The Federal Food Safety System: A Primer
Renée Johnson
Specialist in Agricultural Policy
January 20, 2012
Congressional Research Service
7-5700
www.crs.gov
RS22600
CRS Report for Congress
Pr
epared for Members and Committees of Congress

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The Federal Food Safety System: A Primer

Summary
Numerous federal, state, and local agencies share responsibilities for regulating the safety of the
U.S. food supply. 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.


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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. Major Federal Food Safety Agencies................................................................................. 6
Table 2. Selected Comparison of FSIS and FDA Responsibilities .................................................. 8

Contacts
Author Contact Information........................................................................................................... 10
Acknowledgments ......................................................................................................................... 10

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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
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. USDA, Economic Research Service (ERS) data, at http://www.ers.usda.gov/Browse/FoodSector/.
2 U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, “Estimates of
Foodborne Illness in the United States,” http://www.cdc.gov/foodborneburden/2011-foodborne-estimates.html.
3 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) on U.S. per capita food consumption at http://www.ers.usda.gov/data/foodconsumption/.
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products, seafood, and processed foods. FDA has jurisdiction over meats from animals or birds
that are not under the regulatory jurisdiction of FSIS. FDA shares responsibility for the safety of
eggs with FSIS. FDA has jurisdiction over establishments that sell or serve eggs or use them as an
ingredient in their products. FDA is also responsible for ensuring that most seafood products do
not endanger public health (FSIS is to begin inspecting farmed catfish products under a 2008
farm bill provision).
The primary statutes governing FDA’s activities are the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended (21 U.S.C. 301 et seq.); the Public Health Service Act, as amended (42
U.S.C. §§201 et seq.); and the Egg Products Inspection Act, as amended (21 U.S.C. §§1031 et
seq.). The 111th Congress passed comprehensive food safety legislation with the FDA Food Safety
Modernization Act (FSMA, P.L. 111-353). FSMA is the largest expansion of FDA’s food safety
authorities since the 1930s. Although numerous agencies share responsibility for regulating food
safety, FSMA focused on foods regulated by FDA and amended FDA’s existing structure and
authorities, in particular FFDCA.4 The Congressional Budget Office (CBO) estimated that
implementing FSMA could increase net federal spending subject to appropriation by about $1.4
billion over a five-year period (FY2011-FY2015); collections from possible revenue and direct
spending increases from new criminal penalties would be “insignificant, yielding a negligible net
impact in each year.”5 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.6
FDA’s FY2011 budget for its foods program was $835.7 million, virtually all of it appropriated
with limited authorized user fees.7 FSMA also authorized additional user fees that provide limited
funds to assist with implementation of the new law. FDA staff working on food-related activities
in FY2011 were estimated at about 3,400 FTEs.
The number of food facilities subject to FDA inspection has been increasing sharply in the past
few years. A report by HHS’s Office of Inspector General (OIG) provided additional insights into
the FDA’s inspections of domestic facilities. The OIG reported that the number of facilities
subject to such inspections had risen from about 59,000 in 2004 to nearly 68,000 in 2008.
However, the number of inspections conducted declined from about 17,000 in 2004 (29% of the
total) to about 15,000 in 2008 (22%). During the five-year period examined by the OIG, 56% of
food facilities were not inspected at all.8 Of these inspections, an increasing number of
inspections have been conducted by states under contract with FDA, rather than by FDA.9

