In 1994, U.S. consumers spent over $600 billion on food—about $334 billion for consumption at home and $268 billion for consumption outside the home. To regulate the safety of this food, the federal government spends over $1 billion annually, and state governments and industry spend unknown additional amounts. However, foodborne illnesses still occur and are a continuing health and economic concern. The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services, estimates that over 6 million illnesses and about 9,000 deaths resulting from foodborne pathogens occur each year.These illnesses and deaths are very costly. For example, FSIS estimated that nearly 5 million illnesses and about 4,000 deaths were caused by meat and poultry products in 1993, at a cost estimated to be from $4.5 billion to $7.5 billion. Twelve federal agencies implement as many as 35 food safety and related laws. The responsibilities of these agencies are outlined in appendix I. FDA, which has primary responsibility for the safety of all foods except meat and poultry, carries out its responsibility through physical inspections of food-processing plants. FSIS, which has primary responsibility for meat and poultry safety, carries out its responsibility largely through organoleptic inspections of meat and poultry—that is, using sight, smell, and touch—to determine the wholesomeness of products at slaughter plants. These carcass-by-carcass inspections date back to the turn of the century. These continuous inspections at slaughter plants, along with FSIS’ daily inspections of processing plants, account for about one-half of the federal government’s expenditures for food safety. In 1992, we reported that this historic approach to food safety is not well suited to preventing the largest current threat to the food safety system—microbiological contamination. We suggested moving to HACCP systems. In December 1995, FDA issued a final regulation, effective in December 1997, that requires fish- and seafood-processing plants to establish HACCP systems. FSIS’ proposed HACCP regulation for meat and poultry was published in February 1995. The final regulation is expected in early 1996, and FSIS plans for it to become effective in 1997 and be phased in over a period of years. The National Marine Fisheries Service (NMFS) issued its final regulation for its ongoing, voluntary HACCP-based inspection program for fish and seafood products in July 1992. As of February 1996, 88 plants were being inspected under this program. Plants are charged a fee for the inspections. The overall structure of and approach taken by the federal food safety system is much the same as it was in 1989. FDA and FSIS are still primarily responsible for regulating food safety. Both agencies continue to physically inspect food-processing plants and products to detect food safety hazards. FDA’s inspection frequency continues to be constrained by resources—in 1989, the agency inspected each plant, on average, once every 3 to 5 years. Currently, FDA plans to inspect food-processing plants once every 8 years, on average. FSIS continues to rely primarily on daily organoleptic inspections to detect contamination in meat and poultry. FSIS’ organoleptic methods are not designed to detect microbiological contamination—the most serious threat to human health from meat and poultry. Both agencies continue to conduct some chemical analyses of products to detect chemical contamination. While the overall structure of and approach taken by the federal food safety system have not changed, FDA and FSIS have both experienced some internal reorganizations in recent years. FDA, for example, reorganized its Center for Food Safety and Applied Nutrition along commodity lines—so there is now the Office of Seafood, for example—rather than by scientific discipline, such as microbiology. Similarly, during its reorganization, USDA transferred all of its food safety activities to FSIS. For example, USDA transferred to FSIS responsibility for (1) inspecting egg products from the Agricultural Marketing Service and for (2) identifying research needs and coordinating efforts among government, industry, and academia on food safety in animal production from the Animal and Plant Health Inspection Service. In addition to FDA and FSIS, 10 other agencies have limited food safety responsibilities and have had no or limited change in their duties since 1989. Table 1 sets forth the 12 agencies and their responsibilities. While the agencies’ structures and approaches to food safety have remained essentially the same over the last 5 years, new congressional mandates and the growth of the food sector have resulted in increased budgets and greater workloads. For example, in 1990, the Congress enacted food-labeling legislation that requires food companies to provide nutrition information so that consumers can make informed choices. FDA and FSIS were both involved in developing and overseeing these new requirements. In addition, from 1989 through 1994, the food sector grew by about $89 billion (about $50 billion in constant dollars), and there has been a large increase in the number of animals slaughtered. From fiscal year 1989 through fiscal year 1994, the 12 agencies’ budgets increased from $851 million