Foodborne illness in the United States is extensive and expensive. The incidence of foodborne illness is estimated to range from 6.5 million to 81 million cases each year and result in as few as 500 to as many as 9,100 related deaths annually. In terms of medical costs and productivity losses, foodborne illness costs the nation between $7 billion and $37 billion annually, according to USDA’s estimates. Public health officials believe that the risk of foodborne illness has been increasing over the last 20 years. Trends in the incidence of foodborne illness in the United States are linked, at least in part, to changes in Americans’ eating habits. For example, Americans today consume more raw fruits and vegetables than they did in the past and in some cases may mishandle them by not washing them. While this change in diet has many health benefits, the mishandling of these foods and other foods, such as undercooking and/or improperly refrigerating meat and poultry, may also contribute to the spread of foodborne illnesses. The scientific community has recognized that preventing contamination is the key to reducing the risk of foodborne illness. However, FSIS conducts organoleptic meat and poultry inspections of each and every meat and poultry carcass in order to fulfill current program requirements for carcass-by-carcass inspections in slaughtering plants. While these inspections fulfill the requirements, they primarily identify defects in quality but do not detect microbial contamination. However, as the threat of microbial contamination has increased, a Hazard Analysis and Critical Control Point (HACCP) system has come to be considered the best approach currently available for ensuring safe food because it focuses on preventing contamination rather than on detecting it once it has occurred. The HACCP system (1) identifies hazards and assesses the risks associated with each phase of food production, (2) determines the critical points where the identified hazards can be controlled, and (3) establishes procedures to monitor these critical control points. In January 1998, FSIS began to require meat and poultry plants to implement HACCP systems. Implementation is expected to take 3 years, starting with the nation’s 300 largest slaughtering plants, which account for 75 percent of all meat and poultry slaughter production. In 2000, this system will be fully implemented and will have reached very small plants—those with fewer than 10 employees. The HACCP system requires FSIS’ verification that a plant’s overall system—not just the individual control points—is working. This verification relies on, among other things, microbial and other types of testing of product samples taken at various times throughout production. These tests contribute to verifying whether the plants meet food safety standards and alert the plants to deficiencies in the slaughtering process. In addition to carcass-by-carcass slaughter inspections, FSIS inspects meat- and poultry-processing plants at least once per day during each operating shift. Its current inspection program practice for processing plants is labor-intensive and is not based on the health risk that a plant poses. Processing plants’ operations can include the simple cutting and packaging of meat and poultry, grinding, complex canning procedures, or the preparation of ready-to-eat products. Multiple agencies share the responsibility for ensuring the safety of the nation’s food supply. In fact, 12 different federal agencies located within six federal entities are involved: HHS’ Food and Drug Administration and Centers for Disease Control and Prevention (CDC); USDA’s FSIS, Agricultural Marketing Service (AMS), Animal and Plant Health Inspection Service (APHIS), Agricultural Research Service (ARS), and Grain Inspection, Packers, and Stockyards Administration; the Department of Commerce’s National Marine Fisheries Service (NMFS); the Department of the Treasury’s U.S. Customs Service and Bureau of Alcohol, Tobacco, and Firearms; the Environmental Protection Agency (EPA); and the Federal Trade Commission. Appendix I describes these 12 agencies’ roles and responsibilities in food safety, and table I.1 shows the food safety funding for and staffing levels of the agencies for selected years. This structure necessitates extensive coordination to minimize duplication of effort, prevent gaps in regulatory coverage, and avoid conflicting actions. Our past reviews have shown inconsistencies and differences between agencies’ approaches and enforcement authorities that undercut overall efforts to ensure a safe food supply. In the past, we have recommended a single food safety agency to correct the problems created by this fragmented system. In addition to the more than $1 billion provided for routine food safety activities, the administration’s food safety initiatives increased funding for federal food safety efforts by $43 million in fiscal year 1998 and requested $101 million for fiscal 1999. These funds went to various agencies—some of which previously did not have any food safety activities—to target efforts for collaborating on food safety priorities in six areas: (1) enhance surveillance of foodborne illnesses and build an early warning system; (2) improve the assessment of the risks associated with exposure to foodborne