4 For more information, see CRS Report R40443, The FDA Food Safety Modernization Act (P.L. 111-353). FSMA does
not directly address meat and poultry products under USDA’s jurisdiction.
5 CBO, Cost Estimate, “S. 510, Food Safety Modernization Act, as reported by the Senate Committee on Health,
Education, Labor, and Pensions on December 18, 2009, incorporating a manager’s amendment released on August 12,
2010,” August 12, 2010. Reflecting the August 2010 Senate amendment to S. 510.
6 For more information, see CRS Report R41964, Agriculture and Related Agencies: FY2012 Appropriations.
7 FDA “Operating Plan for FY 2011 and Comparisons to FY 2010,” http://www.hhs.gov/asfr/ob/docbudget/
2011operatingplan_fda.pdf.
8 HHS OIG, FDA Inspections of Domestic Food Facilities (OEI-02-08-00080), Table 1 , April 2010, http://oig.hhs.gov/
oei/reports/oei-02-08-00080.pdf.
9 HHS, OIG, Vulnerabilities in FDA’s Oversight of State Food Facility Inspections (OEI-02-09-00430), December
2011, http://oig.hhs.gov/oei/reports/oei-02-09-00430.pdf.
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In addition, some 200,000 foreign food facilities are registered with the agency. Various estimates
of unannounced compliance inspections of domestic establishments by FDA officials range from
once every five years to once every 10 years, on average, although the agency claims to visit
about 6,000 so-called high-risk facilities on an annual basis. FDA relies on notifications from
within the industry or from other federal or state inspection personnel, as well as other sources, to
alert it to situations calling for increased inspection. GAO reported that, in 2000, FDA inspections
covered only about 1% of the food imported under its jurisdiction.10 Changes to FDA’s import
regime now being implemented under FSMA are expected to address some of these concerns.
In the Washington, DC, area, two FDA offices are the focal point for food safety-related
activities. The Center for Food Safety and Applied Nutrition (CFSAN) is responsible for
(1) conducting and supporting food safety research; (2) developing and overseeing enforcement
of food safety and quality regulations; (3) coordinating and evaluating FDA’s food surveillance
and compliance programs; (4) coordinating and evaluating cooperating states’ food safety
activities; and (5) developing and disseminating food safety and regulatory information to
consumers and industry. FDA’s Center for Veterinary Medicine (CVM) is responsible for ensuring
that all animal drugs, feeds (including pet foods), and veterinary devices are safe for animals, are
properly labeled, and produce no human health hazards when used in food-producing animals.
The FDA also cooperates with over 400 state agencies across the nation that carry out a wide
range of food safety regulatory activities. However, the state agencies are primarily responsible
for actual inspection. FDA works with the states to set the safety standards for food
establishments and commodities and evaluates the states’ performance in upholding such
standards as well as any federal standards that may apply. FDA also contracts with states to use
their food safety agency personnel to carry out certain field inspections in support of FDA’s own
statutory responsibilities.
Food Safety and Inspection Service
Available USDA data indicate that FSIS is roughly responsible for 10%-20% of the U.S. food
supply, while FDA is responsible for the remainder.11 FSIS regulates the safety, wholesomeness,
and proper labeling of most domestic and imported meat and poultry and their products sold for
human consumption.
Under the Federal Meat Inspection Act of 1906, as amended (21 U.S.C. §§601 et seq.), FSIS is
required to inspect all cattle, sheep, swine, goats, and equines during slaughtering and processing.
Under the Poultry Products Inspection Act of 1957, as amended (21 U.S.C. §§451 et seq.), FSIS
is required to inspect “any domesticated bird” being processed for human consumption; however,
USDA 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.12 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, plus another approximately
$150 million in industry-paid user fees.13 FSIS staff numbers around 9,600; roughly 8,000 of
them, including about 1,000 veterinarians, are in about 6,300 meat slaughtering and/or processing
plants nationwide. FSIS personnel inspect all meat and poultry animals at slaughter on a
continuous basis, and at least one federal inspector is on the line during all hours the plant is
operating. Processing inspection does not require an FSIS inspector to remain constantly on the
production line or to inspect every item. Instead, inspectors are on site daily to monitor the plant’s
adherence to the standards for sanitary conditions, ingredient levels, and packaging, and to
conduct statistical sampling and testing of products. Because all plants are visited daily,
processing inspection also is considered to be continuous.
FSIS also is responsible for certifying that foreign meat and poultry plants are operating under an
inspection system equivalent to the U.S. system before they can export their product to the United
States. FSIS inspectors located at U.S. ports of entry carry out a statistical sampling program to
verify the safety of imported meats from cattle, sheep, swine, goats, and equines and imported
poultry meat from chickens, turkeys, ducks, geese, quail, ratites, and guineas before they are
released into domestic commerce. FDA is responsible for ensuring the safety of imported meat
from any other species.
Twenty-seven states operate their own meat and/or poultry inspection programs. FSIS is
statutorily responsible for ensuring that the states’ programs are at least equal to the federal
program.14 Plants processing meat and poultry under state inspection can market their products
