Food Safety: Overview of Federal and State Expenditures
Published: 2001-02-20T00:00:00

Fast Facts:

Highlights:
section_title: What GAO Found
paragraphs: The Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS), and the state agriculture and health departments spent about $1.3 billion in fiscal year 1999. FSIS and FDA spent about $1 billion, and the states reported spending about $300 million. The amounts and proportions of food safety expenditures for fiscal year 1998 were similar. Regarding the $1 billion in federal funds spent in fiscal year 1999, FSIS spent about 70 percent, overseeing about 20 percent of federally regulated foods; FDA spent about 30 percent, overseeing about 80 percent of federally regulated foods. These outlays reflect the regulatory approaches or inspection frequencies contained in the laws under which each agency operates.

section_title: Letter
paragraphs: Foodborne illness in the United States is an extensive and expensive problem. The Centers for Disease Control and Prevention (CDC) estimates that unsafe foods cause as many as 76 million illnesses annually. The U.S. Department of Agriculture (USDA) estimates that the costs associated with foodborne illness due to seven pathogens, including salmonella, campylobacter, and E. coli O157:H7, range up to $37 billion annually. Federal and state expenditures for activities to help ensure the safety of the nation’s food supply are also significant, with federal efforts alone exceeding $1 billion annually. While there are 12 federal agencies with food safety responsibilities, USDA’s Food Safety and Inspection Service (FSIS) and the Department of Health and Human Service’s (HHS) Food and Drug Administration (FDA) are the primary federal regulatory agencies responsible for food safety. FSIS is responsible for ensuring that meat, poultry, and processed egg products moving in interstate and foreign commerce are safe, wholesome, and marked, labeled, and packaged correctly. FDA is responsible for ensuring that (1) all foods moving in interstate and foreign commerce, except those under FSIS’ jurisdiction, are safe, wholesome, and labeled properly; and (2) all animal drugs and feeds are safe, properly labeled, and produce no human health hazards when used in food-producing animals. In addition, state agencies conduct inspection and regulation activities that help ensure the safety of foods produced, processed, or sold within their borders.
To obtain a better understanding of federal and state food safety efforts, you asked us to determine for fiscal years 1998 and 1999 the amount of resources that were expended by FSIS, FDA, and the states for food safety and how the agencies used these resources.
To make this determination for FSIS and FDA, we analyzed their annual appropriations and financial documentation, which included information on actual food safety expenditures, activities and accomplishments. For food safety activities, we obtained and reviewed the associated costs and staff year levels and supplemented this information with agency programmatic documents and discussions we had with agency officials.
To determine the amounts that states expended on food safety and how they used the resources, we surveyed the agriculture and health departments of all 50 states, 3 territories, the commonwealths of Puerto Rico and North Mariana Islands, the Federated States of Micronesia, and the District of Columbia. The survey asked respondents for information on the scope of food safety activities their departments performed, the costs and staffing levels of those activities, and the scope and frequency of inspection activities. We analyzed these data to determine the extent of state food safety activities and expenditures nationwide. The survey was limited to state agriculture and health departments and did not include other state agencies or county and city agencies. Appendix I provides details on our scope and methodology.
subsections: section_title: Background
paragraphs: 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.
section_title: FSIS, FDA, and State Agency Food Safety Expenditures Total Nearly $1.3 Billion
paragraphs: 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.
subsections: section_title: FSIS’ Field Inspection Activities Account for Most of the Agency’s Food Safety Expenditures
paragraphs: 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. The acts also require FSIS inspectors to monitor processing plant operations, such as deboning and canning, to ensure that plants are sanitary and adhere to approved procedures and label specifications. The acts do not explicitly set inspection frequencies for meat- and poultry-processing plants; however, FSIS has interpreted the acts as requiring the daily inspection of such plants and has established its regulations accordingly. That is, an FSIS inspector must visit each meat- and poultry-processing plant for an unspecified period of time—which may be as little as an hour—each operating day. As such, the majority of FSIS expenditures are directed to conducting inspection activities based on frequencies derived from the regulatory acts, rather than on the food safety risk of a specific plant or process.
In 1998, we reported that FSIS’ funds could be used more effectively if they were redirected using risk-based criteria. Specifically, the approximate $296 million in fiscal year 1999 expenditures 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. Rather, some of these funds and funds used for daily inspections of meat- and poultry-processing plants could be used, for example, to increase testing for microbial and other types of contamination, risk assessment, and scientific research, or could be congressionally redirected to other food plants, such as seafood processors, based on the health risk posed. We continue to hold this view.
section_title: FDA’s Food Safety Expenditures Are More Closely Divided Between Field Inspection and Headquarters Activities
paragraphs: FDA expended $253 million in fiscal year 1998 and $283 million in fiscal year 1999 on food safety activities. These activities represent the combined efforts of FDA’s three centers with food safety responsibilities: the Center for Food Safety and Applied Nutrition, the Center for Veterinary Medicine, and the National Center for Toxicological Research, as well as the field activities conducted by the Office of Regulatory Affairs in support of the centers. As with FSIS, FDA’s food safety activities can be separated into two major elements: (1) inspection and enforcement operations conducted in the field by district offices or at headquarters in direct support of those district offices, and (2) operations conducted primarily in headquarters offices. As shown in figure 3, about 56 percent of FDA’s fiscal year 1999 food safety expenditures were for field activities and about 44 percent were for headquarters-based activities of FDA’s centers. Appendix III provides detailed information on FDA’s fiscal years 1998 and 1999 activities, expenditures, and staff years.
In aggregate, FDA’s field activities accounted for about $159 million in fiscal year 1999, or about 56 percent of the agency’s total food safety expenditures. The Office of Regulatory Affairs (ORA) is responsible for conducting field activities designated by the centers. ORA’s compliance, inspection, and laboratory field staff manage, supervise, and conduct enforcement, compliance, inspection, sample collection and analysis activities, as well as criminal investigation, education, and outreach activities. Specifically:   The ORA-conducted field activities in support of the Center for Food Safety and Applied Nutrition accounted for about $145 million in expenditures for fiscal year 1999. Using these funds, FDA conducted over 14,600 domestic food establishment inspections, including those conducted by states under contract with FDA, at a cost of about $2 million; and about 765 inspections of food importers. About $27 million, or 19 percent, of the $145 million went to domestic and imported seafood hazard analysis and critical control point inspection activities. Also included in these total expenditures is more than $40 million for laboratory analysis of about 25,000 domestic and foreign product samples associated with field inspection activities.
The ORA-conducted field activities in support of the Center for Veterinary Medicine accounted for about $13.5 million in expenditures in fiscal year 1999. With these funds, FDA conducted nearly 3,500 domestic animal drug and feed establishment inspections, including those conducted by states under contract with FDA at a cost of about $600,000. Also included in these expenditures is about $2 million for laboratory analysis of about 1,800 feed samples associated with field inspection activities.
