I 

108TH CONGRESS 

2D SESSION H. R. 5259

To establish the Food Safety Administration to protect the public health 

by preventing food-borne illness, ensuring the safety of food intended 

for human consumption, improving research on contaminants leading 

to food-borne illness, and improving security of food from intentional 

contamination. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 7, 2004

Ms. DELAURO (for herself, Ms. SLAUGHTER, Ms. LEE, and Ms. ROYBAL-ALLARD) 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 food-borne illness, ensuring 

the safety of food intended for human consumption, improving research on contaminants leading to food-borne 

illness, and improving security of food from intentional 

contamination.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,
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1 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

3 ‘‘Safe Food Act of 2004’’. 

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

5 this Act is as follows:

Sec. 1. Short title; table of contents. 

Sec. 2. Findings; purposes. 

Sec. 3. Definitions. 

TITLE I—ESTABLISHMENT OF FOOD SAFETY ADMINISTRATION 

Sec. 101. Establishment of Food Safety Administration. 

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

agencies. 

Sec. 103. Additional duties of the Administration. 

TITLE II—ADMINISTRATION OF FOOD SAFETY PROGRAM 

Sec. 201. Administration of national program. 

Sec. 202. Registration of food establishments and foreign food establishments. 

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

Sec. 204. Performance standards for contaminants in food. 

Sec. 205. Inspections of food establishments. 

Sec. 206. Food production facilities. 

Sec. 207. Federal and State cooperation. 

Sec. 208. Imports. 

Sec. 209. Resource plan. 

Sec. 210. Traceback. 

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. Food detention, seizure, and condemnation. 

Sec. 403. Notification and recall. 

Sec. 404. Injunction proceedings. 

Sec. 405. Civil and criminal penalties. 

Sec. 406. Presumption. 

Sec. 407. Whistleblower protection. 

Sec. 408. Administration and enforcement. 

Sec. 409. Citizen civil actions. 

TITLE V—IMPLEMENTATION 

Sec. 501. Definition. 

Sec. 502. Reorganization plan. 

Sec. 503. Transitional authorities. 
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Sec. 504. Savings provisions. 

Sec. 505. Conforming amendments. 

Sec. 506. Additional technical and conforming amendments. 

Sec. 507. Regulations. 

Sec. 508. Authorization of appropriations. 

Sec. 509. Limitation on authorization of appropriations. 

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, system-wide approach to pre13 venting food-borne illness, a thorough and broad14 based approach to basic and applied research, and 

15 intensive, effective, and efficient management of the 

16 Nation’s food safety program; 

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

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

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

22 contamination; 
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1 (B) an aging and immune compromised 

2 population, with a growing number of people at 

3 high-risk for food-borne illnesses; 

4 (C) an increasing volume of imported food, 

5 without adequate monitoring and inspection; 

6 and 

7 (D) maintenance of rigorous inspection of 

8 the domestic food processing and food service 

9 industries; 

10 (5) Federal food safety standard setting, in11 spection, enforcement, and research efforts should be 

12 based on the best available science and public health 

13 considerations and food safety resources should be 

14 systematically deployed in ways that most effectively 

15 prevent food-borne illness; 

16 (6) the Federal food safety system is frag17 mented, with at least 12 Federal agencies sharing 

18 responsibility for food safety, and operates under 

19 laws that do not reflect current conditions in the 

20 food system or current scientific knowledge about 

21 the cause and prevention of food-borne illness; 

22 (7) the fragmented Federal food safety system 

23 and outdated laws preclude an integrated, system24 wide approach to preventing food-borne illness, to 

25 the effective and efficient operation of the Nation’s 
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1 food safety program, and to the most beneficial de2 ployment of food safety resources; 

3 (8) the National Academy of Sciences rec4 ommended in the report ‘‘Ensuring Safe Food from 

5 Production to Consumption’’ that Congress establish 

6 by statute a unified and central framework for man7 aging Federal food safety programs, and rec8 ommended modifying Federal statutes so that in9 spection, enforcement, and research efforts are 

10 based on scientifically supportable assessments of 

11 risks to public health; and 

12 (9) the lack of a single focal point for food safe13 ty leadership in the United States undercuts the 

14 ability of the United States to exert food safety lead15 ership internationally, which is detrimental to the 

16 public health and the international trade interests of 

17 the United States. 

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

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

20 the ‘‘Food Safety Administration’’—

21 (A) to regulate food safety and labeling to 

22 protect the public health; 

23 (B) to ensure that food establishments ful24 fill their responsibility to produce food in a 
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1 manner that protects the public health of all 

2 people in the United States; 

3 (C) to lead an integrated, system-wide ap4 proach to food safety and to make more effec5 tive and efficient use of resources to prevent 

6 food-borne illness; and 

7 (D) to provide a single focal point for food 

8 safety leadership, both nationally and inter9 nationally; 

10 (2) to transfer to the Food Safety Administra11 tion the food safety, labeling, inspection, and en12 forcement functions that, as of the day before the ef13 fective date of this Act, are performed by other Fed14 eral agencies; and 

15 (3) to modernize the Federal food safety laws 

16 to achieve more effective application and efficient 

17 management of the laws for the protection and im18 provement of public health. 

19 SEC. 3. DEFINITIONS. 

20 In this Act: 

21 (1) ADMINISTRATION.—The term ‘‘Administra22 tion’’ means the Food Safety Administration estab23 lished under section 101(a)(1). 
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1 (2) ADMINISTRATOR.—The term ‘‘Adminis2 trator’’ means the Administrator of Food Safety ap3 pointed under section 101(a)(3). 

4 (3) ADULTERATED.—

5 (A) IN GENERAL.—The term ‘‘adulter6 ated’’ has the meaning described in subsections 

7 (a) through (c) of section 402 of the Federal 

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

9 342(a)–(c)). 

10 (B) INCLUSION.—The term ‘‘adulterated’’ 

11 includes bearing or containing a contaminant 

12 that causes illness or death among sensitive 

13 populations. 

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

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

16 United States Code. 

17 (5) CATEGORY 1 FOOD ESTABLISHMENT.—The 

18 term ‘‘category 1 food establishment’’ means a food 

19 establishment that routinely slaughters animals for 

20 human consumption. 

21 (6) CATEGORY 2 FOOD ESTABLISHMENT.—The 

22 term ‘‘category 2 food establishment’’ means a food 

23 establishment that processes raw meat, poultry, sea24 food products, and other products that the Adminis25 trator determines by regulation to be at high risk of 
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1 contamination and the processes of which do not in2 clude a step validated to destroy contaminants. 

3 (7) CATEGORY 3 FOOD ESTABLISHMENT.—The 

4 term ‘‘category 3 food establishment’’ means a food 

5 establishment that processes meat, poultry, seafood 

6 products, and other products that the Administrator 

7 determines by regulation to be at high risk of con8 tamination and whose processes include a step vali9 dated to destroy contaminants. 

10 (8) CATEGORY 4 FOOD ESTABLISHMENT.—The 

11 term ‘‘category 4 food establishment’’ means a food 

12 establishment that processes all other categories of 

13 food products not described in paragraphs (5) 

14 through (7). 

15 (9) CATEGORY 5 FOOD ESTABLISHMENT.—The 

16 term ‘‘category 5 food establishment’’ means a food 

17 establishment that stores, holds, or transports food 

18 products prior to delivery for retail sale. 

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

20 includes a bacterium, chemical, natural or manufac21 tured toxin, virus, parasite, prion, physical hazard, 

22 or other human pathogen that when found on or in 

23 food can cause human illness, injury, or death. 

24 (11) CONTAMINATION.—The term ‘‘contamina25 tion’’ refers to a presence of a contaminant in food. 
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1 (12) FOOD.—

2 (A) IN GENERAL.—The term ‘‘food’’ 

3 means a product intended to be used for food 

4 or drink for a human. 

5 (B) INCLUSIONS.—The term ‘‘food’’ in6 cludes any product (including a meat food prod7 uct, as defined in section 1(j) of the Federal 

8 Meat Inspection Act (21 U.S.C. 601(j))), capa9 ble for use as human food that is made in whole 

10 or in part from any animal, including cattle, 

11 sheep, swine, or goat, or poultry (as defined in 

12 section 4 of the Poultry Products Inspection 

13 Act (21 U.S.C. 453)). 

14 (C) EXCLUSION.—The term ‘‘food’’ does 

15 not include dietary supplements, as defined in 

16 section 201(ff) of the Federal Food, Drug, and 

17 Cosmetic Act (21 U.S.C. 321(ff)). 

18 (13) FOOD ESTABLISHMENT.—

19 (A) IN GENERAL.—The term ‘‘food estab20 lishment’’ means a slaughterhouse, factory, 

21 warehouse, or facility owned or operated by a 

22 person located in any State that processes food. 

23 (B) EXCLUSIONS.—For the purposes of 

24 registration, the term ‘‘food establishment’’ 

25 does not include a farm, restaurant, other retail 
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1 food establishment, nonprofit food establish2 ment in which food is prepared for or served di3 rectly to the consumer, or fishing vessel (other 

4 than a fishing vessel engaged in processing, as 

5 that term is defined in section 123.3 of title 21, 

6 Code of Federal Regulations). 

7 (14) FOOD PRODUCTION FACILITY.—The term 

8 ‘‘food production facility’’ means any farm, ranch, 

9 orchard, vineyard, aquaculture facility, confined ani10 mal-feeding operation, or animal feed production fa11 cility. 

12 (15) FOOD SAFETY LAW.—The term ‘‘food safe13 ty law’’ means—

14 (A) the provisions of the Federal Food, 

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

16 seq.) related to and requiring the safety, label17 ing, and inspection of food, infant formulas, 

18 food additives, pesticide residues, and other 

19 substances present in food under that Act; 

20 (B) the provisions of the Federal Food, 

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

22 seq.) and of any other Act that are adminis23 tered by the Center for Veterinary Medicine of 

24 the Food and Drug Administration; 
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1 (C) the Poultry Products Inspection Act 

2 (21 U.S.C. 451 et seq.); 

3 (D) the Federal Meat Inspection Act (21 

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

5 (E) the Egg Products Inspection Act (21 

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

7 (F) the Sanitary Food Transportation Act 

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

9 (G) the provisions of the Humane Methods 

10 of Slaughter Act of 1978 (Public Law 95–448) 

11 administered by the Food Safety and Inspection 

12 Service; 

13 (H) the provisions of this Act; and 

14 (I) such other provisions of law related to 

15 and requiring food safety, labeling, inspection, 

16 and enforcement as the President designates by 

17 Executive order as appropriate to include within 

18 the jurisdiction of the Administration. 

