[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 4745 Introduced in Senate (IS)]
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118th CONGRESS
2d Session
S. 4745
To establish the Federal Food Administration to protect the public
health by ensuring the safety of food, preventing foodborne illness,
maintaining safety reviews and reassessments of food additives,
reducing the prevalence of diet-related chronic diseases, enforcing
pesticide residue tolerances, improving the surveillance of foodborne
pathogens, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 23, 2024
Mr. Durbin (for himself and Mr. Blumenthal) introduced the following
bill; which was read twice and referred to the Committee on Health,
Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To establish the Federal Food Administration to protect the public
health by ensuring the safety of food, preventing foodborne illness,
maintaining safety reviews and reassessments of food additives,
reducing the prevalence of diet-related chronic diseases, enforcing
pesticide residue tolerances, improving the surveillance of foodborne
pathogens, 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 ``Federal Food Administration Act of
2024''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Administration.--The term ``Administration'', except as
otherwise provided, means the Federal Food Administration
established under section 101(a)(1).
(2) Commissioner.--The term ``Commissioner'', except as
otherwise provided, means the Commissioner of Foods appointed
under section 101(a)(2).
(3) Facility.--The term ``facility'' means any factory,
warehouse, or establishment that is subject to the requirements
of section 415 or 419 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 350d; 350h).
SEC. 3. EFFECTIVE DATE.
This Act, including the amendments made by this Act, shall take
effect 180 days after the date of enactment of this Act.
SEC. 4. FUNDING.
(a) Transfer of Funds.--The appropriations, allocations, and other
funds that relate to the authorities, functions and agencies
transferred under section 102 shall be transferred to the
Administration.
(b) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section, such sums as may be necessary
for fiscal year 2025 and each fiscal year thereafter.
TITLE I--ESTABLISHMENT OF FEDERAL FOOD ADMINISTRATION
SEC. 101. ESTABLISHMENT OF FEDERAL FOOD ADMINISTRATION.
(a) Establishment.--
(1) In general.--There is established within the Department
of Health and Human Services an agency to be known as the
``Federal Food Administration''.
(2) Head of administration.--The Administration shall be
headed by the Commissioner of Foods, who shall have food safety
expertise, and be appointed by the President, by and with the
advice and consent of the Senate.
(3) Effect.--The Federal Food and Drug Administration shall
be renamed the ``Federal Drug Administration'' and retain
responsibility for carrying out its responsibilities related to
drugs, cosmetics, devices, biological products, color
additives, and tobacco. The Commissioner of Food and Drugs
shall be renamed the ``Commissioner of Drugs'', and shall
retain the responsibilities of the Commissioner of Food and
Drugs, as of the day before the date of enactment of this Act,
except such responsibilities that relate to food, which shall
be assumed by the Commissioner of Food. Each reference in law,
regulation, document, paper, or other record of the United
States to the ``Food and Drug Administration'' shall be deemed
a reference to the ``Federal Drug Administration'', and each
reference in law, regulation, document, paper, or other record
of the United States to the ``Commissioner of Food and Drugs''
shall be deemed a reference to the ``Commissioner of Drugs''.
(b) Duties of the Commissioner.--The Commissioner shall--
(1) administer and enforce all authorities under chapter IV
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et
seq.);
(2) serve as a representative to international food safety
bodies and discussions;
(3) promulgate and enforce regulations to ensure the
security of the food supply from all forms of contamination,
including intentional contamination; and
(4) oversee--
(A) implementation of Federal food efforts;
(B) inspection, labeling, enforcement, and research
efforts to protect the public health;
(C) development of consistent and science-based
standards for safe food;
(D) safety reviews and reassessments of food
additives;
(E) establishment and enforcement of tolerances for
poisonous or deleterious substances;
(F) monitoring and enforcement of pesticide residue
tolerances in or on foods;
(G) coordination and prioritization of food
research and education programs with other Federal
agencies;
(H) prioritization of Federal food efforts and
deployment of Federal food resources to achieve the
greatest benefit in reducing foodborne illness and
diet-related chronic diseases;
(I) coordination of the Federal response to
foodborne illness outbreaks with other Federal and
State agencies;
(J) integration of Federal food activities with
State and local agencies; and
(K) assignment of tolerances for animal drugs used
in food-producing animals.
SEC. 102. TRANSFER OF AUTHORITY, FUNCTIONS AND AGENCIES.
(a) Transfer of Authority.--The Administration shall assume
responsibility for carrying out chapter IV of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 341 et seq.) and maintain all enforcement
authorities with respect to food held by the Food and Drug
Administration on the date of enactment of this Act.