In aggregate, the headquarters-based activities of FDA’s centers accounted for about $125 million in fiscal year 1999, or 44 percent of the agency’s total food safety expenditures. Specifically:   The Center for Food Safety and Applied Nutrition’s activities accounted for about $96 million in fiscal year 1999, or 34 percent of total agency food safety expenditures. The center operates FDA’s Foods Program, which is responsible for ensuring that FDA-regulated food is safe, sanitary, wholesome, and labeled properly. To attain this goal, the center implements programs that address specific food safety concerns; premarket review of food and color additives, infant formula and medical foods accounted for about $10 million in expenditures, and postmarket monitoring and response activities accounted for about $17 million in expenditures, and cross-cutting activities that address both premarket and postmarket concerns, such as regulatory policy development and education and outreach activities, accounted for about $61 million in expenditures. Food safety research and risk assessment accounted for about $32 million, or about half of cross-cutting activity expenditures.
The Center for Veterinary Medicine’s activities accounted for about $28 million in fiscal year 1999, or 10 percent, of total agency food safety expenditures. The center operates FDA’s Animal Drugs and Feeds Program, which has primary goals of ensuring that only safe and effective animal drugs, feeds, and feed additives are marketed and that foods from animals that are administered drugs and food additives are safe for human consumption. The center maintains surveillance over all animal drugs and feeds to minimize threats to human health. Premarket application review for new animal drugs accounted for the center’s largest expenditures, about $12.8 million in fiscal year 1999. In the same year, FDA reviewed 36 original new animal drug applications, approving 17, and reviewed 767 supplemental applications to change the conditions of existing approvals, approving 421.
The National Center for Toxicological Research located in Jefferson, Arkansas, accounted for nearly $1.5 million in fiscal year 1999, or about 1 percent of total agency expenditures. The center’s mission is to conduct peer-reviewed scientific research that provides the basis for FDA to make sound, science-based regulatory decisions and to protect the public health through pre- and post-market surveillance. During fiscal year 1999, the center conducted 10 research projects that contributed to FDA’s food safety mission; due to the center’s research focus, it did not engage in field activities related to food safety.
FDA’s relatively small proportion of expenditures on field inspection and supporting activities in comparison to FSIS’ expenditures for those activities reflects the absence of specified inspection frequencies in the Federal Food, Drug and Cosmetics Act. The act, which FDA has primary responsibility for administering, generally follows the regulatory approach of allowing almost all food products to enter the market without preapproval by federal agencies. Therefore, FDA is not required to inspect foods or food firms on a given schedule. As a result, FDA inspects the more than 57,000 food establishments under its jurisdiction about once every 5 years, on average, and according to FDA officials, inspected less than 1 percent of the 3.7 million imported food entries in fiscal year 1999.
section_title: States Report Expenditures of About $300 Million Annually for Food Safety
paragraphs: State agriculture and health departments reported expenditures of about $292 million in fiscal year 1998 and $301 million in fiscal year 1999. As shown in figure 4, nearly half of the expenditures reported by state agencies, or about $144 million in fiscal year 1999, were for inspection and licensing activities. Appendix IV provides detailed information on the state agencies’ fiscal years 1998 and 1999 expenditures and staff years for food safety activities.
State agriculture and health departments reported food safety expenditures in six categories: licensing and inspection, response to food safety problems, laboratory analysis, technical assistance and training, administration and support, and other expenditures. Specifically, for fiscal year 1999:   Licensing and inspection activities for a wide variety of establishments, including meat and poultry slaughter and processing plants, fish and seafood plants, shellfish operations, dairy product and egg product plants, as well as groceries, restaurants, and institutions, accounted for about $144 million, or about 48 percent, of state expenditures.
Laboratory analysis activities, including analysis for microbial contamination, pesticides and other chemical residues, filth and/or sanitation, and food label accuracy, accounted for about $34 million, or about 11 percent, of state expenditures.
Administration and support for food safety activities accounted for about $33 million, or about 11 percent, of state expenditures.
Technical assistance and training activities for a wide variety of recipients, including farmers, producers, processors, consumers, department staff, and the staff of outside departments, accounted for about $18 million, or about 6 percent, of state expenditures.
Response to food safety problems, including investigation of outbreaks, recall activities, natural disasters, and regulatory enforcement activities, accounted for about $16 million, or about 5 percent, of state expenditures.
Other activities that did not fit into the above categories, such as committee or council activities, computer or equipment purchases, and database development, accounted for about $5 million, or about 2 percent, of state expenditures.
State agriculture and health departments reported in aggregate over 1 million establishments under their collective inspection jurisdictions and about 2 million inspections conducted each year, not counting continuous inspections at meat and poultry slaughter plants and other establishments. Groceries, other retail outlets, and restaurants were by far the largest proportion of establishments under state inspection jurisdiction, representing more than 60 percent of all establishments under state jurisdiction. Dairy farms were the next largest group of establishments under state inspection jurisdiction, representing almost 10 percent of the establishments.
While state agriculture and health departments are generally charged with primary food safety responsibilities, a wide variety of other state and local agencies that were not included in our survey also have food safety responsibilities and associated expenditures. About half of the state departments of agriculture and health that we surveyed reported that other state departments or agencies had a role in ensuring food safety, but often only at a specific type of establishment or for a specific food product. States also reported that local governments are involved in conducting food safety inspections at some types of establishments, such as groceries and other retail outlets, restaurants, and at institutions, but are less involved in conducting laboratory analysis, responding to food safety problems, or providing technical assistance and training.
section_title: Agency Comments and Our Response
paragraphs: We provided FSIS and FDA with a draft of this report for review and comment. FSIS generally agreed with the information provided but said that the report should clearly state that FSIS’ responsibilities and expenditures also involve some nonfood safety activities, such as ensuring that products meet consumer expectations for wholesomeness and quality. We believe that the report clearly identifies FSIS’ responsibilities—i.e., ensuring that meat, poultry, and processed egg products moving in interstate and foreign commerce are safe, wholesome, and marked, labeled, and packaged correctly. Regarding nonfood safety expenditures, throughout our review, FSIS officials said that the expenditure information provided to us was for food safety or food safety- related activities. As such, we believe that the FSIS expenditures in this report are appropriately characterized as “food safety” expenditures.
FSIS also said that it would be useful if we included the size and scope of the products it regulates. We believe the report adequately describes the size and scope of FSIS’ activities. For example, the report includes information on the number of meat, poultry, egg product, and import establishments FSIS oversees; the number of state and foreign programs it reviewed; and the number and type of inspections it conducted. The level of detail provided on FSIS’ responsibilities and activities is similar to that provided on FDA’s activities.