pathogens; (3) improve coordination among local, state, and federal health authorities; (4) improve the efficiency and effectiveness of seafood, fruits and vegetables, and other FDA inspections; (5) develop educational messages for a variety of audiences, such as consumers and schoolchildren, on the hazards associated with handling food; and (6) research methodologies for, among other things, more rapid and accurate identification and characterization of foodborne hazards. These areas represent important and specific food safety activities that, in many cases, existed prior to the initiatives but had difficulty obtaining funding through their agencies’ processes for setting budget priorities. Appendix II shows, by agency, the fiscal year 1998 funding and fiscal 1999 request for these initiatives. A significant area in which food safety funds could be spent more effectively is inspection resources. Most of the $271 million—over one-fourth of the food safety budget—spent annually on FSIS’ organoleptic, carcass-by-carcass slaughter inspections could be spent more effectively on other food safety activities that better address food safety risks. Once HACCP is fully implemented, the funds could become available through the Congress’s (1) authorizing FSIS to impose user fees on meat and poultry plants for carcass-by-carcass slaughter inspections, (2) eliminating the legislatively mandated requirement for these federal inspections and allowing slaughter plants to hire their own inspectors, or (3) combining the above options—permitting the slaughter plants to either pay the user fees for federal inspections or hire their own inspectors. In addition, if daily inspections of the processing plants—at an annual cost of about $109 million—were replaced by inspections based on health risk, an undetermined amount of funds could be made available. All or part of the funds made available through the implementation of revisions to food safety inspections could be redirected to other food safety priorities. Currently, FSIS spends about $271 million annually on inspectors who are present at each slaughter plant nationwide every day that it is in operation. These inspectors, under current FSIS rules and regulations, inspect each carcass—over 8 billion birds and livestock annually—for visible defects, such as lesions and diseases. Under the traditional organoleptic inspection system, an inspector has about 2 seconds per bird, at the fastest line speeds, to determine whether the carcass meets federal standards for wholesomeness. We previously reported that with the introduction of the HACCP system, the traditional system of organoleptic meat and poultry inspections of each meat and poultry carcass will become obsolete for improving the safety of meat and poultry because it does not prevent microbial contamination.Moreover, experts have recognized that post-mortem organoleptic inspections on every carcass must be changed because (1) they waste resources and cannot detect microbial pathogens, (2) the animal diseases for which they were originally designed have been eradicated in many countries, and (3) they result in unnecessary cross-contamination because the hands-on inspection techniques used virtually ensure that contamination spreads from one carcass to another. However, this type of inspection may be useful to slaughter plants, since it primarily provides an assurance of quality, such as ensuring that feathers are removed and that tumors and blood clots are not present. While these conditions do not generally threaten human health, they affect the quality of the product. Because the organoleptic inspections of slaughtered animals primarily help to ensure quality rather than food safety, these inspections are foremost in the slaughter plants’ interest. Therefore, as we previously reported, it may be appropriate to charge user fees to cover the cost of these activities. Historically, FSIS has sought but never received the authority to charge user fees for all of its inspection activities. FSIS is requesting user fees again in its fiscal year 1999 budget for all inspection activities. Although the Congress has decided in the past that it is not appropriate to impose user fees for all food safety inspections, the Congress, as a first option, may consider it appropriate to authorize user fees for the federal organoleptic, carcass-by-carcass inspection of slaughtered animals after FSIS has fully implemented the new science- and risk-based HACCP inspection system. If this authority were granted and used, most of the $271 million that FSIS currently spends on these inspections could be recovered. As a second option, the Congress could amend the mandated requirement for federal carcass-by-carcass inspections by stipulating that after a slaughter plant has operated under a HACCP system for a period of time, the plant could conduct its own carcass-by-carcass slaughter inspections, with appropriate FSIS oversight. Alternatively, as we previously recommended, the Congress could revise the meat and poultry acts to provide FSIS with the flexibility and discretion to target its inspection resources to meet the most serious food safety risks. Finally, the Congress could provide for a combination of the first two options. That is, a plant could (1) pay a user fee to