The safety and quality of the U.S. food supply is governed by a highly complex system that is based on more than 30 laws and administered by 12 agencies. In addition, there are over 50 interagency agreements to govern the combined food safety oversight responsibilities of the various agencies. The federal system is supplemented by the states, which have their own statutes, regulations, and agencies for regulating and inspecting the safety and quality of food products. The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), have most of the regulatory responsibilities for ensuring the safety of the nation’s food supply and account for most federal food safety spending. Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, USDA is responsible for the safety of meat, poultry, and certain egg products. FDA, under the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act, regulates all other foods, including whole (or shell) eggs, seafood, milk, grain products, and fruits and vegetables. Appendix I summarizes the agencies’ responsibilities. Existing statutes give the agencies different regulatory and enforcement authorities. For example, food products under FDA’s jurisdiction may be marketed without the agency’s prior approval. On the other hand, food products under USDA’s jurisdiction must generally be inspected and approved as meeting federal standards before being sold to the public. Although recent legislative changes have strengthened FDA’s enforcement authorities, the division of inspection authorities and other food safety responsibilities has not changed. As we have reported, USDA traditionally had more comprehensive enforcement authority than FDA; however, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 has granted FDA additional enforcement authorities that are similar to USDA’s. For example, FDA can now require all food processors to register with the agency so that they can be inspected. FDA can also temporarily detain food products when there is credible evidence that the products present a threat of serious adverse health consequences, and FDA can require that entities such as the manufacturers, processors, and receivers of imported foods keep records to allow FDA to identify the immediate previous source and the immediate subsequent recipients of food, including its packaging. This record keeping authority is designed to help FDA track foods in the event of future health emergencies, such as terrorism-related contamination. In addition, FDA now has the authority to require advance notice of imported food shipments under its jurisdiction. Despite the additional enforcement authorities recently granted to FDA, important differences between the agencies’ inspection and enforcement authorities remain. Finally, in addition to their established food safety and quality responsibilities, following the events of September 11, 2001, the federal agencies began to address the potential for deliberate contamination of agriculture and food products. In 2001, by Executive Order, the President added the food industries to the list of critical infrastructure sectors that need protection from possible terrorist attack. As a result of this Executive Order, the Homeland Security Act of 2002 establishing the Department of Homeland Security, and subsequent Presidential Directives, the Department of Homeland Security provides overall direction on how to protect the U.S. food supply from deliberate contamination. The Public Health Security and Bioterrorism Preparedness and Response Act also included numerous provisions to strengthen and enhance food safety and security. As we have stated in numerous reports and testimonies, the fragmented federal food safety system is not the product of strategic design. Rather, it emerged piecemeal, over many decades, typically in response to particular health threats or economic crises. In short, what authorities agencies have to enforce food safety regulations, which agency has jurisdiction to regulate what food products, and how frequently they inspect food facilities is determined by the legislation that governs each agency, or by administrative agreement between the two agencies, without strategic design as to how to best protect public health. It is important to understand that the origin of this problem is historical and, for the most part, grounded in the federal laws governing food safety. We and other organizations, including the National Academies, have issued many reports detailing problems with the federal food safety system and have made numerous recommendations for change. While many of these recommendations have been acted upon, problems in the food safety system persist, largely because food safety responsibilities are still divided among agencies that continue to operate under different laws and regulations. As a result there is fragmentation, inconsistency, and overlap in the federal food safety system. These problems are manifested in numerous ways as discussed below. Federal agencies have overlapping oversight responsibilities. Agency jurisdictions either assigned by law over time or determined by agency agreements result in overlapping oversight of single food products. For example, which agency is responsible for ensuring the safety of frozen pizzas depends on whether or not pepperoni is used as a topping. Figure 1 shows the agencies involved in regulating the safety of frozen pizza. In other instances, such as canned soups, it is the amount of a particular ingredient contained in the food product that