(b) Transfer of Functions.--For each Federal agency, office, and
center specified in subsection (c), there are transferred to the
Administration all functions that the head of the Federal agency
exercised on the day before the date of enactment of this Act
(including all related functions of any officer or employee of the
Federal agency) that relate to administration or enforcement of the
food law, as determined by the President.
(c) Transferred Agencies.--The Federal agencies referred to in
subsection (b) are--
(1) the resources and facilities of the Center for Food
Safety and Applied Nutrition of the Food and Drug
Administration that administer chapter IV of the Federal Food,
Drug, and Cosmetics Act (21 U.S.C. 341 et seq.);
(2) the resources and facilities of the Office of
Regulatory Affairs of the Food and Drug Administration that
administer and conduct inspections of food and feed facilities
and imports;
(3) the resources and facilities of the Center for
Veterinary Medicine of the Food and Drug Administration that
administer chapter IV of the Federal Food, Drug, and Cosmetics
Act (21 U.S.C. 341 et seq.);
(4) the Office of Food Policy and Response of the Food and
Drug Administration; and
(5) such other offices, services, or agencies as the
President designates by Executive order to carry out this Act.
(d) Conforming Amendment.--Subchapter A of chapter VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended
by adding at the end the following:
``SEC. 716. REGULATION OF FOOD.
``Notwithstanding any other provision of this Act, beginning on the
date that is 180 days after the date of enactment of the Federal Food
Administration Act of 2024, any authority under this Act that relates
to food shall be under the authority of the Federal Food
Administration, and shall be carried out by the Commissioner of Food.
Any reference in this Act to authorities related to food held by the
Secretary shall be deemed to be a reference to authorities held by the
Commissioner of Food.''.
SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.
(a) Officers and Employees.--The Commissioner may--
(1) appoint officers and employees for the Administration
in accordance with the provisions of title 5, United States
Code, relating to appointment in the competitive service; and
(2) fix the compensation of those officers and employees in
accordance with chapter 51 and with subchapter III of chapter
53 of that title, relating to classification and General
Schedule pay rates.
(b) Experts and Consultants.--The Administration may--
(1) procure the services of temporary or intermittent
experts and consultants as authorized by section 3109 of title
5, United States Code; and
(2) pay in connection with those services the travel
expenses of the experts and consultants, including
transportation and per diem in lieu of subsistence while away
from the homes or regular places of business of the
individuals, as authorized by section 5703 of that title.
(c) Bureaus, Offices, and Divisions.--The Commissioner may
establish within the Administration such bureaus, offices, and
divisions as the Commissioner determines are necessary to perform the
duties of the Commissioner.
(d) Advisory Committees.--
(1) In general.--The Commissioner shall establish advisory
committees that consist of representative of scientific expert
bodies, academics, industry specialists, and consumers.
(2) Duties.--The duties of an advisory committee
established under paragraph (1) may include developing
recommendations with respect to the development of regulatory
science and processes, research, communications, performance
standards, and inspection.
TITLE II--ADMINISTRATION OF FOODS PROGRAM
SEC. 201. ESTABLISHMENT OF INSPECTION PROGRAM.
(a) In General.--The Commissioner shall establish an inspection
program, which shall include inspections of food facilities subject to
subsection (b) and in accordance with section 202.
(b) Facility Categories.--Not later than 6 months after the date of
enactment of this Act, the Commissioner shall issue formal guidance
defining the criteria by which food facilities will be divided into
``high-risk,'' ``intermediate risk,'' and ``low-risk'' facilities.
(c) Inspection Frequencies.--Frequency of inspections of food
facilities under this Act shall be based on the categories defined
pursuant to subjection (b) and in accordance with section 202.
SEC. 202. INSPECTIONS OF FOOD FACILITIES.
(a) Frequency of Inspections.--
(1) High-risk facilities.--The Commissioner shall inspect
high-risk facilities not less than once per a year.
(2) ``intermediate-risk facilities .--The Commissioner
shall inspect intermediate-risk facilities not less than once
every 2 years.
(3) ``low-risk facilities.--The Commissioner shall inspect
low risk facilities, which shall include warehouses or similar
facilities that engage in packaging or distribution, and pose
very minimal public health risk, not less than once every 3
years.
(b) Infant Formula Manufacturing Facilities.--The Commissioner
shall inspect the facilities of each manufacturer of infant formula not
less than every 6 months.
(c) Federal and State Cooperation.--The Commissioner shall contract
with State officials to carry out half of the safety inspections
required under this section.
SEC. 203. COMPLIANCE CHECKS.
Not later than 30 days after issuing a form that is equivalent to
an FDA Form 483 to a facility, pursuant to an inspection under section
704 of Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374), the
Commissioner shall conduct a follow-up compliance check with the
facility.
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