The extent of foodborne illness in the United States and its associated costs are significant. CDC estimates that unsafe foods cause as many as 76 million illnesses, 325,000 hospitalizations, and 5,000 deaths annually. In terms of medical costs and productivity losses, foodborne illnesses associated with seven major pathogens cost the nation between $7 billion and $37 billion annually, according to USDA’s estimates. According to CDC, almost 12,000 cases of foodborne illness were reported in 1997, the latest year for which data are available. Of the approximately 7,000 cases in which the food source for the illness was known, about 85 percent were associated with food products that are regulated by FDA, such as fish, shellfish, fruits, vegetables, and salads. The remaining 15 percent were associated with food products, such as meat and poultry, that fall under FSIS’ jurisdiction. The relative proportion of illness associated with foods under each agency’s jurisdiction reflects consumer expenditures for food products under the jurisdiction of each. Nearly 80 percent of consumer expenditures are for foods under FDA’s jurisdiction, while FSIS is responsible for the remaining 20 percent. While 12 different federal agencies located within six federal departments conduct food safety activities, FSIS and FDA have primary regulatory responsibility for ensuring the safety of the nation’s food supply. FSIS has responsibility for ensuring the safety of meat, poultry, and processed egg products, overseeing about 6,000 meat, poultry, egg product and import establishments. Under the governing inspection acts, FSIS, in effect, preapproves products before they are marketed. As such, FSIS operates under a mandated continuous inspection frequency for meat and poultry slaughter plants and egg processing plants and inspects meat and poultry processing plants daily. FSIS marks all inspected and approved meat, poultry, and egg products with a USDA inspection stamp. Without this marking, the products cannot be legally marketed. FSIS also reviews and assesses the effectiveness of state intrastate meat, poultry, and egg product inspection programs to ensure that their standards are at least equal to federal standards. In addition, FSIS reviews and assesses foreign inspection systems and facilities that export FSIS-regulated products to the United States for equivalency with U.S. standards. In 1998, FSIS reviewed 7 of the 26 states with intrastate inspection programs for meat and/or poultry and reviewed foreign inspection programs in 22 of the 37 countries that were eligible to export to the United States. In addition to the inspection activities, FSIS conducts emergency responses, including retention, detention, or voluntary recall of adulterated foods and epidemiological investigations of foodborne hazards or disease outbreaks. Furthermore, FSIS engages in developing and implementing cooperative strategies to prevent health hazards associated with animal production practices, coordinating U.S. participation in international sanitary standard-setting activities, and providing safety information to food handlers and consumers. FDA is responsible for ensuring the safety of a broad range of products, including foods, animal drugs and feeds, human medicines and vaccines, radiation-emitting devices, medical devices, blood and blood products, and cosmetics. Specifically, under the Federal Food, Drug and Cosmetic Act, FDA is responsible for ensuring that domestic and imported food products (except meat, poultry, and processed egg products) are safe, wholesome, and labeled properly. This includes ensuring the safety of ingredients that make up foods, such as food additives that change a food’s color or taste, and reviewing and approving new additives unless they are generally recognized as being safe. In administering the act, which generally follows the regulatory approach of allowing food products to enter the market without preapproval, FDA inspects and tests domestic and imported food products. However, the act does not mandate or specify inspection frequencies for overseeing an estimated 57,000 food establishments under FDA’s jurisdiction. Products under FDA’s jurisdiction do not require, and FDA does not place, any inspection mark on the products before they can be legally marketed. FDA is also responsible for maintaining surveillance of all animal drugs and feeds to ensure that they are safe and labeled properly and produce no human health hazards when used in food-producing animals and for overseeing more than 9,000 animal drug and feed establishments. States all have departments that are responsible for the regulation and enforcement of their own food safety laws to ensure the safety of foods produced, processed, or sold within their borders. These responsibilities are primarily within the state departments of agriculture and health and may involve others, such as state environmental protection agencies and county departments of health. States and territories may also perform inspections for FSIS or FDA under contract or form partnerships to report their results to the federal agencies. For example, in fiscal year 1998, FDA contracted with 38 states to conduct inspections in accordance with the federal regulations. Under partnership agreements, 29 states shared the results of inspections conducted under their own standards with FDA. FSIS was responsible for food safety expenditures of $678 million in fiscal year 1998 and $712 million in