The Federal Food Safety System: A Primer
Renée Johnson
Specialist in Agricultural Policy
January 11, 201120, 2012
Congressional Research Service
7-5700
www.crs.gov
RS22600
CRS Report for Congress
Prepared for Members and Committees of Congress
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. Federal responsibility for food safety rests primarily with the Food and Drug
Administration (FDA) and the U.S. Department of Agriculture (USDA). FDA, an agency of the
Department of Health and Human Services, is responsible for ensuring the safety of all domestic
and imported food products (except for most meats and poultry). FDA also has oversight of all
seafood, fish, and shellfish products. USDA’s Food Safety and Inspection Service (FSIS)
regulates most meat and poultry and some egg products. State and local food safety authorities
collaborate with federal agencies for inspection and other food safety functions, and they regulate
retail food establishments.
The combined efforts of the food industry and government regulatory agencies often are credited
with making the U.S. food supply among the safest in the world. However, 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. Some critics also
note that the organizational complexity of the U.S. food safety system as well as trends in U.S.
food markets—for example, increasing imports as a share of U.S. food consumptions, increasing
and
increasing consumption of fresh, often unprocessed, foods—pose ongoing challenges to ensuring
food safety.
The 111th Congress passed comprehensive food safety legislation in December 2010 (FDA Food
Safety Modernization Act, P.L. 111-353)with the FDA Food Safety
Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety
authorities since the 1930s. Although numerous agencies share responsibility for
regulating food safety, this newly enacted legislation
safety, FSMA focused on foods regulated by FDA and
amended FDA’s existing structure and authorities, in particular the Federal Food, Drug, and
Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.). This newly enacted law is the largest
expansion of FDA’s food safety authorities since the 1930s; it does
authorities, and did not directly address meat and
poultry products under the jurisdiction of USDA. The 112th Congress will likely provide oversight
and scrutiny over how the law is implemented, including FDA’s coordination with other federal
agencies such as USDA and the Department of Homeland Security (DHS).
In addition, some in Congress have long claimed that once FDA’s food safety laws were amended
and updated, it would be expected that Congress would next turn to amending laws and
regulations governing USDA’s meat and poultry products. Food safety incidents and concerns
regarding USDA-regulated meat and poultry products are similarly well-documented. A series of
bills were introduced and debated in the previous few Congresses. These bills may be reintroduced and debated in the 112th Congress poultry products under USDA’s jurisdiction.
Beyond these changes, some in Congress continue to push for additional policy reforms to
address other perceived concerns about the safety of the U.S. food supply.
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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.... 1
Food Safety and Inspection Service .......................................................................................... 3
Centers for Disease Control and Prevention.............................................................................. 4
National Marine Fisheries Service ............................................................................................ 5
Environmental Protection Agency ............................................................................................. 5
Other Federal Agencies .........................................................................................................5
Congressional Committees ..........................................................................................................5
Issues for Congress ........................... 5
Congressional Committees ................................................................................................................6
Food Safety Incidents............................................................................................................6
Food Safety Legislation ........................................................................................................7 6
Tables
Table 1. Major Federal Food Safety Agencies..............................................................................8... 6
Table 2. Selected Comparison of FSIS and FDA Responsibilities .................................................. 8 10
Contacts
Author Contact Information ......................................................................................................... 11.. 10
Acknowledgments .................................................................................................................... 11..... 10
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The Federal Food Safety System: A Primer
Background
Americans spend more than $1 trillion on food each year, nearly half of it in restaurants, schools,
and other places outside the home. 1 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, the Centers for Disease
Control and Prevention (CDC) reports that each year an estimated one in six Americans—a total
of 48 million people—becomebecomes sick from contaminated food foodborne illnesses caused by
contamination from any one of a number of microbial pathogens.2 Of these, an estimated 128,000
cases require hospitalization and 3,000 cases result in death. 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 a
growing share of the U.S. food supply is from overseas sources. These concerns, combined with
the ongoing recurrence of major food safety-related incidents, have heightenheightened public and media
scrutiny of the U.S. food safety system, and magnified congressional interest in the issue.
