B Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997

April 21, 1998

Donna U. Vogt

Analyst in Social Sciences Science, Technology, and Medicine Division

Congressional Research Service

The Library of Congress

NOTE: Formatted from a file version received from Donna U. Vogt.



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B Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997 April 21, 1998 Donna U. Vogt Analyst in Social Sciences Science, Technology, and Medicine Division Congressional Research Service The Library of Congress NOTE: Formatted from a file version received from Donna U. Vogt.

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ABSTRACT This report describes recommendations to change the structure of federal food safety responsibilities and gives the reader background information on the debate over the last five decades over which structure would best improve the system for ensuring "safe" food for U.S. consumers. The report lists all the major efforts that were made from 1949 through 1997 by groups inside and outside the federal government. The sets of recommendations are placed chronologically under one of four categories, depending on which organizational structure the group thought would improve food safety. The categories of organization are as follows: an independent single food safety agency, the U.S. Department of Agriculture, or the Food and Drug Administration, or with the Consumer Product Safety Commission. This product will be updated periodically. See also CRS Issue Brief 98009, Food Safety Issues in the 105th Congress.

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Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997 SUMMARY This report summarizes twenty-one sets of recommendations, made in the last five decades, for changing the organization of federal food safety responsibilities. Since 1906, food safety responsibilities and inspections have been split by product under different laws. Congress passed the Pure Food Act and the Meat Inspection Act on June 30, 1906. Both Acts placed the responsibility for food safety in the U.S. Department of Agriculture (USDA), Division of Chemistry (later Bureau). That Bureau later became the Food and Drug Administration. Over time, USDA kept responsibility for meat safety, while most other foods came to be regulated by the Food and Drug Administration (FDA) of the Public Health Service in the Department of Health and Human Services (DHHS). Recommendations for changing the federal food safety system can be fit into one of four categories. The recommendations proposed that 1) a single, independent institution be given responsibility for all food safety; 2) responsibility for all food products should be returned to USDA; 3) responsibility for all food products should be given to FDA; or 4) responsibility for all food products should be given to the Consumer Product Safety Commission (CPSC). Most of the recommendations had both supporters and critics. Supporters of the first recommendation claim that the agency could promulgate consistent risk-based regulations and inspections for all types of foods, whether meats or canned foods, and increase the confidence of consumers in the U.S. food supply. Critics claim that a single, independent food safety agency would have large start-up costs in an era of tight budgets and would not be able to take advantage of the long-term experience and regulatory organization developed for different foods by USDA and FDA. Supporters of the second recommendation claim that USDA could utilize its nationwide network for new research and enforcement. Critics claim that USDA has little institutional culture to support legal regulatory work. They are also concerned that USDA's mission of supporting and promoting agriculture would interfere with its ability to take regulatory action when needed. Supporters of the third recommendation feel that FDA could use its long-term expertise in combining law and science to regulate consumer products. Critics argue that FDA is not organized to regulate all foods, would have to completely change its orientation, and could be overwhelmed by the process.

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Supporters of the fourth recommendation claim that under the CPSC, the fragmented federal authority for food safety could be modernized and focused on protecting U.S. consumers by strengthening the links to federal and state public health departments. Critics are concerned that food is unlike other products that the CPSC has regulated and may not receive the attention it deserves.

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Contents     Introduction   121     Background   121     Current Federal Food Safety Responsibilities   127     Overlapping Responsibilities   129     Recommendations for Changes in the Federal Organization of Food Safety Responsibilities   130     Food Safety Under a Single, Independent Agency   132     White House Conference on Food, 1969   132     GAO Food Inspection Report, 1970   133     Hearings on S. 3419, Consumer Safety Act of 1972   134     Ralph Nader Report, Sowing the Wind, 1972   136     GAO's Risk-Based Inspection Report, 1992   136     The Durenberger Food Safety Bill, 1993   137     The Torricelli/Bradley Food Safety Bill, 1994   138     The Fazio-Durbin Food Safety Administration Bill, 1997   139     Food Safety Under the U.S. Department of Agriculture   140     The Hoover Commission Report, May 20, 1949   140     Acts Restructuring Meat and Poultry Products Inspection: Wholesome Meat Act of 1967 and the Poultry Products Act of 1968   141     Food Safety Under the Food and Drug Administration   143     HEW Reorganization Directive of March, 1968   143     The Malek Report, December 10, 1969   143     Senate Governmental Affairs Report on Federal Regulation, 1977   144     President Carter's 1978 Government Reorganization Project or White House Study (never released)   145     Lester Crawford, 1980   146     Dr. Sanford Miller, 1989   147     The Edwards FDA Advisory Committee, May 1991   147     National Performance Review, September 1993   148     Carol Tucker Foreman, Safe Food Coalition, October 6, 1993   149     Hearings in Support of the Vice President's National Performance Review Recommendations for Reinventing the Food Safety System, 1993-1994   150     Food Safety Under the Consumer Product Safety Commission   153     The Metzenbaum Bill, 1993   153