FSIS also said that the statistics provided in the report regarding the relative proportions of food purchases and agency food safety expenditures were misleading due to the high risk of FSIS-regulated products compared with some of the FDA-regulated products. While the relative risk of FSIS-regulated products may be greater in some cases than FDA-regulated products, it was not our intent to analyze or compare the risk of products. We believe that the data accurately reflect the proportion of each agency’s expenditures and the proportion of consumer expenditures for foods under each agency’s jurisdiction. The report also clearly identifies the food products for which each agency has responsibility.
Finally, FSIS said that the report should further define its responsibilities under the Federal Meat Inspection Act and Poultry Products Inspection Act. FSIS also described court actions related to its efforts to design new inspection models that would realign roles and responsibilities of industry and federal inspectors. We modified the report to clearly identify FSIS’ responsibilities under the federal meat and poultry inspection acts and described its efforts, with guidance from the courts, to realign the responsibilities and roles of industry and federal inspectors.
FDA agreed with the report and said that it contained valuable information on the allocation of food safety resources. FDA applauded the report for including important information on the efforts and resources expended by states but believed that the report was incomplete because it did not include information on the expenditures and efforts of other agencies, such as USDA’s Agricultural Research Service and Animal and Plant Health Inspection Service. We have previously reported on the resources and staffing of the 12 federal agencies involved in food safety activities. By design, the scope of this report was limited to FSIS and FDA food safety activities and expenditures.
FSIS and FDA also provided technical clarifications, which we incorporated into the report as appropriate. FSIS’ comments and our responses are included in appendix VI; FDA’s comments and our responses are included in appendix VII.
We conducted our review from March through December 2000 in accordance with generally accepted government auditing standards.
As agreed with your offices, unless you publicly announce its contents earlier, we plan no further distribution of this report until 30 days from its issue date. At that time, we will send copies of this report to the Honorable Ann Veneman, Secretary of Agriculture; the Honorable Bernard Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner of the Food and Drug Administration; the Honorable Mitchell Daniels, Jr., Director, Office of Management and Budget; and other interested parties. We will also make copies available to others upon request.
If you have any questions about this report, please contact me at  (202) 512-3841. Major contributors to this report are listed in appendix VIII.
section_title: Appendix I: Objectives, Scope, and Methodology
paragraphs: To determine for fiscal years 1998 and 1999 the amount of resources that were expended by the Food Safety and Inspection Service (FSIS), the Food and Drug Administration (FDA), and the states for food safety and how the agencies actually used these resources, we conducted work at each of the federal agencies and mailed surveys to food safety agencies in 50 states, 3 territories, the Commonwealths of Puerto Rico and the North Mariana Islands, the Federated States of Micronesia, and the District of Columbia (hereafter referred to as states unless specified otherwise). Regarding FSIS and FDA, we obtained appropriations documentation showing the amount of funding provided to each agency. We collected records of expenditures and staff years for specific activities from each of the agencies as follows:   FSIS provided expenditure and full-time equivalent staff-year information from its accounting system for each of its headquarters and field offices for specific food safety activities within those offices, such as inspection, education, and laboratory activities. FSIS could not provide expenditure information from its accounting system for approximately 2 weeks at the end of fiscal year 1999 because of problems created by the implementation of a new accounting system. Instead, FSIS determined the allocation of expenditures for that time period based on other expenditure records. The Office of Inspector General could not give an opinion on the U.S. Department of Agriculture’s (USDA) financial statements for fiscal years 1998 and 1999 because of weaknesses in evidence and internal controls.We did not verify FSIS’ accounting information, as it was the only information available, and such an audit was outside of the scope of our review.
FDA provided records of expenditures and staff years from the agency’s Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), National Center for Toxicological Research (NCTR), and Office of Regulatory Affairs (ORA). Each center used its own methodology to identify and provide expenditures and staff years for specific food safety activities, using a combination of accounting system information, staff activity time records, and estimations. FDA’s Office of Financial Management reviewed the information provided by the centers for accuracy and consistency and also provided us with the share of FDA central administrative costs allocable to each center. We did not verify FDA’s accounting information; we relied on an independent auditor’s finding that FDA’s accounting records fairly reported its financial position and had no internal control weaknesses in fiscal years 1998 and 1999.
At each agency, we gathered documentation and interviewed agency officials to (1) obtain additional information on the specific activities funded by the expenditures and accomplishments associated with those activities and (2) discuss the expenditure and staff-year information they provided. We also collected documentation and the transfer of funds between food safety and nonfood safety activities at each agency and discussed other financial concerns, such as FSIS’ fiscal years 1997 and 1998 anti-deficiency violations caused by the over-obligation of as much as $4 million each year.
To determine the amounts that states expended on food safety and how they actually used the resources, we surveyed the agriculture and health departments of 50 states, 3 territories, Puerto Rico, and the District of Columbia; we surveyed the health departments of the Commonwealth of the North Mariana Islands and the Federated States of Micronesia, which do not have agriculture departments. In total, we sent out 112 surveys. The survey requested information on the scope of food safety activities performed by their departments, the costs and staffing levels of those activities, the scope and frequency of inspection activities, how the states allocated expenditures between various activities, and perceptions regarding the extent of local government involvement in food safety activities. In developing the survey, we coordinated with staff from FDA’s Office of Regulatory Affairs, Division of Federal/State Relations, which is also surveying the states.
We pretested the survey at seven food safety departments in four states—Colorado, Louisiana, Pennsylvania and Virginia—to ensure that our questions were clear, unbiased, and precise and that responding to the survey did not place an undue burden on their agencies. We did not independently verify the accuracy of the state officials’ responses. We also reviewed each response to identify internal data inconsistencies and other issues needing clarification, called respondents to resolve questions, and made agreed-upon changes to their responses as appropriate. We received surveys from 98 of the 100 state health and agriculture departments; 6 of the 10 food safety agencies in the territories and other entities; and both the health and agriculture departments in the District of Columbia. Our overall response rate was 95 percent.
In completing the survey, we asked the states to obtain information from staff who are most knowledgeable about food safety activities, that they respond only for their department’s activities, and that they submit only one survey reflecting the entire department’s activities. Regarding expenditures, we asked that states report actual expenditures for each state fiscal year, but if these were not available, to report budget allocations and to inform us which of the two data types they provided to us. Of the responding agencies, 37 reported actual expenditures, 9 reported actual budget allocations, and 55 reported estimates. The majority of the respondents did not report all indirect costs for food safety activities or in-kind contributions, although some did.
