Role of Science and Other Factors in Relation to Risk Analysis (Agenda Item 7.1)
Application in the Case of BST (Agenda Item 7.2)
64. The Committee recalled that at its last session it had reviewed a paper on the role of science and the extent to which other factors are taken into account in relation to BST. It was agreed at the time that a separate paper should be prepared on the application of other legitimate factors in the framework of risk analysis.[21]
65. The Delegation of the United States expressed the view that the scientific basis of risk assessment was essential in the decision process and that the introduction of other factors that are more appropriately considered at the national level was not appropriate in Codex; in particular economic interests should not be considered when the primary focus was health protection. According to the Delegation, environmental aspects were not in the mandate of Codex. The Delegation pointed out that the precautionary principle should not be considered as an other factor as it related to uncertainty, which was already addressed in the framework of risk assessment. This position was supported by several countries and the Observers of ICGMA, COMISA, GCPF and CRN.
66. The Delegation of Germany, speaking on behalf of the member states of the European Union, and referring to its written comments, supported the consideration of other legitimate factors, as the Commission had requested on the basis of the recommendations of the FAO/WHO Expert Consultation on Risk Management. The Delegation pointed out that some of these factors would be relevant for the Working Principles for Risk Analysis, and proposed that guidelines should be prepared on their integration in the decision process.
67. The Delegation of the Netherlands, supported by the Delegation of Denmark, emphasized the importance of other legitimate factors linked to the production process such as animal welfare, biotechnology and the use of growth promoters, which might influence the decision-making process; for this reason Codex should take into account the recommendations made at the international level on these issues.
68. The Delegation of Norway pointed out that animal health and welfare were already taken into account in relation to the registration and administration of veterinary drugs at the national level and environmental aspects were also relevant to public health; it would therefore be necessary to clarify whether the second statement included aspects which were relevant for health but not for food safety.
69. Several delegations expressed the view that environmental aspects should be considered as other legitimate factors, while other delegations expressed their disagreement with their consideration in the framework of Codex as it was outside its mandate. Some delegations pointed out that even if Codex did not consider such issues per se, it should take into account recommendations made at the international level, as in the case of methods of analysis using ozone-depleting substances. However, many delegations agreed that Codex standards should avoid, to the extent possible, having a negative impact on the application of internationally agreed environmental measures.
70. Several delegations pointed out that according to the second Statement of Principle, only legitimate factors which were relevant for health protection and fair trade practices should be taken into account in Codex. Other delegations and the Observer from the EC expressed the view that the factors which affected human health indirectly should be taken into account and that consumer concerns and societal factors were relevant to fair trade practices and important elements of the decision process. This position was supported by the Observers of Consumers International, ICA and IACFO.
71. Several delegations expressed the view that a list of other factors could not be exhaustive and might put an additional constraint on the work of committees, and proposed to consider the relevance of other factors on a case-by-case basis in the elaboration of Codex texts. Other delegations suggested that it would be preferable to provide general guidelines on the integration of such factors for the guidance of the committees. Other legitimate factors mentioned by some delegations included the concept of ALARA (As Low As Reasonably Achievable), the appropriate level of protection and religious and ethical considerations.
72. The Delegation of Uruguay pointed out that, in view of the differences between the consumers’ points of view and concerns in different countries, only those other legitimate factors that could be accepted on a world-wide basis should be taken into account in Codex.
73. The Delegation of Sweden, supported by other delegations, stressed the importance of considering the whole food chain, and especially primary production, when deciding on measures for the protection of human health, and stressed that some of the factors mentioned, such as GAP and GMP had a scientific basis and were part of the overall risk analysis process. The Observer from CGPF agreed with this statement as regards Good Agricultural Practice.
74. The Committee agreed that other factors should be defined according to the principles of transparency, objectivity, and proportionality and that their application should be clearly documented in the decision process. The Committee recognized that there was no consensus on the integration of a number of other factors including animal health, animal welfare and the environment, and agreed that the document should be revised in the light of the above discussion for further consideration at the next session.
