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. To take into account food safety risks in processing plants, FSIS plans to consider risk when scheduling the daily tasks that inspectors will perform. In addition, in slaughtering plants, FSIS plans to initiate pilot projects to explore other ways to perform its mandated carcass-by-carcass inspections with fewer resources. Unlike these other agencies, NMFS bases the frequency of inspections, for seafood plants participating in the voluntary HACCP-based inspection program, on the risk that they present. NMFS determines the riskiness of the plants as indicated by past inspections and the inherent risk associated with the product. As plants achieve and maintain compliance with NMFS’ standards, NMFS reduces the frequency of its inspections. The higher the plant’s NMFS rating for safety, the fewer inspections the plant receives and the lower the cost to the plant, since plants pay for the inspection. Plants with the best safety rating are inspected every 6 months, while plants with the lowest safety rating are inspected every 2 weeks. Plants that are not able to maintain compliance with NMFS’ program standards are dropped from the program or placed under daily inspection while deficiencies are being corrected. Of the about 300 seafood plants that participate in NMFS’ voluntary inspection programs, 88 seafood plants are under the HACCP program. These plants, like the approximately 4,800 total seafood plants, are also subject to FDA’s inspections. Appendix II provides a comparison of some aspects of NMFS’ and FDA’s seafood HACCP initiatives. We provided copies of a draft of this report to each of the 12 agencies for its review and comment. Seven of these agencies generally agreed with the information discussed, and provided clarifying comments and technical corrections, which we have incorporated into the report. Four agencies did not have any comments. FDA disagreed with our characterization of HACCP systems as a fundamental change for the agency. FDA officials, including the Strategic Manager for HACCP Policy, viewed the changes planned for the seafood inspection program as a continuation of historical efforts by the agency and cited their low-acid canned food program and their issuance of good manufacturing practices as examples. While we recognize that FDA’s approach to food safety has evolved over the years, we continue to believe that the move to HACCP represents a significant shift in FDA’s policy. We further believe that our characterization of this shift is consistent with FDA’s previous characterizations. In particular, in its HACCP rulemaking proposal, FDA stated that it was responding to the need for a “new paradigm” for seafood inspection, one that provides an ongoing, scientifically established system of intensive, preventative monitoring. We believe that taken in context, the HACCP-related changes being implemented by FSIS, FDA, and NMFS do represent a fundamental shift in the federal government’s approach to food safety. To obtain information on agencies’ responsibilities, funding, staffing, and workloads, we asked the 12 agencies involved in food safety to provide data similar to the 1989 data presented in our two-volume 1990 report. We did not verify the accuracy of these data. We also visited five seafood-processing plants that NMFS had identified to understand and observe how its user-fee, voluntary HACCP-based inspection program worked. In addition, we examined other reports and studies on meat, poultry, and seafood inspection and used prior GAO studies. We interviewed agency and industry officials and obtained additional data from FDA, FSIS, and NMFS concerning HACCP proposals, plans, and operations. We attended public meetings on FSIS’ HACCP proposal. We conducted our work at agencies’ headquarters in the Washington, D.C., area and in NMFS’ Western Inspection Region. We performed our work from July 1995 through March 1996 in accordance with generally accepted government auditing standards. We are sending copies of this report to the Senate Committee on Agriculture, Nutrition, and Forestry, and other appropriate congressional committees. We will also send copies of this report to the Secretaries of Agriculture, Commerce, Health and Human Services, and the Treasury; the Administrator, Environmental Protection Agency; and the Commissioner, Federal Trade Commission. We will also make copies available to others upon request. Please contact me at (202) 512-5138 if you or your staff have any questions. Major contributors to this report are listed in appendix III. Food and Drug Administration (FDA) is responsible for ensuring that domestic and imported food products (except meat, poultry, and processed egg products) are safe, wholesome, and properly labeled. The Federal Food, Drug, and Cosmetic Act, as amended, is the major law relating to FDA’s food safety and quality activities. The act also authorizes FDA to maintain surveillance of all animal drugs, feeds, and veterinary devices to ensure that drugs and feeds used in animals are safe, are properly labeled, and produce no human health hazards when used in food-producing animals. Food Safety and Inspection Service (FSIS) is responsible for ensuring that meat, poultry, and processed egg products moving in interstate and foreign commerce are safe, wholesome, and correctly marked, labeled, and packaged. FSIS carries out its meat and poultry inspection responsibilities under the Federal Meat Inspection Act, as amended, and the Poultry Products Inspection Act, as amended. Amendments to these