II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Food Safety Adminis5 tration Act of 2022’’. 


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1 SEC. 2. DEFINITIONS. 

2 In this Act: 

3 (1) ADMINISTRATION.—The term ‘‘Administra4 tion’’ means the Food Safety Administration estab5 lished under section 101(a)(1). 

6 (2) ADMINISTRATOR.—The term ‘‘Adminis7 trator’’ means the Administrator of Food Safety ap8 pointed under section 101(a)(2). 

9 (3) FACILITY.—The term ‘‘facility’’ means any 

10 factory, warehouse, or establishment that is subject 

11 to the requirements of section 415 or 419 of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 350d; 350h). 

14 SEC. 3. EFFECTIVE DATE. 

15 This Act, including the amendments made by this 

16 Act, shall take effect 180 days after the date of enactment 

17 of this Act. 

18 SEC. 4. FUNDING. 

19 (a) TRANSFER OF FUNDS.—The appropriations, allo20 cations, and other funds that relate to the authorities, 

21 functions and agencies transferred under section 102 shall 

22 be transferred to the Administration. 

23 (b) AUTHORIZATION OF APPROPRIATIONS.—There 

24 are authorized to be appropriated to carry out this section, 

25 such sums as may be necessary for fiscal year 2023 and 

26 each fiscal year thereafter. 


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1 TITLE I—ESTABLISHMENT OF 

2 FOOD SAFETY ADMINISTRATION 

3 SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRA4 TION. 

5 (a) ESTABLISHMENT.— 

6 (1) IN GENERAL.—There is established within 

7 the Department of Health and Human Services an 

8 agency to be known as the ‘‘Food Safety Adminis9 tration’’. 

10 (2) HEAD OF ADMINISTRATION.—The Adminis11 tration shall be headed by the Administrator of Food 

12 Safety, who shall have food safety expertise, and be 

13 appointed by the President, by and with the advice 

14 and consent of the Senate. 

15 (3) EFFECT.—The Federal Food and Drug Ad16 ministration shall be renamed ‘‘Federal Drug Ad17 ministration’’ and retain responsibility for carrying 

18 out its responsibilities related to drugs, cosmetics, 

19 devices, biological products, color additives, and to20 bacco. The Commissioner of Food and Drugs shall 

21 be renamed the ‘‘Commissioner of Drugs’’, and shall 

22 retain the responsibilities of the Commissioner of 

23 Food and Drugs, except such responsibilities that re24 late to food, which shall be assumed by the Adminis25 trator of Food Safety. Each reference in statute to 


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1 the ‘‘Food and Drug Administration’’ shall be 

2 deemed a reference to the ‘‘Federal Drug Adminis3 tration’’, and each reference in statute to the ‘‘Com4 missioner of Food and Drugs’’ shall be deemed a 

5 reference to the ‘‘Commissioner of Drugs’’. 

6 (b) DUTIES OF THE ADMINISTRATOR.—The Adminis7 trator shall— 

8 (1) administer and enforce all authorities under 

9 chapter IV of the Federal Food, Drug, and Cosmetic 

10 Act (21 U.S.C. 341 et seq.); 

11 (2) serve as a representative to international 

12 food safety bodies and discussions; 

13 (3) promulgate and enforce regulations to en14 sure the security of the food supply from all forms 

15 of contamination, including intentional contamina16 tion; and 

17 (4) oversee— 

18 (A) implementation of Federal food safety; 

19 (B) inspection, labeling, enforcement, and 

20 research efforts to protect the public health; 

21 (C) development of consistent and science22 based standards for safe food; 

23 (D) safety reviews and reassessments of 

24 food additives; 


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1 (E) establishment and enforcement of tol2 erances for poisonous or deleterious substances; 

3 (F) monitoring and enforcement of pes4 ticide residue tolerances in or on foods; 

5 (G) coordination and prioritization of food 

6 safety research and education programs with 

7 other Federal agencies; 

8 (H) prioritization of Federal food safety 

9 efforts and deployment of Federal food safety 

10 resources to achieve the greatest benefit in re11 ducing foodborne illness; 

12 (I) coordination of the Federal response to 

13 foodborne illness outbreaks with other Federal 

14 and State agencies; 

15 (J) integration of Federal food safety ac16 tivities with State and local agencies; and 

17 (K) assignment of tolerances for animal 

18 drugs used in food-producing animals. 