19 (16) FOREIGN FOOD ESTABLISHMENT.—

20 (A) IN GENERAL.—The term ‘‘foreign food 

21 establishment’’ means a slaughterhouse, fac22 tory, warehouse, or facility located outside the 

23 United States that processes food that is im24 ported into the United States without further 
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1 processing or packaging inside the United 

2 States. 

3 (B) FURTHER PROCESSING OR PACK4 AGING.—A food shall not be considered to have 

5 undergone further processing or packaging sole6 ly because labeling was added or a similar activ7 ity of a de minimis nature was carried out with 

8 respect to the food. 

9 (17) INTERSTATE COMMERCE.—The term 

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

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

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

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

14 has the meaning given that term in section 403 of 

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

16 U.S.C. 343). 

17 (19) PROCESS.—The term ‘‘process’’ or ‘‘proc18 essing’’ means the commercial harvesting, slaughter, 

19 packing, preparation, or manufacture of food. 

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

21 health. 

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

23 (A) a State; 

24 (B) the District of Columbia; 
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1 (C) the Commonwealth of Puerto Rico; 

2 and 

3 (D) any other territory or possession of the 

4 United States. 

5 TITLE I—ESTABLISHMENT OF 

6 FOOD SAFETY ADMINISTRATION 

7 SEC. 101. ESTABLISHMENT OF FOOD SAFETY ADMINISTRA8 TION. 

9 (a) ESTABLISHMENT.—

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

11 executive branch an agency to be known as the 

12 ‘‘Food Safety Administration’’. 

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

14 independent establishment (as defined in section 104 

15 of title 5, United States Code). 

16 (3) HEAD OF ADMINISTRATION.—The Adminis17 tration shall be headed by the Administrator of Food 

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

19 and with the advice and consent of the Senate. 

20 (b) DUTIES OF ADMINISTRATOR.—The Adminis21 trator shall—

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

23 (2) serve as a representative to international 

24 food safety bodies and discussions; 
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1 (3) promulgate regulations to ensure the secu2 rity of the food supply from all forms of contamina3 tion, including intentional contamination; and 

4 (4) oversee—

5 (A) implementation of Federal food safety 

6 inspection, enforcement, and research efforts, to 

7 protect the public health; 

8 (B) development of consistent and science9 based standards for safe food; 

10 (C) coordination and prioritization of food 

11 safety research and education programs with 

12 other Federal agencies; 

13 (D) prioritization of Federal food safety ef14 forts and deployment of Federal food safety re15 sources to achieve the greatest possible benefit 

16 in reducing food-borne illness; 

17 (E) coordination of the Federal response to 

18 food-borne illness outbreaks with other Federal 

19 and State agencies; and 

20 (F) integration of Federal food safety ac21 tivities with State and local agencies. 

22 SEC. 102. CONSOLIDATION OF SEPARATE FOOD SAFETY 

23 AND INSPECTION SERVICES AND AGENCIES. 

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

25 agency specified in subsection (b), there are transferred 
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1 to the Administration all functions that the head of the 

2 Federal agency exercised on the day before the effective 

3 date of this Act (including all related functions of any offi4 cer or employee of the Federal agency) that relate to ad5 ministration or enforcement of the food safety law, as de6 termined by the President. 

7 (b) TRANSFERRED AGENCIES.—The Federal agen8 cies referred to in subsection (a) are—

9 (1) the Food Safety and Inspection Service of 

10 the Department of Agriculture; 

11 (2) the Center for Food Safety and Applied Nu12 trition of the Food and Drug Administration; 

13 (3) the part of the Agriculture Marketing Serv14 ice that administers shell egg surveillance services 

15 established under the Egg Products Inspection Act 

16 (21 U.S.C. 1031 et seq.); 

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

18 Regulatory Affairs of the Food and Drug Adminis19 tration that administer and conduct inspections of 

20 food establishments and imports; 

21 (5) the resources and facilities of the Office of 

22 the Commissioner of the Food and Drug Adminis23 tration 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 (6) the Center for Veterinary Medicine of the 

6 Food and Drug Administration; 

7 (7) the resources and facilities of the Environ8 mental Protection Agency that control and regulate 

9 pesticide residues in food; 

10 (8) the part of the Research, Education, and 

11 Economics mission area of the Department of Agri12 culture related to food safety and animal feed re13 search; 

14 (9) the part of the National Marine Fisheries 

15 Service of the National Oceanic and Atmospheric 

16 Administration of the Department of Commerce that 

17 administers the seafood inspection program; and 

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

19 the President designates by Executive order to carry 

20 out this Act. 

21 SEC. 103. ADDITIONAL DUTIES OF THE ADMINISTRATION. 

22 (a) OFFICERS AND EMPLOYEES.—The Administrator 

23 may—

24 (1) appoint officers and employees for the Ad25 ministration in accordance with the provisions of 
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1 title 5, United States Code, relating to appointment 

2 in the competitive service; and 

3 (2) fix the compensation of those officers and 

4 employees in accordance with chapter 51 and with 

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

6 classification and General Schedule pay rates. 

7 (b) EXPERTS AND CONSULTANTS.—The Adminis8 trator may—

9 (1) procure the services of temporary or inter10 mittent experts and consultants as authorized by 

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

12 (2) pay in connection with those services the 

13 travel expenses of the experts and consultants, in14 cluding transportation and per diem in lieu of sub15 sistence while away from the homes or regular 

16 places of business of the individuals, as authorized 

17 by section 5703 of that title. 

18 (c) BUREAUS, OFFICES, AND DIVISIONS.—The Ad19 ministrator may establish within the Administration such 

20 bureaus, offices, and divisions as the Administrator deter21 mines are necessary to perform the duties of the Adminis22 trator. 
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1 TITLE II—ADMINISTRATION OF 

2 FOOD SAFETY PROGRAM 

3 SEC. 201. ADMINISTRATION OF NATIONAL PROGRAM. 

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

5 (1) administer a national food safety program 

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

7 protect public health; and 

8 (2) ensure that persons who produce or process 

9 food for human consumption meet their responsi10 bility to prevent or minimize food safety hazards re11 lated to their products. 

12 (b) COMPREHENSIVE ANALYSIS.—The program shall 

13 be based on a comprehensive analysis of the hazards asso14 ciated with different food and with the processing of dif15 ferent food, including the identification and evaluation 

16 of—

17 (1) the severity of the potential health risks; 

18 (2) the sources and specific points of potential 

19 contamination extending from the farm or ranch to 

20 the consumer that may render food unsafe for 

21 human consumption; 

22 (3) the potential for persistence, multiplication, 

23 or concentration of naturally occurring or added 

24 contaminants in food; 
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1 (4) opportunities across the food production, 

2 processing, distribution, and retail system to reduce 

3 potential health risks; and 

4 (5) opportunities for intentional contamination. 

5 (c) PROGRAM ELEMENTS.—In carrying out the pro6 gram, the Administrator shall—

7 (1) implement a national system for the reg8 istration of food establishments and foreign food es9 tablishments and regular unannounced inspection of 

10 food establishments; 

11 (2) enforce the adoption of process controls in 

12 food establishments, based on best available sci13 entific and public health considerations and best 

14 available technologies; 

15 (3) establish and enforce science-based stand16 ards for—

17 (A) substances that may contaminate food; 

18 and 

19 (B) safety and sanitation in the processing 

20 and handling of food; 

21 (4) implement a sampling program to ensure 

22 that industry programs and procedures that prevent 

23 food contamination are effective on an ongoing basis 

24 and that food meets the standards established under 

25 this Act; 
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1 (5) implement procedures and requirements to 

2 ensure the safety and security of imported food; 

3 (6) coordinate with other agencies and State or 

4 local governments in carrying out inspection, en5 forcement, and monitoring; 

6 (7) have access to the surveillance data of the 

7 Centers for Disease Control and Prevention, and 

8 other Federal Government agencies, in order to im9 plement a national surveillance system to assess the 

10 health risks associated with the human consumption 

11 of food; 

12 (8) develop public education risk communica13 tion and advisory programs; 

14 (9) implement a research program to further 

15 the purposes of this Act; and 

16 (10) coordinate and prioritize food safety re17 search and educational programs with other agen18 cies, including State or local agencies. 

19 SEC. 202. REGISTRATION OF FOOD ESTABLISHMENTS AND 

20 FOREIGN FOOD ESTABLISHMENTS. 

21 (a) IN GENERAL.—The Administrator shall by regu22 lation require that any food establishment or foreign food 

23 establishment engaged in processing food for human con24 sumption in the United States be registered with the Ad25 ministrator. 
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1 (b) REGISTRATION REQUIREMENTS.—

2 (1) IN GENERAL.—To be registered under sub3 section (a)—

4 (A) in the case of a food establishment, the 

5 owner, operator, or agent in charge of the food 

6 establishment shall submit a registration to the 

7 Administrator; and 

8 (B) in the case of a foreign food establish9 ment, the owner, operator, or agent in charge 

10 of the foreign food establishment shall—

11 (i) submit a registration to the Ad12 ministrator; and 

13 (ii) provide the name, address, and 

14 emergency contact information of the 

15 United States agent for the foreign food 

16 establishment. 

