---.- ,_.. “.._..-._..-..- --.. ._._ -“__- ..__.----~ -..-- Ikt*t~rlrlN~l~1‘IVM) * FOOD SAFETY AND QUALITY Who Does What in the Federal Government , -.. IllllllIlllll1 142970 RFI FA’CFn I\LLL./-lLJ)LU RESTRICTED-- Not to be released outside t . General Accounthg Office unless specifically approved by the Office of Congressional Relations. I (;AO/K(‘ISl)-!)I-I!)A United States GAO General Accounting Office Washington, D.C. 20648 Resources, Community, and Economic Development Division B-240663 December 21,lQQO The Honorable Patrick J. Leahy Chairman, Committee on Agriculture, Nutrition and Forestry United States Senate The Honorable Tom Harkin United States Senate The Honorable Dennis E. Eckart House of Representatives This report responds to your requests to provide an overall perspective on federal efforts to ensure food safety and quality. For the purposes of our review, we defined food safety activities as those carried out to ensure that food is safe, sanitary, wholesome, and properly labeled. Food quality activities are defined as those establishing standards of quality and condition, grading food products according to the standards, certifying that food products ‘meetthe standards, and inspecting food products for compliance with the standards. As agreed with your offices, this report provides information on (1) the statutory responsibilities, programs, activities, staffing, and budgets of the federal agenciesinvolved with food safety and quality; (2) the inter- agency agreementsused by the agenciesto cooperate in meeting their statutory duties; (3) the ways in which funding and staffing levels have changed during the 1980s relative to the agencies’work loads; and (4) the issues that federal officials believe will be critical for food safety and quality in the 1990s. As agreed, we did not evaluate how well the agenciescarried out their responsibilities or whether there was duplica- tion of effort or gaps in coverage among agencies. . The fragmented, complex federal food safety and quality regulatory Results in Brief system consists of as many as 35 different laws and involves 12 federal agencies.Of the 12 agencies,6 have the major roles in carrying out food safety and quality activities. They are the Food and Drug Administra- tion (FDA), which is part of the U.S. Department of Health and Human Services (HHS); the US. Department of Agriculture’s (USDA) Agricultural Marketing Service (AMS), Federal Grain Inspection Service (FGIS), and Food Safety and Inspection Service (FSIS); the Environmental Protec- tion Agency (EPA); and the National Marine Fisheries Service (NMFS), Page 1 GAO/RCED-91-19A Federal Food Safety and Quality Program which is part of the U.S. Department of Commerce. Collectively, these agencies are responsible for assuring the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions. In fiscal year 1989 these six agencies devoted over $800, million and almost 17,000 staff years to their food safety and quality activities. FDA and USDAtogether had about 92 percent of the funding and about 96 percent of the staffing. . The fragmentation of responsibility for carrying out food safety and quality laws has required extensive efforts by federal regulatory agen- cies to coordinate their activities. We identified 51 different interagency agreementsinvolving the six agenciesdirected at avoiding wasteful duplication of effort, preventing gaps in coverage,and avoiding con- flicting actions. l The four agenciesthat had comparable data-EPA, FDA,FGIS,and FSIS- had less staff and less funds (in constant dollars) available to carry out their food safety and quality activities in fiscal year 1989 compared with 1980. Moreover, all four agenciesgenerally had larger work loads related to food safety and quality in fiscal year 1989 than in 1980. Two agencies-AMs and NMPs-did not have comparable data for their food safety and quality activities for fiscal years 1980 and 1989. However, available data for AMSshow that funding (in constant dollars) decreased from fiscal year 1980 to 1989 and that staffing decreasedfrom fiscal year 1986 to 1989. NMFS’ funding data for the early 1980swere not available. However, NMFS’ staffing level increased between the early 1980s and 1989, while the amount of seafood it inspected decreased between 1981 and 1989. We did not evaluate the impact that the changesin funding, staffing, and work load had on the effectiveness of the agencies’food safety and quality activities. . Officials of the agenciesgenerally agreed that microbiological contami- nation (e.g., bacteria and viruses) and pesticide/chemical contamination of foods will be the critical food safety and quality issuesof the 1990s. Beyond these two issues,concernswere focused primarily on issuesthat pertained to each agency’s area of jurisdiction or responsibility. USDAestimates that U.S. consumerspurchased about $513 billion worth Background of food in 1989. Federal laws place on manufacturers the basic responsi- bility for processingfood under sanitary conditions and for producing wholesome and safe products. But consumersalso rely on the US. food ” safety and quality regulatory system, which includes state, local, fed- eral, and international agencies,to ensure the quality and safety of food products. Becauseof the combined efforts of the food industry and the regulatory agencies,the U.S. food supply is generally recognizedas one Page 2 GAO/RCED-91-19A Federal Food Safety and Quality Programs of the safest in the world. Nonetheless,the Centers for DiseaseControl estimates that about 6 million casesof illness and 9,000 deaths from foodborne diseaseoccur each year in the United States. Federal legislation regulating food safety and quality has evolved piece- meal over many decadesto address particular risks to public health. For example, the first federal comprehensivefood law-the Pure Food and Drug Act-became law in 1906. This act and other old food safety and quality statutes have been amendedover time and new legislation has been enacted to address specific concerns about the safety of the food supply, such as the use of chemicals to color and preserve food, the use of drugs in food animals, the large-scaleuse of pesticides on food crops, and technological changesin handling, processing,and packaging food. The six agenciesperform a broad array of activities relating to food reg- The Federal Food ulation. Their programs Safety and Quality Regulatory System Is l set standards for what processedfoods should contain; approve facilities, equipment, and processesused in preparing foods; Complex and : approve additives, animal drugs, or pesticides before their marketing or Fragmented . use; set tolerances for acceptableamounts of