II 

116TH CONGRESS 

1ST SESSION S. 1995 

To establish the Food Safety Administration to protect the public health 

by preventing foodborne illness, ensuring the safety of food, improving 

research on contaminants leading to foodborne illness and the chronic 

health outcomes associated with foodborne illnesses, improving the surveillance of foodborne pathogens (including foodborne pathogens identified as antibiotic resistant), and improving security of food from intentional contamination, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 26, 2019 

Mr. DURBIN (for himself, Mr. BLUMENTHAL, Mrs. FEINSTEIN, and Mrs. 

GILLIBRAND) introduced the following bill; which was read twice and referred to the Committee on Agriculture, Nutrition, and Forestry 

A BILL 

To establish the Food Safety Administration to protect the 

public health by preventing foodborne illness, ensuring 

the safety of food, improving research on contaminants 

leading to foodborne illness and the chronic health outcomes associated with foodborne illnesses, improving the 

surveillance of foodborne pathogens (including foodborne 

pathogens identified as antibiotic resistant), and improving security of food from intentional contamination, 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, 


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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

2 (a) SHORT TITLE.—This Act may be cited as the 

3 ‘‘Safe Food Act of 2019’’. 

4 (b) TABLE OF CONTENTS.—The table of contents of 

5 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Findings; purposes. 

Sec. 3. Definitions. 

TITLE I—ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION 

Sec. 101. Establishment of Food Safety Administration. 

Sec. 102. Consolidation of separate food safety and inspection services and 

agencies. 

Sec. 103. Additional duties of the Administration. 

TITLE II—ADMINISTRATION OF FOOD SAFETY PROGRAM 

Sec. 201. Administration of national program. 

Sec. 202. Registration of food facilities. 

Sec. 203. Preventive process controls to reduce adulteration of food. 

Sec. 204. Performance standards for contaminants in food. 

Sec. 205. Inspections of food facilities. 

Sec. 206. Food production establishments. 

Sec. 207. Federal and State cooperation. 

Sec. 208. Foreign supplier verification program. 

Sec. 209. Imports. 

Sec. 210. Traceback. 

Sec. 211. Food safety technology. 

TITLE III—RESEARCH AND EDUCATION 

Sec. 301. Public health assessment system. 

Sec. 302. Public education and advisory system. 

Sec. 303. Research. 

TITLE IV—ENFORCEMENT 

Sec. 401. Prohibited acts. 

Sec. 402. Mandatory recall authority. 

Sec. 403. Injunction proceedings. 

Sec. 404. Civil and criminal penalties. 

Sec. 405. Presumption. 

Sec. 406. Whistleblower protection. 

Sec. 407. Administration and enforcement. 

Sec. 408. Citizen civil actions. 

TITLE V—IMPLEMENTATION 

Sec. 501. Definition. 

Sec. 502. Reorganization plan. 

Sec. 503. Transitional authorities. 


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Sec. 504. Savings provisions. 

Sec. 505. Conforming amendments. 

Sec. 506. Additional technical and conforming amendments. 

Sec. 507. Regulations. 

Sec. 508. Authorization of appropriations. 

Sec. 509. Limitation on authorization of appropriations. 

1 SEC. 2. FINDINGS; PURPOSES. 

2 (a) FINDINGS.—Congress finds that— 

3 (1) the safety of the food supply of the United 

4 States is vital to the public health, to public con5 fidence in the food supply, and to the success of the 

6 food sector of the Nation’s economy; 

7 (2) lapses in the protection of the food supply 

8 and loss of public confidence in food safety are dam9 aging to consumers and the food industry, and place 

10 a burden on interstate commerce; 

11 (3) the safety and security of the food supply 

12 requires an integrated, systemwide approach to pre13 venting foodborne illness, a thorough and broad14 based approach to basic and applied research, and 

15 intensive, effective, and efficient management of the 

16 Nation’s food safety program; 

17 (4) the task of preserving the safety of the food 

18 supply of the United States faces tremendous pres19 sures with regard to— 

20 (A) emerging pathogens and other con21 taminants and the ability to detect all forms of 

22 contamination; 


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1 (B) an aging and immune-compromised 

2 population, with a growing number of people at 

3 high risk for foodborne illnesses, including in4 fants and children; 

5 (C) a concern regarding food fraud for eco6 nomic gain, especially with mislabeling and in7 tentionally misleading claims; 

8 (D) an increasing volume of imported food, 

9 without adequate monitoring and inspection; 

10 and 

11 (E) maintenance of rigorous inspection of 

12 the domestic food processing and food service 

13 industries; 

14 (5) Federal food safety standard setting, in15 spection, enforcement, and research efforts should be 

16 based on the best available science and public health 

17 considerations and food safety resources should be 

18 systematically deployed in ways that most effectively 

19 prevent foodborne illness; 

20 (6) the Federal food safety system is frag21 mented, with at least 15 Federal agencies sharing 

22 responsibility for food safety, and operates under 

23 laws that do not reflect current conditions in the 

24 food system or current scientific knowledge about 

25 the cause and prevention of foodborne illness; 


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1 (7) the fragmented Federal food safety system 

2 and outdated laws preclude an integrated, system3 wide approach to preventing foodborne illness, to the 

4 effective and efficient operation of the Nation’s food 

5 safety program, and to the most beneficial deploy6 ment of food safety resources; 

7 (8) the National Academy of Sciences rec8 ommended in the report ‘‘Ensuring Safe Food from 

9 Production to Consumption’’ that Congress establish 

10 by statute a unified and central framework for man11 aging Federal food safety programs, and rec12 ommended modifying Federal statutes so that in13 spection, enforcement, and research efforts are 

14 based on scientifically supportable assessments of 

15 risks to public health; and 

16 (9) the lack of a single focal point for food safe17 ty leadership in the United States undercuts the 

18 ability of the United States to exert food safety lead19 ership internationally, which is detrimental to the 

20 public health and the international trade interests of 

21 the United States. 

22 (b) PURPOSES.—The purposes of this Act are— 

23 (1) to establish a single agency to be known as 

24 the ‘‘Food Safety Administration’’ to— 


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1 (A) regulate food safety and related label2 ing to strengthen the protection of the public 

3 health; 

4 (B) ensure that food facilities fulfill their 

5 responsibility to produce food in a manner that 

6 protects the public health of all people in the 

7 United States; 

8 (C) lead an integrated, systemwide ap9 proach to food safety and to make more effec10 tive and efficient use of resources to prevent 

11 foodborne illness; 

12 (D) provide a single focal point for food 

13 safety leadership, both nationally and inter14 nationally; and 

15 (E) provide an integrated food safety re16 search capability, utilizing internally generated, 

17 scientifically and statistically valid studies or 

18 other food safety initiatives, in cooperation with 

19 academic institutions, food safety nonprofit or20 ganizations, and other scientific entities of the 

21 Federal and State governments, to achieve the 

22 continuous improvement of research on 

23 foodborne illness and contaminants; 

24 (2) to transfer to the Food Safety Administra25 tion the food safety, labeling, inspection, and enVerDate Sep 11 2014 01:24 Jul 02, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1995.IS S1995

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1 forcement functions that, as of the day before the 

2 date of enactment of this Act, are performed by 

3 other Federal agencies; and 

4 (3) to modernize and strengthen the Federal 

5 food safety laws to achieve more effective application 

6 and efficient management of the laws for the protec7 tion and improvement of public health. 

8 SEC. 3. DEFINITIONS. 

9 In this Act: 

10 (1) ADMINISTRATION.—The term ‘‘Administra11 tion’’ means the Food Safety Administration estab12 lished under section 101(a)(1). 

13 (2) ADMINISTRATOR.—The term ‘‘Adminis14 trator’’ means the Administrator of Food Safety ap15 pointed under section 101(a)(3). 

16 (3) ADULTERATED.— 

17 (A) IN GENERAL.—The term ‘‘adulter18 ated’’ has the meaning given the term in— 

19 (i) section 402 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 342) 

21 for food regulated under such Act; 

22 (ii) section 1(m) of the Federal Meat 

23 Inspection Act (21 U.S.C. 601(m)) for 

24 food regulated under such Act; 


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1 (iii) section 4(g) of the Poultry Prod2 ucts Inspection Act (21 U.S.C. 453(g)) for 

3 food regulated under such Act; and 

4 (iv) section 4(a) of the Egg Products 

5 Inspection Act (21 U.S.C. 1033(a)) for 

6 food regulated under such Act. 

7 (B) INCLUSION.—In applying the defini8 tions cited in subparagraph (A), poisonous or 

9 deleterious substances in food shall be treated 

10 as an added substance if the poisonous or dele11 terious substances are known to cause serious 

12 illness or death in persons, including in sen13 sitive populations. 

14 (4) AGENCY.—The term ‘‘agency’’ has the 

15 meaning given the term in section 551 of title 5, 

16 United States Code. 

17 (5) CATEGORY 1 FOOD FACILITY.—The term 

18 ‘‘category 1 food facility’’ means a facility that 

19 slaughters animals for food. 

20 (6) CATEGORY 2 FOOD FACILITY.—The term 

21 ‘‘category 2 food facility’’ means a facility that proc22 esses— 

23 (A) raw meat, poultry, or seafood in a 

24 manner that may reduce but is not validated to 

25 destroy contaminants; or 


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1 (B) other products that the Administrator 

2 determines by regulation to be at high risk of 

3 contamination. 

4 (7) CATEGORY 3 FOOD FACILITY.—The term 

5 ‘‘category 3 food facility’’ means a facility— 

6 (A) that processes meat, poultry, or sea7 food, or other products that the Administrator 

8 determines by regulation to be at high risk of 

9 contamination; and 

10 (B) whose processes include one or more 

11 steps validated to destroy contaminants. 

12 (8) CATEGORY 4 FOOD FACILITY.—The term 

13 ‘‘category 4 food facility’’ means a facility that proc14 esses food but is not a category 1, 2, or 3 food facil15 ity. 

16 (9) CATEGORY 5 FOOD FACILITY.—The term 

17 ‘‘category 5 food facility’’ means a facility that 

18 stores, holds, or transports food prior to delivery for 

19 retail sale. 

20 (10) CONTAMINANT.—The term ‘‘contaminant’’ 

21 includes biological, chemical, physical, or radiological 

22 hazards, natural toxins, pesticides, drug residues, 

23 decomposition, parasites, allergens, and unapproved 

24 food or color additives. 


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1 (11) CONTAMINATION.—The term ‘‘contamina2 tion’’ refers to a presence of a contaminant in food, 

3 which may occur naturally or be introduced into a 

4 food. 

5 (12) FEED FACILITY.—The term ‘‘feed facility’’ 

6 means a domestic or foreign feed manufacturer, 

7 processor, packer, warehouse, or other facility that— 

8 (A) if operating in the United States, man9 ufactures, slaughters, processes, or holds animal 

10 feed or feed ingredients; or 

11 (B) if operating elsewhere, manufactures, 

12 slaughters, processes, or holds animal feed or 

13 feed ingredients intended for consumption in 

14 the United States. 