acts require that meat inspected by state inspection programs and imported meat are to meet inspection standards “at least equal to” those of the federal program. Furthermore, the Department of Agriculture Reorganization Act of 1994 transferred to FSIS food safety inspections previously being performed by other organizations within the U.S. Department of Agriculture (USDA). Animal and Plant Health Inspection Service (APHIS) is responsible for ensuring the health and care of animals and plants. APHIS has no statutory authority for public health issues unless the concern to public health is also a concern to animal or plant health. APHIS identifies research and data needs and coordinates research programs designed to protect the animal industry against pathogens or diseases that are a risk to humans to improve food safety. Grain Inspection, Packers and Stockyards Administration (GIPSA) is responsible for sharing information with FDA concerning food safety and for ensuring the quality of grains for marketing. For example, GIPSA covers the inspecting of corn, sorghum, and rice for aflatoxin, which causes human illness. GIPSA caries out its responsibilities under the U.S. Grain Standards Act, as amended, and the Agricultural Marketing Act of 1946, as amended. Agricultural Marketing Service (AMS) is primarily responsible for establishing the standards of quality and condition and for grading the quality of dairy, egg, fruit, meat, poultry, seafood, and vegetable products. As part of this grading process, AMS considers safety factors, such as the cleanliness of the product. AMS carries out its wide array of programs to facilitate marketing under more than 30 statutes—for example, the Agricultural Marketing Agreement Act of 1937, as amended; the Agricultural Marketing Act of 1946, as amended; the Egg Products Inspection Act, as amended; the Export Apple and Pear Act, as amended; and the Export Grape and Plum Act, as amended. Agricultural Research Service (ARS) is responsible for conducting a wide range of research relating to USDA’s mission including food safety research. ARS carries out its programs under the Department of Agriculture Organic Act of 1862; the Research and Marketing Act of 1946, as amended; and the National Agricultural Research, Extension, and Teaching Policy Act of 1977, as amended. National Marine Fisheries Service (NMFS), within the Department of Commerce, conducts its voluntary seafood safety and quality inspection programs under the Agricultural Marketing Act of 1946, as amended, and the Fish and Wildlife Act of 1956, as amended. In addition to the inspection and certification services provided for fishery products for human consumption, NMFS also provides inspection and certification services for animal feeds and pet foods containing a fishery base. Environmental Protection Agency (EPA) is responsible for regulating all pesticide products sold or distributed in the country and setting maximum allowed residue levels—tolerances—for pesticides on food commodities and animal feed. EPA’s activities are conducted under the Federal Insecticide, Fungicide, and Rodenticide Act, as amended, and the Federal Food, Drug, and Cosmetic Act, as amended. Centers for Disease Control and Prevention (CDC) is charged with protecting the nation’s public health by providing leadership and direction in preventing and controlling diseases and responding to public health emergencies. CDC engages in public health activities related to food safety under the general authority of the Public Health Service Act, as amended. Federal Trade Commission (FTC) enforces the Federal Trade Commission Act, which prohibits unfair or deceptive acts or practices. FTC’s food safety objective is to prevent consumer deception through the misrepresentation of food. U.S. Customs Service (Customs) is responsible for collecting revenues and enforcing various customs and related laws. Customs assists FDA and FSIS in carrying out their regulatory role in food safety. Bureau of Alcohol, Tobacco and Firearms (ATF) is responsible for administering and enforcing laws covering the production (including safety), use, and distribution of alcoholic beverages under the Federal Alcohol Administration Act and the Internal Revenue Code. Critical control point: Any step in a process that, if not properly controlled, may result in an unacceptable safety, wholesomeness, or economic fraud risk. Critical control point: A point in a food process at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels. Process: One or more actions or operations to harvest, produce, store, handle, distribute, or sell a product or group of similar products. Processing: With respect to fish or fishery products, the handling, storing, preparing into different market forms, packing, labeling, or holding of a product. Firms that wish to participate in the program may apply orally or in writing. However, the applicant must submit a written HACCP plan, which must be reviewed and approved prior to validation. Every processor shall conduct a hazard analysis to determine whether food safety hazards are reasonably likely to occur and to identify preventive measures. If this analysis reveals one or more such hazards, the processor shall implement a written HACCP plan for each processing location and for each kind of fish and fishery product. Failure to have and implement a HACCP plan that complies with the requirements shall render the products adulterated. (1) Organization chart and narrative describing duties of personnel. (2) Description of fishery products. (3) Process flow