We recognize that the total funding amounts reported for food safety activities, as well as the amounts reported for specific categories of activities, could be under- or over-reported because of differences in state department reporting, budgeting, and accounting practices. In some cases, states did not report expenditures, staff years, or establishments by the individual categories provided in the survey; rather, they may have pooled categories together or reported only a total amount. These amounts are reported as “uncategorized.” A few state departments sent in several individual responses from various entities, which we consolidated into a single departmental response. Some states provided a response for only one of the two departments. The reported expenditures do not reflect the full cost of food safety activities within each state, because expenditures and activities of other state agencies, local agencies, and private industry, by design, are not included in our scope. However, we believe the information presented in the report reasonably and conservatively represents the food safety activities and expenditures of the survey respondents. Appendix V contains the survey results.
We performed our work from March through December 2000 in accordance with generally accepted government auditing standards.
section_title: Appendix II: The Food Safety and Inspection Service’s Fiscal Years 1998 and 1999 Food Safety Expenditures
paragraphs: USDA’s 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 labeled and packaged correctly. The food safety activities undertaken by FSIS to attain these goals during fiscal years 1998 and 1999, the costs and staff years associated with each activity, and outcomes associated with selected activities are presented in the following sections.
subsections: section_title: Mission, Organization, and Funding
paragraphs: FSIS accomplishes its mission to ensure that the nation’s meat, poultry, and egg products moving interstate and into foreign commerce are safe, wholesome, and labeled and packaged correctly through five program offices located in Washington, D.C. The offices include the Office of the Administrator; Office of Public Health and Science; Office of Policy, Program Development and Evaluation; Office of Field Operations (headquarters and district offices); and Office of Management. In addition, FSIS operates a Technical Service Center in Omaha, Nebraska; three field laboratories located in Alameda, California; St. Louis, Missouri, and Athens, Georgia; and 17 district offices located throughout the United States.
FSIS’ food safety activities are funded through annual congressional appropriations, industry reimbursements, and trust funds for meat and poultry inspection. In fiscal years 1998 and 1999, funds available to FSIS totaled about $678 million and $714 million, respectively.
section_title: Food Safety Activities, Expenditures, and Staffing
paragraphs: For fiscal years 1998 and 1999, FSIS expended about $678 million and $712 million, respectively, for its food safety activities. As shown in table 1, about 84 percent of the expenditures were for the Office of Field Operations to conduct headquarters and district office food safety activities. The other four offices accounted for about 16 percent of expenditures in aggregate.
subsections: section_title: Office of Field Operations
paragraphs: The Office of Field Operations is responsible for managing a program of regulatory oversight and inspection for the meat, poultry, and egg product laws enforced by FSIS. As such, the office was responsible for the largest proportion of agency expenditures—$568 million and $600 million in fiscal years 1998 and 1999, respectively, or about 84 percent of agency expenditures and over 90 percent of staff years. The office is divided into two components—headquarters operations and field district operations. The headquarters unit located in Washington, D.C., sets policy and manages field operations. As shown in table 2, the headquarters unit accounted for about $69 million and $79 million in fiscal years 1998 and 1999, respectively, or about 10 percent of total FSIS expenditures. Included within this unit is the Technical Service Center, which serves as the agency’s center for technical assistance and guidance for field operations personnel and industry. The center also reviews domestic and foreign inspection programs.
Three activities—grants provided to states, the Field Automation and Information Management initiative, and reviews conducted by the Technical Service Center—accounted for $70 million, or about 88 percent, of the total office expenditures in fiscal year 1999.
Grants to states accounted for almost 60 percent of total office expenditures. Most of the grants, about $40 million, funded up to 50 percent of state costs to operate inspection programs for meat and poultry plants that are “equivalent to” federal programs. In fiscal year 1999, 26 states received funding through grants.
The Field Automation and Information Management initiative accounted for about 17 percent of the Office of Field Operations headquarters expenditures for fiscal year 1999. This initiative provides for uniform automation of FSIS’ inspection functions at plants inspected by FSIS and state inspectors. Expenditures were for the purchase and installation of the equipment, as well as training inspectors. For example, during fiscal year 1999, over 750 federal inspectors were trained and 700 computers delivered to FSIS field locations. In addition, over 550 state inspectors were trained, and states received over 500 computers.
The Technical Service Center conducted review activities that accounted for about 12 percent of field operation’s headquarters expenditures for fiscal year 1999. The center is responsible for designing and implementing guidelines and procedures for review of foreign, state, and federal domestic inspection programs. The center also conducts special inquiries and reviews, such as reviews of state inspection programs, to ensure they are equivalent to the federal programs. In fiscal year 1999, the center reviewed the program documentation of 36 countries exporting to the United States to determine if they had implemented Hazard Analysis and Critical Control Point systems and Salmonella testing programs equivalent to U.S. requirements. In that same year, the center’s review staff reviewed 96 state-inspected establishments in 11 states to determine their effectiveness and whether or not they were equivalent to the federal inspection programs.
The Office of Field Operation’s field district offices conduct compliance and inspection activities for meat, poultry, and egg products. As shown in table 3, the field district offices accounted for expenditures of about $499 million and $520 million in fiscal years 1998 and 1999, respectively, or about 73 percent, of agency expenditures and about 90 percent of staff years. Within the district offices, 93 percent of their expenditures were for in-plant inspections and 7 percent for the administration of those activities and compliance activities.
Under the guidance and direction of the Office of Field Operation’s headquarters District Inspection and District Enforcement offices, the districts manage and direct both inspection and compliance activities. As shown in table 4, the district offices direct inspections of meat and poultry slaughter plants, processing plants, and plants that have combined slaughter and processing operations, and other establishments such as egg product plants. In addition, the offices inspect these products at import points. For example, in fiscal year 1999, they inspected over 99 billion pounds of meat and poultry and 3 billion pounds of egg products at about 6,000 domestic plants and inspected 3.2 billion pounds of imported meat and poultry from 34 countries. The district offices also direct compliance reviews that are designed to (1) monitor businesses engaged in the production, distribution, and marketing of food products and (2) prevent the violation of laws and regulations. As a result of these reviews, in fiscal year 1999, the district offices detained approximately 20 million pounds of adulterated meat and poultry products and initiated 118 enforcement actions to stop inspection operations in federally inspected plants.
section_title: Office of Management
paragraphs: The Office of Management is responsible for providing centralized administrative and support services to all other FSIS program offices, including human resource management, strategic planning, procurement, and financial management. As shown in table 5, the office accounted for expenditures of about $63 million and $62 million in fiscal years 1998 and 1999, respectively, or about 9 percent, of agency expenditures and 4 percent of staff years. About 46 percent of the office’s expenditures were for “central charges” attributed to the entire agency. Almost one-half of these charges were expenditures for benefits such as worker’s compensation and unemployment. Other charges included “other services” such as contractual and consulting services, communications, utilities, and rent.
section_title: Office of Public Health and Science
paragraphs: The Office of Public Health and Science is responsible for conducting scientific analysis, providing advice, collecting 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, response to food safety emergencies, and laboratory analysis by the agency’s three field laboratories. As shown in table 6, the office accounted for expenditures of about $24 million and $25 million in fiscal years 1998 and 1999, respectively, or about 4 percent, of agency expenditures and 2 to 3 percent of staff years.
