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Ensuring Safe Food: From Production to Consumption (1998)

Chapter: Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997

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Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
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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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
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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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
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

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.).

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

Table 1. Institutional Chronology of Food Safety Responsibilities, 1862-1998

Years

Statute/Plan

Name of Organization

Department

1890-1901

Act of March 3, 1891 and Act of March 2, 1895 on exported meats

Division of Chemistry

USDA

1901-1927

1906 Pure Food Act 

1906 Appropriations Act

Bureau of Chemistry and Bureau of Animal Industry

USDA

1927-1930

1906 Pure Food Act 

1906 Appropriations Act

Food, Drug, and Insecticide Administration

USDA

1930-194013

1938 Federal Food, Drug, and Cosmetic Act (FFDCA)

Food and Drug Administration

USDA

1940-1953

Reorganization Plan No. 4, effective June 3, 1940.

Food and Drug Administration

Federal Security Agency

1953-1970

1954 Miller Pesticide Act and 1958 Food Additives Amendment (Delaney Clause) 

1960 Color Additives Amendment (Delaney Clause)

Food and Drug Administration

Department of Health, Education, and Welfare

(1958-1968)

1958 Humane Slaughter Act; 

1967 Wholesome Meat Act; 

1968 Poultry Products Act

Meat Inspection Branch of Agricultural Research Service

USDA

1970-1979

Reorganization Plan No. 3 of 1970; sect. 346, 346a, 348, and 408 of FFDCA and 135-135k of FIFRA

All pesticide regulation responsibilities were transferred to EPA as were all functions of Environmental Quality Branch, Plant Protection Division of Agricultural Research Service

Environmental Protection Agency (EPA)

13  

The name "Food and Drug Administration" was first used in the Agriculture Appropriation Act of 1931 (46 Stat. 32).

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

Years

Statute/Plan

Name of Organization

Department

(1972)

1972 Meat and Poultry Inspection

Food Safety and Inspection Service

USDA

(1968-1979)

Reorganization Plan of March 1968.

Public Health Service Act

Food and Drug Administration Public Health Service

Department of Health, Education, and Welfare

1980-

 

Food and Drug Administration Public Health Services

Department of Health and Human Services

 

Source: Peter Barton Hutt and Richard A. Merrill, eds. Food and Drug Law: Cases and Materials, 2nd ed., (Westbury, New York: The Foundation Press, Inc., 1991), 4-5.

Current Federal Food Safety Responsibilities

Historically, Congress passed laws in reaction to immediate food safety problems. Those laws assigned food safety responsibilities to several executive departments. Today, the primary federal agencies responsible for regulating the safety of the U.S. food supply are the Food and Drug Administration (FDA) under the Public Health Service of the Department of Health and Human Services (DHHS), and the Food Safety and Inspection Service (FSIS) under the U.S. Department of Agriculture (USDA). FDA and USDA together try to ensure that food products, as sold in the United States, will not adversely affect human health.

FDA is charged with ensuring that foods (except meat, poultry, and certain egg products) are safe, nutritious, sanitary, wholesome, and honestly labeled. The primary statute governing FDA's food safety activities is the Federal Food, Drug, and Cosmetic Act (FFDCA).14 FDA monitors whether food manufacturers are adhering to their legal responsibility of ensuring that foods are not defective, unsafe, filthy, or produced under unsanitary conditions. USDA is responsible for

14  

Other relevant statutes are the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended (P.L. 104-61, Stat. 163-172, 1947, 7 U.S.C. §136 et seq.); the Public Health Service Act (Chapter 288, 37 Stat. 309 (1912), 7 U.S.C. §201 et seq.); the Fair Packaging and Labeling Act, as amended (P.L. 89-755, 15 U.S.C. §1451 et seq.); the Federal Meat Inspection Act, as amended (P.L. 90-201, 21 U.S.C. §601 et seq.); the Poultry Products Inspection Act (P.L. 85-172, 21 U.S.C. §451 et seq.); Federal Import Milk Act (P.L. 69625, 21 U.S.C. §141 et seq.); Plant Quarantine Act, as amended (P.L 85-36, 7 U.S.C. §150 et seq.) and the Pesticide Monitoring Improvements Act (P.L. 100-418, 21 U.S.C. § 1401, et seq.).

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

monitoring meat, poultry, and commercially processed egg products under the Federal Meat Inspection Act, as amended, the Poultry Products Inspection Act, as amended, and the Egg Products Inspection Act, as amended. FSIS is directly responsible for the daily inspection of all meat and poultry entering U.S. commerce. FSIS also shares responsibility with FDA on combination products such as stews and pizzas. For example, FSIS regulates all products that contain 2% or more of poultry and poultry products and 3% or more of red meat or red meat products. FDA regulates all other foods.

In total, thirteen agencies in the federal government have food safety responsibilities.15 FDA has three centers conducting and supporting food safety activities: Center for Food Safety and Applied Nutrition (CFSAN), Center for Veterinary Medicine (CVM), and the National Center for Toxicological Research (NCTR). Besides FSIS, the USDA agencies with food safety responsibilities are the Animal and Plant Health Inspection Service (APHIS),which has regulatory programs to protect animals and plants from pests and disease; the Agricultural Research Service (ARS), which conducts a wide range of food safety related research; the Cooperative State Research, Education, and Extension Service (CSREES), which carries out a program of fundamental and applied research in several areas, including food safety and health; and the Economic Research Service (ERS), which provides cost and benefit information on food-borne illnesses. The National Center for Infectious Diseases of the Centers for Disease Control and Prevention (CDC), under DHHS, monitors and investigates food-borne illnesses and diseases and shares that information with the other agencies.