FSIS, adjusted periodically to reflect FSIS’ increased costs, and use FSIS inspectors for carcass-by-carcass slaughter inspections or (2) hire its own employees to do these inspection activities with the appropriate FSIS oversight. In prior work, we reported on the opportunity to more effectively use federal food safety resources by adopting a risk-based approach rather than the approach currently used by FSIS, which requires daily inspections at all processing plants. This inflexible, labor-intensive approach costs an estimated $109 million annually. Under FSIS’ current approach, an inspector must visit each meat and poultry processing plant every 8-hour operating shift to perform a number of tasks, such as monitoring the cleanliness of the workers’ bathrooms and ensuring that the canning process operates under the right temperatures and pressures. An undetermined amount of funds could be made available by adopting a risk-based approach to determine the appropriate frequency for these inspections and to allow for more substantial inspections, if needed, when they do occur. Funds made available from this new approach could then be redirected to other food safety priorities. Developing a risk-based system to determine the frequency of daily inspections would result in fewer inspections but also in inspections that are more closely tied to risk. Our past work pointed out the inefficiencies of FSIS’ daily inspection of all 5,900 meat- and poultry-processing plants (or once per shift if a plant operates more than one 8-hour shift) with the same frequency and intensity of inspection regardless of the processing plant’s public health risk and compliance history. In fiscal year 1997, the annual cost associated with inspectors traveling between processing plants on daily “patrol assignments,” which averaged three to six plants per day, was $6 million. Under a risk-based approach, some of these inspections would occur less frequently because they would be based on the risk that specific food products pose to public health and the plants’ past inspection histories. If FSIS changes its current approach to carcass-by-carcass slaughter inspections, all or part of the $271 million annually spent on these inspections could be redirected to other federal food safety activities that better reduce the threat of foodborne illness. In prior work, we identified a number of food safety concerns that could be addressed, such as the following: FSIS could help to install HACCP inspection systems at the smallest meat and poultry slaughter and processing plants. Since industry will bear most of the installation cost for these new systems and the smallest plants have a smaller volume over which to spread this cost, these plants will be disproportionately affected by the cost of the new inspection systems. FDA could increase the frequency of its inspections of other U.S. food-processing plants, such as nonmeat soup plants, cereal manufacturers, and canned fruit and vegetable processors. Currently, FDA inspects such plants under its jurisdiction only once in 10 years, on average. These inspections are not based on the health risks that these plants pose, but rather on available resources. FDA officials informed us that if they had increased resources, FDA could increase the frequency of inspections of high-, moderate-, and low-risk firms, in that order. In general, the inspections of lower-risk firms would be based on the availability of resources. FDA could improve its oversight of imported foods by assisting foreign countries in developing equivalent food safety systems or it could use the funds to improve its oversight of imported foods at ports of entry. In addition to these actions, the food safety agencies may have other priorities for the use of the funds that are made available from organoleptic slaughter inspections of meat and poultry plants or by basing the frequency of meat- and poultry-processing plant inspections on risk. For example, an ARS official stated that FDA could use additional funding to support an ongoing surveillance system of food animals. This system samples tissue from food animals that have been treated with antibiotics. The system monitors (1) the buildup of antibiotic tolerances in animals and (2) the mutation of pathogens due to antibiotic treatment. The health concern is antibiotic resistance to pathogens in humans as a result of consuming these food animals. The national food safety initiatives were announced by the President for fiscal years 1998-99 and provided additional funds for identified weaknesses. These initiatives have improved some food safety activities. However, the initiatives do not address the fundamental problem of the system—its fragmented structure. In fact, for certain food safety activities, the initiatives intensified the need for coordination among the loosely networked group of federal food safety agencies. For fiscal year 1998, the administration’s initiative received $43 million for specific food safety activities to improve the nation’s food safety system. Prior to the initiative, these activities had competed with other agency priorities for funding. The $43 million in funding was aimed at, among other things, (1) improving a nationwide early-warning system for foodborne illnesses, (2) increasing seafood safety