The Federal Food Safety System: A Primer
Renée Johnson
Specialist in Agricultural Policy
January 20November 26, 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 and
increasing consumption of fresh, often unprocessed, foods—pose ongoing challenges to ensuring
food safety.
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, and did not directly address meat and 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.
After FSMA was signed into law in January 2011, concerns were voiced about whether there
would be enough money to overhaul the U.S. food safety system and also whether expanded
investment in this area is appropriate in the current budgetary climate. Although Congress
authorized appropriations and new user fees for FDA when it enacted FSMA, it did not provide
the full funding needed for FDA to perform these activities. FDA’s FY2012 budget for its foods
program was $866 million, and FSIS’s FY2012 budget was $1.004 billion in appropriated funds,
with some additional funding available from authorized user fees. Funding levels specific to food
safety responsibilities at other federal and state agencies is not readily available.
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The Federal Food Safety System: A Primer
Contents
Background ...................................................................................................................................... 1
The Agencies and Their Roles ......................................................................................................... 1
Food and Drug Administration .................................................................................................. 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 .............................................................................................................. 6
Tables
Table 1. Major5
Funding for Federal Food Safety AgenciesPrograms ..................................................................................... 6
Tables
Table 2. 1. Appropriations for Food Safety, FY2010-FY2013 ............................................................ 7
Appendixes
Appendix A. Major Federal Food Safety Agencies and Selected Laws .......................................... 8
Appendix B. Selected Comparison of FSIS and FDA Responsibilities .................................................. 8.. 10
Contacts
Author Contact Information........................................................................................................... 1012
Acknowledgments ......................................................................................................................... 1012
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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—becomes 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 heightened 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
Appendix A and Appendix B provide a
brief comparative look at the agencies’ responsibilities.)
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. products, seafood, and processed foods. FDA has jurisdiction over meats from animals or birds
1
USDA, Economic Research Service (ERS) food sales data, data, at http://www.ers.usda.gov/Browse/FoodSector/data-products/foodexpenditures.aspx.
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
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 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)-ERS on U.S.
per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/.
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The Federal Food Safety System: A Primer
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)..4
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.45 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.”56 FSMA authorizes an increase in FDA staff to up to 5,000 staff members in
FY2014. Given the current budgetary climate, funding to undertake many federal activities in
FSMA is uncertain.6by
FY2014.
FDA’s FY2011 budget for its foods program was $835.7836.2 million, virtually all of it appropriated
with limited authorized user fees (Table 1)..7 FSMA also authorized additional user fees that
provide limited
funds to assist with implementation of the new law. FDA staff working on food-relatedfoodrelated activities
in FY2011 were estimated at about 3,400600 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.87 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.
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.
88
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
4
FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, § 11016).
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.
6
CBO cost estimate, “S. 510, Food Safety Modernization Act,” August 12, 2010.
7
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.
98
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.10covered only about 1% of the food imported under its jurisdiction.9 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., comprising roughly 10%-20%
of the U.S. food supply.10
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.1211 The latter is responsible for the safety of liquid, frozen, and dried egg products,
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).
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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 (Table 1), with, plus another approximatelyroughly
$150 million to $180 million in industry-paid user fees.13 annually.12 FSIS staff numbers around 9,600
9,500; 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,
9
GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/
new.items/d0247t.pdf.
10
See footnote 3.
11
USDA’s Agricultural Marketing Service (AMS) also has responsibility for ensuring shell eggs for quality, but not
safety, considerations (see Appendix A).
12
USDA, 2012 Explanatory Notes, Food Safety and Inspection Service, February 12, 2011, http://www.obpa.usda.gov/
21fsis2012notes.pdf.
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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.1413 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.1514
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.
13
USDA, “Listing of Participating States,” http://www.fsis.usda.gov/regulations_&_policies/
Listing_of_participating_states/index.asp.
14
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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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.
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.
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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
As may be amended by the FDA Food
Safety Modernization Act (FSMA): Federal
Food, Drug, and Cosmetic Act (FFDCA;
21 U.S.C. 301), Public Health Service Act
(42 U.S.C. 201), Egg Products Inspection
Act (21 U.S.C. 1031), Public Health
Security and Bioterrorism Preparedness
and Response Act (21 U.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 U.S.C. 201)
Department of Agriculture
Food Safety
Inspection Servicea
Regulating
Funding for Federal Food Safety Programs
Historically, federal funding and staffing levels between FDA and FSIS have been
disproportionate to their respective responsibilities to address food safety activities. Although
FSIS is responsible for 10%-20% of the U.S. food supply, it has had approximately 60% of the
two agencies’ combined food safety budget; and although FDA has been responsible for 80%90% of the U.S. food supply, it has received about 40% the available budget.