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 Table 1 and Table 2 for a brief
comparative look at the agencies’ responsibilities.)
FSIS’s FY2010 budget was $1.019 billion in appropriated funds plus another approximately $130
million in industry-paid user fees. 3 FDA’s budget for foods was $784.1 million in FY2010,4
virtually all of it appropriated with limited authorized user fees.5 Thus, FSIS had approximately
60% of the two agencies’ combined food safety budget, and FDA had the other approximately
40%. This discrepancy in funding exists although FSIS is responsible for between 10%-20% of
Food and Drug Administration
Excluding the roughly 10%-20% of the U.S. food supply that is estimated to be under the
jurisdiction of FSIS, it may be argued that the safety of the majority of all foods—about 80%90%—falls under FDA’s responsibility.3 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
1
Roughly two-thirds of the $1 trillion is for domestically produced farm foods; imports and seafood account for the
balance. USDA, Economic Research Service (ERS) data, at http://www.ers.usda.gov/Browse/FoodSector/.
2
U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Estimates of
Foodborne Illness in the United States,” http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html.
3
CRS Report R41475, Agriculture and Related Agencies: FY2011 Appropriations. Fees are from the explanatory notes
of the President’s Budget request: http://www.obpa.usda.gov/explan_notes.html. FSIS collects user fees to cover
overtime and other services, including inspection and laboratory costs, and also trust fund activities.
4
FDA data are from the President’s Budget Request “All Purpose Table—Total Program Level.”
5
CRS Report R41288, Food and Drug Administration FY2011 Budget and Appropriations, by Susan Thaul. User fees
related to foods have been proposed in legislation and in budget requests over time. The FY2011 President’s Budget
request has proposed user fees for reinspection, export certification, inspection and registration.
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the U.S. food supply, while FDA is responsible for the remainder.6 Staffing levels also vary
considerably among the two agencies: FSIS staff numbers around 9,400, while FDA staff working
on food-related activities numbers 2,800.
The comprehensive food safety legislation that passed in the 111th Congress (FDA Food Safety
Modernization Act, P.L. 111-353) authorized additional appropriations and staff for FDA’s future
food safety activities. This newly enacted law is the largest expansion of FDA’s food safety
authorities since the 1930s; it does not directly address meat and poultry products under the
jurisdiction of USDA. The Congressional Budget Office (CBO) estimated that implementing the
newly enacted lawThe 20% estimate is based on information reported by the Government Accountability Office (GAO) in “Revamping
Oversight of Food Safety,” prepared for the 2009 Congressional and Presidential Transition, and appears to represent
proportions of total spending for food consumed at home. The 10% estimate is based on data from USDA’s Economic
Research Service (ERS) on U.S. per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/.
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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
(FFDCA), 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.). The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety
Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety
authorities since the 1930s. Although numerous agencies share responsibility for regulating food
safety, FSMA focused on foods regulated by FDA and amended FDA’s existing structure and
authorities, in particular FFDCA.4 The Congressional Budget Office (CBO) estimated that
implementing FSMA could increase net federal spending subject to appropriation by about $1.4
billion over a five-year period (FY2011-FY2015); collections from possible revenue and direct
spending increases from new criminal penalties would be “insignificant, yielding a negligible net
impact in each year.”7 The enacted bill5 FSMA authorizes an increase in FDA staff, reaching to up to 5,000
staff members in FY2014.
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
6
The 20% estimate is based on information reported by the Government Accountability Office (GAO) in “Revamping
Oversight of Food Safety,” prepared for the 2009 Congressional and Presidential Transition, and appear to represent
proportions of total spending for food consumed at home. The 10% estimate is based on data from USDA’s Economic
Research Service (ERS) on U.S. per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/.