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List of Tables Table 1.   Institutional Chronology of Food Safety Responsibilities, 1862-1998   126 Table 2.   Recommendations for Changes in the Federal Organization of Food Safety Responsibilities, 1949-1997   154

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Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-19971 INTRODUCTION At times, consumers have questioned whether the organization of federal food safety efforts works well enough or whether a different system may better serve consumer needs. Questions often revolve around which standards are used when judging whether food is considered safe, and how the federal government should be organized to respond appropriately to food safety concerns. During the past five decades, those concerns have led the executive branch and Congress to consider recommendations for changes in the organization of federal food safety efforts. This report summarizes twenty-one sets of recommendations, presented to the President or to Congress between 1949 and 1997 to change the structure of food safety responsibilities. These recommendations were developed by entities inside and outside the federal government. They have included Presidential and other official commissions, Members and committees of Congress, the U.S. General Accounting Office (GAO), and prominent food policy representatives. All recommendations have influenced the debate on restructuring the federal organization of food safety. Background2 The federal government's role in food safety began when safety questions about food were referred to the Division (later Bureau) of Chemistry within a newly created Department of Agriculture (USDA) in the latter half of the nineteenth century. USDA's role began to increase when, at the turn of the century, developments in transportation systems increasingly brought processed food into growing cities. The residents of those cities lost the ability that villagers had possessed of being first-hand judges of the food they ate. U.S. consumers began questioning the safety of what they were buying in stores and expressed concern about the safety of chemical preservatives being used by commercial food processors to extend the life of meats, dairy products, and vegetables, and sometimes to mask their decomposition. 1   CRS Report 93-955, which this report supersedes, was coauthored by Karen L. Alderson, Library Services Division, Congressional Research Service. 2   Most of the historical material used to prepare this section was provided by Suzanne White Junod, Ph.D., History Office, Food and Drug Administration.

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The conditions of some foods led the Bureau of Chemistry to conduct studies of the extent to which adulterated foods had begun to permeate the nation's food supply. While the chief chemist of USDA at that time, Dr. Harvey W. Wiley, estimated that less than 5% of the nation's food was adulterated, he surmised that the overuse of chemical preservatives such as borax, formaldehyde, benzoate of soda, salicylic acid, and copper salts, commonly used as additives in food, could be harmful to health. Those studies convinced Congress to appropriate funds for Dr. Wiley's famous "poison squad." The squad consisted of a group of young men who were given increasing doses of the chemicals to discover their effects on the human metabolism. Many of the young men became ill when they consumed foods containing preservatives in amounts commonly used at that time. The scientific value of the studies remained questionable, but the effect on the public was dramatic when the results were reported. The "poison squad" stories provoked interest in food safety throughout the country. The time was ripe for federal action. Under pressure from consumer groups and from President Theodore Roosevelt, Congress passed the 1906 Food and Drugs Act on June 30, 1906.3 That Act set up the regulatory role of the federal government for foods other than meat and poultry by prohibiting from interstate commerce the sale of food and drugs that were adulterated and/or misbranded. Adulteration in the act was defined as . . . the intermixture or substitution of substances reducing quality, the abstraction of valuable constituents, the concealment of damage or inferiority, the addition of deleterious ingredients, and the use of spoiled animal or vegetable products.4 Misbranding meant placing false or misleading statements on the label. Yet, food safety involved more than adulteration and misbranding. The 1906 Food and Drugs Act also had a provision for enforcement. It required that adulterated foods not only be seized but also destroyed. In 1905, Upton Sinclair published The Jungle, a book about the way meat was mishandled in Chicago's slaughterhouses. It had a major impact on consumers with meat sales falling around the country by nearly a third almost overnight. Congress appointed a commission to examine the charges made in the book. The commission found that while some of the allegations might have been slightly exaggerated, other evidence showed situations actually worse than portrayed by Sinclair. That evidence was used to convince lawmakers to pass the Meat Inspection Act of 19065, which set sanitary standards for slaughter of animals and for 3   P.L. 59-384, 34 Stat. 768 (1906). 4   Lauffer Hayes and Frank Ruff, "The Administration of the Federal Food and Drugs Act," in Food and Drug Law: Cases and Materials, ed. Peter Barton Hutt and Richard A. Merrill 2nd ed. (Westbury, New York: The Foundation Press, Inc., 1991), 9. 5   P.L. 59-242, 21 U.S.C. §601 et seq.

