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The Federal Food Safety System: A Primer

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The Federal Food Safety System: A Primer Renée Johnson Specialist in Agricultural Policy January 20November 26, 2012 Congressional Research Service 7-5700 www.crs.gov RS22600 CRS Report for Congress Prepared for Members and Committees of Congress The Federal Food Safety System: A Primer Summary Numerous federal, state, and local agencies share responsibilities for regulating the safety of the U.S. food supply. Federal responsibility for food safety rests primarily with the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). FDA, an agency of the Department of Health and Human Services, is responsible for ensuring the safety of all domestic and imported food products (except for most meats and poultry). FDA also has oversight of all seafood, fish, and shellfish products. USDA’s Food Safety and Inspection Service (FSIS) regulates most meat and poultry and some egg products. State and local food safety authorities collaborate with federal agencies for inspection and other food safety functions, and they regulate retail food establishments. The combined efforts of the food industry and government regulatory agencies often are credited with making the U.S. food supply among the safest in the world. However, critics view this system as lacking the organization, regulatory tools, and resources to adequately combat foodborne illness—as evidenced by a series of widely publicized food safety problems, including concerns about adulterated food and food ingredient imports, and illnesses linked to various types of fresh produce, to peanut products, and to some meat and poultry products. Some critics also note that the organizational complexity of the U.S. food safety system as well as trends in U.S. food markets—for example, increasing imports as a share of U.S. food consumptions and increasing consumption of fresh, often unprocessed, foods—pose ongoing challenges to ensuring food safety. The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety authorities since the 1930s. Although numerous agencies share responsibility for regulating food safety, FSMA focused on foods regulated by FDA and amended FDA’s existing structure and authorities, and did not directly address meat and poultry products under USDA’s jurisdiction. Beyond these changes, some in Congress continue to push for additional policy reforms to address other perceived concerns about the safety of the U.S. food supply. After FSMA was signed into law in January 2011, concerns were voiced about whether there would be enough money to overhaul the U.S. food safety system and also whether expanded investment in this area is appropriate in the current budgetary climate. Although Congress authorized appropriations and new user fees for FDA when it enacted FSMA, it did not provide the full funding needed for FDA to perform these activities. FDA’s FY2012 budget for its foods program was $866 million, and FSIS’s FY2012 budget was $1.004 billion in appropriated funds, with some additional funding available from authorized user fees. Funding levels specific to food safety responsibilities at other federal and state agencies is not readily available. Congressional Research Service The Federal Food Safety System: A Primer Contents Background ...................................................................................................................................... 1 The Agencies and Their Roles ......................................................................................................... 1 Food and Drug Administration .................................................................................................. 1 Food Safety and Inspection Service .......................................................................................... 3 Centers for Disease Control and Prevention.............................................................................. 4 National Marine Fisheries Service ............................................................................................ 5 Environmental Protection Agency ............................................................................................. 5 Other Federal Agencies ............................................................................................................. 5 Congressional Committees .............................................................................................................. 6 Tables Table 1. Major5 Funding for Federal Food Safety AgenciesPrograms ..................................................................................... 6 Tables Table 2. 1. Appropriations for Food Safety, FY2010-FY2013 ............................................................ 7 Appendixes Appendix A. Major Federal Food Safety Agencies and Selected Laws .......................................... 8 Appendix B. Selected Comparison of FSIS and FDA Responsibilities .................................................. 8.. 10 Contacts Author Contact Information........................................................................................................... 1012 Acknowledgments ......................................................................................................................... 