[Congressional Record Volume 168, Number 115 (Wednesday, July 13, 2022)]
[Senate]
[Pages S3273-S3274]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. DURBIN (for himself and Mr. Blumenthal):
  S. 4520. 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; to the 
Committee on Health, Education, Labor, and Pensions.
  Mr. DURBIN. Mr. President, I ask unanimous consent that the text of 
the bill be printed in the Record.
  There begin no objection, the text of the bill was ordered to be 
printed in the Record as follows:

                                S. 4520

       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:

[[Page S3274]]

  


     ``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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