Title: Food Safety Administration Act of 2022
Policy area: Health

Summary:
Food Safety Administration Act of 2022
This bill splits the current Food and Drug Administration into the Federal Drug Administration (to regulate drugs, cosmetics, devices, biological products, color additives, and tobacco) and the Food Safety Administration (to regulate food safety). The bill also establishes specific requirements with respect to manufacturers of infant formula, such as requiring manufacturers to notify the newly created Food Safety Administration of potential infant formula shortages.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 4520 Introduced in Senate (IS)]

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117th CONGRESS
  2d Session
                                S. 4520

   To establish the Food Safety Administration to protect the public 
 health by ensuring the safety of food, preventing foodborne illness, 
    maintaining safety reviews and reassessments of food additives, 
 enforcing pesticide residue tolerances, improving the surveillance of 
              foodborne pathogens, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 13, 2022

 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 Food Safety Administration to protect the public 
 health by ensuring the safety of food, preventing foodborne illness, 
    maintaining safety reviews and reassessments of food additives, 
 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 ``Food Safety Administration Act of 
2022''.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Administration.--The term ``Administration'' means the 
        Food Safety Administration established under section 101(a)(1).
            (2) Administrator.--The term ``Administrator'' means the 
        Administrator of Food Safety 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 2023 and each fiscal year thereafter.

          TITLE I--ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION

SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION.

    (a) Establishment.--
            (1) In general.--There is established within the Department 
        of Health and Human Services an agency to be known as the 
        ``Food Safety Administration''.
            (2) Head of administration.--The Administration shall be 
        headed by the Administrator of Food Safety, 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 ``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, except such responsibilities that relate to food, which 
        shall be assumed by the Administrator of Food Safety. Each 
        reference in statute to the ``Food and Drug Administration'' 
        shall be deemed a reference to the ``Federal Drug 
        Administration'', and each reference in statute to the 
        ``Commissioner of Food and Drugs'' shall be deemed a reference 
        to the ``Commissioner of Drugs''.
    (b) Duties of the Administrator.--The Administrator 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 safety;
                    (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 safety 
                research and education programs with other Federal 
                agencies;
                    (H) prioritization of Federal food safety efforts 
                and deployment of Federal food safety resources to 
                achieve the greatest benefit in reducing foodborne 
                illness;
                    (I) coordination of the Federal response to 
                foodborne illness outbreaks with other Federal and 
                State agencies;
                    (J) integration of Federal food safety 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 Agency 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 safety 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. 703. 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 Food Safety 
Administration Act of 2022, any authority under this Act that relates 
to food shall be under the authority of the Food Safety Administration, 
and shall be carried out by the Administrator of Food Safety. Any 
reference in this Act to authorities related to food held by the 
Secretary shall be deemed to be references to authorities held by the 
Administrator of Food Safety.''.

SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION.

    (a) Officers and Employees.--The Administrator 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 Administrator may 
establish within the Administration such bureaus, offices, and 
divisions as the Administrator determines are necessary to perform the 
duties of the Administrator.
    (d) Advisory Committees.--
            (1) In general.--The Administrator 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 FOOD SAFETY PROGRAM

SEC. 201. ESTABLISHMENT OF INSPECTION PROGRAM.

    (a) In General.--The Administrator 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 Administrator 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 Administrator shall inspect 
        high-risk facilities not less than once per a year.
            (2) Intermediate-risk facilities.--The Administrator shall 
        inspect intermediate-risk facilities not less than once every 2 
        years.
            (3) Low-risk facilities.--The Administrator 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 Administrator 
shall inspect the facilities of each manufacturer of infant formula not 
less than every 6 months.
    (c) Federal and State Cooperation.--The Administrator 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 
Administrator shall conduct a follow-up compliance check with the 
facility.

SEC. 204. TRACEABILITY RULE.

    Not later than November 7, 2022, the Administrator shall promulgate 
a final rule that is based on the proposed rule issued by the Food and 
Drug Administration titled, ``Requirements for Additional Traceability 
Records for Certain Foods'' (85 Fed. Reg. 59984 (Sept. 23, 2021)).

SEC. 205. NOTICE OF CIRCUMSTANCES THAT COULD LEAD TO A SHORTAGE.

    Chapter IV of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
341 et seq.) is amended by adding at the end the following:

``SEC. 424. NOTICE OF CIRCUMSTANCES THAT COULD LEAD TO A SHORTAGE.

    ``(a) Notice Requirement.--Not later than 5 business days after a 
manufacturer of infant formula or essential medical food becomes aware 
of circumstances that could lead to a shortage of infant formula or 
essential medical food in the United States, such manufacturer shall 
give written notice of such circumstances to the Administrator.
    ``(b) Fines.--If the Administrator finds that a manufacturer of 
infant formula or essential medical food is in violation of the 
requirement of this section to give written notice, such violation 
shall be treated as an infraction for purposes of imposing a fine in 
accordance with title 18, United States Code.
    ``(c) Definitions.--In this section:
            ``(1) The term `Administrator' means the Administrator of 
        Food Safety.
            ``(2) The term `essential medical food' means a food that--
                    ``(A) is formulated to be consumed or administered 
                enterally under the supervision of a physician;
                    ``(B) is intended for the specific dietary 
                management of a disease or condition for which 
                distinctive nutritional requirements, based on 
                recognized scientific principles, are established by 
                medical evaluation; and
                    ``(C) is identified by the Administrator as being 
                essential for any urgent medical condition.''.
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