pesticides and other chemical residues in food; . inspect food and food processingfacilities, including testing food for illegal residues; . determine what information labels should contain and what packaging is acceptable;and l monitor state and local inspection programs for food retail and service establishments. In carrying out their legislative responsibilities, the six agenciesoften perform similar types of activities. For example, most agenciesconduct food-related research, inspect food processingestablishments,collect and analyze food samplesfor pesticide and other chemical contami- nants, and develop food standards. Their specific responsibilities are as follows: . FDAensures that domestic and imported food products (except for meat and poultry products) are safe, sanitary, nutritious, and wholesome and are honestly labeled. FDA shares responsibility for egg products with Page 9 GAO/lZCED91-19A Federal Food Safety and Qua.lIty Programs AMS; the latter agency inspects egg products plants, while FDA has juris- diction over restaurants, food-manufacturing plants, and similar estab- lishments that serve eggs or use them in their products, FDA is also responsible for pre-approval and surveillance of animal drugs and food additives in feeds marketed in interstate commerce. l FSIS ensures that meat and poultry products moving in interstate and foreign commerce for use as human food are safe, wholesome, and cor- rectly marked, labeled, and packaged. l AMSensures the safety of shell eggsmoving in consumer channels and egg products produced by processing plants involved in intrastate, inter- state, and foreign commerce.AMS also performs food quality services such as commodity standardization, inspection, and grading services upon request for dairy, egg, fruit, meat, poultry, and vegetable products. l FGIS inspects corn, sorghum, and rice for aflatoxin (a natural contami- nant considered to be carcinogenic) as well as the quality of domestic and exported grain, rice, and related commodities. . EPA regulates all pesticide products sold or distributed in the United States and establishes tolerances (maximum legal limits) for pesticide residues in or on food commodities and animal feed. l NMFS conducts a voluntary seafood inspection and grading program, which is primarily a food quality activity, and performs research on sea- food safety. The federal resources devoted to food safety and quality activities vary considerably among the six agencies.Table 1 shows their fiscal year 1989 funding and staffing levels. FSIS-the largest in terms of resources used-accounted for about 66 percent of the total funds and 62 percent of the total staff years used by these agenciesin fiscal year 1989. In con- trast, FDA’Sshare amounted to about 19 percent of the total funds and about 14 percent of the staff years. NMFS had the least resources, accounting for only about 1.6 percent of both the total funds and total staff years. Page 4 GAO/RCJDQl-19A Federal Food Safety and Quality Programe B-240663 . Table 1: 81x Phnolpal Federal Agencies’ Flrcal Year 1989 Fundlng and Staffing Dollars in millions Level8 FY 1989 funding FY 1969 staffing Agency Amount Percent Number Percent FSIS $457 55.7 10,399 61.7 FDA 158 19.2 2,337 13.8 AMS 97 11.8 2,372 14.1 EPA 55 6.7 624 3.7 FGIS 42 5.1 860 5.1 NMFS 12 1.5 265 1.6 Total $821 100.0 16.657 100.0 To facilitate the use of the information we developed on federal efforts to ensure food safety and quality, we compiled several summary tables that characterize these activities in different ways. We have included these tables as appendixes to this report. Appendix I lists the principal food safety and quality legislation and the federal agenciesresponsible for implementing the legislation. Appendix II provides major provisions of principal food safety and quality legislation. Appendix III provides information on the legislative responsibilities, programs, and fiscal year 1989 staffing and funding levels for the principal agencies.Appendix IV lists food safety and quality activities carried out by federal agencies. Appendix V shows which agenciesregulate, monitor, or perform quality grading services for various food industries. In light of the many laws and agenciesinvolved in regulating the U.S. Federal Interagency food supply, it is essential that the federal government coordinate its Coordination Is activities. Coordination is needed, among other things, to help ensure Extensive effective use of resources,avoid duplication of effort, prevent gaps in coverage,and avoid conflicting actions. According to our analysis, 61 written interagency agreementsare aimed at addressing potential problems in federal food safety and quality. The agreementsvary in scope,detail, and number of agenciesinvolved. For example, some are between two agenciesand are lim ited in scope,such as the agreementbetween AMS and FDAinvolving the effective control of the aflatoxin problem in peanuts destined for consumerconsumption. Other agreementsare with several agenciesand are broader in scope, such as the agreementamong AMS, EPA, FDA, and FSISconcerning residues of drugs, pesticides, and environmental contaminants in food. (Seeapp. VI for examples of the agreements.) Page 6 GAO/WED-91-19A Federal Food Safety and Quality Programm These interagency agreementsare necessaryfor a variety of reasons. The following two examples illustrate the nature of the agreements: . EPAhas statutory responsibility for establishing tolerances for pesticide residues on food and animal feeds, while FDAis responsible for estab- lishing tolerances for other chemical residues on food. Statutory respon- sibility for enforcing the tolerances is vested in FSISfor meat and poultry products, AMYfor egg products, and FDA for all other foods. AMS, EPA, FDA, and FSIShave an interagency agreementthat establishesthe.working relationships for promoting more effective, efficient, and coordinated federal regulatory activities concerning residues that may adulterate food, EPA is to notify FDAand USDAof any pesticide use it encounters that may have resulted in residues that adulterate human food or animal feed. FDAis to notify (1) EPA of possible misuse of pesticides or chemical substancesthat may indicate a violation of EPA'S laws and (2) USDAof illegal residues of drugs, pesticides, or environmental contaminants in human food or animal feed that indicate that the residues may also be present in meat, poultry, or egg products. USDA is to notify FDA of find- ings of illegal residues in edible meat, poultry, or egg products and to keep FLN and EPA informed of all FSISand AMS sampling and testing pro- grams for illegal residues. l Fishery products plants that are under NMFS