1012 Congressional Research Service The Federal Food Safety System: A Primer Background Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools, and other places outside the home.1 Federal laws give food manufacturers, distributors, and retailers the basic responsibility for assuring that foods are wholesome, safe, and handled under sanitary conditions. A number of federal agencies, cooperating with state, local, and international entities, play a major role in regulating food quality and safety under these laws. The combined efforts of the food industry and the regulatory agencies often are credited with making the U.S. food supply among the safest in the world. Nonetheless, the Centers for Disease Control and Prevention (CDC) reports that each year an estimated one in six Americans—a total of 48 million people—becomes sick from contaminated food foodborne illnesses caused by contamination from any one of a number of microbial pathogens.2 Of these, an estimated 128,000 cases require hospitalization and 3,000 cases result in death. In addition, experts have cited numerous other hazards to health, including the use of unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of particular concern at a time when a growing share of the U.S. food supply is from overseas sources. These concerns, combined with the ongoing recurrence of major food safety-related incidents, have heightened public and media scrutiny of the U.S. food safety system and magnified congressional interest in the issue. The Agencies and Their Roles The Government Accountability Office (GAO) has identified as many as 15 federal agencies collectively administering at least 30 laws related to food safety. The Food and Drug Administration (FDA), which is part of the U.S. Department of Health and Human Services (HHS), and the Food Safety and Inspection Service (FSIS), which is part of the U.S. Department of Agriculture (USDA), together comprise the majority of both the total funding and the total staffing of the government’s food regulatory system. (See Table 1 and Table 2 for a brief Appendix A and Appendix B provide a brief comparative look at the agencies’ responsibilities.) Food and Drug Administration Excluding the roughly 10%-20% of the U.S. food supply that is estimated to be under the jurisdiction of FSIS, it may be argued that the safety of the majority of all foods—about 80%90%—falls under FDA’s responsibility.3 The FDA is responsible for ensuring that all domestic and imported food products—except for most meats and poultry—are safe, nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are produce, dairy 1 Roughly two-thirds of the $1 trillion is for domestically produced farm foods; imports and seafood account for the balance. products, seafood, and processed foods. FDA has jurisdiction over meats from animals or birds 1 USDA, Economic Research Service (ERS) food sales data, data, at http://www.ers.usda.gov/Browse/FoodSector/data-products/foodexpenditures.aspx. 2 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Estimates of Foodborne Illness in the United States,” http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html. 3 The 20% estimate is based on information reported by the Government Accountability Office (GAO) in “Revamping Oversight of Food Safety,” prepared for the 2009 Congressional and Presidential Transition, and appears to represent proportions of total spending for food consumed at home. The 10% estimate is based on data from USDA’s Economic Research Service (ERS)-ERS on U.S. per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/. Congressional Research Service 1 The Federal Food Safety System: A Primer products, seafood, and processed foods. FDA has jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of FSIS. FDA shares responsibility for the safety of eggs with FSIS. FDA has jurisdiction over establishments that sell or serve eggs or use them as an ingredient in their products. FDA is also responsible for ensuring that most seafood products do not endanger public health (FSIS is to begin inspecting farmed catfish products under a 2008 farm bill provision)..4 The primary statutes governing FDA’s activities are the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended (21 U.S.C. 301 et seq.); the Public Health Service Act, as amended (42 U.S.C. §§201 et seq.); and the Egg Products Inspection Act, as amended (21 U.S.C. §§1031 et seq.). The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety authorities since the 1930s. Although numerous agencies share responsibility for regulating food safety, FSMA focused on foods regulated by FDA and amended FDA’s existing structure and authorities, in particular FFDCA.45 The Congressional Budget Office (CBO) estimated that implementing FSMA could increase net federal spending subject to appropriation by about $1.4 billion over a five-year period (FY2011-FY2015); collections from possible revenue and direct spending increases from new criminal penalties would be “insignificant, yielding a negligible net impact in each year.”56 FSMA authorizes an increase in FDA staff to up to 5,000 staff members in FY2014. Given the current budgetary climate, funding to undertake many federal activities in FSMA is uncertain.6by FY2014. FDA’s FY2011 budget for its foods program was $835.7836.2 million, virtually all of it appropriated with limited authorized user fees (Table 1)..7 FSMA also authorized additional user fees that provide limited funds to assist with implementation of the new law. FDA staff working on food-relatedfoodrelated activities in FY2011 were estimated at about 3,400600 FTEs. The number of food facilities subject to FDA inspection has been increasing sharply in the past few years. A report by HHS’s Office of Inspector General (OIG) provided additional insights into the FDA’s inspections of domestic facilities. The OIG reported that the number of facilities subject to such inspections had risen from about 59,000 in 2004 to nearly 68,000 in 2008. However, the number of inspections conducted declined from about 17,000 in 2004 (29% of the total) to about 15,000 in 2008 (22%). During the five-year period examined by the OIG, 56% of food facilities were not inspected at all.87 Of these inspections, an increasing number of inspections have been conducted by states under contract with FDA, rather than by FDA.9 4 For more information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). FSMA does not directly address meat and poultry products under USDA’s jurisdiction. 