15 (13) FOOD.— 

16 (A) IN GENERAL.—The term ‘‘food’’ 

17 means a product intended to be used for food 

18 or drink for a human or an animal. 

19 (B) INCLUSIONS.—The term ‘‘food’’ in20 cludes any product (including a meat food prod21 uct, as defined in section 1(j) of the Federal 

22 Meat Inspection Act (21 U.S.C. 601(j))), capa23 ble for use as human and animal food that is 

24 made in whole or in part from any animal, in25 cluding cattle, sheep, swine, goat, or poultry (as 


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1 defined in section 4 of the Poultry Products In2 spection Act (21 U.S.C. 453)), and animal feed. 

3 (14) FOOD FACILITY.— 

4 (A) IN GENERAL.—The term ‘‘food facil5 ity’’ means a domestic or foreign food manufac6 turer, slaughterhouse, processor, packer, ware7 house, or other facility that— 

8 (i) if operating in the United States, 

9 manufactures, slaughters, processes, or 

10 holds food or food ingredients; or 

11 (ii) if operating outside the United 

12 States, manufactures, slaughters, proc13 esses, or holds food intended for consump14 tion in the United States. 

15 (B) EXCLUSIONS.—For the purposes of 

16 registration, the term ‘‘food facility’’ does not 

17 include— 

18 (i) a farm, restaurant, other retail 

19 food establishment, or nonprofit food es20 tablishment in which food is prepared for 

21 or served directly to the consumer; or 

22 (ii) a fishing vessel (other than a fish23 ing vessel engaged in processing, as that 

24 term is defined in section 123.3(k) of title 

25 21, Code of Federal Regulations). 


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1 (15) FOOD PRODUCTION ESTABLISHMENT.— 

2 The term ‘‘food production establishment’’ means 

3 any farm, ranch, orchard, vineyard, aquaculture fa4 cility, or confined animal-feeding operation. 

5 (16) FOOD SAFETY LAW.—The term ‘‘food safe6 ty law’’ means— 

7 (A) the provisions of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 301 et 

9 seq.) related to and requiring the safety, label10 ing, and inspection of food, infant formulas, 

11 food additives, pesticide residues, and other 

12 substances present in food under that Act; 

13 (B) the provisions of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 301 et 

15 seq.) and of any other Act that are adminis16 tered by the Center for Veterinary Medicine of 

17 the Food and Drug Administration; 

18 (C) the Poultry Products Inspection Act 

19 (21 U.S.C. 451 et seq.); 

20 (D) the Federal Meat Inspection Act (21 

21 U.S.C. 601 et seq.); 

22 (E) the FDA Food Safety Modernization 

23 Act (Public Law 111–353; 124 Stat. 3885); 

24 (F) the Egg Products Inspection Act (21 

25 U.S.C. 1031 et seq.); 


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1 (G) chapter 57 of title 49, United States 

2 Code (formerly known as the ‘‘Sanitary Food 

3 Transportation Act of 1990’’); 

4 (H) Public Law 85–765 (commonly known 

5 as the ‘‘Humane Methods of Slaughter Act of 

6 1958’’) (7 U.S.C. 1901 et seq.); 

7 (I) this Act; and 

8 (J) such other provisions of law related to 

9 and requiring food safety, labeling, inspection, 

10 and enforcement as the President designates by 

11 Executive order as appropriate to include within 

12 the jurisdiction of the Administration. 

13 (17) INTERSTATE COMMERCE.—The term 

14 ‘‘interstate commerce’’ has the meaning given the 

15 term in section 201(b) of the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 321(b)). 

17 (18) MISBRANDED.—The term ‘‘misbranded’’ 

18 has the meaning given the term in— 

19 (A) section 403 of the Federal Food, 

20 Drug, and Cosmetic Act (21 U.S.C. 343) for 

21 food regulated under such Act; 

22 (B) section 1(n) of the Federal Meat In23 spection Act (21 U.S.C. 601(n)) for food regu24 lated under such Act; 


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1 (C) section 4(h) of the Poultry Products 

2 Inspection Act (21 U.S.C. 453(h)) for food reg3 ulated under such Act; and 

4 (D) section 4(l) of the Egg Products In5 spection Act (21 U.S.C. 1033(l)) for food regu6 lated under such Act. 

7 (19) PROCESS.—The term ‘‘process’’ or ‘‘proc8 essing’’ means the commercial slaughter, packing, 

9 preparation, or manufacture of food. 

10 (20) SAFE.—The term ‘‘safe’’ refers to human 

11 and animal health. 

12 (21) STATE.—The term ‘‘State’’ means— 

13 (A) a State; 

14 (B) the District of Columbia; 

15 (C) the Commonwealth of Puerto Rico; 

16 and 

17 (D) any other territory or possession of the 

18 United States. 

19 (22) VALIDATION.—The term ‘‘validation’’ 

20 means the act of obtaining evidence that the process 

21 control measure or measures selected to control a 

22 contaminant in food is capable of effectively and 

23 consistently controlling the contaminant. 

24 (23) STATISTICALLY VALID.—The term ‘‘statis25 tically valid’’ means evaluated and conducted under 


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1 standards set by the National Institute of Standards 

2 and Technology. 

3 TITLE I—ESTABLISHMENT OF 

4 FOOD SAFETY ADMINISTRATION 

5 SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRA6 TION. 

7 (a) ESTABLISHMENT.— 

8 (1) IN GENERAL.—There is established in the 

9 Executive branch an agency to be known as the 

10 ‘‘Food Safety Administration’’. 

11 (2) STATUS.—The Administration shall be an 

12 independent establishment (as defined in section 104 

13 of title 5, United States Code). 

14 (3) HEAD OF ADMINISTRATION.—The Adminis15 tration shall be headed by the Administrator of Food 

16 Safety, who shall be appointed by the President, by 

17 and with the advice and consent of the Senate. 

18 (b) DUTIES OF ADMINISTRATOR.—The Adminis19 trator shall— 

20 (1) administer and enforce the food safety law; 

21 (2) serve as a representative to international 

22 food safety bodies and discussions; 

23 (3) promulgate regulations to ensure the secu24 rity of the food supply from all forms of contamina25 tion, including intentional contamination; and 


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1 (4) oversee— 

2 (A) implementation of Federal food safety 

3 inspection, labeling, enforcement, and research 

4 efforts to protect the public health; 

5 (B) development of consistent and science6 based standards for safe food; 

7 (C) coordination and prioritization of food 

8 safety research and education programs with 

9 other Federal agencies; 

10 (D) prioritization of Federal food safety ef11 forts and deployment of Federal food safety re12 sources to achieve the greatest benefit in reduc13 ing foodborne illness; 

14 (E) coordination of the Federal response to 

15 foodborne illness outbreaks with other Federal 

16 and State agencies; and 

17 (F) integration of Federal food safety ac18 tivities with State and local agencies. 

19 SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY 

20 AND INSPECTION SERVICES AND AGENCIES. 

21 (a) TRANSFER OF FUNCTIONS.—For each Federal 

22 agency specified in subsection (b), there are transferred 

23 to the Administration all functions that the head of the 

24 Federal agency exercised on the day before the date of 

25 enactment of this Act (including all related functions of 


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1 any officer or employee of the Federal agency) that relate 

2 to administration or enforcement of the food safety law, 

3 as determined by the President. 

4 (b) TRANSFERRED AGENCIES.—The Federal agen5 cies referred to in subsection (a) are— 

6 (1) the Food Safety and Inspection Service of 

7 the Department of Agriculture; 

8 (2) the Center for Food Safety and Applied Nu9 trition of the Food and Drug Administration; 

10 (3) the part of the Agriculture Marketing Serv11 ice that administers shell egg surveillance services 

12 established under the Egg Products Inspection Act 

13 (21 U.S.C. 1031 et seq.); 

14 (4) the resources and facilities of the Office of 

15 Regulatory Affairs of the Food and Drug Adminis16 tration that administer and conduct inspections of 

17 food and feed facilities and imports; 

18 (5) the Center for Veterinary Medicine of the 

19 Food and Drug Administration; 

20 (6) the Office of Food Policy and Response of 

21 the Food and Drug Administration; 

22 (7) the part of the Research, Education, and 

23 Economics mission area of the Department of Agri24 culture related to food and feed safety; 


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1 (8) the part of the National Marine Fisheries 

2 Service of the National Oceanic and Atmospheric 

3 Administration of the Department of Commerce that 

4 administers the seafood inspection program; 

5 (9) the part of the Animal and Plant Inspection 

6 Health Service of the Department of Agriculture re7 lated to the management of animals going into the 

8 food supply; and 

9 (10) such other offices, services, or agencies as 

10 the President designates by Executive order to carry 

11 out this Act. 

12 SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 

13 (a) OFFICERS AND EMPLOYEES.—The Administrator 

14 may— 

15 (1) appoint officers and employees for the Ad16 ministration in accordance with the provisions of 

17 title 5, United States Code, relating to appointment 

18 in the competitive service; and 

19 (2) fix the compensation of those officers and 

20 employees in accordance with chapter 51 and with 

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

22 classification and General Schedule pay rates. 

23 (b) EXPERTS AND CONSULTANTS.—The Adminis24 trator may— 


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1 (1) procure the services of temporary or inter2 mittent experts and consultants as authorized by 

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

4 (2) pay in connection with those services the 

5 travel expenses of the experts and consultants, in6 cluding transportation and per diem in lieu of sub7 sistence while away from the homes or regular 

8 places of business of the individuals, as authorized 

9 by section 5703 of that title. 

10 (c) BUREAUS, OFFICES, AND DIVISIONS.—The Ad11 ministrator may establish within the Administration such 

12 bureaus, offices, and divisions as the Administrator deter13 mines are necessary to perform the duties of the Adminis14 trator. 

15 (d) ADVISORY COMMITTEES.— 

16 (1) IN GENERAL.—The Administrator shall es17 tablish advisory committees that consist of rep18 resentatives of scientific expert bodies, academics, 

19 industry specialists, and consumers. 

20 (2) DUTIES.—The duties of an advisory com21 mittee established under paragraph (1) may include 

22 developing recommendations with respect to the de23 velopment of regulatory science and processes, re24 search, communications, performance standards, and 

25 inspection. 


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1 TITLE II—ADMINISTRATION OF 

2 FOOD SAFETY PROGRAM 

3 SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM. 

4 (a) IN GENERAL.—The Administrator shall— 

5 (1) administer a national food safety program 

6 (referred to in this section as the ‘‘program’’) to 

7 protect public health; and 

8 (2) ensure that persons who produce or process 

9 food meet their responsibility to prevent or minimize 

10 food safety hazards related to their products. 