For example, in FY2010, FSIS received $1.018 billion in appropriated funds plus another
approximately $150 million in industry-paid user fees, whereas FDA’s FY2010 budget for foods
was $783 million, virtually all of it appropriated with limited authorized user fees (Table 1).
Staffing levels also vary considerably among the two agencies: FSIS staff numbered around 9,400
FTEs in FY2010, while FDA staff working on food-related activities numbers about 3,400 FTEs.
FSMA (P.L. 111-353) authorized additional appropriations and staff for FDA’s future food safety
activities and authorized new user fees.15 New fees authorized under FSMA include an annual fee
for participants in the voluntary qualified importer program (VQIP) and three fees for certain
periodic activities involving reinspection, recall, and export certification.16 FSMA did not impose
any new facility registration fees. FSMA also authorized an increase in FDA staff, reaching 5,000
by FY2014.17 Although Congress authorized appropriations and new user fees when it enacted
FSMA, it did not provide the full funding needed for FDA to perform these activities. After
FSMA was signed into law in January 2011, concerns were voiced about whether there would be
enough money to overhaul the U.S. food safety system and also whether expanded investment in
this area is appropriate in the current budgetary climate.18
In the past few years the balance of overall funding for food safety between FDA and USDA has
slowly started to shift (Table 1).
Funding levels specific to food safety responsibilities at other federal and state agencies are not
readily available.
15
P.L. 111-353 amended the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 U.S.C. §§ 301 et seq.).
FSMA, P.L. 111-353, Sections 107 and 401. Details of these annual and periodic fees are presented in CRS Report
R40443, The FDA Food Safety Modernization Act (P.L. 111-353).
17
FSMA, P.L. 111-353, Section 401. By fiscal year, staff level increases were authorized to a total of not fewer than
4,000 staff members (FY2011); 4,200 staff (FY2012); 4,600 staff (FY2013); and 5,000 staff (FY2014).
18
See, for example, “Food Safety Bill Advocates Expect Funding Fight,” Food Safety News, January 4, 2011.
16
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Table 1. Appropriations for Food Safety, FY2010-FY2013
(FTEs as indicated, and budget and appropriation figures in millions of dollars)
Agency/Year
FTEsa
Appropriationb
Program Level,
Including Fees
HHS Food and Drug Administration (FDA), “Foods” Subtotal Only
FY2010 Actual
3,387
783.2
783.2
FY2011 Actual
FY2012 Enacted
3,605
836.2
836.2
3,757
866.1
882.7
FY2013 Administration Budget
4,047
855.2
1,083.9
FY2013, H.R. 5973, House
NA
866.1
883.5
FY2013, S. 2375, Senate
NA
867.0
884.5
FY2012 Appropriation
NA
0 (0%)
0.8 (0.1%)
FY2013 Administration Budget
NA
10.9 (1.3%)
-200.4 (-18.5%)
FY2012 Appropriation
NA
1.0 (0.1%)
1.7 (0.2%)
FY2013 Administration Budget
NA
11.8 (1.4%)
-199.5 (-18.4%)
FY2010 Appropriation
9,401
1,018.5
1,172.5
FY2011 Appropriation
9,465
1,006.5
1,185.2
FY2012 Enacted
9,540
1,004.4
1,166.6
FY2013 Administration Budget
9,040
995.5
NA
FY2013, H.R. 5973, House
NA
995.5
NA
FY2013, S. 2375, Senate
NA
1,001.4
NA
FY2012 Appropriation
NA
-8.9 (-0.9%)
NA
FY2013 Administration Budget
NA
0.0 (0.0%)
NA
FY2012 Appropriation
NA
-3.0 (-0.3%)
NA
FY2013 Administration Budget
NA
5.9 (0.6%)
NA
Comparison with House bill to:
Comparison with Senate bill to:
USDA Food Safety and Inspection Service (FSIS)
Comparison with House bill to:
Comparison with Senate bill to:
Source: CRS, from data in H.R. 5973 (H.Rept. 112-542) and S. 2375 (S.Rept. 112-163); FTEs and FDA “Foods”
are from USDA and FDA data: HHS, “FY2013 FDA: Justification of Estimates for Appropriations Committees,”
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM291555.pdf; and
USDA, “2013 Explanatory Notes, FSIS,” http://www.obpa.usda.gov/21fsis2013notes.pdf. NA=not available.
Notes: Percentages in parentheses reflect differences relative to FY2012 or the Administration’s proposal.
a.
Staffing in full time equivalents: HHS, “FY2013 FDA: Justification of Estimates for Appropriations
Committees,” pp. 96 and 144; and USDA, “2013 Explanatory Notes, FSIS,” p. 21-5.
b.
