II
118th CONGRESS
2d Session
S. 4745
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.
Short title
This Act may be cited as the Federal Food Administration Act of 2024
.
Definitions
In this Act:
Administration
The term Administration, except as otherwise provided, means the Federal Food Administration established under section 101(a)(1).
Commissioner
The term Commissioner, except as otherwise provided, means the Commissioner of Foods appointed under section 101(a)(2).
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).
Effective date
This Act, including the amendments made by this Act, shall take effect 180 days after the date of enactment of this Act.
Funding
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.
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.
Establishment of Federal Food Administration
Establishment of Federal Food Administration
Establishment
In general
There is established within the Department of Health and Human Services an agency to be known as the Federal Food Administration
.
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.
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
.
Duties of the Commissioner
The Commissioner shall—
administer and enforce all authorities under chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 et seq.);
serve as a representative to international food safety bodies and discussions;
promulgate and enforce regulations to ensure the security of the food supply from all forms of contamination, including intentional contamination; and
oversee—
implementation of Federal food efforts;
inspection, labeling, enforcement, and research efforts to protect the public health;
development of consistent and science-based standards for safe food;
safety reviews and reassessments of food additives;
establishment and enforcement of tolerances for poisonous or deleterious substances;
monitoring and enforcement of pesticide residue tolerances in or on foods;
coordination and prioritization of food research and education programs with other Federal agencies;
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;
coordination of the Federal response to foodborne illness outbreaks with other Federal and State agencies;
integration of Federal food activities with State and local agencies; and
assignment of tolerances for animal drugs used in food-producing animals.
Transfer of authority, functions and agencies
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.
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.
Transferred agencies
The Federal agencies referred to in subsection (b) are—
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.);
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;
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.);
the Office of Food Policy and Response of the Food and Drug Administration; and
such other offices, services, or agencies as the President designates by Executive order to carry out this Act.
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:
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.
.
Additional duties of the administration
Officers and employees
The Commissioner may—
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
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.
Experts and consultants
The Administration may—
procure the services of temporary or intermittent experts and consultants as authorized by section 3109 of title 5, United States Code; and
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.
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.
Advisory committees
In general
The Commissioner shall establish advisory committees that consist of representative of scientific expert bodies, academics, industry specialists, and consumers.
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.
Administration of foods program
Establishment of inspection program
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.
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.
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.
Inspections of food facilities
Frequency of inspections
High-risk facilities
The Commissioner shall inspect high-risk facilities not less than once per a year.
“intermediate-risk facilities
The Commissioner shall inspect intermediate-risk facilities not less than once every 2 years.
“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.
Infant formula manufacturing facilities
The Commissioner shall inspect the facilities of each manufacturer of infant formula not less than every 6 months.
Federal and State cooperation
The Commissioner shall contract with State officials to carry out half of the safety inspections required under this section.
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.