The Environmental Protection Agency (EPA) regulates pesticides and is charged with setting pesticide-residue tolerances for each pesticide-food combination. The Bureau of Alcohol, Tobacco, and Firearms (BATF), of the U.S. Treasury Department, regulates production, distribution, and labeling of alcoholic beverages.16 The National Marine Fisheries Service (NMFS) of the U.S. Department of Commerce conducts a voluntary fee-for-service seafood inspection program. The Federal Trade Commission (FTC) regulates advertising of food products. The U.S. Customs Service of the Department of the Treasury assists FDA by notifying FDA of incoming shipments of products under FDA jurisdiction. FDA officials examine all paperwork and electronic submissions related to these imports and at times collect samples.

In addition, federal agencies work in close collaboration with state officials. Often, federal agencies such as FDA will train and contract with state enforcement officials to conduct food plant inspections. FDA also developed a model ordinance for milk sanitation and a "Food Code" for retail food store and restaurant sanita-

15  

Detailed information on those responsibilities can be found in Congressional Research Service, Food Safety Agencies and Authorities: A Primer, by Jean Rawson and Donna U. Vogt, Report No. 98-91 ENR, 5 February 1998, 6.

16  

FDA is responsible for all nonalcoholic beverages, and wine beverages (i.e. fermented fruit juices) containing less than 7% alcohol.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

tion to be adopted by state legislatures. FDA also works with groups such as the Association of Food and Drug Officials of the United States and the Association of Official Analytical Chemists.17 FDA, in conjunction with the states, regulates animal feed ingredients and feeds as part of the American Association of Feed Control Officials.18

Overlapping Responsibilities

Critics charge that part of the "food safety problem" is that U.S. food safety laws and regulations are fragmentary and inconsistent and are not comprehensive. Critics also claim that too many agencies are responsible for food safety activities. Foods posing similar health risks may be inspected by different agencies at different frequencies. The roles that these agencies play depend for the most part on their statutory authority and their resources. One former official who served in both USDA and FDA said that the fragmentation and diversity of the agencies' authority undercuts the government's accountability for food safety, and he added:

FDA has jurisdiction over plants producing cheese pizza, but rarely inspects such plants. USDA has jurisdiction over plants producing pepperoni pizza, and inspects such plants on a daily basis, after having already inspected both the animal from which the pepperoni was made and the processing of the meat into pepperoni.19

Other examples abound. USDA daily inspects meat and poultry for contamination of various pathogens, including Listeria monocytogenes and E. coli 01 57:H7. At the same time, FDA may inspect once every ten years soft cheeses or apple juice in which those same pathogens have been found. Some believe that it is inappropriate for separate agencies using different risk and inspection criteria to regulate the nation's food supply. These critics also think that the same or similar risk criteria should be used by all federal agencies to prevent microbial contamination on all foods.20

Others charge that safety cannot be properly regulated when food safety responsibility is placed in the hands of the same agency in charge also of promoting

17  

James T. O'Reilly, Food and Drug Administration (Colorado Springs, Colorado: Shepard's/McGraw-Hill, Inc., Oct. 1993).

18  

Edward L. Korwek, 1997 United States Biotechnology Regulations Handbook, vol. 1, (Washington, D.C.:Food and Drug Law Institute, 1997), 112.

19  

Michael R. Taylor, "Preparing America's Food Safety System for the Twenty-First Century - Who is Responsible for What When it Comes to Meeting the Food Safety Challenges of the Consumer-Driven Global Economy?" in Food and Drug Law Journal, vol. 52, n. 1, (Washington, D.C.:Food and Drug Law Institute, 1997) 13.

20  

Dr. Sanford Miller, Professor and Dean, Graduate School of Biomedical Sciences, The University of Texas Health Science Center at San Antonio, telephone conversation with the author, 17 September 1993, (210) 567-3709.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

regulated products. Many think that an organization that promotes and subsidizes production agriculture and other consumer products should be separate from one that watches over food safety.

The meaning of "food safety" responsibilities continues to expand. Food safety functions of federal agencies have come to signify certain responsibilities regarding foods. The responsibilities were aptly defined in an FDA report to Congress:

Under the foods program, FDA sets food standards; evaluates food additives and packaging for potential health hazards; conducts research to reduce food-borne disease to determine specific health impacts of hazardous substances in food and to develop methods for detecting them in foods; and maintains surveillance over foods through plant inspections, laboratory analyses, and legal action where necessary.21

USDA carries out similar functions for meats, poultry, and certain egg products.

Whether all food should be regulated by the same or different agencies is currently under debate. Some argue that a clearer direction to food safety policy could emerge if a single, independent agency were charged with administering all food safety programs. Others oppose forming a single agency, asserting that the various agencies with differing expertise strike a balance among divergent interests.

Recommendations for Changes in the Federal Organization of Food Safety Responsibilities

This report contains 21 separate sets of recommendations that have had a significant impact on the debate over whether the federal organization that ensures safe food needs to be changed. This debate has recurred over 48 years with long periods when little interest was expressed in changing the organization for federal food safety. The debate has been carried on by a range of different entities from major government bodies such as presidential commissions, agency commissions, congressional Members, the General Accounting Office (GAO), to interested parties or influential food policy experts.

The recommendations are grouped chronologically into four categories:

21  

Senate Committee on Agriculture, Rural Development, and Related Agencies, Appropriation Bill, 1990, 101st Cong., 2nd sess., 1989, S.Rept. 101-84, as found in Peter Barton Hutt and Richard A. Merrill, Food and Drug Law: Cases and Materials, 2nd ed. (Westbury, New York: The Foundation Press, Inc., 1991) 21.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
  • a separate, independent food safety agency or some modification of that idea;
  • all food safety functions given to USDA;
  • all food safety functions given to FDA;
  • all food safety functions be given to the Consumer Product Safety Commission.

