Proposed Reorganization of U.S. Federal Food Safety Agencies

Proposed Reorganization of U.S. Federal Food Safety Agencies

September 7, 2018
Proposed Reorganization of U.S. Federal Food Safety Agencies
The Trump Administration is proposing to consolidate the
identified up to 15 federal agencies, including FDA and
federal government’s primary food safety functions into a
FSIS, as collectively responsible for ensuring the safety of
single federal agency based in the U.S. Department of
food produced and sold in the United States. State and local
Agriculture (USDA). This proposal is part of its broader
food safety authorities collaborate with federal agencies on
effort to reorganize the U.S. federal government under its
inspection and other food safety functions.
reform plan and reorganization proposals released in June
2018. Some in Congress—and also previous
Primary U.S. Food Safety Laws
Administrations—have long pursued similar efforts to
HHS’s Food and Drug Administration (FDA)
consolidate U.S. federal food safety functions.
 Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C.
Organization of the Food Safety System
§§341 et seq.), as amended by the FDA Food Safety
Numerous federal, state, and local agencies share
Modernization Act (FSMA, 21 U.S.C. §§2201 et seq.)
responsibilities for regulating the safety of the U.S. food
 Fair Packaging and Labeling Act (15 U.S.C. §1454)
supply. Federal responsibility for food safety rests primarily
 Public Health Service Act (42 U.S.C. §§201 et seq.)
with USDA and the Food and Drug Administration (FDA).
 Federal Import Milk Act (21 U.S.C. §§141-149)
FDA, an agency of the Department of Health and Human
 Federal Anti-Tampering Act (18 U.S.C. §1365)
Services (HHS), is responsible for ensuring the safety of all
 Pesticide Monitoring Improvements Act (21 U.S.C. §1401)
domestic and imported foods except meat and poultry.
USDA's Food Safety and Inspection Service (FSIS)
USDA’s Food Safety and Inspection Service (FSIS)
 Federal Meat Inspection Act (FMIA, 21 U.S.C. §§601 et seq.)
regulates meat, poultry, some egg products, and catfish.
 Poultry Products Inspection Act (PPIA, 21 U.S.C. §§451 et seq.)
 Egg Products Inspection Act (EPIA, 21 U.S.C. §§1031 et seq.)
At FDA, the Center for Food Safety and Applied Nutrition
 Agriculture Marketing Act (7 U.S.C. §§1621 et seq.)
(CFSAN) oversees the safety of food and cosmetic
Source: CRS Report RS22600, The Federal Food Safety System: A
products. CFSAN’s primary responsibilities include the
Primer.
safety of most foods, food additives, infant formulas,

medical foods, dietary supplements, and foods and
ingredients developed through biotechnology; programs
Proposed Food Safety Reorganization
addressing health risks associated with foodborne,
The Trump Administration’s proposal to reorganize the
chemical, and biological contaminants; and food and
U.S. federal government includes a proposal to consolidate
nutrition labeling. CFSAN also collaborates with FDA’s
FSIS and FDA’s food safety functions into a single
Office of Regulatory Affairs to conduct field activities,
“Federal Food Safety Agency” to be housed at USDA.
including facility inspections. FDA’s authority extends
According to the Administration, this effort would address
beyond foods to also include pharmaceutical drugs, medical
a “fragmented and illogical division of federal oversight”
devices, biologics, animal drugs and feeds, veterinary
and would “merge approximately 5,000 full-time equivalent
devices, radiation-emitting products, and tobacco.
(FTE) employees and $1.3 billion from FDA with about
9,200 FTEs and $1 billion in resources in USDA.” FDA
At USDA, FSIS conducts continual inspection at federally
would be renamed the “Federal Drug Administration” and
inspected facilities that slaughter meat and poultry. In these
its focus would be on drugs, devices, biologics, tobacco,
inspections, FSIS ensures that state inspection standards are
dietary supplements, and cosmetics.
at least equivalent to federal standards and that imported
meat and poultry products are produced under standards
To the extent a reorganization would transfer an agency or
equivalent to U.S. inspection standards. Other USDA
entity vested by law in a particular department to a different
agencies also play a role in U.S. food safety oversight. For
department, additional legislation might be needed. These
example, USDA’s Animal and Plant Health Inspection
food safety laws specifically delegate authority to HHS in
Service oversees animal and plant health, including
the case of FFDCA and FSMA and to USDA in the case of
preventing the introduction of foreign diseases and pests.
the FMIA, PPIA, and EPIA.
USDA’s Agricultural Marketing Service establishes quality
and marketing grades and standards for a range of
Previous Reorganization Efforts
agricultural products. USDA’s research agencies are also
The organization of the U.S. food safety system has been
involved in food safety, providing federal funding and
debated on and off since FDA was removed from USDA in
collaborating with universities and research institutions.
the 1940s. Since then, a number of congressional and
executive branch initiatives have raised the prospect of
The first text box summarizes the primary U.S. food safety
creating a single federal food safety agency. For example,
laws governing FDA and FSIS. The laws listed are among
in 1949, a presidential commission under the Truman
roughly 30 related to food safety, according to Government
Administration proposed transferring federal food safety
Accountability Office (GAO) estimates. GAO has also
activities to USDA. Years later, Congress passed the
https://crsreports.congress.gov