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meat sold in interstate commerce.6 With the passage of the 1906 Act, USDA began a system of continuous daily inspection in slaughterhouses using organoleptic (sight, smell, touch) means to detect problems. If problems were found, inspectors could instantly condemn carcasses. With the signing of the 1906 Food and Drugs Act, USDA officials in the Bureau of Chemistry emphasized the development of detection methods to find chemical problems in foods. During the 1920's, conflicts sometimes occurred within the department between officials who were charged with promoting the use of chemicals to produce food and regulators who were concerned about food being adulterated by those chemicals. For example, California apple growers at the time used large quantities of arsenic on apples to fight pests. USDA chemists had set a limit for the maximum amount of arsenic residue that could be left on the fruit. Some of the apples had residues that exceeded that limit. The regulators wanted to declare the apples adulterated; other officials did not. The conflict in mission began early in the century. The following statement characterizes it: The Bureau of Chemistry had originated as a research bureau and law enforcement was a superimposed responsibility. The task of undertaking research designated to improve the methods of utilizing agricultural products was frequently in striking conflict with enforcement of the Pure Food and Drugs law. These conflicts arose, first, because there was a constant tendency to stop a research project so as to permit the scientist to assist in acquiring evidence immediately needed in a lawsuit and second, because the objectives of law enforcement frequently did not coincide with increasing the utilization of a particular agricultural product, but instead might retard its utilization.7 In 1927, Dr. Walter Campbell of the Bureau of Chemistry recommended that the Secretary of Agriculture separate the functions of agricultural research and enforcement. At the time, USDA was enforcing several other laws.8 Campbell 6   Meat had been separated from other food for special legislative treatment in 1890 and 1891. Federal inspection began as a means of reassuring European nations that U.S. meats were safe. Europe had banned imports of U.S. pork on the charge that it had caused epidemics of trichinosis. A newspaper scare arose during the Spanish-American War when U.S. packers were blamed for shipping "embalmed beef' that sickened the troops. Investigation attributed some of the trouble to the rapid growth of bacteria in meat exposed to the hot Cuban sun. James Harvey Young, "The Long Struggle for the 1906 Law," FDA Consumer, v. 15, no. 5, June 1981, 16. 7   Michael Brannon,"Organizing and Reorganizing FDA," in Seventy-Fifth Anniversary Commemorative Volume of Food and Drug Law, Food and Drug Law Institute Series, (Washington, D.C., Food Drug Law Institute, 1984), 142. 8   Laws included the Food and Drugs Act (34 Stat. 768 (1906)), the Insecticide Act (7 U.S.C. §121-134), the Caustic Poison Act (15 U.S.C. §410-411), Naval Stores Act (7 U.S.C. §91 et seq.), Federal Import Milk Act (21 U.S.C. §141 et seq.), Filled Milk Act(21 U.S.C. §61 et seq.), and Tea Importation Act(21 U.S.C. §41 et seq.).

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suggested that the Secretary of Agriculture create a Food, Drug, and Insecticide Administration (FDIA) within the Department. Congress supported this suggestion and the 1927 appropriations bill created the FDIA and gave it the responsibility to enforce the 1906 Pure Foods Act.9 Simultaneously, the Secretary created a soil and chemistry bureau to handle research functions. In 1930, USDA dropped ''insecticide" from the agency's title, and its name became the Food and Drug Administration (FDA). FDA's new enforcement responsibilities continued to grow as did the agency's commitment to consumer protection. In 1930, Congress passed an act setting standards for canned foods, but excluding canned meat and milk products from those standards. As the New Deal began in 1933, pressures mounted to pass a new law that would fill the gaps in the 1906 Pure Food and Drugs Act. A tragedy occurred in 1937 that resulted in strengthening the federal role of premarket review of drugs. At least 73, and perhaps over 90, persons died as a result of taking "Elixir Sulfanilamide." Franklin Roosevelt's son had recovered from a near fatal infection using sulfanilamide, a European wonder drug. Problems developed when the producer began using diethylene glycol as a solvent for sulfanilamide without first determining that the solvent was safe. The disaster prompted passage of the 1938 amendments to the law, requiring manufacturers to prove a drug's safety to FDA before marketing the drug. Consumers began to support the idea that there should be federal premarket approval for both drugs and substances added to foods. On June 25, 1938, President Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act of 193810 (FFDCA) that today remains the basic authorizing legislation for food safety. Even though USDA had primary responsibility for food safety for almost 80 years, the new law defined more clearly USDA's authority to regulate livestock and poultry feeds and drugs used in animal disease control. After the 1938 law was passed, President Roosevelt said, "The work of the Food and Drug Administration is unrelated to the basic function of the Department of Agriculture," and he expressed his belief that "the opportunity for the Food and Drug Administration to develop along increasingly constructive lines" lay in the Federal Security Administration.11 In 1940, the President moved FDA out of USDA and into the Federal Security Agency (FSA), a separate part of the executive branch. FSA was a new agency; it had been in existence for only one year. At the time, the FSA mission was to protect the public health, and it had under its jurisdiction the Public Health Service, 9   Donald R. Whitnah, ed., Government Agencies, (Westport, CT: Greenwood Press, 1983), 251. 10   21 U.S.C. §301-392. 11   Brannon, Organizing and Reorganizing FDA, 158.

