The Federal Food Safety System: A Primer
Renée Johnson
Specialist in Agricultural Policy
August 18, 2010
Congressional Research Service
7-5700
www.crs.gov
RS22600
CRS Report for Congress
P
repared for Members and Committees of Congress

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The Federal Food Safety System: A Primer

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, regulatory tools, 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, to peanut products, and to some meat and poultry products.
A number of comprehensive food safety proposals aimed at addressing perceived shortcomings in
the U.S. food safety system were introduced but not enacted by the 110th Congress. These
included measures to reform the Food and Drug Administration’s (FDA’s) oversight of food and
other imports, to create a new independent food safety agency, and to impose a variety of new
requirements on food manufacturers, handlers, and producers (including farms), such as
mandated risk-based safety plans, recordkeeping for product tracing purposes, more rigorous
registration requirements, and performance standards. The adequacy of inspection resources also
has been at issue, and appropriators have been ramping up funding for the major agencies,
particularly FDA.
Bills with similarly broad goals (such as H.R. 759, which was revised and reintroduced in June
2009 as H.R. 2749; H.R. 875; H.R. 1332; and S. 510) re-emerged in the 111th Congress. On the
one hand, food safety reform is a relatively complex, controversial matter competing for attention
with a long list of domestic priorities. On the other hand, there has been a growing consensus that
changes are needed.
Lawmakers took the first step toward new legislation on June 10, 2009, when the House Energy
and Commerce Subcommittee on Health approved an amended version of H.R. 2749. The full
committee approved the bill, with additional changes, on June 17, 2009, and the full House
passed a further-modified H.R. 2749 on July 30, 2009. Senate work on a comprehensive, but
differing, food safety bill (S. 510 by Senator Durbin) commenced with a November 18, 2009,
markup by the Health, Education, Labor, and Pensions Committee. This was followed by
additional changes agreed to by Senate leaders in a “Manager’s Package” that was released on
August 12, 2010. Senate floor action remains pending, but is widely anticipated by stakeholders.
(For more details see CRS Report R40443, Food Safety: Selected Issues and Bills in the 111th
Congress.)

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The Federal Food Safety System: A Primer

Contents
Background ................................................................................................................................ 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 ............................................................................................... 5
Other Federal Agencies with Food Safety Responsibilities .......................................................... 5
Congressional Committees .......................................................................................................... 5
Selected Issues ............................................................................................................................ 6

Tables
Table 1. Major Federal Food Safety Agencies.............................................................................. 8
Table 2. Selected Comparison of FSIS and FDA Responsibilities .............................................. 10

Contacts
Author Contact Information ...................................................................................................... 11
Acknowledgments .................................................................................................................... 11

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The Federal Food Safety System: A Primer

Background1
Americans spend more than $1 trillion on food each year, 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.
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 In addition, experts have cited numerous other hazards to health, including the use of
unapproved veterinary drugs, pesticides, and other dangerous substances in food commodities, of
particular concern at a time when an growing share of the U.S. food supply is from overseas
sources.
At issue is whether the current U.S. regulatory system has the resources and structural
organization to protect consumers from these dangers. Also at issue is whether the federal food
safety laws themselves, 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 as many as 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. (See Tables 1 and 2 at the end of this report
for a brief comparative look at the agencies’ responsibilities.)4
FSIS’s FY2009 budget was approximately $972 million in appropriated funds plus another
estimated $140 million in industry-paid user fees. FDA’s budget for foods was $649 million in
FY2009, virtually all of it appropriated (plus an additional $137 million for regulation of animal