The recommendations described in this report were selected because each expresses a position on how the federal organization of food safety could be improved or changed. Each recommendation was acknowledged as contributing to the debate in later documents discussing changes in the organization for federal food safety. The gaps in the chronology represent the fluctuating nature of the debate. The recommendations listed also represent all the major official bodies that debated this issue in the last five decades.

No President or Congress has adopted these recommendations. However, the reports and publicity surrounding each set has added to the debate and helped define current food safety responsibilities. Eight sets of the recommendations would have created some type of independent federal entity for the regulation of food safety, with responsibility for all foods. Two would have given all responsibility to USDA, and 10 would have FDA reorganize and regulate the safety of all foods including meat and poultry. One would have the Consumer Product Safety Commission carry out all food safety functions. The most recent proposals appear to be evenly divided between giving food safety responsibility to a single, independent agency or to a reorganized FDA that links food safety explicitly to public health. Table 2, at the end of the report, summarizes in chronological order the selected sets of recommendations presented to Presidents and Congresses from 1949 to 1997 period.

Most of the reports or recommendations examine what are perceived to be five separate issues in food safety:

  • Should food safety be considered to be a public health responsibility only or should it also be linked with research and development of new standards that not only protect consumers but also lead to the development and marketing of new products?
  • Will the cost to the federal government increase or decrease if all activities related to regulating food are combined into a single food safety agency?
  • By competing among each other for food safety resources, have agencies become more or less efficient in carrying out their food safety functions?
  • If Congress and the Administration chose to create an independent food safety agency, should such an agency be independent of or located within the Public Health Service?
  • Would U.S. consumers be better protected by having a uniform set of regulations and laws that covered all foods and were enforced by a single agency?
Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

Some believe that one food safety agency could apply consistent and strong food standards that would assist in building public confidence in the federal system of food safety. Others argue that, although some consumers are very vocal in their distress with the current regulatory framework, it does provide some of the safest, most abundant, and least expensive food in the world.

Most believe that pressures for change will continue focusing mainly on streamlining policies for food, nutrition, and veterinary drug activities. There have always been threads that link the different food safety programs with those of production agriculture and nutrition research.

FOOD SAFETY UNDER A SINGLE, INDEPENDENT AGENCY 

Popular Name and Date

White House Conference on Food, 1969.22

Description and Mission of Group Making Recommendations

President Nixon asked a large group of experts to meet and make recommendations on revising the federal regulatory policy for food and on certain aspects of food, nutrition, and health policy. He requested recommendations regarding administration and operations, community affairs, information, and education. The Conference was chaired by Dr. Jean Mayer, and the deputy chairman was James D. Grant.

Summary of Recommendations

The Conference recommended that there should be one federal regulatory policy with respect to safety, sanitation, identity, and labeling of foods. The Conference also recommended that the Secretary of Health, Education, and Welfare (HEW) issue an order establishing a separate interdepartmental coordinating committee on federal food regulatory policy with the aim of implementing national nutritional and health goals. The committee would be comprised of representatives of all federal departments and agencies having jurisdiction over safety, sanitation, identity, and labeling of any food. Within certain schedules, the committee should issue reports on the progress of reconciling all pertinent federal food policies and practices. The committee should initially consider the question of   

22  

White House Conference on Food, Nutrition, and Health, Final Report, (Washington, D.C.: White House, 1969), 118-119.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

whether a single federal regulatory agency for foods should be established, and particularly whether the jurisdiction of USDA over food products derived from or utilizing inspected meat and poultry should be transferred to HEW.

Dissenting views

Not Available

Popular Name and Date

GAO Food Inspection Report, 1970.23

Description and Mission of Group Making Recommendations

In a letter to the President of the Senate and the Speaker of the House of Representatives, the Comptroller General of the United States presented the results of a review of the roles of federal organizations involved in inspecting food. GAO's authority to conduct the review was contained in the Budget and Accounting Act of 1921 (31 U.S.C. 53); the Accounting and Auditing Act of 1950 (31 U.S.C. 67); and the authority of the Comptroller General to examine contractor's records as set forth in 10 U.S.C. 231(b).

Summary of Recommendations

Federal food inspection evolved from piecemeal legislation and regulations, designed to solve specific problems when they arose. The report claimed that current practice at the time did not clearly express an overall federal policy on food inspection. Many federal, state, and local organizations performed different parts of the food inspection process. Such a process led to some overlap in responsibility and caused dissatisfaction among members of the food industry. Some of the dissatisfaction related to inspections being made for different purposes and with varying intensity. The GAO recommended that the different agencies arrange agreements among themselves to use the skills and experience of each to establish clearer lines of responsibility, and to reduce overlap. The report did concede that those agreements would be time-consuming to arrange and difficult to administer.

Although the report did not specifically recommend consolidation, it criticized the overlapping inspection activities of USDA, FDA, and other federal agencies and the lack of consistency in their requirements, procedures, and concepts. GAO 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 inspection efforts.

23  

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, Rept. No. B-168966, 30 June 1970.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Dissenting views

Most of the federal agencies responsible for food inspections agreed to evaluate their separate functions. However, USDA's comments indicated that agency officials believed that GAO had not properly characterized certain USDA inspection functions. In its response letter, as published in the GAO report, it stated,

Meat inspection, for example, is looked upon primarily as a program for consumer protection or benefit. This it is, but we believe it also facilitates interstate commerce in meats and enhances the market for farm animals sold for meat. Similarly meat grading, while it may be primarily looked upon as a program for facilitating marketing or dealing in meat, is recognized by consumers as a purchasing tool and, we believe as well, benefits the farmer by giving him added assurance of a return related to the quality of the animals sold. On the other hand, the consumer benefits from grading of grain are quite indirect. Performance standards are designed to be uniform whether the service is mandatory or voluntary. Thus procedures and regulations are geared to the particular need. The consumer's interests are expected to be recognized and protected in each case. It is the needs, and not whether the primary beneficiary is the producer, consumer, or industry that determines requirements and methods.