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the Office of Education, the Civilian Conservation Corps, and the Social Security Administration, among other agencies. FDA's responsibilities within the FSA included regulating food quality, sanitation, and consumer protection. Under the new FFDCA, FDA was also given the authority to test the safety of new products and was given research responsibilities. The agency focused on whether a given substance in foods was "poisonous or deleterious" within the meaning of section 406 of the statute. As an operational rule, FDA sought to ban in the diet any substance that proved toxic to laboratory animals at 1% of their diet. Not everyone agreed with the President's decision about reorganizing FDA. Secretary of Agriculture Henry A. Wallace argued that the meat inspection work of USDA's Bureau of Animal Industry also should be transferred. He claimed, This activity might be associated with other health or public welfare work. Meat inspection is of course a technical job and it seems logical to have the technical inspectors attached to the bureau most competent in this field12 However, President Roosevelt was not persuaded; meat and poultry inspection remained within USDA. The USDA meat inspection system had developed on a parallel track within USDA's Bureau of Chemistry for over 50 years. Veterinarians within the Bureau trained inspectors to spot animal diseases. Those inspectors performed continuous inspections of animals before slaughter and examined every carcass for disease and contamination after slaughter. The system positioned the United States to supply meat to the world during World War II. The war effort was not confined to USDA. Even after FDA was transferred out of USDA, FDA was charged with ensuring the enrichment of breads in 1942 for the soldiers serving in World War II. Several years later (1953), the FSA became the Department of Health, Education, and Welfare (HEW). In 1968, FDA became part of the Public Health Service (PHS) where it added a focus on health and nutrition to its food safety responsibilities. Since the start of federal regulation, food safety has been the primary responsibility of either of two different cabinet agencies, USDA and Department of Health and Human Services (DHHS). Table 1 shows which statute and consequently which organization and department has been responsible for carrying out the statutes' mandates for food safety since the federal government became involved. 12   Memo to President Franklin D. Roosevelt from Henry Wallace, 20 April 1939. Found in Senate Committee on Governmental Affairs, "Food Regulation: A Case Study of USDA and FDA," Chapter 4, Study on Federal Regulation, 95th Cong., 2nd sess., December 1977, S. Rept. 95-91,140.

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the congressional committees who would be responsible for oversight and the appropriation of its funds would be those "whose principal concerns are the health and economic welfare of this countries' citizens, and not those whose principal interests are in the economic welfare of the producers of food or the inspected food industries." The group also suggested that Congress should amend existing food safety laws to provide uniform regulatory authority that would be adequate to monitor and control food-borne health hazards at any point in the country's food production system. The group suggested that all food safety research functions be assigned to the single food safety agency. Finally, the group wanted the agency to fill each decision-making position with people who had appropriate scientific backgrounds. None of those recommendations were in the final National Performance Review report. Some in Congress would have preferred that FSIS absorb all food and seafood inspection responsibilities. For example, House Speaker Thomas S. Foley said that, if USDA regulated all foods, the FDA would be free to concentrate on the safety of drugs.46 Popular Name and Date Carol Tucker Foreman, Safe Food Coalition, October 6, 1993.47 Description and Mission of Group Making Recommendations These recommendations, in the form of a press release issued by the Safe Food Coalition, reflect support for reorganizing food safety functions from the American Public Health Association, Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food and Allied Service Trades AFLCIO; Government Accountability Project; National Consumers League; Public Citizen; Public Voice for Food and Health Policy; United Food and Commodity Workers International Union. Ms. Foreman is a former Assistant Secretary of Agriculture. Summary of Recommendations The press release states that the Safe Food Coalition strongly endorses Vice President Gore's National Performance Review recommendation that would transfer USDA's meat and poultry inspection functions to FDA. The Coalition believes that the inspection of meat and poultry should be a public health program and 46   Kenneth J. Cooper, "Hill Turf Fights May 'Reinvent' Gore Proposals," Washington Post, 13 September 1993, A19; Also see Rodney E. Leonard, "A Single Food Safety Agency," Nutrition Week v. 23, September 1993, 2. 47   Safe Food Coalition, "Safe Food Coalition Endorses Gore Proposal to Consolidate Food Safety Functions," Press Release and Letter to Members of the House, 6 October 1993, Ms. Joy Stevens, FDA/OLA, conversation with author, 2 September 1993.

