative effects on animal health or the environment.
67. Some delegations and the Observer from Consumers International noted both the difficulties and the importance of determining the legitimacy or relevance of other factors andemphasized that they should be clearly identified and based on objective criteria, in order to prevent their use as a disguised barrier to trade, especially in view of the TBT Agreement provisions that "technical regulations shall not be more trade-restrictive than necessary". Some delegations also raised the issue of the stage in the decision process where other factors should be taken into account, and how this could be achieved at the national and the international levels.
68. It was pointed out that in practice, other factors were already being integrated in the elaboration process and that should be recognized formally in the Procedural Manual through appropriate recommendations. This was the case of risk management decisions, where practical aspects such as manufacturing practices, feasibility and economic cost, had to be integrated into the process. In addition, several areas of Codex work were not related to food safety and science was not the critical element in the decision process: the objective of food labelling texts was to provide reliable information to the consumer, as well as consideration of sound science in relation to health-related issues where applied to specific labelling provisions in Codex Standards and guidelines; while many commodity standards were intended to ensure fair trade practices and protect the economic interests of exporting and importing countries. The Observer from CIAA stated that labelling was a limited resource that should not be over-used and that consumer protection and consumer information should not be confused. The Chairperson of the Codex Committee on Food Labelling and others suggested that in order to ensure that other factors were being identified appropriately and consistently by different bodies of Codex, a general policy on the integration of other factors be articulated by the Committee on General Principles.
69. Several delegations proposed to discuss first the other factors from a general point of view before applying them to the case of BST. The Secretariat however recalled that the mandate given to the Committee by the Commission referred explicitly to the application of these factors to BST, and not to a general consideration of the issue. However, it was also noted that in the framework of the discussion on risk analysis the Commission had endorsed the recommendations of the Joint FAO/WHO Expert Consultation on Risk Management to the effect that the application of the second Statement of Principle should be clarified[11]. It was therefore recognized that this issue should be addressed by the Committee.
70. The Committee recognized that no consensus existed at this stage on the application of other factors in the case of BST and that further discussion was needed. It agreed that although the general and specific issues under consideration were related, they should be clearly identified in order to avoid confusion and to facilitate discussion. To this effect, the Committee agreed that two papers should be prepared by the Secretariat on these issues: 1) consideration of other legitimate factors in the framework of risk analysis as recommended by the Commission, and 2) application of other legitimate factors to the case of BST. The Committee agreed to return to these matters at its next Session. It was noted that the Committee should endeavour to decide the latter issue at its 14th Session so that the matter could be considered by the Commission at its 23rd Session. It was further noted that the general consideration of other legitimate factors should be viewed as a longer-term process.