75. The Representative of WTO indicated that under the TBT Agreement member countries could take measures addressing environment, animal welfare or other legitimate objectives; under the SPS Agreement they could take measures to protect animal and plant life and health on their territory, and noted that measures concerning animal health relevant for international trade were the competence of OIE.
76. The Committee agreed to ask the relevant committees to identify and clarify the relevant factors taken into account in their work, in the framework of risk analysis, as this would facilitate the general debate in the CCGP on other legitimate factors.
77. The Committee recalled that the Commission at its 22nd Session had adopted by roll-call vote, a proposal to suspend consideration of the adoption of the MRLs for BST pending the re-evaluation of scientific data by JECFA and the CCRVDF and the examination of the application of the “other legitimate factors” in relation to BST by this Committee. It was further recalled that this matter was discussed at the Committee’s 13th Session, when it was agreed that separate papers would be prepared on the application of “other legitimate factors” in general, and on “other legitimate factors” in relation to BST in order to respond more precisely to the request of the Commission.[23]
78. The Delegation of Germany, speaking on behalf of the member states of the European Union, pointed out that the EC could not accept the adoption of MRLs for BST for reasons including consideration of other legitimate factors (OLFs), and proposed that after the discussion on OLFs had been completed the Commission should refer this question back to the Committee for further consideration.
79. Some Delegations drew attention to the potential public health implications of the use of BST, especially as milk was an important element in the diet of children. However, it was noted that these matters did not fall under “other legitimate factors” since they were taken into account in the scientific risk analyses of the use of BST. Delegations noted the lateness of the publication of the relevant JECFA reports and monograph and some delegations stated that consensus had not been achieved by the CCRVDF on this matter. Delegations stressed that the protection of consumers’ health was the primary consideration.
80. The Delegation of France expressed the view that the proceedings used in the case of BST had not respected the principles of risk analysis (separation between risk assessment and risk management, documents allowing risk managers to take decisions in case of uncertainty) and that the decision taken by the CCRVDF was contrary to the objective of seeking to achieve consensus.
81. Some Delegations referred to recently published scientific reports in which the conclusions differed from those of JECFA and stated that there may be a need to recognize that there was a difference of scientific opinion on some matters related to the use and safety of BST.
82. Several Delegations stated that apart from the protection of consumers’ health, no other legitimate factors needed to be addressed since the scientifically-based risk analysis should be the determining factor. They expressed concern that consideration of other factors that were more legitimately addressed at the national level, would lead to paralysis of the Codex system. The countries making this point also stressed that individual countries did not have to approve the use of BST on their territories. The Delegation of Canada pointed out that it had used this approach in its recent decision on BST.
83. Other Delegations referred explicitly to animal health and welfare as legitimate factors that had to be taken into account in relation to the use of BST. It was noted that the welfare of animals was included in the Codex International Recommended Code of Practice for the Control and Use of Veterinary Drugs (CAC/RCP 38/1993). Furthermore, it was suggested that different consideration should be given to the evaluation of substances used for therapeutic purposes than those use for production efficiency and growth promotion. The Observer from Consumers International suggested that in the light of the Committee’s earlier decision to seek the advice of Codex Committees on their use of other factors, the CCRVDF should be asked to indicate which factors it had included in its consideration of BST.
84. Attention was also drawn to consumer concerns expressed in several countries and some delegations stated that this was a legitimate factor that had to be addressed especially in relation to the acceptability of products by consumers. Other delegations however stated that while such concerns might be appropriate considerations at the national level, they were not “other legitimate factors” within the meaning of the second of the Four Statements of Principle Concerning the Role of Science for Codex purposes.
85. The Committee noted that Delegations remained divided on the consideration of other factors as requested by the Commission in the mandate given to the Committee and that as a result it had not been possible to arrive at a consensus decision. It agreed to inform the Commission accordingly.