5 CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health, Education, Labor, and Pensions on December 18, 2009, incorporating a manager’s amendment released on August 12, 2010,” August 12, 2010. Reflecting the August 2010 Senate amendment to S. 510. 6 For more information, see CRS Report R41964, Agriculture and Related Agencies: FY2012 Appropriations. 7 FDA “Operating Plan for FY 2011 and Comparisons to FY 2010,” http://www.hhs.gov/asfr/ob/docbudget/ 2011operatingplan_fda.pdf. 88 In addition, some 200,000 foreign food facilities are registered with the agency. Various estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called high-risk facilities on an annual basis. FDA relies on notifications from within the industry or from other federal or state inspection personnel, as well as other sources, to alert it to situations calling for increased inspection. GAO reported that, in 2000, FDA inspections 4 FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, § 11016). For more information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). FSMA does not directly address meat and poultry products under USDA’s jurisdiction. 6 CBO cost estimate, “S. 510, Food Safety Modernization Act,” August 12, 2010. 7 HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), Table 1 , April 2010, http://oig.hhs.gov/ oei/reports/oei-02-08-00080.pdf. 98 HHS, OIG, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections (OEI-02-09-00430), December 2011, http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf. 5 Congressional Research Service 2 The Federal Food Safety System: A Primer In addition, some 200,000 foreign food facilities are registered with the agency. Various estimates of unannounced compliance inspections of domestic establishments by FDA officials range from once every five years to once every 10 years, on average, although the agency claims to visit about 6,000 so-called high-risk facilities on an annual basis. FDA relies on notifications from within the industry or from other federal or state inspection personnel, as well as other sources, to alert it to situations calling for increased inspection. GAO reported that, in 2000, FDA inspections covered only about 1% of the food imported under its jurisdiction.10covered only about 1% of the food imported under its jurisdiction.9 Changes to FDA’s import regime now being implemented under FSMA are expected to address some of these concerns. In the Washington, DC, area, two FDA offices are the focal point for food safety-related activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for (1) conducting and supporting food safety research; (2) developing and overseeing enforcement of food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance and compliance programs; (4) coordinating and evaluating cooperating states’ food safety activities; and (5) developing and disseminating food safety and regulatory information to consumers and industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are properly labeled, and produce no human health hazards when used in food-producing animals. The FDA also cooperates with over 400 state agencies across the nation that carry out a wide range of food safety regulatory activities. However, the state agencies are primarily responsible for actual inspection. FDA works with the states to set the safety standards for food establishments and commodities and evaluates the states’ performance in upholding such standards as well as any federal standards that may apply. FDA also contracts with states to use their food safety agency personnel to carry out certain field inspections in support of FDA’s own statutory responsibilities. Food Safety and Inspection Service Available USDA data indicate that FSIS is roughly responsible for 10%-20% of the U.S. food supply, while FDA is responsible for the remainder.11 FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported meat and poultry and their products sold for human consumption., comprising roughly 10%-20% of the U.S. food supply.10 Under the Federal Meat Inspection Act of 1906, as amended (21 U.S.C. §§601 et seq.), FSIS is required to inspect all cattle, sheep, swine, goats, and equines during slaughtering and processing. Under the Poultry Products Inspection Act of 1957, as amended (21 U.S.C. §§451 et seq.), FSIS is required to inspect “any domesticated bird” being processed for human consumption; however, USDA regulations implementing this law limit the definition of domesticated birds to chickens, turkeys, ducks, geese, ratites (emus, ostriches, and rheas), and guineas. FDA has jurisdiction over exotic and alternative meats not inspected by FSIS, and shares the responsibility for egg safety with FSIS.1211 The latter is responsible for the safety of liquid, frozen, and dried egg products, 10 GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/ new.items/d0247t.pdf. 11 See footnote 3. 12 USDA’s Agricultural Marketing Service (AMS) also has responsibility for ensuring shell eggs for quality, but not safety, considerations (see Table 1). Congressional Research Service 3 The Federal Food Safety System: A Primer domestic and imported, and for the safe use or disposition of damaged and dirty eggs under the Egg Products Inspection Act, as amended (21 U.S.C. §§1031 et seq.). FSIS’s FY2011 budget was $1.007 billion in appropriated funds (Table 1), with, plus another approximatelyroughly $150 million to $180 million in industry-paid user fees.13 annually.12 FSIS staff numbers around 9,600 9,500; roughly 8,000 of them, including about 1,000 veterinarians, are in about 6,300 meat slaughtering and/or processing plants nationwide. FSIS personnel inspect all meat and poultry animals at slaughter on a continuous basis, and at least one federal inspector is on the line during all hours the plant is operating. Processing inspection does not require an FSIS inspector to remain constantly on the production line or to inspect every item. Instead, inspectors are on site daily to monitor the plant’s adherence to the standards for sanitary conditions, ingredient levels, and packaging, and to conduct statistical sampling and testing of products. Because all plants are visited daily, 9 GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/ new.items/d0247t.pdf. 10 See footnote 3. 