The Federal Food Safety System: A Primer
Renée Johnson
Specialist in Agricultural Policy
November 26, 2012January 17, 2014
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. Other federal agencies also play a role. The Government
Accountability Office (GAO) has identified as many as 15 federal agencies, including FDA and
FSIS, as collectively administering at least 30 laws related to food safety. 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.
Over the years, GAO has published a series of reports highlighting how food safety oversight in
the United States is fragmented, and recommending broad restructuring of the nation’s food
safety system. Similar observations are noted in a series of food safety studies by the National
Research Council (NRC) and Institute of Medicine (IOM), recommending that the core federal
food safety responsibilities should reside within a single entity/agency, and have a unified
administrative structure, clear mandate, and dedicated budget, and maintain full responsibility for
oversight of the entire U.S. food supply.
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 .................................................................................................. 14
Food Safety and Inspection Service .......................................................................................... 35
Centers for Disease Control and Prevention.............................................................................. 47
National Marine Fisheries Service ............................................................................................ 57
Environmental Protection Agency ............................................................................................. 58
Agricultural Marketing Service ................................................................................................. 8
Other Federal Agencies ............................................................................................................. 58
Congressional Committees .............................................................................................................. 59
Funding for Federal Food Safety Programs ..................................................................................... 6
Tables
Table 1. Appropriations for Food Safety, FY2010-FY2013 9
Federal Food Safety Inspections .................................................................................................. 7
Appendixes
Appendix A. Major Federal Food Safety Agencies and Selected Laws .. 11
Figures
Figure 1. Selected Important Dates for Food Safety in the United States, 1862-2011 .................... 3
Tables
Table 1. Appropriations for Food Safety, FY2009-FY2014 ..................................................... 8
Appendix B. Selected Comparison of FSIS and FDA Responsibilities..... 10
Table 2. FDA Food-Related Inspection Data, FY2004-FY2012 ................................................. 10
Contacts
Author Contact Information11
Table 3. Registered Food Facilities, FY2004-FY2012 ................................................................. 12
Table 4. FSIS Employees, Inspectors, and Establishments, FY2002-2012 .................................. 13
Appendixes
Appendix A. Major Federal Food Safety Agencies and Selected Laws ........................................ 14
Appendix B. Selected Comparison of FSIS and FDA Responsibilities................................................... 12
Acknowledgments ................................ 16
Contacts
Author Contact Information........................................................................................... 12................ 18
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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. TheNumerous 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), 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. 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
products, seafood, and processed foods. FDA has jurisdiction over meats from animals or birds
1
USDA, Economic Research Service (ERS) food sales data, http://www.ers.usda.gov/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-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
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.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.5 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.”6 FSMA authorizes an increase in FDA staff to up to 5,000 staff members by
FY2014.
FDA’s FY2011 budget for its foods program was $836.2 million, virtually all of it appropriated
with limited authorized user fees (Table 1). FSMA also authorized additional user fees that
provide limited funds to assist with implementation of the new law. FDA staff working on foodrelated activities in FY2011 were estimated at about 3,600 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.7 Of these inspections, an increasing number of
inspections have been conducted by states under contract with FDA, rather than by FDA.8
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.
8
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.
5
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The Federal Food Safety System: A Primer
covered 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.. 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. 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 and fish products.
The Government Accountability Office (GAO) has identified as many as 15 federal agencies,
including FDA and FSIS, as collectively administering at least 30 laws related to food safety.3
Appendix A and Appendix B provide a brief comparative look at each of these agencies and
their responsibilities. State and local food safety authorities collaborate with federal agencies for
inspection and other food safety functions, and they regulate retail food establishments. This
organizational complexity, and trends in U.S. food markets—for example, increasing imports as a
share of U.S. food consumption and increasing consumption of fresh, often unprocessed, foods—
pose ongoing challenges to ensuring food safety.
The text box below provides a comparison of FDA and USDA and other federal agencies’
responsibilities for food safety and related food quality and other requirements.
1
USDA, Economic Research Service (ERS) food sales data.
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
GAO, Federal Food Safety Oversight, GAO-11-289, March 2011.
