I 

115TH CONGRESS 

2D SESSION H. R. 7338 

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 improving 

security of food from intentional contamination, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

DECEMBER 19, 2018 

Ms. DELAURO introduced the following bill; which was referred to the Committee on Energy and Commerce, and in addition to the Committee on 

Agriculture, for a period to be subsequently determined by the Speaker, 

in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

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 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, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Safe Food Act of 2018’’. 


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

2 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. 

Sec. 504. Savings provisions. 

Sec. 505. Conforming amendments. 

Sec. 506. Additional technical and conforming amendments. 

Sec. 507. Regulations. 

Sec. 508. Authorization of appropriations. 


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Sec. 509. Limitation on authorization of appropriations. 

Sec. 510. Effective date. 

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; 

23 (B) an aging and immune-compromised 

24 population, with a growing number of people at 


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1 high risk for foodborne illnesses, including in2 fants and children; 

3 (C) a concern regarding food fraud for eco4 nomic gain, especially with mislabeling and in5 tentionally misleading claims; 

6 (D) an increasing volume of imported food, 

7 without adequate monitoring and inspection; 

8 and 

9 (E) maintenance of rigorous inspection of 

10 the domestic food processing and food service 

11 industries; 

12 (5) Federal food safety standard setting, in13 spection, enforcement, and research efforts should be 

14 based on the best available science and public health 

15 considerations and food safety resources should be 

16 systematically deployed in ways that most effectively 

17 prevent foodborne illness; 

18 (6) the Federal food safety system is frag19 mented, with at least 15 Federal agencies sharing 

20 responsibility for food safety, and operates under 

21 laws that do not reflect current conditions in the 

22 food system or current scientific knowledge about 

23 the cause and prevention of foodborne illness; 

24 (7) the fragmented Federal food safety system 

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1 wide approach to preventing foodborne illness, to the 

2 effective and efficient operation of the Nation’s food 

3 safety program, and to the most beneficial deploy4 ment of food safety resources; 

5 (8) the National Academy of Sciences rec6 ommended in the report ‘‘Ensuring Safe Food from 

7 Production to Consumption’’ that Congress establish 

8 by statute a unified and central framework for man9 aging Federal food safety programs, and rec10 ommended modifying Federal statutes so that in11 spection, enforcement, and research efforts are 

12 based on scientifically supportable assessments of 

13 risks to public health; and 

14 (9) the lack of a single focal point for food safe15 ty leadership in the United States undercuts the 

16 ability of the United States to exert food safety lead17 ership internationally, which is detrimental to the 

18 public health and the international trade interests of 

19 the United States. 

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

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

22 the ‘‘Food Safety Administration’’ to— 

23 (A) regulate food safety and related label24 ing to strengthen the protection of the public 

25 health; 


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1 (B) ensure that food facilities fulfill their 

2 responsibility to produce food in a manner that 

3 protects the public health of all people in the 

4 United States; 

5 (C) lead an integrated, systemwide ap6 proach to food safety and to make more effec7 tive and efficient use of resources to prevent 

8 foodborne illness; 

9 (D) provide a single focal point for food 

10 safety leadership, both nationally and inter11 nationally; and 

12 (E) provide an integrated food safety re13 search capability, utilizing internally generated, 

14 scientifically and statistically valid studies, in 

15 cooperation with academic institutions and 

16 other scientific entities of the Federal and State 

17 governments, to achieve the continuous im18 provement of research on foodborne illness and 

19 contaminants; 

20 (2) to transfer to the Food Safety Administra21 tion the food safety, labeling, inspection, and en22 forcement functions that, as of the day before the ef23 fective date of this Act, are performed by other Fed24 eral agencies; and 


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1 (3) to modernize and strengthen the Federal 

2 food safety laws to achieve more effective application 

3 and efficient management of the laws for the protec4 tion and improvement of public health. 

5 SEC. 3. DEFINITIONS. 

6 In this Act: 

7 (1) ADMINISTRATION.—The term ‘‘Administra8 tion’’ means the Food Safety Administration estab9 lished under section 101(a)(1). 

10 (2) ADMINISTRATOR.—The term ‘‘Adminis11 trator’’ means the Administrator of Food Safety ap12 pointed under section 101(a)(3). 

13 (3) ADULTERATED.— 

14 (A) IN GENERAL.—The term ‘‘adulter15 ated’’ has the meaning given such term in— 

16 (i) section 402 of the Federal Food, 

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

18 for food regulated under such Act; 

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

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

21 food regulated under such Act; 

22 (iii) section 4(g) of the Poultry Prod23 ucts Inspection Act (21 U.S.C. 453(g)) for 

24 food regulated under such Act; and 


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

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

3 food regulated under such Act. 

4 (B) INCLUSION.—In applying the defini5 tions cited in subparagraph (A), poisonous or 

6 deleterious substances in food shall be treated 

7 as an added substance if the poisonous or dele8 terious substances are known to cause serious 

9 illness or death in persons, including in sen10 sitive populations. 

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

12 meaning given that term in section 551 of title 5, 

13 United States Code. 

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

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

16 slaughters animals for food. 

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

18 ‘‘category 2 food facility’’ means a facility that proc19 esses— 

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

21 manner that may reduce but is not validated to 

22 destroy contaminants; or 

23 (B) other products that the Administrator 

24 determines by regulation to be at high risk of 

25 contamination. 


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

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

3 (A) that processes meat, poultry, or sea4 food, or other products that the Administrator 

5 determines by regulation to be at high risk of 

6 contamination; and 

7 (B) whose processes include one or more 

8 steps validated to destroy contaminants. 

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

10 ‘‘category 4 food facility’’ means a facility that proc11 esses food but is not a category 1, 2, or 3 food facil12 ity. 

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

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

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

16 retail sale. 

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

18 includes biological, chemical, physical, or radiological 

19 hazards, natural toxins, pesticides, drug residues, 

20 decomposition, parasites, allergens, and unapproved 

21 food or color additives. 

22 (11) CONTAMINATION.—The term ‘‘contamina23 tion’’ refers to a presence of a contaminant in food, 

24 which may occur naturally or be introduced into a 

25 food. 


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

2 means a domestic or foreign feed manufacturer, 

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

4 (A) if operating in the United States, man5 ufactures, slaughters, processes, or holds animal 

6 feed or feed ingredients; or 

7 (B) if operating elsewhere, manufactures, 

8 slaughters, processes, or holds animal feed or 

9 feed ingredients intended for consumption in 

10 the United States. 

11 (13) FOOD.— 

12 (A) IN GENERAL.—The term ‘‘food’’ 

13 means a product intended to be used for food 

14 or drink for a human or an animal. 

15 (B) INCLUSIONS.—The term ‘‘food’’ in16 cludes any product (including a meat food prod17 uct, as defined in section 1(j) of the Federal 

18 Meat Inspection Act (21 U.S.C. 601(j))), capa19 ble for use as human and animal food that is 

20 made in whole or in part from any animal, in21 cluding cattle, sheep, swine, goat, or poultry (as 

22 defined in section 4 of the Poultry Products In23 spection Act (21 U.S.C. 453)), and animal feed. 

24 (14) FOOD FACILITY.— 


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1 (A) IN GENERAL.—The term ‘‘food facil2 ity’’ means a domestic or foreign food manufac3 turer, slaughterhouse, processor, packer, ware4 house, or other facility that— 

5 (i) if operating in the United States, 

6 manufactures, slaughters, processes, or 

7 holds food or food ingredients; or 

8 (ii) if operating outside the United 

9 States, manufactures, slaughters, proc10 esses, or holds food intended for consump11 tion in the United States. 

12 (B) EXCLUSIONS.—For the purposes of 

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

14 include— 

15 (i) a farm, restaurant, other retail 

16 food establishment, nonprofit food estab17 lishment in which food is prepared for or 

18 served directly to the consumer; or 

19 (ii) a fishing vessel (other than a fish20 ing vessel engaged in processing, as that 

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

22 21, Code of Federal Regulations). 