11 USDA’s Agricultural Marketing Service (AMS) also has responsibility for ensuring shell eggs for quality, but not safety, considerations (see Appendix A). 12 USDA, 2012 Explanatory Notes, Food Safety and Inspection Service, February 12, 2011, http://www.obpa.usda.gov/ 21fsis2012notes.pdf. Congressional Research Service 3 The Federal Food Safety System: A Primer slaughtering and/or processing plants nationwide. FSIS personnel inspect all meat and poultry animals at slaughter on a continuous basis, and at least one federal inspector is on the line during all hours the plant is operating. Processing inspection does not require an FSIS inspector to remain constantly on the production line or to inspect every item. Instead, inspectors are on site daily to monitor the plant’s adherence to the standards for sanitary conditions, ingredient levels, and packaging, and to conduct statistical sampling and testing of products. Because all plants are visited daily, processing inspection also is considered to be continuous. FSIS also is responsible for certifying that foreign meat and poultry plants are operating under an inspection system equivalent to the U.S. system before they can export their product to the United States. FSIS inspectors located at U.S. ports of entry carry out a statistical sampling program to verify the safety of imported meats from cattle, sheep, swine, goats, and equines and imported poultry meat from chickens, turkeys, ducks, geese, quail, ratites, and guineas before they are released into domestic commerce. FDA is responsible for ensuring the safety of imported meat from any other species. Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is statutorily responsible for ensuring that the states’ programs are at least equal to the federal program.1413 Plants processing meat and poultry under state inspection can market their products only within the state. If a state chooses to discontinue its own inspection program, or if FSIS determines that it does not meet the agency’s equivalency standards, FSIS must assume the responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSIS also has cooperative agreements with more than two dozen states under which state inspection personnel are authorized to carry out federal inspection in meat and/or poultry plants. Products from these plants may travel in interstate commerce.1514 Centers for Disease Control and Prevention CDC is responsible for (1) monitoring, identifying, and investigating foodborne disease problems to determine the contributing factors; (2) working with FDA, FSIS, NMFS, state and local public health departments, universities, and industry to develop control methods; and (3) evaluating the effect of control methods. In 1995, CDC launched “FoodNet,” a collaborative project with the FDA and USDA to improve data collection on foodborne illness outbreaks. FoodNet includes active surveillance of clinical microbiology laboratories to obtain a more accurate accounting of positive test results for foodborne illness; a physician survey to determine testing and laboratory 13 USDA, 2012 Explanatory Notes, Food Safety and Inspection Service, February 12, 2011, http://www.obpa.usda.gov/ 21fsis2012notes.pdf. 14 USDA, “Listing of Participating States,” http://www.fsis.usda.gov/regulations_&_policies/ Listing_of_participating_states/index.asp 15 The 2008 farm bill (P.L. 110-246, § 11017) contained new provisions intended to enable more interstate shipment of state-inspected products. Congressional Research Service 4 The Federal Food Safety System: A Primer practices; population surveys to identify illnesses not reported to doctors; and research studies to obtain new and more precise information about which food items or other exposures may cause diseases. FoodNet data allows CDC to have a clearer picture of the incidence and causes of foodborne illness and to establish baseline data against which to measure the success of changes in food safety programs. The Public Health Service Act provides legislative authority for CDC’s food safety-related activities. 13 USDA, “Listing of Participating States,” http://www.fsis.usda.gov/regulations_&_policies/ Listing_of_participating_states/index.asp. 14 The 2008 farm bill (P.L. 110-246, § 11017) contained new provisions intended to enable more interstate shipment of state-inspected products. Congressional Research Service 4 The Federal Food Safety System: A Primer National Marine Fisheries Service Although the FDA is the primary agency responsible for ensuring the safety, wholesomeness, and proper labeling of domestic and imported seafood products, the National Marine Fisheries Service (NMFS), which is part of the U.S. Department of Commerce, conducts, on a fee-forservice basis, a voluntary seafood inspection and grading program that focuses on marketing and quality attributes of U.S. fish and shellfish. The primary legislative authority for NMFS’s inspection program is the Agricultural Marketing Act of 1946, as amended (7 U.S.C. §§1621 et seq.). NMFS has approximately 160 seafood safety and quality inspectors, and inspection services are funded with user fees. Environmental Protection Agency EPA has the statutory responsibility for ensuring that the chemicals used on food crops do not endanger public health. EPA’s Office of Pesticide Programs is the part of the agency that (1) registers new pesticides and determines residue levels for regulatory purposes; (2) performs special reviews of pesticides of concern; (3) reviews and evaluates all the health data on pesticides; (4) reviews data on pesticides’ effects on the environment and on other species; (5) analyzes the costs and benefits of pesticide use; and (6) interacts with EPA regional offices, state regulatory counterparts, other federal agencies involved in food safety, the public, and others to keep them informed of EPA regulatory actions. The Federal Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 et seq.), and the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), are the primary authorities for EPA’s activities in this area. Other Federal Agencies Among the other agencies that play a role in food safety, USDA’s Agricultural Research Service (ARS) performs food safety research in support of FSIS’s inspection program. It has scientists working in animal disease bio-containment laboratories in Plum Island, NY, and Ames, IA. USDA’s Animal and Plant Health Inspection Service (APHIS) indirectly protects the nation’s food supply through programs to protect plant and animal resources from domestic and foreign pests and diseases, such as brucellosis and bovine spongiform encephalopathy (BSE, or “mad cow” disease). The Department of Homeland Security (DHS) is to coordinate many food security activities, including at U.S. borders. USDA’s Agricultural Marketing Service (AMS) is responsible for establishing quality and marketing grades and standards for many foods (including dairy products, fruits and vegetables, livestock, meat, poultry, seafoods, and shell eggs), and for certifying quality programs and conducting quality grading services. Accordingly, AMS is primarily responsible for ensuring product quality and not food safety. Congressional Research Service 5 The Federal Food Safety System: A Primer Congressional Committees In the Senate, food safety issues are considered by the Committees on Agriculture, Nutrition, and Forestry; Homeland Security and Governmental Affairs; and Health, Education, Labor, and Pensions. In the House, various food safety activities fall under the jurisdiction of the Committees on Agriculture; Energy and Commerce; Oversight and Government Reform; and Science. Congressional Research Service 5 The Federal Food Safety System: A Primer Agriculture subcommittees of the House and Senate Appropriations Committees also serve oversight and funding roles in how the major agencies carry out food safety policies. Table 1. Major Federal Food Safety Agencies Agency Major Responsibilities and Activities Primary Authorities Department of Health and Human Services Food and Drug Administrationa Ensuring that all domestic and imported foods, except processed egg products and major types of meat and poultry, are safe, wholesome, and properly labeled, by setting safety and sanitation standards, periodically inspecting manufacturing facilities, reviewing records of and spot-checking imports. Also overseeing the safety of animal drugs and feeds including those used in food-producing animals As may be amended by the FDA Food Safety Modernization Act (FSMA): Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 301), Public Health Service Act (42 U.S.C. 201), Egg Products Inspection Act (21 U.S.C. 1031), Public Health Security and Bioterrorism Preparedness and Response Act (21 U.S.C. 341), others Centers for Disease Control and Prevention Monitoring, identifying, and investigating foodborne diseases; developing and evaluating improved epidemiological and laboratory methods Public Health Service Act (42 U.S.C. 201) Department of Agriculture Food Safety Inspection Servicea Regulating Funding for Federal Food Safety Programs Historically, federal funding and staffing levels between FDA and FSIS have been disproportionate to their respective responsibilities to address food safety activities. Although FSIS is responsible for 10%-20% of the U.S. food supply, it has had approximately 60% of the two agencies’ combined food safety budget; and although FDA has been responsible for 80%90% of the U.S. food supply, it has received about 40% the available budget. For example, in FY2010, FSIS received $1.018 billion in appropriated funds plus another approximately $150 million in industry-paid user fees, whereas FDA’s FY2010 budget for foods was $783 million, virtually all of it appropriated with limited authorized user fees (Table 1). Staffing levels also vary considerably among the two agencies: FSIS staff numbered around 9,400 FTEs in FY2010, while FDA staff working on food-related activities numbers about 3,400 FTEs. FSMA (P.L. 111-353) authorized additional appropriations and staff for FDA’s future food safety activities and authorized new user fees.15 New fees authorized under FSMA include an annual fee for participants in the voluntary qualified importer program (VQIP) and three fees for certain periodic activities involving reinspection, recall, and export certification.16 FSMA did not impose any new facility registration fees. FSMA also authorized an increase in FDA staff, reaching 5,000 by FY2014.17 Although Congress authorized appropriations and new user fees when it enacted FSMA, it did not provide the full funding needed for FDA to perform these activities. After FSMA was signed into law in January 2011, concerns were voiced about whether there would be enough money to overhaul the U.S. food safety system and also whether expanded investment in this area is appropriate in the current budgetary climate.18 In the past few years the balance of overall funding for food safety between FDA and USDA has slowly started to shift (Table 1). Funding levels specific to food safety responsibilities at other federal and state agencies are not readily available. 15 P.L. 111-353 amended the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). FSMA, P.L. 111-353, Sections 107 and 401. Details of these annual and periodic fees are presented in CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). 17 FSMA, P.L. 111-353, Section 401. By fiscal year, staff level increases were authorized to a total of not fewer than 4,000 staff members (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014). 