The combined expenditures for the three field laboratories and the Office of Public Health and Science’s Office of Deputy accounted for 77 percent of all expenditures for that program office in fiscal year 1999.
Three field laboratories located in Alameda, California; Athens, Georgia; and St. Louis, Missouri, accounted for more than 50 percent of the office expenditures and almost 70 percent of the staff years. These laboratories coordinate and conduct analyses in microbiology, chemistry, and pathology for food safety in meat, poultry, and egg products. Among other things, they conduct these services to (1) support both domestic and import inspections done by FSIS, (2) support the agency’s Hazard Analysis and Critical Control Point initiative, and (3) identify emerging pathogens in the food supply. In addition, the laboratories provide technical assistance to FSIS field staff.
The Office of Deputy accounted for about 22 percent of office expenditures, with the majority of these being for charges attributed specifically to the Office of Public Health and Science. Most of these charges are for “other services” such as facilities renovations, equipment, or payments to other agencies for studies. For example, in fiscal year 1999, the Office of Deputy expended $1.2 million to repair its Eastern Laboratory in Athens, Georgia, and provided the Centers for Disease Control and Prevention (CDC) with $1.5 million for Food Net surveys.
section_title: Office of Policy, Program Development and Evaluation
paragraphs: The Office of Policy, Program Development and Evaluation is responsible for, among other things, coordinating activities such as developing and recommending domestic and international policies for FSIS; reviewing product processes, standards, and labeling; and developing and evaluating inspection programs. As shown in table 7, the office accounted for expenditures of about $18 million and $19 million in fiscal years 1998 and 1999, respectively, or about 3 percent, of agency expenditures and 1 percent of staff years.
The combined expenditures of two offices in the Office of Policy, Program Development and Evaluation—the Inspection Development Division and the Office of Deputy— accounted for over 40 percent of all expenditures for that office in fiscal year 1999.
The Inspection Systems Development Division designs, develops, and tests new or modified inspection systems for food safety. This division works on developing specific changes to FSIS’ inspection procedures, including work related to hazard analysis and critical control point procedures. For example, this division has contracted for the collection of microbiological and organoleptic data in poultry and hog plants to support the proposed Hazard Analysis and Critical Control Point-based Inspection Models Project.
The Office of Deputy accounted for about 20 percent of total office expenditures. Other than personnel expenditures, the majority of these were for “centrally administered” charges. According to FSIS officials, these are charges associated with the entire Office of Policy, Program Development and Evaluation office, rather than a specific division within that office. Most of these charges are for “other services,” such as production of food safety educational materials.
section_title: Office of the Administrator
paragraphs: The Office of the Administrator is responsible for overall management of the agency and activities such as public affairs, food safety education, and coordination of U.S. involvement in international standard setting for food safety and maintaining liaisons with trade organizations. As shown in table 8, the office accounted for expenditures of about $5 million and $6 million in fiscal years 1998 and 1999, respectively, or about 1 percent of agency expenditures and 1 percent of staff years.
A significant portion of the Office of the Administrator’s funding, about 30 percent in fiscal year 1999, was expended on food safety education. The functions of the Food Safety Education staff are different from other units in the office because, while others primarily conduct management and policy type activities, the food safety education staff provides FSIS food safety education programs to the public. These programs are designed to educate producers, distributors, food preparers, and consumers on the prevention of foodborne illnesses. This office also operates the agency’s Meat and Poultry Hotline to answer consumer inquiries. In fiscal year 1999, this staff coordinated the agency’s food safety education campaign, FightBAC! tm, and handled about 36,000 consumer calls to the hotline.
section_title: Appendix III: The Food and Drug Administration’s Fiscal Year 1998 and 1999 Food Safety Expenditures
paragraphs: Food safety is one of the Health and Human Service’s (HHS) Food and Drug Administration’s (FDA) many responsibilities, shared by multiple units within the agency. FDA food safety activities undertaken by each unit during fiscal years 1998 and 1999, the costs and staff years associated with each activity, and outcomes associated with selected activities are presented in the following sections.
subsections: section_title: Mission, Organization, and Funding
paragraphs: FDA accomplishes its mission of protecting the public health by 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 through six centers. Three of these centers are responsible for food safety activities: the Center for Food Safety and Applied Nutrition (CFSAN) for the Foods Program; the Center for Veterinary Medicine (CVM) for the Animal Drugs and Feeds Program; and the National Center for Toxicological Research (NCTR) for research into the toxicity of products. In addition, the Office of Regulatory Affairs conducts inspections and compliance reviews and collects and analyzes product samples in support of the centers. The three centers and the Office of Regulatory Affairs are also provided administrative support through numerous offices, such as the Office of the Commissioner and the Office of Management and Systems.
FDA food safety facilities are distributed nationwide. FDA headquarters and CVM are located in Rockville, Maryland, CFSAN is located in Washington, D.C., and NCTR is located in Jefferson, Arkansas. The two Centers, CVM and CFSAN, have a research facility in Beltsville, Maryland; CFSAN has a fishery research center in Dauphin Island, Alabama, and a food technology research center in Chicago, Illinois. Field facilities, primarily staffed by Office of Regulatory Affairs personnel conducting inspections and laboratory activities, are distributed across 5 regional offices, 19 district offices, and 13 laboratories, and are supported by over 120 resident posts.
FDA’s appropriations for fiscal years 1998 and 1999 were about $1.050 billion and $1.130 billion, respectively. Each of FDA’s programs received a specified amount of the total appropriation to conduct both their food safety and nonfood safety-related responsibilities. For example, in fiscal year 1999, the Foods Program received about $235 million, of which about $222 million was expended on CFSAN and related field food safety activities. The difference reflects that while most of the Food Program’s responsibilities relate to food safety, the program also has other responsibilities and related expenditures for other activities, such as cosmetics safety. Similarly, in fiscal year 1999, the Animal Drugs and Feeds Program received about $43 million, of which about $38 million was expended on CVM and related field food safety activities. The difference reflects that while the majority of the Animal Drugs and Feeds Program’s responsibilities relate to food safety, the program also has responsibilities and related expenditures for nonfood animals, such as dogs and cats. The Office of Regulatory Affairs receives a specific amount of the appropriation for each program to conduct field activities in support of the centers.
