Under the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act, USDA, through FSIS, is responsible for ensuring the safety of meat, poultry, and certain egg products. Under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, FDA is responsible for all other foods, including fruits and vegetables; dairy products; seafood; and certain canned, frozen, and packaged foods. The food-processing sector is generally described as the middle segment of the farm-to-table continuum—it extends from the time livestock and crops leave the farm for slaughter and processing into food until it reaches retail establishments. FDA and FSIS work to ensure the safety of food products processed in the United States through a regulatory system of preventive controls that identifies hazards early in the production process to minimize the risk of contamination. Known as the Hazard Analysis and Critical Control Point (HACCP) system, it makes food-processing facilities responsible for developing a plan that identifies harmful microbiological, chemical, and physical hazards that are reasonably likely to occur and establishes critical control points to prevent or reduce contamination. Through their inspection programs, FDA and FSIS verify that food processors are implementing their HACCP plans. FDA inspects over 57,000 food facilities every 5 years on average, and USDA inspects over 6,000 meat and poultry slaughter and processing facilities daily. Individual states also conduct yearly inspections of about 300,000 food-processing facilities, including small firms with fewer than 10 employees and large corporations with thousands of employees and multiple processing plants located in many states. Both FDA and FSIS have the authority to take enforcement actions as necessary to ensure that facilities meet the agencies’ safety and sanitation regulatory requirements. As we reported in 2001, in fiscal year 1999, the latest year for which such information was available, FDA, FSIS, and the states spent a total of about $1.3 billion on food safety activities. Following the events of September 11, 2001, the federal government intensified its efforts to address the potential for deliberate contamination of agriculture and food products. On October 8, 2001, the President issued an executive order establishing the Office of Homeland Security, which added the agriculture and food industries to the list of critical infrastructure systems needing protection from terrorist attack. In addition, the Congress provided FDA and USDA with emergency funding to prevent, prepare for, and respond to potential bioterrorist attacks through the Department of Defense Appropriation Act of 2002: $97 million for FDA and $15 million for FSIS. For the most part, FDA has used the emergency funds to enhance the security of imported food by hiring new inspectors and increasing inspections at U.S. ports of entry. FSIS has used its emergency funds to support its food security activities, which include, among other things, providing educational and specialized training. FDA’s fiscal year 2003 budget builds upon funding received from the fiscal year 2002 appropriation plus the fiscal year 2002 emergency supplemental funding of $97 million to counter terrorism. FDA plans to seek additional funding in the future for food safety activities and security activities related to terrorism. FSIS is asking for an additional $28 million. The Congress also enacted the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which contains numerous provisions designed to enhance the safety and security of the food, drug, and water industries. In addition, both FDA and USDA have taken many actions to better protect the food supply against deliberate contamination. For example, FDA has hired 655 new food safety investigators and laboratory personnel in the field. In addition, it has participated in several exercises at the federal and state levels to enhance emergency response procedures. Furthermore, FDA is working with CDC to initiate and implement a nationwide Laboratory Response Network for foods to identify laboratory capacity for testing agents that could be used to deliberately contaminate food. It has also provided additional laboratory training for food safety personnel and sought stakeholders’ input to develop regulations that are required by the new bioterrorism legislation. Moreover, FDA worked with the Office of the Surgeon General, U.S. Air Force, to adapt a version of the Operational Risk Management approach to examine the relative risks of intentional contamination during various stages of food production and distribution. Within the Department of Health and Human Services, both FDA and CDC have worked closely with federal, state, and local agencies to enhance their surveillance of diseases caused by foodborne pathogens. FDA’s efforts to reduce food security risks also include working with other federal agencies, trade associations, and the Alliance for Food Security. USDA has formed a Homeland Security Council to develop a Department- wide plan to coordinate efforts between all USDA agencies and offices. The Department has also established the FSIS Office of Food Security and Emergency Preparedness to centralize the Department’s work on security matters. USDA has also coordinated with other government agencies, such as the Office of Homeland Security, the Federal Bureau of Investigation (FBI), and FDA, to develop prevention, detection, and response procedures to better protect the nation’s food supply. USDA will be increasing the number