18 See, for example, “Food Safety Bill Advocates Expect Funding Fight,” Food Safety News, January 4, 2011. 16 Congressional Research Service 6 The Federal Food Safety System: A Primer Table 1. Appropriations for Food Safety, FY2010-FY2013 (FTEs as indicated, and budget and appropriation figures in millions of dollars) Agency/Year FTEsa Appropriationb Program Level, Including Fees HHS Food and Drug Administration (FDA), “Foods” Subtotal Only FY2010 Actual 3,387 783.2 783.2 FY2011 Actual FY2012 Enacted 3,605 836.2 836.2 3,757 866.1 882.7 FY2013 Administration Budget 4,047 855.2 1,083.9 FY2013, H.R. 5973, House NA 866.1 883.5 FY2013, S. 2375, Senate NA 867.0 884.5 FY2012 Appropriation NA 0 (0%) 0.8 (0.1%) FY2013 Administration Budget NA 10.9 (1.3%) -200.4 (-18.5%) FY2012 Appropriation NA 1.0 (0.1%) 1.7 (0.2%) FY2013 Administration Budget NA 11.8 (1.4%) -199.5 (-18.4%) FY2010 Appropriation 9,401 1,018.5 1,172.5 FY2011 Appropriation 9,465 1,006.5 1,185.2 FY2012 Enacted 9,540 1,004.4 1,166.6 FY2013 Administration Budget 9,040 995.5 NA FY2013, H.R. 5973, House NA 995.5 NA FY2013, S. 2375, Senate NA 1,001.4 NA FY2012 Appropriation NA -8.9 (-0.9%) NA FY2013 Administration Budget NA 0.0 (0.0%) NA FY2012 Appropriation NA -3.0 (-0.3%) NA FY2013 Administration Budget NA 5.9 (0.6%) NA Comparison with House bill to: Comparison with Senate bill to: USDA Food Safety and Inspection Service (FSIS) Comparison with House bill to: Comparison with Senate bill to: Source: CRS, from data in H.R. 5973 (H.Rept. 112-542) and S. 2375 (S.Rept. 112-163); FTEs and FDA “Foods” are from USDA and FDA data: HHS, “FY2013 FDA: Justification of Estimates for Appropriations Committees,” http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM291555.pdf; and USDA, “2013 Explanatory Notes, FSIS,” http://www.obpa.usda.gov/21fsis2013notes.pdf. NA=not available. Notes: Percentages in parentheses reflect differences relative to FY2012 or the Administration’s proposal. a. Staffing in full time equivalents: HHS, “FY2013 FDA: Justification of Estimates for Appropriations Committees,” pp. 96 and 144; and USDA, “2013 Explanatory Notes, FSIS,” p. 21-5. b. Data from “FY2013 FDA: Justification of Estimates for Appropriations Committees,” FY2010-FY2012 from p. 144, FY2013 calculated from tables on pp. 93-96; USDA, “2013 Explanatory Notes, FSIS,” p. 21-5. Congressional Research Service 7 The Federal Food Safety System: A Primer Appendix A. Major Federal Food Safety Agencies and Selected Laws Agency Major Responsibilities and Activities Primary Authorities Department of Health and Human Services Food and Drug Administration (FDA)a Ensures that all domestic and imported foods, except processed egg products and major types of meat and poultry, are safe, wholesome, and properly labeled, by setting safety and sanitation standards, periodically inspecting manufacturing facilities, reviewing records of and spot-checking imports. Also oversees the safety of animal drugs and feeds, including those used in food-producing animals. Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301-399a) as amended; Public Health Service Act (42 U.S.C. § 201), Egg Products Inspection Act (21 U.S.C. § 1031); Federal Import Milk Act (21 U.S.C. §§ 141-149); Fair Packaging and Labeling Act (15 U.S.C. §§ 1451-1461); Federal Anti-Tampering Act (18 U.S.C. § 1365); Pesticide Monitoring Improvements Act of 1988 (21 U.S.C. § 1401) Centers for Disease Control and Prevention (CDC) Monitors, identifies, and investigates foodborne diseases; develops and evaluates improved epidemiological and laboratory methods. Public Health Service Act (42 U.S.C. § 201) Food Safety Inspection Service (FSIS)a Regulates the safety, wholesomeness and proper labeling of most commercial types of both domestic and imported meat and poultry, catfish products, and processed egg products, by approving establishment designs, safety plans; inspecting every animal and carcass in slaughtering plants and daily inspecting all meat and poultry processing plants; determining the equivalency of importing countries’ meat and poultry safety systems. Federal Meat Inspection Act (21 U.S.C. 601), Poultry Products Inspection Act (21 U.S.C. 451), Egg Products Inspection Act Animal and Plant Health Inspection Service Overseeing §§ 601-695); Poultry Products Inspection Act (21 USC §§ 451-472); Egg Products Inspection Act (21 U.S.C. §§ 1031-1056); Humane Methods of Slaughter Act of 1978 (7 U.S.C. §§ 1902, 1904, 21 U.S.C. §§ 603, 610, 620); Federal Anti-Tampering Act (18 U.S.C. § 1365); Agricultural Marketing Act of 1946 (7 U.S.C. § 1622); Richard B. Russell National School Lunch Act (42 U.S.C. §§ 1751-1770), as amended by Child Nutrition and WIC Reauthorization Acts (42 U.S.C. § 1762a(h)) Animal and Plant Health Inspection Service (APHIS) Oversees animal and plant health, including the prevention of foreign diseases and pests, eradication and eradication and containment of such problems domestically domestically (including those that threaten public health). Animal Health Protection Act (7 U.S.C. 8301), §§ 8301-8322); Plant Health Protection Act (7 U.S.C. 7701) Agricultural Marketing Service Establishing (7 U.S.C. §§ 7701-7721); Agricultural Bioterrorism Act of 2002 (7 U.S.C. § 8401) Agricultural Marketing Service (AMS) Establishes quality and marketing grades and standards for dairy products, fruits and vegetables, livestock, meat, poultry, seafoods, and shell eggs; certifyingcertifies quality programs; conductingconducts quality grading grading services, generally user fee-funded. Agricultural Marketing Act of 1946 (7 U.S.C. 1621), Egg Products Inspection Act (21 U.S.C. 1031), Agricultural Marketing Agreement Act (7 U.S.C. 601) Food and Nutrition Service Encouraging and coordinating§§ 1621-1638d), Perishable Agricultural Commodities Act, 1930 (7 U.S.C. §§ 499a- 499s); Federal Seed Act (7 