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should be within the responsibility of a public health agency. In supporting the consolidation of food safety functions within the FDA, the Coalition cited two concerns that they believed prevented USDA from effectively administering an adequate food safety inspection program. First, they believe that USDA knows more about animal health than human health, and second, that USDA cares more about promoting sales of agricultural products than it does about protecting consumers. Dissenting Views Giving the task of regulating meat and poultry to FDA would be similar to "the gnat swallowing the elephant," says a New York Times reporter, Marian Burros, in a newspaper article at the time.48 FDA currently has about 1,042 full time equivalent (FTE) positions to do all types of inspection and to analyze food samples and other products, whereas FSIS of USDA has about 7,500 FTEs to inspect meat and poultry. The types of inspections are somewhat different from one agency to the other. FDA staff pointed out that most FDA inspectors have extensive scientific training. FDA inspectors also make periodic inspections of food plants where they can take samples for laboratory analysis, check temperatures in canning processes, check machinery, and collect information in their evaluations to be able to support any regulatory action that may lead to a legal proceeding. FSIS staff explained that FSIS meat and poultry inspectors rely on constant and daily organoleptic inspection (based on sight, touch, or smell) of products as they flow by on the assembly line. FSIS inspectors can immediately condemn carcasses that do not pass standards. They also can take samples and send them for laboratory analysis, and inspect both the product and the paperwork connected with exports and imports.49 In addition to the organoleptic approach, FSIS inspectors check each meat or poultry plant's Hazard Analysis and Critical Control Point (HACCP) plan and records. Every meat and poultry plant must implement, by the year 2000, a HACCP plan that identifies where hazards occur and what steps are needed to control those hazards.50 48   Marian Burros, "Clinton Plan Would Move Meat and Poultry Inspections to FDA" New York Times, 13 September 1993, A18. 49   Mrs. Joy Stevens, FDA/OLA, telephone conversation with author, 23 September 1993. Will Kerr, USDA/FSIS/BFPB, telephone conversation with author 24 September 1993. 50   Congressional Research Service, Food Safety Issues in the 105th Congress, by Donna U. Vogt, IB98009, March 30, 1998; and Meat and Poultry Inspection Issues, by Jean Rawson, IB 95062, March 1998.

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Popular Name and Date Hearings in Support of the Vice President's National Performance Review Recommendations for Reinventing the Food Safety System, 1993-1994.51 Description and Mission of Group Making Recommendations A series of five hearings of two subcommittees of the House Committee on Government Operations took place during both sessions of the 103rd Congress. The Subcommittee on Human Resources and Intergovernmental Relations held hearings on Nov. 4 and 19, 1993 (both were on USDA's progress in reforming meat and poultry inspection); May 25, 1994 (review of FDA's food safety programs); Sept 28, 1994 (chemical residues and contaminants in food); and a joint hearing with the Subcommittee on Information, Justice, Transportation, and Agriculture on June 16, 1994 (fresh versus frozen chickens and other issues involving USDA's regulation of poultry products). Summary of Recommendations The hearing records contain thousands of pages of testimony and submitted documents from hundreds of experts considering whether the current federal food safety system is adequately protecting U.S. consumers; whether the existing system has a comprehensive federal food safety mission and objective that protects the public's health; and whether Vice President Gore's National Performance Review recommendation to consolidate all federal food safety programs within FDA is warranted. Principally, most of the recommendations discussed the need to revise the food safety system to monitor for microbiological pathogens in the food supply and to prevent food-borne illnesses. Representative Edolphus Towns stated in his opening remarks, "The current federal food safety system is not just fragmented; it is broken. The system is not designed to prevent food-borne disease...There is no question about it. USDA has known for over 20 years that its inspection system cannot detect harmful microbes in meat and poultry, but did absolutely nothing about it." Several witnesses also testified on the need to transfer meat and poultry inspection functions to a "public health" agency because of the perceived conflict in USDA's dual mission, agriculture production and consumer protection. Dissenting Views USDA officials testified that they were implementing a "two track" approach for reforming the meat and poultry safety system: first, to maximize the performance of the current inspection system; and second, to design, test, and implement a regulatory program for the future. A key component of this approach was the Pathogen Reduction Program/Hazard Analysis and Critical Control Point system 51   House Committee on Government Operations, Hearings on Reinventing the Federal Food Safety System, 103rd Cong., 1st and 2nd sess, v. 1 and 2, 1995, Joint Committee Print.