voluntary inspection con- tracts are also subject to FDAinspection under the Federal Food, Drug, and CosmeticAct. The agreement covering these plants provides that NMFSis to apply appropriate FDArequirements pertaining to good manu- facturing practices, labeling, food additives, tolerances, standards of identity, minimum quality, and fill of containers. NMF$ is to notify FDA if inspections reveal violations of mandatory FDA requirements, and FDAis to notify NMFSof any official FDAactions to seizefishery products processedor packed in NMFB-inspected plants. FE@had the most interagency agreementsbecauseit is responsible for the safety of most food types and uses the personnel and results of other federal agency inspection and quality-grading programs to help carry out its food safety mission. In fiscal year 1989 FDA had 2’7inter- agency agreementsrelating to food safety and quality with other federal agencies,primarily UsnA. Page6 GAO/lUXD-@1-19A Fedeml Food Safety and Quality Programs B-240063 Available data show that the resources of four agencieshave decreased Federal Resources since 1980 while their work loads related to food safety and quality Have Decreased While have increased. We requested that the six agenciesprovide data on their Work Loads InCreased Have in the 1 g80S food safety and quality resources and inspection activities for fiscal years 1980439.Four agencies-EPA, FDA, FWS, and MS-were able to pro- vide us with comparable staffing and funding data for 1980 and 1989 to allow a comparison of the resources available for those 2 years. (App. VII provides the details of the data submitted.) Each of the four agencieshad less staff available to carry out its food safety and quality activities in fiscal year 1989 than in 1980. FGIS had about 58 percent less, EPA about 17 percent less, FDA about 8 percent less, and ISIS about 6 percent less staff in fiscal year 1989 than in 1980. Although EPA, FDA, and FGIS had smaller staffs in fiscal year 1989 than in 1980, their staffs have increased since fiscal year 1985. Each of the four agenciesalso had less funds (in constant 1989 dollars) available in fiscal year 1989 than in 1980. FGIS had about SOpercent less funds, EPA and FDAeach about 8 percent less, and FSIS about 3 percent less. Despite less staff and less funds in fiscal year 1989, these four agencies generally had larger work loads in fiscal year 1989 than in 1980. For example, IBIS inspected about 38 percent more pounds of meat and poultry products and analyzed about 182 percent more laboratory sam- ples in fiscal year 1989 than in 1980. FGIS inspected about 7 percent more tons of grain in fiscal year 1989 than in 1980. Two agencies,AMS and NMFS, did not have comparable data for their food safety and quality activities for fiscal years 1980 and 1989, principally becauseof changesin organization and/or responsibilities or the destruction of data pursuant to agency records retention guidelines. However, available data for AMS' two largest programs, which accounted for about 96 percent of the agency’s fiscal year 1989 funding, show that AMS’funding decreasedabout 6 percent (in constant dollars) from fiscal year 1980 to 1989 and that its staffing decreasedabout 3 percent from fiscal year 1986 to 1989. NMFS' funding data for the early 1980s were not available. However, NMFS' direct inspection staff increased about 30 percent from the early 1980s to 1989. During this time the average number of plants participating in the voluntary seafood inspection pro- gram increased by about 50 percent, while the pounds of seafood NMFS inspected decreasedabout 10 percent from 1981 to 1989. Page 7 GAO/RCED-91.19A Federal Food Safety and Quality Programs When asked what they believed would be the critical food safety and Critical Food Safety quality issues of the 199Os,officials of the six agenciesmost often men- and Quality Issues of tioned microbiological contamination and pesticide/chemical contamina- the 1990s - tion of foods, Several agenciesalso expressed concern about issues such as the safety of new food processing technology; the safety of new tech- nology such as vacuum and modified-atmosphere packaging; nutritional and other product labeling; and the public’s perception of food safety. In addition to broader issues,most agencieswere concerned about crit- ical food safety and quality issues that pertained to their areas of juris- diction or responsibility. For example, NMFS was concerned about adequate water of acceptable quality in seafood processing facilities. EPA had several issues relating to the present law governing pesticide regula- tion, such as the need for improved authority to remove questionable pesticides from the market; and enhanced enforcement authority. (See app. VIII.) In addition to the six major agencies,six other federal agenciescarry out Other Federal important, but less significant, food safety and quality activities. Their Agencies Involved responsibilities and the fiscal year 1989 funding and staff years for the With Food Safety and three agenciesable to identify the amount of resources devoted to food safety and quality follow: Quality . USDA’S Agricultural ResearchService (ARS) performs food safety research, such as developing a methodology for detecting and control- ling bacterial contamination of meat and poultry products. During fiscal year 1989 ARS used 168 scientist years and about $25 million for food safety and quality activities. l USDA'S Animal and Plant Health Inspection Service (APHIS) protects the nation’s animal and plant resources from diseasesand pests that indi- rectly affect food safety. . The Treasury Department’s Bureau of Alcohol, Tobacco and Firearms enforces the laws that cover the production, distribution, and labeling of alcoholic beverages,except wine beveragesthat contain less than 7 per- cent alcohol, which are the responsibility of FDA. By agreement with FDA the Bureau also has primary federal responsibility for ensuring the safety of alcoholic beverages. . The Treasury Department’s Customs Service assists other federal food safety and quality agenciesin carrying out their responsibilities relating to imported foods, such as collecting samplesof imports. . HHS' Centers for DiseaseControl engagesin public health activities related to food safety and quality, such as monitoring, identifying, and Page 8 GAO/RCED-91.19A Federal Food Safety and Quality Programs B240063 investigating foodborne disease problems to determine their contrib- uting factors. In fiscal year 1989 the Centers for Disease Control used about 25 staff years and about $2.6 million for food safety and quality activities. l The Federal Trade Commission regulates food advertising. In fiscal year 1989 