fiscal year 1999, or about 55 percent of the nearly $1.3 billion fiscal year 1999 federal and state expenditures. In fiscal years 1998 and 1999, FSIS employed 11,057 and 10,951 staff years, respectively. FDA food safety activities accounted for about 22 percent of the total expenditures—$253 million in fiscal year 1998 and $283 million in fiscal year 1999—and employed 2,505 and 2,609 staff years, respectively. State agriculture and health departments reported food safety expenditures of about $292 million in fiscal year 1998 and $301 million in fiscal year 1999 and employed 5,617 and 5,717 staff years, respectively. About 85 percent of FSIS’ expenditures were for field activities, while FDA’s expenditures were almost evenly divided between field and nonfield activities. The federal agencies’ expenditures reflect the regulatory approaches or inspection frequencies contained in the laws under which they operate. FSIS expended $678 million in fiscal year 1998 and $712 million in fiscal year 1999 on food safety. FSIS’ food safety activities can be separated into two major components—operations conducted in the field by district offices or in direct support of those district offices and operations conducted primarily in headquarters offices. As shown in figure 2, about 85 percent of FSIS’ fiscal year 1999 expenditures were for field activities and 15 percent were for headquarters office activities. See appendix II for details on FSIS’ activities, expenditures, and staff years for fiscal years 1998 and 1999. In aggregate, FSIS’ field activities accounted for $614 million in fiscal year1999. Specifically: Inspections at more than 6,000 slaughter, processing, and import establishments accounted for $486 million, or 68 percent, of total agency expenditures. Of the $486 million, FSIS estimates that slaughter inspections conducted at 262 establishments accounted for about $324 million; daily meat and poultry processing inspections at about 4,300 establishments accounted for about $145 million; continuous inspections at 75 egg processor establishments accounted for about $8 million; and inspections at 129 import/export establishments accounted for about $7 million. Regarding slaughter inspections, FSIS estimates that carcass-by- carcass organoleptic (see, touch, smell) inspections accounted for about $296 million of the total inspection expenditures. FSIS does not track expenditures specifically related to Hazard Analysis and Critical Control Point system inspections and thus could not provide that information. Field office administration, supervision, and compliance activities, such as following-up on inspection findings, accounted for $34.1 million, or 5 percent, of total expenditures. Field office management by the Office of Field Operations located in Washington, D.C., accounted for $79.9 million, or 11 percent, of total expenditures. The largest expenditure was for grants to states for inspections, field automation, and other activities, accounting for almost $47 million, or over half, of the office’s total expenditures for fiscal year 1999. Field laboratory analysis services provided by the Office of Public Health and Science accounted for $14 million of field activity expenditures, or 2 percent, of total expenditures. FSIS’ headquarters-based activities accounted for the remaining $98 million of fiscal year 1999 expenditures, or about 15 percent, of total agency expenditures. Four program offices—Management; Public Health and Science; Policy, Program Development, and Evaluation; and the Office of the Administrator—conduct FSIS’ headquarters food safety activities. Specifically: The Office of Management accounted for about $61.8 million, or 9 percent, of total expenditures. The office is responsible for providing centralized administrative and support services to all other FSIS program offices, including functions such as human resource management, strategic planning, procurement, and financial management. The Office of Policy, Program Development, and Evaluation accounted for about $18.9 million, or 3 percent, of total expenditures. The office is responsible for, among other things, coordinating activities, such as developing and recommending domestic and international policies for FSIS; reviewing product process standards; product labeling; and developing and evaluating inspection programs. The Office of Public Health and Science accounted for about $11.4 million, or 2 percent, of total expenditures. The office is responsible for conducting scientific analysis, providing scientific advice and data, and making recommendations involving all public health and science concerns relating to products under FSIS’ jurisdiction. This includes mission activities such as epidemiology and risk assessment, surveillance, and response to food safety emergencies. The Office of the Administrator accounted for about $6.1 million, or 1 percent, of total expenditures. The office is responsible for managing agency activities such as public affairs, food safety education, coordinating U.S. involvement in international standard-setting for food safety, and maintaining liaison with trade organizations. FSIS’ large proportion of expenditures on field and supporting activities reflects the mandate of the meat and poultry acts. The two acts require that meat and poultry slaughter plants be under continuous FSIS inspection. If a federal inspector is not present, the animals cannot be slaughtered. FSIS inspects animals both before and after slaughter.