Order Code RS22600
Updated February 720, 2007
The Federal Food Safety System: A Primer
Geoffrey S. Becker
Specialist in Agricultural Policy
Resources, Science and Industry Division
Donna V. Porter
Specialist in Life Sciences
Domestic Social Policy Division
Summary
Numerous federal, state, and local agencies share responsibilities for regulating the
safety of the U.S. food supply, which many experts say is among the safest in the world.
Nevertheless, critics view this system as lacking the organization and resources to
adequately combat foodborne illness, which sickens an estimated 76 million people and
kills an estimated 5,000 each year in this country. The 110th Congress may face calls for
a review of federal food safety agencies and authorities, and proposals for reorganizing
them have been introduced (e.g., H.R. 1148; S. 654). Among the issues likely to arise
are whether reform can improve oversight, and
the cost to industry, consumers, and
taxpayers. This report provides a brief introduction
to the system and the debate on
whether reorganization is needed.
Background1
Americans spent more than $1 trillion on food in 2005, nearly half of it in
restaurants, schools, and other places outside the home.2 Federal laws give food
manufacturers, distributors, and retailers the basic responsibility for assuring that foods
are wholesome, safe, and handled under sanitary conditions. A number of federal
agencies, cooperating with state, local, and international entities, play a major role in
regulating food quality and safety under these laws.
1
Background on the agencies is based largely on CRS Report 98-91, Food Safety Agencies and
Authorities: A Primer, by Jean M. Rawson, Alejandro E. Segarra, and Donna U. Vogt (out of
print). Primary sources for that report included various documents and materials provided by
federal food safety agencies and by the U.S. Government Accountability Office.
2
Roughly two-thirds of the $1 trillion was for domestically produced farm foods; imports and
seafood account for the balance. Source: USDA, Economic Research Service, data accessed
February 2007 at the “Food Sector” Web page at [http://www.ers.usda.gov/Browse/FoodSector/].
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The combined efforts of the food industry and the regulatory agencies often are
credited with making the U.S. food supply among the safest in the world. Nonetheless,
public health officials estimate that each year 76 million people become sick, 325,000 are
hospitalized, and 5,000 die from foodborne illnesses caused by contamination from any
one of a number of microbial pathogens.3 At issue is whether the current system has the
resources and structural organization to protect consumers from these dangers. Also at
issue is whether federal food safety laws, first enacted in the early 1900s, have kept pace
with the significant changes that have occurred in the food production, processing, and
marketing sectors since then.
The Agencies and Their Roles
The Government Accountability Office (GAO) has identified 15 federal agencies
collectively administering at least 30 laws related to food safety. The Food and Drug
Administration (FDA), which is part of the U.S. Department of Health and Human
Services (HHS), and the Food Safety and Inspection Service (FSIS), which is part of the
U.S. Department of Agriculture (USDA), together comprise the majority of both the total
funding and the total staffing of the government’s food regulatory system.4 FSIS’s
FY2006 budget was approximately $980 million, $832 million of it appropriated funds
and the balance industry-paid user fees. FDA’s budget for foods was approximately $440
million in FY2006; oversight of animal drugs and feeds totaled another $99 million, of
which approximately $90 million was appropriated and the balance user fees.5
Among other agencies with smaller but still significant shares of the food safety
portfolio are the National Marine Fisheries Service (NMFS), which is part of the U.S.
Department of Commerce (DOC), the Environmental Protection Agency (EPA), and the
Centers for Disease Control and Prevention (CDC) in HHS.
Food and Drug Administration. The FDA is responsible for ensuring that all
domestic and imported food products — except for most meats and poultry — are safe,
nutritious, wholesome, and accurately labeled. Examples of FDA-regulated foods are
produce, dairy products, seafood, and processed foods. FDA has jurisdiction over meats
from animals or birds that are not under the regulatory jurisdiction of FSIS. FDA shares
responsibility for the safety of eggs with FSIS. FDA has jurisdiction over establishments
that sell or serve eggs or use them as an ingredient in their products. FDA is also
responsible for ensuring that seafood products, including those from aquaculture, do not
endanger public health. The primary statutes governing FDA’s activities are the Federal
Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.); the Public Health
Service Act, as amended (42 U.S.C. 201 et seq.); and the Egg Products Inspection Act,
as amended (21 U.S.C. 1031 et seq.).
3
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention,
Foodborne Illness: Frequently Asked Questions, at [http://www.cdc.gov/foodsafety/].
4
5
High Risk Series: An Update (GAO-07-310), January 2007.
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies
Appropriations for 2007, hearings before a Subcommittee of the Committee on Appropriations,
House of Representatives, 109th Cong., 2nd sess. (Part 5, pp. 755 and 848).
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FDA’s food inspection force numbers more than 1,900 in field offices throughout
the United States, plus nearly 900 in the Washington, DC, area. FDA regulates food
manufacturers’ safety practices by relying on companies’ self-interest in producing safe
products, and by working with the industry to improve production practices. About
57,000 food manufacturers are subject to periodic FDA inspection for regulatory
compliance. According to GAO, unannounced compliance inspections of individual
establishments by FDA officials occur roughly once every five years. FDA relies on
notifications from within the industry or from other federal or state inspection personnel,
as well as other sources, to alert it to situations calling for increased inspection.
