Background Document The Role of Science in Codex Decision Making and the Consideration of Other Legitimate Factors. Issue: The Codex Alimentarius Commission adopted the Statements of Principle Concerning the Role of Science in the Codex Decision Making Process and the Extent to Which other Factors Are Taken into Account at the 21st session in 1995, and the report, Alinorm 95/37, reflects “overwhelming” confirmation that Codex standards and other texts should be based on the “principle of sound science.” These can be found in the Appendix of the Codex Alimentarius Commission Procedural Manual. The report of the 21st session the Commission also notes the implications of the World Trade Organization (WTO) Agreements that were adopted that year and recognized the role of Codex in international harmonization and agreed to further work on risk analysis, mandated in Article 2.2. of the Agreement on Sanitary and Phytosanitary Measures (SPS Agreement). Background: The debate on the role of science did not end with the adoption of the principles. The statements of principle provide for “having regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and for the promotion of fair trade practices.” In subsequent years, consensus eluded committees on several standards because of failure to agree on legitimate “factors” for consideration by Codex. Controversial examples of such factors include: animal health, environment and consumer information (“consumers’ right to know”). Debate was particularly contentious over the adoption of an maximum residue level (MRL) for the use of Bovine Somatatrophin (BST), which had been evaluated by the FAO/WHO Joint Expert Committee on Food Additives (JECFA). The BST standard still remains at Step 8 in 2012. However, in 1998, the FAO Secretariat put forward a paper to the Codex Committee on General Principles (CCGP) that responded to the Commission’s decision to suspend adoption of the MRLs that addressed “other legitimate factors.” The Secretariat’s paper was a strong endorsement of science based standards and concluded that Codex decisions must be based on science, health and economic interest based on objective data. It also noted that “to a certain extent risk management includes aspects which are not strictly scientifically based.” The Secretariat also underscored that “other factors” for consideration in Codex could only be those relevant for public health protection and the promotion of fair trade practices. While the paper related to BST, it was quickly recognized the far reaching consequences for Codex. Following a contentious discussion, and over the objections of the EC member states, the 24th session of the Commission, in 2001, amended the Statements of Principle on the Role of Science to include appropriate, science-based criteria for the consideration of the other factors. These are also included in the Procedural Manual. Industry Engagement: Industry organizations and companies that are engaged in the work of Codex represent a broad range of products and interests. Common to the industry is the overlying principle that international food standards should have a strong scientific base. A Washington based coalition, the Food Industry Codex Coalition, was energized to respond to this Codex issue and was instrumental in the adoption of The Four Principles of Science. Likewise, the food industry was concerned that a broad interpretation of “other legitimate factors” could give rise to new trade barriers as individual nations introduced regulation based on differing societal or protectionist interests. The industry worked to help ensure that consideration of other factors be limited in scope to those relevant to the protection of consumers and for the promotion of fair trade. The industry recognized that all nations have specific cultural and societal interests, science is the only objective common denominator shared by countries collectively. A food industry coalition submitted a consensus position to the U.S. government urging strong leadership to ensure that “Codex decisions continue to be based on science, health and economic interests based on objective data” and pointed out that the SPS Agreement obligates member countries to ensure that measures are based on scientific principles and do not arbitrarily discriminate between countries or become a disguised trade barrier to protect a domestic industry. The U.S. government launched an aggressive international outreach effort intended to demonstrate potential implications of “factors” on trade specifically for developing nations. INGOs trade associations and food companies prepared positions and articles for international circulation.