If FDA Does Not Regulate Food, Who Will? A Study of Hormones and Antibiotics in Meat Production

I. INTRODUCTIONApproximately 128,000 Americans are hospitalized and 3000 die each year from foodborne illness.1 A ten-year study of 4589 foodborne outbreaks attributed 46% of these hospitalizations and 43% of the deaths to meat.2 The Food and Drug Administration (FDA), the primary federal agency tasked with regulating food, is aware of these statistics, and characterizes them as "largely preventable."3 It is becoming clear that modern meat production methods allow pathogens to spread with ease, creating great food safety risks.4 Startling numbers of people continue to get sick each year from food, even though regulators believe the harms are preventable, and know the source of many of the risks. This Note explores why the United States underregulates its food as compared to other nations, and suggests improvements to the domestic regulatory structure that would facilitate better regulation.FDA's failure to improve foodborne disease rates in recent decades evidences its struggle to ensure basic food safety. The agency is, perhaps not surprisingly, even less successful at protecting against those harms that do not immediately manifest themselves, and against those emergent risks that have not been thoroughly analyzed. This Note considers public health risks associated with food production that are not at the forefront of regulation. A case study of the use of hormones and antibiotics in meat production illustrates that the division of responsibilities among agencies for monitoring farmed food has resulted in under-regulation of an industry that is vital to protecting human health. Part II introduces the primary agencies involved in regulating food, and provides some background on the use of hormones and antibiotics in farming. Part III outlines some of the scientific studies that have been conducted on these farming practices. Part IV discusses U.S. regulation of hormones and antibiotics, and Part V provides a comparison with the practices of the European Union. Part VI illustrates how the political and economic systems surrounding food regulation in the United States account for the leniency of its regulations. Part VII draws conclusions about the main problems that cause under-regulation in the United States, and explains why FDA is central to solving these problems. Finally, this Note provides three proposals to improve the food safety regime.II. BACKGROUNDA. FOOD SAFETY RESPONSIBILITIES OF FDA, USDA, AND EPAMultiple agencies participate in ensuring the health of meat-eating Americans by regulating meat production. Three of the agencies heavily involved are FDA, the United States Department of Agriculture (USDA), and the United States Environmental Protection Agency (EPA). Each agency's mission statement makes clear both why it is involved in food regulation and why no single agency is responsible for all aspects. The agencies' mandates often overlap, resulting in multiple agencies regulating the same product or process, making effective regulation difficult.FDA's mission centers on public health. With respect to food, FDA must "protect[] the public health by assuring the safety, efficacy and security of . . . our nation's food supply . . . . FDA is also responsible for advancing the public health by . . . helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health."5 Its mission also includes protecting animal health.6 In this realm, FDA approves and monitors the safety of drugs given to animals, and is responsible for ensuring that drugs administered to farmed animals do not make their food products unsafe to consume.7 In the context of farmed animals, then, FDA is the primary authority on the safety of drugs administered to the animals for both animal and human health.USDA has a notably different mission: "[t]o expand economic opportunity . . . to promote agriculture production sustainably that better nourishes Americans while also helping to feed others throughout the world. …