1 Background on the agencies is updated information that first appeared in CRS Report 98-91, Food Safety Agencies
and Authorities: A Primer (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 is for domestically produced farm foods; imports and seafood account for the
balance. Source: USDA, Economic Research Service, data accessed January 2008 at the “Food Sector” Web page at
http://www.ers.usda.gov/Browse/FoodSector/.
3 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Foodborne Illness:
Frequently Asked Questions,” accessed at http://www.cdc.gov/foodsafety/. However, this estimate appears to be based
primarily on 1997 and earlier data in a report by Paul S. Mead et al., “Food-related Illness and Death in the United
States,” Emerging Infectious Diseases, vol. 5, pp. 607-625, 1999.
4 High Risk Series: An Update (GAO-07-310), January 2007.
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drugs and feeds, which includes $20 million in user fees). Thus, FSIS had approximately 65% of
the two agencies’ combined food safety budget, and FDA had the other approximately 35%.5
Conversely, FSIS is responsible for approximately 20% of the U.S. food supply, but FDA is
responsible for 80%.6
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 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. Overall, FDA has oversight of more than 44,000
U.S. food manufacturers, plus well over 100,000 additional registered food facilities such as
warehouses and grain elevators. In addition, some 200,000 foreign food facilities are registered
with the agency. Various estimates of unannounced compliance inspections of domestic
establishments by FDA officials range from once every five years to once every 10 years, on
average, although the agency claims to visit about 6,000 so-called high-risk facilities on an annual
basis. 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.

5 Data source: various documents of the Agriculture, Rural Development, Food and Drug Administration, and Related
Agencies Subcommittee of the House Committee on Appropriations.
6 Source for the food supply proportions is GAO, “Revamping Oversight of Food Safety,” urgent issues prepared for
the 2009 Congressional and Presidential Transition, accessed December 2008 at http://www.gao.gov/transition_2009/
urgent/food-safety.php. GAO here does not provide a basis for its calculations, although they appear to represent
proportions of total spending for food consumed at home. Examined another way, meat and poultry could account for
as little as 10% of U.S. per capita food consumption, according to data maintained by USDA’s Economic Research
Service (ERS); these per capita data adjust food availability for spoilage, plate waste, and other losses. Source: ERS
Food Availability (Per Capita) Data System, accessed December 29, 2008, at http://www.ers.usda.gov/data/
foodconsumption/.
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A report by HHS’s Office of Inspector General (OIG) provided additional insights into the FDA’s
inspections of domestic facilities. The OIG reported that the number of facilities subject to such
inspections has risen from about 59,000 in 2004 to nearly 68,000 in 2008. However, the number
of inspections conducted declined from about 17,000 in 2004 (29% of the total) to about 15,000
in 2008 (22%). During the five-year period examined by the OIG, 56% of food facilities were not
inspected at all.7
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
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 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

7 HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), April 2010.
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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. 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.8
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 provides 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

8 The 2008 farm bill (P.L. 110-246) contains new provisions intended to enable more interstate shipment of state-
inspected products; USDA published proposed regulations to implement these provisions in the September 16, 2009,
Federal Register.
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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.
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 to coordinate many 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.
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Selected Issues
Food safety-related incidents have tended to heighten congressional scrutiny of the issue and to
fuel interest in food safety reform, as a number of developments in recent years have illustrated.
These incidents have included a major outbreak of Salmonella Typhimurium infections linked to
the consumption of products containing peanut ingredients from a single firm, the Peanut
Corporation of America. Between September 1, 2008, and mid-March, 2009, the CDC identified
nearly 700 cases in 46 states; the infection may have contributed to the deaths of nine people,
according to the CDC. A series of expanding recalls was announced by FDA in early 2009,
involving thousands of products from more than 200 companies (though not the major peanut
butter brands). These developments unfolded two years after a different nationwide recall of
peanut butter, in February 2007, due to Salmonella contamination, when hundreds of illnesses,
dating back to August 2006, were linked to the bacterium.9
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 expanded 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
were found in some hog, chicken, and fish feed.10 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 being 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; seven infants reportedly were killed and approximately 300,000 sickened
there after consuming tainted infant formula.
These types of incidents have been cited repeatedly in a series of congressional and non-
congressional hearings, reports, and studies, issued throughout the 110th Congress, as evidence of
significant shortcomings in the federal food safety system. In the last Congress, a subcommittee
of the House Energy and Commerce Committee alone held eight hearings on food safety
problems, and various other Senate and House panels held similarly focused hearings. One topic
of interest was the Bush Administration’s Food Protection Plan, an “integrated strategy for
protecting the nation’s food supply” issued in late 2007 by FDA. The plan was simultaneously
applauded for recommending a comprehensive three-pronged approach to food safety reform
(prevention, intervention, and response) and criticized for offering too few implementing and
funding details. The Obama Administration has proposed increases for food safety oversight in its
FY2010 budget plan, and the President has charged an interagency Food Safety Working Group
with developing more detailed recommendations for change.