inspections, and (3) expanding research, training, and education in food safety. Under the initiative for fiscal year 1999, the administration has requested $101 million to build upon the food safety efforts in the 1998 initiative and to enhance the safety of imported and domestic fruits and vegetables, among other things. CDC used initiatives funding to improve its monitoring of foodborne illnesses and will expand its surveillance locations throughout the country to eight. This program, now known as FoodNet, provides national data to better identify illnesses associated with foods; these data allow for more informed decisions about dealing with microbial contamination. Prior to FoodNet, CDC had very limited information on the extent of foodborne illnesses. Since this surveillance effort was undertaken, for example, CDC has learned that the incidence of one pathogen, Campylobacter, is far more frequent than previously known. Policymakers can now use this information to direct research and other activities to reduce illnesses from this pathogen. While these food safety initiatives have addressed, and intend to address, some targeted problems, they do not effectively deal with the underlying fragmentation in the federal food safety system. As we have reported, past efforts to correct deficiencies in the federal inspection system for food safety have fallen short, in part because they did not address the fundamental problems in the system. Agencies operate under different regulatory approaches, have widely disparate budgets and staffs, and lack the flexibility needed to respond to changing consumption patterns and emerging food safety issues. These agencies’ efforts are hampered by laws that were designed to address safety concerns in specific foods in a piecemeal fashion, typically in response to particular health threats or economic crises. In addition, this fragmentation may have impeded the effective implementation of some of the activities funded through the food safety initiatives. For example, the initiatives for fiscal years 1998-99 included about $15.7 million to FSIS, FDA, and the Cooperative State Research, Education, and Extension Service, among other agencies, to jointly develop a national campaign to educate the public about the safe handling of fruits and vegetables. However, this effort excluded EPA, which is spending about $230,000 in fiscal year 1998 and about $400,000 in fiscal 1999 to develop and distribute its own brochure to educate the public about pesticides and foods. While EPA attempted to coordinate its educational brochure with the other agencies, significant differences over the message still occurred. According to USDA and FDA officials and consumer groups, EPA’s message implied that there are risks associated with eating fruits and vegetables treated with pesticides. These groups said that EPA’s message contradicted USDA’s advice to eat more fruits and vegetables. At the same time, the other agencies’ effort developed a message that discussed the safe handling of fruits and vegetables and encouraged their consumption. In March 1998, after receiving comments from other agencies and the public on its draft brochure as published in the Federal Register, EPA began revising its brochure to reflect the concerns of the other agencies and advised us that it is still in that process. Even when an activity under the initiatives has been designed to address a fragmentation problem, there is no assurance that it will be successful. For example, in January 1997, the President’s Food Safety Initiative (Food Safety From Farm to Table: A National Food Safety Initiative) proposed improving seafood inspection activities by consolidating seafood inspections under one agency by October 1998. Under the proposal, NMFS’ voluntary fee-for-service seafood inspection program would be moved to FDA. Progress on this consolidation has been slow because some of the necessary legislative changes are still being drafted. As of May 1998, NMFS officials told us that they have drafted legislation, in conjunction with FDA, to transfer the program to FDA but budget issues have delayed the legislation from being sent to the Office of Management and Budget for its review and approval. Consequently, the Congress has not had the opportunity to decide on the proposed legislation. Commerce’s fiscal year 1999 budget request does not show NMFS’ program as part of Commerce’s fiscal 1999 budget, because Commerce assumed that legislation to transfer the program would be enacted during fiscal 1998. In addition, neither FDA’s fiscal year 1999 budget nor its initiative funds provide for transferring NMFS’ program to FDA, which has primary responsibility for seafood inspections. FDA officials told us that they did not include the transfer in their fiscal year 1999 budget request because they had not received the legislative authority to charge the user fees that are associated with NMFS’ inspection program. We provided the Department of Commerce, the CDC, EPA, FDA, and USDA with a draft of this report for their review and comment. The following summarizes their comments, which are shown in their entirety with our point-by-point responses, in appendixes III through VII. USDA disagreed with the draft report and had concerns with (1) the draft’s description of the