only within the state. If a state chooses to discontinue its own inspection program, or if FSIS
determines that it does not meet the agency’s equivalency standards, FSIS must assume the
responsibility for inspection if the formerly state-inspected plants are to remain in operation. FSIS
also has cooperative agreements with more than two dozen states under which state inspection
personnel are authorized to carry out federal inspection in meat and/or poultry plants. Products
from these plants may travel in interstate commerce.15
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.
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-for-
service basis, a voluntary seafood inspection and grading program that focuses on marketing and
quality attributes of U.S. fish and shellfish. The primary legislative authority for NMFS’s
inspection program is the Agricultural Marketing Act of 1946, as amended (7 U.S.C. §§1621 et
seq.). NMFS has approximately 160 seafood safety and quality inspectors, and inspection
services are funded with user fees.
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.
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
Ensuring that all domestic and imported foods,
As may be amended by the FDA Food
Administrationa
except processed egg products and major types of
Safety Modernization Act (FSMA): Federal
meat and poultry, are safe, wholesome, and properly
Food, Drug, and Cosmetic Act (FFDCA;
labeled, by setting safety and sanitation standards,
21 U.S.C. 301), Public Health Service Act
periodically inspecting manufacturing facilities,
(42 U.S.C. 201), Egg Products Inspection
reviewing records of and spot-checking imports. Also Act (21 U.S.C. 1031), Public Health
overseeing the safety of animal drugs and feeds
Security and Bioterrorism Preparedness
including those used in food-producing animals
and Response Act (21 U.S.C. 341), others
Centers for
Monitoring, identifying, and investigating foodborne
Public Health Service Act (42 U.S.C. 201)
Disease Control
diseases; developing and evaluating improved
and Prevention
epidemiological and laboratory methods
Department of Agriculture
Food Safety
Regulating the safety, wholesomeness and proper
Federal Meat Inspection Act (21 U.S.C.
Inspection Servicea labeling of most commercial types of both domestic
601), Poultry Products Inspection Act (21
and imported meat and poultry, catfish products, and
U.S.C. 451), Egg Products Inspection Act
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
Animal and Plant
Overseeing animal and plant health, including the
Animal Health Protection Act (7 U.S.C.
Health Inspection
prevention of foreign diseases and pests, eradication
8301), Plant Health Protection Act (7
Service
and containment of such problems domestically
U.S.C. 7701)
(including those that threaten public health)
Agricultural
Establishing quality and marketing grades and
Agricultural Marketing Act of 1946 (7
Marketing Service
standards for dairy products, fruits and vegetables,
U.S.C. 1621), Egg Products Inspection Act
livestock, meat, poultry, seafoods, and shell eggs;
(21 U.S.C. 1031), Agricultural Marketing
certifying quality programs; conducting quality
Agreement Act (7 U.S.C. 601)
grading services, generally user fee-funded
Food and
Encouraging and coordinating efforts to ensure the
Program subsidies authorized by Richard
Nutrition Service
safety of foods in school lunch and other domestic
B. Russel National School Lunch Act (42
programs
U.S.C. 1751),Child Nutrition Act (42
U.S.C. 1771).
Grain Inspection,
Setting quality standards for, and testing, grains and
U.S. Grain Standards Act (7 U.S.C. 71),
Packers and
related commodities, primarily for marketing
Agricultural Marketing Act of 1946
Stockyards
purposes
Administration
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Agency
Major Responsibilities and Activities
Primary Authorities
Agricultural
Conducts in-house USDA research on agricultural
Numerous laws dating to the Department
Research Service
and food topics, of which food safety is one of many
of Agriculture Organic Act of 1862 (7
U.S.C. 2201 note), up through and
including recent omnibus farm laws
Cooperative State
Coordinates and administers federal funding of land
Numerous laws dating to the Department
Research,
grant and other institutions to conduct agricultural
of Agriculture Organic Act of 1862, up
Education, and
and food research, education and extension
through and including recent omnibus
Extension Service
activities; food safety is one of many subject areas
farm laws
Department of Commerce
National Oceanic
Offering a variety of voluntary seafood safety and
Agricultural Marketing Act of 1946, Fish
and Atmospheric
quality inspection services on a fee-for-service basis
and Wildlife Act of 1956 (16 U.S.C. 742)
Administration
Environmental
Regulating pesticide products; setting maximum
Federal Insecticide, Fungicide, and
Protection Agency
allowable tolerances for residue levels on food
Rodenticide Act (7 U.S.C. 136), FFDCA
commodities and animal feeds
Federal Trade
Enforcing federal prohibitions against unfair or
Federal Trade Commission Act (15 U.S.C.
Commission
deceptive acts or practices in trade, including
41)
consumer deception regarding foods
Department of the Treasury
Alcohol and
Administering and enforcing laws on the production,
Federal Alcohol Administration Act (27
Tobacco Tax and
safety, distribution and use of alcoholic beverages
U.S.C. 201), Internal Revenue Code (26
Trade Bureau
U.S.C. Ch. 51)
Department of Homeland Security
U.S. Customs and
Coordinating many food security activities, including
Homeland Security Act (6 U.S.C. 101)
Border Protection at the border; now conducting agricultural border
inspection activities formerly done by APHIS
Source: Prepared by CRS based in part on various reports by the Government Accountability Office.
a. These agencies have the leading food safety regulatory authorities.