17 (2) REGISTRATION.—A food establishment or 

18 foreign food establishment shall submit a registra19 tion under paragraph (1) to the Administrator 

20 that—

21 (A) identifies the name, address, and emer22 gency contact information of each food estab23 lishment or foreign food establishment that the 

24 registrant operates under this Act and all trade 
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1 names under which the registrant conducts 

2 business relating to food; 

3 (B) lists the primary purpose and business 

4 activity of each food establishment or foreign 

5 food establishment, including the dates of oper6 ation if the food establishment or foreign food 

7 establishment is seasonal; 

8 (C) lists the types of food processed or sold 

9 at each food establishment or, for foreign food 

10 establishments selling food for consumption in 

11 the United States, identifies the specific food 

12 categories of that food as listed under section 

13 170.3 of title 21, Code of Federal Regulations; 

14 and 

15 (D) not later than 30 days after a change 

16 in the products, function, or legal status of the 

17 food establishment or foreign food establish18 ment (including cessation of business activities), 

19 notifies the Administrator of the change. 

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

21 registration described in paragraph (1), the Admin22 istrator shall notify the registrant of the receipt of 

23 the registration and assign a registration number to 

24 each food establishment and foreign food establish25 ment. 
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1 (4) LIST.—The Administrator shall compile and 

2 maintain an up-to-date list of food establishments 

3 and foreign food establishments that are registered 

4 under this section. 

5 (5) DISCLOSURE EXEMPTION.—The disclosure 

6 requirements under section 552 of title 5, United 

7 States Code, shall not apply to—

8 (A) the list compiled under paragraph (4); 

9 and 

10 (B) information derived from the list under 

11 paragraph (4), to the extent that it discloses 

12 the identity or location of a specific registered 

13 person. 

14 (6) SUSPENSION OF REGISTRATION.—

15 (A) IN GENERAL.—The Administrator may 

16 suspend the registration of a food establishment 

17 or foreign food establishment, including the fa18 cility of an importer, for violation of a food 

19 safety law. 

20 (B) NOTICE AND OPPORTUNITY FOR

21 HEARING.—The Administrator shall provide no22 tice to a registrant immediately upon the sus23 pension of the registration of the facility and 

24 provide registrant with an opportunity for a 

25 hearing within 3 days of the suspension. 
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1 (7) REINSTATEMENT.—A registration that is 

2 suspended under this section may be reinstated pur3 suant to criteria published in the Federal Register 

4 by the Administrator. 

5 SEC. 203. PREVENTATIVE PROCESS CONTROLS TO REDUCE 

6 ADULTERATION OF FOOD. 

7 (a) IN GENERAL.—The Administrator shall, upon the 

8 basis of best available public health, scientific, and techno9 logical data, promulgate regulations to ensure that food 

10 establishments—

11 (1) process food in a sanitary manner; 

12 (2) limit the presence of potentially harmful 

13 contaminants in food; 

14 (3) implement appropriate measures of prevent15 ative process control to minimize and reduce the 

16 presence and growth of contaminants in food and 

17 meet the performance standards established under 

18 section 204; 

19 (4) process all fully processed or ready-to-eat 

20 food in a sanitary manner, using reasonably avail21 able techniques and technologies to eliminate any po22 tentially harmful contaminants; and 

23 (5) label food intended for final processing out24 side commercial food establishments with instruc-
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1 tions for handling and preparation for consumption 

2 that, when adhered to, will destroy contaminants. 

3 (b) REGULATIONS.—Not later than 1 year after the 

4 effective date of this Act, the Administrator shall promul5 gate regulations that—

6 (1) require all food establishments to adopt pre7 ventative process controls that are—

8 (A) adequate to protect the public health; 

9 (B) meet relevant regulatory and food 

10 safety standards; and 

11 (C) limit the presence and growth of con12 taminants in food prepared in a food establish13 ment; 

14 (2) set standards for sanitation; 

15 (3) meet any performance standards for con16 taminants established under section 204; 

17 (4) require recordkeeping to monitor compli18 ance; 

19 (5) require sampling and testing at a frequency 

20 and in a manner sufficient to ensure that process 

21 controls are effective on an ongoing basis and that 

22 regulatory standards are being met; and 

23 (6) provide for agency access to records kept by 

24 food establishments and submission of copies of the 
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1 records to the Administrator, as the Administrator 

2 determines appropriate. 

3 (c) PROCESSING CONTROLS.—The Administrator 

4 may require any person with responsibility for or control 

5 over food or food ingredients to adopt process controls, 

6 if the process controls are needed to ensure the protection 

7 of the public health. 

8 SEC. 204. PERFORMANCE STANDARDS FOR CONTAMINANTS 

9 IN FOOD. 

10 (a) IN GENERAL.—To protect the public health, the 

11 Administrator shall establish by regulation and enforce 

12 performance standards that define, with respect to specific 

13 food-borne contaminants and foods, the level of food safety 

14 performance that a person responsible for producing, proc15 essing, or selling food shall meet. 

16 (b) IDENTIFICATION OF CONTAMINANTS; PERFORM17 ANCE STANDARDS.—

18 (1) IN GENERAL.—Not later than 6 months 

19 after the date of enactment of this Act, the Adminis20 trator shall identify the food-borne contaminants 

21 and food that contribute significantly to the risk of 

22 food-borne illness. 

23 (2) PERFORMANCE STANDARDS.—As soon as 

24 practicable after the identification of the contami25 nants under paragraph (1), the Administrator shall 
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1 establish appropriate performance standards to pro2 tect against all food-borne contaminants. 

3 (3) SIGNIFICANT CONTAMINANTS.—The Admin4 istrator shall establish performance standards for 

5 the 5 most significant contaminants associated with 

6 raw meat, poultry, and seafood not later than 3 

7 years after the date of enactment of this Act. 

8 (c) PERFORMANCE STANDARDS.—

9 (1) IN GENERAL.—The performance standards 

10 established under this section shall include—

11 (A) health-based standards that set the 

12 level of a contaminant that can safely and law13 fully be present in food; 

14 (B) zero tolerances, in addition to any 

15 zero-tolerance standards in effect on the day be16 fore the date of enactment of this Act, when 

17 necessary to protect against significant adverse 

18 health outcomes; 

19 (C) process standards, such as log reduc20 tion criteria for cooked products, when suffi21 cient to ensure the safety of processed food; and 

22 (D) in the absence of data to support a 

23 performance standard described in subpara24 graph (A), (B), or (C), standards that define 

25 required performance in terms of ‘‘best reason-
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•HR 5259 IH 

1 ably achievable performance’’, using best avail2 able technologies, interventions, and practices. 

3 (2) BEST REASONABLY ACHIEVABLE PERFORM4 ANCE STANDARDS.—In developing best reasonably 

5 achievable performance standards, the Administrator 

6 shall collect, or contract for the collection of, data on 

7 current best practices and food safety outcomes re8 lated to the contaminants and foods in question, as 

9 the Administrator determines necessary. 

10 (3) REVOCATION BY ADMINISTRATOR.—All per11 formance standards, tolerances, action levels, or 

12 other similar standards in effect on the date of en13 actment of this Act shall remain in effect until re14 vised or revoked by the Administrator. 

15 (d) ENFORCEMENT.—

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

17 the promulgation of a performance standard under 

18 this section, the Administrator shall implement a 

19 sampling program to determine whether food estab20 lishments are complying with the performance stand21 ards promulgated under this section. The program 

22 established under this paragraph shall be at least as 

23 stringent as the Hazard Analysis and Critical Con24 trol Point System requirements established under 
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•HR 5259 IH 

1 part 417 of title 9, Code of Federal Regulations (or 

2 successor regulation). 

3 (2) INSPECTIONS.—If the Administrator deter4 mines that a food establishment fails to meet a 

5 standard promulgated under this section, and such 

6 establishment fails to take appropriate corrective ac7 tion as determined by the Administrator, the Admin8 istrator shall, as appropriate—

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

10 the food establishment under section 402; 

11 (B) order a recall of food from the food es12 tablishment under section 403; 

13 (C) increase the inspection frequency for 

14 the food establishment; 

15 (D) withdraw the mark of inspection from 

16 the food establishment, if in use; or 

17 (E) take other appropriate enforcement ac18 tion concerning the food establishment. 

19 (e) NEWLY IDENTIFIED CONTAMINANTS.—Notwith20 standing any other provision of this section, the Adminis21 trator shall promulgate interim performance standards for 

22 newly identified contaminants as necessary to protect the 

23 public health. 
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•HR 5259 IH 

1 SEC. 205. INSPECTIONS OF FOOD ESTABLISHMENTS. 

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

3 an inspection program, which shall include sampling and 

4 testing of food and food establishments, to determine if 

5 each food establishment—

6 (1) is operating in a sanitary manner; 

7 (2) has continuous systems, interventions, and 

8 processes in place to minimize or eliminate contami9 nants in food; 

10 (3) is in compliance with applicable perform11 ance standards established under section 203, and 

12 other regulatory requirements; 

13 (4) is processing food that is safe for human 

14 consumption and not adulterated or misbranded; 

15 (5) maintains records of process control plans 

16 under section 203, and other records related to the 

17 processing, sampling, and handling of food; and 

18 (6) is in compliance with the requirements of 

19 the food safety law. 

20 (b) ESTABLISHMENT CATEGORIES AND INSPECTION

21 FREQUENCIES.—The resource plan required under section 

22 209, including the description of resources required to 

23 carry out inspections of food establishments, shall be 

24 based on the following categories and inspection fre25 quencies, subject to subsections (c) and (d): 
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•HR 5259 IH 

1 (1) CATEGORY 1 FOOD ESTABLISHMENTS.—A 

2 category 1 food establishment shall be subject to 

3 antemortem and continuous inspection of each 

4 slaughter line during all operating hours, and other 

5 inspection on a daily basis, sufficient to verify 

6 that—

7 (A) diseased animals are not offered for 

8 slaughter; 

9 (B) the food establishment has successfully 

10 identified and removed from the slaughter line 

11 visibly defective or contaminated carcasses and 

12 destroyed or reprocessed them in a manner ac13 ceptable to the Administrator; and 

14 (C) that applicable performance standards 

15 and other provisions of the food safety law have 

16 been satisfied. 

17 (2) CATEGORY 2 FOOD ESTABLISHMENTS.—A 

18 category 2 food establishment shall be randomly in19 spected at least daily. 