19 SEC. 102. TRANSFER OF AUTHORITY, FUNCTIONS, AND 

20 AGENCIES. 

21 (a) TRANSFER OF AUTHORITY.—The Agency shall 

22 assume responsibility for carrying out chapter IV of the 

23 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 341 

24 et seq.) and maintain all enforcement authorities with reVerDate Sep 11 2014 01:16 Jul 15, 2022 Jkt 029200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4520.IS S4520

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1 spect to food held by the Food and Drug Administration 

2 on the date of enactment of this Act. 

3 (b) TRANSFER OF FUNCTIONS.—For each Federal 

4 agency, office, and center specified in subsection (c), there 

5 are transferred to the Administration all functions that 

6 the head of the Federal agency exercised on the day before 

7 the date of enactment of this Act (including all related 

8 functions of any officer or employee of the Federal agency) 

9 that relate to administration or enforcement of the food 

10 safety law, as determined by the President. 

11 (c) TRANSFERRED AGENCIES.—The Federal agencies 

12 referred to in subsection (b) are— 

13 (1) the resources and facilities of the Center for 

14 Food Safety and Applied Nutrition of the Food and 

15 Drug Administration that administer chapter IV of 

16 the Federal Food, Drug, and Cosmetics Act (21 

17 U.S.C. 341 et seq.); 

18 (2) the resources and facilities of the Office of 

19 Regulatory Affairs of the Food and Drug Adminis20 tration that administer and conduct inspections of 

21 food and feed facilities and imports; 

22 (3) the resources and facilities of the Center for 

23 Veterinary Medicine of the Food and Drug Adminis24 tration that administer chapter IV of the Federal 


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1 Food, Drug, and Cosmetics Act (21 U.S.C. 341 et 

2 seq.); 

3 (4) the Office of Food Policy and Response of 

4 the Food and Drug Administration; and 

5 (5) such other offices, services, or agencies as 

6 the President designates by Executive order to carry 

7 out this Act. 

8 (d) CONFORMING AMENDMENT.—Subchapter A of 

9 chapter VII of the Federal Food, Drug, and Cosmetic Act 

10 (21 U.S.C. 371 et seq.) is amended by adding at the end 

11 the following: 

12 ‘‘SEC. 703. REGULATION OF FOOD. 

13 ‘‘Notwithstanding any other provision of this Act, be14 ginning on the date that is 180 days after the date of 

15 enactment of the Food Safety Administration Act of 2022, 

16 any authority under this Act that relates to food shall be 

17 under the authority of the Food Safety Administration, 

18 and shall be carried out by the Administrator of Food 

19 Safety. Any reference in this Act to authorities related to 

20 food held by the Secretary shall be deemed to be references 

21 to authorities held by the Administrator of Food Safety.’’. 

22 SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 

23 (a) OFFICERS AND EMPLOYEES.—The Administrator 

24 may— 


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1 (1) appoint officers and employees for the Ad2 ministration in accordance with the provisions of 

3 title 5, United States Code, relating to appointment 

4 in the competitive service; and 

5 (2) fix the compensation of those officers and 

6 employees in accordance with chapter 51 and with 

7 subchapter III of chapter 53 of that title, relating to 

8 classification and General Schedule pay rates. 

9 (b) EXPERTS AND CONSULTANTS.—The Administra10 tion may— 

11 (1) procure the services of temporary or inter12 mittent experts and consultants as authorized by 

13 section 3109 of title 5, United States Code; and 

14 (2) pay in connection with those services the 

15 travel expenses of the experts and consultants, in16 cluding transportation and per diem in lieu of sub17 sistence while away from the homes or regular 

18 places of business of the individuals, as authorized 

19 by section 5703 of that title. 

20 (c) BUREAUS, OFFICES, AND DIVISIONS.—The Ad21 ministrator may establish within the Administration such 

22 bureaus, offices, and divisions as the Administrator deter23 mines are necessary to perform the duties of the Adminis24 trator. 

25 (d) ADVISORY COMMITTEES.— 


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1 (1) IN GENERAL.—The Administrator shall es2 tablish advisory committees that consist of rep3 resentative of scientific expert bodies, academics, in4 dustry specialists, and consumers. 

5 (2) DUTIES.—The duties of an advisory com6 mittee established under paragraph (1) may include 

7 developing recommendations with respect to the de8 velopment of regulatory science and processes, re9 search, communications, performance standards, and 

10 inspection. 