9 For sources and updates see the FDA website: http://www.fda.gov/opacom/7alerts.html.
10 FDA has the same basic safety standards for human foods and animal feeds, including pet food.
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Several dozen bills were introduced in 2007 and 2008 addressing one or more aspects of the
issue. Provisions affecting food safety were 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 increased funding for food safety activities for FY2008 and
FY2009.
However, a number of more comprehensive food safety proposals were not enacted by the 110th
Congress, and similar measures have emerged in the 111th Congress, where major new legislation
is possible although by no means certain. On the one hand, food safety reform is a relatively
complex, controversial matter competing for attention with a long list of domestic priorities. On
the other hand, there has been a growing consensus for making major changes, several of them
supported not only by consumer advocates but by many in the food industry.
Lawmakers took the first step toward new legislation on June 10, 2009, when the House Energy
and Commerce Subcommittee on Health amended and approved a bill (H.R. 2749) introduced by
Representative Dingell. The bill is a revised version, focusing on FDA-regulated foods, of a more
wide-ranging FDA reform bill (H.R. 759) introduced earlier by Representative Dingell. The full
committee approved the bill, with additional changes, on June 17, 2009. A further-amended bill
was adopted by the full House on July 30, 2009.
On the Senate side, a comprehensive but differing bill (S. 510 by Senator Durbin) was modified
and approved by the Senate Health, Education, Labor, and Pensions Committee on November 18,
2009. Floor action was pending, but widely anticipated by stakeholders, in spring 2010. This was
followed by additional changes agreed to by Senate leaders in a “Manager’s Package” that was
released on August 12, 2010. Senate floor action remains pending, but is widely anticipated by
stakeholders.
The congressional appropriations process annually offers another potential venue for food safety
changes. In addition to determining annual funding levels for FSIS, FDA, and other agencies with
food safety responsibilities, the House and Senate Appropriations Committees frequently include
directives in either the appropriation itself, or in accompanying report language, intended to
instruct the Administration in how it is to use that money.
(For additional reports on food safety, where more detailed discussion of selected issues and
updates on legislative and related activities may be found, see the CRS Current Legislative Issue
entitled “Food Safety,” at http://www.crs.gov/Pages/subissue.aspx?cliid=2621&parentid=1.)



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Table 1. Major Federal Food Safety Agencies
Agency
Major Responsibilities and Activities
Primary Authorities
Department of Health and


Human Services:
Food and Drug
Ensuring that all domestic and imported foods, except
Federal Food, Drug, and
Administrationa
processed egg products and major types of meat and
Cosmetic Act (FFDCA; 21
poultry, are safe, wholesome, and properly labeled, by
USC 301), Public Health
setting safety and sanitation standards, periodical y
Service Act (42 USC 201),
inspecting manufacturing facilities, reviewing records of
Egg Products Inspection Act
and spot-checking imports. Also overseeing the safety of
(21 USC 1031), Public
animal drugs and feeds including those used in food-
Health Security and
producing animals
Bioterrorism Preparedness
and Response Act (21 USC
341). among others
Centers for Disease
Monitoring, identifying, and investigating foodborne
Public Health Service Act
Control and
diseases; developing and evaluating improved
(42 USC 201)
Prevention
epidemiological and laboratory methods
Department of Agriculture:


