FDA’s Independent Evaluation of Its Food Safety Programs

FDA’s Independent Evaluation of Its Food Safety Programs

INSIGHTi

FDA’s Independent Evaluation of Its Food
Safety Programs
January 25, 2023
The U.S. Food and Drug Administration (FDA) has primary responsibility for the safety of about 78% of
the U.S. food supply. 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. In 2010, the 111th Congress
passed the Food Safety Modernization Act to improve FDA’s ability to minimize incidences of foodborne
illness. Nevertheless, the Centers for Disease Control and Prevention (CDC) report that each year about
48 million people become sick from contaminated food in the United States with an estimated 128,000
hospitalizations and 3,000 deaths.
Major foodborne illness events, such as the 2020 leafy greens outbreak and 2022 powdered infant formula
incident, have heightened public and media scrutiny of FDA’s Human Foods Program and magnified
congressional interest in foodborne illness outbreaks. An April 2022 Politico report cited FDA failures to
safeguard U.S. food supplies and organizational dysfunction. Recent Congresses have held multiple
hearings and introduced several bills addressing food safety (see, for example, the Subcommittee on
Agriculture, Rural Development, Food and Drug Administration, and Related Agencies’ hearing on FDA
and food safety, H.R. 8358, and S. 2958).
In response to increased media and congressional scrutiny, FDA Commissioner Dr. Robert Califf
requested that the Reagan-Udall Foundation—an independent organization created by Congress to
advance FDA’s mission—convene an independent expert panel to comprehensively evaluate FDA’s
Human Foods Program.
The Reagan-Udall Foundation published its evaluation report in December 2022. It describes numerous
shortcomings within the agency’s organizational culture, leadership structure, access to resources, and
regulatory authorities. The report makes recommendations for improvement, some of which may require
congressional action if they are to be implemented.
Reagan-Udall Evaluation
The commissioner requested the scope of the panel’s evaluation include the Office of Food Policy and
Response (OFPR), the Center for Food Safety and Applied Nutrition (CFSAN), and relevant parts of the
Office of Regulatory Affairs (ORA). A summary of the panel’s key findings follows.
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Culture. The report found the cultural factors contributing to the Human Foods Program’s shortcomings
include a lack of a clear vision and mission, competing priorities, lack of a single leader, decisionmaking
based on consensus, and risk aversion.
Structure. Under FDA’s current organizational structure, OFPR, CFSAN, and ORA each report to the
commissioner and are independent of one another. The report found FDA’s Human Foods Program lacks
a formal definition and clear leader or decisionmaker, outside of the commissioner. The report concluded
that the lack of a clear, overarching leader has contributed to a culture of indecisiveness and inaction and
created disincentives for collaboration between OFPR, CFSAN, and ORA.
Resources. The report found that financial resources, personnel, and information technology resources
have remained relatively flat over the past decade and flat compared with expansion of these resources for
other FDA programs, such as the Human Drugs Program. The report asserts that congressional
appropriations have not kept pace with the Human Foods Program’s needs, and user fees (e.g.,
reinspections fees) cover about 1% of its $1 billion budget. The report concluded that recent FDA
initiatives, such as the Technology Modernization Action Plan (2019), Digital Modernization Action Plan
(2021), and Enterprise Modernization Plan (2022), will require adequate resources to be implemented in a
manner that would positively affect FDA’s Human Foods Program.
Authorities. The report concluded that the Human Foods Program lacks key enabling authorities to
successfully perform its mission. The report recommends authorities related to hiring and salary
flexibility; data reporting and sharing with state, local, territorial, and tribal authorities to achieve better
coordination and cooperation; and allowing appropriations to be available over multiple fiscal years.
Issues for Congress
The Reagan-Udall Foundation’s evaluation report makes recommendations that FDA can implement on
its own. Other recommendations, if they are to be implemented, may need congressional action. Report
recommendations that may need congressional action to implement include
 Create an entity where all elements of the Human Foods Program are defined and have
clear lines of authority. The report identifies several possible structures, including
keeping the entity within a restructured FDA or creating a new food-safety-focused
Department of Health and Human Services operating division separate from FDA.
 Provide sufficient funding through annual appropriations and user fees. The report
acknowledges that attempts to implement user fees in this program have failed in the past
and such implementation faces opposition from industry and “significant skepticism”
from the public interest community.
 Authorize “until expended” funding for the Human Foods Program, particularly for
funding infusions intended to address longer-term challenges (e.g., information
technology).
 Establish hiring authorities and salary flexibility (similar to those provided to FDA’s
Human Drugs Program by the 21st Century Cures Act, P.L. 114-255) to improve FDA’s
ability to recruit, hire, and retain personnel with expertise and skills to support the Human
Foods Program.
 Amend the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379) to allow FDA to
disclose nonpublic information to state, local, tribal, and U.S. territorial government
agencies with counterpart functions related to FDA-regulated products by preempting
related state, local, or territorial disclosure laws. The report asserts that this would allow

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 FDA to work more closely with its regulatory partners and effectively leverage their
oversight capabilities and resources.
 Authorize FDA to establish notification requirements when designated food categories,
such as medical foods/infant formula, are likely to experience shortages or when supply
chain disruptions are anticipated or occur.
These recommendations vary in the degree of complexity required for implementation. For example,
previous Administrations have proposed a restructure of FDA’s Human Foods Program, which would
require a coordinated effort among several federal agencies whose authorities and jurisdictions may be
affected (e.g., U.S. Department of Agriculture, National Oceanic and Atmospheric Administration, and
U.S. Environmental Protection Agency). Other recommendations, such as authorizing “until expended”
funding, may be more straightforward to legislate and implement. Congressional discourse on the Human
Foods Program is likely to be shaped not only by the evaluation report’s recommendations but also by
perspectives of other food-safety stakeholders and decisionmakers on issues and policy alternatives to
advance U.S. food safety.

Author Information

Amber D. Nair

Analyst in Agricultural Policy

Disclaimer
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