to nearly $1.2 billion, an increase of about $170 million when adjusted for inflation. For FDA and FSIS—the two principal food safety agencies—funds for food safety increased by about 37 percent and about 14 percent, respectively, in constant 1989 dollars. The remaining 10 agencies either lost funding or had small increases. While responsibilities and budgets increased over this period, staffing remained constant at about 17,000 employees. Table 2 gives information on funding and staffing levels for the 12 agencies for fiscal years 1989 and 1994. In the face of increased responsibilities and workloads, FDA and FSIS have reduced the number of food safety inspections and shortened the length of the inspections in each plant, respectively. While FDA has had an increase in its number of inspectors, it performed fewer food safety inspection activities than it did in 1989. Although the number of food-processing plants for which FDA has inspection responsibility remains about the same, at 53,000, other activities for which it has responsibility, such as ones involving blood banks and plants that manufacture medical devices, have higher priority than inspecting food-processing plants. To meet its increased responsibilities, FDA reduced the number of food safety inspections in its operating plan from about once every 3 to 5 years, on average, in 1989 to about once every 8 years in 1994. As a result, the number of food plants FDA inspected dropped from 6,368 in 1989 to 4,799 in 1994. FSIS’ workload also increased because of the growth in the number of animals being slaughtered. Because its staff has not increased sufficiently to carry out carcass-by-carcass and bird-by-bird inspections under its traditional practices, FSIS has taken a number of steps, including having supervisors conduct slaughter inspections, reducing the amount of time spent on inspecting processing plants, and increasing the number of processing plants that inspectors cover. Table 3 shows the increase in the number of animals slaughtered. Three federal food safety agencies are embracing HACCP programs, which will fundamentally alter the federal food safety system and industry operations for ensuring meat, poultry, and seafood safety. FDA and FSIS have proposed mandatory HACCP systems for meat, poultry, and seafood. NMFS has adopted a voluntary HACCP-based inspection program for seafood. In contrast to the current system, these initiatives emphasize the detection and prevention of microbiological contamination by the industry and call for the industry’s increased accountability for food safety. Federal agencies’ inspection roles will also change—in addition to detecting safety hazards, the agencies will oversee the plants’ HACCP systems. Under these HACCP initiatives, industry is responsible for identifying the points where any microbiological, chemical, and physical safety hazard may occur in food production—known as the critical control points—and establishing procedures at those control points to detect and/or prevent such hazards. In addition, plants are required to document their activities, including establishing a record of actions taken to address any safety hazards. FDA’s and FSIS’ current inspection systems concentrate on detecting physical contamination and abnormalities and plants’ compliance with good manufacturing practices and sanitation procedures. While each agency performs some testing for microbiological and chemical contamination, these activities are currently a small part of the overall inspection activities. In contrast, HACCP systems call for plants to employ quality control procedures designed to identify opportunities for preventing all safety hazards, including microbiological contamination—the most serious food safety threat. FDA and FSIS plan to continue their inspection activities. In addition, the agencies will oversee the plants’ HACCP systems to ensure that each plant implements and operates an effective system. The scientific community has specified that in order for HACCP systems to be effective, there must be two components: (1) Each plant in the industry must implement an effective HACCP plan, and (2) federal agencies must inspect each plant’s HACCP-based quality control system to ensure that it is working as designed. Furthermore, to ensure the systems’ integrity, the National Academy of Sciences has recommended that the level of federal inspections be based on the compliance history of each plant and that the risk of the product be based on the safety hazards of each step in production. However, because of FDA’s resource constraints and FSIS’ regulatory restrictions, the agencies’ ability to inspect plants on the basis of the risk they pose is limited. Specifically, FDA plans to inspect seafood plants once every 2 years, on average, regardless of their compliance history, and plants producing the highest-risk seafood once per year. While individual inspectors may visit noncompliant plants more frequently, other plants will not be inspected as a result because of limited inspection resources. Because FSIS is required by law to have continuous inspections of slaughtering plants and daily inspections of processing plants, the agency must continue its daily and carcass-by-carcass inspections.