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aimed at reducing the likelihood of harmful microorganisms that could enter the food system anywhere in the production, distribution, and consumption chain. USDA officials and representatives from state agriculture and health departments testified that there was no need to reorganize food safety activities because, in carrying out food safety inspections and other activities, they were ensuring already that the foods under their jurisdictions were safe.  FOOD SAFETY UNDER THE CONSUMER PRODUCT SAFETY COMMISSION  Popular Name The Metzenbaum Bill, 1993.52 Description and Mission of Group Making Recommendations The Food Safety Reform Act of 1993 (S. 1750) was introduced on November 20, 1993, by Senator Metzenbaum and was referred to the Senate Committee on Governmental Affairs. S. 1750 had no cosponsors. Summary of Recommendations The act would have transferred to the Consumer Product Safety Commission (CPSC) all food safety and inspection functions of the USDA and the Departments of the Interior and Commerce, FDA, and EPA. It would have established the position of "Executive Director of Food Safety" in the CPSC, which would be charged with preparing and submitting to the appropriate congressional committees a plan for a nationwide food safety database and the implementation of food inspection techniques. The plan would include hazard analysis of critical control points, rapid pathogen detection, trace-back technology, food irradiation, and other necessary techniques. The purpose of this bill would have been to centralize responsibility for the management of all federal food safety activities into one existing agency to lessen the cost on the federal budget. Dissenting Views Not Available 52   S. 1750 was introduced 20 November 1993.

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Table 2. Recommendations for Changes in the Federal Organization of Food Safety Responsibilities, 1949-1997 (In chronological order) Name and Source Proposed Changes in Organization 1949 The Hoover Commission Report. U.S. Commission on Organization of the Executive Branch of the Government (1947-1949). May 20, 1949. Westport, CT:Greenwood Press, 1970. Recommended that all regulatory functions relating to food products to protect the consumer be transferred to USDA and that those relating to other products be placed under a reorganized Drug Bureau administered by the public health agency. 1968 Department of Health, Education, and Welfare Reorganization Directive of March. Found in: Janssen, Wallace. FDA Since 1962. Vol. 1. Unpublished papers entitled History of the Department of Health, Education and Welfare During the Presidency of Lyndon Baines Johnson. November 1963-January 1969. Placed FDA under the Public Health Service and in July 1968 made FDA a part of the newly created Consumer Protection and Environmental Health Service (CPEHS). FDA received resources devoted to pesticides, shellfish, product safety, and poison control from other Public Health agencies. FDA then began to operate under the Public Health Service Act. 1967-68 Acts Restructuring of Meat and Poultry Inspection: Wholesome Meat Act of 1967, and the Poultry Products Act of 1968. U.S. Department of Agriculture. Economic Research Service. National Economy and History Branch. Agriculture and Rural History Branch. Unpublished chapters from forthcoming history of the Food Safety and Inspection Service. Both required states to have meat and poultry inspections programs "at least equal in rigor to" federally run programs (under APHIS), even though the state inspected plants could still only market their products within the state. Under deadlines of December 1969 (meat) and August 1970 (poultry), states could receive federal matching funds to bring their programs up to federal safety and purity standards. One-year extensions were to be granted under certain conditions. 1969 White House Conference on Food, Nutrition, and Health. Final Report. Washington, D.C. 1969. Recommended that there should be one federal regulatory policy with respect to safety, sanitation, identity, and labeling of foods.

