The Federal Food Safety System: A Primer

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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—as evidenced by a series of widely publicized food safety problems, including concerns
about adulterated food and food ingredient imports, and illnesses linked to various types of fresh
produce and to meat and poultry products. Numerous bills addressing various aspects of food ^th
safety were introduced into the 110 Congress, including proposals to reorganize oversight
authorities, increase funding, tighten regulation of imported foods, and establish new authorities
for enforcement, recall, and notification regarding adulterated foods, among others. Portions of
several proposals became law; debate on the need for more sweeping changes in the federal food ^th
safety system was expected to continue in the 111 Congress.

Backgr ound ..................................................................................................................................... 1
The Agencies and Their Roles.........................................................................................................1
Food and Drug Administration..................................................................................................2
Food Safety and Inspection Service..........................................................................................3
Centers for Disease Control and Prevention (HHS)..................................................................4
National Marine Fisheries Service (DOC)................................................................................4
Environmental Protection Agency............................................................................................4
Other Federal Agencies with Food Safety Responsibilities......................................................4
Congressional Committees........................................................................................................5
Selected Issues.................................................................................................................................5
Author Contact Information............................................................................................................6

Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools, ²
and other places outside the home. Federal laws give food manufacturers, distributors, and
retailers the basic responsibility for assuring that foods are wholesome, safe, and handled under
sanitary conditions. A number of federal agencies, cooperating with state, local, and international
entities, play a major role in regulating food quality and safety under these laws.
The combined efforts of the food industry and the regulatory agencies often are credited with
making the U.S. food supply among the safest in the world. Nonetheless, 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 ³
pathogens. 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 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 ⁴
food regulatory system.
FSIS’s FY2008 budget was approximately $930 million in appropriated funds plus another
estimated $140 million in industry-paid user fees. FDA’s budget for foods was $577 million in
FY2008, virtually all of it appropriated. Thus, FSIS has approximately 65% of the two agencies’ ⁵
combined food safety budget, and FDA has the other approximately 35%. Conversely, FSIS is ⁶
responsible for approximately 20% of the U.S. food supply, but FDA is responsible for 80%.

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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.
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 most seafood products do not endanger public health (FSIS is to
begin inspecting farmed catfish products under a 2008 farm bill provision). 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.).
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 safety-related
activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for (1)
conducting and supporting food safety research; (2) developing and overseeing enforcement of
food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance and
compliance programs; (4) coordinating and evaluating cooperating states’ food safety activities;
and (5) developing and disseminating food safety and regulatory information to consumers and
industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring that all animal
drugs, feeds (including pet foods), and veterinary devices are safe for animals, are properly
labeled, and produce no human health hazards when used in food-producing animals.
The FDA also cooperates with over 400 state agencies across the nation that carry out a wide
range of food safety regulatory activities. However, the state agencies are primarily responsible
for actual inspection. FDA works with the states to set the safety standards for food
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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.
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 is required to inspect all cattle,
sheep, swine, goats, and equines during slaughtering and processing. Under the Poultry Products
Inspection Act of 1957, as amended (21 U.S.C. 451 et seq.), FSIS is required to inspect “any
domesticated bird” being processed for human consumption; however, USDA regulations
implementing this law limit the definition of domesticated birds to chickens, turkeys, ducks,
geese, ratites (emus, ostriches, and rheas), and guineas. FDA has jurisdiction over exotic and
alternative meats not inspected by FSIS, and shares the responsibility for egg safety with FSIS.
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 packaging, and to conduct statistical sampling and testing of products.
Because all plants are visited daily, processing inspection also is considered to be continuous.
FSIS also is responsible for certifying that foreign meat and poultry plants are operating under an
inspection system equivalent to the U.S. system before they can export their product to the United
States. FSIS inspectors located at U.S. ports of entry carry out a statistical sampling program to
verify the safety of imported meats from cattle, sheep, swine, goats, and equines and imported
poultry meat from chickens, turkeys, ducks, geese, quail, ratites, and guineas before they are
released into domestic commerce. FDA is responsible for ensuring the safety of imported meat
from any other species.
Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is
statutorily responsible for ensuring that the states’ programs are at least equal to the federal
program. Plants processing meat and poultry under state inspection can market their products
only within the state (although the 2008 farm bill will permit interstate shipment in some cases).
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.