7
FY2014. Given the current budgetary climate, funding to undertake many federal activities in
FSMA is uncertain.6
FDA’s FY2011 budget for its foods program was $835.7 million, virtually all of it appropriated
with limited authorized user fees.7 FSMA also authorized additional user fees that provide limited
funds to assist with implementation of the new law. FDA staff working on food-related activities
in FY2011 were estimated at about 3,400 FTEs.
The number of food facilities subject to FDA inspection has been increasing sharply in the past
few years. 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 had 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.8 Of these inspections, an increasing number of
inspections have been conducted by states under contract with FDA, rather than by FDA.9
4
For more information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). FSMA does
not directly address meat and poultry products under USDA’s jurisdiction.
5
CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health,
Education, Labor, and Pensions on December 18, 2009, incorporating a manager’s amendment released on August 12,
2010,” August 12, 2010. Reflecting the August 2010 Senate amendment to S. 510.
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inspection personnel, as well as other sources, to alert it to situations calling for increased
inspection.
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.8
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
6
For more information, see CRS Report R41964, Agriculture and Related Agencies: FY2012 Appropriations.
7
FDA “Operating Plan for FY 2011 and Comparisons to FY 2010,” http://www.hhs.gov/asfr/ob/docbudget/
2011operatingplan_fda.pdf.
8
HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), Table 1 , April 2010, http://oig.hhs.gov/
oei/reports/oei-02-08-00080.pdf.
9
HHS, OIG, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections (OEI-02-09-00430), December
2011, http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf.
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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. GAO reported that, in 2000, FDA inspections
covered only about 1% of the food imported under its jurisdiction.10 Changes to FDA’s import
regime now being implemented under FSMA are expected to address some of these concerns.
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
Available USDA data indicate that FSIS is roughly responsible for 10%-20% of the U.S. food
supply, while FDA is responsible for the remainder.11 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
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
exotic and alternative meats not inspected by FSIS, and shares the responsibility for egg safety with
with FSIS.912 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.).
8
HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), April 2010.
10
GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/
new.items/d0247t.pdf.
11
See footnote 3.
12
USDA’s Agricultural Marketing Service (AMS) also has responsibility for ensuring shell eggs for quality, but not
safety, considerations (see Table 1).
9
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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’s FY2011 budget was $1.007 billion in appropriated funds, plus another approximately
$150 million in industry-paid user fees.13 FSIS staff numbers around 9,600FSIS 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.14 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. 1015
Centers for Disease Control and Prevention
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
13
USDA, 2012 Explanatory Notes, Food Safety and Inspection Service, February 12, 2011, http://www.obpa.usda.gov/
21fsis2012notes.pdf.
14
USDA, “Listing of Participating States,” http://www.fsis.usda.gov/regulations_&_policies/
Listing_of_participating_states/index.asp
15
The 2008 farm bill (P.L. 110-246, § 11017) contained new provisions intended to enable more interstate shipment of
state-inspected products.
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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.
10
The 2008 farm bill (P.L. 110-246) contains new provisions intended to enable more interstate shipment of stateinspected products; USDA published proposed regulations to implement these provisions in the September 16, 2009,
Federal Register.
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National Marine Fisheries Service
Although the FDA is the primary agency responsible for ensuring the safety, wholesomeness, and
proper labeling of domestic and imported seafood products, the National Marine Fisheries
Service (NMFS), which is part of the U.S. Department of Commerce, conducts, on a fee-forservice 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
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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Issues for Congress
Food Safety Incidents
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. 11
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.
In July 2010, CDC noticed a spike in cases of infection with Salmonella Enteritidis, a strain
commonly associated with shell eggs, which are regulated by FDA.12 In August, FDA found the
same pathogen on two egg farms in Iowa, leading to the nationwide recall by the companies of
more than 500 million eggs packaged under several brand names. 13 According to the CDC, this is
the largest such outbreak reported since the start of its outbreak surveillance in the early 1970s.14
This investigation is ongoing.