the Federal Trade Commission used about 29 staff years and about $2 million for food safety and quality activities. To accomplish our objectives, we discussedwith officials of each federal Scope and agency included in our review its food safety and quality activities. We Methodology also gathered from the agenciestheir budget data and other program information relating to food safety and quality. Although other federal agenciesare involved with food safety and quality activities, we determined that the 12 agenciesdiscussedin this report had the most significant roles. Our methodology for determining which agenciesto include was based on identifying (1) the principal fed- eral food safety and quality legislation, (2) the agenciesresponsible for implementing the legislation, and (3) the agencieswith which the imple- menting agenciescoordinated their activities. We made our review from June 1989 through June 1990 in accordance with generally accepted government auditing standards. We did not verify the accuracy of the data and information the agenciesprovided to us becauseof the enormous volume provided. We discussedthe information contained in this report with responsible AMS, EPA, FDA, FGIS, ISIS, and NMFS officials, who generally agreed with the f+cts. Their comments have been incorporated into the report where appropriate. As requested, we did not obtain official agency comments on the report. Appendix IX to this report discussesfederal food safety and quality activities for meat and poultry products to illustrate the complexity and fragmentation of the federal system for regulating food safety and quality. A companion volume to this report, Food Safety and Quality: Who Does What in the Federal Government (GAOIRCED-91-iSB), presents more details on the food safety and quality activities of the 12 federal agenciesdiscussedin this volume. Information is included on (1) major legislation, (2) organizational units and responsibilities, (3) program activities, (4) funding levels, (5) staffing levels, (6) agreementswith Page 9 GAO/RCED-91-19A Federal Food Safety and Quality Programs other federal agencies,and (7) critical food safety and quality issuesof the 1990s. As arranged with your offices, unless you publicly announceits contents earlier, we plan no further distribution of this report until 30 days from the date of this letter. At that time, we will send copies to the Secretary of Agriculture; the Secretary of Commerce;the Secretary of Health and Human Services;the Commissioner,Food and Drug Administration; the Administrator, Environmental Protection Agency; and other interested parties. Pleasecall me on (202) 275-5138 if you have any questions concerning the report. Other major contributors to this report are listed in appendix X. John W. Harman Director, Food and Agriculture Issues Page 10 GAO/RCED-91.19A Federal Food Safety and Quality Programs Page 11 GAO/RCED-9149A Federal Food Safety and Quality Pmgrama Letter Appendix I 16 Principal Food Safety and Quality Legislation and Federal Agencies Responsible for Implementation Appendix II Major Provisions of Principal Food Safety and Quality Legislation Appendix III Responsibilities, Funding, and Staffing of Principal Federal Agencies Involved With Food Safety and Quality Appendix IV 22 Types of Food Safety and Quality Activities Carried Out by Principal Federal Agencies * Page 12 GAO/NED-91-19A Federal Food Safety and Quality Prorprme Appendix V 23 Federal Agencies Responsible for Regulating, Monitoring, or Performing Quality Grading Services for Various Food Industries Appendix VI 24 Examples of Federal Interagency Agreements Relating to Food Safety and Quality Appendix VII 25 Changes in Staffing and Funding Levels of Principal Federal Agencies Involved With Food Safety and Quality Activities, Fiscal Years 1980, 1985, and 1989 Page 13 GAO/RCED91-19A Federal had StUety and Quality Programe C4mtenta Appendix VIII 26 Critical Food Safety Issues of the 1990s as Perceived by Officials of Principal Federal Agencies Appendix IX 27 Federal Food Safety Size and Makeup of the Meat and Poultry Industry 27 Federal Legislative Responsibilities 27 and Quality Activities Major Federal Activities 29 Relating to Meat and Federal Interagency Agreements 29 Poultry Products Relationship to State Inspection Programs 30 Critical Food Safety Issues of the 1990s 30 Appendix X 32 Major Contributors to This Report Table Table 1: Six Principal Federal Agencies’Fiscal Year 1989 Funding and Staffing Levels Page 14 GAO/RCJSD-91.19A Federal Faod Safety and Quality Program8 Content6 Abbreviations AMA Agricultural Marketing Act AMS Agricultural Marketing Service APHIS Animal and Plant Health Inspection Service ARS Agricultural ResearchService CDC Centers for DiseaseControl EPA Environmental Protection Agency EPIA Egg Products Inspection Act FDA Food and Drug Administration FFDCA Federal Food, Drug, and Cosmetic Act FGIS Federal Grain Inspection Service FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FMIA Federal Meat Inspection Act ISIS Food Safety and Inspection Service FY fiscal year GAO General Accounting Office HHS Department of Health and Human Services NMFS National Marine Fisheries Service NOAA National Oceanic and Atmospheric Administration PHSA Public Health Service Act PPIA Poultry Products Inspection Act USDA U.S. Department of Agriculture USGSA U.S. Grain Standards Act Page 15 GAO/RCED-91-19A Federal Foad Safety and Quality Frogcanw Appendix I principal Food Safety and Quality Legislation and FederalAgenciesResponsible for Implementation USDA LegislatiotV FDA AMS FGIS FSIS EPA NMFS Agncultural Marketing Act of 1946 (AMA) . X x l l X _. r.. _...... -._._. II_.___-.. -- L_ Agricultural Marketing Agreement Act of 1937 . x . . . . _-...-._-- .-_-_ --_-.____ Egg Products Inspection Act (EPIA) X x . . . . - __- - ._..__. _______~_ Federal Anti-Tampering Act X x l x ’ l Federal Food, Drug, .-_. and ___-__. Cosmetic Act (FFDCA) x . . . x . _ ..- .._.._.. --.-l__.“.--__- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) . . . . x l Federal Meat Inspection Act (FMIA) . . . x l l Federal Import Milk Act x . . . . . __..- ._.._I ._..... -.---._-. .-_._.-__ -..--__- Infant Formula Act of 1960 x . . . . ; -...-_-.-. ._. -__--. ~-..---___-___- Lacev Act . . . . . X Maanuson Fisherv Conservation and Manaaement Act . . . . . X . . . . . X - _....-.-__--Ocean Pollution National -...---Research_-. and Development and Monitoring Planning Act Pesticide Monitoring Improvements Act )( . . . . . Poultry Products . . . x . --a . .. . - ..__.. . ..*“.“--.- Inspection .