20 (3) CATEGORY 3 FOOD ESTABLISHMENTS.—A 

21 category 3 food establishment shall—

22 (A) have ongoing verification that its proc23 esses are controlled; and 

24 (B) be randomly inspected at least month25 ly. 
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•HR 5259 IH 

1 (4) CATEGORY 4 FOOD ESTABLISHMENTS.—A 

2 category 4 food establishment shall be randomly in3 spected at least quarterly. 

4 (5) CATEGORY 5 FOOD ESTABLISHMENTS.—A 

5 category 5 food establishment shall be randomly in6 spected at least annually. 

7 (c) ALTERNATIVE INSPECTION FREQUENCIES.—

8 With respect to a category 2, 3, 4, or 5 food establishment, 

9 the Administrator may establish alternative inspection fre10 quencies for subcategories of food establishments or indi11 vidual establishments, to foster risk-based allocation of re12 sources, subject to the following criteria and procedures: 

13 (1) Subcategories of food establishments and 

14 their alternative inspection frequencies shall be de15 fined by regulation, subject to paragraphs (2) and 

16 (3). 

17 (2) Regulations of alternative inspection fre18 quencies for subcategories of food establishments 

19 under paragraph (1) and for a specific food estab20 lishment under paragraph (4) shall provide that—

21 (A) category 2 food establishments shall be 

22 inspected at least monthly; and 

23 (B) category 3, 4, and 5 food establish24 ments shall be inspected at least annually. 
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•HR 5259 IH 

1 (3) In defining subcategories of food establish2 ments and their alternative inspection frequencies 

3 under paragraphs (1) and (2), the Administrator 

4 shall consider—

5 (A) the nature of the food products being 

6 processed, stored, or transported; 

7 (B) the manner in which food products are 

8 processed, stored, or transported; 

9 (C) the inherent likelihood that the prod10 ucts will contribute to the risk of food-borne ill11 ness; 

12 (D) the best available evidence concerning 

13 reported illnesses associated with the foods pro14 duced in the proposed subcategory of establish15 ments; and 

16 (E) the overall record of compliance with 

17 the food safety law among establishments in the 

18 proposed subcategory, including compliance 

19 with applicable performance standards and the 

20 frequency of recalls. 

21 (4) The Administrator may adopt alternative 

22 inspection frequencies for a specific establishment, 

23 subject to paragraphs (2) and (5) and shall periodi24 cally publish a list of establishments subject to alter25 native inspections. 
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•HR 5259 IH 

1 (5) In adopting alternative inspection fre2 quencies for a specific establishment, the Adminis3 trator shall consider—

4 (A) the criteria in paragraph (3); 

5 (B) whether products from the specific es6 tablishment have been associated with a case or 

7 an outbreak of food-borne illness; and 

8 (C) the record of the establishment of com9 pliance with the food safety law, including com10 pliance with applicable performance standards 

11 and the frequency of recalls. 

12 (6) Before establishing alternative inspection 

13 frequencies for subcategories of establishments or in14 dividual establishments, the Administrator shall—

15 (A) determine, based on the best available 

16 evidence, that the alternative uses of the re17 sources required to carry out the inspection ac18 tivity would make a greater contribution to pro19 tecting the public health and reducing the risk 

20 of food-borne illness than the use of resources 

21 described in subsection (b); 

22 (B) describe the alternative uses of re23 sources in general terms when issuing the regu24 lation or order that establishes the alternative 

25 inspection frequency; 
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•HR 5259 IH 

1 (C) consider the supporting evidence that 

2 an individual food establishment shall submit 

3 related to whether an alternative inspection fre4 quency should be established for such establish5 ment by the Administrator; and 

6 (D) include a description of the alternative 

7 uses in the annual resource plan required in 

8 section 209. 

9 (d) INSPECTION TRANSITION.—The Administrator 

10 shall manage the transition to the inspection system de11 scribed in this Act as follows: 

12 (1) In the case of a category 1 or 2 food estab13 lishment, the Administrator shall continue to imple14 ment the applicable inspection mandates of the Fed15 eral Meat Inspection Act (21 U.S.C. 601 et seq.), 

16 the Poultry Products Inspection Act (21 U.S.C. 451 

17 et seq.), and the Federal Food, Drug, and Cosmetic 

18 Act (21 U.S.C. 301 et seq.) until—

19 (A) regulations required to implement this 

20 section have been promulgated; 

21 (B) the performance standards required by 

22 section 204(c) have been promulgated and im23 plemented for 1 year; and 
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•HR 5259 IH 

1 (C) the establishment has achieved compli2 ance with the other applicable provisions of the 

3 food safety law. 

4 (2) In the case of a category 1 or 2 food estab5 lishment that, within 2 years after the promulgation 

6 of the performance standards required by section 

7 204(c), has not achieved compliance with the food 

8 safety law, the Administrator shall—

9 (A) issue an order prohibiting the estab10 lishment from operating pending a demonstra11 tion by the establishment that sufficient 

12 changes in facilities, procedures, personnel, or 

13 other aspects of the process control system have 

14 been made such that the Administrator deter15 mines that compliance with the food safety law 

16 is achieved; and 

17 (B) following the demonstration required 

18 in subparagraph (A), issue an order authorizing 

19 the food establishment to operate subject, at a 

20 minimum, to—

21 (i) the inspection requirement applica22 ble to the establishment under subsection 

23 (b) (1) or (2); and 

24 (ii) such other inspection or compli25 ance measures determined by the Adminis-
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•HR 5259 IH 

1 trator necessary to assure compliance with 

2 the applicable food safety law. 

3 (3) In the case of a category 3 food establish4 ment, the Administrator shall continue to implement 

5 the applicable inspection mandates of the Federal 

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

7 Poultry Products Inspection Act (21 U.S.C. 451 et 

8 seq.), and the Federal Food, Drug, and Cosmetic 

9 Act (21 U.S.C. 301 et seq.) until—

10 (A) the regulations required to implement 

11 this section have been promulgated; 

12 (B) the first resource plan under section 

13 209 has been submitted; and 

14 (C) for individual establishments, compli15 ance with the food safety law has been dem16 onstrated. 

17 (4) In the case of a category 3 food establish18 ment that, within 1 year after the promulgation of 

19 the regulations required to implement this section, 

20 have not demonstrated compliance with the food 

21 safety law, the Administrator shall—

22 (A) issue an order prohibiting the estab23 lishment from operating, pending a demonstra24 tion by the establishment that sufficient 

25 changes in facilities, procedures, personnel, or 
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•HR 5259 IH 

1 other aspects of the process control system have 

2 been made such that the Administrator deter3 mines that compliance with the food safety law 

4 is achieved; and 

5 (B) following the demonstration required 

6 in subparagraph (A), issue an order authorizing 

7 the establishment to operate subject, at a min8 imum, to—

9 (i) the inspection requirement applica10 ble to the establishment under subsection 

11 (b)(3); and 

12 (ii) such other inspection or compli13 ance measures determined by the Adminis14 trator necessary to assure compliance with 

15 the food safety law. 

16 (5) In the case of a category 4 or 5 food estab17 lishment, the inspection requirements of this Act 

18 shall be implemented as soon as possible after—

19 (A) the promulgation of the regulations re20 quired to implement this section; 

21 (B) the publication of the first resource 

22 plan under section 209; and 

23 (C) the commencement of the first fiscal 

24 year in which the Administration is operating 

25 with budgetary resources that Congress has ap-
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•HR 5259 IH 

1 propriated following consideration of the re2 source plan under section 209. 

3 (e) OFFICIAL MARK.—

4 (1) IN GENERAL.—

5 (A) ESTABLISHMENT.—Before the comple6 tion of the transition process under paragraphs 

7 (1) through (3) of subsection (d), the Adminis8 trator shall by regulation establish an official 

9 mark that shall be affixed to a food product 

10 produced in a category 1, 2, or 3 establishment, 

11 subject to subparagraph (B). 

12 (B) PREREQUISITE.—The official mark re13 quired under subparagraph (A) shall be affixed 

14 to a food product by the Administrator if the 

15 establishment has been inspected by the Admin16 istrator in accordance with the inspection fre17 quencies under this section and the establish18 ment is in compliance with the food safety law. 

19 (2) CATEGORY 1, 2, OR 3 FOOD ESTABLISH20 MENTS.—In the case of products produced in a cat21 egory 1, 2, or 3 food establishment—

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 
40

•HR 5259 IH 

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 paragraphs (1) through (3) of sub8 section (d); 

9 (B) the Administrator shall publicly certify 

10 on a monthly basis that the inspection fre11 quencies required under this Act have been 

12 achieved; and 

13 (C) a product from an establishment that 

14 has not been inspected in accordance with the 

15 required frequencies under this section shall not 

16 bear the official mark and shall not be shipped 

17 in interstate commerce. 

18 (3) CATEGORY 4 AND 5 FOOD ESTABLISH19 MENTS.—In the case of a product produced in a cat20 egory 4 or 5 food establishment the Administrator 

21 shall provide by regulation for the voluntary use of 

22 the official mark established under paragraph (1), 

23 subject to—
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•HR 5259 IH 

1 (A) such minimum inspection frequencies 

2 as determined appropriate by the Adminis3 trator; 

4 (B) compliance with applicable perform5 ance standards and other provisions of the food 

6 safety law; and 

7 (C) such other requirements the Adminis8 trator considers appropriate. 

9 (f) IMPLEMENTATION.—Not later than 1 year after 

10 the effective date of this Act, the Administrator shall issue 

11 regulations to implement subsections (b) through (d). 

12 (g) MAINTENANCE AND INSPECTION OF RECORDS.—

13 (1) IN GENERAL.—

14 (A) RECORDS.—A food establishment 

15 shall—

16 (i) maintain such records as the Ad17 ministrator shall require by regulation, in18 cluding all records relating to the proc19 essing, distributing, receipt, or importation 

20 of any food; and 

21 (ii) permit the Administrator, in addi22 tion to any authority of the food safety 

23 agencies in effect on the day before the 

24 date of enactment of this Act, upon pres25 entation of appropriate credentials and at 
42

•HR 5259 IH 

1 reasonable times and in a reasonable man2 ner, to have access to and copy all records 

3 maintained by or on behalf of such food es4 tablishment representative in any format 

5 (including paper or electronic) and at any 

6 location, that are necessary to assist the 

7 Administrator—

8 (I) to determine whether the food 

9 is contaminated or not in compliance 

10 with the food safety law; or

11 (II) to track the food in com12 merce. 