11 (b) COMPREHENSIVE ANALYSIS.—The program shall 

12 be based on a comprehensive analysis of the hazards asso13 ciated with different food and with the processing of dif14 ferent food, including the identification and evaluation 

15 of— 

16 (1) the severity of the health risks; 

17 (2) the sources and specific points of potential 

18 contamination extending from the farm or ranch to 

19 the consumer that may render food unsafe; 

20 (3) the potential for persistence, multiplication, 

21 or concentration of naturally occurring or added 

22 contaminants in food; 

23 (4) opportunities across the food production, 

24 processing, distribution, and retail system to manage 

25 and reduce potential health risks; and 


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1 (5) opportunities for intentional contamination. 

2 (c) PROGRAM ELEMENTS.—In carrying out the pro3 gram, the Administrator shall— 

4 (1) adopt and implement a national system for 

5 the registration of food facilities and regular unan6 nounced inspection of food facilities; 

7 (2) verify and enforce the adoption of preven8 tive process controls in food facilities, based on the 

9 best available scientific and public health consider10 ations and best available technologies; 

11 (3) establish and enforce science-based stand12 ards for— 

13 (A) substances that may contaminate food; 

14 and 

15 (B) safety and sanitation in the processing 

16 and handling of food; 

17 (4) implement a statistically valid sampling pro18 gram to ensure that industry programs and proce19 dures that prevent food contamination are effective 

20 on an ongoing basis and that food meets the per21 formance standards established under this Act; 

22 (5) implement procedures and requirements to 

23 ensure the safety and security of imported food; 


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1 (6) coordinate with other agencies and State or 

2 local governments in carrying out inspection, en3 forcement, research, and monitoring; 

4 (7) access the surveillance data of the Centers 

5 for Disease Control and Prevention, and other Fed6 eral Government agencies, in order to develop and 

7 implement a national surveillance system to assess 

8 the health risks associated with the human consump9 tion of food or to create surveillance data and stud10 ies to mitigate food threats (such as antibiotic resist11 ance) or to identify the ways that food contamina12 tion spreads through environments; 

13 (8) partner with relevant agencies to identify 

14 and prevent terrorist threats to food; 

15 (9) establish a process for providing a single 

16 point of contact to assist impacted consumers in 

17 navigating Federal, State, and local agencies in18 volved in responding to or monitoring a foodborne 

19 outbreak; 

20 (10) develop public education risk communica21 tion and advisory programs; 

22 (11) implement a basic and applied research 

23 program to further the purposes of this Act; and 


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1 (12) coordinate and prioritize food safety re2 search and educational programs with other agen3 cies, including State or local agencies. 

4 SEC. 202. REGISTRATION OF FOOD FACILITIES. 

5 (a) IN GENERAL.—The Administrator shall require 

6 that all food and feed facilities register before the facility 

7 can operate in the United States or import food, feed, or 

8 ingredients into the United States. 

9 (b) REGISTRATION REQUIREMENTS.— 

10 (1) IN GENERAL.—To be registered under sub11 section (a)— 

12 (A) all food facilities covered under this 

13 Act shall comply with registration requirements 

14 in section 415 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 350d); 

16 (B) for food facilities that have not reg17 istered under such section 415 prior to the date 

18 of enactment of this Act, the requirement in 

19 subparagraph (A) applies beginning on the day 

20 that is 180 days after the date of enactment of 

21 this Act; and 

22 (C) for food facilities that have registered 

23 under such section 415 prior to the date of en24 actment of this Act, such facilities shall file an 

25 amended registration within 180 days of such 


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1 date of enactment to deliver the information re2 quired by paragraph (2). 

3 (2) CATEGORIES.—In addition to the informa4 tion required under section 415 of the Federal Food, 

5 Drug, and Cosmetic Act (21 U.S.C. 350d) to be in6 cluded in registration, a food facility shall— 

7 (A) list the facility’s primary purpose and 

8 business activity, including the dates of oper9 ation if the food facility is operating seasonally; 

10 and 

11 (B) list the types of food handled at the 

12 facility and identify the activities conducted in 

13 the facility, that are relevant to determining 

14 whether the facility is a category 1, 2, 3, 4, or 

15 5 facility. 

16 (3) PROCEDURE.—Upon receipt of a completed 

17 or amended registration described in paragraph (1), 

18 the Administrator shall notify the registrant of the 

19 receipt of the registration, review the activities iden20 tified in the registration, designate the facility as a 

21 category 1, 2, 3, 4, or 5 food facility for the pur22 poses of inspection, and assign a registration num23 ber to each food facility. 

24 (4) LIST.—The Administrator— 


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1 (A) shall compile and maintain an up-to2 date list of food facilities that are registered 

3 under this section, in accordance with section 

4 415(a)(5) of the Federal Food, Drug, and Cos5 metic Act (21 U.S.C. 350d(a)(5)); and 

6 (B) may establish regulations on how the 

7 list may be shared with other governmental au8 thorities. 

9 SEC. 203. PREVENTIVE PROCESS CONTROLS TO REDUCE 

10 ADULTERATION OF FOOD. 

11 (a) IN GENERAL.—The Administrator shall review 

12 existing regulations on hazard analysis and process con13 trols and amend existing regulations as appropriate, upon 

14 the basis of best available public health, scientific, and 

15 technological information, to ensure that those regulations 

16 are working effectively to— 

17 (1) ensure food facilities operate in a sanitary 

18 manner so that food is not adulterated; 

19 (2) limit the presence of contaminants in food; 

20 (3) meet the performance standards established 

21 under section 204; 

22 (4) ensure fully processed or ready-to-eat foods 

23 are processed using reasonably available techniques 

24 and technologies to eliminate contaminants; 


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1 (5) label food intended for final processing out2 side commercial food facilities with instructions for 

3 handling and preparation for consumption that will 

4 destroy contaminants; 

5 (6) require sampling and testing at a frequency 

6 and in a manner sufficient to ensure that process 

7 controls are effective on an ongoing basis and that 

8 performance standards are being met; and 

9 (7) provide for agency access to records kept by 

10 food facilities and submission of copies of the 

11 records to the Administrator, as the Administrator 

12 determines appropriate. 

13 (b) PROCESSING CONTROLS.—The Administrator 

14 may require any person with responsibility for or control 

15 over food or food ingredients to adopt process controls, 

16 if the process controls are needed to ensure the protection 

17 of the public health. 

18 SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS 

19 IN FOOD. 

20 (a) PERFORMANCE STANDARDS.—Whenever the Ad21 ministrator determines that a foodborne contaminant pre22 sents the risk of serious adverse health consequences or 

23 death to consumers, causes food to be adulterated, or 

24 could promote the spread of communicable disease de25 scribed in section 361 of the Public Health Service Act 


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1 (42 U.S.C. 264), the Administrator shall issue a perform2 ance standard (in the form of guidance, action levels, or 

3 regulations) to prevent or control the contaminant. 

4 (b) ENFORCEMENT.— 

5 (1) IN GENERAL.—Not later than 1 year after 

6 the promulgation of a performance standard under 

7 this section, the Administrator shall implement a 

8 statistically significant sampling program to deter9 mine whether food facilities are complying with the 

10 standards promulgated under this section. 

11 (2) ACTIONS.—If the Administrator determines 

12 that a food facility fails to meet a standard promul13 gated under this section, and such facility fails to 

14 take appropriate corrective action as determined by 

15 the Administrator, the Administrator shall, as ap16 propriate— 

17 (A) detain, seize, or condemn food from 

18 the food facility under section 209(i); 

19 (B) order a recall of food from the food fa20 cility under section 402; 

21 (C) increase the inspection frequency for 

22 the food facility; 

23 (D) withdraw the mark of inspection from 

24 the food facility, if in use; or 


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1 (E) take other appropriate enforcement ac2 tion concerning the food facility, including sus3 pension of registration. 

4 (c) NEWLY IDENTIFIED CONTAMINANTS.—Notwith5 standing any other provision of this section, the Adminis6 trator shall promulgate interim performance standards for 

7 newly identified contaminants as necessary to protect the 

8 public health. 

9 (d) REVOCATION BY ADMINISTRATOR.—All perform10 ance standards, tolerances, action levels, or other similar 

11 standards with respect to food in effect on the date of en12 actment of this Act shall remain in effect until revised or 

13 revoked by the Administrator. 

14 SEC. 205. INSPECTIONS OF FOOD FACILITIES. 

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

16 an inspection program, which shall include sampling and 

17 testing of food and food facilities, to determine if each food 

18 facility— 

19 (1) is operating in a sanitary manner; 

20 (2) has continuous systems, interventions, and 

21 processes in place to minimize or eliminate contami22 nants in food; 

23 (3) uses validated process controls and ongoing 

24 verification; 


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1 (4) is in compliance with applicable perform2 ance standards established under section 204, proc3 ess control regulations, and other requirements; 

4 (5) is processing food that is safe and not adul5 terated or misbranded; 

6 (6) maintains records of process control plans 

7 under section 203, and other records related to the 

8 processing, sampling, and handling of food; and 

9 (7) is in compliance with the requirements of 

10 the applicable food safety law. 

11 (b) FACILITY CATEGORIES AND INSPECTION FRE12 QUENCIES.—Inspections of food facilities under this Act 

13 shall be based on the following categories and inspection 

14 frequencies, subject to subsections (c), (d), and (e): 

15 (1) CATEGORY 1 FOOD FACILITIES.—A category 

16 1 food facility shall be subject to antemortem, post17 mortem, and continuous inspection of each slaughter 

18 line during all operating hours, and other inspection 

19 on a daily basis, sufficient to verify that— 

20 (A) diseased animals are not offered for 

21 slaughter; 

22 (B) the food facility has successfully iden23 tified and removed from the slaughter line visi24 bly defective or contaminated carcasses, has 

25 avoided cross-contamination, and has destroyed 


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1 or reprocessed contaminated carcasses in a 

2 manner acceptable to the Administrator; and 

3 (C) applicable performance standards and 

4 other provisions of the food safety law, includ5 ing those intended to eliminate or reduce patho6 gens, have been satisfied. 

7 (2) CATEGORY 2 FOOD FACILITIES.—A category 

8 2 food facility shall be randomly inspected at least 

9 daily. 

10 (3) CATEGORY 3 FOOD FACILITIES.—A category 

11 3 food facility shall— 

12 (A) provide documentation to the Adminis13 trator on request that ongoing verification 

14 shows that its processes are controlled; and 

15 (B) be randomly inspected at least month16 ly. 

17 (4) CATEGORY 4 FOOD FACILITIES.—A category 

18 4 food facility shall be randomly inspected at least 

19 quarterly. 

20 (5) CATEGORY 5 FOOD FACILITIES.—A category 

21 5 food facility shall be randomly inspected at least 

22 annually. 