23 (15) FOOD PRODUCTION ESTABLISHMENT.— 

24 The term ‘‘food production establishment’’ means 


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1 any farm, ranch, orchard, vineyard, aquaculture fa2 cility, or confined animal-feeding operation. 

3 (16) FOOD SAFETY LAW.—The term ‘‘food safe4 ty law’’ means— 

5 (A) the provisions of the Federal Food, 

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

7 seq.) related to and requiring the safety, label8 ing, and inspection of food, infant formulas, 

9 food additives, pesticide residues, and other 

10 substances present in food under that Act; 

11 (B) the provisions of the Federal Food, 

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

13 seq.) and of any other Act that are adminis14 tered by the Center for Veterinary Medicine of 

15 the Food and Drug Administration; 

16 (C) the Poultry Products Inspection Act 

17 (21 U.S.C. 451 et seq.); 

18 (D) the Federal Meat Inspection Act (21 

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

20 (E) the FDA Food Safety Modernization 

21 Act (Public Law 111–353); 

22 (F) the Egg Products Inspection Act (21 

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

24 (G) the Sanitary Food Transportation Act 

25 of 1990 (49 U.S.C. App. 2801 et seq.); 


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

2 Code; 

3 (I) Public Law 85–765 (commonly known 

4 as the ‘‘Humane Methods of Slaughter Act of 

5 1958’’) (7 U.S.C. 1901 et seq.); 

6 (J) the provisions of this Act; and 

7 (K) such other provisions of law related to 

8 and requiring food safety, labeling, inspection, 

9 and enforcement as the President designates by 

10 Executive order as appropriate to include within 

11 the jurisdiction of the Administration. 

12 (17) INTERSTATE COMMERCE.—The term 

13 ‘‘interstate commerce’’ has the meaning given that 

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

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

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

17 has the meaning given to it in— 

18 (A) section 403 of the Federal Food, 

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

20 food regulated under such Act; 

21 (B) section 1(n) of the Federal Meat In22 spection Act (21 U.S.C. 601(n)) for food regu23 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 effective 

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1 cer or employee of the Federal agency) that relate to ad2 ministration or enforcement of the food safety law, as de3 termined 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 resources and facilities of the Office of 

21 the Commissioner of the Food and Drug Adminis22 tration, known as the Office of Food and Veterinary 

23 Medicine, that support— 

24 (A) the Center for Food Safety and Ap25 plied Nutrition; 


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1 (B) the Center for Veterinary Medicine; 

2 and 

3 (C) the Office of Regulatory Affairs facili4 ties and resources described in paragraph (4); 

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

6 Economics mission area of the Department of Agri7 culture related to food and feed safety; 

8 (8) the part of the National Marine Fisheries 

9 Service of the National Oceanic and Atmospheric 

10 Administration of the Department of Commerce that 

11 administers the seafood inspection program; 

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

13 Health Service of the Department of Agriculture re14 lated to the management of animals going into the 

15 food supply; and 

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

17 the President designates by Executive order to carry 

18 out this Act. 

19 SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 

20 (a) OFFICERS AND EMPLOYEES.—The Administrator 

21 may— 

22 (1) appoint officers and employees for the Ad23 ministration in accordance with the provisions of 

24 title 5, United States Code, relating to appointment 

25 in the competitive service; and 


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1 (2) fix the compensation of those officers and 

2 employees in accordance with chapter 51 and with 

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

4 classification and General Schedule pay rates. 

5 (b) EXPERTS AND CONSULTANTS.—The Adminis6 trator may— 

7 (1) procure the services of temporary or inter8 mittent experts and consultants as authorized by 

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

10 (2) pay in connection with those services the 

11 travel expenses of the experts and consultants, in12 cluding transportation and per diem in lieu of sub13 sistence while away from the homes or regular 

14 places of business of the individuals, as authorized 

15 by section 5703 of that title. 

16 (c) BUREAUS, OFFICES, AND DIVISIONS.—The Ad17 ministrator may establish within the Administration such 

18 bureaus, offices, and divisions as the Administrator deter19 mines are necessary to perform the duties of the Adminis20 trator. 

21 (d) ADVISORY COMMITTEES.— 

22 (1) IN GENERAL.—The Administrator shall es23 tablish advisory committees that consist of rep24 resentatives of scientific expert bodies, academics, 

25 industry specialists, and consumers. 


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1 (2) DUTIES.—The duties of an advisory com2 mittee established under paragraph (1) may include 

3 developing recommendations with respect to the de4 velopment of regulatory science and processes, re5 search, communications, performance standards, and 

6 inspection. 

7 TITLE II—ADMINISTRATION OF 

8 FOOD SAFETY PROGRAM 

9 SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM. 

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

11 (1) administer a national food safety program 

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

13 protect public health; and 

14 (2) ensure that persons who produce or process 

15 food meet their responsibility to prevent or minimize 

16 food safety hazards related to their products. 

17 (b) COMPREHENSIVE ANALYSIS.—The program shall 

18 be based on a comprehensive analysis of the hazards asso19 ciated with different food and with the processing of dif20 ferent food, including the identification and evaluation 

21 of— 

22 (1) the severity of the health risks; 

23 (2) the sources and specific points of potential 

24 contamination extending from the farm or ranch to 

25 the consumer that may render food unsafe; 


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1 (3) the potential for persistence, multiplication, 

2 or concentration of naturally occurring or added 

3 contaminants in food; 

4 (4) opportunities across the food production, 

5 processing, distribution, and retail system to manage 

6 and reduce potential health risks; and 

7 (5) opportunities for intentional contamination. 

8 (c) PROGRAM ELEMENTS.—In carrying out the pro9 gram, the Administrator shall— 

10 (1) adopt and implement a national system for 

11 the registration of food facilities and regular unan12 nounced inspection of food facilities; 

13 (2) verify and enforce the adoption of preven14 tive process controls in food facilities, based on the 

15 best available scientific and public health consider16 ations and best available technologies; 

17 (3) establish and enforce science-based stand18 ards for— 

19 (A) substances that may contaminate food; 

20 and 

21 (B) safety and sanitation in the processing 

22 and handling of food; 

23 (4) implement a statistically valid sampling pro24 gram to ensure that industry programs and proce25 dures that prevent food contamination are effective 


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1 on an ongoing basis and that food meets the per2 formance standards established under this Act; 

3 (5) implement procedures and requirements to 

4 ensure the safety and security of imported food; 

5 (6) coordinate with other agencies and State or 

6 local governments in carrying out inspection, en7 forcement, research, and monitoring; 

8 (7) access the surveillance data of the Centers 

9 for Disease Control and Prevention, and other Fed10 eral Government agencies, in order to develop and 

11 implement a national surveillance system to assess 

12 the health risks associated with the human consump13 tion of food or to create surveillance data and stud14 ies; 

15 (8) partner with relevant agencies to identify 

16 and prevent terrorist threats to food; 

17 (9) establish a process for providing a single 

18 point of contact to assist impacted consumers in 

19 navigating Federal, State, and local agencies in20 volved in responding to or monitoring a foodborne 

21 outbreak; 

22 (10) develop public education risk communica23 tion and advisory programs; 

24 (11) implement a basic and applied research 

25 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 destroyed or 


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1 reprocessed contaminated carcasses in a man2 ner acceptable to the Administrator; and 

3 (C) that applicable performance standards 

4 and other provisions of the food safety law, in5 cluding those intended to eliminate or reduce 

6 pathogens, 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 With respect to a category 2, 3, 4, or 5 food facility, the 

5 Administrator may establish alternative increased or de6 creased inspection frequencies for subcategories of food fa7 cilities or for individual facilities, to foster risk-based allo8 cation of resources, subject to the following criteria and 

9 procedures: 

10 (1) Subcategories of food facilities and their al11 ternative inspection frequencies shall be defined by 

12 regulation, subject to paragraphs (2) and (3). 