13 (B) REQUIRED DISCLOSURE.—A food es14 tablishment shall have an affirmative obligation 

15 to disclose to the Administrator the results of 

16 testing or sampling of food, equipment, or ma17 terial in contact with food, that is positive for 

18 any contaminant. 

19 (2) MAINTENANCE OF RECORDS.—The records 

20 in paragraph (1) shall be maintained for a reason21 able period of time, as determined by the Adminis22 trator. 

23 (3) REQUIREMENTS.—The records in para24 graph (1) shall include records describing—
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•HR 5259 IH 

1 (A) the origin, receipt, delivery, sale, move2 ment, holding, and disposition of food or ingre3 dients; 

4 (B) the identity and quantity of ingredi5 ents used in the food; 

6 (C) the processing of the food; 

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

8 other tests performed on the food or in the food 

9 establishment; 

10 (E) consumer complaints concerning the 

11 food or packaging of the food; 

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

13 and locations of food production; and 

14 (G) other matters reasonably related to 

15 whether food is unsafe for human consumption, 

16 is adulterated or misbranded, or otherwise fails 

17 to meet the requirements of this Act. 

18 (h) PROTECTION OF SENSITIVE INFORMATION.—

19 (1) IN GENERAL.—The Administrator shall de20 velop and maintain procedures to prevent the unau21 thorized disclosure of any trade secret or confiden22 tial information obtained by the Administrator. 

23 (2) LIMITATION.—The requirement under this 

24 subsection does not—
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•HR 5259 IH 

1 (A) limit the authority of the Adminis2 trator to inspect or copy records or to require 

3 the establishment or maintenance of records 

4 under this Act; 

5 (B) have any legal effect on section 1905 

6 of title 18, United States Code; 

7 (C) extend to any food recipe, financial 

8 data, pricing data, personnel data, or sales data 

9 (other than shipment dates relating to sales); or 

10 (D) limit the public disclosure of distribu11 tion records or other records related to food 

12 subject to a voluntary or mandatory recall 

13 under section 403. 

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

15 OFFICERS AND ACCEPTANCE OF GIFTS.—Section 22 of 

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

17 apply to an inspection under this Act. 

18 SEC. 206. FOOD PRODUCTION FACILITIES. 

19 In carrying out the duties of the Administrator and 

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

21 authority, with respect to food production facilities, to—

22 (1) visit and inspect food production facilities in 

23 the United States and in foreign countries to inves24 tigate bioterrorism threats and for other critical food 

25 safety purposes; 
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•HR 5259 IH 

1 (2) review food safety records as required to be 

2 kept by the Administrator to carry out traceback 

3 and for other critical food safety purposes; 

4 (3) set good practice standards to protect the 

5 public and animal health and promote food safety; 

6 (4) conduct monitoring and surveillance of ani7 mals, plants, products, or the environment, as ap8 propriate; and

9 (5) collect and maintain information relevant to 

10 public health and farm practices. 

11 SEC. 207. FEDERAL AND STATE COOPERATION. 

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

13 with the States to carry out activities and programs that 

14 contribute to the national food safety program so that 

15 Federal and State programs function in a coordinated and 

16 cost-effective manner. 

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

18 with States to—

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

20 safety programs, especially with respect to the regu21 lation of retail commercial food establishments, 

22 transportation, harvesting, and fresh markets; 

23 (2) establish inspection programs and require24 ments to ensure that food under the jurisdiction of 

25 the State is safe for human consumption; and 
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•HR 5259 IH 

1 (3) support recall authorities at the State and 

2 local levels. 

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

4 and implementing a food safety program, the Adminis5 trator may provide to a State—

6 (1) advisory assistance; 

7 (2) technical and laboratory assistance and 

8 training (including necessary materials and equip9 ment); and 

10 (3) financial and other aid. 

11 (d) SERVICE AGREEMENTS.—

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

13 under agreements entered into with Federal, State, 

14 or local agencies, use on a reimbursable basis or oth15 erwise, the personnel and services of those agencies 

16 in carrying out this Act. 

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

18 this subsection may provide for training of State em19 ployees. 

20 (3) MAINTENANCE OF AGREEMENTS.—The Ad21 ministrator shall maintain any agreement that is in 

22 effect on the day before the date of enactment of 

23 this Act until the Administrator evaluates such 

24 agreement and determines whether to maintain or 

25 substitute such agreement. 
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•HR 5259 IH 

1 (e) AUDITS.—

2 (1) IN GENERAL.—The Administrator shall an3 nually conduct a comprehensive review of each State 

4 program that provides services to the Administrator 

5 in carrying out the responsibilities under this Act, 

6 including mandated inspections under section 205. 

7 (2) REQUIREMENTS.—The review shall—

8 (A) include a determination of the effec9 tiveness of the State program; and 

10 (B) identify any changes necessary to en11 sure enforcement of Federal requirements 

12 under this Act. 

13 SEC. 208. IMPORTS. 

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

15 effective date of this Act, the Administrator shall establish 

16 a system under which a foreign government or foreign 

17 food establishment seeking to import food to the United 

18 States shall submit a request for certification to the Ad19 ministrator. 

20 (b) CERTIFICATION STANDARD.—A foreign govern21 ment or foreign food establishment requesting a certifi22 cation to import food to the United States shall dem23 onstrate, in a manner determined appropriate by the Ad24 ministrator, that food produced under the supervision of 

25 a foreign government or by the foreign food establishment 
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•HR 5259 IH 

1 has met standards for food safety, inspection, labeling, 

2 and consumer protection that are at least equivalent to 

3 standards applicable to food produced in the United 

4 States. 

5 (c) CERTIFICATION APPROVAL.—

6 (1) REQUEST BY FOREIGN GOVERNMENT.—

7 Prior to granting the certification request of a for8 eign government, the Administrator shall review, 

9 audit, and certify the food safety program of a re10 questing foreign government (including all statutes, 

11 regulations, and inspection authority) as at least 

12 equivalent to the food safety program in the United 

13 States, as demonstrated by the foreign government. 

14 (2) REQUEST BY FOREIGN FOOD ESTABLISH15 MENT.—Prior to granting the certification request of 

16 a foreign food establishment, the Administrator shall 

17 certify, based on an onsite inspection, the food safe18 ty programs and procedures of a requesting foreign 

19 firm as at least equivalent to the food safety pro20 grams and procedures of the United States. 

21 (d) LIMITATION.—A foreign government or foreign 

22 firm approved by the Administrator to import food to the 

23 United States under this section shall be certified to ex24 port only the approved food products to the United States 

25 for a period not to exceed 5 years. 
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•HR 5259 IH 

1 (e) WITHDRAWAL OF CERTIFICATION.—The Admin2 istrator may withdraw certification of any food from a for3 eign government or foreign firm—

4 (1) if such food is linked to an outbreak of 

5 human illness; 

6 (2) following an investigation by the Adminis7 trator that finds that the foreign government pro8 grams and procedures or foreign food establishment 

9 is no longer equivalent to the food safety programs 

10 and procedures in the United States; or 

11 (3) following a refusal to allow United States 

12 officials to conduct such audits and investigations as 

13 may be necessary to fulfill the requirements under 

14 this section. 

15 (f) RENEWAL OF CERTIFICATION.—The Adminis16 trator shall audit foreign governments and foreign food 

17 establishments at least every 5 years to ensure the contin18 ued compliance with the standards set forth in this sec19 tion. 

20 (g) REQUIRED ROUTINE INSPECTION.—The Admin21 istrator shall routinely inspect food before it enters the 

22 United States to ensure that it is—

23 (1) safe for human consumption;

24 (2) labeled as required for food produced in the 

25 United States; and
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•HR 5259 IH 

1 (3) otherwise meets requirements under the 

2 food safety law. 

3 (h) ENFORCEMENT.—The Administrator—

4 (1) may deny importation of food from any for5 eign government that does not permit United States 

6 officials to enter the foreign country to conduct such 

7 audits and inspections as may be necessary to fulfill 

8 the requirements under this section; 

9 (2) may deny importation of food from any for10 eign government or foreign firm that does not con11 sent to an investigation by the Administration when 

12 food from that foreign country or foreign firm is 

13 linked to a food-borne illness outbreak or is other14 wise found to be adulterated or mislabeled; and

15 (3) is authorized to promulgate rules and regu16 lations to carry out the purposes of this section, in17 cluding setting terms and conditions for the destruc18 tion of products that fail to meet the standards of 

19 this Act. 

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

21 for consumption in the United States may be detained, 

22 seized, or condemned pursuant to section 402. 

23 SEC. 209. RESOURCE PLAN. 

24 (a) IN GENERAL.—The Administrator shall prepare 

25 and update annually a resource plan describing the re-
51

•HR 5259 IH 

1 sources required, in the best professional judgment of the 

2 Administrator, to develop and fully implement the national 

3 food safety program established under this Act. 

4 (b) CONTENTS OF PLAN.—The resource plan shall—

5 (1) describe quantitatively the personnel, finan6 cial, and other resources required to carry out the 

7 inspection of food establishments under section 205 

8 and other requirements of the national food safety 

9 program; 

10 (2) allocate inspection resources in a manner 

11 reflecting the distribution of risk and opportunities 

12 to reduce risk across the food supply to the extent 

13 feasible based on the best available information, and 

14 subject to section 205; and 

15 (3) describe the personnel, facilities, equipment, 

16 and other resources needed to carry out inspection 

17 and other oversight activities, at a total resource 

18 level equal to at least 50 percent of the resources re19 quired to carry out inspections in food establish20 ments under section 205—

21 (A) in foreign establishments; 

22 (B) at the point of importation; and 

23 (C) at the point of production on farms, 

24 ranches, and feedlots.
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•HR 5259 IH 

1 (c) GRANTS.—The resource plan shall include rec2 ommendations for funding to provide grants to States and 

3 local governments to carry out food safety activities in re4 tail and food service facilities and the required inspections 

5 in food establishments.