In the Washington, DC, area, two FDA offices are the focal point for food safetyrelated activities. The Center for Food Safety and Applied Nutrition (CFSAN) is
responsible for (1) conducting and supporting food safety research; (2) developing and
overseeing enforcement of food safety and quality regulations; (3) coordinating and
evaluating FDA’s food surveillance and compliance programs; (4) coordinating and
evaluating cooperating states’ food safety activities; and (5) developing and disseminating
food safety and regulatory information to consumers and industry. FDA’s Center for
Veterinary Medicine (CVM) is responsible for ensuring that all animal drugs, feeds
(including pet foods), and veterinary devices are safe for animals, are properly labeled,
and produce no human health hazards when used in food-producing animals.
The FDA also cooperates with over 400 state agencies across the nation that carry
out a wide range of food safety regulatory activities. However, the state agencies are
primarily responsible for actual inspection. FDA works with the states to set the safety
standards for food establishments and commodities and evaluates the states’ performance
in upholding such standards as well as any federal standards that may apply. FDA also
contracts with states to use their food safety agency personnel to carry out certain field
inspections in support of FDA’s own statutory responsibilities.
Food Safety and Inspection Service.
FSIS regulates the safety,
wholesomeness, and proper labeling of most domestic and imported meat and poultry and
their products sold for human consumption. Under the Federal Meat Inspection Act of
1906, as amended (21 U.S.C. 601 et seq.), FSIS inspects all cattle, sheep, swine, goats,
and equines during slaughtering and processing. Under the Poultry Products Inspection
Act of 1957, as amended (21 U.S.C. 451 et seq.), FSIS is required to inspect “any
domesticated bird” being processed for human consumption; however, USDA regulations
implementing this law limit the definition of domesticated birds to chickens, turkeys,
ducks, geese, ratites (emus, ostriches, and rheas), and guineas. FDA has jurisdiction over
exotic and alternative meats not inspected by FSIS, and shares the responsibility for egg
safety with FSIS. The latter is responsible for the safety of liquid, frozen, and dried egg
products, domestic and imported, and for the safe use or disposition of damaged and dirty
eggs under the Egg Products Inspection Act, as amended (21 U.S.C. 1031 et seq.).
FSIS staff numbers around 9,400; roughly 8,000 of them, including about 1,000
veterinarians, are in about 6,300 meat slaughtering and/or processing plants nationwide.
FSIS personnel inspect all meat and poultry animals at slaughter on a continuous basis,
and at least one federal inspector is on the line during all hours the plant is operating.
Processing inspection does not require an FSIS inspector to remain constantly on the
production line or to inspect every item. Instead, inspectors are on site daily to monitor
the plant’s adherence to the standards for sanitary conditions, ingredient levels, and
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packaging, and to conduct statistical sampling and testing of products. Because all plants
are visited daily, processing inspection also is considered to be continuous.
FSIS also is responsible for certifying that foreign meat and poultry plants are
operating under an inspection system equivalent to the U.S. system before they can export
their product to the United States. FSIS inspectors located at U.S. ports of entry carry out
a statistical sampling program to verify the safety of imported meats from cattle, sheep,
swine, goats, and equines and imported poultry meat from chickens, turkeys, ducks, geese,
quail, ratites, and guineas before they are released into domestic commerce. FDA is
responsible for ensuring the safety of imported meat from any other species.
Approximately 28 states operate their own meat and/or poultry inspection programs.
FSIS is statutorily responsible for ensuring that the states’ programs are at least equal to
the federal program. Plants processing meat and poultry under state inspection can market
their products only within the state. If a state chooses to discontinue its own inspection
program, or if FSIS determines that it does not meet the agency’s equivalency standards,
FSIS must assume the responsibility for inspection if the formerly state-inspected plants
are to remain in operation. FSIS also has cooperative agreements with more than two
dozen states under which state inspection personnel are authorized to carry out federal
inspection in meat and/or poultry plants. Products from these plants may travel in
interstate commerce.6
Centers for Disease Control and Prevention (HHS). CDC is responsible for
(1) monitoring, identifying, and investigating foodborne disease problems to determine the
contributing factors; (2) working with FDA, FSIS, NMFS, state and local public health
departments, universities, and industry to develop control methods; and (3) evaluating the
effect of control methods. In 1995, CDC launched ‘FoodNet,’ a collaborative project with
the FDA and USDA to improve data collection on foodborne illness outbreaks. FoodNet
includes active surveillance of clinical microbiology laboratories to obtain a more accurate
accounting of positive test results for foodborne illness; a physician survey to determine
testing and laboratory practices; population surveys to identify illnesses not reported to
doctors; and research studies to obtain new and more precise information about which
food items or other exposures may cause diseases. FoodNet data allows CDC to have a
clearer picture of the incidence and causes of foodborne illness and to establish baseline
data against which to measure the success of changes in food safety programs. The Public
Health Service Act, as amended (42 U.S.C. 201 et seq.), provides the legislative authority
for CDC’s food safety related activities.