charts. (4) Critical control point work sheet, including critical points, hazards, preventive measures, critical limits, monitoring procedures, corrective actions, and records. (5) Record-keeping system. (6) Verification procedures. (7) Sanitation standard operating procedures. (8) Consumer complaint file. (9) Recall procedures. (1) A list of the food safety hazards that are reasonably likely to occur and thus must be controlled for each fish and fishery product. (2) A list of the critical control points for each identified hazard. (3) List of the critical limits that must be met at each of the critical control points. (4) Procedures used to monitor each of the critical control points to ensure compliance with critical limits. (5) Any corrective action plans that have been developed to respond to deviations from critical control point limits. (6) List of the verification procedures and frequency of verification. (7) Record-keeping system to document monitoring of critical control points. On a fee basis, regional officials will review and approve a HACCP plan. When ready for validation, the plan is sent to the National HACCP Coordinator for final review and approval. One or more Consumer Safety Officers and inspectors will perform an on-site validation of the plan. The validation team will conduct the test after the firm has operated for at least 10 production days. FDA’s HACCP rule does not mention any requirement for prior FDA review and approval of a firm’s HACCP plan. FDA’s HACCP rule provides for an overall verification that the HACCP plan is being effectively implemented. (continued) Each facility must employ a NMFS-certified person knowledgeable of the HACCP program’s principles to be present during all processing times. Functions, such as developing a HACCP plan, reassessing and modifying the HACCP plan, and performing the record review, shall be performed by an individual who has successfully completed a standardized course of instruction recognized by FDA in the application of HACCP principles in the processing of fish and fishery products at a program of instruction approved by FDA. This trained individual need not be an employee of the processor. Different audit schedules exist for participating vessels, processors, and retail and food service firms. The audit schedules are on a sliding frequency scale: as performance improves, the frequency of audits decreases. Audits are unannounced. For processors, the frequency ranges from daily audits in plants that are temporarily out of compliance to audits every 6 months for a high level of proven compliance. The entry level in the HACCP program calls for audits every 2 weeks. FDA plans to review the seafood-processing plants about once every 2 years on average. These inspections have occurred nearly once per year, on average, for the highest-risk fish and seafood firms and about once every 3 to 4 years, on average, for low-risk firms. All of the plant’s records must be maintained by the firm for a period of 6 months beyond the expected shelf life of the product and must be accessible at all times to NMFS’ inspection personnel. Records required by the regulations shall be retained at the processing facility or importer’s business for at least 1 year after preparation for refrigerated products and 2 years for frozen, shelf-stable, or processed products. All records shall be available for official review and copying by FDA inspectors. NMFS has fees and charges to recover costs for administering the HACCP program. Fees are collected for preplan consultation, plan review and validation, inspections, and laboratory analysis of samples. Travel and per diem charges are added. FDA will not fund the additional work on HACCP’s compliance with user fees. Edward M. Zadjura, Assistant Director John M. Nicholson, Jr., Evaluator-in-Charge Dennis Richards Karla Springer Carol Herrnstadt Shulman The first copy of each GAO report and testimony is free. Additional copies are $2 each. Orders should be sent to the following address, accompanied by a check or money order made out to the Superintendent of Documents, when necessary. VISA and MasterCard credit cards are accepted, also. Orders for 100 or more copies to be mailed to a single address are discounted 25 percent. U.S. General Accounting Office P.O. 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Summary: Pursuant to a congressional request, GAO provided information on the federal food safety system, focusing on recent federal initiatives to improve meat, poultry, and seafood safety. GAO found that: (1) the Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) are primarily responsible for regulating food safety; (2) both agencies inspect meat, poultry, and seafood plants, but are constrained by resource limitations; (3) FDA plans to inspect each food processing plant once every 8 years, or once every 5 years when it can use state inspection resources; (4) Congress has increased the mandates of both agencies since 1989, including requiring FDA and FSIS to help develop and oversee new food labelling requirements; (5) while the agencies' budgets have increased, their staffing remained constant; (6) FDA, FSIS, and the National Marine Fisheries Service, which maintains a voluntary seafood inspection program, are implementing hazard analysis and critical control point (HACCP) programs, which emphasize the detection and prevention of microbial contamination and increase the role of industry in ensuring food safety; and (7) HACCP initiatives represent a fundamental shift in the government's approach to ensuring food safety.