-.. ._------ Act (PPIA) Public Health Service Act (PHSA) x . . . . . Safe Drinking Water Act x . . . x l Toxic Substances Control Act . . . . x l US Grain Standards Act (USGSA) . . x.9 . . aThis lists 18 of the principal laws administered by these six agencies, which also administer 10 other less significant food safety and quality laws. Page 16 GAO/RCED-91-19A Federal Food Safety and Quality Frograms Appendix II Major Provisions of Principal Food Safety and &uality Legislation The Agricultural Marketing Act of 1946 authorizes the Secretary of Agriculture to provide services upon request to inspect, certify, and identify the class, quality, quantity, and condition of agricultural prod- ucts shipped or received in interstate commerce.The act also authorizes the Secretary to develop and improve standards of quality, quantity, condition, grade, and packaging and to recommendand demonstrate such standards in order to encourageuniformity and consistency in commercial practices. AM& FGIS, and NMFS develop standards and perform inspection and grading services under the act. AMSis responsible for dairy products, fruits and vegetables,livestock, meat, poultry, rabbits, and shell eggs. FGIS is responsible for rice, pulses, processedgrain products, hops, and related commodities.NMF-Sis responsible for fish and shellfish. The Agricultural Marketing Agreement Act of 1937 authorizes the establishment of programs and agreementsto regulate the quality, quantity, or container or pack requirements for fruits, vegetables,and certain specialty crops and to regulate the minimum prices paid to pro- ducers of milk and dairy products. The act also requires the regulation of certain of these commodities imported into the United States when- ever domestic shipments of the commodities are subject to quality regu- lations under a marketing order. The Egg Products Inspection Act (1) requires continuous AMS inspection of all egg products processingplants; (2) requires mandatory quarterly inspections of shell egg handlers packing for consumer sales;(3) restricts certain types of shell eggsfrom moving into consumer chan- nels; and (4) prohibits state or local governments from imposing stan- dards differing from official USDA standards for grade and size of eggs moving in interstate commerce.Under the act AMS is responsible for inspecting egg product processingplants and firms marketing eggs, while FDA is responsible for restaurants, institutions, and food manufac- turing establishments that serve eggsor use them in their products. The Federal Anti-Tampering Act provides for monetary penalties and imprisonment for tampering with consumer products, including food, and their labeling and packaging that affect interstate and foreign com- merce. The act gives FDA, USDA, and the Federal Bureau of Investigation the authority to follow up on tampering violations. Page 17 GAO/RCED-91.19A Federal Food Safety and Quality Programs Appendix II Mlajor Provleiona of Principal Food Safety and Quality Legislation The Federal Food, Drug, and Cosmetic Act authorizes FDA to (1) regulate food (except meat, poultry, and egg products, which are covered by sep- arate legislation and are USDA'S responsibility) production and manufac- turing to ensure that food is safe, clean, and wholesome and (2) establish reasonable standards of identity, quality, and fill of container for food products. The act also (1) requires FDA to review and approve food and color additives before they can be marketed and (2) prohibits the interstate commerceof adulterated foods and false or misleading labeling of food products. Under the act EPA is responsible for setting tolerances for pesticide residues on food commodities and animal feed marketed in the United States. The act also directs FDA to maintain surveillance of all animal drugs, feeds, and veterinary devices marketed in interstate commerceto ensure their compliance with the act. The act requires that all animal drugs that are not generally recognized as safe and effective be approved by FDA before marketing on the basis of studies made by the sponsor. The Federal Insecticide, Fungicide, and Rodenticide Act requires EPA to register pesticide products, specify the terms and conditions of their use prior to being marketed, and remove unreasonably hazardous pesticides from the marketplace. The act requires EPA to take into account the eco- nomic, social, and environmental costs and benefits in making decisions. The Federal Meat Inspection Act requires FSIS to administer an inspec- tion program to ensure that meat and meat products moving in inter- state and foreign commercefor use as human food are safe, wholesome, and correctly marked, labeled, and packaged. The act was amended in 1967 to establish the federal-state cooperative program under which USDA helps fund state inspection programs conducted by state employees for meat sold in intrastate commerce.It also required state inspection programs to be “at least equal to” the federal program and strengthened the regulation of imported meat. Under the Federal Import Milk Act, milk and cream may be imported into the United States only under a permit from the Secretary of Health and Human Services after certain sanitary and other prerequisites have been fulfilled. The InfantFormula Act of 1980 established nutrient requirements for infant formulas and gave FDA authority to establish requirements for quality control, record keeping, reporting, and recall procedures. The act also extended FDA'S factory inspection authority to permit accessto Page 18 GAO/RCED-91-19A Federal Food safety and Quality Program Appendix II h,jor Provbiio~~ of Principal Food Safety and Quality Leglalation manufacturers’records and test results necessaryto determine compliance. The Lacey Act, administered by NMFS, makes it unlawful to deliver, carry, transport, or ship by any means for commercial or noncommercial purposes or sell in interstate or foreign commerceany fish or wildlife that was taken, transported, or sold in violation of any federal, state, or foreign law or regulation. NMFS investigates alleged violations of the act. The Magnuson Fishery Conservation and ManagementAct, administered by NMF-S,requires fishery resources to be used to the greatest overall benefit to the nation, with specific reference to the use of the nation’s fishery resources as food. The act includes a mandate for NMFS program- matic activities to, among other things, maximize the quality of seafood products to ensure the greatest economicreturn for harvested resources. The National OceanPollution Researchand Development and Moni- toring Planning Act of 1978 requires the National Oceanicand Atmos- pheric Administration (NOAA) to develop the necessarybase of information to protect public health and provide for the rational, effi- cient, and equitable