Data from “FY2013 FDA: Justification of Estimates for Appropriations Committees,” FY2010-FY2012 from
p. 144, FY2013 calculated from tables on pp. 93-96; USDA, “2013 Explanatory Notes, FSIS,” p. 21-5.
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The Federal Food Safety System: A Primer
Appendix A. Major Federal Food Safety Agencies
and Selected Laws
Agency
Major Responsibilities and Activities
Primary Authorities
Department of Health and Human Services
Food and Drug
Administration (FDA)a
Ensures 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 oversees the
safety of animal drugs and feeds, including those used
in food-producing animals.
Federal Food, Drug, and Cosmetic Act
(FFDCA; 21 U.S.C. §§ 301-399a) as
amended; Public Health Service Act (42
U.S.C. § 201), Egg Products Inspection Act
(21 U.S.C. § 1031); Federal Import Milk
Act (21 U.S.C. §§ 141-149); Fair Packaging
and Labeling Act (15 U.S.C. §§ 1451-1461);
Federal Anti-Tampering Act (18 U.S.C. §
1365); Pesticide Monitoring Improvements
Act of 1988 (21 U.S.C. § 1401)
Centers for Disease
Control and Prevention
(CDC)
Monitors, identifies, and investigates foodborne
diseases; develops and evaluates improved
epidemiological and laboratory methods.
Public Health Service Act (42 U.S.C. §
201)
Food Safety Inspection
Service (FSIS)a
Regulates 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 U.S.C.
601), Poultry Products Inspection Act (21
U.S.C. 451), Egg Products Inspection Act
Animal and Plant
Health Inspection
Service
Overseeing §§
601-695); Poultry Products Inspection Act
(21 USC §§ 451-472); Egg Products
Inspection Act (21 U.S.C. §§ 1031-1056);
Humane Methods of Slaughter Act of
1978 (7 U.S.C. §§ 1902, 1904, 21 U.S.C. §§
603, 610, 620); Federal Anti-Tampering
Act (18 U.S.C. § 1365); Agricultural
Marketing Act of 1946 (7 U.S.C. § 1622);
Richard B. Russell National School Lunch
Act (42 U.S.C. §§ 1751-1770), as amended
by Child Nutrition and WIC Reauthorization Acts (42 U.S.C. § 1762a(h))
Animal and Plant Health
Inspection Service (APHIS)
Oversees animal and plant health, including the
prevention of foreign diseases and pests, eradication
and
eradication and containment of such problems domestically
domestically (including those that threaten public
health).
Animal Health Protection Act (7 U.S.C.
8301), §§
8301-8322); Plant Health Protection Act (7
U.S.C. 7701)
Agricultural
Marketing Service
Establishing
(7 U.S.C. §§ 7701-7721); Agricultural Bioterrorism Act of 2002 (7 U.S.C. § 8401)
Agricultural Marketing
Service (AMS)
Establishes quality and marketing grades and
standards for dairy products, fruits and vegetables,
livestock, meat, poultry, seafoods, and shell eggs;
certifyingcertifies quality programs; conductingconducts quality
grading grading
services, generally user fee-funded.
Agricultural Marketing Act of 1946 (7
U.S.C. 1621), Egg Products Inspection Act
(21 U.S.C. 1031), Agricultural Marketing
Agreement Act (7 U.S.C. 601)
Food and
Nutrition Service
Encouraging and coordinating§§ 1621-1638d), Perishable
Agricultural Commodities Act, 1930 (7
U.S.C. §§ 499a- 499s); Federal Seed Act
(7 U.S.C. §§ 1551-1611)
Food and Nutrition
Service (FNS)
Encourages and coordinates 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
U.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 U.S.C. 71),
Agricultural Marketing Act of 1946
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6§§ 1751-1770), as amended by
Child Nutrition and WIC Reauthorization
Acts (42 U.S.C. § 1762a(h))
Grain Inspection, Packers
and Stockyards
Administration (GIPSA)
Sets quality standards for and tests grains and related
commodities, primarily for marketing purposes.
U.S. Grain Standards Act (7 USC §§ 7187k), Agricultural Marketing Act of 1946
(7 U.S.C. §§ 1622, 1624)
Department of Agriculture
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The Federal Food Safety System: A Primer
Agency
Major Responsibilities and Activities
Primary Authorities
Agricultural
Research Service Research
Service (ARS)
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
U.S.C. § 2201 note), up through and
including recent omnibus farm laws
Cooperative State
Research,
Education, and
Extension ServiceNational Institute of Food
and Agriculture (NIFA)
(formerly 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
OfferingOffers a variety of voluntary seafood safety and
quality inspection services on a fee-for-service basis.