2
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Comparison of Selected Agency Responsibilities for Food Safety and Quality
Agency
Responsibility
Food and Drug Administration (FDA)
• Food (but not meat)
• Dietary supplements
• Bottled water
• Seafood
• Wild game (“exotic” meat)
• Eggs in the shell
U.S. Department of Agriculture (USDA)
• Grading of raw fruit and vegetables
• Meat and Poultry
• Eggs, processing and grading
• Certifying organic production
National Oceanic and Atmospheric Administration
• Grading of fish and seafood
Environmental Protection Agency (EPA)
• Drinking water
• Pesticide residues
Customs and Border Protection (CBP)
• Front-line enforcement and referral
Department of Justice (DOJ)
• Law enforcement
Federal Trade Commission (FTC)
• Advertising
Alcohol and Tobacco Tax and Trade Bureau (TTB)
• Alcohol
Source: CRS, as adapted by N. D. Fortin, Introduction to Food Regulation in the United States, Part 1, May 2008.
The division of food safety responsibility between FDA and USDA is rooted in the early history
of U.S. food regulation. Congress created separate statutory frameworks when it enacted, in 1906,
both the Pure Food and Drugs Act and the Meat Inspection Act. The former addressed the
widespread marketing of intentionally adulterated foods, and its implementation was assigned to
USDA’s Bureau of Chemistry. The latter law addressed unsafe and unsanitary conditions in meat
packing plants, and implementation was assigned to the USDA’s Bureau of Animal Industry. This
bifurcated system has been perpetuated and split further into additional food safety activities
under additional agencies (for example, the Environmental Protection Agency, the National
Marine Fisheries Service, and others) by a succession of statutes and executive directives. The
separation of the two major food safety agencies was further reinforced when, in 1940, the
President moved responsibilities for safe foods and drugs, other than meat and poultry, from
USDA to the progenitor of HHS, the Federal Security Agency. Meat inspection remained in
USDA. There has been discussion over time regarding whether this dispersal of food safety
responsibilities has been problematic, or whether a reorganization would divert time and attention
from other fundamental problems in the system.4 Figure 1 shows this history by providing a
timeline of selected important dates for food safety in the United States.
4
For a discussion of the history of federal food safety organization and of efforts to change it, see R.A. Merrill and J.K.
Francer, “Organizing Federal Food Safety Regulation,” Seton Hall Law Review, vol. 31:61, 2000. See also National
Research Council, Ensuring Safe Food From Production to Consumption, National Academy Press, 1998.
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Figure 1. Selected Important Dates for Food Safety in the United States, 1862-2011
Source: Compiled by CRS from various government and industry sources (see footnote 4).
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The Federal Food Safety System: A Primer
Over the years, GAO has published a series of reports highlighting how food safety oversight in
the United States is fragmented, and recommending broad restructuring of the nation’s food
safety system.5 These GAO reports document examples where a number of federal agencies are
responsible for some aspect of food safety or product quality, with limited coordination and also
sharing of information, resulting in often overlapping and/or duplication of efforts. Similar
observations are noted in a series of food safety studies by the National Research Council (NRC)
and Institute of Medicine (IOM).6 The NRC/IOM studies further recommend that the core federal
food safety responsibilities should reside within a single entity/agency, and have a unified
administrative structure, clear mandate, dedicated budget, and maintain full responsibility for
oversight of the entire U.S. food supply.
Food and Drug Administration
FDA has primary responsibility for the safety of most (about 80%-90%) of all U.S. domestic and
imported foods.7 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, and processed foods.
FDA also has oversight of all seafood and shellfish products, and most fish products.8 FDA has
jurisdiction over meats from animals or birds that are not under the regulatory jurisdiction of
FSIS. FDA shares some 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.
As described in a memorandum of understanding between FDA and FSIS:9
FDA is responsible for implementing and enforcing the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301, et seq.), the Public Health Service Act (42 U.S.C. 201, et seq.), the Fair
Packaging and Labeling Act (15 U.S.C. 1451 et seq.), and parts of the Egg Products Inspection
Act [21 U.S.C. §§1031 et seq.]. In carrying out its responsibilities under these acts, FDA conducts
inspections of establishments that manufacture, process, pack, or hold foods, with the exception
of certain establishments that are regulated exclusively by FSIS. FDA also inspects vehicles and
other conveyances, such as boats, trains, and airplanes, in which foods are transported or held in
interstate commerce.