section_title: FDA Food Safety Activities, Expenditures, and Staffing
paragraphs: For fiscal years 1998 and 1999, as shown in table 9, about 56 percent of FDA’s food safety expenditures and over 60 percent of its staff years were for food safety activities conducted in the field, and the remaining 44 percent of expenditures and nearly 40 percent of the staff years were for the headquarters-based activities of the centers.
subsections: section_title: FDA Field Food Safety Activities for Foods and Animal Drugs and Feeds
paragraphs: Field activity expenditures of about $141 million and $159 million in fiscal years 1998 and 1999, respectively, accounted for about 56 percent of total FDA food safety expenditures each year and 62 to 64 percent of FDA’s staff years. CFSAN is responsible for directing field activities related to food products, and CVM is responsible for field activities related to feeds and drugs for food animals. These field activities, conducted by FDA’s Office of Regulatory Affairs, include the inspection of food and animal feed and drug establishments under the agency’s jurisdiction, field examination of food and feed products, and the collection and analysis of product samples to ensure that the products comply with applicable regulations. The overall results of FDA’s inspection and sample analysis fieldwork are presented in table 10.
Field activities for foods accounted for about $127 million in fiscal year 1998 and $145 million in fiscal year 1999, or about 90 percent of FDA’s food safety field expenditures. Table 11 lists the fiscal years 1998 and 1999 food field expenditures of $1 million or more. FDA food field activities accounting for less than $1 million in annual expenditures each, such as criminal investigations, emergency response to foodborne outbreaks, and various unplanned activities, represented in aggregate less than $8 million in expenditures each year. The expenditures reflect the total cost of each activity, including inspection, investigation, field examination, sample collection, sample analysis, and other costs, such as Office of Regulatory Affairs management and administrative support expenditures, associated with each activity. FDA agencywide support expenditures accounted for about 8 percent of food product field expenditures.
Five of the field activities listed in table 11 accounted for about $71 million, or almost 50 percent, of total food field expenditures in fiscal year 1999.
Imported foods general activities accounted for about $27 million, or about 19 percent, of food field expenditures. The objective of this activity was to ensure that imported foods comply with federal law and with guidelines for gross and microbiological filth. To attain this objective, FDA conducted import field examinations of the foods most likely to be out of compliance, collected samples, and conducted analysis for filth, decomposition, and microbiological contamination.
The domestic fish and fish products inspection activity accounted for about $14 million, or about 10 percent, of food field expenditures. The objective of this activity was to ensure that domestic establishments involved in the production, storage, and distribution of fish and fish products are in compliance with the applicable hazard analysis and critical control point regulations as well as with federal law. To attain this objective, FDA conducted establishment inspections, and samples were collected and analyzed when appropriate, with a priority on firms processing scombrotoxic products, smoked products, vacuum packed products, and ready-to-eat products, as well as follow-up on firms found to be in noncompliance with hazard analysis and critical control point regulations.
The imported seafood products inspection activity accounted for about $13 million, or about 9 percent, of food field expenditures. The objective of this activity was to ensure a safe imported seafood supply by enforcing importer compliance with the seafood hazard analysis and critical control point regulation and federal law, focusing on importers of high-risk products and firms found in noncompliance with the hazard analysis and critical control point regulations. To attain this objective, trained investigators reviewed importers’ written documentation demonstrating that the product was produced under a hazard analysis and critical control point program, with priority assigned to firms processing scombrotoxic products, smoked products, vacuum packed products, and ready-to-eat products.
The domestic food safety activity accounted for about $11 million, or about 7 percent, of food field expenditures. The objective of this activity was to ensure that domestic establishments involved in the production, storage and distribution of food products are in compliance with federal law and that manufacturers produce products under good manufacturing practices. To attain this objective, FDA conducted inspections (including hazard analysis and critical control point) and investigations and necessary sample collections and analyses to document and support inspection findings.
The pesticides and chemicals in imported foods activity accounted for about $7 million, or about 5 percent, of food field expenditures. The objective of this activity was to determine the incidence and level of pesticides and industrial chemicals in imported food (including seafood and aquaculture products) and to prevent importation of products not meeting federal requirements. To attain this objective, FDA developed pesticide import sampling plans, collected samples, and analyzed samples for chemical contamination.
Animal drugs and feeds field activity expenditures of about $13.7 million and $13.5 million in fiscal years 1998 and 1999, respectively, accounted for about 10 percent of FDA’s total food safety field expenditures each year. Table 12 lists the fiscal years 1998 and 1999 animal feed and drug field activity expenditures of $1 million or more. Other field activities, such as criminal investigations, response to consumer complaints, and various unplanned activities in aggregate, accounted for just over $3 million in expenditures each year. The expenditure amounts reflect the total cost of each activity, including inspection, investigation, field examination, sample collection, sample analysis, and other costs, such as Office of Regulatory Affairs management and administrative support expenditures, associated with each activity. FDA agencywide support expenditures accounted for about 8 percent of feed and drug field expenditures.
Five of the field activities listed in table 12 accounted for about $9 million, or almost 70 percent, of total animal drugs and feeds field expenditures in fiscal year 1999.
The feed contaminants activity accounted for about $2.4 million, or about 18 percent, of expenditures. The objective of this activity is to monitor domestic and imported animal feed and feed ingredients to prevent the widespread contamination of the nation’s food supply. To attain this objective, FDA conducts inspections and investigations and collects and analyzes samples of feed and feed ingredients, including chemical and microbiological testing for mycotoxins, pesticides, industrial chemicals, metals, and microbiologicals.
The medicated feeds activity accounted for about $2.1 million, or about 15 percent, of expenditures. The objective of this activity is to ensure the marketing of safe and effective animal feeds. To attain this objective, FDA conducts inspections of registered medicated feed establishments, collects and analyzes feed samples, and audits the results of coordinated state inspection efforts.
The illegal residues in meat and poultry activity accounted for about $1.8 million, or about 13 percent, of expenditures. The objective of this activity is to ensure a safe food supply by conducting follow-up investigations and inspections when illegal residues are reported to FDA by the Food Safety and Inspection Service, and to initiate regulatory sanctions against those persistently causing residues. To attain this objective, FDA works cooperatively via memorandums of understanding with the Food Safety and Inspection Service and the Environmental Protection Agency, as well as through agreements or contracts with states to inspect first-time violators.
The drug processing and new animal drug inspection activity accounted for about $1.6 million, or about 12 percent, of expenditures. The objective of this activity is to fulfill FDA’s obligation to inspect animal drug establishments that are registered with FDA, ensuring that animal drug products are being manufactured, processed, and controlled under approved conditions. To attain this objective, FDA conducts inspections of registered animal drug establishments and chemical and microbiological examinations to ensure the sterility, purity, identity, and potency of the drugs.