6 (d) SUBMISSION OF PLAN.—The Administrator shall 

7 submit annually to the Committee on Appropriations of 

8 the Senate, the Committee on Appropriations of the House 

9 of Representatives, and other relevant committees of Con10 gress, the resource plan required under this section. 

11 SEC. 210. TRACEBACK. 

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

13 protect the public health, shall establish requirements for 

14 tracing food and food producing animals from point of ori15 gin to retail sale, subject to subsection (b). 

16 (b) APPLICABILITY.—Traceability requirements 

17 shall—

18 (1) be established in accordance with regula19 tions and guidelines issued by the Administrator; 

20 and 

21 (2) apply to food production facilities and food 

22 establishments.

23 (c) RELATIONSHIP TO COUNTRY OF ORIGIN LABEL24 ING.—Nothing contained in this section prevents or inter25 feres with implementation of the country of origin labeling 
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•HR 5259 IH 

1 requirements of subtitle D of the Agricultural Marketing 

2 Act of 1946 (7 U.S.C. 1638 et seq.). 

3 TITLE III—RESEARCH AND 

4 EDUCATION 

5 SEC. 301. PUBLIC HEALTH ASSESSMENT SYSTEM. 

6 (a) IN GENERAL.—The Administrator, acting in co7 ordination with the Director of the Centers for Disease 

8 Control and Prevention and with the Research Education 

9 and Economics mission area of the Department of Agri10 culture, shall—

11 (1) have access to the applicable data systems 

12 of the Centers for Disease Control and Prevention; 

13 (2) maintain an active surveillance system of 

14 food, food products, and epidemiological evidence 

15 submitted by States to the Centers for Disease Con16 trol and Prevention based on a representative pro17 portion of the population of the United States; 

18 (3) assess the frequency and sources of human 

19 illness in the United States associated with the con20 sumption of food; and 

21 (4) maintain a state-of-the-art DNA matching 

22 system and epidemiological system dedicated to food23 borne illness identification, outbreaks, and contain24 ment. 

25 (b) PUBLIC HEALTH SAMPLING.—
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•HR 5259 IH 

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

2 the effective date of this Act, the Administrator shall 

3 establish guidelines for a sampling system under 

4 which the Administrator shall take and analyze sam5 ples of food—

6 (A) to assist the Administrator in carrying 

7 out this Act; and 

8 (B) to assess the nature, frequency of oc9 currence, and quantities of contaminants in 

10 food. 

11 (2) REQUIREMENTS.—The sampling system de12 scribed in paragraph (1) shall provide—

13 (A) statistically valid monitoring, including 

14 market-based studies, on the nature, frequency 

15 of occurrence, and quantities of contaminants 

16 in food available to consumers; and 

17 (B) at the request of the Administrator, 

18 such other information, including analysis of 

19 monitoring and verification samples, as the Ad20 ministrator determines may be useful in assess21 ing the occurrence of contaminants in food. 

22 (c) ASSESSMENT OF HEALTH HAZARDS.—

23 (1) IN GENERAL.—Through the surveillance 

24 system referred to in subsection (a) and the sam-
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•HR 5259 IH 

1 pling system described in subsection (b), the Admin2 istrator shall—

3 (A) rank food categories based on the haz4 ard to human health presented by the food cat5 egory; 

6 (B) identify appropriate industry and regu7 latory approaches to minimize hazards in the 

8 food supply; and 

9 (C) assess the public health environment 

10 for emerging diseases, including zoonosis, for 

11 their risk of appearance in the United States 

12 food supply. 

13 (2) COMPONENTS OF ANALYSIS.—The analysis 

14 under subsection (b)(1) may include—

15 (A) a comparison of the safety of commer16 cial processing with the health hazards associ17 ated with food that is harvested for recreational 

18 or subsistence purposes and prepared non19 commercially; 

20 (B) a comparison of the safety of food that 

21 is domestically processed with the health haz22 ards associated with food that is processed out23 side the United States; 
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1 (C) a description of contamination origi2 nating from handling practices that occur prior 

3 to or after the sale of food to consumers; and

4 (D) use of comparative risk assessments. 

5 SEC. 302. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

6 (a) PUBLIC EDUCATION.—

7 (1) IN GENERAL.—The Administrator, in co8 operation with private and public organizations, in9 cluding the cooperative extension services and appro10 priate State and local entities, shall establish a na11 tional public education program on food safety. 

12 (2) REQUIREMENTS.—The program shall pro13 vide—

14 (A) information to the public regarding 

15 Federal standards and best practices and pro16 motion of public awareness, understanding, and 

17 acceptance of those standards and practices; 

18 (B) information for health professionals—

19 (i) to improve diagnosis and treatment 

20 of food-related illness; and 

21 (ii) to advise individuals at special 

22 risk for food-related illnesses; and 

23 (C) such other information or advice to 

24 consumers and other persons as the Adminis-
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1 trator determines will promote the purposes of 

2 this Act. 

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

4 consultation with other Federal departments and agencies 

5 as the Administrator determines necessary, shall work 

6 with the States and other appropriate entities—

7 (1) to develop and distribute regional and na8 tional advisories concerning food safety; 

9 (2) to develop standardized formats for written 

10 and broadcast advisories; 

11 (3) to incorporate State and local advisories 

12 into the national public education program estab13 lished under subsection (a); and 

14 (4) to present prompt, specific information re15 garding foods found to pose a threat to the public 

16 health. 

17 SEC. 303. RESEARCH. 

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

19 research to carry out this Act, including studies—

20 (1) to improve sanitation and food safety prac21 tices in the processing of food; 

22 (2) to develop improved techniques to monitor 

23 and inspect food; 

24 (3) to develop efficient, rapid, and sensitive 

25 methods to detect contaminants in food; 
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1 (4) to determine the sources of contamination 

2 of contaminated food; 

3 (5) to develop food consumption data; 

4 (6) to identify ways that animal production 

5 techniques could improve the safety of the food sup6 ply; and 

7 (7) to conduct other research that supports the 

8 purposes of this Act. 

9 (b) CONTRACT AUTHORITY.—The Administrator may 

10 enter into contracts and agreements with any State, uni11 versity, Federal Government agency, or person to carry 

12 out this section. 

13 TITLE IV—ENFORCEMENT 

14 SEC. 401. PROHIBITED ACTS. 

15 It is prohibited—

16 (1) to manufacture, introduce, deliver for intro17 duction, or receive into interstate commerce any food 

18 that is adulterated, misbranded, or otherwise unsafe 

19 for human consumption; 

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

22 (3) for a food establishment or foreign food es23 tablishment to fail to register under section 202, or 

24 to operate without a valid registration; 
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1 (4) to refuse to permit access to a food estab2 lishment for the inspection and copying of a record 

3 as required 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 establishment 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(h); 

13 (8) to fail to comply with a provision, regula14 tion, or order of the Administrator under section 

15 202, 203, 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 es18 tablishment processing any such food for commerce, 

19 except in compliance with the food safety law; 

20 (10) to transfer food in violation of an adminis21 trative detention order under section 402 or to re22 move or alter a required mark or label identifying 

23 the food as detained; 

24 (11) to fail to comply with a recall or other 

25 order under section 403; or 
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1 (12) to otherwise violate the food safety law. 

2 SEC. 402. FOOD DETENTION, SEIZURE, AND CONDEMNA3 TION. 

4 (a) ADMINISTRATIVE DETENTION OF FOOD.—

5 (1) EXPANDED AUTHORITY.—The Adminis6 trator shall have authority under section 304 of the 

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

8 334) to administratively detain and seize any food 

9 that the Administrator has reason to believe is un10 safe for human consumption, is adulterated or mis11 branded, or otherwise fails to meet the requirements 

12 of the food safety law. 

13 (2) DETENTION AUTHORITY.—If, during an in14 spection conducted in accordance with section 205 or 

15 208, an officer, employee, or agent of the Adminis16 tration making the inspection has reason to believe 

17 that a domestic food, imported food, or food offered 

18 for import is unsafe for human consumption, is 

19 adulterated or misbranded, or otherwise fails to meet 

20 the requirements of this Act, the officer or employee 

21 may order the food detained. 

22 (3) PERIOD OF DETENTION.—

23 (A) IN GENERAL.—A food may be detained 

24 for a reasonable period, not to exceed 20 days, 

25 unless a longer period, not to exceed 30 days, 
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1 is necessary for the Administrator to institute a 

2 seizure action. 

3 (B) PERISHABLE FOOD.—The Adminis4 trator shall provide by regulation for procedures 

5 to institute a seizure action on an expedited 

6 basis with respect to perishable food. 

7 (4) SECURITY OF DETAINED FOOD.—

8 (A) IN GENERAL.—A detention order—

9 (i) may require that the food be la10 beled or marked as detained; and 

11 (ii) shall require that the food be re12 moved to a secure facility, if appropriate. 

13 (B) FOOD SUBJECT TO AN ORDER.—A 

14 food subject to a detention order shall not be 

15 transferred by any person from the place at 

16 which the food is removed, until released by the 

17 Administrator or until the expiration of the de18 tention period applicable under the order, 

19 whichever occurs first. 

20 (C) DELIVERY OF FOOD.—This subsection 

21 does not authorize the delivery of a food in ac22 cordance with execution of a bond while the ar23 ticle is subject to the order. 

24 (b) APPEAL OF DETENTION ORDER.—
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1 (1) IN GENERAL.—A person who would be enti2 tled to be a claimant for a food subject to a deten3 tion order if the food were seized under section 304 

4 of the Federal Food, Drug, and Cosmetic Act (21 

5 U.S.C. 334), may appeal the order to the Adminis6 trator. 

7 (2) ACTION BY THE ADMINISTRATOR.—Not 

8 later than 5 days after an appeal is filed under para9 graph (1), the Administrator, after providing an op10 portunity for an informal hearing, shall confirm, 

11 modify, or terminate the order involved. 

12 (3) FINAL AGENCY ACTION.—Confirmation, 

13 modification, or termination by the Administrator 

14 under paragraph (2) shall be considered a final 

15 agency action for purposes of section 702 of title 5, 

16 United States Code. 

17 (4) TERMINATION.—The order shall be consid18 ered to be terminated if, after 5 days, the Adminis19 trator has failed—

20 (A) to provide an opportunity for an infor21 mal hearing; or 

22 (B) to confirm, modify, or terminate the 

23 order. 