5
See, for example, GAO, Opportunities to Reduce Potential Duplication in Government Programs, Save Tax Dollars,
and Enhance Revenue (GAO-11-318SP, March 2011); GAO, Federal Food Safety and Security System: Fundamental
Restructuring Is Needed to Address Fragmentation and Overlap, GAO-04-588T, March 2004; and GAO, Food Safety
and Security: Fundamental Changes Needed to Ensure Safe Food, GAO-02-47T, October 2001; GAO’s reports on
Federal Food Safety Oversight (2011, 2008 and 2005).
6
NRC/IOM, Enhancing Food Safety: The Role of the Food and Drug Administration, 2010 (National Academy of
Sciences); NRC/IOM, Ensuring Safe Food from Production to Consumption, 1998; and NRC/IOM, Scientific Criteria
for Safe Food, 2003.
7
Estimated by backing out the reported 10%-20% of foods under USDA’s jurisdiction. The 20% estimate is based on
information reported by 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-ERS on U.S. per capita food consumption at http://www.ers.usda.gov/data/
foodconsumption/. See also DHS, “National Infrastructure Protection Plan: Agriculture and Food Sector Snapshot,”
http://www.dhs.gov/food-and-agriculture-sector.
8
FSIS was authorized to inspect farmed catfish products under a 2008 farm bill provision (P.L. 110-246, §11016), but
has not yet implemented the program.
9
MOU 225-99-2001, http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/
domesticmous/ucm117094.htm.
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In addition, the 111th Congress passed comprehensive food safety legislation with the FDA Food
Safety Modernization Act (FSMA, P.L. 111-353), amending FFDCA. FSMA was the largest
expansion of FDA’s food safety authorities since the 1930s.10 FSMA did not directly address meat
and poultry products under USDA’s jurisdiction. New rules governing FDA’s food inspection
regime of both domestic and imported foods under the agency’s jurisdiction are currently being
developed and under public review and comment. For up-to-date information on FDA’s ongoing
rulemaking progress under FSMA, see FDA’s website (“The Law, Rules, and Guidance,”
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm359436.htm).11
In the Washington, DC, area, two FDA offices are the focal point for food safety-related
activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for
(1) conducting and supporting food safety research; (2) developing and overseeing enforcement
of food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance
and compliance programs; (4) coordinating and evaluating cooperating states’ food safety
activities; and (5) developing and disseminating food safety and regulatory information to
consumers and industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring
that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are
properly labeled, and produce no human health hazards when used in food-producing animals.
The FDA also cooperates with over 400 state agencies across the nation that carry out a wide
range of food safety regulatory activities. However, the state agencies are primarily responsible
for actual inspection. FDA works with the states to set the safety standards for food
establishments and commodities and evaluates the states’ performance in upholding such
standards as well as any federal standards that may apply. FDA also contracts with states to use
their food safety agency personnel to carry out certain field inspections in support of FDA’s own
statutory responsibilities.
Food Safety and Inspection Service
FSIS regulates the safety, wholesomeness, and proper labeling of most domestic and imported
meat and poultry and their products sold for human consumption, 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.11 The latter is responsible for the safety of liquid, frozen, and dried egg products,
domestic and imported, and for the safe use or disposition of damaged and dirty eggs under the
Egg Products Inspection Act, as amended (21 U.S.C. §§1031 et seq.).
FSIS’s FY2011 budget was $1.007 billion in appropriated funds (Table 1), with another roughly
$150 million to $180 million in industry-paid user fees annually.12 FSIS staff numbers around
9,500; roughly 8,000 of them, including about 1,000 veterinarians, are in about 6,300 meat
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.1312 As described in a memorandum of understanding between FDA and
FSIS, FSIS’s jurisdiction is as follows:13
FSIS is responsible for implementing and enforcing the Federal Meat Inspection Act (21 U.S.C.
601, et seq.), the Poultry Products Inspection Act (21 U.S.C. 451, et seq.), and parts of the Egg
Products Inspection Act (21 U.S.C. 1031, et seq.). In carrying out its responsibilities under these
acts, FSIS places inspectors in meat and poultry slaughterhouses and in meat, poultry, and egg
processing plants. FSIS also conducts inspections of warehouses, transporters, retail stores,
restaurants, and other places where meat, poultry, and egg products are handled and stored. In
addition, FSIS conducts voluntary inspections under the Agriculture Marketing Act (7 U.S.C.