Popular Name and Date

Hearings on S. 3419, Consumer Safety Act of 1972.24

Description and Mission of Group Making Recommendations

Three committees of the Senate held hearings to discuss S. 3419, the Consumer Safety Act of 1972 and its proposal to restructure food safety responsibilities in the federal government. The Commerce Committee held a hearing on April 13, 1972. The Committee on Government Operations, Subcommittee on Executive Reorganization and Government Research held hearings on April 20, 21, May 2, 3, 1972. The Senate Labor and Public Welfare Committee, Subcommittee of Health held hearings on May 2, 3, 1972.

Summary of Recommendations

The report of the Senate Committee on Labor and Public Welfare stated that the purpose of S. 3419, the Consumer Safety Act of 1972, was to establish an independent agency to regulate foods, drugs, and consumer products. The bill

24  

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. 92-2. Senate Committee on Labor and Public Welfare, Food, Drug, and Consumer Product Safety Act of 1972, 92nd Cong., 2nd sess., S.Rept. 92-835.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

would have combined several different responsibilities under a single agency. For example, all FDA's authority to regulate foods and drugs would be transferred, as would the authority, at that time, of the Center for Disease Control over the licensing of certain clinical laboratories. The Department of Commerce and the Federal Trade Commission authority over flammable fabrics and refrigerator doors would be transferred as would USDA's authority over meat and poultry inspection and animal biological drugs. 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 Food, Drug, and Consumer Product Safety Act of 1972.25 It passed the Senate on June 21. 1972. However, the House did not agree with the transfer of functions administered by FDA. In conference, legislators exempted all food, drugs, devices, and cosmetics as defined in the FFDCA from the jurisdiction of the new Consumer Product Safety Commission.

Dissenting Views

The Nixon Administration thought that the establishment of an independent consumer safety agency would prove to be regressive rather than progressive and opposed establishment of an independent ''Consumer Safety Agency." On March 16, 1972, in a press release on S. 3419, Secretary of Health, Education, and Welfare Richardson stated,

I think ... that if the Food and Drug Administration is going to have any problems of digestion of new responsibilities, the problems would be multiplied several fold by the effort to create a new agency duplicating administrative authorities and having to seek scientific capabilities and resources that are already within the Food and Drug Administration.... It is ... much greater if we build upon the experience and capabilities of the Food and Drug Administration, than if we start all over again through the creation of comparatively small, isolated outside body.26

25  

P.L. 92-573.

26  

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. 92-2; Senate Committee on Labor and Public Welfare, Food, Drug, and Consumer Product Safety Act of 1972,2nd Cong., 2nd sess., S.Rept. 92-835.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Popular Name and Year of Document

Ralph Nader Report, Sowing the Wind, 1972.27

Description and Mission of Group Making Recommendations

This report, sponsored by the Center for Study of Responsive Law, was conducted by an interdisciplinary task force of young professionals trained in law and science. Its members conducted research on a wide range of issues, from the fat and chemical content of hot dogs to the potential birth-defect hazards of pesticides. Ralph Nader wrote the introduction to the report. It had some influence on consumer opinion about certain food hazards.

Summary of Recommendations

The report 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 FDA should be transferred to a new food safety agency where the goal of protecting public health would be consolidated. It also suggested that food inspection be included in the responsibilities of the independent "consumer safety agency" under consideration at the time in Congress.

Dissenting Views

Not Available

Popular Name and Date

GAO's Risk-Based Inspection Report, 1992.28

Description and Mission of Group Making Recommendations

GAO published this report in response to a request from the Honorable John D. Dingell, Chairman Subcommittee on Oversight and Investigations, House Committee on Energy and Commerce. GAO's mandate was to examine the consistency, efficiency, and effectiveness of the federal food safety inspection system.

Summary of Recommendations

GAO found that 12 agencies that were involved in food safety inspect similar foods posing similar risks at inconsistent frequencies and under different enforcement authorities. It also found long-standing problems whereby those agencies use

27  

Harrison Wellford, 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.

28  

General Accounting Office, Food Safety and Quality: Uniform, Risk-based Inspection System Needed to Ensure Safe Food Supply, GAO/RCED-92-152, June 1992.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

their inspection resources inefficiently and do not effectively coordinate with each other. GAO 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."

On October 8, 1997, a GAO division director advocated before the Senate Agriculture Committee that all federal food safety functions be assigned to a new agency. He stated that GAO "believes the existing federal food safety structure needs to be replaced with a uniform, risk-based inspection system under a single food safety agency. While some administrative actions can be taken to improve the system, the fundamental changes that are needed will require legislative action."29

Dissenting Views

DHHS officials responded to this GAO report by stating that there was no reason to believe that creating a new single agency would improve basic food safety. FDA, through DHHS, suggested that it could, without new legislation, formally establish regulations that could address the nature and extent of problems encountered by the food production industry; the food industry could be held accountable for self-regulation to an even greater degree; and a policy that compares risks could be established through regulation. The response implied that an independent agency was unnecessary. In addition, FDA claimed that the GAO report failed to analyze some major issues for the food industry such as whether the food industry needs uniformity in regulations by states and international harmonization of standards among countries; whether market promotion activities should be commingled with safety regulation; and whether the potential impact of new food technologies, both in producing and developing new and novel foods, would affect how regulations could ensure food safety.

Popular Name and Date

The Durenberger Food Safety Bill, 1993.30

Description and Mission of Group Making Recommendations

On August 3, 1993, Senator Durenberger introduced S. 1349, the Food Safety and Inspection Agency Act of 1993. It was referred to the Senate Committee on Governmental Affairs. There were no hearings on this bill.

