The Codex Alimentarius Commission, Corporate Influence, and International Trade: A Perspective on FDA's Global Role.

I. INTRODUCTIONThe FDA Food Safety Modernization Act (FSMA)1 is by all accounts the most sweeping and comprehensive update to U.S. food laws in seventy years, aiming to confront the reality that the nation's food supply has undergone fundamental shifts in its sources, distribution channels, and intermediate handlers. The law's intent is to prevent problems that can cause foodborne illness and enable the Food and Drug Administration (FDA) to keep a record of facilities processing food for sale in the United States, a mandate that expands FDA's already global regulatory activities.2 FSMA gives FDA broad new powers to prevent food safety problems, detect and respond to food safety issues, and improve the safety of imported foods.3 Because the law specifically aims to update FDA authority in light of the reality of global food and food additive markets, Section 305 FSMA calls for FDA to develop a comprehensive plan to expand the "technical, scientific, and regulatory capacity of foreign governments and their respective food industries in countries that export foods to the United States."4 Part of its plan for fulfilling its Section 305 obligation is actual presence: FDA has established overseas offices in China, India, Costa Rica, Chile, Mexico, Belgium, the UK, Italy, South Africa, and Jordan (closed).5 A separate aim is to incorporate the work and insights from international organizations ranging from the Food and Agriculture Organization to the World Health Organization to the World Bank to the OECD. 6 The FSMA statute specifies one particular international organization for FDA attention with respect to its global activities: the Codex Alimentarius Commission ("Codex").FSMA requires that FDA develop "[r]ecommendations on whether and how to harmonize requirements under" Codex, an international organization charged with developing food standards, guidelines, codes of practice and other recommendations "to protect the health of consumers and to ensure fair practices in food trade."7 Codex sets standards on food quality and safety, including food commodity standards and codes of hygienic or technological practice.8 In addition, Codex evaluates pesticides, food additives and veterinary drugs, establishes limits for pesticide residues, and creates guidelines for contaminants.9 Although the statutory language takes an agnostic approach to Codex standards, FDA's International Food Safety Capacity-Building Plan is supportive and deferential to Codex, arguing that "the use of Codex standards helps assure a safe global food supply."10 To be sure, Codex's stated mission and policies should create and facilitate adoption of universal standards and best practices to ensure a safe global food supply, supported as it is by the World Health Organization and the Food and Agricultural Organization, specialized U.N. agencies with well-regarded research capacity and public health-oriented mandates. 11 Yet Codex has been the subject of substantial criticism for failing to uphold its consumer protection mandate.Using the principal common criticisms of Codex-that it favors trade liberalization over health, industry concerns over consumers', and rich countries over poor ones-this article encourages FDA to leverage its new role as a global regulatory body to inform its Codex work. This article contributes to the existing literature by clarifying the scope and gravity of these common criticisms and showing how FDA may use them to anticipate the changes global trade liberalization portends for keeping the food supply safe. First, Codex's lean toward trade liberalization over consumer health did not commence after it became the international standard-setting organization under the WTO's Sanitary and Phytosanitary Measures Agreement (SPS). From its structure to its purpose, Codex processes have always favored trade liberalization over high levels of health protection. Emphasizing Codex's emergence from relative obscurity after 1994 distracts from the political and economic forces that have shaped the organization from its founding and the infrastructure WHO, FAO and Codex have put in place to ensure those forces are harnessed to the greatest extent possible to further the organization's mission. …