1621, et seq.).
10
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.
11
Selected summary information is provided in CRS Report R42885, Food Safety Issues for the 113th Congress.
12
See footnote 7.
13
MOU 225-99-2001, http://www.fda.gov/aboutfda/partnershipscollaborations/memorandaofunderstandingmous/
domesticmous/ucm117094.htm.
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The Federal Meat Inspection Act (FMIA) of 1906, as amended, requires USDA to inspect all
cattle, sheep, swine, goats, horses, mules, and other equines slaughtered and processed for human
consumption. The Poultry Products Inspection Act (PPIA) of 1957, as amended, gives USDA the
authority to inspect poultry meat. The PPIA mandates USDA inspection of any domesticated
birds (chickens, turkeys, ducks, geese, guineas, ratites (ostrich, emu, and rhea), and squab
(pigeons up to one month old)) intended for use as human food. The Egg Products Inspection Act,
as amended, provides USDA authority to inspect liquid, frozen, and dried egg products. Each of
these laws also contains provisions governing USDA’s authority to label food products under its
jurisdiction.14
Under the authority of the Agricultural Marketing Act of 1946 as amended, USDA’s FSIS may
provide voluntary inspection for buffalo, antelope, reindeer, elk, migratory waterfowl, game
birds, and rabbits. This type of inspection is performed by FSIS on a fee-for-service basis.
However, these meat and poultry species are still within the purview of FDA under FFDCA,
whether or not inspected under the voluntary FSIS program. FDA has jurisdiction over meat
products from such species in interstate commerce, even if they bear the USDA inspection mark.
FDA also has jurisdiction over shell eggs. In addition, the 2008 farm bill requires that FSIS
inspect and grade farmed catfish products.15
Meat and poultry animals and products undergo continuous (i.e., 100%) inspection, which may in
turn act as a deterrent to fraud in some cases. FSIS inspects all meat and poultry animals to look
for signs of disease, contamination, and other abnormal conditions, both before and after
slaughter (“antemortem” and “postmortem,” respectively), on a continuous basis—meaning that
no animal may be slaughtered and dressed unless an inspector has examined it. One or more
federal inspectors are on the line during all hours the plant is operating. Processing plants visited
once every day by an FSIS inspector are considered to be under continuous inspection in keeping
with the laws. Inspectors monitor operations, check sanitary conditions, examine ingredient levels
and packaging, review records, verify food safety plans16, and conduct statistical sampling and
testing of products for pathogens and residues during their inspections.17
FSIS 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.18 Meat and poultry imports are 100% visually inspected (process-based, documentation,
labeling), although physical inspections of imports may be more random. FSIS conducts
evaluations of foreign meat safety programs and visits establishments to determine whether they
are providing a level of safety equivalent to that of U.S. safeguards. No foreign plant can ship
meat or poultry to the United States unless its country has received such an FSIS determination.
14
“A Guide to federal Food Labeling Requirements for meat, Poultry, and Egg Products,” prepared for USDA Food
Safety and Inspection Service by Hogan & Hartson, LLP, August, 2007, http://www.fsis.usda.gov/wps/wcm/connect/
f4af7c74-2b9f-4484-bb16-fd8f9820012d/Labeling_Requirements_Guide.pdf?MOD=AJPERES.
15
P.L. 110-246, §11016 (Inspection and Grading). USDA has not yet finished its catfish inspection rule (76 Federal
Register 10434, February 24, 2011), and will inspect catfish facilities when the rule is finalized.
16
In a Hazard Analysis and Critical Control Point (HACCP) plan a facility must identify each point in its processes
where contamination could occur (“critical control point”) and have a plan to control it, as well as document and
maintain records.
17
For more information, see CRS Report RL32922, Meat and Poultry Inspection: Background and Selected Issues.
18
For information, see FSIS, “FSIS Import Procedures for Meat, Poultry & Egg Products,” http://www.fsis.usda.gov/.