23 (c) ESTABLISHMENT OF INSPECTION PROCE24 DURES.—The Administrator shall establish procedures 

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1 cilities, which shall allow the taking of random samples, 

2 photographs, and copies of records in food facilities. 

3 (d) ALTERNATIVE INSPECTION FREQUENCIES.— 

4 (1) IN GENERAL.—With respect to a category 

5 2, 3, 4, or 5 food facility, to foster a risk-based allo6 cation of resources, the Administrator may establish, 

7 in accordance with this subsection, alternative in8 creased or decreased inspection frequencies for— 

9 (A) 1 or more subcategories of food facili10 ties under paragraph (2); and 

11 (B) 1 or more specific food facilities under 

12 paragraph (3). 

13 (2) DETERMINATION OF SUBCATEGORIES AND

14 FREQUENCIES.— 

15 (A) IN GENERAL.—The Administrator 

16 shall define, by regulation, each subcategory of 

17 food facilities established under paragraph 

18 (1)(A) and the alternative inspection frequency 

19 of that subcategory. 

20 (B) CONSIDERATIONS.—In defining a sub21 category of food facilities and the alternative in22 spection frequency of that subcategory under 

23 subparagraph (A), the Administrator shall con24 sider— 


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1 (i) the nature of the foods being proc2 essed, stored, or transported; 

3 (ii) the manner in which foods are 

4 processed, stored, or transported; 

5 (iii) the inherent likelihood that the 

6 foods will contribute to the risk of 

7 foodborne illness; 

8 (iv) the best available evidence con9 cerning reported illnesses associated with 

10 the foods produced in the proposed sub11 category of facilities; and 

12 (v) the overall record of compliance 

13 with the food safety law among facilities in 

14 the proposed subcategory, including com15 pliance with applicable performance stand16 ards and the frequency of recalls. 

17 (3) SPECIFIC FACILITIES.— 

18 (A) IN GENERAL.—The Administrator— 

19 (i) may establish an alternative in20 spection frequency for increased or de21 creased inspection for a specific food facil22 ity; and 

23 (ii) shall annually publish a list of 

24 food facilities subject to alternative inspec25 tion frequencies under clause (i). 


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1 (B) CONSIDERATIONS.—In establishing an 

2 alternative inspection frequency for a specific 

3 food facility, the Administrator shall consider— 

4 (i) the supporting evidence that the 

5 specific food facility shall submit to the 

6 Administrator relating to whether an alter7 native inspection frequency should be es8 tablished for that facility by the Adminis9 trator; 

10 (ii) whether products from the specific 

11 food facility have been associated with a 

12 case or an outbreak of foodborne illness; 

13 (iii) the record of the facility of com14 pliance with the food safety law, including 

15 compliance with applicable performance 

16 standards and the frequency of recalls; and 

17 (iv) the considerations described in 

18 clauses (i) through (iii) of paragraph 

19 (2)(B). 

20 (4) FREQUENCY REQUIREMENTS FOR CAT21 EGORIES 2, 3, AND 4.—An alternative inspection fre22 quency for a subcategory of food facilities or a spe23 cific food facility under this subsection shall be— 

24 (A) in the case of a category 2 food facil25 ity, not less frequently than monthly; and 


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1 (B) in the case of a category 3 or 4 food 

2 facility, not less frequently than annually. 

3 (5) REQUIREMENTS FOR DECREASED FRE4 QUENCIES.—Before issuing a regulation or order es5 tablishing a decreased alternative inspection fre6 quency for a subcategory of food facilities or an indi7 vidual food facility under this subsection, the Admin8 istrator shall— 

9 (A) describe, in general terms, the alter10 native uses of resources of the Administration 

11 that would have been required to carry out the 

12 inspection activity; and 

13 (B) determine, based on the best available 

14 evidence, that the alternative uses of the re15 sources would make a greater contribution to 

16 protecting the public health and reducing the 

17 risk of foodborne illness. 

18 (e) INSPECTION TRANSITION.—The Administrator 

19 shall manage the transition to the inspection system de20 scribed in this Act as follows: 

21 (1) REGULATIONS.—The Administrator shall 

22 promulgate regulations to implement this section no 

23 later than 24 months after the date of enactment of 

24 this Act. 


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1 (2) LIMIT ON REDUCTION IN INSPECTION FRE2 QUENCY.—For any food facility, the Administrator 

3 shall not reduce the inspection frequency from the 

4 frequency required pursuant to the Federal Meat In5 spection Act (21 U.S.C. 601 et seq.), the Poultry 

6 Products Inspection Act (21 U.S.C. 451 et seq.), 

7 and the Federal Food, Drug, and Cosmetic Act (21 

8 U.S.C. 301 et seq.) until the food facility has dem9 onstrated that sufficient changes in facilities, proce10 dures, personnel, or other aspects of the process con11 trol system have been made such that the Adminis12 trator determines that compliance with the food 

13 safety law is achieved. 

14 (f) OFFICIAL MARK.— 

15 (1) IN GENERAL.— 

16 (A) ESTABLISHMENT.—Before the comple17 tion of the transition process under subsection 

18 (e), the Administrator shall by regulation estab19 lish an official mark that can be affixed to a 

20 food produced in a category 1, 2, or 3 food fa21 cility if— 

22 (i) the facility is in compliance with 

23 the food safety law; and 


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1 (ii) has been inspected in accordance 

2 with the inspection frequencies under this 

3 section. 

4 (B) REMOVAL OF OFFICIAL MARK.—The 

5 Administrator shall promulgate regulations that 

6 provide for the removal of the official mark 

7 under this subsection if— 

8 (i) the Administrator makes a finding 

9 that the facility is not in compliance with 

10 the food safety law; or 

11 (ii) the Administrator suspends the 

12 registration of the facility. 

13 (2) CATEGORY 1, 2, OR 3 FOOD FACILITIES.— 

14 In the case of products manufactured, slaughtered, 

15 processed, or held in a category 1, 2, or 3 food facil16 ity— 

17 (A) products subject to the Federal Meat 

18 Inspection Act (21 U.S.C. 601 et seq.), the 

19 Poultry Products Inspection Act (21 U.S.C. 

20 451 et seq.), the Egg Products Inspection Act 

21 (21 U.S.C. 1031 et seq.), and the Federal 

22 Food, Drug, and Cosmetic Act (21 U.S.C. 301 

23 et seq.) as of the date of enactment of this Act 

24 shall remain subject to the requirement under 

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1 tion pending completion of the transition proc2 ess under subsection (e); 

3 (B) the Administrator shall publicly certify 

4 on a monthly basis that the inspection fre5 quencies required under this section have been 

6 achieved; and 

7 (C) a product from a facility that has not 

8 been inspected in accordance with the required 

9 frequencies under this section shall not bear the 

10 official mark and shall not be shipped in inter11 state commerce. 

12 (3) CATEGORY 4 AND 5 FOOD FACILITIES.—In 

13 the case of a product manufactured, slaughtered, 

14 processed, or held in a category 4 or 5 food facility, 

15 the Administrator shall provide by regulation for the 

16 voluntary use of the official mark established under 

17 paragraph (1), subject to— 

18 (A) such minimum inspection frequencies 

19 as determined appropriate by the Adminis20 trator; 

21 (B) compliance with applicable perform22 ance standards and other provisions of the food 

23 safety law; and 

24 (C) such other requirements as the Admin25 istrator considers appropriate. 


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1 (g) MAINTENANCE AND INSPECTION OF RECORDS.— 

2 (1) IN GENERAL.— 

3 (A) RECORDS.—A food facility shall— 

4 (i) maintain such records as the Ad5 ministrator requires by regulation, includ6 ing all records relating to the processing, 

7 distributing, receipt, or importation of any 

8 food; and 

9 (ii) permit the Administrator, in addi10 tion to any authority of the food safety 

11 agencies in effect on the day before the 

12 date of enactment of this Act, upon pres13 entation of appropriate credentials and at 

14 reasonable times and in a reasonable man15 ner, to have access to and copy all records 

16 maintained by or on behalf of such food fa17 cility representative in any format (includ18 ing paper or electronic) and at any loca19 tion, that are necessary to assist the Ad20 ministrator to determine whether the food 

21 is contaminated or not in compliance with 

22 the food safety law. 

23 (B) REQUIRED DISCLOSURE.—A food facil24 ity shall have an affirmative obligation to dis25 close to the Administrator the results of testing 


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1 or sampling of food, equipment, or material in 

2 contact with food that is positive for any con3 taminant. 

4 (2) MAINTENANCE OF RECORDS.—The records 

5 required by paragraph (1) shall be maintained for a 

6 reasonable period of time, as determined by the Ad7 ministrator. 

8 (3) REQUIREMENTS.—The records required by 

9 paragraph (1) shall include records describing— 

10 (A) the origin, receipt, delivery, sale, move11 ment, holding, and disposition of food or ingre12 dients; 

13 (B) the identity and quantity of ingredi14 ents used in the food; 

15 (C) the processing of the food; 

16 (D) the results of laboratory, sanitation, or 

17 other tests performed on the food or in the food 

18 facility; 

19 (E) consumer complaints concerning the 

20 food or packaging of the food; 

21 (F) the production codes, open date codes, 

22 and locations of food production; and 

23 (G) other matters reasonably related to 

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1 branded, or otherwise fails to meet the require2 ments of this Act. 

3 (h) PROTECTION OF SENSITIVE INFORMATION.— 

4 (1) IN GENERAL.—The Administrator shall de5 velop and maintain procedures to prevent the unau6 thorized disclosure of any trade secret or confiden7 tial information obtained by the Administrator. 

8 (2) LIMITATION.—The requirement under this 

9 subsection does not— 

10 (A) limit the authority of the Adminis11 trator to inspect or copy records or to require 

12 the facility or maintenance of records under 

13 this Act; 

14 (B) have any legal effect on section 1905 

15 of title 18, United States Code; 

16 (C) extend to any food recipe, financial 

17 data, pricing data, personnel data, or sales data 

18 (other than shipment dates relating to sales); 

19 (D) limit the public disclosure of distribu20 tion records or other records related to food 

21 subject to a voluntary or mandatory recall 

22 under section 402; or 

23 (E) limit the authority of the Adminis24 trator to promulgate regulations to permit the 


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1 sharing of data with other governmental au2 thorities. 

3 (i) BRIBERY OF OR GIFTS TO INSPECTOR OR OTHER

4 OFFICERS AND ACCEPTANCE OF GIFTS.—Section 22 of 

5 the Federal Meat Inspection Act (21 U.S.C. 622) shall 

6 apply under this Act. 