24 (5) EFFECT OF INSTITUTING COURT ACTION.—

25 If the Administrator initiates an action under sec-
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1 tion 302 of the Federal Food, Drug, and Cosmetic 

2 Act (21 U.S.C. 332) or section 304(a) of that Act 

3 (21 U.S.C. 334(a)), the process for the appeal of the 

4 detention order shall terminate. 

5 (c) CONDEMNATION OF FOOD.—

6 (1) IN GENERAL.—After confirming a detention 

7 order, the Administrator may order the food con8 demned. 

9 (2) DESTRUCTION OF FOOD.—Any food con10 demned shall be destroyed under the supervision of 

11 the Administrator. 

12 (3) RELEASE OF FOOD.—If the Administrator 

13 determines that, through reprocessing, relabeling, or 

14 other action, a detained food can be brought into 

15 compliance with this Act, the food may be released 

16 following a determination by the Administrator that 

17 the relabeling or other action as specified by the Ad18 ministrator has been performed. 

19 (d) TEMPORARY HOLDS AT PORTS OF ENTRY.—

20 (1) IN GENERAL.—If an officer or qualified em21 ployee of the Administration has reason to believe 

22 that a food is unsafe for human consumption, is 

23 adulterated or misbranded, or otherwise fails to meet 

24 the requirements of this Act, and the officer or 

25 qualified employee is unable to inspect, examine, or 
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1 investigate the food when the food is offered for im2 port at a port of entry into the United States, the 

3 officer or qualified employee shall request the Sec4 retary of Homeland Security to hold the food at the 

5 port of entry for a reasonable period of time, not to 

6 exceed 24 hours, to enable the Administrator to in7 spect or investigate the food as appropriate. 

8 (2) REMOVAL TO SECURE FACILITY.—The Ad9 ministrator shall work in coordination with the Sec10 retary of Homeland Security to remove a food held 

11 in accordance with paragraph (1) to a secure facility 

12 as appropriate. 

13 (3) PROHIBITION ON TRANSFER.—During the 

14 period in which the food is held, the food shall not 

15 be transferred by any person from the port of entry 

16 into the United States, or from the secure facility to 

17 which the food has been removed. 

18 (4) DELIVERY IN ACCORDANCE WITH A

19 BOND.—The delivery of the food in accordance with 

20 the execution of a bond while the food is held is not 

21 authorized. 

22 SEC. 403. NOTIFICATION AND RECALL. 

23 (a) NOTICE TO ADMINISTRATOR OF VIOLATION.—

24 (1) IN GENERAL.—A person (other than a 

25 household consumer or other individual who is the 
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1 intended consumer of a food) that has reason to be2 lieve that any food introduced into or in interstate 

3 commerce, or held for sale (whether or not the first 

4 sale) after shipment in interstate commerce, may be 

5 in violation of the food safety law shall immediately 

6 notify the Administrator of the identity and location 

7 of the food. 

8 (2) MANNER OF NOTIFICATION.—Notification 

9 under paragraph (1) shall be made in such manner 

10 and by such means as the Administrator may re11 quire by regulation. 

12 (b) RECALL AND CONSUMER NOTIFICATION.—

13 (1) VOLUNTARY ACTIONS.—If the Adminis14 trator determines that food is in violation of the food 

15 safety law when introduced into or while in inter16 state commerce or while held for sale (whether or 

17 not the first sale) after shipment in interstate com18 merce and that there is a reasonable probability that 

19 the food, if consumed, would present a threat to 

20 public health, as determined by the Administrator, 

21 the Administrator shall give the appropriate persons 

22 (including the manufacturers, importers, distribu23 tors, or retailers of the food) an opportunity to—

24 (A) cease distribution of the food; 

25 (B) notify all persons—
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1 (i) processing, distributing, or other2 wise handling the food to immediately 

3 cease such activities with respect to the 

4 food; or 

5 (ii) to which the food has been distrib6 uted, transported, or sold, to immediately 

7 cease distribution of the food; 

8 (C) recall the food; 

9 (D) in conjunction with the Administrator, 

10 provide notice of the finding of the Adminis11 trator—

12 (i) to consumers to whom the food 

13 was, or may have been, distributed; and 

14 (ii) to State and local public health of15 ficials; or 

16 (E) take any combination of the measures 

17 described in this paragraph, as determined by 

18 the Administrator to be appropriate in the cir19 cumstances. 

20 (2) MANDATORY ACTIONS.—If a person re21 ferred to in paragraph (1) refuses to or does not 

22 adequately carry out the actions described in that 

23 paragraph within the time period and in the manner 

24 prescribed by the Administrator, the Administrator 

25 shall—
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1 (A) have authority to control and possess 

2 the food, including ordering the shipment of the 

3 food from the food establishment to the Admin4 istrator—

5 (i) at the expense of the food estab6 lishment; or 

7 (ii) in an emergency (as determined 

8 by the Administrator), at the expense of 

9 the Administration; and 

10 (B) by order, require, as the Administrator 

11 determines to be necessary, the person to imme12 diately—

13 (i) cease distribution of the food; and 

14 (ii) notify all persons—

15 (I) processing, distributing, or 

16 otherwise handling the food to imme17 diately cease such activities with re18 spect to the food; or 

19 (II) if the food has been distrib20 uted, transported, or sold, to imme21 diately cease distribution of the food. 

22 (3) NOTIFICATION TO CONSUMERS BY ADMINIS23 TRATOR.—The Administrator shall, as the Adminis24 trator determines to be necessary, provide notice of 
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1 the finding of the Administrator under paragraph 

2 (1)—

3 (A) to consumers to whom the food was, or 

4 may have been, distributed; and 

5 (B) to State and local public health offi6 cials. 

7 (4) NONDISTRIBUTION BY NOTIFIED PER8 SONS.—A person that processes, distributes, or oth9 erwise handles the food, or to which the food has 

10 been distributed, transported, or sold, and that is 

11 notified under paragraph (1)(B) or (2)(B) shall im12 mediately cease distribution of the food. 

13 (5) AVAILABILITY OF RECORDS TO ADMINIS14 TRATOR.—Each person referred to in paragraph (1) 

15 that processed, distributed, or otherwise handled 

16 food shall make available to the Administrator infor17 mation necessary to carry out this subsection, as de18 termined by the Administrator, regarding—

19 (A) persons that processed, distributed, or 

20 otherwise handled the food; and 

21 (B) persons to which the food has been 

22 transported, sold, distributed, or otherwise han23 dled. 

24 (c) INFORMAL HEARINGS ON ORDERS.—
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1 (1) IN GENERAL.—The Administrator shall pro2 vide any person subject to an order under subsection 

3 (b) with an opportunity for an informal hearing, to 

4 be held as soon as practicable but not later than 2 

5 business days after the issuance of the order. 

6 (2) SCOPE OF THE HEARING.—In a hearing 

7 under paragraph (1), the Administrator shall con8 sider the actions required by the order and any rea9 sons why the food that is the subject of the order 

10 should not be recalled. 

11 (d) POST-HEARING RECALL ORDERS.—

12 (1) AMENDMENT OF ORDER.—If, after pro13 viding an opportunity for an informal hearing under 

14 subsection (c), the Administrator determines that 

15 there is a reasonable probability that the food that 

16 is the subject of an order under subsection (b), if 

17 consumed, would present a threat to the public 

18 health, the Administrator, as the Administrator de19 termines to be necessary, may—

20 (A) amend the order to require recall of 

21 the food or other appropriate action; 

22 (B) specify a timetable in which the recall 

23 shall occur; 
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1 (C) require periodic reports to the Admin2 istrator describing the progress of the recall; 

3 and 

4 (D) provide notice of the recall to con5 sumers to whom the food was, or may have 

6 been, distributed. 

7 (2) VACATION OF ORDERS.—If, after providing 

8 an opportunity for an informal hearing under sub9 section (c), the Administrator determines that ade10 quate grounds do not exist to continue the actions 

11 required by the order, the Administrator shall vacate 

12 the order. 

13 (e) REMEDIES NOT EXCLUSIVE.—The remedies pro14 vided in this section shall be in addition to, and not exclu15 sive of, other remedies that may be available. 

16 SEC. 404. INJUNCTION PROCEEDINGS. 

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

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

19 possessions of the United States, shall have jurisdiction, 

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

21 203, 204, 207, or 401 (or a regulation promulgated under 

22 that section). 

23 (b) TRIAL.—In a case in which violation of an injunc24 tion or restraining order issued under this section also 
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1 constitutes a violation of the food safety law, trial shall 

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

3 SEC. 405. CIVIL AND CRIMINAL PENALTIES. 

4 (a) CIVIL SANCTIONS.—

5 (1) CIVIL PENALTY.—

6 (A) IN GENERAL.—Any person that com7 mits an act that violates the food safety law (in8 cluding a regulation promulgated or order 

9 issued under a Federal food safety law) may be 

10 assessed a civil penalty by the Administrator of 

11 not more than $10,000 for each such act. 

12 (B) SEPARATE OFFENSE.—Each act de13 scribed in subparagraph (A) and each day dur14 ing which that act continues shall be considered 

15 a separate offense. 

16 (2) OTHER REQUIREMENTS.—

17 (A) WRITTEN ORDER.—The civil penalty 

18 described in paragraph (1) shall be assessed by 

19 the Administrator by a written order, which 

20 shall specify the amount of the penalty and the 

21 basis for the penalty under subparagraph (B) 

22 considered by the Administrator. 

23 (B) AMOUNT OF PENALTY.—Subject to 

24 paragraph (1)(A), the amount of the civil pen-
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1 alty shall be determined by the Administrator, 

2 after considering—

3 (i) the gravity of the violation; 

4 (ii) the degree of culpability of the 

5 person; 

6 (iii) the size and type of the business 

7 of the person; and 

8 (iv) any history of prior offenses by 

9 the person under the food safety law. 

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

11 be reviewed only in accordance with subsection 

12 (c). 