of import inspectors by 20. These inspectors will place special emphasis on food security in addition to their traditional food safety role. In addition, USDA has participated in several exercises at the federal and state levels to enhance response procedures and has conducted risk assessments for domestic and imported food. Since this review began, USDA has conducted three simulation exercises at the Department and agency level to test the Department’s response to a terrorist attack and is planning three additional simulations for the spring of 2003. USDA has also conducted preparedness-training sessions for veterinarians and circuit supervisors. (Circuit supervisors supervise the work of in-plant inspection personnel and discuss the security guidelines with them.) Experts from government and academia generally agree that terrorists could use food products as a vehicle for introducing harmful agents into the food supply. Just recently, the National Academies reported that terrorists could use toxic chemicals or infectious agents to contaminate food production facilities and that, although much attention has been paid to ensuring safety and purity throughout the various stages of processing and distribution, protecting the food supply from intentional contamination has not been a major focus of federal agencies. Among other things, the report says that FDA should act promptly to extend its HACCP methodology so that it could be used to deal effectively with the deliberate contamination of the food supply. In February 2002, CDC reported that although the food and water systems in the United States are among the safest in the world, the nationwide outbreaks due to unintentional food or water contamination demonstrate the ongoing need for vigilance in protecting food and water supplies. All of the bioterrorism experts whom we consulted from academia agreed that the food supply is at risk. The food safety statutes do not specifically authorize FDA or USDA to require food processors to implement any type of security measures designed to prevent the intentional contamination of the foods they produce. While these agencies’ food safety statutes can be interpreted to provide authority to impose certain security requirements, as opposed to food safety requirements, neither agency believes it has the authority to regulate all aspects of security. Counsel in the Department of Health and Human Service’s Office of the Assistant Secretary for Legislation advised that FDA’s authorities under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act provide FDA with tools to adopt measures to control insanitary preparation, packing, and holding conditions that could lead to unsafe food; detect contamination of food; and control contaminated food. However, Counsel also advised that FDA’s food safety authorities do not extend to the regulation of physical facility security measures. FDA’s counsel provided a similar assessment, telling us that, to the extent that food safety and security overlap, FDA might be able to require the industry to take precautionary steps to improve security but observed that there is little overlap between safety and security. One area where safety and security do overlap is in the handling of hazardous materials. FDA’s existing safety regulations specify that hazardous chemicals should be stored so that they cannot contaminate food products. This requirement overlaps with FDA’s food security guidelines advising that hazardous chemicals be stored in a secure area and that access to them be limited. USDA, on the other hand, has a somewhat more expansive view of the extent to which its statutory authority allows it to require food processors to adopt certain security measures. USDA’s general counsel concluded that to the extent that security precautions pertain to activities closely related to sanitary conditions in the food preparation process, FSIS has the authority to require food processors to implement certain security measures. The general counsel concluded that FSIS could require facilities to develop and maintain a food security management plan concerning their response to an actual threat involving product tampering, since this is directly related to food adulteration. Such a plan could be added to a current HACCP plan or it could be entirely separate. USDA also believes that FSIS has authority to mandate its “inside security” guidelines, such as controlling or restricting access to certain areas, monitoring the operation of equipment to prevent tampering, and keeping accurate inventories of restricted ingredients and hazardous chemicals. Similarly, USDA believes that many of its security measures that address shipping and receiving food products or protecting water and ice used in processing products also could be made mandatory. These measures include putting tamper-proof seals on incoming and outgoing shipments and controlling access to water lines and ice storage. On the other hand, USDA believes that the “outside security” measures included in its guidelines, such as securing plant boundaries and providing guards, alarms, and outside lighting, have little to do with sanitation in the facility or the immediate food-processing environment and, therefore, could not be made mandatory under existing authorities. With respect to the guidelines’ personnel security measures, USDA noted that FSIS has limited authority over personnel matters at food-processing facilities and could not require facilities to perform personnel background checks before hiring.