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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.19 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.1420
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 launchedCDC’s “FoodNet,” ” is a collaborative project with the
FDA and USDA
to improve data collection on foodborne illness outbreaks. FoodNet includes
active surveillance
of clinical microbiology laboratories to obtain a more accurate accounting of
positive test results
for foodborne illness; a physician survey to determine testing and laboratory
practices; population
surveys to identify illnesses not reported to doctors; and research studies to
obtain new and more
precise information about which food items or other exposures may cause
diseases. FoodNet data allows
allow 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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The Public Health Service Act (42 U.S.C. §§201, et seq.) provides legislative authority for CDC’s
food safety-related activities.
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.21 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. NMFS works with FDA, which helps provide training and
other technical assistance to NMFS. Under the program, NMFS inspects a reported 20% of the
seafood consumed in the United States.22
19
USDA, “Listing of Participating States,” http://www.fsis.usda.gov/regulations_&_policies/
Listing_of_participating_states/index.asp.
20
The 2008 farm bill (P.L. 110-246, §11017) contained new provisions intended to enable more interstate shipment of
state-inspected products.
21
NOAA Seafood Inspection Program, http://www.seafood.nmfs.noaa.gov/Program_Services.html. See also CRS
Report RS22797, Seafood Safety: Background and Issues.
22
NOAA, “Inspecting Seafood—A Highly Trained Nose Knows,” Fishwatch.gov, http://www.fishwatch.gov/features/
steve_wilson_10_15_12.htm.
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Environmental Protection Agency
EPA has the statutory responsibility for ensuring that the chemicals used on food crops do not
endanger public health. EPA’s Office of Pesticide Programs is the part of the agency that
(1) registers new pesticides and determines residue levels for regulatory purposes; (2) performs
special reviews of pesticides of concern; (3) reviews and evaluates all the health data on
pesticides; (4) reviews data on pesticides’ effects on the environment and on other species;
(5) analyzes the costs and benefits of pesticide use; and (6) interacts with EPA regional offices,
state regulatory counterparts, other federal agencies involved in food safety, the public, and others
to keep them informed of EPA regulatory actions. The Federal Insecticide, Fungicide, and
Rodenticide Act, as amended (7 U.S.C. §§136 et seq.), and the Federal Food, Drug, and Cosmetic
Act, as amended (21 U.S.C. §§301 et seq.), are the primary authorities for EPA’s activities in this
area.
Agricultural Marketing Service
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. USDA programs establishing quality grade standards to
encourage uniformity and consistency in commercial practices are provided for under the
Agricultural Marketing Act of 1946 (7 U.S.C. §1621).
AMS also administers the Pesticide Data Program (PDP), a cooperative federal-state residue
testing program through which it collects data on residual pesticides, herbicides, insecticides,
fungicides, and growth regulators in over 50 different commodities.23 The pesticides and
commodities to be tested each year are chosen based on EPA data needs, and on information
about the types and amounts foods consumed, in particular, by infants and children. Authorization
for the program is under the Federal Food, Drug, and Cosmetic Act, as amended by the 1996
Food Quality Protection Act (21 U.S.C. §§301 et seq.).
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.
23
For more information, see AMS’s website, http://www.ams.usda.gov/AMSv1.0/pdp.
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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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The Federal Food Safety System: A Primer
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.
Funding for Federal Food Safety Programs
Historically, federal funding and staffing levels between FDA and FSIS have been
disproportionate to their respective responsibilities to addressfor addressing 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% of the available budget.
For (Table 1). 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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The Federal Food Safety System: A Primer
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.
Congressional Research Service
7In the past few years the balance of overall funding for food safety between FDA and USDA has
slowly started to shift. Over the years, congressional appropriators have increased funding for
FDA food activities, which more than doubled from $435.5 million in FY2005 to an estimated
$882.7 million in FY2012, including user fees (Table 1). FDA’s operating level in FY2013,
including sequestration, totaled an estimated $813.2 million. FSMA also provided for additional
limited funding through certain types of industry-paid user fees, currently estimated at roughly
$16 million annually. 24 Although the law authorized appropriations when FSMA was enacted, it
did not provide the actual funding needed for FDA to perform these activities. When FSMA was
enacted, the Congressional Budget Office (CBO) estimated that implementing the law could
increase net federal spending subject to appropriation by about $1.4 billion over a five-year
period (FY2011-FY2015), with “insignificant” collections from possible revenue and direct
spending increases from new criminal penalties.25
Funding for FSIS has remained more or less consistent over the years. FSIS’s FY2013 budget
was $977.3 million in appropriated funds, with another roughly $160 million in user fees.