Proposed Reorganization of U.S. Federal Food Safety Agencies
Wholesome Meat Act of 1967 and the Wholesome Poultry
focused, centralized leadership, a primary voice on food
Products Act of 1968, substantially restructuring U.S. meat
safety standards, and clear lines of responsibility and
and poultry products inspection. Also during this time, a
accountability that will enhance both prevention of and
1969 White House Conference on Food, Nutrition and
responses to outbreaks of foodborne illnesses.” The
Health report highlighted the divergence in food safety
proposal would not have created a new independent agency
policy between USDA and the Department of Health,
but would have instead transferred existing food safety
Education, and Welfare (which later became HHS), where
functions into a new agency within HHS. The proposal was
FDA resided at that time. In the following years, there were
not included in the enacted appropriation.
a series of reports and congressional hearings adding to the
debate over a single food safety agency. For example, in
Views Expressed by Outside Groups
1977, the Senate Committee on Governmental Affairs
Establishing a single food agency has the support of GAO
conducted its Study on Federal Regulation, recommending
and the National Academies of Sciences, Engineering, and
that USDA’s food safety functions be transferred to FDA.
Medicine and others within academia, as documented in
myriad studies and reports. GAO’s reports on food safety
Committee Jurisdiction for Food Safety Issues
have regularly highlighted that the U.S. food safety system
is fragmented across different departments and agencies
House: The Committee on Energy and Commerce claims
that have overlapping responsibilities and that a single food
general jurisdiction over all FDA-regulated products, including
foods. The Committee on Agriculture asserts jurisdiction over
safety agency would improve effectiveness and efficiency
USDA’s inspection programs.
of food safety regulation.
Senate: The Committee on Health, Education, Labor, and
While some view consolidation as a way to improve
Pensions claims jurisdiction over all FDA-regulated products,
efficiency and effectiveness, others worry that it could
including foods. The Committee on Agriculture, Nutrition, and
Forestry asserts jurisdiction over USDA's inspection programs.
unnecessarily compromise day-to-day food safety efforts.
Some food safety advocates claim that USDA’s principal
Congressional Appropriations Committees: The
purpose is supporting agribusiness and that food safety
Agriculture subcommittees are responsible for funding and
oversight of both FDA and USDA in the House and Senate.
regulation and promotion should remain separate. Some
also raise concerns about merging two agencies with

Recent Congressional Efforts
distinctly different authorities, inspection regimes, and
cultures. Others say it is unclear what this would mean for
Some in Congress have advocated for reforms to the
ongoing FSMA implementation at FDA and for both
nation’s food safety system, particularly with respect to
domestic and international food producers affected by the
coordination and organization among federal agencies.
law’s regulations. Others assert that any federal overhaul
Efforts to establish a single food safety agency were active
would be complex and costly, given the sheer number of
from the 103rd Congress through the 111th Congress.
federal agencies and different statutes involved, and could
create new forms of fragmentation. Some also anticipate
Although Congress passed comprehensive food safety
resistance by congressional committees that cover different
legislation in 2010 (FSMA, P.L. 111-353)—representing
agency jurisdiction, powers, and expertise. (Authorizing
the largest expansion and overhaul of FDA’s food safety
committees are identified in the second text box.)
authorities since the 1930s—FSMA did not alter the
existing food safety jurisdiction between FDA and USDA.
Most consumer advocacy groups have opposed
While FSMA was being debated, however, Congress did
consolidating food safety operations within HHS, claiming
consider options to reorganize and consolidate certain
that HHS does not have the necessary expertise or adequate
federal food safety functions. For example, in the 111th
resources to manage an expanded food safety function.
Congress, H.R. 875 (Food Safety Modernization Act of
Others point to differing legal authorities and inspection
2009) included provisions to consolidate certain food safety
approaches. Others have claimed that USDA has a better
functions into a single federal agency, the Food Safety
record regarding food safety inspection and enforcement
Administration, to be housed within HHS.
and worry that transferring these functions to HHS will
lower meat and poultry inspection standards.
Following FSMA’s enactment, some in Congress continued
to be interested in establishing a single federal food safety
Creating a single food safety agency housed at USDA often
agency. In the 114th Congress, the Safe Food Act of 2015
raises concerns about the complexity of FDA’s oversight
(H.R. 609/S. 287) proposed creating a single independent
authorities, which cover not only foods and beverages but
Food Safety Administration, which would be responsible
other food-related responsibilities (e.g., safety of additives,
for regulating food safety and related labeling, inspection,
biotechnology) and products. For example, under current
enforcement, and research functions of both domestically
law, dietary supplements are regulated as part of FDA's
produced and imported foods. H.R. 609/S. 287 proposed
food safety responsibilities. The Trump Administration’s
transferring and consolidating the food safety authorities at
proposal would keep supplements within the purview of the
FDA and USDA as well as portions of the National Marine
renamed “Federal Drug Administration,” which is opposed
Fisheries Service at Department of Commerce.
by many within the industry.
Recent Administration Efforts
Renée Johnson, Specialist in Agricultural Policy
The Obama Administration proposed to establish a single
Agata Dabrowska, Analyst in Health Policy
federal food agency as part of its FY2016 budget request,
claiming that a single food safety agency would “provide
IF10974
https://crsreports.congress.gov

Proposed Reorganization of U.S. Federal Food Safety Agencies

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