29  

Robert A. Robinson, Director, Food and Agriculture Issues, RCED/GAO, "Food Safety: Fundamental Changes Needed to Improve the Nation's Food Safety System," statement for the record before the Senate Committee on Agriculture, Nutrition, and Forestry, 8 October 1997.

30  

S. 1349 was introduced by Senator Durenberger on 3 August 1993.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Summary of Recommendations

The act, if passed, would have placed all food safety and inspection activities in a single, independent agency that, with the guidance of a 15-person expert commission, would have set uniform risk-based inspection standards by which food safety could be ensured. It also would have established a state-federal communications network to educate consumers on potential microbial diseases.

Dissenting Views

Some critics claimed that the proposed bill did not clearly define what a uniform risk-based safety system was or how the existing two separate field-inspection systems would be organized. Also, critics claimed that this bill would have cost the federal government more to create a new agency than to transfer responsibility to an existing agency.

Popular Name and Date

The Torricelli/Bradley Food Safety Bill, 1994.31

Description and Mission of the Group Making Recommendations

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 1, 1994, it was referred to the Agriculture Subcommittees on Livestock, and Departmental Operations and Nutrition; and on February 24, 1994, it was referred to the Commerce Subcommittee on Health and the Environment. 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. No hearings were held on either bill. The bills received only a few cosponsors: three for H.R. 3751 and one for S. 2350.

Summary of Recommendations

The act, if it had passed, would have transferred responsibility for enforcing meat, poultry, and egg inspections from FSIS of USDA to an independent federal health agency called the Meat, Poultry and Eggs Inspection Agency. It would have created a position of director of meat, poultry, and eggs inspection and authorized 8 assistant directors. It also would have established an advisory commission made up of representatives from federal and state governments, industry, and the scientific community. This advisory commission would have recommended how the agency could improve inspection by using more technologically advanced techniques in meat, poultry, and egg product inspections.

31  

H.R. 3751 was introduced 26 January 1994; S.2350 was introduced 2 August 1994.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Dissenting Views

No dissenting views available, but the bill had few cosponsors.

Popular Name and Date

The Fazio-Durbin Food Safety Administration Bill, 1997.32

Description and Mission of Group Making Recommendations

In November 1997, Representative Vic Fazio and Senator Richard Durbin introduced identical bills, the Safe Food Act of 1997. On November 4, 1997, H.R. 2801 was referred to the Committees on Agriculture and Commerce and, on November 14, 1997, to the Subcommittee on Health and the Environment. S. 1465 was introduced on November 9, 1997, and referred to the Committee on Government Affairs. So far, there have been no hearings.

Summary of Recommendations

This act, if passed, would consolidate all federal food safety, labeling, and inspection programs into a new independent agency known as the Food Safety Administration (FSA). The new agency would be funded by transferring appropriated funds that are currently designated for food safety functions of four agencies (FDA, USDA, EPA, and National Marine Fisheries Service). According to supporters, the purpose of the new agency would be to replace an outdated, fragmented, and overlapping food safety system. Supporters also say that a single food safety agency could identify the most serious public health risks from specific food-borne pathogens. In addition, resources could be used to develop better testing methods, conduct risk assessments, and identify the most cost-effective interventions without regard to the type of food or bureaucratic "turf."

Dissenting Views

Critics believe that the time is not right for major reform of the current food safety system. Some resist the formation of a new agency because of fear that a whole new FSA would cause dislocation and upheaval. It could also mean that the current parent agencies would have to relinquish their budget authority and control over functions related to food safety. Most opponents to an independent agency advocate allowing the Clinton Administration's 1997 food safety initiatives to take effect. They await the Administration's reports to Congress as to whether these new policies reduce incidences of food-borne illnesses. Other critics claim that the proposed legislation does not define a new food safety mandate to be carried out, but only reorganizes food safety functions by moving the current functions to the new FSA. They argue that a new FSA could be hindered in setting priorities for

32  

H.R. 2801 was introduced 4 November 1997; S. 1465 was introduced 9 November 1997.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

food safety activities because the bills would not amend or change the basic food safety statutes that establish the policies on which the current food safety system is based. For example, the meat and poultry statutes require that a government inspector be in continuous attendance and the food and drug statute grants FDA the authority to act only when adulterated and/or misbranded foods are found in interstate commerce. 

FOOD SAFETY UNDER THE U.S. DEPARTMENT OF AGRICULTURE  

Popular Name and Date

The Hoover Commission Report, May 20, 1949.33

Description and Mission of the Group Making Recommendations

Headed by Herbert Hoover, former President of the United States, the Commission on Organization of the Executive Branch of the Government was established in accordance with P. L.80-162, approved July 7, 1947. It was created by unanimous vote of Congress in July 1947, and submitted a series of reports to Congress. The Lodge-Brown Act, which brought the commission into being, conceived of its mission as being bipartisan. Therefore it had six members from each party. Four Commissioners each were chosen by the President of the Senate, the Speaker of the House of Representatives, and President Truman. The Commission members consisted of Herbert Hoover, Chairman; Dean Acheson, Vice Chair; Arthur S. Flemming; James Forrestal; George H. Mead; George D. Aikin; Joseph P. Kennedy; John L. McClellan; James K. Pollock; Clarence J. Brown; Carter Manasco; and James H. Rowe, Jr.

Summary of Recommendations

The commission recommended that all regulatory functions relating to food products be transferred to the Department of Agriculture and that those relating to other products be placed under a reorganized Drug Bureau administered by a public health agency. At the time, four agencies (Federal Security Agency, Federal Trade Commission, the Bureau of Internal Revenue in the Treasury Department, and USDA) exercised food regulatory functions, and some manufacturers had to comply with the regulations of more than one federal agency. The commission noted that many regulations related to food were once the responsibility of the

33  

The Hoover Commission report on organization of the Executive Branch of the Government (1947-1949), Westport, CT: Greenwood Press, 1970).