Department’s food safety inspection operations as well as the laws supporting these operations and (2) any implication that food safety resources should be transferred out of the Department. Concerning the former, USDA stated that we mischaracterized the statutory authorities for FSIS’ programs that ensure the safety of the meat and poultry supply and inaccurately described FSIS’ current inspection practices. For example, USDA noted that, in contrast to statements in the draft report, the statutes do not mandate how carcass-by-carcass inspections are to be carried out nor do they state the frequency of processing inspections. We used the Department’s comments, where appropriate, to clarify certain aspects of the report. These clarifications are described in more detail in appendix VII. However, none of these revisions changed the fundamental description of the Department’s inspection operations. Furthermore, they do not change our principal observation that USDA’s current carcass-by-carcass inspection process as well as its daily processing plant inspection process are not risk-based and, therefore, in our view, may not be an efficient use of federal food safety resources. USDA’s second concern stemmed from a misinterpretation of the draft. USDA officials incorrectly inferred that the report implied that any resources made available by revising the Department’s current carcass-by-carcass inspection and daily plant inspection processes should be redirected outside FSIS. The report does not say this; rather, it presents several food safety activities that these resources could be redirected toward, both within and outside of FSIS. EPA and FDA each had one primary concern about the draft report. This concern related to one of several examples used to illustrate our observation that the food safety initiatives did not address the underlying problems of fragmentation in food safety regulation. More specifically, the draft report noted that under the food safety initiative for fiscal year 1999, USDA and FDA had planned to consolidate efforts for monitoring microbial contamination in fruits and vegetables but had missed an opportunity to take a similar approach to monitor for pesticide residues in these foods. In commenting on the draft, both FDA and EPA stated that the objectives of USDA’s and FDA’s pesticide-monitoring efforts differed significantly enough that it would be difficult to develop a single monitoring program that would satisfy both agencies’ monitoring objectives. On the basis of their concerns, we eliminated this particular example. However, our overall observation concerning fragmentation and the problems it creates for ensuring food safety remains unchanged. The Department of Commerce and CDC generally agreed with our report and provided several technical corrections, which we incorporated as appropriate. You asked us to (1) analyze the federal food safety agencies’ budgets for fiscal year 1999 to determine whether the appropriated funds of more than $1 billion can be spent more effectively and (2) provide our views on whether the food safety initiatives for fiscal years 1998-99 will address underlying problems in the federal food safety system. To address the first question, we reviewed the two food safety agencies with the largest budgets and another seven agencies with budgetary increases in their fiscal year 1999 budget requests for selected food safety programs and projects. In total, we examined 10 agencies’ budgets: FDA and CDC, within HHS; FSIS, AMS, APHIS, ARS, the Grain Inspection, Packers, and Stockyards Administration, and the Cooperative State Research, Education, and Extension Service, within USDA; NMFS, within the Department of Commerce; and EPA. In addition, we asked the agencies’ program and budget officials to explain budget justifications in more detail for selected programs and projects to ascertain if these various agencies’ budgets represented the best way to spend $1 billion on federal food safety activities through appropriations and user fees. In order to provide our views on whether the food safety initiatives for fiscal years 1998-99 will address the underlying problems in the federal food safety system, we reviewed the administration’s initiatives on food safety, examined four of the six priority areas identified within the initiatives because these areas had the largest budgets, and interviewed knowledgeable food safety agencies’ program and budget officials on selected projects within those four areas. In addition, to address both issues, we used information from our prior reports and reports from the Congressional Research Service. We conducted our review from February through May 1998 in accordance with generally accepted government auditing standards. We are sending this report to various congressional committees because of their role in overseeing the activities and funding of the issues discussed. We are also sending copies of this report to the Secretaries of Agriculture, Commerce, and HHS; Administrator, EPA; and Director, Office of Management and Budget. In addition, we will make copies available to others on request. See appendix VIII for major contributors to this report. Please contact me at (202) 512-5138 if you or your staff have any questions. Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), 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 governing FDA’s activities to ensure food safety and quality. The act also authorizes FDA to maintain a surveillance of all animal drugs, feeds, and veterinary devices to ensure that drugs and feeds used in animals are safe and properly labeled, and produce no human health hazards when used in food-producing animals. Centers for Disease Control and Prevention (CDC), within HHS, 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 conducts surveillance for foodborne diseases; develops new epidemiologic and laboratory tools to enhance the surveillance and detection of outbreaks; and performs other activities to strengthen local, state, and national capacity to identify, characterize, and control foodborne hazards. CDC engages in public health activities related to food safety under the general authority of the Public Health Service Act, as amended. Food Safety and Inspection Service (FSIS), within the U.S. Department of Agriculture (USDA), 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 as well as 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 some food safety inspections previously performed by other organizations within USDA. Animal and Plant Health Inspection Service (APHIS), within USDA, 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 the health of animals or plants. 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), within USDA, is responsible for establishing quality standards and providing for a national inspection system to facilitate the marketing of grain and other related products. Certain inspection services, such as testing corn for the presence of aflatoxin, enable the market to assess the value of a product on the basis of its compliance with contractual specifications and FDA requirements. Those requesting inspection services, typically the owner of the grain, are responsible for complying with FDA regulations. GIPSA has no regulatory responsibility regarding food safety. Under a memorandum of understanding with FDA, GIPSA reports to FDA certain lots of grain, rice, pulses, or food products (which were officially inspected as part of GIPSA’s service functions) that are considered objectionable under the Federal Food, Drug, and Cosmetic Act. GIPSA carries 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), within USDA, 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. AMS is largely funded with user fees. Agricultural Research Service (ARS), within USDA, is responsible for conducting a wide range of research relating to the Department’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 provides inspection and certification services for animal feeds and pet foods containing a fish base. Environmental Protection Agency (EPA) is responsible for regulating all pesticide products sold or distributed in the United States 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. 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, within the Department of the Treasury, is responsible for collecting revenues and enforcing various customs and related laws. Customs assists FDA and FSIS in carrying out their regulatory roles in food safety. Bureau of Alcohol, Tobacco, and Firearms (ATF), within the Department of the Treasury, 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. FDA’s data include funding and staffing for various programs across FDA that are involved with food safety activities, including the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, the field components for these centers, and overall agencywide support. The agency did not specify its food safety resources. Agencies’ funding and staffing levels are for both safety and quality inspection activities. AMS’ funding and staffing totals for fiscal year 1989 reflect egg inspection activities, which were transferred to FSIS in 1994. Totals for fiscal years 1994 and 1998 include data for the Pesticide Data Program, which began in 1991. Numbers for EPA are from the following sources: Fiscal Year 1991 President’s Budget, 1989 Actuals; Fiscal Year 1996 President’s Budget, 1994 Actuals; and Fiscal Year 1999 President’s Budget, 1998 Enacted, and includes the total Office of Pesticides Programs. We did not review these agencies’ food safety budgets because of the small amount of funds for these activities in previous years. (continued) FY = fiscal year. The following are GAO’s comments on the Department of Commerce’s letter dated June 24, 1998. 1. We revised the report to reflect the Department of Commerce’s language changes. However, we did not delete the “January 1997” date because we wanted to clearly demonstrate the time frame involved with the activity. 2. We revised the report to reflect the language requested by the Department. The following are GAO’s comments on CDC’s letter dated June 25, 1998. 1. We revised the report to reflect the language requested by CDC. The following are GAO’s comments on EPA’s letter dated July 6, 1998. 1. The report now reflects the $230,000 that EPA expects to spend on the effort for fiscal year 1998. In addition, the $1 million estimate for fiscal year 1999, which EPA’s budget officials had previously provided us with, has been revised to reflect EPA’s current estimate of $400,000. 