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.15 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
11
For sources and updates see the FDA website at http://www.fda.gov/opacom/7alerts.html.
USDA regulates processed eggs, and grades shell eggs for quality (such as grade and size), but does not oversee the
safety of shell eggs.
13
FDA, “Salmonella Enteritidis Outbreak in Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/
ucm222684.htm.
14
FDA, “Frequently Asked Questions and Answers: FDA’s Investigation into the Salmonella Enteritidis Outbreak
Involving the Recall of Shell Eggs,” http://www.fda.gov/Food/NewsEvents/WhatsNewinFood/ucm223723.htm.
15
FDA has the same basic safety standards for human foods and animal feeds, including pet food.
12
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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 noncongressional 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.
Food Safety Legislation
In the 110th Congress, several bills were introduced 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 have
consistently increased funding for food safety activities in recent years. A number of more
comprehensive food safety proposals were introduced, but not enacted.
In the 111th Congress, nearly a dozen food safety bills, several of them comprehensive, were
introduced. The major vehicle in the House is H.R. 2749, introduced by Representative John
Dingell. This bill passed the House, with a recorded vote of 283 to 142, on July 30, 2009. In the
Senate, S. 510 was introduced by Senator Richard Durbin. During 2010, a series of substitute
amendments to the bill were offered and debated, which included additional modifications to the
proposal. On November 30, 2010, S. 510 passed the Senate with a recorded vote of 73-25.
However, a procedural issue held up final action on the legislation, which was resolved when the
Senate inserted its version of the bill into an earlier House bill (H.R. 2751) that was cleared by the
House in December 2010. The FDA Food Safety Modernization Act (P.L. 111-353) was signed
into law on January 4, 2011.16
The 112th Congress will likely provide oversight and scrutiny over how the law is implemented,
including FDA’s coordination with other federal agencies, such as USDA and DHS.
Implementation of the law will depend largely on discretionary appropriations, and some have
questioned whether funding is available in the current budgetary climate. The 112th Congress also
16
For more detailed information see CRS Report R40443, Food Safety in the 111th Congress: H.R. 2749 and S. 510,
coordinated by Renée Johnson.
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may continue to consider changes to other food safety laws and policies that continue to be
actively debated in Congress. Among these are food safety initiatives covering meat, poultry, and
seafood products; legislation intended to curtail the non-medical use of antibiotics in animal feeds
and to ban the use of certain plastic components commonly used in food containers; food
labeling; and the use of plant and animal biotechnology.
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.
Table 1. Major Federal Food Safety Agencies
Agency
Major Responsibilities and Activities
Primary Authoritiesa
Department of Health and Human Services
Food and Drug
Administrationb
USDA’s Agricultural Marketing Service (AMS) is responsible for establishing quality and
marketing grades and standards for many foods (including dairy products, fruits and vegetables,
livestock, meat, poultry, seafoods, and shell eggs), and for certifying quality programs and
conducting quality grading services. Accordingly, AMS is primarily responsible for ensuring
product quality and not food safety.
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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.
Table 1. Major Federal Food Safety Agencies
Agency
Major Responsibilities and Activities
Primary Authorities
Department of Health and Human Services
Food and Drug
Administrationa
Ensuring that all domestic and imported foods,
except processed egg products and major types of
meat and poultry, are safe, wholesome, and properly
labeled, by setting safety and sanitation standards,
periodically inspecting manufacturing facilities,
reviewing records of and spot-checking imports. Also
overseeing the safety of animal drugs and feeds
including those used in food-producing animals
Federal As may be amended by the FDA Food
Safety Modernization Act (FSMA): Federal
Food, Drug, and Cosmetic Act
(FFDCA; 21 USC
21 U.S.C. 301), Public Health
Service Act
(42 USCU.S.C. 201), Egg Products
Inspection Inspection
Act (21 USCU.S.C. 1031), Public
Health Health
Security and Bioterrorism
Preparedness Preparedness
and Response Act (21 USC
341). amongU.S.C. 341), others
Centers for
Disease Control
and Prevention
Monitoring, identifying, and investigating foodborne
diseases; developing and evaluating improved
epidemiological and laboratory methods
Public Health Service Act (42 USC 201)
U.S.C. 201)
Department of Agriculture
Food Safety
Inspection ServicebServicea
Regulating the safety, wholesomeness and proper
labeling of most commercial types of both domestic
and imported meat and poultry, catfish products, and
processed egg products, by approving establishment
designs, safety plans; inspecting every animal and
carcass in slaughtering plants and daily inspecting all
meat and poultry processing plants; determining the
equivalency of importing countries’ meat and poultry
safety systems
Federal Meat Inspection Act (21 USCU.S.C.