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

Department of Agriculture. The commission found that, "their separation from other departmental activities [meaning USDA's activities]...creates great overlap and also confuses the public." With food inspections scattered among four government agencies, the commission argued that too many agencies had jurisdiction over food and drug products.

Dissenting views

Two of the commissioners, James K. Pollock, and James H. Rowe, Jr., disagreed with the recommendation to transfer the food regulatory activities of the FDA to USDA. They claimed that the purpose of the food provisions of the FFDCA was to protect the consumer. They advocated that a unified program under the FDA part of the Federal Security Agency should be kept together. They also stated that one food safety system under the FDA, that "safeguarded" consumers from a series of common problems, would accomplish that purpose. The common problems were characterized as "economic cheating (misleading and deceptive labels, substitution of cheaper ingredients, short weight); filth and other extraneous or obnoxious materials; harmful products or products containing harmful ingredients." The dissenting Commissioners also believed that splitting the regulatory functions of foods and drugs between two separate agencies would require two sets of laboratories and staffs working independently of each other and would limit the flexibility and economy of work assignments. These commissioners, the Committee on Medical Services, and the Brookings Institution recommended that the [food safety] function be continued as part of a reorganized public health service within the Federal Security Agency or its successor.

Popular Name and Date

Acts Restructuring Meat and Poultry Products Inspection: Wholesome Meat Act of 1967 and the Poultry Products Act of 1968.34

Description and Mission of Group Making Recommendations

The Wholesome Meat Act of 196735 substantially revised the 1906 Meat Act. Soon afterwards, the Wholesome Poultry Act36, signed on August 18, 1968, extended to poultry inspection many aspects of the meat inspection act approved in 1967. These acts were the result of a long debate over the differences in federal, state, and local meat inspections. The federal system continued to be responsible

34  

Vivian Wiser, "Part V: Meat and Poultry Inspection in the United States Department of Agriculture," in, 100 Years of Animal Health. 1884-1984, eds. Vivian Wiser, Larry Mark, and H. Graham Purchase (Beltsville, MD: The Associates of the National Agricultural Library, 1986).

35  

P.L. 90-201.

36  

P.L. 90-492.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

for meats moving in interstate commerce and international trade, whereas state and local authorities oversaw meats consumed in their own jurisdictions. Thus, the control over all meat products was mixed; some areas had rigid standards, and others had lax standards. From this background came a call for legislation setting common standards from various interested groups.

The Talmadge-Aiken Act of 1962 had provided for cooperation among federal and state agencies in regulating the marketing of agricultural products. However, few states took advantage of the authority to enter into broad cooperative agreements for meat inspection with USDA. Under the Talmadge-Aiken Act, the states were to establish "equal to" meat inspection systems. In 1967, President Johnson urged that the law be amended to provide greater protection to consumers and federal assistance to states in developing state inspection programs.

Summary of Recommendations

Both Acts required states to have meat and poultry inspection programs "at least equal in rigor to" federally-run programs (under APHIS), even though the state-inspected plants could still market their products only 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 could be granted under certain conditions. The Acts encouraged uniformity in the inspection systems and closed loopholes in various phases of the inspection program. Annual reports to Congress on operations and effectiveness of the inspection system were required.

Interest in restructuring the meat and poultry inspection systems had grown as certain Members of Congress became aware that some food additives were becoming a safety problem. Members received letters from constituents concerned about the presence of nitrosamine, a carcinogen, in bacon. Food processors added nitrite as a curing agent to pork, and that addition caused the formation of nitrosamine when the naturally occurring amine and nitrite combined. Consumers were also alarmed about meat safety when Canada prohibited meats from DES-treated animals (DES—Diethylstilbestrol—is a synthetic estrogenic drug) to be sold in its market. At the time, FDA considered banning its use altogether.

Dissenting views

There were charges that APHIS wanted the complete federalization of meat inspection. A number of representatives of the packing and processing industries joined others from some state agriculture departments opposing the new federal inspection programs. However, over time, the states dropped out of the meat inspection business because of its high cost. By 1976, APHIS inspectors monitored meat and poultry processing in 60% of the nation's plants.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

FOOD SAFETY UNDER THE FOOD AND DRUG ADMINISTRATION  

Popular Name and Date

HEW Reorganization Directive of March 1968.37

Description and Mission of Group Making Recommendations

President Lyndon Johnson sent a message to Congress on March 4, 1968, with "Health Recommendations." Among the many proposals and recommendations was a directive to the Secretary of Health, Education, and Welfare to submit a "modern plan of organization to achieve the most efficient and economical operation of the health programs of the Federal Government." On March 13, 1968, the Secretary of Health, Education, and Welfare (HEW), Wilbur J. Cohen, announced his first step in carrying out the President's directive. He placed the FDA and the Public Health Service under the direction of Dr. Phillip R Lee, the Assistant Secretary for Health and Scientific Affairs. The Commissioner of Food and Drugs would report directly to Dr. Lee, rather than to the Secretary. On June 14, 1968, Secretary Cohen's report to the President was made public and recommended the creation of a new Consumer Protection and Environmental Health Service (CPEHS) which would include FDA along with other agencies.

Summary of Recommendations

The rationale for making FDA a part of the newly created CPEHS was stated in the message from the Secretary to the President:

The fact that similar or interacting contaminants manifest themselves in more than one type of environmental exposure argues strongly for focusing in a single agency the responsibility for identifying the hazards to health, developing and promulgating criteria and standards, and mounting programs that will promote compliance therewith. ... Retention of a separate FDA relates to its history as a regulatory agency with an operational pattern historically different from that of the Public Health Service (PHS). The historic role of the FDA has been primarily one of policing industry to assure compliance with provisions of the FFDCA.... In the last two years, the FDA has markedly modified its policeman posture [with the food industry.]