13 (2) Alternative inspection frequencies for sub14 categories of food facilities under paragraph (1) and 

15 for a specific food facility under paragraph (4) shall 

16 provide that— 

17 (A) category 2 food facilities shall be in18 spected at least monthly; and 

19 (B) category 3 and 4 food facilities shall 

20 be inspected at least annually. 

21 (3) In defining subcategories of food facilities 

22 and their alternative inspection frequencies under 

23 paragraphs (1) and (2), the Administrator shall con24 sider— 


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

3 (B) the manner in which foods are proc4 essed, stored, or transported; 

5 (C) the inherent likelihood that the foods 

6 will contribute to the risk of foodborne illness; 

7 (D) the best available evidence concerning 

8 reported illnesses associated with the foods pro9 duced in the proposed subcategory of facilities; 

10 and 

11 (E) the overall record of compliance with 

12 the food safety law among facilities in the pro13 posed subcategory, including compliance with 

14 applicable performance standards and the fre15 quency of recalls. 

16 (4) The Administrator may adopt alternative 

17 inspection frequencies for increased or decreased in18 spection for a specific facility, subject to paragraphs 

19 (2) and (5), and shall annually publish a list of fa20 cilities subject to alternative inspections. 

21 (5) In adopting alternative inspection fre22 quencies for a specific facility, the Administrator 

23 shall consider— 

24 (A) the supporting evidence that an indi25 vidual food facility shall submit related to 


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1 whether an alternative inspection frequency 

2 should be established for such facility by the 

3 Administrator; 

4 (B) whether products from the specific fa5 cility have been associated with a case or an 

6 outbreak of foodborne illness; 

7 (C) the record of the facility of compliance 

8 with the food safety law, including compliance 

9 with applicable performance standards and the 

10 frequency of recalls; and 

11 (D) the criteria in paragraph (3). 

12 (6) Before establishing decreased alternative in13 spection frequencies for subcategories of facilities or 

14 individual facilities, the Administrator shall— 

15 (A) describe the alternative uses of re16 sources in general terms when issuing the regu17 lation or order that establishes the alternative 

18 inspection frequency; and 

19 (B) determine, based on the best available 

20 evidence, that the alternative uses of the re21 sources required to carry out the inspection ac22 tivity would make a greater contribution to pro23 tecting the public health and reducing the risk 

24 of foodborne illness. 


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1 (e) INSPECTION TRANSITION.—The Administrator 

2 shall manage the transition to the inspection system de3 scribed in this Act as follows: 

4 (1) REGULATIONS.—The Administrator shall 

5 promulgate regulations to implement this section no 

6 later than 24 months after the date of enactment of 

7 this Act. 

8 (2) LIMIT ON REDUCTION IN INSPECTION FRE9 QUENCY.—For any food facility, the Administrator 

10 shall not reduce the inspection frequency from the 

11 frequency required pursuant to the Federal Meat In12 spection Act (21 U.S.C. 601 et seq.), the Poultry 

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

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

15 U.S.C. 301 et seq.) until the food facility has dem16 onstrated that sufficient changes in facilities, proce17 dures, personnel, or other aspects of the process con18 trol system have been made such that the Adminis19 trator determines that compliance with the food 

20 safety law is achieved. 

21 (f) OFFICIAL MARK.— 

22 (1) IN GENERAL.— 

23 (A) ESTABLISHMENT.—Before the comple24 tion of the transition process under subsection 

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1 lish an official mark that can be affixed to a 

2 food produced in a category 1, 2, or 3 food fa3 cility if— 

4 (i) the facility is in compliance with 

5 the food safety law; and 

6 (ii) has been inspected in accordance 

7 with the inspection frequencies under this 

8 section. 

9 (B) REMOVAL OF OFFICIAL MARK.—The 

10 Administrator shall promulgate regulations that 

11 provide for the removal of the official mark 

12 under this subsection if— 

13 (i) the Administrator makes a finding 

14 that the facility is not in compliance with 

15 the food safety law; or 

16 (ii) the Administrator suspends the 

17 registration of the facility. 

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

19 In the case of products manufactured, slaughtered, 

20 processed, or held in a category 1, 2, or 3 food facil21 ity— 

22 (A) products subject to Federal Meat In23 spection Act (21 U.S.C. 601 et seq.), the Poul24 try Products Inspection Act (21 U.S.C. 451 et 

25 seq.), the Egg Products Inspection Act (21 


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1 U.S.C. 1031 et seq.), and the Federal Food, 

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

3 seq.) as of the date of enactment of this Act, 

4 shall remain subject to the requirement under 

5 those Acts that they bear the mark of inspec6 tion pending completion of the transition proc7 ess under subsection (e); 

8 (B) the Administrator shall publicly certify 

9 on a monthly basis that the inspection fre10 quencies required under this section have been 

11 achieved; and 

12 (C) a product from an facility that has not 

13 been inspected in accordance with the required 

14 frequencies under this section shall not bear the 

15 official mark and shall not be shipped in inter16 state commerce. 

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

18 the case of a product manufactured, slaughtered, 

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

20 the Administrator shall provide by regulation for the 

21 voluntary use of the official mark established under 

22 paragraph (1), subject to— 

23 (A) such minimum inspection frequencies 

24 as determined appropriate by the Adminis25 trator; 


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1 (B) compliance with applicable perform2 ance standards and other provisions of the food 

3 safety law; and 

4 (C) such other requirements as the Admin5 istrator considers appropriate. 

6 (g) MAINTENANCE AND INSPECTION OF RECORDS.— 

7 (1) IN GENERAL.— 

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

9 (i) maintain such records as the Ad10 ministrator requires by regulation, includ11 ing all records relating to the processing, 

12 distributing, receipt, or importation of any 

13 food; and 

14 (ii) permit the Administrator, in addi15 tion to any authority of the food safety 

16 agencies in effect on the day before the 

17 date of enactment of this Act, upon pres18 entation of appropriate credentials and at 

19 reasonable times and in a reasonable man20 ner, to have access to and copy all records 

21 maintained by or on behalf of such food fa22 cility representative in any format (includ23 ing paper or electronic) and at any loca24 tion, that are necessary to assist the Ad25 ministrator to determine whether the food 


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1 is contaminated or not in compliance with 

2 the food safety law. 

3 (B) REQUIRED DISCLOSURE.—A food facil4 ity shall have an affirmative obligation to dis5 close to the Administrator the results of testing 

6 or sampling of food, equipment, or material in 

7 contact with food, that is positive for any con8 taminant. 

9 (2) MAINTENANCE OF RECORDS.—The records 

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

11 reasonable period of time, as determined by the Ad12 ministrator. 

13 (3) REQUIREMENTS.—The records required by 

14 paragraph (1) shall include records describing— 

15 (A) the origin, receipt, delivery, sale, move16 ment, holding, and disposition of food or ingre17 dients; 

18 (B) the identity and quantity of ingredi19 ents used in the food; 

20 (C) the processing of the food; 

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

22 other tests performed on the food or in the food 

23 facility; 

24 (E) consumer complaints concerning the 

25 food or packaging of the food; 


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

2 and locations of food production; and 

3 (G) other matters reasonably related to 

4 whether food is unsafe, is adulterated or mis5 branded, or otherwise fails to meet the require6 ments of this Act. 