601), Poultry Products Inspection Act (21
USCU.S.C. 451), Egg Products Inspection Act
Animal and Plant
Health Inspection
Service
Overseeing animal and plant health, including the
prevention of foreign diseases and pests, eradication
and containment of such problems domestically
(including those that threaten public health)
Animal Health Protection Act (7 USCU.S.C.
8301), Plant Health Protection Act (7 USC
U.S.C. 7701)
Agricultural
Marketing Service
Establishing quality and marketing grades and
standards for dairy products, fruits and vegetables,
livestock, meat, poultry, seafoods, and shell eggs;
certifying quality programs; conducting quality
grading services, generally user fee-funded
Agricultural Marketing Act of 1946 (7
USCU.S.C. 1621), Egg Products Inspection Act
(21 USCU.S.C. 1031), Agricultural Marketing
Agreement Act (7 USCU.S.C. 601)
Food and
Nutrition Service
Encouraging and coordinating efforts to ensure the
safety of foods in school lunch and other domestic
programs
Program subsidies authorized by Richard
B. Russell National School Lunch Act (42
USC 1751),Child Nutrition Act (42 USC
1771).
Department of Agriculture
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Agency
Major Responsibilities and Activities
Primary AuthoritiesaU.S.C. 1751),Child Nutrition Act (42
U.S.C. 1771).
Grain Inspection,
Packers and
Stockyards
Administration
Setting quality standards for, and testing, grains and
related commodities, primarily for marketing
purposes
U.S. Grain Standards Act (7 USCU.S.C. 71),
Agricultural Marketing Act of 1946
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Agency
Major Responsibilities and Activities
Primary Authorities
Agricultural
Research Service
Conducts in-house USDA research on agricultural
and food topics, of which food safety is one of many
Numerous laws dating to the Department
of Agriculture Organic Act of 1862 (7
USCU.S.C. 2201 note), up through and including
including recent omnibus farm laws
Cooperative State
Research,
Education, and
Extension Service
Coordinates and administers federal funding of land
grant and other institutions to conduct agricultural
and food research, education and extension
activities; food safety is one of many subject areas
Numerous laws dating to the Department
of Agriculture Organic Act of 1862, up
through and including recent omnibus
farm laws
Department of Commerce
National Oceanic
and Atmospheric
Administration
Offering a variety of voluntary seafood safety and
quality inspection services on a fee-for-service basis
Agricultural Marketing Act of 1946, Fish
and Wildlife Act of 1956 (16 USCU.S.C. 742)
Environmental
Protection Agency
Regulating pesticide products; setting maximum
allowable tolerances for residue levels on food
commodities and animal feeds
Federal Insecticide, Fungicide, and
Rodenticide Act (7 USCU.S.C. 136), FFDCA
Federal Trade
Commission
Enforcing federal prohibitions against unfair or
deceptive acts or practices in trade, including
consumer deception regarding foods
Federal Trade Commission Act (15 USC
41)U.S.C.