7 SEC. 206. FOOD PRODUCTION ESTABLISHMENTS. 

8 In carrying out the duties of the Administrator and 

9 the purposes of this Act, the Administrator shall have the 

10 authority, with respect to food production establishments, 

11 to— 

12 (1) visit and inspect food production establish13 ments in the United States and in foreign countries 

14 for food safety purposes; 

15 (2) review food safety records as needed to 

16 carry out traceback and for other food safety pur17 poses; 

18 (3) set good practice standards to protect the 

19 public and promote food safety; 

20 (4) partner with appropriate agencies to mon21 itor animals, plants, products, or the environment, 

22 as appropriate; and 

23 (5) collect and maintain information relevant to 

24 public health and farm practices. 


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1 SEC. 207. FEDERAL AND STATE COOPERATION. 

2 (a) IN GENERAL.—The Administrator shall work 

3 with the States to carry out activities and programs that 

4 create a national food safety program so that Federal and 

5 State programs function in a coordinated and cost-effec6 tive manner. 

7 (b) STATE ACTION.—The Administrator shall work 

8 with States to— 

9 (1) continue, strengthen, or establish State food 

10 safety programs, especially with respect to the regu11 lation of retail commercial food establishments, 

12 transportation, harvesting, and fresh markets; 

13 (2) continue, strengthen, or establish inspection 

14 programs and requirements to ensure that food 

15 under the jurisdiction of the State is safe; and 

16 (3) support recall authorities at the State and 

17 local levels. 

18 (c) ASSISTANCE.—To assist in planning, developing, 

19 and implementing a food safety program, the Adminis20 trator may provide to a State— 

21 (1) advisory assistance; 

22 (2) technical and laboratory assistance and 

23 training (including necessary materials and equip24 ment); and 

25 (3) financial assistance, in kind assistance, and 

26 other aid. 


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1 (d) SERVICE AGREEMENTS.— 

2 (1) IN GENERAL.—The Administrator may, 

3 under agreements entered into with Federal, State, 

4 or local agencies, use on a reimbursable basis or oth5 erwise the personnel and services of those agencies 

6 in carrying out this Act. 

7 (2) TRAINING.—Agreements with a State under 

8 this subsection may provide for training of State em9 ployees. 

10 (3) MAINTENANCE OF AGREEMENTS.—The Ad11 ministrator shall maintain any agreement that is in 

12 effect on the day before the date of enactment of 

13 this Act until the Administrator evaluates such 

14 agreement and determines whether to maintain or 

15 substitute such agreement. 

16 (e) AUDITS.— 

17 (1) IN GENERAL.—The Administrator shall an18 nually conduct a comprehensive review of each State 

19 program that provides services to the Administrator 

20 in carrying out the responsibilities under this Act, 

21 including mandated inspections under section 205. 

22 (2) REQUIREMENTS.—The review shall— 

23 (A) include a determination of the effec24 tiveness of the State program; and 


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1 (B) identify any changes necessary to en2 sure enforcement of Federal requirements 

3 under this Act. 

4 (f) NO FEDERAL PREEMPTION.—Nothing in this Act 

5 shall be construed to preempt the enforcement of State 

6 food safety laws and standards that are at least as strin7 gent as those under this Act. 

8 SEC. 208. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

9 (a) IN GENERAL.—The Administrator shall require 

10 that each importer of products from a feed facility, food 

11 facility, or food producer establishment be in compliance 

12 with the foreign supplier verification program require13 ments under section 805 of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 384a). 

15 (b) RULE OF CONSTRUCTION.—In applying sub16 section (a) with respect to products subject to the Federal 

17 Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry 

18 Products Inspection Act (21 U.S.C. 451 et seq.), or the 

19 Egg Products Inspection Act (21 U.S.C. 1031 et seq.), 

20 references in section 805 of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 384a) to sections 402, 403(w), 

22 418, and 419 of such Act (21 U.S.C. 342, 343(w), 350g, 

23 and 350h) shall be construed to be references to the cor24 responding provisions of the food safety law, if any, that 


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1 apply to such products, as determined by the Adminis2 trator. 

3 (c) REPEAL OF EXEMPTIONS.—Section 805 of the 

4 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 384a) 

5 is amended— 

6 (1) in subsection (a)(1), by striking ‘‘sub7 sections (e) and (f)’’ and inserting ‘‘subsection (e)’’; 

8 (2) by striking subsection (e); and 

9 (3) by redesignating subsections (f) and (g) as 

10 subsections (e) and (f), respectively. 

11 SEC. 209. IMPORTS. 

12 (a) IN GENERAL.—Not later than 2 years after the 

13 date of enactment of this Act, the Administrator shall es14 tablish a system under which a foreign government seek15 ing to certify food for importation into the United States 

16 shall submit a request for accreditation to the Adminis17 trator. 

18 (b) ACCREDITATION STANDARD.—A foreign govern19 ment requesting to be accredited to certify food for impor20 tation into the United States shall demonstrate, in a man21 ner determined appropriate by the Administrator, that the 

22 foreign government (or an agency thereof) is capable of 

23 adequately ensuring that eligible entities or foods certified 

24 by such government (or agency) meet the requirements of 

25 the food safety law. 


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1 (c) REQUEST BY FOREIGN GOVERNMENT.—Prior to 

2 granting accreditation to a foreign government under this 

3 section, the Administrator shall review and audit the food 

4 safety program of the requesting foreign government and 

5 certify that such program (including all statutes, regula6 tions, and inspection authority) meets the standard speci7 fied in subsection (b). 

8 (d) LIMITATIONS.—Any accreditation of a foreign 

9 government under this section shall— 

10 (1) specify the foods covered by the accredita11 tion; and 

12 (2) be limited to a period not to exceed 5 years. 

13 (e) WITHDRAWAL OF ACCREDITATION.—The Admin14 istrator may withdraw accreditation fully or partially from 

15 a foreign government if the Administrator finds that— 

16 (1) food covered by the accreditation is linked 

17 to an outbreak of human illness; 

18 (2) the programs or procedures of the foreign 

19 government no longer meet the standards of the food 

20 safety programs and procedures of the United 

21 States; or 

22 (3) the foreign government refuses to allow 

23 United States officials to conduct such audits and 

24 investigations as may be necessary to fulfill the re25 quirements under this section. 


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1 (f) RENEWAL OF ACCREDITATION.—The Adminis2 trator shall audit foreign governments accredited under 

3 this section at least every 5 years to ensure the continued 

4 compliance by such governments with the standard set 

5 forth in subsection (b). 

6 (g) REQUIRED ROUTINE INSPECTION.—The Admin7 istrator shall routinely inspect food or food animals by 

8 physical examination before the food or food animals enter 

9 the United States to ensure that the food or food ani10 mals— 

11 (1) are safe; 

12 (2) are labeled as required for food produced in 

13 the United States; and 

14 (3) otherwise meet the requirements of the food 

15 safety law. 

16 (h) ENFORCEMENT.—The Administrator may— 

17 (1) deny importation of food from any country 

18 if the country’s government does not permit United 

19 States officials to enter the country to conduct such 

20 audits and inspections as may be necessary to fulfill 

21 the requirements under this section; 

22 (2) deny importation of food from any country 

23 or foreign facility that does not consent to an inves24 tigation by the Administrator when food from that 

25 country or foreign facility is linked to a foodborne 


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1 illness outbreak or is otherwise found to be adulter2 ated or mislabeled; and 

3 (3) promulgate regulations to carry out the pur4 poses of this section, including setting terms and 

5 conditions for the destruction of products that fail to 

6 meet the standards of the food safety law. 

7 (i) DETENTION AND SEIZURE.—Any food imported 

8 for consumption in the United States that fails to meet 

9 the standards of the food safety law may be detained, 

10 seized, or condemned. 

11 SEC. 210. TRACEBACK. 

12 (a) IN GENERAL.—The Administrator, in order to 

13 protect the public health, shall establish requirements for 

14 a national system for tracing food, animals, or ingredients 

15 from point of origin to retail sale, subject to subsection 

16 (b). 

17 (b) APPLICABILITY.—Traceability requirements 

18 shall— 

19 (1) be established in accordance with regula20 tions and guidelines issued by the Administrator; 

21 and 

22 (2) apply to food production establishments and 

23 food facilities. 


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1 SEC. 211. FOOD SAFETY TECHNOLOGY. 

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

3 and implement a program, to be known as the Food Safety 

4 Technology Program, to foster innovation in food tech5 nologies and foods that have the potential to improve food 

6 safety at the point of production, processing, transport, 

7 storage, or final preparation. 

8 (b) PROGRAM DESCRIBED.—The program under this 

9 section shall consist of technical guidance to and consulta10 tion with technology developers to assist them in meeting 

11 requirements for approval of technologies and products de12 scribed in subsection (a). 

13 TITLE III—RESEARCH AND 

14 EDUCATION 

15 SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM. 

16 (a) IN GENERAL.—The Administrator, acting in co17 ordination with the Director of the Centers for Disease 

18 Control and Prevention and the Deputy Under Secretary 

19 of Agriculture for Research, Education, and Economics, 

20 shall— 

21 (1) have access to the applicable data systems 

22 of the Centers for Disease Control and Prevention 

23 and to the databases made available by a State; 

24 (2) partner with relevant agencies to maintain 

25 or access an active surveillance system of food and 

26 epidemiological evidence submitted by States to the 


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1 Centers for Disease Control and Prevention based 

2 on a representative proportion of the population of 

3 the United States; 

4 (3) assess the frequency and sources of human 

5 illness in the United States associated with the con6 sumption of food; 

7 (4) partner with relevant agencies to maintain 

8 or access a state-of-the-art partial or full genome se9 quencing system and epidemiological system dedi10 cated to foodborne illness identification, outbreaks, 

11 and containment; and 

12 (5) have access to the surveillance data created 

13 via monitoring and statistical studies conducted as 

14 part of its own inspection. 

15 (b) PUBLIC HEALTH SAMPLING.— 

16 (1) IN GENERAL.—Not later than 1 year after 

17 the date of enactment of this Act, the Administrator 

18 shall establish guidelines for a sampling system 

19 under which the Administrator shall take and ana20 lyze samples of food— 

21 (A) to assist the Administrator in carrying 

22 out this Act; and 

23 (B) to assess the nature, frequency of oc24 currence, and quantities of contaminants in 

25 food. 


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1 (2) REQUIREMENTS.—The sampling system de2 scribed in paragraph (1) shall provide— 

3 (A) statistically valid monitoring, including 

4 market-based studies, on the nature, frequency 

5 of occurrence, and quantities of contaminants 

6 in food available to consumers; and 

7 (B) at the request of the Administrator, 

8 such other information, including analysis of 

9 monitoring and verification samples, as the Ad10 ministrator determines may be useful in assess11 ing the occurrence of contaminants in food. 

12 (c) ASSESSMENT OF HEALTH HAZARDS.—Through 

13 the surveillance system referred to in subsection (a), the 

14 sampling system described in subsection (b), and other 

15 available data, the Administrator shall— 

16 (1) rank food categories based on the hazard to 

17 human health presented by the food category; 

18 (2) identify appropriate industry and regulatory 

19 approaches to minimize hazards in the food supply; 

20 and 

21 (3) assess the public health environment for 

22 emerging diseases, including zoonosis, for their risk 

23 of appearance in the United States food supply. 