National Marine Fisheries Service (DOC). Although the FDA is the primary
agency responsible for ensuring the safety, wholesomeness and proper labeling of
domestic and imported seafood products, NMFS conducts, on a fee-for-service basis, a
voluntary seafood inspection and grading program that focuses on marketing and quality
attributes of U.S. fish and shellfish. The primary legislative authority for NMFS’s
inspection program is the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621
et seq.). NMFS has approximately 160 seafood safety and quality inspectors, and
inspection services are funded with user fees.
6
See also CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues,
by Geoffrey S. Becker.
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Environmental Protection Agency. EPA has the statutory responsibility for
ensuring that the chemicals used on food crops do not endanger public health. EPA’s
Office of Pesticide Programs is the part of the agency that (1) registers new pesticides and
determines residue levels for regulatory purposes; (2) performs special reviews of
pesticides of concern; (3) reviews and evaluates all the health data on pesticides; (4)
reviews data on pesticides’ effects on the environment and on other species; (5) analyzes
the costs and benefits of pesticide use; and (6) interacts with EPA regional offices, state
regulatory counterparts, other federal agencies involved in food safety, the public, and
others to keep them informed of EPA regulatory actions. The Federal Insecticide,
Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136 et seq.), and the Federal Food,
Drug, and Cosmetic Act, as amended (21 U.S.C. 301 et seq.), are the primary authorities
for EPA’s activities in this area.
Other Federal Agencies with Food Safety Responsibilities. Among the
other agencies that play a role in food safety, USDA’s Agricultural Research Service
(ARS) performs food safety research in support of FSIS’s inspection program. It has
scientists working in animal disease bio-containment laboratories in Plum Island, NY, and
Ames, IA. USDA’s Animal and Plant Health Inspection Service (APHIS) indirectly
protects the nation’s food supply through programs to protect plant and animal resources
from domestic and foreign pests and diseases, such as brucellosis and bovine spongiform
encephalopathy (BSE, or “mad cow” disease). The Department of Homeland Security
(DHS) is responsible for coordinating agencies’ food security activities, including at U.S.
borders.
Congressional Committees. In the Senate, food safety issues are considered by
the Committees on Agriculture, Nutrition, and Forestry; Homeland Security and
Governmental Affairs; and Health, Education, Labor, and Pensions. In the House, various
food safety activities fall under the jurisdiction of the Committees on Agriculture; Energy
and Commerce; Oversight and Government Reform; and Science. Agriculture
subcommittees of the House and Senate Appropriations Committees also serve oversight
and funding roles in how the major agencies carry out food safety policies.
Reorganization of the Federal Food Safety Regulatory Structure
In its annual (January 2007) report, GAO designated food safety oversight as one of
29 “high risk” federal program areas. The report stated: “Any food contamination could
undermine consumer confidence in the government’s ability to ensure the safety of the
U.S. food supply, as well as cause severe economic consequences. The current fragmented
federal system has caused inconsistent oversight, ineffective coordination, and inefficient
use of resources. GAO has recommended that Congress consider a fundamental reexamination of the system and other improvements to help ensure the rapid detection of
and response to any accidental or deliberate contamination of food before public health
and safety is compromised.”7
Earlier, the Institute of Medicine of the National Academy of Sciences (IOM/NAS)
and the National Commission on the Public Service studied the issue and recommended
7
GAO, High Risk Series: An Update. Numerous earlier GAO reports reiterated this theme.
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options for change.8 IOM/NAS has been among those who maintain that reorganizing
agencies, by itself, would not provide safer food; its 1998 report recommended a more
science-based statute and additional inspection resources, among other things. Opponents
of major food safety changes, including many in the food and agricultural industries, assert
that the system already is scientifically based, that the statutes are adequate, and that food
companies already produce and distribute safe food, making the U.S. system a model for
food safety around the world.
Legislative proposals to combine these agencies and responsibilities into a single
federal food safety agency have beenwere introduced in past Congresses, but have not
advanced. The 110th Congress may be asked to consider did not advance. In the
110th Congress, the first bills to establish a new Food Safety Administration were offered
on February 15, 2007, as H.R. 1148 by Representative DeLauro and S. 654 by Senator
Durbin. On February 8, 2007, the House Appropriations Subcommittee on Agriculture,
Rural Development, Food and Drug Administration, and Related Agencies, which is
chaired by Representative DeLauro, held a hearing on food safety reorganization.
Lawmakers may be asked to consider these or other proposals that would either
reorganize or consolidate the federal food safety organization. A range of policy options
could be debated, including whether the current regulatory approaches and their
authorizing statutes remain appropriate, particularly given the diversity of food types,
different health risks, methods of production, and sources of supply; the continuously
evolving science on foodborne illness and how to prevent future outbreaks; the impacts
on industry competitiveness, particularly in a global economy; and funding constraints.
8
See National Research Council, Institute of Medicine, Ensuring Safe Food From Production
to Consumption, Washington, DC, National Academy Press, 1998; and National Commission on
the Public Service, Urgent Business For America: Revitalizing the Federal Government For the
21st Century, Washington, DC, 2003.