7 (h) PROTECTION OF SENSITIVE INFORMATION.— 

8 (1) IN GENERAL.—The Administrator shall de9 velop and maintain procedures to prevent the unau10 thorized disclosure of any trade secret or confiden11 tial information obtained by the Administrator. 

12 (2) LIMITATION.—The requirement under this 

13 subsection does not— 

14 (A) limit the authority of the Adminis15 trator to inspect or copy records or to require 

16 the facility or maintenance of records under 

17 this Act; 

18 (B) have any legal effect on section 1905 

19 of title 18, United States Code; 

20 (C) extend to any food recipe, financial 

21 data, pricing data, personnel data, or sales data 

22 (other than shipment dates relating to sales); 

23 (D) limit the public disclosure of distribu24 tion records or other records related to food 


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1 subject to a voluntary or mandatory recall 

2 under section 402; or 

3 (E) limit the authority of the Adminis4 trator to promulgate regulations to permit the 

5 sharing of data with other governmental au6 thorities. 

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

8 OFFICERS AND ACCEPTANCE OF GIFTS.—Section 22 of 

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

10 apply under this Act. 

11 SEC. 206. FOOD PRODUCTION ESTABLISHMENTS. 

12 In carrying out the duties of the Administrator and 

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

14 authority, with respect to food production establishments, 

15 to— 

16 (1) visit and inspect food production establish17 ments in the United States and in foreign countries 

18 for food safety purposes; 

19 (2) review food safety records as needed to 

20 carry out traceback and for other food safety pur21 poses; 

22 (3) set good practice standards to protect the 

23 public and promote food safety; 


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1 (4) partner with appropriate agencies to mon2 itor animals, plants, products, or the environment, 

3 as appropriate; and 

4 (5) collect and maintain information relevant to 

5 public health and farm practices. 

6 SEC. 207. FEDERAL AND STATE COOPERATION. 

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

8 with the States to carry out activities and programs that 

9 create a national food safety program so that Federal and 

10 State programs function in a coordinated and cost-effec11 tive manner. 

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

13 with States to— 

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

15 safety programs, especially with respect to the regu16 lation of retail commercial food establishments, 

17 transportation, harvesting, and fresh markets; 

18 (2) continue, strengthen, or establish inspection 

19 programs and requirements to ensure that food 

20 under the jurisdiction of the State is safe; and 

21 (3) support recall authorities at the State and 

22 local levels. 

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

24 and implementing a food safety program, the Adminis25 trator may provide to a State— 


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1 (1) advisory assistance; 

2 (2) technical and laboratory assistance and 

3 training (including necessary materials and equip4 ment); and 

5 (3) financial assistance, in kind, and other aid. 

6 (d) SERVICE AGREEMENTS.— 

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

8 under agreements entered into with Federal, State, 

9 or local agencies, use on a reimbursable basis or oth10 erwise, the personnel and services of those agencies 

11 in carrying out this Act. 

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

13 this subsection may provide for training of State em14 ployees. 

15 (3) MAINTENANCE OF AGREEMENTS.—The Ad16 ministrator shall maintain any agreement that is in 

17 effect on the day before the date of enactment of 

18 this Act until the Administrator evaluates such 

19 agreement and determines whether to maintain or 

20 substitute such agreement. 

21 (e) AUDITS.— 

22 (1) IN GENERAL.—The Administrator shall an23 nually conduct a comprehensive review of each State 

24 program that provides services to the Administrator 


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1 in carrying out the responsibilities under this Act, 

2 including mandated inspections under section 205. 

3 (2) REQUIREMENTS.—The review shall— 

4 (A) include a determination of the effec5 tiveness of the State program; and 

6 (B) identify any changes necessary to en7 sure enforcement of Federal requirements 

8 under this Act. 

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

10 shall be construed to preempt the enforcement of State 

11 food safety laws and standards that are at least as strin12 gent as those under this Act. 

13 SEC. 208. FOREIGN SUPPLIER VERIFICATION PROGRAM. 

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

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

16 facility, or food producer establishment be in compliance 

17 with the foreign supplier verification program require18 ments under section 805 of the Federal Food, Drug, and 

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

20 (b) RULE OF CONSTRUCTION.—In applying sub21 section (a) with respect to products subject to the Federal 

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

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

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

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


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

2 418, and 419 of such Act (21 U.S.C. 342, 343(w), 350g, 

3 and 350h) shall be construed to be references to the cor4 responding provisions of the food safety law, if any, that 

5 apply to such products, as determined by the Adminis6 trator. 

7 (c) REPEAL OF EXEMPTIONS.—Subsection (e) of sec8 tion 805 of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 384a) is hereby repealed. 

10 SEC. 209. IMPORTS. 

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

12 effective date of this Act, the Administrator shall establish 

13 a system under which a foreign government seeking to cer14 tify food for importation into the United States shall sub15 mit a request for accreditation to the Administrator. 

16 (b) ACCREDITATION STANDARD.—A foreign govern17 ment requesting to be accredited to certify food for impor18 tation into the United States shall demonstrate, in a man19 ner determined appropriate by the Administrator, that the 

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

21 adequately ensuring that eligible entities or foods certified 

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

23 the food safety law. 

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

25 granting accreditation to a foreign government under this 


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1 section, the Administrator shall review and audit the food 

2 safety program of the requesting foreign government and 

3 certify that such program (including all statutes, regula4 tions, and inspection authority) meets the standard speci5 fied in subsection (b). 

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

7 government under this section shall— 

8 (1) specify the foods covered by the accredita9 tion; and 

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

11 (e) WITHDRAWAL OF ACCREDITATION.—The Admin12 istrator may withdraw accreditation fully or partially from 

13 a foreign government if the Administrator finds that— 

14 (1) food covered by the accreditation is linked 

15 to an outbreak of human illness; 

16 (2) the programs or procedures of the foreign 

17 government no longer meet the standards of the food 

18 safety programs and procedures of the United 

19 States; or 

20 (3) the foreign government refuses to allow 

21 United States officials to conduct such audits and 

22 investigations as may be necessary to fulfill the re23 quirements under this section. 

24 (f) RENEWAL OF ACCREDITATION.—The Adminis25 trator shall audit foreign governments accredited under 


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

2 compliance by such governments with the standard set 

3 forth in subsection (b). 

4 (g) REQUIRED ROUTINE INSPECTION.—The Admin5 istrator shall routinely inspect food or food animals by 

6 physical examination before the food or food animals enter 

7 the United States to ensure that the food or food ani8 mals— 

9 (1) are safe; 

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

11 the United States; and 

12 (3) otherwise meet the requirements of the food 

13 safety law. 

14 (h) ENFORCEMENT.—The Administrator may— 

15 (1) deny importation of food from any country 

16 if the country’s government does not permit United 

17 States officials to enter the country to conduct such 

18 audits and inspections as may be necessary to fulfill 

19 the requirements under this section; 

20 (2) deny importation of food from any country 

21 or foreign facility that does not consent to an inves22 tigation by the Administrator when food from that 

23 country or foreign facility is linked to a foodborne 

24 illness outbreak or is otherwise found to be adulter25 ated or mislabeled; and 


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1 (3) promulgate regulations to carry out the pur2 poses of this section, including setting terms and 

3 conditions for the destruction of products that fail to 

4 meet the standards of the food safety law. 

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

6 for consumption in the United States that fails to meet 

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

8 seized, or condemned. 

9 SEC. 210. TRACEBACK. 

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

11 protect the public health, shall establish requirements for 

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

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

14 (b). 