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1969 Malek Report. House Committee on Interstate and Foreign Commerce. Subcommittee on Commerce and Finance. Consumer Product Safety Act. Hearings, 92nd Congress, 2nd sess. Part 3, Nov. 1, 1971-Feb. 3, 1972. Serial No. 92-61. Washington, U.S. Govt. Print. Off., 1972. Recommended that a new Consumer Protection and Environmental Health Service be created, separate from FDA, with FDA becoming a major health agency reporting to the Assistance Sec. for Health and Scientific Affairs. Within FDA, a new Bureau of Foods, Pesticides, and Product Safety and a Bureau of Drugs would be created, each with full responsibility and authority for all activities from initial research to final regulatory action. 1970 General Accounting Office, Need to Reassess Food Inspection Roles of Federal Organizations. Department of Agriculture, Department of Defense, Department of Health Education, and Welfare, Department of the Interior. Report to the Congress by the Comptroller General of the United States. Rept. No. B168966. June 30, 1970. Did not specifically recommend consolidation, but criticized the overlapping inspection activities among USDA, FDA, and other federal agencies. Instead, it recommended that the Director, Bureau of the Budget, make a detailed evaluation of the federal food inspection system to see how to improve its administration and determine if it was feasible to consolidate some of the inspections. 1972 Ralph Nader Report. Wellford, Harrison. Sowing the Wind: A Report from Ralph Nader's Center for Study of Responsive Law on Food Safety and the Chemical Harvest. (New York: Grossman Publishers, 1972), 354. Found that food inspection ''remains embarrassed by departmental conflicts of interest and overlapping jurisdictions in USDA and FDA." In its conclusions, the report recommended that meat inspection and chemical monitoring by USDA and the food inspection functions of FDA be transferred to a new food safety agency to improve the likelihood of protecting the public health.

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1972 Hearings before the U.S. Senate on S. 3419. Senate Committee on Commerce, Consumer Safety Act of 1972, 92nd Cong., 2nd sess., 1972, S.Rept. 92-749. Senate Committee on Government Operations, Subcommittee on Executive Reorganization and Government Research, S.3419, The Consumer Safety Act of 1972, 92nd Cong., 2nd sess., S.Rept. 922. Senate Committee on Labor and Public Welfare, Food, Drug, and Consumer Product Safety Act of 1972, 92nd Cong., 2nd sess., S.Rept. 92-835. The purpose of S. 3419, Consumer Safety Act of 1972, was to establish an independent agency to regulate foods, drugs, and consumer products. The bill would have combined under a single agency, a number of different responsibilities. The purpose of this independent Consumer Safety Agency was to have been to protect consumers against unreasonable risk of injury from hazardous products. The independent agency would have had responsibility to set product safety standards for all consumer products representing unreasonable risk of injury or death. S. 3419 became the umbrella legislation and was called the Food, Drug, and Consumer Product Safety Act of 1972. It passed the Senate on June 21. 1972. 1977, Senate Committee on Governmental Affairs Report. U.S. Congress. Senate. Committee on Governmental Affairs. Study on Federal Regulation. Senate Document No. 95-91, 95th Cong., 2d sess. vol. V. Regulatory Organization. December 1977. p. 140. Recommended a transfer of USDA food regulatory functions to FDA. 1978 President Carter's Government Reorganization Project or White House Study (never released). U.S. Congress. House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, and Related Agencies. Agriculture, Rural Development and Related Agencies Appropriations for 1979. Hearings, Parts 1 and 4, Feb., 1978. Washington, D.C., U.S. Govt. Print. Off., 1978. p. 75 (pt .1), p. 367-371 (pt. 4). Recommended consolidation of all food regulatory functions of FDA. 1980 Lester Crawford Speech. Crawford, Dr. Lester. Critique of Animal Health Regulation. Proceedings of the 84th Annual Meeting. Washington, D.C., U.S. Animal Health Association, 1980. Suggested consolidation of all food safety functions within DHHS, transfer of FDA's divisions of Center of Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM)to USDA, or at least merge CFSAN with CVM.

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1989 Dr. Sanford Miller. Quest for Safe Food: Knowledge and Wisdom. 1989 S. B. Hendricks Memorial Lecture presented by Dr. Sanford A. Miller by USDA, ARS before the American Chemical Society, Miami Beach, Florida. September 11, 1989. U.S. Department of Agriculture. Agricultural Research Service. Washington, D.C., U.S. Govt. Print. Off., 1990. p. 11. Recommended that a special commission be set up to make recommendations on the optimal food safety regulatory process which may be a single agency. 1991 The Edwards Committee Report. U.S. Dept. of Health and Human Services. Advisory Committee on the Food and Drug Administration. Final Report. Charles C. Edwards, Chairman. May 1991. Washington, D.C., 1991. p. iii-iv, 19-24. Recommended that FDA be removed from the Public Health Service (PHS) and the FDA Commissioner report directly to the Secretary of Health and Human Services 1992 Risk-Based Food Safety Inspection. U.S. General Accounting Office. Food Safety and Quality: Uniform, Risk-based Inspection system Needed to Ensure Safe Food Supply. GAO/RCED-92-152, June 1992. Recommended that Congress hold oversight hearings to evaluate options for revamping the federal food safety and quality system, including creating a single food safety agency responsible for administering a uniform set of food safety laws. 1993 S. 1349, Food Safety and Inspection Agency Act was introduced by Senator Durenberger and referred to the Senate Committee on Governmental Affairs, August 3, 1993. Would have placed all food safety and inspection activities in a single, independent agency which would, with the guidance of a 15-person expert commission, set uniform risk-based inspection standards by which food safety would be ensured. In addition, it would have established a state-federal communications network to educate consumers on potential microbial diseases. 1993. National Performance Review. Gore, Al. From Red Tape to Results: Creating a Government that Works Better and Costs Less. Report of the National Performance Review. Washington, D.C. September 7, 1993, 101. Recommended consolidating all federal food safety responsibilities under the FDA.