governs whether it is subject to FDA or USDA inspection. As a result, canned soup producers are also subject to overlapping jurisdiction by the two food safety agencies. Overlap and duplication result in inefficient use of inspection resources. Food processing establishments may be inspected by more than one federal agency because they process foods that are regulated under different federal laws or because they participate in voluntary inspection programs. As of February 2004, FDA’s records show that there are about 2,000 food processing facilities in the United States that may handle foods regulated by both FDA and USDA because their products include a variety of ingredients. Multi-ingredient products that are regulated by both FDA and USDA include pizza, canned soups, and sandwiches. GAO found that 514 of the 8,653 FDA inspections conducted in six states between October 1987 and March 1991, duplicated those of other federal agencies. For example, FSIS had five inspectors assigned full time to a plant that processed soups containing meat or poultry, yet FDA inspected the same plant because it also processed soups that did not contain meat or poultry. Thus, rather than having the full-time inspectors assigned to the plant conduct inspections for all the plant’s products, additional inspectors from another agency were required to conduct separate inspections of products as a result of the different ingredients contained in the product. Moreover, there is also inefficient use of federal inspection resources dedicated to overseeing the safety of seafood products. FDA has responsibility for ensuring the safety of domestic and imported seafood products. However, as we reported in January 2004, the NOAA Seafood Inspection Program also provides fee-for-service safety, sanitation, and/or product inspections for approximately 2,500 foreign and domestic firms annually. Thus, both FDA and NOAA’s programs duplicate inspections of seafood firms. To make more efficient use of federal inspection resources, we have recommended that FDA work toward developing a memorandum of understanding that leverages NOAA’s Seafood Inspection Program resources to augment FDA’s inspection capabilities. Federal agencies’ different authorities result in inconsistent inspection and enforcement. Despite the additional enforcement authorities granted to FDA by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, differences between the agencies’ inspection and enforcement authorities remain. For example, when FSIS inspectors observe serious noncompliance with USDA’s food safety regulations, they have the authority to immediately withdraw their inspection services. This effectively stops plant operations because a USDA inspector must be present and food products under USDA’s jurisdiction generally must be inspected and approved as meeting federal standards before being sold to the public. This ensures more timely correction of problems that could affect the safety of meat and poultry products. In contrast, food products under FDA’s jurisdiction may be marketed without the agency’s prior approval. Thus, while FDA may temporarily detain food products when there is credible evidence that the products present a threat of serious adverse health consequences, FDA currently has no authority comparable with USDA’s allowing it to stop plant operations. As a result, problems identified during FDA inspections may take longer to correct. Federal agencies’ different authorities to oversee imported foods also result in inconsistent efforts to ensure safety. A significant amount of the food we consume is imported; yet, as we have testified in the past, the same fragmented structure and inconsistent regulatory approach is being used to ensure the safety of imported foods. For example, more than three-quarters of the seafood Americans consume is imported from an estimated 13,000 foreign suppliers in about 160 different countries. As we have reported, however, FDA’s system for ensuring the safety of imported seafood does not sufficiently protect consumers. For example, the agency inspected about 100 of roughly 13,000 foreign firms in 2002 and tested slightly over 1 percent of imported seafood products. In January 2004, we reported that despite some improvements, FDA is still able to inspect only a small proportion of U.S. seafood importers and visit few seafood firms overseas yearly. As we have previously recommended, a better alternative would be to strengthen FDA’s ability to ensure the safety of imported foods by requiring that all food eligible for importation to the United States be produced under equivalent food safety systems. USDA has such authority. In fact, USDA is legally required to review certifications made by other countries that their meat and poultry food safety systems ensure compliance with U.S. standards and USDA must also conduct on-site inspections before those products can be exported to the United States. At this time, 37 countries are approved to export meat and poultry products to the United States. Frequency of inspections is not based on risk. Under current law, USDA inspectors maintain continuous inspection at slaughter facilities and examine each slaughtered meat and poultry carcass. They also visit each processing plant at least once during each operating day. For foods under FDA jurisdiction, however, federal law does not mandate the frequency of inspections. The differences in inspection frequencies are, at times, quite arbitrary, as in the case of jointly regulated food products.