U.S.C. §§ 1551-1611) Food and Nutrition Service (FNS) Encourages and coordinates efforts to ensure the safety of foods in school lunch and other domestic programs. Program subsidies authorized by Richard B. Russell National School Lunch Act (42 U.S.C. 1751),Child Nutrition Act (42 U.S.C. 1771). Grain Inspection, Packers and Stockyards Administration Setting quality standards for, and testing, grains and related commodities, primarily for marketing purposes U.S. Grain Standards Act (7 U.S.C. 71), Agricultural Marketing Act of 1946 Congressional Research Service 6§§ 1751-1770), as amended by Child Nutrition and WIC Reauthorization Acts (42 U.S.C. § 1762a(h)) Grain Inspection, Packers and Stockyards Administration (GIPSA) Sets quality standards for and tests grains and related commodities, primarily for marketing purposes. U.S. Grain Standards Act (7 USC §§ 7187k), Agricultural Marketing Act of 1946 (7 U.S.C. §§ 1622, 1624) Department of Agriculture Congressional Research Service 8 The Federal Food Safety System: A Primer Agency Major Responsibilities and Activities Primary Authorities Agricultural Research Service Research Service (ARS) Conducts in-house USDA research on agricultural and food topics, of which food safety is one of many. Numerous laws dating to the Department of Agriculture Organic Act of 1862 (7 U.S.C. § 2201 note), up through and including recent omnibus farm laws Cooperative State Research, Education, and Extension ServiceNational Institute of Food and Agriculture (NIFA) (formerly Cooperative State Research, Education, and Extension Service) Coordinates and administers federal funding of land grant and other institutions to conduct agricultural and food research, education and extension activities; food safety is one of many subject areas. Numerous laws dating to the Department of Agriculture Organic Act of 1862, up through and including recent omnibus farm laws Department of Commerce National Oceanic and Atmospheric Administration OfferingOffers a variety of voluntary seafood safety and quality inspection services on a fee-for-service basis. Agricultural Marketing Act of 1946, Fish (7 U.S.C. §§ 1622, 1624); Lacey Act (16 U.S.C. § 3371); Fish and Wildlife Act of 1956 (16 U.S.C. § 742) U.S. Environmental Protection Agency (EPA) Regulates the use of certain chemicals and substances that present an unreasonable risk of injury to health or the environment. Regulates742) Environmental Protection Agency Regulating pesticide products; setting sets maximum allowable tolerances for residue levels on food commodities and animal feeds Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136), FFDCA Federal Trade Commission Enforcing. Sets national drinking water standards and consults with FDA. Sets scientific water quality criteria for rivers, lakes, and streams that are protective of human health and wildlife. Federal Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301-399a), as amended; Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. §§ 136-136y), as amended by the Food Quality Protection Act of 1996 (21 U.S.C. § 346a); Clean Water Act (33 U.S.C. 1251-1387); Safe Drinking Water Act of 1974 (21 U.S.C. § 349 and 42 U.S.C. §§ 300f-300j-26); Toxic Substance Control Act (15 U.S.C. §§ 2601-2697) Federal Trade Commission (FTC) Enforces federal prohibitions against unfair or deceptive acts or practices in trade, including consumer deception regarding foods. Federal Trade Commission Act (15 U.S.C. 41) Department of the Treasury Alcohol and Tobacco Tax and Trade Bureau Administering and enforcing§§ 41-58) Administers and enforces laws on the production, safety, distribution and use of alcoholic beverages. Federal Alcohol Administration Act (27 U.S.C. 201),§§ 201-219a); Internal Revenue Code (26 U.S.C. Ch. 51) Department of Homeland Security U.S. Customs and Border Protection Coordinating many food security activities, including at the border; now conducting agricultural border inspection U.S.C. Ch. 51) Coordinates many food security activities, including inspecting imports of food, plants, and animals at the border. Conducts agricultural border inspection activities formerly done by APHIS. Homeland Security Act of 2002 (6 U.S.C. § 101); Tariff Act of 1930 (19 U.S.C. §§ 1202-1654) Department of Commerce National Oceanic and Atmospheric Administration (NOAA) Department of the Treasury Alcohol and Tobacco Tax and Trade Bureau (ATF) Department of Homeland Security U.S. Customs and Border Protection (CBP) Source: Prepared by CRS based in part on various reports by the Government Accountability Office, including GAO, Federal Food Safety Oversight, GAO-11-289, March 2011. Does not include two USDA agencies included by GAO (Research, Education, and Economics (REE) agencies: National Economic Research Service (ERS) and National Agricultural Statistics Service (NASS). a. 101) Source: Prepared by CRS based in part on various reports by the Government Accountability Office. a. These agencies have the leading food safety regulatory authorities. Congressional Research Service 79 The Federal Food Safety System: A Primer Table 2Appendix B. Selected Comparison of FSIS and FDA Responsibilities Food and Drug Administration (Foods Program only) Activity Food Safety and Inspection Service Primary Authorizations Federal Meat Inspection Act (21 U.S.C. 601), Poultry Products Inspection Act (21 U.S.C. 451), Egg Products Inspection Act (21 U.S.C. 1031) As may be amended by the FDA Food Safety Modernization Act (FSMA): Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. 