Agricultural Marketing Act of 1946, Fish
(7
U.S.C. §§ 1622, 1624); Lacey Act (16
U.S.C. § 3371); Fish and Wildlife Act of
1956 (16 U.S.C. § 742)
U.S. Environmental
Protection Agency (EPA)
Regulates the use of certain chemicals and substances
that present an unreasonable risk of injury to health
or the environment. Regulates742)
Environmental
Protection Agency
Regulating pesticide products; setting
sets maximum
allowable tolerances for residue levels
on food
commodities and animal feeds
Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136), FFDCA
Federal Trade
Commission
Enforcing. Sets national
drinking water standards and consults with FDA. Sets
scientific water quality criteria for rivers, lakes, and
streams that are protective of human health and
wildlife.
Federal Food, Drug, and Cosmetic Act (21
U.S.C. §§ 301-399a), as amended; Federal
Insecticide, Fungicide, and Rodenticide Act
(7 U.S.C. §§ 136-136y), as amended by the
Food Quality Protection Act of 1996 (21
U.S.C. § 346a); Clean Water Act (33
U.S.C. 1251-1387); Safe Drinking Water
Act of 1974 (21 U.S.C. § 349 and 42
U.S.C. §§ 300f-300j-26); Toxic Substance
Control Act (15 U.S.C. §§ 2601-2697)
Federal Trade Commission
(FTC)
Enforces federal prohibitions against unfair or
deceptive acts or practices in trade, including
consumer deception regarding foods.
Federal Trade Commission Act (15 U.S.C.
41)
Department of the Treasury
Alcohol and
Tobacco Tax and
Trade Bureau
Administering and enforcing§§ 41-58)
Administers and enforces laws on the production,
safety, distribution and use of alcoholic beverages.
Federal Alcohol Administration Act (27
U.S.C. 201),§§ 201-219a); Internal Revenue
Code (26
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 U.S.C. Ch. 51)
Coordinates many food security activities, including
inspecting imports of food, plants, and animals at the
border. Conducts agricultural border inspection
activities formerly done by APHIS.
Homeland Security Act of 2002 (6 U.S.C.
§ 101); Tariff Act of 1930 (19 U.S.C. §§
1202-1654)
Department of Commerce
National Oceanic and
Atmospheric
Administration (NOAA)
Department of the Treasury
Alcohol and Tobacco Tax
and Trade Bureau (ATF)
Department of Homeland Security
U.S. Customs and Border
Protection (CBP)
Source: Prepared by CRS based in part on various reports by the Government Accountability Office, including
GAO, Federal Food Safety Oversight, GAO-11-289, March 2011. Does not include two USDA agencies included by
GAO (Research, Education, and Economics (REE) agencies: National Economic Research Service (ERS) and
National Agricultural Statistics Service (NASS).
a. 101)
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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The Federal Food Safety System: A Primer
Table 2Appendix B. Selected Comparison of FSIS and FDA
Responsibilities
Food and Drug Administration
(Foods Program only)
Activity
Food Safety and Inspection Service
Primary
Authorizations
Federal Meat Inspection Act (21 U.S.C.
601), Poultry Products Inspection Act (21
U.S.C. 451), Egg Products Inspection Act
(21 U.S.C. 1031)
As may be amended by the FDA Food Safety
Modernization Act (FSMA): Federal Food, Drug,
and Cosmetic Act (FFDCA; 21 U.S.C. 301; Public
Health Service Act (42 U.S.C. 201); Egg Products
Inspection Act (21 U.S.C. 1031); Public Health
Security and Bioterrorism Preparedness and
Response Act (21 U.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 (enacted
FY2012)
Appropriated: $1.004 billion for FY2012.
Expected user fees are estimated to
include another $150 million. Including
authorized fees, total available funding is
estimated at about $1.154 billion.
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
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 establishmentestablishments to prepare and
and have preapproved “HACCP” (hazard
analysis and critical control point) plans
determining risks, controlling them (with
documentation)
Prior to FSMA, facilities followed general
regulations on good manufacturing practices
(GMPs) to address safe handling and plant
sanitation—except a form of HACCP required for
seafood, low-acid 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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The Federal Food Safety System: A Primer
Activity
Food Safety and Inspection Service
Food and Drug Administration
(Foods Program only)
Imports
Specified products only from countries
where FSIS has determined “equivalence”
of foreign safety system, with annual
verification; imports exempt from prior
notice but subject to reinspection at 150
import establishments (est. 10%
reinspected)
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)
Prior to FSMA, there was no accreditation for
food testing labs or use of third parties for import
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
Prior to FSMA, those engaged solely in harvesting,
storing or distributing raw agricultural
commodities were generally exempt from
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 §11017 amended meat and
poultry laws to require an establishment
to notify USDA if it has reason to believe
that an adulterated or misbranded
product has entered commerce
P.L. 110-85 (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 efforts
Prior to FSMA, FDA had no authority to mandate
recalls (except infant 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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The Federal Food Safety System: A Primer
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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