Office of Regulatory Affairs/Center directed research projects accounted for about $1.2 million, or about 9 percent, of expenditures. The objective of this activity is to develop new and/or improved methodology in support of regulatory analysis for animal drugs and feeds. To attain this objective, FDA establishes research goals in its workplan; the research results are distributed within FDA and/or published in the scientific literature.
section_title: Center for Food Safety and Applied Nutrition Headquarters Food Safety Activities
paragraphs: CFSAN headquarters operations, which is responsible for FDA’s Foods Program, accounted for expenditures of about $86 million and $96 million in fiscal years 1998 and 1999, respectively, or about 34 percent of total agency food safety expenditures. As shown in table 13, CFSAN’s fiscal years 1998 and 1999 headquarters activities were divided into four major categories: premarket, postmarket, crosscutting, and FDA agencywide support expenditures. CFSAN expenditures for management and administrative support of food safety activities are included in the expenditure amount for each activity.
Premarket activities to evaluate the safety of products before they are available to consumers accounted for about 11 percent of CFSAN’s headquarters expenditures in fiscal year 1999. Food and color additive activity expenditures accounted for about $9 million, or nearly 90 percent, of premarket expenditures. In addition to its ongoing review of food additive petitions, CFSAN implemented procedures to expedite the review of food additives intended to decrease the incidence of foodborne illness through their antimicrobial actions against pathogens that may be present in food. Other activities addressed food contact substances and irradiation labeling.
Postmarket activities to evaluate the safety of products that are in the marketplace accounted for about 18 percent of CFSAN’s headquarters expenditures in fiscal year 1999. CFSAN’s planning and policy implementation for microbial contaminants, which accounted for $6.7 million, or 39 percent, of postmarket expenditures, included surveillance to assess antimicrobial resistance, microbiological research, and risk assessment to develop science-based solutions to detect and control microbial contamination. Another $3.5 million, or 21 percent, of postmarket expenditures, were for cooperative programs with states addressing the safety of retail dairy and shellfish products.
Crosscutting activities that address both premarket and postmarket food safety issues accounted for about 63 percent of CFSAN’s headquarters expenditures in fiscal year 1999. CFSAN’s food safety research and risk assessment, which accounted for $32.3 million, or 53 percent of crosscutting expenditures, included activities such as the completion of draft risk assessments for Listeria, Vibrio parahaemolytics, and methylmercury and food safety research in support of the National Food Safety Initiative.
FDA agencywide support accounted for about 8 percent of CFSAN’s headquarters expenditures in fiscal year 1999. These expenditures represent CFSAN’s allocation for its share of central direction and administrative services to ensure that FDA’s efforts are effectively managed and that resources are put to the most efficient use. Functions include agencywide policy, regulatory and legislative development, scientific coordination, planning and evaluation, consumer communication and public information, and management expertise and coordination in financial management, personnel, contracts and grants administration, and procurement.
section_title: Center for Veterinary Medicine Headquarters Food Safety Activities
paragraphs: CVM headquarters operations, responsible for FDA’s Animal Drugs and Feeds Program, accounted for about $26 million and $28 million in fiscal years 1998 and 1999, respectively, or about 10 percent of total agency food safety expenditures. As shown in table 14, for fiscal years 1998 and 1999, CVM headquarters activities were divided into three major categories: premarket, postmarket, and FDA agencywide support expenditures.CVM expenditures for management and administrative support for food safety activities are included in the total cost for each activity.
Premarket activities to ensure that products are safe before they are available to consumers, accounted for about 46 percent of expenditures each year. CVM’s New Animal Drug Application review and approval process, including associated education, research and risk assessment activities, accounted for $12.8, or 100 percent, of its premarket expenditures. CVM is implementing a phased review process, which will provide drug application sponsors with more timely feedback and early detection of application deficiencies. CVM approved 523 original or supplemental new and generic animal drug applications in fiscal year 1999.
Postmarket activities to ensure the safety of products that are in the marketplace accounted for about 46 percent of expenditures each year. CVM’s epidemiological systems and surveillance activities, which accounted for nearly $4.4 million, or about 34 percent, of postmarket expenditures, included collaborative efforts with other federal agencies to monitor nationwide changes in susceptibilities to 17 antimicrobial drugs through the National Antimicrobial Resistance Monitoring System and efforts to monitor and reduce drug residues in meats. Intramural research to detect microbial and chemical contaminants that may be present in animal feeds and animal food products consumed by humans and research on antibiotic resistance accounted for another $3.6 million, or 30 percent, of postmarket expenditures. This included the development and validation of a test for detecting bovine protein in animal feeds, an important component of its Bovine Spongiform Encephalopathy regulatory strategy.
Agencywide support accounted for about 8 percent of expenditures. These expenditures represent CVM’s share of central direction and administrative services, as previously described for CFSAN. These expenditures represent CVM’s allocation for its share of central direction and administrative services to ensure that FDA’s efforts are effectively managed and that resources are put to the most efficient use.
section_title: National Center for Toxicological Research Headquarters Food Safety Activities
paragraphs: NCTR, FDA’s center for peer-reviewed scientific research upon which the agency bases its regulatory decisions, was responsible for no more than 1 percent of agency food safety expenditures. In fiscal year 1998, NCTR expended $842,000, including $75,000 from CVM, and 5 staff years on eight food safety research projects. In fiscal year 1999, NCTR expended nearly $1.5 million and 10 staff years on 10 research projects, including $500,000 to expand food safety method development research.The annual expenditures include about $100,000 for agencywide support. NCTR’s expenditures do not include any field activities related to food safety.
section_title: Appendix IV: States’ Fiscal Years 1998 and 1999 Food Safety Expenditures
paragraphs: States (used hereafter to refer collectively to states, territories, commonwealths, federated states, and the District of Columbia) play an important role in overseeing the nation’s food supply. State and local (e.g., county and city) governments conduct the majority of inspections in the United States, including food retailers, manufacturers, processors, and distributors within their state boundaries in accordance with their own laws and authorities. State agriculture departments and health departments are the two primary agencies that are responsible for food safety in states. As shown in table 15, states devoted various amounts of resources for activities to ensure the safety of foods under its jurisdiction in fiscal years 1998 and 1999.
subsections: section_title: Food Safety Activities, Funding, Expenditures, and Staffing
paragraphs: State food safety responsibilities can be grouped into four categories that cover a broad range of activities: licensing and inspection, response to food safety problems, laboratory analysis, and training and technical assistance. States reported a high degree of involvement in some activities within each category and little involvement with others. For example:   Regarding licensing and inspection activities, more than 40 states reported that they were involved to a great or very great extent in registering and licensing food producers, processors, sellers, and others and inspecting dairy farms and dairy product plants. The number of states engaged in inspection activities at other types of establishments such as meat and poultry slaughter and processing plants, egg and egg product plants, groceries and restaurants varied more widely. Forty-five states reported that they engaged in little or no inspection activity at nondairy food- producing farms.