24 SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

25 (a) PUBLIC EDUCATION.—The Administrator shall— 


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1 (1) in cooperation with private and public orga2 nizations, including the cooperative extension serv3 ices and building on the efforts of appropriate State 

4 and local entities, establish a national public edu5 cation program on food safety; and 

6 (2) coordinate with other Federal departments 

7 and agencies to integrate food safety messaging into 

8 all food-related agricultural, nutrition, and health 

9 promotion programs. 

10 (b) HEALTH ADVISORIES.—The Administrator, in 

11 consultation with such other Federal departments and 

12 agencies as the Administrator determines necessary, shall 

13 work with the States and other appropriate entities— 

14 (1) to develop and distribute regional and na15 tional advisories concerning food safety; 

16 (2) to develop standardized formats for written 

17 and broadcast advisories; 

18 (3) to incorporate State and local advisories 

19 into the national public education program estab20 lished under subsection (a); and 

21 (4) to present prompt, specific information re22 garding foods found to pose a threat to the public 

23 health. 


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1 SEC. 303. RESEARCH. 

2 (a) IN GENERAL.—The Administrator shall conduct 

3 research to carry out this Act, including studies to— 

4 (1) improve sanitation and food safety practices 

5 in the processing of food; 

6 (2) develop improved techniques to monitor and 

7 inspect food; 

8 (3) develop efficient, rapid, and sensitive meth9 ods to detect contaminants in food; 

10 (4) determine the sources of contamination of 

11 contaminated food; 

12 (5) develop food consumption data; 

13 (6) identify ways that animal production tech14 niques could improve the safety of the food supply; 

15 (7) draw upon research and educational pro16 grams that exist at the State and local level; 

17 (8) determine the food safety education needs 

18 of vulnerable populations, including children less 

19 than 10 years of age, pregnant women, adults 65 

20 years of age and older, and individuals with com21 promised immune systems; 

22 (9) utilize the partial or full genome sequencing 

23 system and other processes to identify and control 

24 pathogens; 

25 (10) address common and emerging zoonotic 

26 diseases; 


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1 (11) develop methods to reduce or destroy 

2 harmful pathogens before, during, and after proc3 essing; 

4 (12) analyze the incidence of antibiotic resist5 ance as it pertains to the food supply and develop 

6 new methods to reduce infection by antibiotic resist7 ant bacteria in humans and animals; and 

8 (13) conduct other research that supports the 

9 purposes of this Act. 

10 (b) CONTRACT AUTHORITY.—The Administrator may 

11 enter into contracts and agreements with any State, insti12 tution of higher education, Federal Government agency, 

13 or person to carry out this section. 

14 TITLE IV—ENFORCEMENT 

15 SEC. 401. PROHIBITED ACTS. 

16 It shall be unlawful— 

17 (1) for a person— 

18 (A) to manufacture, introduce, deliver for 

19 introduction, or receive into interstate com20 merce any food that is adulterated, misbranded, 

21 or otherwise unsafe; 

22 (B) to adulterate or misbrand any food in 

23 interstate commerce; 


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1 (C) to refuse to permit access to a food fa2 cility for the inspection and copying of a record 

3 as required under section 205(g); 

4 (D) to fail to establish or maintain any 

5 record or to make any report as required under 

6 section 205(g); 

7 (E) to refuse to permit entry to or inspec8 tion of a food facility as required under section 

9 205; 

10 (F) to fail to provide to the Administrator 

11 the results of a testing or sampling of a food, 

12 equipment, or material in contact with contami13 nated food under section 205(g)(1)(B); 

14 (G) to fail to comply with an applicable 

15 provision of, or a regulation or order of the Ad16 ministrator under, section 202, 204, or 208; 

17 (H) to slaughter an animal that is capable 

18 for use in whole or in part as human food at 

19 a food facility processing any such food for 

20 commerce, except in compliance with the food 

21 safety law; 

22 (I) to fail to comply with a recall or other 

23 order under section 402; or 

24 (J) to otherwise violate the food safety law; 

25 and 


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1 (2) for a food facility or foreign food facility to 

2 fail to register under section 202, or to operate with3 out a valid registration. 

4 SEC. 402. MANDATORY RECALL AUTHORITY. 

5 (a) VOLUNTARY PROCEDURES.—If the Administrator 

6 determines that there is a reasonable probability that an 

7 article of food (other than infant formula) is adulterated 

8 or misbranded and the use of or exposure to such article 

9 will cause serious adverse health consequences or death 

10 to humans or animals, the Administrator shall provide to 

11 the owner, operator, or agent in charge of the facility that 

12 created, caused, or was otherwise responsible for that arti13 cle of food an opportunity to cease distribution and recall 

14 that article of food in a manner and within a time period 

15 determined by the Administrator. 

16 (b) PREHEARING ORDER TO CEASE DISTRIBUTION

17 AND GIVE NOTICE.— 

18 (1) IN GENERAL.—If the owner, operator, or 

19 agent in charge of a facility refuses to, or does not 

20 voluntarily, cease distribution or recall an article of 

21 food in the manner and within the time period deter22 mined by the Administrator under subsection (a), 

23 the Administrator may by order require, as the Ad24 ministrator determines to be necessary— 

25 (A) that owner, operator, or agent— 


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1 (i) to immediately cease distribution 

2 of that article of food; and 

3 (ii) as applicable, to immediately no4 tify all persons manufacturing, processing, 

5 packing, transporting, distributing, receiv6 ing, holding, or importing and selling that 

7 article of food; and 

8 (B) any person to which that article of 

9 food has been distributed, transported, or sold, 

10 to immediately cease distribution of that article 

11 of food. 

12 (2) REQUIRED ADDITIONAL INFORMATION.— 

13 (A) IN GENERAL.—If an article of food 

14 covered by a recall order issued under para15 graph (1) has been distributed to a warehouse16 based, third-party logistics provider without 

17 providing such provider sufficient information 

18 to know or reasonably determine the precise 

19 identity of the article of food covered by a recall 

20 order that is in its possession, the notice pro21 vided by the owner, operator, or agent of a fa22 cility under paragraph (1)(A)(ii) shall include 

23 such information as is necessary for the ware24 house-based, third-party logistics provider to 

25 identify the article of food. 


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1 (B) RULES OF CONSTRUCTION.—Nothing 

2 in this paragraph shall be construed— 

3 (i) to exempt a warehouse-based, 

4 third-party logistics provider from the re5 quirements of food safety law; or 

6 (ii) to exempt a warehouse-based, 

7 third-party logistics provider from being 

8 the subject of a mandatory recall order. 

9 (3) DETERMINATION TO LIMIT AREAS AF10 FECTED.—If the Administrator requires an owner, 

11 operator, or agent in charge of the facility to cease 

12 distribution under paragraph (1)(A)(i) of an article 

13 of food identified under subsection (a), the Adminis14 trator may limit the size of the geographic area and 

15 the markets affected by such cessation if such limi16 tation would not compromise the public health. 

17 (c) HEARING ON ORDER.—The Administrator shall 

18 provide the owner, operator, or agent in charge of the fa19 cility subject to an order under subsection (b) with an op20 portunity for an informal hearing, to be held as soon as 

21 possible, but not later than 2 days after the issuance of 

22 the order, on the actions required by the order and on 

23 why the article that is the subject of the order should not 

24 be recalled. 


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1 (d) POST-HEARING RECALL ORDER AND MODIFICA2 TION OF ORDER.— 

3 (1) AMENDMENT OF ORDER.—If, after pro4 viding opportunity for an informal hearing under 

5 subsection (c), the Administrator determines that re6 moval of the applicable article of food from com7 merce is necessary, the Administrator shall, as ap8 propriate— 

9 (A) amend the order to require recall of 

10 such article or other appropriate action; 

11 (B) specify a timetable in which the recall 

12 shall occur; 

13 (C) require periodic reports to the Admin14 istrator describing the progress of the recall; 

15 and 

16 (D) provide notice to consumers to whom 

17 such article was, or may have been, distributed. 

18 (2) VACATING OF ORDER.—If, after an informal 

19 hearing under subsection (c), the Administrator de20 termines that adequate grounds do not exist to con21 tinue the actions required by the applicable order, or 

22 that such actions should be modified, the Adminis23 trator shall vacate the order or modify the order, as 

24 appropriate. 


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1 (e) RULE REGARDING ALCOHOLIC BEVERAGES.— 

2 The Administrator shall not initiate a mandatory recall 

3 or take any other action under this section with respect 

4 to any alcohol beverage until the Administrator has pro5 vided the Administrator of the Alcohol and Tobacco Tax 

6 and Trade Bureau with a reasonable opportunity to cease 

7 distribution and recall the alcohol beverage under the au8 thority of the Administrator of the Alcohol and Tobacco 

9 Tax and Trade Bureau. 

10 (f) COOPERATION AND CONSULTATION.—The Ad11 ministrator shall work with State and local public health 

12 officials in carrying out this section, as appropriate. 

13 (g) PUBLIC NOTIFICATION.—In conducting a recall 

14 under this section, the Administrator shall— 

15 (1) ensure that a press release is published re16 garding the recall, as well as alerts and public no17 tices, as appropriate, in order to provide notifica18 tion— 

19 (A) of the recall to consumers and retailers 

20 to whom the applicable article of food was, or 

21 may have been, distributed; and 

22 (B) that includes, at a minimum— 

23 (i) the name of the article of food sub24 ject to the recall; 


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1 (ii) a description of the risk associated 

2 with such article; and 

3 (iii) to the extent practicable, informa4 tion for consumers about similar articles of 

5 food that are not affected by the recall; 

6 (2) provide to the public a list of retail con7 signees receiving products for which there is deter8 mined to be a reasonable probability that eating the 

9 food will cause serious adverse health consequences 

10 or death to humans or animals; and 

11 (3) if available, publish on the internet website 

12 of the Administration an image of the article that is 

13 the subject of the press release described in para14 graph (1). 

15 (h) NO DELEGATION.—The authority conferred by 

16 this section to order a recall or vacate a recall order shall 

17 not be delegated to any officer or employee other than the 

18 Administrator. 

19 (i) EFFECT.—Nothing in this section shall affect the 

20 authority of the Administrator to request or participate 

21 in a voluntary recall, or to issue an order to cease distribu22 tion or to recall under any other provision of the food safe23 ty law or under the Public Health Service Act (42 U.S.C. 

24 201 et seq.). 

25 (j) COORDINATED COMMUNICATION.— 


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1 (1) IN GENERAL.—To assist in carrying out the 

2 requirements of this subsection, the Administrator 

3 shall establish an incident command operation or a 

4 similar operation that will operate not later than 24 

5 hours after the initiation of a mandatory recall or 

6 the recall of an article of food for which the use of, 

7 or exposure to, such article will cause serious ad8 verse health consequences or death to humans or 

9 animals. 

