Food Safety: Foodborne Illness and Selected Recalls of FDA-Regulated Foods

Sarah A. Lister
Specialist in Public Health and Epidemiology

Geoffrey S. Becker
Specialist in Agricultural Policy

The 111th Congress is considering legislation to revise the U.S. food safety system, focusing primarily on those laws and programs administered by the Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). The House has passed a comprehensive bill, H.R. 2749, and the Senate Committee on Health, Education, Labor, and Pensions has reported its comprehensive proposal, S. 510. The ultimate goal of both bills is to reduce the burden of foodborne illness, which is a considerable and persistent public health problem in the United States. However, an understanding of the true burden of illness caused by foodborne hazards, the risks associated with various types of foods, and the types of regulatory and other approaches that can effectively address these problems has been elusive. 

Public health officials monitor and investigate foodborne illnesses in a number of ways. For example, active surveillance is used to track trends in the incidence of several common bacterial and parasitic foodborne illnesses. Outbreaks of foodborne illness are tracked to help improve approaches to investigation and to identify the foods that cause illnesses, among other things. Genetic "fingerprinting" is used to identify infections from a common source, including large multistate outbreaks, and can also help identify the foods that cause illnesses. These systems are administered jointly by various federal agencies, in partnership with state health officials. Collectively, these tools and others can shed light on the burden of foodborne illness in the United States, and ways to decrease it. However, these systems also have two significant shortcomings. First, because they monitor a limited number of known food safety threats, and because foodborne illnesses are substantially underreported, these systems do not, individually or collectively, capture the magnitude of foodborne illness that occurs each year. Second, these systems often detect or track the contaminant that causes illness, rather than the type of food that was contaminated, although it is the latter that government officials actually regulate. 

Consumers and the media often focus on recalls—particularly those that are extensive and/or that involve widely consumed products—as indicators of the safety of the U.S. food supply. In many but certainly not all cases, products subject to a recall may have sickened or killed people or other animals. It is not always clear, however, how useful recall data are as a measure of the burden of foodborne illness or the effectiveness of federal food safety programs. For example, does a relatively high number of recalls signify a failure of the system to keep unsafe products from being consumed? Or is it actually an indication that the safety net is working by finding and getting tainted products off the market? Conversely, is a relatively low number of recalls an indication of the system's effectiveness, or simply of not reporting or finding all defective food products? Because of these questions, caution should be exercised in using recall data as the basis for concluding that certain changes are needed in the nation's food safety systems. 

This report describes several systems to monitor foodborne illnesses, discussing their strengths and the gaps that remain in understanding the burden of foodborne illness in the United States. Next, this report presents recent data on more serious recalls of FDA-regulated foods, also discussing the strengths and gaps associated with the information. Finally, this report describes three recent foodborne outbreaks that led to nationwide recalls of FDA-regulated foods: (1) Salmonella in peanut products, (2) melamine in pet foods and dairy products, and (3) E. coli in spinach. Following each description are discussions of associated policy issues, and, if applicable, how these issues are addressed in food safety legislation pending before the 111th Congress. Descriptions of selected authorities in the Federal Food, Drug, and Cosmetic Act (FFDCA), FDA's principal food safety law, are provided in the Appendix.


Date of Report: April 15, 2010
Number of Pages: 30
Order Number: R40916
Price: $29.95

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