301; Public Health Service Act (42 U.S.C. 201); Egg Products Inspection Act (21 U.S.C. 1031); Public Health Security and Bioterrorism Preparedness and Response Act (21 U.S.C. 341) Foods Regulated Major types of domestic and imported meat and poultry and their products; catfish products; processed (dried, frozen, liquid) egg products (20% of athome U.S. food spending) All other domestic and imported foods, also animal drugs and feeds including those used in food-producing animals (80% of at-home U.S. food spending) Funding (enacted FY2012) Appropriated: $1.004 billion for FY2012. Expected user fees are estimated to include another $150 million. Including authorized fees, total available funding is estimated at about $1.154 billion. Appropriated: $866.1 million for FDA’s Foods Program, not including funding from expected user fees. Expected user fees are estimated to include another $79 million. Including authorized fees, total available funding is estimated at about $945 million. Staff (2011) 9,600 FTEs 3,400 FTEs Domestic facilities 6,300 slaughter and/or processing establishments 68,000 subject to inspection Inspection Approach Ante- and post-mortem inspection of every animal, carcass and part; traditionally organoleptic (but see “Food safety plans” below); only USDAinspected and passed products may enter commerce Prohibits adulteration or misbranding; relies on facilities that manufacture, process, pack, or hold food for humans or animals to be meet prescribed standards (e.g., regarding additives, contaminants, etc.); all facilities must register, report changes in timely manner. Required inspection frequency Slaughter plants: all times of operation; processing plants: at least once daily FSMA requires increased inspection rates for any registered facility, particularly those identified as “high-risk.” Domestic high-risk facilities are to be inspected not less than once in the five-year period after enactment, and not less than once every three years thereafter. Domestic non-highrisk facilities are to be inspected not less than once in the seven-year period after enactment, and not less than once every five years thereafter. Food safety plans Requires all establishmentestablishments to prepare and and have preapproved “HACCP” (hazard analysis and critical control point) plans determining risks, controlling them (with documentation) Prior to FSMA, facilities followed general regulations on good manufacturing practices (GMPs) to address safe handling and plant sanitation—except a form of HACCP required for seafood, low-acid canned foods, juices. FSMA §103 created new requirements for facilities to evaluate hazards, implement preventive controls, monitor controls, and maintain records. FDA rulemaking is clarifying requirements under new written HACCP-type and/or broader written food safety plans as part of its so-called Hazard Analysis and Risk-Based Preventive Controls. Congressional Research Service 810 The Federal Food Safety System: A Primer Activity Food Safety and Inspection Service Food and Drug Administration (Foods Program only) Imports Specified products only from countries where FSIS has determined “equivalence” of foreign safety system, with annual verification; imports exempt from prior notice but subject to reinspection at 150 import establishments (est. 10% reinspected) Prior to FSMA, food safety system equivalence was not determined beforehand; reliance on inspections was at 300 ports (est. 1% of notified entries inspected). FSMA provides for tighter controls and use certification or verification systems for imported foods(to be determined by FDA rulemaking). At least 600 foreign facilities must be inspected the year following enactment, and in each of the subsequent five years the number of foreign facilities inspected is to double. Third party certification Private labs accredited for chemical testing of meat and poultry (for imports, see above) Prior to FSMA, there was no accreditation for food testing labs or use of third parties for import oversight. FSMA §202 requires FDA to establish a program for testing of food by accredited labs and to recognize accreditation bodies to accredit labs. FSMA §303 creates a system of accreditation of third-party auditors and audit agents to certify importing entities. FDA’s rulemaking is ongoing. On-farm oversight FSIS inspection authority begins at slaughter plant Prior to FSMA, those engaged solely in harvesting, storing or distributing raw agricultural commodities were generally exempt from registration, GMP regulations, and record-keeping. FSMA §105 created new farm-level requirements, particularly for fresh produce determined to be higher-risk (FDA rulemaking is ongoing). Some small farm businesses are exempt from regulation. Labeling Review and preapproval required for all labels All foods must adhere to food labeling requirements such as statement of identity, declaration of net contents, nutrition labeling; labels cannot be false or misleading. Notification Requirements P.L. 110-246 §11017 amended meat and poultry laws to require an establishment to notify USDA if it has reason to believe that an adulterated or misbranded product has entered commerce P.L. 110-85 (amended by FSMA) requires FDA to maintain a reportable food registry for industry to report food safety cases in order to help FDA better track patterns and target inspections. FSMA §204 provided for an enhanced tracing system for foods that FDA determines to pose a higher food safety risk. As part of the ongoing rulemaking process, FDA has launched product tracing pilots. Recall Authority No authority to mandate recalls; relies on voluntary efforts Prior to FSMA, FDA had no authority to mandate recalls (except infant formula). FSMA §206 provides for mandatory recall authority where there is a reasonable probability that a food is adulterated or misbranded, and its use or exposure to it will cause serious adverse health consequences or death. Civil/criminal penalties apply for failure to comply with a recall order. Source: Prepared by CRS. Congressional Research Service 911 The Federal Food Safety System: A Primer Author Contact Information Renée Johnson Specialist in Agricultural Policy rjohnson@crs.loc.gov, 7-9588 Acknowledgments This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy. Congressional Research Service 1012