10 (2) REQUIREMENTS.—To reduce the potential 

11 for miscommunication during recalls or regarding in12 vestigations of a foodborne illness outbreak associ13 ated with a food that is subject to a recall, each inci14 dent command operation or similar operation under 

15 paragraph (1) shall use regular staff and resources 

16 of the Administration to— 

17 (A) ensure timely and coordinated commu18 nication within the Administration, including 

19 enhanced communication and coordination be20 tween different agencies and organizations with21 in the Administration; 

22 (B) ensure timely and coordinated commu23 nication from the Administration, including 

24 public statements, throughout the duration of 


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1 the investigation and related foodborne illness 

2 outbreak; 

3 (C) identify a single point of contact within 

4 the Administration for public inquiries regard5 ing any actions by the Administrator related to 

6 a recall; 

7 (D) coordinate with Federal, State, local, 

8 and Tribal authorities, as appropriate, that 

9 have responsibilities related to the recall of a 

10 food or a foodborne illness outbreak associated 

11 with a food that is subject to the recall, includ12 ing notification of the Secretary of Agriculture 

13 and the Secretary of Education in the event 

14 such recalled food is a commodity intended for 

15 use in a child nutrition program (as defined in 

16 section 25(b) of the Richard B. Russell Na17 tional School Lunch Act (42 U.S.C. 1769f(b))); 

18 and 

19 (E) conclude operations at such time as 

20 the Administrator determines appropriate. 

21 (3) MULTIPLE RECALLS.—The Administrator 

22 may establish multiple or concurrent incident com23 mand operations or similar operations in the event 

24 of multiple recalls or foodborne illness outbreaks. 


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1 (4) FEES APPLICABLE TO ALL FACILITIES.— 

2 Fees described in section 743 of the Federal Food, 

3 Drug, and Cosmetic Act (21 U.S.C. 379j–31) for 

4 not complying with a recall order are applicable to 

5 all food facilities under this Act as if— 

6 (A) the term ‘‘responsible party’’ means 

7 ‘‘owner, operator, or agent in charge of the fa8 cility’’; and 

9 (B) references to section 423 of the Fed10 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

11 350l) are references to section 402 of this Act. 

12 SEC. 403. INJUNCTION PROCEEDINGS. 

13 (a) JURISDICTION.—The district courts of the United 

14 States, and the United States courts of the territories and 

15 possessions of the United States, shall have jurisdiction, 

16 for cause shown, to restrain a violation of section 202, 

17 203, 204, 207, or 401 (or a regulation promulgated under 

18 that section). 

19 (b) TRIAL.—In a case in which violation of an injunc20 tion or restraining order issued under this section also 

21 constitutes a violation of the food safety law, trial shall 

22 be by the court or, upon demand of the accused, by a jury. 

23 SEC. 404. CIVIL AND CRIMINAL PENALTIES. 

24 (a) CIVIL SANCTIONS.— 

25 (1) CIVIL PENALTY.— 


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1 (A) IN GENERAL.—Any person that vio2 lates section 401 may be assessed a civil pen3 alty by the Administrator of not more than 

4 $250,000 for each violation. 

5 (B) SEPARATE OFFENSE.—Each violation 

6 described in subparagraph (A) and each day 

7 during which that violation continues shall be 

8 considered a separate offense. 

9 (2) OTHER REQUIREMENTS.— 

10 (A) WRITTEN ORDER.—The civil penalty 

11 described in paragraph (1) shall be assessed by 

12 the Administrator by a written order, which 

13 shall specify the amount of the penalty and the 

14 basis for the penalty under subparagraph (B) 

15 considered by the Administrator. 

16 (B) AMOUNT OF PENALTY.—Subject to 

17 paragraph (1)(A), the amount of the civil pen18 alty shall be determined by the Administrator, 

19 after considering— 

20 (i) the gravity of the violation; 

21 (ii) the degree of culpability of the 

22 person; 

23 (iii) the size and type of the business 

24 of the person; and 


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1 (iv) any history of prior offenses by 

2 the person under the food safety law. 

3 (C) REVIEW OF ORDER.—A written order 

4 under subparagraph (A) may be reviewed only 

5 in accordance with subsection (c). 

6 (b) CRIMINAL SANCTIONS.— 

7 (1) IN GENERAL.—Except as provided in para8 graphs (2) and (3), a person that violates subpara9 graph (A) or (B) of section 401(1) shall be impris10 oned for not more than 1 year, fined not more than 

11 $10,000, or both. 

12 (2) SEVERE VIOLATIONS.—A person that com13 mits a violation described in paragraph (1) after a 

14 conviction of that person under this section has be15 come final, or commits such a violation with the in16 tent to defraud or mislead, shall be imprisoned for 

17 not more than 3 years, fined not more than 

18 $100,000, or both. 

19 (3) EXCEPTION.—No person shall be subject to 

20 the penalties of this subsection— 

21 (A) for having received, proffered, or deliv22 ered in interstate commerce any food, if the re23 ceipt, proffer, or delivery was made in good 

24 faith, unless that person refuses to furnish (on 


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1 request of an officer or employee designated by 

2 the Administrator)— 

3 (i) the name, address, and contact in4 formation of the person from whom that 

5 person purchased or received the food; 

6 (ii) copies of all documents relating to 

7 the person from whom that person pur8 chased or received the food; and 

9 (iii) copies of all documents pertaining 

10 to the delivery of the food to that person; 

11 or 

12 (B) if that person establishes a guaranty 

13 signed by, and containing the name and address 

14 of, the person from whom that person received 

15 in good faith the food, stating that the food is 

16 not adulterated or misbranded within the mean17 ing of this Act. 

18 (c) JUDICIAL REVIEW.— 

19 (1) IN GENERAL.—An order assessing a civil 

20 penalty under subsection (a) shall be a final order 

21 unless the person— 

22 (A) not later than 30 days after the effec23 tive date of the order, files a petition for judi24 cial review of the order in— 


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1 (i) the court of appeals of the United 

2 States for the judicial circuit in which that 

3 person resides or has its principal place of 

4 business; or 

5 (ii) the United States Court of Ap6 peals for the District of Columbia Circuit; 

7 and 

8 (B) simultaneously serves a copy of the pe9 tition by certified mail to the Administrator. 

10 (2) FILING OF RECORD.—Not later than 45 

11 days after the service of a copy of the petition under 

12 paragraph (1)(B), the Administrator shall file in the 

13 court a certified copy of the administrative record 

14 upon which the order was issued. 

15 (3) STANDARD OF REVIEW.—The findings of 

16 the Administrator relating to the order shall be set 

17 aside only if found to be unsupported by substantial 

18 evidence on the record as a whole. 

19 (d) COLLECTION ACTIONS FOR FAILURE TO PAY.— 

20 (1) IN GENERAL.—If any person fails to pay a 

21 civil penalty assessed under subsection (a) after the 

22 order assessing the penalty has become a final order, 

23 or after the court of appeals described in subsection 

24 (c) has entered final judgment in favor of the Ad25 ministrator, the Administrator shall refer the matter 


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1 to the Attorney General, who shall institute in a dis2 trict court of the United States of competent juris3 diction a civil action to recover the amount assessed. 

4 (2) LIMITATION ON REVIEW.—In a civil action 

5 under paragraph (1), the validity and appropriate6 ness of the order of the Administrator assessing the 

7 civil penalty shall not be subject to judicial review. 

8 (e) PENALTIES PAID INTO ACCOUNT.—The Adminis9 trator— 

10 (1) shall deposit penalties collected under this 

11 section in an account in the Treasury; and 

12 (2) may use the funds in the account, without 

13 further appropriation or fiscal year limitation— 

14 (A) to carry out enforcement activities 

15 under food safety law; or 

16 (B) to provide assistance to States to in17 spect retail commercial food establishments or 

18 other food or firms under the jurisdiction of 

19 State food safety programs. 

20 (f) DISCRETION OF THE ADMINISTRATOR TO PROS21 ECUTE.—Nothing in this Act requires the Administrator 

22 to report for prosecution, or for the commencement of an 

23 action, the violation of the food safety law in a case in 

24 which the Administrator finds that the public interest will 


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1 be adequately served by the assessment of a civil penalty 

2 under this section. 

3 (g) REMEDIES NOT EXCLUSIVE.—The remedies pro4 vided in this section may be in addition to, and not exclu5 sive of, other remedies that may be available. 

6 SEC. 405. PRESUMPTION. 

7 In any action to enforce the requirements of the food 

8 safety law, the connection with interstate commerce re9 quired for jurisdiction shall be presumed to exist. 

10 SEC. 406. WHISTLEBLOWER PROTECTION. 

11 Section 1013 of the Federal Food, Drug, and Cos12 metic Act (21 U.S.C. 399d) shall apply with respect to 

13 any violation of, or any act or omission an employee rea14 sonably believes to be a violation of, any provision of this 

15 Act to the same extent and in the same manner as that 

16 section applies with respect to a violation of, or any act 

17 or omission an employee reasonably believes to be a viola18 tion of, any provision of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 301 et seq.). 

20 SEC. 407. ADMINISTRATION AND ENFORCEMENT. 

21 (a) IN GENERAL.—For the efficient administration 

22 and enforcement of the food safety law, the provisions (in23 cluding provisions relating to penalties) of sections 6, 8, 

24 9, and 10 of the Federal Trade Commission Act (15 

25 U.S.C. 46, 48, 49, and 50) (except subsections (c) through 


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1 (h) of section 6 of that Act (15 U.S.C. 46)), relating to 

2 the jurisdiction, powers, and duties of the Federal Trade 

3 Commission and the Attorney General to administer and 

4 enforce that Act, and to the rights and duties of persons 

5 with respect to whom the powers are exercised, shall apply 

6 to the jurisdiction, powers, and duties of the Adminis7 trator and the Attorney General in administering and en8 forcing the provisions of the food safety law and to the 

9 rights and duties of persons with respect to whom the 

10 powers are exercised, respectively. 

11 (b) INQUIRIES AND ACTIONS.— 

12 (1) IN GENERAL.—The Administrator, in per13 son or by such agents as the Administrator may des14 ignate, may prosecute any inquiry necessary to carry 

15 out the duties of the Administrator under the food 

16 safety law in any part of the United States. 

17 (2) POWERS.—The powers conferred by sec18 tions 9 and 10 of the Federal Trade Commission 

19 Act (15 U.S.C. 49, 50) on the United States district 

20 courts may be exercised for the purposes of this 

21 chapter by any district court of the United States of 

22 competent jurisdiction. 