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1993. Carol Tucker Foreman and the Safe Food Coalition, "Safe Food Coalition Endorses Gore Proposal to Consolidate Food Safety Functions," Press Release and Letter to Members of the House, 6 October 1993 in which they strongly supported the National Performance Review recommendation to move the food safety function of inspection of meat and poultry to the FDA. The Coalition is composed of members of the from the American Public Health Association; Center for Science in the Public Interest; Consumer Federation of America; Consumers Union; Food and Allied Service Trades, AFL-CIO; Government Accountability Project; National Consumers League; Public Citizen; Public Voice for Food and Health Policy; United Food and Commercial Workers International Union. States that the Safe Food Coalition strongly endorses Vice President Gore's National Performance Review recommendation that would transfer USDA's meat and poultry inspection functions to FDA. The Coalition believes that the inspection of meat and poultry should be a public health program and should be within the responsibility of a public health agency. In supporting the consolidation of food safety functions within the FDA, the Coalition cited two concerns that they believed prevented USDA from effectively administering an adequate food safety inspection program. First, they believe that USDA knows more about animal health than human health, and second, that USDA cares more about promoting sales of agricultural products than it does about protecting consumers. 1993 and 1994 Hearings in Support of the Vice President's National Performance Review Recommendations for Reinventing the Food Safety System. House Committee on Government Operations, Hearings, Reinventing the Federal Food Safety System, 103rd Cong., 1st and 2nd Sess., Volume 1 and 2. Washington, D.C.: GPO, 1995. Hearing experts discussed whether the current federal food safety system was adequately protecting U.S. consumers, whether the existing system has a comprehensive federal food safety mission and objective that can protect the public health, and whether Vice President Gore's National Performance Review recommendation to consolidate all federal food safety programs within FDA is warranted. 1993 The Food Safety Reform Act (S. 1750 ) was introduced on November 20, 1993 by Senator Metzenbaum and referred to the Senate Committee on Governmental Affairs. Would have transferred to the Consumer Product Safety Commission (CPSC) all food safety and inspection functions of the USDA, and the Departments of the Interior and Commerce, FDA, and EPA.

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1994 The Katie O'Connell Safe Food Act (H.R. 3751) was introduced on January 26, 1994 by Representative Robert G. Torricelli; it was referred to the House Committees on Energy and Commerce and Agriculture. On February 24, 1994, it was referred to the Commerce Subcommittee on Health and the Environment; and on Feb. 1, 1994 it was referred to the Agriculture Subcommittees on Livestock, and Departmental Operations and Nutrition. On August 2, 1994, Senator Bradley introduced the Katie O'Connell Safe Food Act (S. 2350); it was referred to the Senate Committee on Agriculture, Nutrition, and Forestry. Would have transferred responsibility for enforcing meat, poultry, and egg inspections from FSIS of USDA to an independent federal health agency entitled the Meat, Poultry and Eggs Inspection Agency. 1997 The Safe Food Act of 1997 (H.R. 2801/S. 1465). Rep. Vic Fazio and Sen. Richard Durbin introduced identical bills. On Nov. 4, 1997, H.R. 2801 was referred to the Committees on Agriculture and Commerce and on Nov. 14, 1997, H.R. 2801 was referred to the Subcommittee on Health and the Environment. S. 1465 was introduced on Nov. 9, 1997, and referred to the Committee on Government Affairs. Would consolidate all federal food safety, labeling, and inspection programs into a new single, independent agency known as the Food Safety Administration (FSA). The purpose of the agency would be to identify the most serious public health risks from specific food borne pathogens and use resources to develop improved testing methods, conduct risk assessments, and identify the most cost-effective interventions without regard to the type of food or bureaucratic "turf."

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