2. This section of the report was deleted. Originally, this section discussed a specific example of how the food safety initiative did not address underlying problems associated with the fragmentation of food safety responsibilities. In particular, the example noted efficiencies that could be gained by combining FDA’s and USDA’s pesticide-residue-monitoring programs for fruits and vegetables. This action would have been consistent with FDA’s and USDA’s plans under the 1999 food safety initiative to combine their systems for monitoring the microbial contamination of fruits and vegetables. However, FDA’s letter expressed concerns about whether the proposed combined microbial-contamination-monitoring program would satisfy its monitoring needs and has similar concerns about combined pesticide residue monitoring. (See app. VI.) In view of these concerns, as well as similar concerns expressed in EPA’s letter, we eliminated the discussion of this particular example. However, we did not change the report’s overall observation concerning the food safety initiative’s failure to address fundamental fragmentation problems. 3. We revised the draft report to reflect EPA’s most recent funding and staffing estimates. The following are GAO’s comments on FDA’s letter dated July 7, 1998. 1. This section of the report was deleted. Originally, this section discussed a specific example of how the food safety initiative did not address underlying problems associated with the fragmentation of food safety responsibilities. In particular, the example noted efficiencies that could be gained by combining FDA’s and USDA’s pesticide-residue-monitoring programs for fruits and vegetables. This action would have been consistent with FDA’s and USDA’s plans under the 1999 food safety initiative to combine their systems for monitoring the microbial contamination of fruits and vegetables. However, FDA’s letter expressed concerns about whether the proposed combined microbial contamination monitoring program would satisfy its monitoring needs and has similar concerns about combined pesticide residue monitoring. In view of these concerns, as well as similar concerns expressed in EPA’s letter (see app. V), we eliminated the discussion of this particular example. However, we did not change the report’s overall observation concerning the food safety initiative’s failure to address fundamental fragmentation problems. The following are GAO’s comments on USDA’s letter dated July 7, 1998. 1. We do not believe that we have seriously mischaracterized descriptions of the Food Safety and Inspection Service’s programs and activities. USDA’s specific comments in this regard and our responses are addressed below. (See comments 2, 3, 4, and 5.) 2. We revised the language to more clearly explain that the law requires carcass-by-carcass inspections but does not specify who should conduct the inspections nor how the inspection should be performed. However, USDA has historically fulfilled this mandate through organoleptic inspections, which are accurately described in this report. Our point remains that the inspections are not risk based and, therefore, resources used for them could be used more effectively in other areas of the federal food safety system. 3. We agree that organoleptic inspections do not solely ensure product quality. In fact, in the draft report, we noted that these inspections provide some measure of safety. However, we continue to believe that they primarily are meant to ensure product quality rather than detect the most serious food safety risk—microbial contamination. Furthermore, experts have increasingly questioned the public health benefits of these inspections. For example, an October 1993 conference of the World Congress on Meat and Poultry Inspection, an international association of government regulators from meat-trading countries, concluded that post-mortem carcass-by-carcass organoleptic inspection must be changed because (1) it wastes resources and cannot detect microbial pathogens, (2) the animal diseases for which it was originally designed have been eradicated in many countries, and (3) it results in unnecessary cross-contamination because the hands-on inspection techniques used virtually ensure that contamination spreads from one carcass to another. 4. We recognize that a statute mandating the frequency of processing plant inspections does not exist and have clarified the report language accordingly. However, the fact remains that FSIS continues to conduct these inspections on a daily basis. The frequency of these inspections is not risk based and therefore, in our view, may not be an efficient use of federal food safety resources. 5. Our use of the word simple was to illustrate the range of processing operations from simple cutting and packing operations through grinding to more complex operations, such as canning and the preparation of ready-to-eat products. We were not describing risks associated with any particular aspect of meat-processing operations. We revised the language of the report to avoid any misinterpretation. 