23 SEC. 408. CITIZEN CIVIL ACTIONS. 

24 (a) CIVIL ACTIONS.—A person may commence a civil 

25 action against— 


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1 (1) a person that violates a regulation (includ2 ing a regulation establishing a performance stand3 ard), order, or other action of the Administrator to 

4 ensure the safety of food; or 

5 (2) the Administrator (in his or her capacity as 

6 the Administrator), if the Administrator fails to per7 form an act or duty to ensure the safety of food that 

8 is not discretionary under the food safety law. 

9 (b) COURT.— 

10 (1) IN GENERAL.—The action shall be com11 menced in the district court of the United States for 

12 the judicial district in which the defendant resides, 

13 is found, or has an agent. 

14 (2) JURISDICTION.—The court described in 

15 paragraph (1) shall have jurisdiction, without regard 

16 to the amount in controversy or the citizenship of 

17 the parties, to enforce a regulation (including a reg18 ulation establishing a performance standard), order, 

19 or other action of the Administrator, or to order the 

20 Administrator to perform the act or duty. 

21 (3) DAMAGES.—The court described in para22 graph (1) may— 

23 (A) award damages, in the amount of dam24 ages actually sustained; and 


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1 (B) if the court determines it to be in the 

2 interest of justice, award the plaintiff the costs 

3 of suit, including reasonable attorney’s fees, 

4 reasonable expert witness fees, and penalties. 

5 (c) REMEDIES NOT EXCLUSIVE.—The remedies pro6 vided for in this section shall be in addition to, and not 

7 exclusive of, other remedies that may be available. 

8 TITLE V—IMPLEMENTATION 

9 SEC. 501. DEFINITION. 

10 In this title, the term ‘‘transition period’’ means the 

11 12-month period beginning on the date of enactment of 

12 this Act. 

13 SEC. 502. REORGANIZATION PLAN. 

14 (a) SUBMISSION OF PLAN.—Not later than 180 days 

15 after the date of enactment of this Act, the President shall 

16 transmit to the appropriate congressional committees a re17 organization plan regarding the following: 

18 (1) The transfer of agencies, personnel, assets, 

19 and obligations to the Administration pursuant to 

20 this Act. 

21 (2) Any consolidation, reorganization, or 

22 streamlining of agencies transferred to the Adminis23 tration pursuant to this Act. 

24 (b) PLAN ELEMENTS.—The plan transmitted under 

25 subsection (a) shall contain, consistent with this Act, such 


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1 elements as the President determines appropriate, includ2 ing the following: 

3 (1) Identification of any functions of agencies 

4 designated to be transferred to the Administration 

5 pursuant to this Act that will not be transferred to 

6 the Administration under the plan. 

7 (2) Specification of the steps to be taken by the 

8 Administrator to organize the Administration, in9 cluding the delegation or assignment of functions 

10 transferred to the Administration among the officers 

11 of the Administration in order to permit the Admin12 istration to carry out the functions transferred 

13 under the plan. 

14 (3) Specification of the funds available to each 

15 agency that will be transferred to the Administration 

16 as a result of transfers under the plan. 

17 (4) Specification of the proposed allocations 

18 within the Administration of unexpended funds 

19 transferred in connection with transfers under the 

20 plan. 

21 (5) Specification of any proposed disposition of 

22 property, facilities, contracts, records, and other as23 sets and obligations of agencies transferred under 

24 the plan. 


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1 (6) Specification of the proposed allocations 

2 within the Administration of the functions of the 

3 agencies and subdivisions that are not related di4 rectly to ensuring the safety of food. 

5 (c) MODIFICATION OF PLAN.—The President may, 

6 on the basis of consultations with the appropriate congres7 sional committees, modify or revise any part of the plan 

8 until that part of the plan becomes effective in accordance 

9 with subsection (d). 

10 (d) EFFECTIVE DATE.— 

11 (1) IN GENERAL.—The reorganization plan de12 scribed in this section, including any modifications 

13 or revisions of the plan under subsection (c), shall 

14 become effective for an agency on the earlier of— 

15 (A) the date specified in the plan (or the 

16 plan as modified pursuant to subsection (c)), 

17 except that such date may not be earlier than 

18 90 days after the date the President has trans19 mitted the reorganization plan to the appro20 priate congressional committees pursuant to 

21 subsection (a); or 

22 (B) the end of the transition period. 

23 (2) STATUTORY CONSTRUCTION.—Nothing in 

24 this subsection may be construed to require the 

25 transfer of functions, personnel, records, balances of 


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1 appropriations, or other assets of an agency on a 

2 single date. 

3 (3) SUPERCEDES EXISTING LAW.—Paragraph 

4 (1) shall apply notwithstanding section 905(b) of 

5 title 5, United States Code. 

6 SEC. 503. TRANSITIONAL AUTHORITIES. 

7 (a) PROVISION OF ASSISTANCE BY OFFICIALS.— 

8 Until the transfer of an agency to the Administration, any 

9 official having authority over or function relating to the 

10 agency on the day before the date of enactment of this 

11 Act shall provide the Administrator such assistance, in12 cluding the use of personnel and assets, as the Adminis13 trator may request in preparing for the transfer and inte14 gration of the agency to the Administration. 

15 (b) SERVICES AND PERSONNEL.—During the transi16 tion period, upon the request of the Administrator, the 

17 head of any Executive agency may, on a reimbursable 

18 basis, provide services or detail personnel to assist with 

19 the transition. 

20 (c) ACTING OFFICIALS.— 

21 (1) IN GENERAL.—During the transition pe22 riod, pending the advice and consent of the Senate 

23 to the appointment of an officer required by this Act 

24 to be appointed by and with such advice and con25 sent, the President may designate any officer whose 


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1 appointment was required to be made by and with 

2 such advice and consent and who was such an officer 

3 on the day before the date of enactment of this Act 

4 (and who continues to be in office) or immediately 

5 before such designation, to act in such office until 

6 the same is filled as provided in this Act. 

7 (2) COMPENSATION.—While acting pursuant to 

8 paragraph (1), such officers shall receive compensa9 tion at the higher of— 

10 (A) the rates provided by this Act for the 

11 respective offices in which they act; or 

12 (B) the rates provided for the offices held 

13 at the time of designation. 

14 (3) LIMITATION.—Nothing in this Act shall be 

15 construed to require the advice and consent of the 

16 Senate to the appointment by the President to a po17 sition in the Administration of any officer whose 

18 agency is transferred to the Administration pursuant 

19 to this Act and whose duties following such transfer 

20 are germane to those performed before such trans21 fer. 

22 (d) TRANSFER OF PERSONNEL, ASSETS, OBLIGA23 TIONS, AND FUNCTION.— 

24 (1) IN GENERAL.—Consistent with section 1531 

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1 sets, liabilities, contracts, property, records, and un2 expended balances of appropriations, authorizations, 

3 allocations, and other funds that relate to the func4 tions transferred under subsection (a) from a Fed5 eral agency shall be transferred to the Administra6 tion. 

7 (2) UNEXPENDED FUNDS.—Unexpended funds 

8 transferred under this subsection shall be used by 

9 the Administration only for the purposes for which 

10 the funds were originally authorized and appro11 priated. 

12 SEC. 504. SAVINGS PROVISIONS. 

13 (a) COMPLETED ADMINISTRATIVE ACTIONS.—The 

14 enactment of this Act or the transfer of functions under 

15 this Act shall not affect any order, determination, rule, 

16 regulation, permit, personnel action, agreement, grant, 

17 contract, certificate, license, registration, privilege, or 

18 other administrative action issued, made, granted, or oth19 erwise in effect or final with respect to that agency on 

20 the day before the transfer date with respect to the trans21 ferred functions. 

22 (b) PENDING PROCEEDINGS.—Subject to the author23 ity of the Administrator under this Act— 

24 (1) pending proceedings in an agency, including 

25 notices of proposed rulemaking, and applications for 


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1 licenses, permits, certificates, grants, and financial 

2 assistance, shall continue notwithstanding the enact3 ment of this Act or the transfer of the agency to the 

4 Administration, unless discontinued or modified 

5 under the same terms and conditions and to the 

6 same extent that such discontinuance could have oc7 curred if such enactment or transfer had not oc8 curred; and 

9 (2) orders issued in such proceedings, and ap10 peals from those orders, and payments made pursu11 ant to such orders, shall be issued in the same man12 ner on the same terms as if this Act had not been 

13 enacted or the agency had not been transferred, and 

14 any such order shall continue in effect until amend15 ed, modified, superceded, terminated, set aside, or 

16 revoked by an officer of the United States or a court 

17 of competent jurisdiction, or by operation of law. 

18 (c) PENDING CIVIL ACTIONS.—Subject to the author19 ity of the Administrator under this Act, any civil action 

20 commenced with regard to that agency pending before 

21 that agency on the day before the transfer date with re22 spect to the transferred functions shall continue notwith23 standing the enactment of this Act or the transfer of an 

24 agency to the Administration. 

25 (d) REFERENCES.— 


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1 (1) IN GENERAL.—After the transfer of func2 tions from a Federal agency under this Act, any ref3 erence in any other Federal law, Executive order, 

4 rule, regulation, directive, document, or other mate5 rial to that Federal agency or the head of that agen6 cy in connection with the administration or enforce7 ment of the food safety laws shall be deemed to be 

8 a reference to the Administration or the Adminis9 trator, respectively. 

10 (2) STATUTORY REPORTING REQUIREMENTS.— 

11 Statutory reporting requirements that applied in re12 lation to such an agency on the day before the date 

13 of enactment of this Act shall continue to apply fol14 lowing such transfer if the reporting requirements 

15 refer to the agency by name. 

16 SEC. 505. CONFORMING AMENDMENTS. 

17 Section 5313 of title 5, United States Code, is 

18 amended by adding at the end the following new item: 

19 ‘‘Administrator of Food Safety.’’. 

20 SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING 

21 AMENDMENTS. 

22 Not later than 60 days after the submission of the 

23 reorganization plan under section 502, the President shall 

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1 forming amendments to any food safety law to reflect the 

2 changes made by this Act. 

3 SEC. 507. REGULATIONS. 

4 The Administrator may promulgate such regulations 

5 as the Administrator determines are necessary or appro6 priate to perform the duties of the Administrator. 

7 SEC. 508. AUTHORIZATION OF APPROPRIATIONS. 

8 There are authorized to be appropriated such sums 

9 as are necessary to carry out this Act. 

10 SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIA11 TIONS. 

12 For the fiscal year that includes the date of enact13 ment of this Act, the amount authorized to be appro14 priated to carry out this Act shall not exceed— 

15 (1) the amount appropriated for that fiscal year 

16 for the Federal agencies identified in section 102(b) 

17 for the purpose of administering or enforcing the 

18 food safety law; or 

19 (2) the amount appropriated for those agencies 

20 for that purpose for the preceding fiscal year, if, as 

21 of the date of enactment of this Act, appropriations 

22 for those agencies for the fiscal year that includes 

23 that date of enactment have not yet been made. 

Æ 


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