conservation and development of ocean and coastal resources. The Pesticide Monitoring Improvements Act of 1988 requires FDA to (1) develop new, or modify existing, data managementsystems to track, summarize, and evaluate pesticide monitoring data; (2) enter into coop- erative agreementswith foreign countries to obtain pesticide usage data on crops imported from those countries; and (3) develop an analytical methods research plan to guide the development of methods to improve the efficiency of food monitoring. The Poultry Products Inspection Act requires FSIS to administer an inspection program to ensure that poultry and poultry products moving in interstate and foreign commerce for use as human food are safe, wholesome, and correctly marked, labeled, and packaged. The act was amendedin 1968 to establish the federal-state cooperative program under which USDA helps fund state inspection programs conducted by state employeesfor poultry products sold in intrastate commerce.It also required state inspection programs to be “at least equal to” the federal program. The Public Health Service Act provides for federal-state cooperative assistancein preventing the interstate transmission of disease,and thus Page 19 GAO/RCED-91-19A Federal Food Safety and Quality Programs Appendix II Ik!or Provisions of Principal Food Safety and Qudity h&mlat~on establishes FDA’s authority for its programs for sanitation in milk processing, shellfish, restaurant and retail market operations, and inter- state travel conveyances. The Safe Drinking Water Act requires FDA, in consultation with EPA, to establish regulations relating to bottled drinking water standards. Pur- suant to the act FDA has established standards of quality and current good manufacturing practice regulations for processing and bottling waters. EPA has jurisdiction over drinking water produced by municipal systems of a certain size but not over individual private wells. Under the Toxic SubstancesControl Act, EPA controls the manufac- turing, processing, distribution, use, and disposal of chemical substances and mixtures, including those that can adulterate food. The US. Grain Standards Act, administered by FGIS, (1) requires a national inspection and weighing system for grain, (2) requires that most export grain be inspected and weighed, (3) provides for inspection and weighing services for domestic grain upon request, (4) prohibits deceptive practices and criminal acts with respect to inspecting and weighing grain, and (5) provides penalties for violations. The act was amendedin 1981 to require FGIS to collect user fees from official agen- cies (states and private agenciesthat perform inspection and weighing services) to fund the costs associatedwith supervising the federal grain inspection and weighing activities of official agencies. Page 20 GAO/RCED-9149A Federal Food safety and Quality Programs Appendix III Responsibilities,F’unding,and Staffing of Principal Federal AgenciesInvolved W ith Food Safety and Qua&y Millions of dollars Principal FY 1989 FY 1989 Agency Program leglrlation Responsible for funding staffing FDA - Food safety Safety/quality of all foods except meat and FIEA poultry; shares eggs with AMS $132 2,093 Animal drugs and FFDCA Safety/effectiveness of animal drugs and feeds; feeds safetv of food animals 26 244 USDA: ----. - FSIS Meatand poultry FMIA Safety/quality of meat and poultry inspection PPIA 457 10.399 AMS Egg products EPIA Safety/quality of egg products and shell eggs inspection; shell egg surveillance 10 201 Commodity AMA Facilitate marketing of agricultural commodities standardization, inspection, and grading; other a7 2,171 .------~ FGIS Grain standardization; tJJ:SA Facilitate marketing of grain and rice grain/rice inspection and weiqhinq 42 860 NMFS Seafood inspection AMA Voluntary seafood inspection/grading and and research research 12 265 iiEi---- Pesticide registration FIFRA Safety of pesticide products and tolerances FFDCA 55 624 Total 6821 16.667 Page 2 1 GAO/RCED-91-19A Federal Food Safety and Quality Programs Appendix IV Types of Food Safety and Quality Activities Cayried Out by Principal FederalAgencies USDA Activity FDA AMS FGIS FSIS EPA NMFS Inspections X X X X X X Quality grading . X x l l X Collect/analvze samples X X X X X X Research X a a a X X Develop standards for: Foodsicroos X X x l l X Facilities . X . . Equipment . X X x l l Processing procedures X x l x l ’ Labels X x l l x l Packapinp . x l l X X Approve before use: Facilities . x . x l l Eauipment . X X x l l Processino procedures . x l x l l Product recipes/formulas . x l x l X Labels . x l X x l Packaging . x . . . . Food colors/additives x . . . . . Animal drugs/food additives x . l . . . Pesticide products . . . . x l Set residue tolerances for: Pesticides . . . . x l Other contaminants )( . . . . . aAgricultural Research Service carries out research for AMS, FGIS, and FSIS. Page 22 GAO/RCED-Bl-19A Federal Food Safety and Quality Frograms Appendix V FederalAgenciesResponsiblefor Regulating, Monitoring, or Performing Quality Grading Servicesfor Various Food Industries USDA Food industry -- FDA AMS FGIS FSIS EPA NMFS Dairy ~.~- x x l l x l Eggs/egg products X x l l x l Fruits/vegetables X x l l x l Grain/rice/pulses x l x l x l interstate conveyances x . . . . . Meat and poultry . x l X x l - Restaurants )( . . . . . --- -- Seafood x . . . X X Page 23 GAO/RCED-91-19A Federal Food Safety and Quality Programa Appendix VI Examplesof Federal InteragencyAgreements Relatingto Food Safety and Quality USDA Subject of agreement FDA AMS FGIS FSIS EPA NMFS Coordination of federal regulatory activities concerning residues of drugs, pesticides, and environmental contaminants that may adulterate food X x l X x l Inspection of food manufacturing firms whose facilities are under the jurisdiction of both FSIS and FDA x l l x l l Recall of meat/poultry products prepared in an FSIS-inspected establishment that contain food inaredients recalled bv FDA x l l x l l Jurisdiction relating to administering the Egg Products Inspection Act X x . . . . Coordination of inspection activities relating to dry-milk-product plants under voluntary AMS inspection . programs to determine whether products are contaminated with salmonella microorganisms X x . . . . Coordination of inspection activities at food (including fruits and vegetables) processing plants operating under AMS resident-type inspection/grading contracts which are also subject to FDA inspection X x .