The Secretary said that, with this new attitude and with states taking over most of the routine surveillance of industry practices, the justification of keeping FDA and PHS as separate agencies had disappeared.

37  

Wallace Janssen, "FDA Since 1962," in unpublished papers, History of the Department of Health, Education and Welfare During the Presidency of Lyndon Baines Johnson, November 1963-January 1969, kept in the FDA History Office by John Swan.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Dissenting views

In the 1968 reorganization Directive of the President, CPEHS was formed to deal with environmental problems, but it never received congressional authorization or appropriations. Other federal programs, funded at the time, contributed funding and positions. Dr. Winton Rankin, Deputy Commissioner of FDA reportedly commented: "We gave him [C.C. Johnson, Director of CPEHS] whatever bit of lip service we had to but didn't offer much cooperation. He finally went under." Dr. Rankin also said that he thought that if CPEHS succeeded, FDA would cease to exist.38

Popular Name and Date

The Malek Report, December 10, 1969.39

Description and Mission of Group Making Recommendations

On December 10, 1969, Frederick V. Malek, Deputy Undersecretary, Department of Health, Education, and Welfare became chairman of a Special Task Force on the Reorganization of the Consumer Protection Programs. The task force's report to Dr. Charles C. Edwards, FDA Commissioner, was called Analysis and Recommendations: The Food and Drug Administration Organizational Review. It contained an organizational and management study of the FDA. The report was delivered August 25, 1970.

Summary of Recommendations

The task force's report proposed a reorganization of FDA because of a growing concern over FDA's ability to carry out its consumer protection responsibilities. The report recommended that FDA become a separate health agency reporting to the Assistant Secretary for Health and Scientific Affairs, and a new Consumer Protection and Environmental Health Service be created separate from FDA. Within FDA, a new bureau for foods, pesticides, and product safety should be created along with a new drug bureau. Each should have full responsibility and authority from initial research to final regulatory action. The rationale was that the new Food Bureau could concentrate on its major product areas without jeopardizing other product areas and would create clearer lines of authority for FDA's compliance activities. 

38  

Brannon, Organizing and Reorganizing FDA, 135-174.

39  

House Committee on Interstate and Foreign Commerce, Subcommittee on Commerce and Finance, Hearings on the Consumer Product Safety Act, 92nd Cong., 1st and 2nd sess., part 3, Nov. 1, 1971-Feb. 3, 1972, H.Rept. 92-61.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Dissenting Views

Not Available

Popular Name and Date

Senate Governmental Affairs Report on Federal Regulation, 1977.40

Description and Mission of Group Making Recommendations

The Chairman of the Senate Committee on Governmental Affairs, Abraham Ribicoff, submitted Study on Federal Regulation to Walter F. Mondale, President of the Senate on December 21, 1977. The report was prepared under the authority of Senate Resolution 71, which authorized the Governmental Affairs Committee to conduct a study on various aspects of the federal regulatory process.

Summary of Recommendations

Senator Ribicoff hoped that the report would provide a basis for congressional action. The report recommended a transfer of USDA food regulatory functions to FDA. The report stated, ''Divided responsibility for regulating food production has resulted in a regulatory program which is often duplicative, sometimes contradictory, undeniably costly, and unduly complex." The report asserted an urgent need to combine and rationalize the dual food regulation system that had existed over 70 years. "We believe the bifurcated food regulatory system should be unified in a single agency."

Dissenting Views

The proposal would have split employees located throughout the country (known as the field force) between the two administrations. USDA officials claimed that USDA's greatest strength was its network of field offices in operation throughout the country, as well as the experience and skills of its field staff. USDA officials were concerned that the transfer of USDA employees to another agency would weaken the network system.

40  

Senate Committee on Governmental Affairs, "V. Regulatory Organization" in Study on Federal Regulation, 95th Cong., 2d sess., December 1977, S.Rept. 95-91, 140.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Popular Name and Date

President Carter's 1978 Government Reorganization Project or White House Study (never released).41

Description and Mission of Group Making Recommendations

In February 1978, during testimony before the Appropriations Subcommittee on Agriculture, Rural Development and Related Agencies, chaired by Representative Whitten, spokespersons for the Carter Administration referred to the President's White House Study for Reorganization. Two of the most prominent officials were the Secretary of Agriculture, R. Bergland, and D. Angelotti, Administrator of the Food Safety and Quality Service (FSQS) (a precursor of FSIS).

Summary of Recommendations

The project recommended consolidation of all federal food regulatory functions. The final report did not resolve where the new organization would be located, although the HEW Secretary Joseph Califano suggested that FDA take over USDA's meat and poultry inspection and labeling duties. In 1977, USDA had formed the FSQS. Its mission was to enhance coordination among food inspection activities as well as food grading, certification and purchasing. USDA made clear that it had reorganized itself along functional lines, and, therefore, it did not believe consolidation of its food safety functions with FDA functions would be beneficial.

Dissenting Views

USDA Secretary Bergland countered Secretary Califano's suggestion with the idea that FDA food inspection authority be transferred to the new FSQS. Secretary Bergland stated, "The President's Reorganization Task Force is reviewing the desirability of combining FDA food activities, and USDA food safety and quality activities operations." In November 1977, HEW proposed that USDA's meat and poultry inspection activities and the women-infants-children program be consolidated within HEW. In February 1978, USDA proposed an alternative arrangement of functions. No final reorganization was initiated.

41  

House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, and Related Agencies, Hearings on Agriculture, Rural Development and Related Agencies Appropriations for 1979, 95 th Cong., 2nd sess., February 1978, 75 and 367-371.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
Popular Name and Date

Lester Crawford, 1980.42

Description and Mission of Group Making Recommendations

From 1987 to 1991, Dr. Lester Crawford was the Administrator of USDA's Food Safety and Inspection Service. In a speech at the 1980 U.S. Animal Health Association annual meeting, he recommended that one agency would do a better job in formulating food regulatory policies.