41)
Department of the Treasury
Alcohol and
Tobacco Tax and
Trade Bureau
Administering and enforcing laws on the production,
safety, distribution and use of alcoholic beverages
Federal Alcohol Administration Act (27
USCU.S.C. 201), Internal Revenue Code (26
USC Ch. 51)
Department of Commerce
National Oceanic
and Atmospheric
Administration
Department of the Treasury
Alcohol and
Tobacco Tax and
Trade Bureau
Department of U.S.C. Ch. 51)
Department of Homeland Security
U.S. Customs and
Border Protection
Coordinating many food security activities, including
at the border; now conducting agricultural border
inspection activities formerly done by APHIS
Homeland Security Act (6 USCU.S.C. 101)
Source: Prepared by CRS based in part on various reports by the Government Accountability Office.
a.
This table has not yet been updated to reflect changes that may have been authorized in the FDA Food
Safety Modernization Act, P.L. 111-353.
b.
These agencies have the leading food safety regulatory authorities.
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Table 2. Selected Comparison of FSIS and FDA Responsibilities
Food and Drug Administration
(Foods Only)
ActivityaProgram only)
Activity
Food Safety and Inspection Service
Primary
Authorizations
Federal Meat Inspection Act (21 USCU.S.C.
601), Poultry Products Inspection Act (21
USCU.S.C. 451), Egg Products Inspection Act
(21 USC 1031)
Federal Food, Drug, U.S.C. 1031)
As may be amended by the FDA Food Safety
Modernization Act (FSMA): Federal Food, Drug,
and Cosmetic Act (FFDCA;
21 USC 301), Public 21 U.S.C. 301; Public
Health Service Act (42 USC
201),U.S.C. 201); Egg Products
Inspection Act (21 USCU.S.C. 1031),
; Public Health
Security and Bioterrorism
Preparedness and
Response Act (21 USCU.S.C. 341)
Foods Regulated
Major types of domestic and imported
meat and poultry and their products;
catfish products; processed (dried,
frozen, liquid) egg products (20% of athome U.S. food spending)
All other domestic and imported foods, also
animal drugs and feeds including those used in
food-producing animals (80% of at-home U.S. food
spending)
Funding (FY2009)
Appropriated: $972 million; user fees:
$140 million
Appropriation: $649 million (plus $137 million for
animal drugs and feeds including $20 million in
user fees)
Staff (est. field
only)
8,000
1,900enacted
FY2012)
Appropriated: $1.004 billion for FY2012.
Expected user fees are estimated to
include another $150 million.
Appropriated: $866.1 million for FDA’s Foods
Program, not including funding from expected
user fees. Expected user fees are estimated to
include another $79 million.
Including authorized fees, total available funding is
estimated at about $945 million.
Staff (2011)
9,600 FTEs
3,400 FTEs
Domestic facilities
6,300 slaughter and/or processing
establishments
68,000 subject to inspection
Inspection
Approach
Ante- and post-mortem inspection of
every animal, carcass and part;
traditionally organoleptic (but see “Food
safety plans” below); only USDAinspected and passed products may enter
commerce
Prohibits adulteration or misbranding; relies on
facilities that manufacture, process, pack, or hold
food for humans or animals to be meet prescribed
standards (e.g., regarding additives, contaminants,
etc.); all facilities must register, report changes in
timely manner.
Required
inspection
frequency
Slaughter plants: all times of operation;
processing plants: at least once daily
Not explicitly required; annual for 6,000 high-risk
facilities; once every 5-10 years for rest (ests.
vary)FSMA requires increased inspection rates for any
registered facility, particularly those identified as
“high-risk.” Domestic high-risk facilities are to be
inspected not less than once in the five-year
period after enactment, and not less than once
every three years thereafter. Domestic non-highrisk facilities are to be inspected not less than
once in the seven-year period after enactment,
and not less than once every five years thereafter.
