September 7, 2018
Proposed Reorganization of U.S. Federal Food Safety Agencies
The Trump Administration is proposing to consolidate the
federal government’s primary food safety functions into a
single federal agency based in the U.S. Department of
Agriculture (USDA). This proposal is part of its broader
effort to reorganize the U.S. federal government under its
reform plan and reorganization proposals released in June
2018. Some in Congress—and also previous
Administrations—have long pursued similar efforts to
consolidate U.S. federal food safety functions.
Organization of the Food Safety System
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 USDA and the Food and Drug Administration (FDA).
FDA, an agency of the Department of Health and Human
Services (HHS), is responsible for ensuring the safety of all
domestic and imported foods except meat and poultry.
USDA’s Food Safety and Inspection Service (FSIS)
regulates meat, poultry, some egg products, and catfish.
At FDA, the Center for Food Safety and Applied Nutrition
(CFSAN) oversees the safety of food and cosmetic
products. CFSAN’s primary responsibilities include the
safety of most foods, food additives, infant formulas,
medical foods, dietary supplements, and foods and
ingredients developed through biotechnology; programs
addressing health risks associated with foodborne,
chemical, and biological contaminants; and food and
nutrition labeling. CFSAN also collaborates with FDA’s
Office of Regulatory Affairs to conduct field activities,
including facility inspections. FDA’s authority extends
beyond foods to also include pharmaceutical drugs, medical
devices, biologics, animal drugs and feeds, veterinary
devices, radiation-emitting products, and tobacco.
At USDA, FSIS conducts continual inspection at federally
inspected facilities that slaughter meat and poultry. In these
inspections, FSIS ensures that state inspection standards are
at least equivalent to federal standards and that imported
meat and poultry products are produced under standards
equivalent to U.S. inspection standards. Other USDA
agencies also play a role in U.S. food safety oversight. For
example, USDA’s Animal and Plant Health Inspection
Service oversees animal and plant health, including
preventing the introduction of foreign diseases and pests.
USDA’s Agricultural Marketing Service establishes quality
and marketing grades and standards for a range of
agricultural products. USDA’s research agencies are also
involved in food safety, providing federal funding and
collaborating with universities and research institutions.
The first text box summarizes the primary U.S. food safety
laws governing FDA and FSIS. The laws listed are among
roughly 30 related to food safety, according to Government
Accountability Office (GAO) estimates. GAO has also
identified up to 15 federal agencies, including FDA and
FSIS, as collectively responsible for ensuring the safety of
food produced and sold in the United States. State and local
food safety authorities collaborate with federal agencies on
inspection and other food safety functions.
Primary U.S. Food Safety Laws
HHS’s Food and Drug Administration (FDA)
Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C.
§§341 et seq.), as amended by the FDA Food Safety
Modernization Act (FSMA, 21 U.S.C. §§2201 et seq.)
Fair Packaging and Labeling Act (15 U.S.C. §1454)
Public Health Service Act (42 U.S.C. §§201 et seq.)
Federal Import Milk Act (21 U.S.C. §§141-149)
Federal Anti-Tampering Act (18 U.S.C. §1365)
Pesticide Monitoring Improvements Act (21 U.S.C. §1401)
USDA's Food Safety and Inspection Service (FSIS)
Federal Meat Inspection Act (FMIA, 21 U.S.C. §§601 et seq.)
Poultry Products Inspection Act (PPIA, 21 U.S.C. §§451 et seq.)
Egg Products Inspection Act (EPIA, 21 U.S.C. §§1031 et seq.)
Agriculture Marketing Act (7 U.S.C. §§1621 et seq.)
Source: CRS Report RS22600, The Federal Food Safety System: A
Proposed Food Safety Reorganization
The Trump Administration’s proposal to reorganize the
U.S. federal government includes a proposal to consolidate
FSIS and FDA’s food safety functions into a single
“Federal Food Safety Agency” to be housed at USDA.
According to the Administration, this effort would address
a “fragmented and illogical division of federal oversight”
and would “merge approximately 5,000 full-time equivalent
(FTE) employees and $1.3 billion from FDA with about
9,200 FTEs and $1 billion in resources in USDA.” FDA
would be renamed the “Federal Drug Administration” and
its focus would be on drugs, devices, biologics, tobacco,
dietary supplements, and cosmetics.
To the extent a reorganization would transfer an agency or
entity vested by law in a particular department to a different
department, additional legislation might be needed. These
food safety laws specifically delegate authority to HHS in
the case of FFDCA and FSMA and to USDA in the case of
the FMIA, PPIA, and EPIA.
Previous Reorganization Efforts
The organization of the U.S. food safety system has been
debated on and off since FDA was removed from USDA in
the 1940s. Since then, a number of congressional and
executive branch initiatives have raised the prospect of
creating a single federal food safety agency. For example,
in 1949, a presidential commission under the Truman
Administration proposed transferring federal food safety
activities to USDA. Years later, Congress passed the
Proposed Reorganization of U.S. Federal Food Safety Agencies
Wholesome Meat Act of 1967 and the Wholesome Poultry
Products Act of 1968, substantially restructuring U.S. meat
and poultry products inspection. Also during this time, a
1969 White House Conference on Food, Nutrition and
Health report highlighted the divergence in food safety
policy between USDA and the Department of Health,
Education, and Welfare (which later became HHS), where
FDA resided at that time. In the following years, there were
a series of reports and congressional hearings adding to the
debate over a single food safety agency. For example, in
1977, the Senate Committee on Governmental Affairs
conducted its Study on Federal Regulation, recommending
that USDA’s food safety functions be transferred to FDA.