Summary of Recommendations

Dr. Crawford stated, "Managerially unsound and duplicative systems of regulation will cause us all to still be spinning on our collective wheels decades from now." He suggested a number of alternatives: 1) consolidation of all food safety functions within DHHS; 2) transfer of FDA's Center of Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) to USDA; or 3) at least merge CFSAN with CVM.

Dissenting Views

Several food safety activists objected to moving all food safety responsibility to USDA, because USDA is not linked to the Public Health Service as is FDA. They argued that communication could be improved on food safety standards if all food safety agencies were affiliated with public health agencies such as the Centers for Disease Control and the National Institutes of Health. 

Popular Name and Date

Dr. Sanford Miller, 1989.43

Description and Mission of Group Making Recommendations

Dr. Sanford Miller was the director of the Center for Food Safety and Applied Nutrition at FDA from 1978 to 1987. He is a national voice on public policy relating to nutrition and food sciences.

Summary of Recommendations

In discussing the underlying philosophical dynamic for the leading food safety agencies, which he believed has led to unnecessary controversies, Dr. Miller rec

42  

Lester Crawford, "Critique of Animal Health Regulation," in Proceedings of the 84th Annual Meeting, (Washington, D.C., U.S. Animal Health Association, 1980.)

43  

Sanford Miller, "Quest for Safe Food: Knowledge and Wisdom," 1989 S. B. Hendricks Memorial Lecture of the USDA, ARS presented before the American Chemical Society, Miami Beach, Florida, 11 September 1989, (Washington:GPO, 1990), 11.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

ommended that it was time to review the structure of food regulation in the United States. He suggested that it would be reasonable for the President and Congress to appoint a very senior level commission to review the requirements for an optimal food regulatory process and make recommendations. Dr. Miller stated, "The commission might very well conclude that the current setup is the best that we can devise, or it may propose a single agency, perhaps at the level of EPA."

Dissenting views

Not Available

Popular Name and Date

The Edwards FDA Advisory Committee, May 1991.44

Description and Mission of Group Making Recommendations

The committee was chaired by Dr. Charles C. Edwards, the former FDA Commissioner (1969-1973), and former Assistant Secretary for Health (1973-75). One of its members, Dr. David A. Kessler, later became the FDA Commissioner. The purpose of the committee was to examine FDA's mission, responsibility, and structure according to its legislative mandate, and to recommend how FDA could be strengthened to fulfill its mission. The committee was to provide advice accordingly to the Secretary of DHHS and to the Assistant Secretary for Health and did so in the Final Report of the Advisory Committee on the Food and Drug Administration. 

Summary of Recommendations

The Committee recommended that FDA be removed from the Public Health Service (PHS) and that the FDA Commissioner report directly to the Secretary of Health and Human Services. It also recommended that the Secretary of DHHS directly delegate to the Commissioner the authority to issue regulations implementing all the laws that FDA administers and to manage the daily operations of the Agency.

The Food Policy Subcommittee of the Advisory Committee recommended that FDA move immediately to improve the Center for Food Safety and Applied Nutrition (CFSAN) management system, increase its resources, upgrade the development of its program planning, and delegate additional authority to the CFSAN director. It also recommended that the Commissioner establish one task force to ensure that FDA meet its nutrition labeling obligations and another to assist

44  

Department of Health and Human Services, Advisory Committee on the Food and Drug Administration, Final Report, May 1991, Charles C. Edwards, Chairman,, (Washington, 1991) iii-iv, 19-24.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

CFSAN in resolving scientific and technical issues. It also said that it found no evidence to show that FDA's performance would improve if its human food responsibilities were combined with those of USDA. It recommended the establishment of a consistent approach to risk assessment among regulatory agencies responsible for food safety (FDA, EPA, and USDA), including for food derived from animals.

Dissenting Views

The Secretary of DHHS responded that the location in Public Health Service (PHS) was not the source of FDA problems. The Secretary contended that FDA gained from the close scientific interaction with other PHS agencies on issues such as AIDS epidemiology and research, pertussis vaccine, outbreaks of Salmonella enteritidis, dental amalgam problems, and food safety issues.

Popular Name and Date

National Performance Review, September 1993.45

Description and Mission of Group Making Recommendations

Vice President Al Gore published his report of the National Performance Review (NPR) on September 7, 1993. He had been asked by President Clinton to undertake a 6-month study of the federal bureaucracy and make recommendations on how to create a government that works better and costs less. 

Summary of Recommendations

The Review recommended that all federal food safety responsibilities be placed under the FDA.

Dissenting Views

A working group of government food safety officials advising the Vice-President's staff in preparing the NPR had recommended that an independent agency be created that would administer a science-based food safety system that would apply the same standards to all foods, thereby representing a more effective method of preventing food-borne illnesses. The working group also suggested that four policy initiatives were needed in conjunction with creating the new agency. The group suggested locating the new agency within the executive branch so that

45  

Al Gore, "From Red Tape to Results: Creating a Government That Works Better and Costs Less," in Report of the National Performance Review, (Washington, D.C., 7 September 1993), 101.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×
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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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.

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
×

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."

Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
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Suggested Citation:"Appendix B CRS Report for Congress, Food Safety: Recommendations for Changes in the Organization of Federal Food Safety Responsibilities, 1949-1997." Institute of Medicine and . 1998. Ensuring Safe Food: From Production to Consumption. Washington, DC: The National Academies Press. doi: 10.17226/6163.
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Next: Appendix C Executive Summary: Food Safety from Farm to Table: A National Food-Safety Initiative »
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How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as:

What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States?

Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.

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