Funding levels specific to food safety responsibilities at other federal and state agencies are not
readily available.
24
FSMA authorized additional appropriations and staff for FDA’s future food safety activities and authorized new user
fees. 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.
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).
25
CBO cost estimate, “S. 510, Food Safety Modernization Act,” August 12, 2010.
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Table 1. Appropriations for Food Safety, FY2009-FY2014
(FTEs as indicated, and budget and appropriation figures in millions of dollars)
Agency/Year
FTEsa
Appropriationb
Program Level,
Including Feesc
HHS Food and Drug Administration (FDA), “Foods” Subtotal
FY2009 Actual
2,995
712.8
712.8
FY2010 Actual
3,387
783.2
783.2
FY2011 Actual
FY2012 Actual
3,605
836.2
836.2
3,546
866.1
882.7
3,684
796.6d
813.2
NA
882.8
NA
4,110
≈882.0
1,106.6e
FY2009 Actual
9,343
971.6
NA
FY2010 Actual
9,401
1,018.5
NA
FY2011 Actual
FY2012 Actual
9,465
1, 008.5
NA
9,351
1,004.4
NA
9,360
977.3f
NA
NA
1,010.7
NA
9,122
1,008.5
NA
FY2013 Operating Level
FY2014, Omnibus (H.R. 3547)
FY2014 Administration Request
USDA Food Safety and Inspection Service (FSIS)
FY2013 Operating Level
FY2014, Omnibus (H.R. 3547)
FY2014 Administration Request
Source: CRS, from annual agency Budget Explanatory Notes for Committee on Appropriations, various years,
for FDA (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm) and FSIS
(http://www.obpa.usda.gov/explan_notes.html). NA=not available.
Notes:
a.
Staffing in full time equivalents (FTEs).
b.
Does not include existing or proposed user fees or other ‘non-federal’ payments.
c.
Includes user fees. For FDA, reflects enacted, CR, and requested fee amounts for “Food Reinspection” and
“Food and Feed Recall” under the “foods field” (page 55 of the FY2014 Congressional justification).
d.
FDA’s “Sequestration Operating Plan.”
e.
The Administration’s requested program level total includes proposed fees in excess of $220 million,
covering a proposed “Food Facility Registration and Inspection” fee and a proposed “Food Import” fee. The
“Appropriation” amount excludes user fees from reported “Program Level” amount (calculated by CRS).
f.
Reported by USDA for FSIS in its “Fiscal Year 2013 Operating Plan” and reflects “2013 Enacted w/
sequester and Rescissions.”
FDA staff working on food-related activities also has increased. Among its many provisions,
FSMA mandated an increase in the number of food safety inspectors within FDA and expanded
the agency’s authority to increase inspection of domestic and foreign food facilities. FSMA states
a “goal of not fewer than ... 5,000 staff members in fiscal year 2014.”26 In FY2013, FDA staff
26
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).
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working on food-related activities totaled an estimated 3,700 staff (full-time equivalent or FTEs),
well below levels mandated in FSMA. There were about 9,100 FSIS staff in 2013, down from
more than 9,400 a few years ago. (Table 1).
The discrepancy between the number of FDA and FSIS inspectors is, in part, attributable to
differences in how each agency fulfills its respective inspection mandate. Whereas FDA
inspection involves primarily review and sampling, FSIS personnel inspect all meat and poultry
animals at slaughter on a continuous basis, requiring that 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.
Federal Food Safety Inspections
As funding for FDA’s food safety oversight and the number of inspection personnel has
increased, so too has the number of food facilities subject to FDA inspection. Food facilities
subject to FDA inspection has been increasing sharply in recent years, rising from about 59,000 in
2004 to nearly 76,000 in 2011 (Table 2). Of these, about one-fourth underwent FDA inspection.
