[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8358 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 8358
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 HOUSE OF REPRESENTATIVES
July 13, 2022
Ms. DeLauro (for herself, Ms. Barragan, Mr. Panetta, Ms. Moore of
Wisconsin, Ms. Jackson Lee, and Mrs. Watson Coleman) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
_______________________________________________________________________
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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