The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS) and the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA) together comprise the majority of both the total funding and the total staffing of the federal government's food regulatory system. The 111 th Congress is considering legislation to revise the U.S. food safety system, focusing primarily on those laws and programs administered by FDA. The Senate Committee on Health, Education, Labor, and Pensions has reported S. 510 , the FDA Food Safety Modernization Act. The ultimate goal of the House and Senate food safety bills is to reduce foodborne illness, which is a considerable and persistent public health problem in the United States. However, a comprehensive understanding of the burden of illness caused by foodborne hazards, the risks posed by different types of foods, and the types of safeguards that can effectively address these problems has been elusive. This report describes several systems to monitor foodborne illnesses and define the burden of this public health problem in the United States. Next, this report presents recent data on more serious recalls of FDA-regulated foods. 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 the food safety legislation pending before the 111 th 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 . The Burden of Foodborne Illness

		Overview and Estimates

Health officials monitor and investigate foodborne illness in a number of ways. For example, surveillance is used to track trends in the incidence of several common bacterial and parasitic foodborne illnesses. Tracking of outbreaks of foodborne illness helps improve approaches to investigation, among other things. Genetic "fingerprinting" is used to identify infections from a common source, including large multistate outbreaks. Collectively, these tools shed light on the burden of foodborne illness in the United States, and ways to decrease it. However, these tools 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, they often detect the contaminant that causes illness, rather than the type of food that was contaminated, although it is the latter that government officials actually regulate. In many, but certainly not all, cases, products subject to a recall may have sickened or killed people or animals. It is not clear, however, how useful FDA 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 does it indicate that the safety system is working by finding unsafe products and removing them from the market? Conversely, is a relatively low number of recalls an indication of the system's effectiveness, or simply of not finding and/or reporting all unsafe food products? Because of these questions, care should be exercised in using recall data as the basis for evaluating the effectiveness of food safety efforts. 2749 and S. 510 ). H.R. With respect to the general safety of food, adulteration is defined in FFDCA § 402(a) [21 USC § 342(a)], as follows:
A food shall be deemed to be adulterated—
(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; [or]
(2)(A) if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or
(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or
(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or
(5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or
(6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or
(7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409.
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.