Table 2. FDA Food-Related Inspection Data, FY2004-FY2012
FY04
Employeesa
Field FTEs
HQ FTEs
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FY12
3,082
2,943
2,774
2,569
2,614
2,995
3,387
3,605
3,757
2,172
2,059
1,962
1,806
1,861
2,166
2,516
2,729
2,824
910
884
812
763
753
829
871
876
933
Inspectionsb
21,876
19,774
17,730
17,038
16,277
17,972
19,024
21,554
24,513
Domestic Facilities
(FDA Inspection)c
59,305
61,930
62,929
65,520
67,819
66,196
73,930
75,990
NA
Inspections
17,032
15,773
14,547
14,339
14,966
16,087
17,640
19,141
NA
29%
25%
23%
22%
22%
24%
24%
25%
NA
% Inspections
Sources: Compiled by CRS from various sources or provided by FDA. NA=not available.
a. FDA Budget Explanatory Notes for Committee on Appropriations, various years (http://www.fda.gov/
AboutFDA/ReportsManualsForms/Reports/BudgetReports/default.htm); and HHS OIG, FDA Inspections of
Domestic Food Facilities (OEI-02-08-00080). FY2004-FY2010 employee data are actual numbers of program
level FTEs (full-time equivalents) reported in FDA annual budget documents in “FDA Program Resources
Table” for Foods, except that the FY2004 numbers are from the FY2006 annual Food and Drug
Administration, President’s Budget Request, “Narrative by Activity, Foods—Center for Food Safety and
Applied Nutrition.” FY2011-FY2012 data are from the FY2013 budget request.
b. FY2004-FY2010 inspection data are actual numbers of “Grand Total Food Establishment Inspections”
(which include FDA and State Contract Inspections), from the FY2006-FY2012 annual Food and Drug
Administration, President’s Budget Request, Field Activities—Office of Regulatory Affairs (ORA), “Field Foods
Program Activity Data.” FY2011-FY2013 inspection data are from the FY2013 budget request. These data
may differ with other data reported by FDA’s Office of Inspector General (OIG) (see, for example, HHS,
OIG, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections (OEI-02-09-00430), Table 1, December
2011, http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf).
c. Data are FDA Office of Legislation (September 22, 2010, and May 7, 2012, communication), and update
information in FDA, “Annual Report HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080),
Table 1, April 2010.
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In addition, since 2004, some 450,000 domestic and foreign food facilities are registered with the
agency, and are potentially subject to inspection (Table 3). These data are drawn from a
requirement set by Congress in 2002, following the enactment of the Public Health Security and
Bioterrorism Preparedness and Response Act (“Bioterrorism Act”, P.L. 107-188). The
Bioterrorism Act requires that domestic and foreign facilities be registered with FDA and that
FDA be given advance notice on shipments of imported food. Under the act, facilities that
manufacture, process, pack, or hold food for human or animal consumption in the United States
were required to register with FDA by December 12, 2003. Domestic facilities must register
whether or not food from the facility enters interstate commerce. Foreign facilities that
manufacture/process, pack, or hold food also must register unless food from that facility
undergoes further processing (including packaging) by another foreign facility before the food is
exported to the United States.27 The total number of registered food facilities does not reflect the
precise number of food facilities subject to FDA inspection, since these data include facilities
under USDA’s jurisdiction, among other facilities.
Table 3. Registered Food Facilities, FY2004-FY2012
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FY12
All Registered
Food Facilities
214,253
253,006
288,092
323,590
356,287
391,281
418,593
438,305
449,859
Domestic
92,719
104,555
115,902
129,345
141,703
154,883
166,160
167,033
171,552
Foreign
121,534
148,451
172,190
194,245
214,584
236,398
252,433
271,272
278,307
Source: Compiled by CRS from data on registered domestic and foreign facilities under FFDCA §415 [21 U.S.C.
§350d]; FDA’s annual reporting requirements of these data are at FFDCA §1003 [21 U.S.C. §393]
Notes: Number of registrants as of November 18, 2013. Available FY2012 data are from FDA, “Registration
Statistics,” http://www.fda.gov/food/guidanceregulation/foodfacilityregistration/ucm236512.htm. FY2004-2011
data are FDA Office of Legislation (September 22, 2010, and May 7, 2012, communication); FDA, “Annual Report
on Food Facilities, Food Imports, and FDA Foreign Offices” for 2011 and 2012,
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.28
Changes to FDA’s import regime now being implemented under FSMA are expected to address
some of these concerns.
By comparison, the number of regulated meat and poultry facilities under USDA’s jurisdiction is
much lower, and has remained more stable over time (Table 4). During the past decade, USDA
inspected an average of about 6,300 establishments each year, including Talmadge-Aiken plants.