Food Safety
Regulating the safety, wholesomeness and proper
Federal Meat Inspection Act
Inspection Servicea
labeling of most commercial types of both domestic and
(21 USC 601), Poultry
imported meat and poultry, catfish products, and
Products Inspection Act (21
processed egg products, by approving establishment
USC 451), Egg Products
designs, safety plans; inspecting every animal and carcass
Inspection Act
in slaughtering plants and daily inspecting all meat and
poultry processing plants; determining the equivalency of
importing countries’ meat and poultry safety systems
Animal and Plant
Overseeing animal and plant health, including the
Animal Health Protection
Health Inspection
prevention of foreign diseases and pests, eradication and
Act (7 USC 8301), Plant
Service
containment of such problems domestically (including
Health Protection Act (7
those that threaten public health)
USC 7701)
Agricultural
Establishing quality and marketing grades and standards
Agricultural Marketing Act
Marketing Service
for dairy products, fruits and vegetables, livestock, meat,
of 1946 (7 U.S.C. 1621), Egg
poultry, seafoods, and egg products; certifying quality
Products Inspection Act (21
programs; conducting quality grading services, general y
USC 1031), Agricultural
user fee-funded
Marketing Agreement Act
(7 U.S.C. 601)
Food and Nutrition
Encouraging and coordinating efforts to ensure the safety Program subsidies
Service
of foods in school lunch and other domestic programs
authorized by Richard B.
Russell National School
Lunch Act (42 USC
1751),Child Nutrition Act
(42 USC 1771).
Grain Inspection,
Setting quality standards for, and testing, grains and
U.S. Grain Standards Act (7
Packers and
related commodities, primarily for marketing purposes
USC 71), Agricultural
Stockyards
Marketing Act of 1946
Administration
Agricultural
Conducts in-house USDA research on agricultural and
Numerous laws dating to
Research Service
food topics, of which food safety is one of many
the Department of
Agriculture Organic Act of
1862 (7 USC 2201 note), up
through and including
recent omnibus farm laws
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Agency
Major Responsibilities and Activities
Primary Authorities
Cooperative State
Coordinates and administers federal funding of land
Numerous laws dating to
Research, Education, grant and other institutions to conduct agricultural and
the Department of
and Extension
food research, education and extension activities; food
Agriculture Organic Act of
Service
safety is one of many subject areas
1862, up through and
including recent omnibus
farm laws
Department of Commerce:


National Oceanic
Offering a variety of voluntary seafood safety and quality
Agricultural Marketing Act
and Atmospheric
inspection services on a fee-for-service basis
of 1946, Fish and Wildlife
Administration
Act of 1956 (16 USC 742)
Environmental Protection Regulating pesticide products; setting maximum
Federal Insecticide,
Agency
allowable tolerances for residue levels on food
Fungicide, and Rodenticide
commodities and animal feeds
Act (7 USC 136), FFDCA
Federal Trade
Enforcing federal prohibitions against unfair or deceptive
Federal Trade Commission
Commission
acts or practices in trade, including consumer deception
Act (15 USC 41)
regarding foods
Department of the


Treasury:
Alcohol and
Administering and enforcing laws on the production,
Federal Alcohol
Tobacco Tax and
safety, distribution and use of alcoholic beverages
Administration Act (27 USC
Trade Bureau
201), Internal Revenue
Code (26 USC Ch. 51)
Department of Homeland


Security:
U.S. Customs and
Coordinating many food security activities, including at
Homeland Security Act (6
Border Protection
the border; now conducting agricultural border
USC 101)
inspection activities formerly done by APHIS
Source: Prepared by CRS based in part on various reports by the Government Accountability Office.
a. These agencies have the leading food safety regulatory authorities.