6. The report does not assert that resources should be transferred from FSIS. Instead, the report identifies examples of food safety resources that could be used more effectively if they were redirected to other food safety activities. As we point out in the report, these activities may be within or outside of FSIS’ area of responsibility. Furthermore, as USDA correctly points out, we did not conduct comparative risk assessments for prioritizing which other food safety activities could be carried out if the resources were redirected. Instead, we present a list of possible activities where food safety resources could be more effectively used, recognizing that food safety officials may have other priorities. 7. The report does not claim that funds appropriated to FSIS could be more effectively used if redirected from the agency. (See comment 6.) 8. While APHIS, AMS, and GIPSA have no regulatory responsibilities for food safety, they do perform food safety activities and provide the food safety regulatory agencies with information. For example, AMS conducts sanitation inspections when doing grading activities. When AMS identifies problems, it notifies the appropriate food safety regulatory agencies. 9. We included this more detailed description of GIPSA’s food safety activities in appendix I. Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are Inconsistent and Unreliable (GAO/RCED-98-103, Apr. 30, 1998). Food Safety: Fundamental Changes Needed to Improve Food Safety (GAO/RCED-97-249R, Sept. 9, 1997). Food-Related Services: Opportunities Exist to Recover Costs by Charging Beneficiaries (GAO/RCED-97-57, Mar. 20, 1997). Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96, May 8, 1996). Food Safety: New Initiatives Would Fundamentally Alter the Existing System (GAO/RCED-96-81, Mar. 27, 1996). Meat and Poultry Inspection: Impact of USDA’s Food Safety Proposal on State Agencies and Small Plants (GAO/RCED-95-228, June 30, 1995). Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat and Poultry (GAO/RCED-94-110, May 19, 1994). Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992). Food Safety and Quality: Who Does What in the Federal Government (GAO/RCED-91-19B, Dec. 21, 1990). Food Safety and Quality: Who Does What in the Federal Government (GAO/RCED-91-19A, Dec. 21, 1990). Food Safety: Reducing the Threat of Foodborne Illnesses (GAO/T-RCED-96-185, May 23, 1996). Food Safety: A Unified, Risk-Based Food Safety System Needed (GAO/T-RCED-94-223, May 25, 1994). Food Safety: A Unified, Risk-Based System Needed to Enhance Food Safety (GAO/T-RCED-94-71, Nov. 4, 1993). 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. 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Summary: Pursuant to a congressional request, GAO: (1) analyzed the federal food safety agencies' budgets for fiscal year 1999 to determine whether the appropriated funds of more than $1 billion can be spent more effectively; and (2) provided its views on whether the food safety initiatives for fiscal years 1998-1999 will address underlying problems in the federal food safety system. GAO noted that: (1) more than one-fourth of the over $1-billion federal budget for food safety--about $271 million--could be used more effectively if most of these funds were congressionally redirected from the Food Safety and Inspection Service's organoleptic carcass-by-carcass slaughter inspections to a number of the other food safety activities that need attention; (2) funds currently used for organoleptic, carcass-by-carcass slaughter inspections do not optimize federal resources because these inspections do not detect the most serious public health threat associated with meat and poultry--microbial contamination; (3) instead, these inspections mostly assure the quality of food and therefore benefit the industry more than they ensure food safety for consumers; (4) the $271 million could be used, for example, by the Food Safety and Inspection Service to help the smallest slaughter and processing plants with the cost of installing new science- and risk-based inspection systems; (5) since industry will bear most of the installation cost and the smallest plants operate at a smaller volume over which to spread this cost, these plants will be disproportionately affected by the cost of the new inspection systems; (6) in addition to the funds that could be made available from the revisions to the carcass-by-carcass slaughter inspections, some funds used for daily inspections of meat- and poultry-processing plants could be congressionally redirected to other needs; (7) for example, inspections could be based on the risks at other food plants, such as cereal manufacturers; (8) if the frequency of these inspections were based on the health risk posed rather than on the Food Safety and Inspection Service's practice of conducting processing plant inspections on a daily basis, these inspections would be more effective; (9) the food safety initiatives have made some improvements to the federal food safety system, but they have not comprehensively addressed the underlying problem of the fragmented nature of this system; (10) in fact, while the initiatives provided funding for specific food safety efforts, the initiatives' effective implementation may be impeded by the system's fragmentation; and (11) for example, progress in carrying out the initiative's objective of consolidating seafood inspection activities under one agency has been impeded by the slow progress of the Food and Drug Administration and the Department of Commerce in developing legislation for congressional consideration.