American Journal of Law & Medicine

Whole Foods: The FSMA and the Challenges of Defragmenting Food Safety Regulation


With respect to addressing food safety--and food system issues in a more general sense--coordination in regulatory approaches can be critical. As a recent Washington Post article stated,

   Diet-related chronic disease, food safety, marketing to children,
   labor conditions, wages for farm and food-chain workers,
   immigration, water and air quality, greenhouse gas emissions, and
   support for farmers: These issues are all connected to the food
   system. Yet they are overseen by eight federal agencies. Amid this
   incoherence, special interests thrive and the public good suffers.

The current federal food regulatory system is highly fragmented. In 2007, the U.S. Government Accountability Office published a comprehensive report on fragmentation in food safety governance, entitled "Federal Oversight of Food Safety: High-Risk Designation Can Bring Needed Attention to Fragmented System." (2) The report highlighted a number of areas of food safety fragmentation, drawing attention to the fifteen federal agencies administering thirty laws related to food. (3) For example, differences in agency jurisdiction can arise from something as arbitrary as packaging, with open-faced sandwiches being regulated by the U.S. Department of Agriculture (USDA), and packaged sandwiches being regulated by the Food and Drug Administration (FDA). (4) Moreover, the report pointed out that differences in agency jurisdiction can result in different regulatory and enforcement authority, with foods under FDA authority being marketable without prior approval, but foods under USDA authority requiring continuous inspection. (5) Finally, these agencies have overlapping activities but do not share resources for conducting those activities; for example, the USDA and the FDA do not share resources even though they both inspect imported food shipments at eighteen ports of entry. (6)

This short essay begins by presenting some of the main federal agencies and state agencies charged with a role in addressing food safety. It next develops some of the more recent attempts at coordinating regulatory approaches, such as the President's Food Safety Working Group (the "Working Group"), and some elements of the Food Safety Modernization Act (FSMA). Finally, the essay discusses various coordination problems still observed within the federal regime, and explores options contained in the FSMA for further coordination activities.


Of the fifteen federal agencies charged with some relevant role in food safety regulation, four play the most significant roles: the USDA, the FDA, the Environmental Protection Agency (EPA), and the Centers for Disease Control and Prevention (CDC). The USDA's regulatory focus, with respect to food safety, covers "grading of raw fruit and vegetables," (7) "meat and poultry," (8) "certifying organic production," (9) and "liquid, frozen, and dried egg[s]." (10) In particular, its component, the Food Safety and Inspection Service (FSIS), is charged with "ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged." (11)

The FDA, in turn, regulates "[f]ood (but not meat)," (12) * "[s]eafood," (13) "[w]ild game ('exotic' meat)," (14) and "[e]ggs in the shell." (15) Its component, the Center for Food Safety and Applied Nutrition (CFSAN), is responsible for "providing] services to consumers, domestic and foreign industry and other outside groups regarding field programs; agency administrative tasks; scientific analysis and support; and policy, planning and handling of critical issues related to food and cosmetics." (16)

The EPA is charged with regulating pesticides. (17) Its component, the Office of Pesticide Programs (OPP), "regulates the manufacture and use of all pesticides (including insecticides, herbicides, rodenticides, disinfectants, sanitizers and more) in the United States and establishes maximum levels for pesticide residues in food, thereby safeguarding the nation's food supply." (18)

The CDC's role in food safety is identifying, tracking and addressing foodborne infections. (19) Its component, the Food Safety Office (FSO), conducts the following activities:

* Supporting projects that build epidemiology, laboratory, and environmental health capacity on the state and local levels.

* Providing information and recommendations based on public health surveillance and epidemiology that have implications for food safety policies.

* Participating in partnerships that inform consumers, healthcare providers, public health professionals, and others in the public and private sectors about prevention and management of foodborne illnesses.

* Maintaining links with the US Food and Drug Administration and US Department of Agriculture through liaisons.

* Evaluating and improving programs through external peer reviews, case research projects, and after action reviews. (20)

In addition to the federal agencies, state and local governments also play a role in the overall regulation of food safety. This role includes acting as the primary inspectors for restaurants and food preparation sites. (21) The FDA has developed a "Food Code" for state food safety regulation using a science-based approach. (22) All fifty states have adopted some version of this food code, although the versions of the code differ. (23) States also differ in their abilities to identify and report outbreaks, as well as communicate with the CDC. (24) Certain programs under the FDA have been developed specifically for state coordination: Foodnet (which "estimates the number of foodborne illnesses, monitors trends in incidence of specific foodborne illnesses over time, attributes illnesses to specific foods and settings, and disseminates this information" (25)), and Pulsenet (which "connects foodborne illness cases together to detect and define outbreaks using DNA 'fingerprinting' of the bacteria making people sick using a standardized process called pulsed-field gel electrophoresis. …

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