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Table 2. Selected Comparison of FSIS and FDA Responsibilities
Activity
Food Safety and Inspection Service
Food and Drug Administration
(Foods Only)
Primary
Federal Meat Inspection Act (21 USC
Federal Food, Drug, and Cosmetic Act (FFDCA;
Authorizations
601), Poultry Products Inspection Act (21 21 USC 301), Public Health Service Act (42 USC
USC 451), Egg Products Inspection Act
201), Egg Products Inspection Act (21 USC 1031),
(21 USC 1031)
Public Health Security and Bioterrorism
Preparedness and Response Act (21 USC 341)
Foods Regulated
Major types of domestic and imported
Al other domestic and imported foods, also
meat and poultry and their products;
animal drugs and feeds including those used in
catfish products; processed (dried,
food-producing animals (80% of at-home U.S. food
frozen, liquid) egg products (20% of at-
spending)
home U.S. food spending)
Funding (FY2009)
Appropriated: $972 million; user fees:
Appropriation: $649 million (plus $137 million for
$140 million
animal drugs and feeds including $20 million in
user fees)
Staff (est. field
8,000 1,900
only)
Domestic facilities
6,300 slaughter and/or processing
68,000 subject to inspection
establishments
Inspection
Ante- and post-mortem inspection of
Prohibits adulteration or misbranding; relies on
Approach
every animal, carcass and part;
facilities that manufacture, process, pack, or hold
traditionally organoleptic (but see “Food
food for humans or animals to be meet prescribed
safety plans” below); only USDA-
standards (e.g., regarding additives, contaminants,
inspected and passed products may enter
etc.); all facilities must register, report changes in
commerce
timely manner
Required
Slaughter plants: all times of operation;
Not explicitly required; annual for 6,000 high-risk
inspection
processing plants: at least once daily
facilities; once every 5-10 years for rest (ests.
frequency
vary)
Food safety plans
Requires al establishment to prepare and
Facilities must follow more general regulations on
have preapproved “HACCP” (hazard
good manufacturing practices (GMPs) which
analysis and critical control point) plans
address safe handling and plant sanitation—except
determining risks, controlling them (with
a form of HACCP required for seafood, low-acid
documentation)
canned foods, juices
Imports
Specified products only from countries
Equivalence not determined beforehand; reliance
where FSIS has determined equivalence
on inspections at 300 ports; all foreign facilities
of foreign safety system, with annual
(like domestic) must register and report changes
verification; imports exempt from prior
in timely manner; must provide prior notice for
notice but subject to reinspection at 150
each food article imported (est. 1% of notified
import establishments (est. 10%
entries inspected)
reinspected)
Third party
Private labs accredited for chemical
No accreditation for food testing labs or use of
certification
testing of meat and poultry (for imports,
third parties for import oversight addressed in
see above)
current law
On-farm oversight
FSIS inspection authority begins at
Those engaged solely in harvesting, storing or
slaughter plant
distributing raw agricultural commodities general y
exempt from registration, GMP regulations,
recordkeeping, although may have authority to
regulate some on-farm activities
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The Federal Food Safety System: A Primer

Food and Drug Administration
Activity
Food Safety and Inspection Service
(Foods Only)
Labeling
Review and preapproval required for al
All foods must adhere to food labeling
labels
requirements such as statement of identity,
declaration of net contents, nutrition labeling;
labels cannot be false or misleading
Notification
P.L. 110-246 requires an establishment to
P.L. 110-85 requires reportable food registry to
Requirements
promptly notify USDA if it has reason to
report if an article of food poses a reasonable
believe that an adulterated or misbranded probability of causing serious adverse health
product has entered commerce
consequences or death to humans or animals; not
yet established by agency
Recall Authority
No authority to mandate recalls; relies
No authority to mandate recalls (except infant
on voluntary
formula); relies on voluntary
Source: Prepared by CRS based on various CRS reports.

Author Contact Information

Renée Johnson

Specialist in Agricultural Policy
rjohnson@crs.loc.gov, 7-9588


Acknowledgments
This report was originally written by Geoffrey S. Becker, Specialist in Agricultural Policy.

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