15 (b) APPLICABILITY.—Traceability requirements 

16 shall— 

17 (1) be established in accordance with regula18 tions and guidelines issued by the Administrator; 

19 and 

20 (2) apply to food production establishments and 

21 food facilities. 

22 SEC. 211. FOOD SAFETY TECHNOLOGY. 

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

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

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1 nologies and foods that have the potential to improve food 

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

3 storage, or final preparation. 

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

5 section shall consist of technical guidance to and consulta6 tion with technology developers to assist them in meeting 

7 requirements for approval of technologies and products de8 scribed in subsection (a). 

9 TITLE III—RESEARCH AND 

10 EDUCATION 

11 SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM. 

12 (a) IN GENERAL.—The Administrator, acting in co13 ordination with the Director of the Centers for Disease 

14 Control and Prevention and with the Research Education 

15 and Economics mission area of the Department of Agri16 culture, shall— 

17 (1) have access to the applicable data systems 

18 of the Centers for Disease Control and Prevention 

19 and to the databases made available by a State; 

20 (2) partner with relevant agencies to maintain 

21 or access an active surveillance system of food and 

22 epidemiological evidence submitted by States to the 

23 Centers for Disease Control and Prevention based 

24 on a representative proportion of the population of 

25 the United States; 


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1 (3) assess the frequency and sources of human 

2 illness in the United States associated with the con3 sumption of food; 

4 (4) partner with relevant agencies to maintain 

5 or access a state-of-the-art partial or full genome se6 quencing system and epidemiological system dedi7 cated to foodborne illness identification, outbreaks, 

8 and containment; and 

9 (5) have access to the surveillance data created 

10 via monitoring and statistical studies conducted as 

11 part of its own inspection. 

12 (b) PUBLIC HEALTH SAMPLING.— 

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

14 the effective date of this Act, the Administrator shall 

15 establish guidelines for a sampling system under 

16 which the Administrator shall take and analyze sam17 ples of food— 

18 (A) to assist the Administrator in carrying 

19 out this Act; and 

20 (B) to assess the nature, frequency of oc21 currence, and quantities of contaminants in 

22 food. 

23 (2) REQUIREMENTS.—The sampling system de24 scribed in paragraph (1) shall provide— 


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1 (A) statistically valid monitoring, including 

2 market-based studies, on the nature, frequency 

3 of occurrence, and quantities of contaminants 

4 in food available to consumers; and 

5 (B) at the request of the Administrator, 

6 such other information, including analysis of 

7 monitoring and verification samples, as the Ad8 ministrator determines may be useful in assess9 ing the occurrence of contaminants in food. 

10 (c) ASSESSMENT OF HEALTH HAZARDS.—Through 

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

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

13 available data, the Administrator shall— 

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

15 human health presented by the food category; 

16 (2) identify appropriate industry and regulatory 

17 approaches to minimize hazards in the food supply; 

18 and 

19 (3) assess the public health environment for 

20 emerging diseases, including zoonosis, for their risk 

21 of appearance in the United States food supply. 

22 SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

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

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1 ices and building on the efforts of appropriate State 

2 and local entities, establish a national public edu3 cation program on food safety; and 

4 (2) coordinate with other Federal departments 

5 and agencies to integrate food safety messaging into 

6 all food-related agricultural, nutrition, and health 

7 promotion programs. 

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

9 consultation with such other Federal departments and 

10 agencies as the Administrator determines necessary, shall 

11 work with the States and other appropriate entities— 

12 (1) to develop and distribute regional and na13 tional advisories concerning food safety; 

14 (2) to develop standardized formats for written 

15 and broadcast advisories; 

16 (3) to incorporate State and local advisories 

17 into the national public education program estab18 lished under subsection (a); and 

19 (4) to present prompt, specific information re20 garding foods found to pose a threat to the public 

21 health. 

22 SEC. 303. RESEARCH. 

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

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


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1 (1) improve sanitation and food safety practices 

2 in the processing of food; 

3 (2) develop improved techniques to monitor and 

4 inspect food; 

5 (3) develop efficient, rapid, and sensitive meth6 ods to detect contaminants in food; 

7 (4) determine the sources of contamination of 

8 contaminated food; 

9 (5) develop food consumption data; 

10 (6) identify ways that animal production tech11 niques could improve the safety of the food supply; 

12 (7) draw upon research and educational pro13 grams that exist at the State and local level; 

14 (8) determine the food safety education needs 

15 of vulnerable populations, including children less 

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

17 years of age and older, and individuals with com18 promised immune systems; 

19 (9) utilize the partial or full genome sequencing 

20 system and other processes to identify and control 

21 pathogens; 

22 (10) address common and emerging zoonotic 

23 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, uni12 versity, Federal Government agency, or person to carry 

13 out this section. 

14 TITLE IV—ENFORCEMENT 

15 SEC. 401. PROHIBITED ACTS. 

16 It is prohibited— 

17 (1) to manufacture, introduce, deliver for intro18 duction, or receive into interstate commerce any food 

19 that is adulterated, misbranded, or otherwise unsafe; 

20 (2) to adulterate or misbrand any food in inter21 state commerce; 

22 (3) for a food facility or foreign food facility to 

23 fail to register under section 202, or to operate with24 out a valid registration; 


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1 (4) to refuse to permit access to a food facility 

2 for the inspection and copying of a record as re3 quired under section 205(g); 

4 (5) to fail to establish or maintain any record 

5 or to make any report as required under section 

6 205(g); 

7 (6) to refuse to permit entry to or inspection of 

8 a food facility as required under section 205; 

9 (7) to fail to provide to the Administrator the 

10 results of a testing or sampling of a food, equip11 ment, or material in contact with contaminated food 

12 under section 205(g)(1)(B); 

13 (8) to fail to comply with an applicable provi14 sion of, or a regulation or order of the Administrator 

15 under, section 202, 204, or 208; 

16 (9) to slaughter an animal that is capable for 

17 use in whole or in part as human food at a food fa18 cility processing any such food for commerce, except 

19 in compliance with the food safety law; 

20 (10) to fail to comply with a recall or other 

21 order under section 402; or 

22 (11) to otherwise violate the food safety law. 

23 SEC. 402. MANDATORY RECALL AUTHORITY. 

24 (a) VOLUNTARY PROCEDURES.—If the Administrator 

25 determines that there is a reasonable probability that an 


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

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

3 will cause serious adverse health consequences or death 

4 to humans or animals, the Administrator shall provide the 

5 owner, operator, or agent in charge of the facility that cre6 ated, caused, or was otherwise responsible for such food 

7 with an opportunity to cease distribution and recall such 

8 article. 

9 (b) PREHEARING ORDER TO CEASE DISTRIBUTION

10 AND GIVE NOTICE.— 

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

12 agent in charge of the facility refuses to or does not 

13 voluntarily cease distribution or recall such article 

14 within the time and in the manner prescribed by the 

15 Administrator (if so prescribed), the Administrator 

16 may by order require, as the Administrator deems 

17 necessary, such person to— 

18 (A) immediately cease distribution of such 

19 article; 

20 (B) as applicable, immediately notify all 

21 persons manufacturing, processing, packing, 

22 transporting, distributing, receiving, holding, or 

23 importing and selling such article; and 


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1 (C) to which such article has been distrib2 uted, transported, or sold, immediately cease 

3 distribution of such article. 

4 (2) REQUIRED ADDITIONAL INFORMATION.— 

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

6 covered by a recall order issued under para7 graph (1)(B) has been distributed to a ware8 house-based, third-party logistics provider with9 out providing such provider sufficient informa10 tion to know or reasonably determine the pre11 cise identity of the article of food covered by a 

12 recall order that is in its possession, the notice 

13 provided by the responsible party subject to the 

14 order issued under paragraph (1)(B) shall in15 clude such information as is necessary for the 

16 warehouse-based, third-party logistics provider 

17 to identify the food. 