Food safety plans
Requires all establishment to prepare and
have preapproved “HACCP” (hazard
analysis and critical control point) plans
determining risks, controlling them (with
documentation)
Facilities must follow more general Prior to FSMA, facilities followed general
regulations on
good manufacturing practices
(GMPs) which
to address safe handling and plant
sanitation—except
a form of HACCP required for
seafood, low-acid
canned foods, juices canned foods, juices. FSMA §103
created new requirements for facilities to evaluate
hazards, implement preventive controls, monitor
controls, and maintain records. FDA rulemaking is
clarifying requirements under new written
HACCP-type and/or broader written food safety
plans as part of its so-called Hazard Analysis and
Risk-Based Preventive Controls.
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Activity
Food Safety and Inspection Service
Food and Drug Administration
(Foods Program only)
Imports
Specified products only from countries
where FSIS has determined equivalence“equivalence”
of foreign safety system, with annual
verification; imports exempt from prior
notice but subject to reinspection at 150
import establishments (est. 10%
reinspected)
Equivalence not determined beforehand; reliance
on inspections at 300 ports; all foreign facilities
(like domestic) must register and report changes
in timely manner; must provide prior notice for
each food article imported (est. 1% of notified
entries inspected)Prior to FSMA, food safety system equivalence
was not determined beforehand; reliance on
inspections was at 300 ports (est. 1% of notified
entries inspected). FSMA provides for tighter
controls and use certification or verification
systems for imported foods(to be determined by
FDA rulemaking). At least 600 foreign facilities
must be inspected the year following enactment,
and in each of the subsequent five years the
number of foreign facilities inspected is to double.
Third party
certification
Private labs accredited for chemical
testing of meat and poultry (for imports,
see above)
NoPrior to FSMA, there was no accreditation for
food testing labs or use of
third parties for import oversight addressed in
current law
oversight. FSMA §202 requires FDA to establish a
program for testing of food by accredited labs and
to recognize accreditation bodies to accredit labs.
FSMA §303 creates a system of accreditation of
third-party auditors and audit agents to certify
importing entities. FDA’s rulemaking is ongoing.
On-farm oversight
FSIS inspection authority begins at
slaughter plant
ThosePrior to FSMA, those engaged solely in harvesting,
storing or
distributing raw agricultural commodities
commodities were generally
exempt from registration, GMP regulations,
recordkeeping, although may have authority to
regulate some on-farm activities
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Activitya
Food Safety and Inspection Service
Food and Drug Administration
(Foods Only)
registration, GMP regulations, and record-keeping.
FSMA §105 created new farm-level requirements,
particularly for fresh produce determined to be
higher-risk (FDA rulemaking is ongoing). Some
small farm businesses are exempt from regulation.
Labeling
Review and preapproval required for all
labels
All foods must adhere to food labeling
requirements such as statement of identity,
declaration of net contents, nutrition labeling;
labels cannot be false or misleading.
Notification
Requirements
P.L. 110-246 requires an establishment to
promptly§11017 amended meat and
poultry laws to require an establishment
to notify USDA if it has reason to
believe believe
that an adulterated or misbranded
product has entered commerce
P.L. 110-85 requires reportable food registry to
report if an article of food poses a reasonable
probability of causing serious adverse health
consequences or death to humans or animals; not
yet established by agency(amended by FSMA) requires FDA to
maintain a reportable food registry for industry to
report food safety cases in order to help FDA
better track patterns and target inspections. FSMA
§204 provided for an enhanced tracing system for
foods that FDA determines to pose a higher food
safety risk. As part of the ongoing rulemaking
process, FDA has launched product tracing pilots.
Recall Authority
No authority to mandate recalls; relies
on voluntary
No efforts
Prior to FSMA, FDA had no authority to mandate
recalls (except infant
formula); relies on voluntary
Source: Prepared by CRS.
a.
This table has not yet been updated to reflect changes that may have been authorized in the FDA Food
Safety Modernization Act, P.L. 111-353. formula). FSMA §206
provides for mandatory recall authority where
there is a reasonable probability that a food is
adulterated or misbranded, and its use or
exposure to it will cause serious adverse health
consequences or death. Civil/criminal penalties
apply for failure to comply with a recall order.
Source: Prepared by CRS.
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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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