I 
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. BARRAGA´N, 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 reas-
sessments of food additives, enforcing pesticide residue 
tolerances, improving the surveillance of foodborne patho-
gens, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Food Safety Adminis-
tration Act of 2022’’. 
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SEC. 2. DEFINITIONS. 
In this Act: 
(1) ADMINISTRATION.—The term ‘‘Administra-
tion’’ means the Food Safety Administration estab-
lished under section 101(a)(1). 
(2) ADMINISTRATOR.—The term ‘‘Adminis-
trator’’ means the Administrator of Food Safety ap-
pointed 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, allo-
cations, 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. 
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TITLE I—ESTABLISHMENT OF 
FOOD SAFETY ADMINISTRATION 
SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRA-
TION. 
(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 Adminis-
tration’’. 
(2) HEAD OF ADMINISTRATION.—The Adminis-
tration 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 Ad-
ministration shall be renamed ‘‘Federal Drug Ad-
ministration’’ and retain responsibility for carrying 
out its responsibilities related to drugs, cosmetics, 
devices, biological products, color additives, and to-
bacco. 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 re-
late to food, which shall be assumed by the Adminis-
trator of Food Safety. Each reference in statute to 
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the ‘‘Food and Drug Administration’’ shall be 
deemed a reference to the ‘‘Federal Drug Adminis-
tration’’, and each reference in statute to the ‘‘Com-
missioner of Food and Drugs’’ shall be deemed a 
reference to the ‘‘Commissioner of Drugs’’. 
(b) DUTIES OF THE ADMINISTRATOR.—The Adminis-
trator 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 en-
sure the security of the food supply from all forms 
of contamination, including intentional contamina-
tion; 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; 
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(E) establishment and enforcement of tol-
erances for poisonous or deleterious substances; 
(F) monitoring and enforcement of pes-
ticide 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 re-
ducing foodborne illness; 
(I) coordination of the Federal response to 
foodborne illness outbreaks with other Federal 
and State agencies; 
(J) integration of Federal food safety ac-
tivities 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 re-
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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, be-
ginning 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— 
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(1) appoint officers and employees for the Ad-
ministration 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 Administra-
tion may— 
(1) procure the services of temporary or inter-
mittent 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, in-
cluding transportation and per diem in lieu of sub-
sistence 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 Ad-
ministrator may establish within the Administration such 
bureaus, offices, and divisions as the Administrator deter-
mines are necessary to perform the duties of the Adminis-
trator. 
(d) ADVISORY COMMITTEES.— 
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(1) IN GENERAL.—The Administrator shall es-
tablish advisory committees that consist of rep-
resentative of scientific expert bodies, academics, in-
dustry specialists, and consumers. 
(2) DUTIES.—The duties of an advisory com-
mittee established under paragraph (1) may include 
developing recommendations with respect to the de-
velopment of regulatory science and processes, re-
search, 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 Ad-
ministrator shall issue formal guidance defining the cri-
teria by which food facilities will be divided into ‘‘high- 
risk,’’ ‘‘intermediate-risk,’’ and ‘‘low-risk’’ facilities. 
(c) INSPECTION FREQUENCIES.—Frequency of in-
spections of food facilities under this Act shall be based 
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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 Ad-
ministrator 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 pack-
aging or distribution, and pose very minimal public 
health risk, not less than once every 3 years. 
(b) INFANT FORMULA MANUFACTURING FACILI-
TIES.—The Administrator shall inspect the facilities of 
each manufacturer of infant formula not less than every 
6 months. 
(c) FEDERAL AND STATE COOPERATION.—The Ad-
ministrator 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 
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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 facil-
ity. 
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 busi-
ness days after a manufacturer of infant formula or essen-
tial 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 Ad-
ministrator. 
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‘‘(b) FINES.—If the Administrator finds that a man-
ufacturer of infant formula or essential medical food is 
in violation of the requirement of this section to give writ-
ten 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 Ad-
ministrator of Food Safety. 
‘‘(2) The term ‘essential medical food’ means a 
food that— 
‘‘(A) is formulated to be consumed or ad-
ministered 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 condi-
tion.’’. 
Æ 
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