American Journal of Law & Medicine

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


The 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.

Second, studies and analyses of Codex decision-making frequently accuse it of subordinating its agenda to industry interests. For the most part, these criticisms are proven indirectly by, for example, counting industry representatives at Codex meetings or as part of national delegations. But the real threats to the integrity of Codex's processes have emerged not through routine industry participation on national delegations or as observers, but through hidden efforts to influence scientists supplying Codex's committees and subcommittees with purportedly objective information. The response to that threat is better systems for declarations of interest and transparency, an effort FDA is well positioned to lead. Third, critics accuse Codex of undertaking its work with insufficient participation by developing countries or inadequate sensitivity to their resource constraints. But, other than the argument that participation matters for its own sake, there has been little investigation as to concrete harms to developing countries by existing levels of participation. Indeed, there is evidence to suggest that the problems for developing countries are not caused by Codex, but by developed countries' insistence on imposing standards more stringent than Codex adopts or allowing private entities to effectively push standards higher through supply agreements.

It is reasonable to assume that, if the Doha trade round ever results in freer trade in agricultural goods, Codex will be a prime target for erecting barriers to entry for those goods not necessarily related to its consumer health protection mandate. These weaknesses in the current Codex standard development process are outlined with the objective of informing FDA's approach to determining which Codex standards have been effectively and responsibly informed and, if so, how they may be harmonized with U.S. law. This article is part of a larger story about how FDA's mandate--protection of U.S. consumers' health--will adapt as rules it adopts will be subject to challenge under international trade and investment treaties.

Part II of this Article provides a brief history of Codex and how its members are chosen as well as the general nature of its activities. Part III outlines the three common criticisms of Codex and how FDA may address each within the scope of its new FSMA authority. Part IV provides a brief conclusion and preview of how FDA's role must adapt in the face of the increasing strength of international trade and investment treaties.



The history of Codex dates back to the creations of the FAO and WHO in the late 1940s. (12) In 1950, the FAO and WHO formed the First Joint Expert Committee on Nutrition ("Joint Expert Committee"), emphasizing the need to address the inconsistencies of international food standards. In 1955, the Fourth Joint Expert Committee declared the uncontrolled use of food additives a pressing matter of public concern and established a committee to draft guidelines on food additive control and use.

The Joint Expert Committee joined a number of international and regional food regulatory agencies that had evolved in the post-war period. The United Nations Economic Commission for Europe, for example, established a Geneva Protocol which proposed standards and guidelines for food commodities, mainly fruits and vegetables. The FAO/WHO Committee of Governmental Experts worked with the International Dairy Federation to implement milk quality and labeling requirements. Europe had worked out a region-wide harmonization system, the Codex Alimentarius Europaeus, based on a model developed under the Austrian-Hungarian Empire. (13) The Codex Europeaeus was co-sponsored by the International Commission on Agricultural Industries and the International Bureau of Analytical Chemistry. (14)

In 1960, the Codex Alimentarius Europaeus partnered with WHO and FAO as part of an effort to create a global set of food safety, testing, labeling and nutrition standards. During the 1961 FAO/WHO Eleventh Joint Expert Committee, the FAO passed the resolution, which led to the establishment of the Codex Alimentarius Commission as it is known today. The resolution created the FAO/WHO Food Standards Programme and designated the newly international Codex as the body responsible for implementing the Programme.

The First Session of the Codex Alimentarius Commission was held in Rome in October 1963, and was attended by an estimated 120 participants from 30 countries. Codex has seen dramatic increase in membership since; 625 delegates from 180 countries and international organizations attended the Commission's thirty-forth session in 2011. Both independent international experts and other international organizations assist Codex in meeting its obligation to develop an extensive scientific basis for the standards it adopts. (15)

Codex offers three avenues of organizational participation based on a party's qualifications. …

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