(In Talmadge-Aiken plants, state inspectors perform inspections, but are supervised by federal
27
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food
for consumption in the U.S. are required to register the facility with the FDA. See FDA, “Registration of Food
Facilities,” http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/RegistrationofFoodFacilities/
default.htm.
28
GAO, Fundamental Changes Needed to Ensure Safe Food (GAO-02-47T), October 10, 2001, http://www.gao.gov/
new.items/d0247t.pdf.
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inspectors.) In 2012, USDA reported that it conducted inspections in 6,263 establishments.29 This
compares to 2002, when USDA reported that it conducted inspections in 6,000 establishments.
The number of Talmadge-Aiken plants has increased to 343 facilities in 2012, from 235 in 2002.
Table 4. FSIS Employees, Inspectors, and Establishments, FY2002-2012
FY02
FY03
FY04
FY05
FY06
FY07
FY08
FY09
FY10
FY11
FY12
9,151
9,170
9,125
9,157
9,029
9,166
9,289
9,256
9,333
9,295
9,235
634
688
688
744
709
674
707
726
710
680
651
8,517
8,482
8,437
8,413
8,320
8,492
8,582
8,530
8,623
8,615
8,584
Inspectors
7,600
7,560
7,587
7,583
7,865
7,800
7,566
7,540
7,563
7,556
NA
Establishments
6,300
6,400
6,300
6,250
6,282
6,200
6,200
6,286
6,278
6,290
6,263
235
359
364
361
368
354
382
341
356
364
343
Employees
HQ
Field
Talmadge-Aiken
Source: USDA, Annual USDA Budget Explanatory Notes for Committee on Appropriations. Employees are
permanent, full-time on September 30. FSIS also has part-time and temporary positions that have averaged nearly
500 employees in recent years.
Notes: A Talmadge-Aiken plant is a federal plant with state inspection program personnel operating under
Federal supervisors. Much of the agency’s work is conducted in cooperation with federal, state and municipal
agencies, as well as private industry.
About 1,100 of the establishments under FSIS’ jurisdiction either slaughter, or slaughter and
process livestock, or poultry.30 More than 4,000 facilities only process meat and poultry, and
about 80 process egg products. In addition to inspecting domestic meat, poultry, and egg
establishments, FSIS also performs re-inspections of imported meat, poultry, and egg products at
about 140 import re-inspection facilities.
Of the roughly 9,200 FSIS staff, approximately 8,000 of them, including about 1,000
veterinarians, are in about 6,300 meat slaughtering and/or processing plants nationwide.
29
USDA, 2013 Explanatory Notes: Food Safety and Inspection Service, p. 21-1, http://www.obpa.usda.gov/
21fsis2013notes.pdf.
30
FSIS’ inspection directory, http://www.fsis.usda.gov/wps/portal/fsis/topics/inspection/mpi-directory.
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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
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. §§
§§601-695); Poultry Products Inspection Act
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, and
eradication and containment of such problems
domestically (including those that threaten public
health).
Animal Health Protection Act (7 U.S.C. §§
§§8301-8322); Plant Health Protection Act
(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;
certifies quality programs; conducts quality grading
services, generally user fee-funded.
Agricultural Marketing Act of 1946 (7
U.S.C. §§ 1621-1638d), Perishable
Agricultural Commodities Act, 1930 (7
U.S.C. §§ 499a- 499s); Federal Seed Act
(7 (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. §§ 1751-1770), as amended by
Child Child
Nutrition and WIC Reauthorization
Acts 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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Agency
Major Responsibilities and Activities
Primary Authorities
Agricultural 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
National 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
Offers a variety of voluntary seafood safety and
quality inspection services on a fee-for-service basis.
Agricultural Marketing Act of 1946 (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. Regulates pesticide products;
sets maximum allowable tolerances for residue levels
on food commodities and animal feeds. 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 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.
§§ 41-58)
Administers and enforces laws on the production,
safety, distribution and use of alcoholic beverages.
Federal Alcohol Administration Act (27
U.S.C. §§ 201-219a); Internal Revenue
Code (26 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. These agencies have the leading food safety regulatory authorities.
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Appendix 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 $7916 million. Including authorized
fees, total available funding is estimated at about
$945882.7 million.
Staff (20112012)
9,600400 FTEs
3,400500 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 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 establishments to prepare
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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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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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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