18 (B) RULES OF CONSTRUCTION.—Nothing 

19 in this paragraph shall be construed— 

20 (i) to exempt a warehouse-based, 

21 third-party logistics provider from the re22 quirements of food safety law; or 

23 (ii) to exempt a warehouse-based, 

24 third-party logistics provider from being 

25 the subject of a mandatory recall order. 


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1 (3) DETERMINATION TO LIMIT AREAS AF2 FECTED.—If the Administrator requires an owner, 

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

4 distribution under paragraph (1)(A) of an article of 

5 food identified in subsection (a), the Administrator 

6 may limit the size of the geographic area and the 

7 markets affected by such cessation if such limitation 

8 would not compromise the public health. 

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

10 provide the owner, operator, or agent in charge of the fa11 cility subject to an order under subsection (b) with an op12 portunity for an informal hearing, to be held as soon as 

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

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

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

16 be recalled. 

17 (d) POST-HEARING RECALL ORDER AND MODIFICA18 TION OF ORDER.— 

19 (1) AMENDMENT OF ORDER.—If, after pro20 viding opportunity for an informal hearing under 

21 subsection (c), the Administrator determines that re22 moval of the article from commerce is necessary, the 

23 Administrator shall, as appropriate— 

24 (A) amend the order to require recall of 

25 such article or other appropriate action; 


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1 (B) specify a timetable in which the recall 

2 shall occur; 

3 (C) require periodic reports to the Admin4 istrator describing the progress of the recall; 

5 and 

6 (D) provide notice to consumers to whom 

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

8 (2) VACATING OF ORDER.—If, after such hear9 ing, the Administrator determines that adequate 

10 grounds do not exist to continue the actions required 

11 by the order, or that such actions should be modi12 fied, the Administrator shall vacate the order or 

13 modify the order. 

14 (e) RULE REGARDING ALCOHOLIC BEVERAGES.— 

15 The Administrator shall not initiate a mandatory recall 

16 or take any other action under this section with respect 

17 to any alcohol beverage until the Administrator has pro18 vided the Alcohol and Tobacco Tax and Trade Bureau 

19 with a reasonable opportunity to cease distribution and re20 call such article under the Alcohol and Tobacco Tax and 

21 Trade Bureau’s authority. 

22 (f) COOPERATION AND CONSULTATION.—The Ad23 ministrator shall work with State and local public health 

24 officials in carrying out this section, as appropriate. 


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

2 under this section, the Administrator shall— 

3 (1) ensure that a press release is published re4 garding the recall, as well as alerts and public no5 tices, as appropriate, in order to provide notifica6 tion— 

7 (A) of the recall to consumers and retailers 

8 to whom such article was, or may have been, 

9 distributed; and 

10 (B) that includes, at a minimum— 

11 (i) the name of the article of food sub12 ject to the recall; 

13 (ii) a description of the risk associated 

14 with such article; and 

15 (iii) to the extent practicable, informa16 tion for consumers about similar articles of 

17 food that are not affected by the recall; 

18 (2) provide to the public a list of retail con19 signees receiving products for which there is deter20 mined to be a reasonable probability that eating the 

21 food will cause serious adverse health consequences 

22 or death to humans or animals; and 

23 (3) if available, publish on the Internet website 

24 of the Administration an image of the article that is 


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1 the subject of the press release described in para2 graph (1). 

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

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

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

6 Administrator. 

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

8 authority of the Administrator to request or participate 

9 in a voluntary recall, or to issue an order to cease distribu10 tion or to recall under any other provision of the food safe11 ty law or under the Public Health Service Act (42 U.S.C. 

12 201 et seq.). 

13 (j) COORDINATED COMMUNICATION.— 

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

15 requirements of this subsection, the Administrator 

16 shall establish an incident command operation or a 

17 similar operation that will operate not later than 24 

18 hours after the initiation of a mandatory recall or 

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

20 or exposure to, such article will cause serious ad21 verse health consequences or death to humans or 

22 animals. 

23 (2) REQUIREMENTS.—To reduce the potential 

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1 ated with a food that is subject to a recall, each inci2 dent command operation or similar operation under 

3 paragraph (1) shall use regular staff and resources 

4 of the Administration to— 

5 (A) ensure timely and coordinated commu6 nication within the Administration, including 

7 enhanced communication and coordination be8 tween different agencies and organizations with9 in the Administration; 

10 (B) ensure timely and coordinated commu11 nication from the Administration, including 

12 public statements, throughout the duration of 

13 the investigation and related foodborne illness 

14 outbreak; 

15 (C) identify a single point of contact within 

16 the Administration for public inquiries regard17 ing any actions by the Administrator related to 

18 a recall; 

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

20 and tribal authorities, as appropriate, that have 

21 responsibilities related to the recall of a food or 

22 a foodborne illness outbreak associated with a 

23 food that is subject to the recall, including noti24 fication of the Secretary of Agriculture and the 

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1 called food is a commodity intended for use in 

2 a child nutrition program (as defined in section 

3 25(b) of the Richard B. Russell National School 

4 Lunch Act (42 U.S.C. 1769f(b))); and 

5 (E) conclude operations at such time as 

6 the Administrator determines appropriate. 

7 (3) MULTIPLE RECALLS.—The Administrator 

8 may establish multiple or concurrent incident com9 mand operations or similar operations in the event 

10 of multiple recalls or foodborne illness outbreaks. 

11 (4) FEES APPLICABLE TO ALL FACILITIES.— 

12 Fees described in section 743 of Federal Food, 

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

14 not complying with a recall order are applicable to 

15 all food facilities under this Act as if— 

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

17 ‘‘owner, operator, or agent in charge of the fa18 cility’’; and 

19 (B) references to section 423 of the Fed20 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

21 350l) are references to section 402 of this Act. 

22 SEC. 403. INJUNCTION PROCEEDINGS. 

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

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

25 possessions of the United States, shall have jurisdiction, 


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

2 203, 204, 207, or 401 (or a regulation promulgated under 

3 that section). 

4 (b) TRIAL.—In a case in which violation of an injunc5 tion or restraining order issued under this section also 

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

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

8 SEC. 404. CIVIL AND CRIMINAL PENALTIES. 

9 (a) CIVIL SANCTIONS.— 

10 (1) CIVIL PENALTY.— 

11 (A) IN GENERAL.—Any person that com12 mits an act that violates the food safety law 

13 may be assessed a civil penalty by the Adminis14 trator of not more than $10,000 for each such 

15 act. 

16 (B) SEPARATE OFFENSE.—Each act de17 scribed in subparagraph (A) and each day dur18 ing which that act continues shall be considered 

19 a separate offense. 

20 (2) OTHER REQUIREMENTS.— 

21 (A) WRITTEN ORDER.—The civil penalty 

22 described in paragraph (1) shall be assessed by 

23 the Administrator by a written order, which 

24 shall specify the amount of the penalty and the 


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1 basis for the penalty under subparagraph (B) 

2 considered by the Administrator. 

3 (B) AMOUNT OF PENALTY.—Subject to 

4 paragraph (1)(A), the amount of the civil pen5 alty shall be determined by the Administrator, 

6 after considering— 

7 (i) the gravity of the violation; 

8 (ii) the degree of culpability of the 

9 person; 

10 (iii) the size and type of the business 

11 of the person; and 

12 (iv) any history of prior offenses by 

13 the person under the food safety law. 

14 (C) REVIEW OF ORDER.—The order may 

15 be reviewed only in accordance with subsection 

16 (c). 