Committee Jurisdiction for Food Safety Issues
House: The Committee on Energy and Commerce claims
general jurisdiction over all FDA-regulated products, including
foods. The Committee on Agriculture asserts jurisdiction over
USDA’s inspection programs.
Senate: The Committee on Health, Education, Labor, and
Pensions claims jurisdiction over all FDA-regulated products,
including foods. The Committee on Agriculture, Nutrition, and
Forestry asserts jurisdiction over USDA's inspection programs.
Congressional Appropriations Committees: The
Agriculture subcommittees are responsible for funding and
oversight of both FDA and USDA in the House and Senate.
Recent Congressional Efforts
Some in Congress have advocated for reforms to the
nation’s food safety system, particularly with respect to
coordination and organization among federal agencies.
Efforts to establish a single food safety agency were active
from the 103rd Congress through the 111th Congress.
Although Congress passed comprehensive food safety
legislation in 2010 (FSMA, P.L. 111-353)—representing
the largest expansion and overhaul of FDA’s food safety
authorities since the 1930s—FSMA did not alter the
existing food safety jurisdiction between FDA and USDA.
While FSMA was being debated, however, Congress did
consider options to reorganize and consolidate certain
federal food safety functions. For example, in the 111th
Congress, H.R. 875 (Food Safety Modernization Act of
2009) included provisions to consolidate certain food safety
functions into a single federal agency, the Food Safety
Administration, to be housed within HHS.
Following FSMA’s enactment, some in Congress continued
to be interested in establishing a single federal food safety
agency. In the 114th Congress, the Safe Food Act of 2015
(H.R. 609/S. 287) proposed creating a single independent
Food Safety Administration, which would be responsible
for regulating food safety and related labeling, inspection,
enforcement, and research functions of both domestically
produced and imported foods. H.R. 609/S. 287 proposed
transferring and consolidating the food safety authorities at
FDA and USDA as well as portions of the National Marine
Fisheries Service at Department of Commerce.
Recent Administration Efforts
The Obama Administration proposed to establish a single
federal food agency as part of its FY2016 budget request,
claiming that a single food safety agency would “provide
focused, centralized leadership, a primary voice on food
safety standards, and clear lines of responsibility and
accountability that will enhance both prevention of and
responses to outbreaks of foodborne illnesses.” The
proposal would not have created a new independent agency
but would have instead transferred existing food safety
functions into a new agency within HHS. The proposal was
not included in the enacted appropriation.
Views Expressed by Outside Groups
Establishing a single food agency has the support of GAO
and the National Academies of Sciences, Engineering, and
Medicine and others within academia, as documented in
myriad studies and reports. GAO’s reports on food safety
have regularly highlighted that the U.S. food safety system
is fragmented across different departments and agencies
that have overlapping responsibilities and that a single food
safety agency would improve effectiveness and efficiency
of food safety regulation.
While some view consolidation as a way to improve
efficiency and effectiveness, others worry that it could
unnecessarily compromise day-to-day food safety efforts.
Some food safety advocates claim that USDA’s principal
purpose is supporting agribusiness and that food safety
regulation and promotion should remain separate. Some
also raise concerns about merging two agencies with
distinctly different authorities, inspection regimes, and
cultures. Others say it is unclear what this would mean for
ongoing FSMA implementation at FDA and for both
domestic and international food producers affected by the
law’s regulations. Others assert that any federal overhaul
would be complex and costly, given the sheer number of
federal agencies and different statutes involved, and could
create new forms of fragmentation. Some also anticipate
resistance by congressional committees that cover different
agency jurisdiction, powers, and expertise. (Authorizing
committees are identified in the second text box.)
Most consumer advocacy groups have opposed
consolidating food safety operations within HHS, claiming
that HHS does not have the necessary expertise or adequate
resources to manage an expanded food safety function.
Others point to differing legal authorities and inspection
approaches. Others have claimed that USDA has a better
record regarding food safety inspection and enforcement
and worry that transferring these functions to HHS will
lower meat and poultry inspection standards.
Creating a single food safety agency housed at USDA often
raises concerns about the complexity of FDA’s oversight
authorities, which cover not only foods and beverages but
other food-related responsibilities (e.g., safety of additives,
biotechnology) and products. For example, under current
law, dietary supplements are regulated as part of FDA's
food safety responsibilities. The Trump Administration’s
proposal would keep supplements within the purview of the
renamed “Federal Drug Administration,” which is opposed
by many within the industry.
Renée Johnson, Specialist in Agricultural Policy
Agata Dabrowska, Analyst in Health Policy
Proposed Reorganization of U.S. Federal Food Safety Agencies
This document was prepared by the Congressional Research Service (CRS). CRS serves as nonpartisan shared staff to
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