In response to food safety problems, 48 states reported a great or very great involvement in activities to enforce food safety regulations, and 45 states reported a great or very great level of involvement in response to natural disasters that effect food safety, such as tornadoes, hurricanes, and floods.
Regarding laboratory analysis, 41 states reported great or very great involvement in analyzing food products for microbial contamination. States were generally involved in laboratory analysis for pesticides and chemical residues, filth, or food labeling accuracy to a lesser extent.
Fifty-one states reported providing training and technical assistance to a great or very great extent to staff employed by their own departments, and more than half reported providing such assistance to grocery, restaurant, and other retail food service workers to a great or very great extent. States provided training and technical assistance to farmers, processors, consumers, health professionals, and others to a lesser extent.
As shown in table 16, state expenditures reported for these categories of activities, as well as administrative and support, other, and uncategorized activities, were about $292 million in fiscal year 1998 and about $301 million in fiscal year 1999. In fiscal year 1999, federal funds accounted for 13 percent of state expenditures, other funding sources such as license fees accounted for 18 percent, and state revenues funded the remaining 65 percent of these expenditures. In aggregate, states dedicated 5,617 staff years to food safety activities in fiscal year 1998 and 5,717 staff years in fiscal year 1999.
subsections: section_title: Licensing and Inspection Activities
paragraphs: State expenditures for licensing and inspection food safety activities were $142 million in fiscal year 1998 and $144 million in fiscal year 1999. As shown in table 17, states reported over 1 million establishments under their jurisdiction in fiscal years 1998 and 1999. This includes over 370,000 restaurants, about 300,000 groceries and other retail outlets, and about 90,000 dairy farms. States also reported their typical frequency of inspection for each type of establishment, which ranged from continuous, meaning that an inspector is onsite at all times during production, to once per year. In total, states reported that they actually conducted about 2 million inspections annually, not counting continuous inspections.
As shown in table 18, states reported how much of their expenditures of over $140 million annually for food safety licensing and inspection were allocated to specific activities within the category. The activities that were allocated a large amount of resources by states include inspections at groceries and other retail outlets and restaurants.
section_title: Response to Problems
paragraphs: As shown in table 19, states reported how much of their total expenditures of about $15 million annually to respond to food safety problems were allocated to specific activities within the category. States allocated a moderate amount of expenditures to enforcement of food safety regulations and lesser amounts to other response activities.
section_title: Laboratory Analysis
paragraphs: As shown in table 20, states reported how much of their total expenditures of more than $30 million annually for food safety laboratory analysis were allocated to specific activities within the category. The activity that the states most often allocated a large amount of expenditures was laboratory analysis for microbial contamination.
section_title: Food Safety Technical Assistance and Training
paragraphs: As shown in table 21, states reported how much of their annual expenditures of about $15 million to $17 million for food safety technical assistance and training were allocated to specific activities within the category. The states allocated a large amount of expenditures to training and technical assistance for staff employed by their own agriculture or health department.
section_title: Role of Other State Agencies and Local Governments
paragraphs: Although state departments of agriculture and health generally have primary responsibility for overall food safety activities in each of the states, other state departments and local governments also have responsibility for such activities. According to the states we surveyed, these other agencies generally had responsibilities for a specific type of establishment, such as restaurants, jails or prisons, childcare facilities, and nursing homes or for specific food products. For example, in the state of Florida, restaurants are under the jurisdiction of the Department of Business and Professional Regulations. And, in several states—Delaware, Louisiana, Maine, Mississippi, New Jersey, New York, and Texas—seafood or shellfish products are the responsibility of a state agency other than agriculture or health.
States also reported that local governments have an extensive role in food safety inspection activities at certain types of establishments such as restaurants, institutions, groceries, and other retail locations. For example, although Georgia’s health department has jurisdiction over almost 20,000 restaurants and institutions, county staff inspected all of those establishments under contracts with the state. In some cases, state health departments reported that local government inspections were conducted primarily through state contracts or agreements. In a few cases, states reported large expenditures by local governments. For example, the Idaho Department of Health reported that most of the state’s expenditures for food safety were made by local multicounty health districts, which spent about $1 million on food safety in fiscal year 1999, while the state spent about $650,000.
section_title: Appendix V: Responses to GAO’s Survey of State Agencies Responsible for Food Safety Activities
section_title: Appendix VI: Comments from the Food Safety and Inspection Service
subsections: section_title: GAO’s Comments
paragraphs: 1.  The report clearly identifies FSIS’ responsibilities—i.e., ensuring that meat, poultry, and processed egg products moving in interstate and foreign commerce are safe, wholesome, and marked, labeled, and packaged correctly. Regarding nonfood safety expenditures, FSIS officials assured us during the review that the expenditure information that they provided was for food safety or primarily food safety related activities. As such, we believe the FSIS expenditures in this report are sufficiently related to food safety to be appropriately characterized as “food safety” expenditures. 2.  We believe the report adequately describes the size and scope of FSIS activities. For example, the report includes information on the number of meat, poultry, egg product, and import establishments FSIS oversees; the number of state and foreign programs it reviewed; and the number and type of inspections it conducted. The level of detail provided on FSIS’ responsibilities and activities is similar to that provided on FDA activities. 3.  It was not our intent to analyze or compare the relative risks of products under the jurisdiction of FSIS and FDA. While the relative risk of FSIS-regulated products may be greater in some cases than FDA-regulated products, we believe that the data accurately reflect the proportion of each agency’s expenditures and the proportion of consumer expenditures for foods under each agency’s jurisdiction. The report also clearly identifies the food products for which each agency has responsibility. 4.  We modified the report to clearly identify FSIS’ responsibilities under the federal meat and poultry inspection acts and to describe its efforts, with guidance from the courts, to realign the responsibilities and roles of industry and federal inspectors.
section_title: Appendix VII: Comments from the Food and Drug Administration
subsections: section_title: GAO’s Comments
paragraphs: 1.  By design, the scope of this report was limited to FSIS and FDA food safety activities and expenditures. However, the report recognizes that 12 federal agencies conduct food safety activities and cites our testimony Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based, Inspection System (GAO/T-RCED-99-256, Aug. 4, 1999), which provides the fiscal year 1998 funding and staffing levels for these federal agencies.
section_title: Appendix VIII: GAO Contacts and Staff Acknowledgements
subsections: section_title: GAO Contacts
section_title: Staff Acknowledgements
paragraphs: In addition to those named above, Brad Dobbins, Kathy Colgrove-Stone, John Nicholson, and Carolyn Boyce made key contributions to this report.