[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 5103 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 5103
To require the Secretary of Health and Human Services to develop a
strategic plan for the Human Foods Program of the Food and Drug
Administration and the food functions of the Office of Inspections and
Investigations, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 19, 2024
Mr. Budd (for himself and Mr. Markey) introduced the following bill;
which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To require the Secretary of Health and Human Services to develop a
strategic plan for the Human Foods Program of the Food and Drug
Administration and the food functions of the Office of Inspections and
Investigations, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration Foods
Accountability Act''.
SEC. 2. FOOD AND DRUG ADMINISTRATION FOODS ACCOUNTABILITY ACT.
(a) FDA Human Foods Program Strategic Plan.--
(1) In general.--Not later than September 30, 2025, and at
least every 4 years thereafter, the Secretary of Health and
Human Services (referred to in this section as the
``Secretary'') shall develop and submit to the appropriate
committees of Congress and post on the website of the Food and
Drug Administration a strategic plan for the Human Foods
Program of the Food and Drug Administration and the food
functions of the Office of Inspections and Investigations (or
any successor programs of the Food and Drug Administration
responsible for the regulation of human foods).
(2) Content of strategic plan.--The strategic plan under
paragraph (1) shall include--
(A) strategic goals and priorities related to--
(i) food safety, including implementation
of the FDA Food Safety Modernization Act
(Public Law 111-353) and coordination and
engagement across the Food and Drug
Administration with Federal, State, local, and
Tribal entities and private sector entities, to
improve food safety oversight;
(ii) food safety inspections, including
coordination and engagement across the Food and
Drug Administration to meet inspection goals
and coordination with Federal agencies,
including the Centers for Disease Control and
Prevention and the Department of Agriculture,
and State, local, and Tribal entities to
oversee food safety and conduct related
inspections;
(iii) administration of the Office of
Critical Foods and related activities of the
food functions of the Office of Inspections and
Investigations and other offices or divisions
of the Food and Drug Administration, including
identification of any potential interruption in
the supply of critical foods and what steps
such Office would take in response,
incorporating lessons from previous similar
scenarios;
(iv) initiatives to support nutritional
health, including initiatives and activities of
the Center for Excellence in Nutrition
designated by the Secretary under the Human
Foods Program, evidence-based initiatives to
address chronic diet-related diseases, and
administration of food labeling requirements,
engagement with the Dietary Guidelines Advisory
Committee in years when the Committee is
reviewing updates to the Dietary Guidelines,
and any other programs related to nutrition;
(v) activities and programs to support
recruiting, hiring, training, developing, and
retaining a qualified workforce within the
Human Foods Program and the food functions of
the Office of Inspections and Investigations,
including any cooperative programs with other
entities to support recruitment and training of
food safety inspectors, and reviewers to
support review of regulatory submissions for
food products;
(vi) in the first such plan, specific
metrics and other information identifying
improvements made as a result of the
reorganization of the Center for Food Safety
and Applied Nutrition and establishment of the
Human Foods Program and the food functions of
the Office of Inspections and Investigations,
including how any full-time equivalent
positions within the Food and Drug
Administration have been reallocated under the
reorganization, and benchmarks against which to
assess the performance of the Human Foods
Program and the food functions of the Office of
Inspections and Investigations; and
(vii) other priorities identified by the
Secretary;
(B) specific activities and strategies for
achieving the goals and priorities identified under
subparagraph (A), and progress towards achieving such
goals and priorities;
(C) specific activities and strategies for
improving and streamlining internal coordination and
communication within the Food and Drug Administration,
including for activities and communications related to
signals of potential public health concerns, as well as
other agencies and offices of the Department of Health
and Human Services and other Federal departments and
agencies, as appropriate;
(D) specific activities and strategies for
improving and streamlining coordination and
communication with non-Federal stakeholders, including
steps to improve outreach regarding rulemaking
activities; and
(E) challenges and risks the Human Foods Program is
expected to face in meeting its strategic goals and
priorities, and the activities the Human Foods Program
will undertake to overcome those challenges and
mitigate those risks.
(3) Evaluation of progress.--Not later than September 30,
2027, and every 2 years thereafter, the Secretary shall submit
to the appropriate committees of Congress and post on the
website of the Food and Drug Administration a progress report
that includes--
(A) a description of the progress the Secretary has
made toward the goals and priorities identified under
paragraph (2)(A) in the most recent strategic report
submitted under paragraph (1); and
(B) whether actions taken in response to the most
recently submitted strategic plan improved the capacity
of the Food and Drug Administration to achieve the
strategic goals and priorities set forth in previous
strategic plans.
(4) Updates.--The Secretary shall, as appropriate, update
the strategic plan to account for significant changes in the
production and regulation of foods or the scientific evidence
related to nutrition and food production, or other significant
changes, as the Secretary determines appropriate.
(b) GAO Report.--
(1) In general.--Not later than September 30, 2028, the
Comptroller General of the United States shall submit to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House of
Representatives a report assessing the initial strategic plan
submitted under subsection (a).
(2) Contents of report.--The report required under
paragraph (1) shall include an assessment of--
(A) the development and implementation of the
strategic plan, including the sufficiency of the plan,
progress of the Human Foods Program in meeting the
results-oriented goals and priorities identified in
such plan, and any gaps in such implementation;
(B) how the Human Foods Program applies hiring
authorities under section 714A of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379d-3a); and
(C) recommendations for the Human Foods Program to
address the identified challenges, improve its
implementation of the Human Foods Program strategic
plan, and to otherwise improve the public health
mandate of the Food and Drug Administration.
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