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 provides legislative authority for CDC’s
food safety related activities.
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.
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.
Among the other agencies that play a role in food safety, USDA’s Agricultural Research Service
(ARS) performs food safety research in support of FSIS’s inspection program. It has scientists
working in animal disease bio-containment laboratories in Plum Island, NY, and Ames, IA.
USDA’s Animal and Plant Health Inspection Service (APHIS) indirectly protects the nation’s
food supply through programs to protect plant and animal resources from domestic and foreign
pests and diseases, such as brucellosis and bovine spongiform encephalopathy (BSE, or “mad

cow” disease). The Department of Homeland Security (DHS) is to coordinate many food security
activities, including at U.S. borders.
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.

Food safety-related incidents frequently heighten congressional scrutiny of the issue, as a number
of developments in recent years have illustrated. For example, more than 200 confirmed illnesses
and three deaths were linked in fall 2006 to the consumption of bagged fresh spinach grown in
California that was found to carry E. coli O157:H7. The incident raised public concern about the
safety of all fresh leafy produce and stimulated a number of industry and government initiatives
to limit future contamination. In February 2007, FDA announced a nationwide recall of peanut
butter due to Salmonella contamination, after hundreds of illnesses, dating back to August 2006, ⁷
were linked to the bacterium.
In April-July 2008, more than 1,300 persons in 43 states, the District of Columbia, and Canada
were found to be infected with the same unusual strain of bacteria (Salmonella Saintpaul).
Officials first suspected fresh tomatoes as the vehicle, but later genetic tests confirmed the
pathogen on samples of a serrano pepper and irrigation water from a farm in Mexico. Throughout
2007 and 2008, USDA announced numerous recalls totaling many million pounds of ground beef
products due to concerns about E. coli O157:H7 contamination.
Attention also had shifted to the safety of food imports in early 2007 when adulterated pet food
ingredients imported from China sickened or killed numerous dogs and cats and subsequently ⁸
were found in some hog, chicken, and fish feed. In June 2007, FDA announced that it was
detaining imports of certain types of farm-raised seafood from China (specifically, shrimp,
catfish, basa, dace, and eel) until their shippers could confirm that they are free of unapproved
drug residues. In late 2008, FDA announced that all Chinese dairy products and dairy ingredients
were to be detained until importers could prove they were free of melamine (the same adulterant
found earlier in the pet food ingredients). The toxic chemical was being added to milk in China to
boost protein readings; as a result, six infants reportedly were killed and nearly 300,000 sickened
there after consuming tainted infant formula.
During the 110^th Congress, a series of congressional and Administration reports were issued
which cited significant gaps in the federal food safety system. Several dozen bills were
introduced addressing one or more aspects of the issue. Provisions affecting food safety were

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included in 2007 in P.L. 110-85, the FDA amendments, including a requirement that FDA
establish a registry to which companies must begin to report events involving potentially
adulterated foods. Food safety provisions in the 2008 farm bill (P.L. 110-234) include subjecting
farmed catfish products to FSIS mandatory inspections similar to those for red meat and poultry;
creating an option for state-inspected meat and poultry plants to ship products across state lines;
and requiring meat and poultry establishments to notify USDA about potentially adulterated or
misbranded products. Congressional appropriators also provided some increased funding for food
safety activities for FY2008 and FY2009.
However, a number of more comprehensive food safety proposals were not enacted by the 110^th
Congress. These included bills to impose new requirements, and possibly user fees, on food
importers; to establish mandatory recall and/or traceability programs for USDA and FDA-
regulated foods; and to increase oversight of domestic food producers, for example. Several
called for consolidating federal food safety responsibilities under a single, independent new
agency. Stakeholders anticipate that new legislation will be introduced and possibly debated in ^th
the 111 Congress.
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