#. . . Coordination of inspection activities at facilities that process, hold, or distribute rain rice, or pulses where an F GIS ‘Inspector . or licensee is stationed which are also subiect to FDA inspection x l x . . . Coordination of inspection activities at fishery products’plants under NMFS voluntary inspection contracts which are also subject to FDA inspection )( . . . . X Page 24 GAO/WED-91-ISA Federal Food Safety and Quality Programs Appendix VII Changesin Staffing and Funding Levels of Principal Federal AgenciesInvolved W ith Food Safety and Quality Activities, Fiscal Years 1980, 1985,and 1989 . .- Staffing level for fiscal year Agency 1980 1985 1989 FSIS 11,084 10,672 10,399 FDA 2,530 2.336 2.337 FGIS 1,778 739 750 EPA 755 591 __- 624 Funding level for fiscal year Millions of (constant 1989) dollars FSIS $469.1~ $469.5 $457.2 FDA 172.2 155.3 158.3 FGIS 85.3 44.6 42.3 EPA 59.4 51.7 54.7 Note: We did not include AMS and NMFS in this appendix because the agencies did not provide staffing and funding data for all 3 fiscal years, principally because of changes in organization and/or responsibili- ties or destruction of data pursuant to agency records retention guidelines. Page 25 GAO/RCED-91-19A Federal Food Ssfety and Quality Programs Appendix VIII Critical Food Safety Issuesof the 1990s ~&IS Perceivedby Officials of Principal Federal Agencies USDA Food safety issue FDA AMS FGIS FSIS EPA NMFS Microbiological contamination X X X x ’ X Pesticide/chemical contamination X X X X X X Foods produced using biotechnoloov X x l l x . Pollutants/contaminants/toxins in seafood x . . . . X Cleansing of contaminated shellfish l l . l l X Potential hazards associated with new processing, packaging, and marketina techniaues . . . . . X Adequate water of acceptable quality for seafood processing . . . . . X Animal feed produced by biotechnoloov x . . . . . Industrial by-product feed for animals x . . . . . ~___I____ Pesticide/chemical contamination of animal feed x . . . x l Lengthy FIFRA cancellation process l l l l x l Compatibility of FFDCA and FIFRA tolerance provisions . . . . x l Difficulty in removing pesticides from the market . . . . x l Weak FIFRA penalties for violations . . . . x l Page 26 GAO/RCED?)l-19A Federal Food Safety and Quality Programs Appendix IX FederalFood Safety and Quality Activities Relatingto Meat and Poultry Products The current federal food safety and quality system, which is complex and fragmented, relies on the cooperation of federal, state, local, and international agenciesand private industry. Meat and poultry safety and quality activities illustrate this complexity and fragmentation. This appendix presents information on the size and makeup of the industry, federal legislative responsibilities, federal food safety and quality activities, federal interagency agreements,relationship to state inspection programs, and critical food safety issuesof the 1990s related to meat and poultry. FSISis the principal federal agency performing meat and poultry safety and quality activities. Other federal agencies,such as FDA, EPA, AMS, APHIS, and ARS, also carry out meat and poultry safety and quality activities. According to FSIS, in fiscal year 1989: Size and Makeup of the Meat and Poultry . About 6,700 meat and poultry plants throughout the United States and Industry . 220 official import establishments were subject to federal inspection. All of the federally inspected meat plants and federally inspected poultry plants were eligible to receive voluntary grading and certifica- tion services from Ms. . About 6,700 meat and poultry plants engagedin intrastate commerce were inspected by states under their own meat and poultry inspection programs. . About 1,400 plants in 34 countries were certified by FSISto export meat or poultry to the United States. . About 2.6 billion pounds of meat and poultry were imported into the United States and about 2.6 billion pounds were exported. Further, FDA estimates that about 80 percent of the livestock and poultry in the United States is treated with some animal drug or feed additive and that its animal drug data system contains information on over 12,000 animal drug products. FSIS is responsible for ensuring that the nation’s commercial supply of Federal Legislative meat and poultry products is safe, wholesome,and correctly marked, ResponsibiliCes labeled, and packaged,as required by law. In carrying out its responsi- bilities, FSIS Page 27 GAO/RCED-ol-19A Federal Food Safety and Quality Frogram~ Appendix IX Federal Food Safety and QuaUty Activities Relating to Meat and Poultry Products . inspects animals intended for use as food before and after slaughter and supervises the further processing of meat and poultry products; . provides pathological, microbiological, chemical, and other scientific examination of meat and poultry products for disease,infection, con- tamination, or other types of adulteration; . reviews and approves a plant’s plans for facilities, equipment, and pro- cedures to make sure the operation will be sanitary before the plant can begin operating as a federally inspected establishment; 9 reviews and approves formulas and labels of meat products containing over 3 percent fresh meat and poultry products containing 2 percent or more cooked poultry before the products are marketed; . reviews and assessesthe effectiveness of state meat and poultry inspec- tion programs for plants under state jurisdiction to ensure that states apply standards at least equal to those of the federal program; . reviews and assessesforeign inspection systems and plants that export meat and poultry to the United States to ensure that standards are maintained equal to those in the United States; and . reinspects imported meat and poultry products at port of entry to ensure that products meet federal standards. FDA is responsible for ensuring that animal drugs and feeds marketed in interstate commerce are safe and effective and produce no human health hazards when used in food-producing animals. In carrying out its responsibilities, FDA 9 reviews and evaluates applications for new animal drugs and food addi- tives for effectiveness, animal safety, environmental impact, labeling, and human safety; . inspects animal drug manufacturing and distribution facilities and medi- cated-feed manufacturing sites for compliance with FFDCA and FDA regu- lations; and l collects and analyzes animal drug and animal feed samples for compli- ance with FFLXA and FDA regulations. By agreement with FSIS,FDA also is responsible for the safety and quality of meat products containing 3 percent or less fresh meat and poultry products containing less than 2 percent cooked poultry. EPA isresponsible for analyzing potential health impacts and setting tol- erances for pesticide residues on meat and poultry products and animal feeds marketed in the United States. FDA, USDA, and state enforcement agenciesare responsible for enforcing the tolerances. Page 