17 (b) CRIMINAL SANCTIONS.— 

18 (1) IN GENERAL.—Except as provided in para19 graphs (2) and (3), a person that knowingly pro20 duces or introduces into commerce food that is un21 safe or otherwise adulterated or misbranded shall be 

22 imprisoned for not more than 1 year or fined not 

23 more than $10,000, or both. 

24 (2) SEVERE VIOLATIONS.—A person that com25 mits a violation described in paragraph (1) after a 


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1 conviction of that person under this section has be2 come final, or commits such a violation with the in3 tent to defraud or mislead, shall be imprisoned for 

4 not more than 3 years or fined not more than 

5 $100,000, or both. 

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

7 the penalties of this subsection— 

8 (A) for having received, proffered, or deliv9 ered in interstate commerce any food, if the re10 ceipt, proffer, or delivery was made in good 

11 faith, unless that person refuses to furnish (on 

12 request of an officer or employee designated by 

13 the Administrator)— 

14 (i) the name, address, and contact in15 formation of the person from whom that 

16 person purchased or received the food; 

17 (ii) copies of all documents relating to 

18 the person from whom that person pur19 chased or received the food; and 

20 (iii) copies of all documents pertaining 

21 to the delivery of the food to that person; 

22 or 

23 (B) if that person establishes a guaranty 

24 signed by, and containing the name and address 

25 of, the person from whom that person received 


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

2 not adulterated or misbranded within the mean3 ing of this Act. 

4 (c) JUDICIAL REVIEW.— 

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

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

7 unless the person— 

8 (A) not later than 30 days after the effec9 tive date of the order, files a petition for judi10 cial review of the order in the United States 

11 court of appeals for the circuit in which that 

12 person resides or has its principal place of busi13 ness or the United States Court of Appeals for 

14 the District of Columbia; and 

15 (B) simultaneously serves a copy of the pe16 tition by certified mail to the Administrator. 

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

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

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

20 court a certified copy of the administrative record 

21 upon which the order was issued. 

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

23 the Administrator relating to the order shall be set 

24 aside only if found to be unsupported by substantial 

25 evidence on the record as a whole. 


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

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

3 civil penalty assessed under subsection (a) after the 

4 order assessing the penalty has become a final order, 

5 or after the court of appeals described in subsection 

6 (b) has entered final judgment in favor of the Ad7 ministrator, the Administrator shall refer the matter 

8 to the Attorney General, who shall institute in a 

9 United States district court of competent jurisdic10 tion a civil action to recover the amount assessed. 

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

12 under paragraph (1), the validity and appropriate13 ness of the order of the Administrator assessing the 

14 civil penalty shall not be subject to judicial review. 

15 (e) PENALTIES PAID INTO ACCOUNT.—The Adminis16 trator— 

17 (1) shall deposit penalties collected under this 

18 section in an account in the Treasury; and 

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

20 further appropriation or fiscal year limitation— 

21 (A) to carry out enforcement activities 

22 under food safety law; or 

23 (B) to provide assistance to States to in24 spect retail commercial food establishments or 


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1 other food or firms under the jurisdiction of 

2 State food safety programs. 

3 (f) DISCRETION OF THE ADMINISTRATOR TO PROS4 ECUTE.—Nothing in this Act requires the Administrator 

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

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

7 which the Administrator finds that the public interest will 

8 be adequately served by the assessment of a civil penalty 

9 under this section. 

10 (g) REMEDIES NOT EXCLUSIVE.—The remedies pro11 vided in this section may be in addition to, and not exclu12 sive of, other remedies that may be available. 

13 SEC. 405. PRESUMPTION. 

14 In any action to enforce the requirements of the food 

15 safety law, the connection with interstate commerce re16 quired for jurisdiction shall be presumed to exist. 

17 SEC. 406. WHISTLEBLOWER PROTECTION. 

18 Section 1012 of the Federal Food, Drug, and Cos19 metic Act (21 U.S.C. 399d) shall apply with respect to 

20 any violation of, or any act or omission an employee rea21 sonably believes to be a violation of, any provision of this 

22 Act to the same extent and in the same manner as such 

23 section 1012 applies with respect to a violation of, or any 

24 act or omission an employee reasonably believes to be a 


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1 violation of, any provision of the Federal Food, Drug, and 

2 Cosmetic Act (21 U.S.C. 301 et seq.). 

3 SEC. 407. ADMINISTRATION AND ENFORCEMENT. 

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

5 and enforcement of the food safety law, the provisions (in6 cluding provisions relating to penalties) of sections 6, 8, 

7 9, and 10 of the Federal Trade Commission Act (15 

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

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

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

11 Commission and the Attorney General to administer and 

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

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

14 to the jurisdiction, powers, and duties of the Adminis15 trator and the Attorney General in administering and en16 forcing the provisions of the food safety law and to the 

17 rights and duties of persons with respect to whom the 

18 powers are exercised, respectively. 

19 (b) INQUIRIES AND ACTIONS.— 

20 (1) IN GENERAL.—The Administrator, in per21 son or by such agents as the Administrator may des22 ignate, may prosecute any inquiry necessary to carry 

23 out the duties of the Administrator under the food 

24 safety law in any part of the United States. 


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1 (2) POWERS.—The powers conferred by sec2 tions 9 and 10 of the Federal Trade Commission 

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

4 courts may be exercised for the purposes of this 

5 chapter by any United States district court of com6 petent jurisdiction. 

7 SEC. 408. CITIZEN CIVIL ACTIONS. 

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

9 action against— 

10 (1) a person that violates a regulation (includ11 ing a regulation establishing a performance stand12 ard), order, or other action of the Administrator to 

13 ensure the safety of food; or 

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

15 the Administrator), if the Administrator fails to per16 form an act or duty to ensure the safety of food that 

17 is not discretionary under the food safety law. 

18 (b) COURT.— 

19 (1) IN GENERAL.—The action shall be com20 menced in the United States district court for the 

21 district in which the defendant resides, is found, or 

22 has an agent. 

23 (2) JURISDICTION.—The court shall have juris24 diction, without regard to the amount in controversy 

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1 tion (including a regulation establishing a perform2 ance standard), order, or other action of the Admin3 istrator, or to order the Administrator to perform 

4 the act or duty. 

5 (3) DAMAGES.—The court may— 

6 (A) award damages, in the amount of dam7 ages actually sustained; and 

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

9 interest of justice, award the plaintiff the costs 

10 of suit, including reasonable attorney’s fees, 

11 reasonable expert witness fees, and penalties. 

12 (c) REMEDIES NOT EXCLUSIVE.—The remedies pro13 vided for in this section shall be in addition to, and not 

14 exclusive of, other remedies that may be available. 

15 TITLE V—IMPLEMENTATION 

16 SEC. 501. DEFINITION. 

17 For purposes of this title, the term ‘‘transition pe18 riod’’ means the 12-month period beginning on the effec19 tive date of this Act. 

20 SEC. 502. REORGANIZATION PLAN. 

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

22 after the effective date of this Act, the President shall 

23 transmit to the appropriate congressional committees a re24 organization plan regarding the following: 


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

2 and obligations to the Administration pursuant to 

3 this Act. 

4 (2) Any consolidation, reorganization, or 

5 streamlining of agencies transferred to the Adminis6 tration pursuant to this Act. 

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

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

9 elements as the President determines appropriate, includ10 ing the following: 

11 (1) Identification of any functions of agencies 

12 designated to be transferred to the Administration 

13 pursuant to this Act that will not be transferred to 

14 the Administration under the plan. 

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

16 Administrator to organize the Administration, in17 cluding the delegation or assignment of functions 

18 transferred to the Administration among the officers 

19 of the Administration in order to permit the Admin20 istration to carry out the functions transferred 

21 under the plan. 