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Table 2. Selected Comparison of FSIS and FDA Responsibilities
Activity
Food Safety and Inspection Service
Food and Drug Administration
(Foods Program only)
Primary
Federal Meat Inspection Act (21 U.S.C.
As may be amended by the FDA Food Safety
Authorizations
601), Poultry Products Inspection Act (21 Modernization Act (FSMA): Federal Food, Drug,
U.S.C. 451), Egg Products Inspection Act
and Cosmetic Act (FFDCA; 21 U.S.C. 301; Public
(21 U.S.C. 1031)
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
All other domestic and imported foods, also
meat and poultry and their products;
animal drugs and feeds including those used in
catfish products; processed (dried,
food-producing animals (80% of at-home U.S. food
frozen, liquid) egg products (20% of at-
spending)
home U.S. food spending)
Funding (enacted
Appropriated: $1.004 billion for FY2012.
Appropriated: $866.1 million for FDA’s Foods
FY2012)
Expected user fees are estimated to
Program, not including funding from expected
include another $150 million.
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
68,000 subject to inspection
establishments
Inspection
Ante- and post-mortem inspection of
Prohibits adulteration or misbranding; relies on
Approach
every animal, carcass and part;
facilities that manufacture, process, pack, or hold
traditional y organoleptic (but see “Food
food for humans or animals to be meet prescribed
safety plans” below); only USDA-
standards (e.g., regarding additives, contaminants,
inspected and passed products may enter
etc.); all facilities must register, report changes in
commerce
timely manner.
Required
Slaughter plants: all times of operation;
FSMA requires increased inspection rates for any
inspection
processing plants: at least once daily
registered facility, particularly those identified as
frequency
“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-high-
risk 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 al establishment to prepare and
Prior to FSMA, facilities followed general
have preapproved “HACCP” (hazard
regulations on good manufacturing practices
analysis and critical control point) plans
(GMPs) to address safe handling and plant
determining risks, controlling them (with
sanitation—except a form of HACCP required for
documentation)
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
Prior to FSMA, food safety system equivalence
where FSIS has determined “equivalence”
was not determined beforehand; reliance on
of foreign safety system, with annual
inspections was at 300 ports (est. 1% of notified
verification; imports exempt from prior
entries inspected). FSMA provides for tighter
notice but subject to reinspection at 150
controls and use certification or verification
import establishments (est. 10%
systems for imported foods(to be determined by
reinspected)
FDA rulemaking). At least 600 foreign facilities
must be inspected the year fol owing enactment,
and in each of the subsequent five years the
number of foreign facilities inspected is to double.
Third party
Private labs accredited for chemical
Prior to FSMA, there was no accreditation for
certification
testing of meat and poultry (for imports,
food testing labs or use of third parties for import
see above)
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
Prior to FSMA, those engaged solely in harvesting,
slaughter plant
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 al
All foods must adhere to food labeling
labels
requirements such as statement of identity,
declaration of net contents, nutrition labeling;
labels cannot be false or misleading.
Notification
P.L. 110-246 §11017 amended meat and
P.L. 110-85 (amended by FSMA) requires FDA to
Requirements
poultry laws to require an establishment
maintain a reportable food registry for industry to
to notify USDA if it has reason to believe
report food safety cases in order to help FDA
that an adulterated or misbranded
better track patterns and target inspections. FSMA
product has entered commerce
§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
Prior to FSMA, FDA had no authority to mandate
on voluntary efforts
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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