11 TITLE II—ADMINISTRATION OF 

12 FOOD SAFETY PROGRAM 

13 SEC. 201. ESTABLISHMENT OF INSPECTION PROGRAM. 

14 (a) IN GENERAL.—The Administrator shall establish 

15 an inspection program, which shall include inspections of 

16 food facilities subject to subsection (b) and in accordance 

17 with section 202. 

18 (b) FACILITY CATEGORIES.—Not later than 6 

19 months after the date of enactment of this Act, the Ad20 ministrator shall issue formal guidance defining the cri21 teria by which food facilities will be divided into ‘‘high22 risk,’’ ‘‘intermediate-risk,’’ and ‘‘low-risk’’ facilities. 

23 (c) INSPECTION FREQUENCIES.—Frequency of in24 spections of food facilities under this Act shall be based 


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1 on the categories defined pursuant to subjection (b) and 

2 in accordance with section 202. 

3 SEC. 202. INSPECTIONS OF FOOD FACILITIES. 

4 (a) FREQUENCY OF INSPECTIONS.— 

5 (1) HIGH-RISK FACILITIES.—The Administrator 

6 shall inspect high-risk facilities not less than once 

7 per a year. 

8 (2) INTERMEDIATE-RISK FACILITIES.—The Ad9 ministrator shall inspect intermediate-risk facilities 

10 not less than once every 2 years. 

11 (3) LOW-RISK FACILITIES.—The Administrator 

12 shall inspect low-risk facilities, which shall include 

13 warehouses or similar facilities that engage in pack14 aging or distribution, and pose very minimal public 

15 health risk, not less than once every 3 years. 

16 (b) INFANT FORMULA MANUFACTURING FACILI17 TIES.—The Administrator shall inspect the facilities of 

18 each manufacturer of infant formula not less than every 

19 6 months. 

20 (c) FEDERAL AND STATE COOPERATION.—The Ad21 ministrator shall contract with State officials to carry out 

22 half of the safety inspections required under this section. 

23 SEC. 203. COMPLIANCE CHECKS. 

24 Not later than 30 days after issuing a form that is 

25 equivalent to an FDA Form 483 to a facility, pursuant 


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1 to an inspection under section 704 of Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 374), the Administrator 

3 shall conduct a follow-up compliance check with the facil4 ity. 

5 SEC. 204. TRACEABILITY RULE. 

6 Not later than November 7, 2022, the Administrator 

7 shall promulgate a final rule that is based on the proposed 

8 rule issued by the Food and Drug Administration titled, 

9 ‘‘Requirements for Additional Traceability Records for 

10 Certain Foods’’ (85 Fed. Reg. 59984 (Sept. 23, 2021)). 

11 SEC. 205. NOTICE OF CIRCUMSTANCES THAT COULD LEAD 

12 TO A SHORTAGE. 

13 Chapter IV of the Federal Food, Drug, and Cosmetic 

14 Act (21 U.S.C. 341 et seq.) is amended by adding at the 

15 end the following: 

16 ‘‘SEC. 424. NOTICE OF CIRCUMSTANCES THAT COULD LEAD 

17 TO A SHORTAGE. 

18 ‘‘(a) NOTICE REQUIREMENT.—Not later than 5 busi19 ness days after a manufacturer of infant formula or essen20 tial medical food becomes aware of circumstances that 

21 could lead to a shortage of infant formula or essential 

22 medical food in the United States, such manufacturer 

23 shall give written notice of such circumstances to the Ad24 ministrator. 


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1 ‘‘(b) FINES.—If the Administrator finds that a man2 ufacturer of infant formula or essential medical food is 

3 in violation of the requirement of this section to give writ4 ten notice, such violation shall be treated as an infraction 

5 for purposes of imposing a fine in accordance with title 

6 18, United States Code. 

7 ‘‘(c) DEFINITIONS.—In this section: 

8 ‘‘(1) The term ‘Administrator’ means the Ad9 ministrator of Food Safety. 

10 ‘‘(2) The term ‘essential medical food’ means a 

11 food that— 

12 ‘‘(A) is formulated to be consumed or ad13 ministered enterally under the supervision of a 

14 physician; 

15 ‘‘(B) is intended for the specific dietary 

16 management of a disease or condition for which 

17 distinctive nutritional requirements, based on 

18 recognized scientific principles, are established 

19 by medical evaluation; and 

20 ‘‘(C) is identified by the Administrator as 

21 being essential for any urgent medical condi22 tion.’’. 

Æ 


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