28 GAO/WED-Sl-19A Federal Food Safety and Quality Programa .1 , Appendix M Federal Food Saf’ety and Quality Activities Rdathg t.a Meat and Poultry Products AMSis responsible for developing standards of quality, quantity, condi- tion, grade, and packaging for meat and poultry and for performing grading and inspection services upon request for a fee. APHIS is responsible for conducting programs to prevent communicable animal diseasesof foreign origin from entering the United States and preventing the spread of animal diseasesthrough interstate shipments of livestock. In carrying out its meat and poultry inspection activities during fiscal Major Federal year 1989, FSIS Activities inspected about 35.4 billion pounds of slaughtered meat, inspected about 29.6 billion pounds of slaughtered poultry, inspected about 74.1 billion pounds of processedmeat products, inspected about 80.9 billion pounds of processedpoultry products, inspected about 2.5 billion pounds of imported meat and poultry, and analyzed 564,060 samples of meat and poultry. In performing its voluntary grading and certification services during fiscal year 1989, AMS graded about 14.6 billion pounds of meat, graded about 14.4 billion pounds of poultry, and certified 769 million pounds of meat. Coordination of meat and poultry safety and quality activities takes Federal Interagency place between FSIS, FDA, EPA, AMS, APHIS, and ARS. Following are examples Agreements of the agreements: . FSIS, FDA, EPA, and AMS have an agreement establishing the working rela- tionships for promoting more effective, efficient, and coordinated fed- eral regulatory activities concerning residues of drugs, pesticides, and environmental contaminants that may adulterate meat, poultry, eggs,or animal feed. . FSIS and FDA have an agreement that is intended to minimize duplication of inspection effort by exchanging work planning information and refer- ring violative conditions concerning food manufacturers whose facilities are under the jurisdiction of both FSIS and FDA. Page 29 GAO/WED-Bl-19A Federal Food Safety and Quality Programs Appendix IX Federal Food Safety and Quality Activities Relating to Meat and Poultry Froducte . FSIS and FDA have an agreementpertaining to meat and poultry products that have been manufactured in an rsis-inspectedestablishment and that contain food ingredients that have been recalled by FDA. l FSIS and AMS have an agreement covering meat and poultry plants where ISIS provides mandatory inspection services and AMS provides voluntary grading services. l FSIS and APHIS have an agreementinvolving surveillance, testing, investi- gation, and tracebacks to points of origin of diseasedanimals. . FSIS and ARS have an agreementrelating to planning, budgeting, and managing studies on chemical residues in meat and conducting chemical and m icrobiological analysis on meat samples. . ISIS and ARS have an agreementinvolving research on meat and poultry products done by ARS for ISIS. Relationship to State Pursuant to the Talmadge-AikenAct of 1962, FSIS established coopera- tive agreementswith states to perm it state employeesto carry out Inspection Programs inspection in meat and poultry slaughtering and processingplants. These plants are consideredto be “federally inspected”and thus may sell their products in interstate commerce. Under the federal-state cooperative inspection program , FSIS monitors state inspection programs that inspect meat and poultry products that will be sold only within the state in which they are produced. The pur- pose is to ensure that states apply inspection standards that are at least equal to those of the federal program . About half the states conduct their own meat and poultry inspection programs, and about 5,700 plants are inspected by state programs. If states chooseto end their state inspection programs or cannot maintain the “at least equal to” standard, ISIS must assumeresponsibility for inspection. AMS has cooperative agreementswith 11 states regarding voluntary meat grading and certification services and with all 60 states, the Virgin Islands, and Puerto Rico regarding poultry grading. APHIS cooperateswith states to control and eradicate animal diseases present in the United States, Meat and poultry pose a wide array of potential health problems, Critical Food Safety including m icrobiological contamination such as Salmonellaand Listeria Issues of the 1990s monocytogenes;chemical and drug residues from pesticides, animal drugs, and medicated feeds; parasites; and decomposition, Page 30 GAO/NED-91-19A Federal Food Safety and 6juallty Frograma Appendix IX Federal Food Safety and Quality Activities Relating to Meat and Poultry Products According to FSIS, it will face three critical issues during the 1990s.ISIS believes that the United States needs a strong food safety research program to uncover more information about emerging foodborne pathogens (bac- teria and viruses capable of causing diseasein humans) and to find better ways to control all pathogens; more research, including development of additional rapid tests for chemical residue detection, is needed;and it is necessaryto modernize meat and poultry inspection. FDA’sCenter for Veterinary Medicine provided the following list of crit- ical food safety issues of the 1990s: Mycotoxin contamination of grains and other feedstuffs and the control procedures used. Pesticide and industrial chemical contamination of feeds and feed ingredients. Microbiological contamination of feed ingredients and the control proce- dures used. Feed products produced using biotechnology. The by-product feed ingredient industry, especially industrial wastes used as feed ingredients. Drug and chemical residues in meat. Page al GAO/RCED-91-19A Federal Food Safety and Quality Programa Appendix X Major Contributors to This Report c Resources, Clifton W. Fowler, Assistant Director Community, and Edward M. Zadjura, Assistant Director Richard B. Shargots, Evaluator-in-Charge Economic Molly W. MacLeod,Reports Analyst Development Division, Earl P. Williams, Writer-Editor Washington, D.C. Monica L. Nickens, Information ProcessingAssistant (097758) Page 32 GAO/RCED-91-19A Federal Food fhfety and Quality Programs I .._...-.. --......_-.-.-.-.--- ..---..--.--.- -.-----.---.----.----.-.-.--.--.----.--- .- I ‘I’t~lt~~JhtJIlt~ 202-276-6241 ‘I’ht~ first, five copies of each report. are free. Additional copies are s2.00 t~actl. ‘I’tit~w is ii 25% discount on orders for 100 or mow copies mailed t.0 a single i~ddrws.
Food Safety and Quality: Who Does What in the Federal Government
Published by the Government Accountability Office on 1990-12-21.
Below is a raw (and likely hideous) rendition of the original report. (PDF)