22 (3) Specification of the funds available to each 

23 agency that will be transferred to the Administration 

24 as a result of transfers under the plan. 


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1 (4) Specification of the proposed allocations 

2 within the Administration of unexpended funds 

3 transferred in connection with transfers under the 

4 plan. 

5 (5) Specification of any proposed disposition of 

6 property, facilities, contracts, records, and other as7 sets and obligations of agencies transferred under 

8 the plan. 

9 (6) Specification of the proposed allocations 

10 within the Administration of the functions of the 

11 agencies and subdivisions that are not related di12 rectly to ensuring the safety of food. 

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

14 on the basis of consultations with the appropriate congres15 sional committees, modify or revise any part of the plan 

16 until that part of the plan becomes effective in accordance 

17 with subsection (d). 

18 (d) EFFECTIVE DATE.— 

19 (1) IN GENERAL.—The reorganization plan de20 scribed in this section, including any modifications 

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

22 become effective for an agency on the earlier of— 

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

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

25 except that such date may not be earlier than 


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1 90 days after the date the President has trans2 mitted the reorganization plan to the appro3 priate congressional committees pursuant to 

4 subsection (a); or 

5 (B) the end of the transition period. 

6 (2) STATUTORY CONSTRUCTION.—Nothing in 

7 this subsection may be construed to require the 

8 transfer of functions, personnel, records, balances of 

9 appropriations, or other assets of an agency on a 

10 single date. 

11 (3) SUPERCEDES EXISTING LAW.—Paragraph 

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

13 title 5, United States Code. 

14 SEC. 503. TRANSITIONAL AUTHORITIES. 

15 (a) PROVISION OF ASSISTANCE BY OFFICIALS.— 

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

17 official having authority over or function relating to the 

18 agency immediately before the effective date of this Act 

19 shall provide the Administrator such assistance, including 

20 the use of personnel and assets, as the Administrator may 

21 request in preparing for the transfer and integration of 

22 the agency to the Administration. 

23 (b) SERVICES AND PERSONNEL.—During the transi24 tion period, upon the request of the Administrator, the 

25 head of any Executive agency may, on a reimbursable 


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1 basis, provide services or detail personnel to assist with 

2 the transition. 

3 (c) ACTING OFFICIALS.— 

4 (1) IN GENERAL.—During the transition pe5 riod, pending the advice and consent of the Senate 

6 to the appointment of an officer required by this Act 

7 to be appointed by and with such advice and con8 sent, the President may designate any officer whose 

9 appointment was required to be made by and with 

10 such advice and consent and who was such an officer 

11 immediately before the effective date of this Act 

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

13 before such designation, to act in such office until 

14 the same is filled as provided in this Act. 

15 (2) COMPENSATION.—While acting pursuant to 

16 paragraph (1), such officers shall receive compensa17 tion at the higher of— 

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

19 respective offices in which they act; or 

20 (B) the rates provided for the offices held 

21 at the time of designation. 

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

23 construed to require the advice and consent of the 

24 Senate to the appointment by the President to a po25 sition in the Administration of any officer whose 


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1 agency is transferred to the Administration pursuant 

2 to this Act and whose duties following such transfer 

3 are germane to those performed before such trans4 fer. 

5 (d) TRANSFER OF PERSONNEL, ASSETS, OBLIGA6 TIONS, AND FUNCTION.— 

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

8 of title 31, United States Code, the personnel, as9 sets, liabilities, contracts, property, records, and un10 expended balances of appropriations, authorizations, 

11 allocations, and other funds that relate to the func12 tions transferred under subsection (a) from a Fed13 eral agency shall be transferred to the Administra14 tion. 

15 (2) UNEXPENDED FUNDS.—Unexpended funds 

16 transferred under this subsection shall be used by 

17 the Administration only for the purposes for which 

18 the funds were originally authorized and appro19 priated. 

20 SEC. 504. SAVINGS PROVISIONS. 

21 (a) COMPLETED ADMINISTRATIVE ACTIONS.—The 

22 enactment of this Act or the transfer of functions under 

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

24 regulation, permit, personnel action, agreement, grant, 

25 contract, certificate, license, registration, privilege, or 


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1 other administrative action issued, made, granted, or oth2 erwise in effect or final with respect to that agency on 

3 the day before the transfer date with respect to the trans4 ferred functions. 

5 (b) PENDING PROCEEDINGS.—Subject to the author6 ity of the Administrator under this Act— 

7 (1) pending proceedings in an agency, including 

8 notices of proposed rulemaking, and applications for 

9 licenses, permits, certificates, grants, and financial 

10 assistance, shall continue notwithstanding the enact11 ment of this Act or the transfer of the agency to the 

12 Administration, unless discontinued or modified 

13 under the same terms and conditions and to the 

14 same extent that such discontinuance could have oc15 curred if such enactment or transfer had not oc16 curred; and 

17 (2) orders issued in such proceedings, and ap18 peals from those orders, and payments made pursu19 ant to such orders, shall be issued in the same man20 ner on the same terms as if this Act had not been 

21 enacted or the agency had not been transferred, and 

22 any such order shall continue in effect until amend23 ed, modified, superceded, terminated, set aside, or 

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

25 of competent jurisdiction, or by operation of law. 


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1 (c) PENDING CIVIL ACTIONS.—Subject to the author2 ity of the Administrator under this Act, any civil action 

3 commenced with regard to that agency pending before 

4 that agency on the day before the transfer date with re5 spect to the transferred functions shall continue notwith6 standing the enactment of this Act or the transfer of an 

7 agency to the Administration. 

8 (d) REFERENCES.— 

9 (1) IN GENERAL.—After the transfer of func10 tions from a Federal agency under this Act, any ref11 erence in any other Federal law, Executive order, 

12 rule, regulation, directive, document, or other mate13 rial to that Federal agency or the head of that agen14 cy in connection with the administration or enforce15 ment of the food safety laws shall be deemed to be 

16 a reference to the Administration or the Adminis17 trator, respectively. 

18 (2) STATUTORY REPORTING REQUIREMENTS.— 

19 Statutory reporting requirements that applied in re20 lation to such an agency immediately before the ef21 fective date of this Act shall continue to apply fol22 lowing such transfer if the reporting requirements 

23 refer to the agency by name. 


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1 SEC. 505. CONFORMING AMENDMENTS. 

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

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

4 ‘‘Administrator of Food Safety.’’. 

5 SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING 

6 AMENDMENTS. 

7 Not later than 60 days after the submission of the 

8 reorganization plan under section 502, the President shall 

9 prepare and submit proposed legislation to Congress con10 taining necessary and appropriate technical and con11 forming amendments to any food safety law to reflect the 

12 changes made by this Act. 

13 SEC. 507. REGULATIONS. 

14 The Administrator may promulgate such regulations 

15 as the Administrator determines are necessary or appro16 priate to perform the duties of the Administrator. 

17 SEC. 508. AUTHORIZATION OF APPROPRIATIONS. 

18 There are authorized to be appropriated such sums 

19 as are necessary to carry out this Act. 

20 SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIA21 TIONS. 

22 For the fiscal year that includes the effective date 

23 of this Act, the amount authorized to be appropriated to 

24 carry out this Act shall not exceed— 

25 (1) the amount appropriated for that fiscal year 

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


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1 for the purpose of administering or enforcing the 

2 food safety law; or 

3 (2) the amount appropriated for those agencies 

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

5 of the effective date of this Act, appropriations for 

6 those agencies for the fiscal year that includes the 

7 effective date have not yet been made. 

8 SEC. 510. EFFECTIVE DATE. 

9 This Act and the amendments made by this Act take 

10 effect on the date of enactment of this Act. 

Æ 


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