13 (b) CRIMINAL SANCTIONS.—

14 (1) IN GENERAL.—Except as provided in para15 graphs (2) and (3), a person that knowingly pro16 duces or introduces into commerce food that is un17 safe for human consumption or otherwise adulter18 ated or misbranded shall be imprisoned for not more 

19 than 1 year or fined not more than $10,000, or 

20 both. 

21 (2) SEVERE VIOLATIONS.—A person that com22 mits a violation described in paragraph (1) after a 

23 conviction of that person under this section has be24 come final, or commits such a violation with the in25 tent to defraud or mislead, shall be imprisoned for 
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1 not more than 3 years or fined not more than 

2 $100,000, or both. 

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

4 the penalties of this subsection—

5 (A) for having received, proffered, or deliv6 ered in interstate commerce any food, if the re7 ceipt, proffer, or delivery was made in good 

8 faith, unless that person refuses to furnish (on 

9 request of an officer or employee designated by 

10 the Administrator)—

11 (i) the name, address and contact in12 formation of the person from whom that 

13 person purchased or received the food; 

14 (ii) copies of all documents relating to 

15 the person from whom that person pur16 chased or received the food; and 

17 (iii) copies of all documents pertaining 

18 to the delivery of the food to that person; 

19 or 

20 (B) if that person establishes a guaranty 

21 signed by, and containing the name and address 

22 of, the person from whom that person received 

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

24 not adulterated or misbranded within the mean25 ing of this Act. 
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1 (c) JUDICIAL REVIEW.—

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

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

4 unless the person—

5 (A) not later than 30 days after the effec6 tive date of the order, files a petition for judi7 cial review of the order in the United States 

8 court of appeals for the circuit in which that 

9 person resides or has its principal place of busi10 ness or the United States Court of Appeals for 

11 the District of Columbia; and 

12 (B) simultaneously serves a copy of the pe13 tition by certified mail to the Administrator. 

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

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

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

17 court a certified copy of the administrative record 

18 upon which the order was issued. 

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

20 the Administrator relating to the order shall be set 

21 aside only if found to be unsupported by substantial 

22 evidence on the record as a whole. 

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

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

25 civil penalty assessed under subsection (a) after the 
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1 order assessing the penalty has become a final order, 

2 or after the court of appeals described in subsection 

3 (b) has entered final judgment in favor of the Ad4 ministrator, the Administrator shall refer the matter 

5 to the Attorney General, who shall institute in a 

6 United States district court of competent jurisdic7 tion a civil action to recover the amount assessed. 

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

9 under paragraph (1), the validity and appropriate10 ness of the order of the Administrator assessing the 

11 civil penalty shall not be subject to judicial review. 

12 (e) PENALTIES PAID INTO ACCOUNT.—The Adminis13 trator—

14 (1) shall deposit penalties collected under this 

15 section in an account in the Treasury; and 

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

17 further appropriation or fiscal year limitation—

18 (A) to carry out enforcement activities 

19 under food safety law; or 

20 (B) to provide assistance to States to in21 spect retail commercial food establishments or 

22 other food or firms under the jurisdiction of 

23 State food safety programs. 

24 (f) DISCRETION OF THE ADMINISTRATOR TO PROS25 ECUTE.—Nothing in this Act requires the Administrator 
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1 to report for prosecution, or for the commencement of an 

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

3 which the Administrator finds that the public interest will 

4 be adequately served by the assessment of a civil penalty 

5 under this section. 

6 (g) REMEDIES NOT EXCLUSIVE.—The remedies pro7 vided in this section may be in addition to, and not exclu8 sive of, other remedies that may be available. 

9 SEC. 406. PRESUMPTION. 

10 In any action to enforce the requirements of the food 

11 safety law, the connection with interstate commerce re12 quired for jurisdiction shall be presumed to exist. 

13 SEC. 407. WHISTLEBLOWER PROTECTION. 

14 (a) IN GENERAL.—No employee or inspector of a 

15 food establishment or other person may be harassed, pros16 ecuted, held liable, or discriminated against in any way 

17 because that person—

18 (1) has commenced, caused to be commenced, 

19 or is about to commence a proceeding, has testified 

20 or is about to testify at a proceeding, or has assisted 

21 or participated or is about to assist or participate in 

22 any manner in a proceeding or other action, to carry 

23 out the objectives, functions, or responsibilities spec24 ified in the food safety law; or 
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1 (2) is refusing to violate or assist in the viola2 tion of a law described in paragraph (1), including 

3 a regulation issued under that law. 

4 (b) PROCEDURES.—

5 (1) IN GENERAL.—A person alleging a violation 

6 of subsection (a) may file a complaint in accordance 

7 with section 31105(b) of title 49, United States 

8 Code. 

9 (2) ADMINISTRATION.—Except as provided in 

10 paragraphs (3) and (4), the process, procedures, and 

11 remedies under subsections (b), (c), and (d) of sec12 tion 31105 of title 49, United States Code, with re13 spect to allegations of violations of subsection (a) of 

14 that section shall be the process, procedures, and 

15 remedies that apply with respect to allegations of 

16 violations of subsection (a). 

17 (3) ALTERNATIVE PROCESS.—The person filing 

18 a complaint under paragraph (1) may elect to use an 

19 alternative dispute resolution procedure, including 

20 mediation or arbitration, in lieu of the hearing de21 scribed in section 31105(b) of title 49, United States 

22 Code. 

23 (4) ADMINISTRATOR.—The powers and duties 

24 that apply to the Secretary of Labor under section 
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1 31105 of title 49, United States Code, shall apply to 

2 the Administrator under the food safety law. 

3 (c) BURDENS OF PROOF.—The legal burdens of proof 

4 with respect to a violation of subsection (a) shall be gov5 erned by the applicable provisions of sections 1214 and 

6 1221 of title 5, United States Code. 

7 SEC. 408. ADMINISTRATION AND ENFORCEMENT. 

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

9 and enforcement of the food safety law, the provisions (in10 cluding provisions relating to penalties) of sections 6, 8, 

11 9, and 10 of the Federal Trade Commission Act (15 

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

13 (h) of section 6 of that Act), relating to the jurisdiction, 

14 powers, and duties of the Federal Trade Commission and 

15 the Attorney General to administer and enforce that Act, 

16 and to the rights and duties of persons with respect to 

17 whom the powers are exercised, shall apply to the jurisdic18 tion, powers, and duties of the Administrator and the At19 torney General in administering and enforcing the provi20 sions of the food safety law and to the rights and duties 

21 of persons with respect to whom the powers are exercised, 

22 respectively. 

23 (b) INQUIRIES AND ACTIONS.—

24 (1) IN GENERAL.—The Administrator, in per25 son or by such agents as the Administrator may des-
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1 ignate, may prosecute any inquiry necessary to carry 

2 out the duties of the Administrator under the food 

3 safety law in any part of the United States. 

4 (2) POWERS.—The powers conferred by sec5 tions 9 and 10 of the Federal Trade Commission 

6 Act (15 U.S.C. 49 and 50) on the United States dis7 trict courts may be exercised for the purposes of this 

8 chapter by any United States district court of com9 petent jurisdiction. 

10 SEC. 409. CITIZEN CIVIL ACTIONS. 

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

12 action against—

13 (1) a person that violates a regulation (includ14 ing a regulation establishing a performance stand15 ard), order, or other action of the Administrator to 

16 ensure the safety of food; or 

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

18 the Administrator), if the Administrator fails to per19 form an act or duty to ensure the safety of food that 

20 is not discretionary under the food safety law. 

21 (b) COURT.—

22 (1) IN GENERAL.—The action shall be com23 menced in the United States district court for the 

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

25 has an agent. 
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1 (2) JURISDICTION.—The court shall have juris2 diction, without regard to the amount in con3 troversy, or the citizenship of the parties, to enforce 

4 a regulation (including a regulation establishing a 

5 performance standard), order, or other action of the 

6 Administrator, or to order the Administrator to per7 form the act or duty. 

8 (3) DAMAGES.—The court may—

9 (A) award damages, in the amount of dam10 ages actually sustained; and 

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

12 interest of justice, award the plaintiff the costs 

13 of suit, including reasonable attorney’s fees, 

14 reasonable expert witness fees, and penalties. 

15 (c) REMEDIES NOT EXCLUSIVE.—The remedies pro16 vided for in this section shall be in addition to, and not 

17 exclusive of, other remedies that may be available. 

18 TITLE V—IMPLEMENTATION 

19 SEC. 501. DEFINITION. 

20 For purposes of this title, the term ‘‘transition pe21 riod’’ means the 12-month period beginning on the effec22 tive date of this Act. 

23 SEC. 502. REORGANIZATION PLAN. 

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

25 after the effective date of this Act, the President shall 
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1 transmit to the appropriate congressional committees a re2 organization plan regarding the following: 

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

4 and obligations to the Administration pursuant to 

5 this Act. 

6 (2) Any consolidation, reorganization, or 

7 streamlining of agencies transferred to the Adminis8 tration pursuant to this Act. 

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

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

11 elements as the President determines appropriate, includ12 ing the following: 

13 (1) Identification of any functions of agencies 

14 designated to be transferred to the Administration 

15 pursuant to this Act that will not be transferred to 

16 the Administration under the plan. 

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

18 Administrator to organize the Administration, in19 cluding the delegation or assignment of functions 

20 transferred to the Administration among the officers 

21 of the Administration in order to permit the Admin22 istration to carry out the functions transferred 

23 under the plan. 
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1 (3) Specification of the funds available to each 

2 agency that will be transferred to the Administration 

3 as a result of transfers under the plan. 

4 (4) Specification of the proposed allocations 

5 within the Administration of unexpended funds 

6 transferred in connection with transfers under the 

7 plan. 

8 (5) Specification of any proposed disposition of 

9 property, facilities, contracts, records, and other as10 sets and obligations of agencies transferred under 

11 the plan. 

12 (6) Specification of the proposed allocations 

13 within the Administration of the functions of the 

14 agencies and subdivisions that are not related di15 rectly to ensuring the safety of food intended for 

16 human consumption. 

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

18 on the basis of consultations with the appropriate congres19 sional committees, modify, or revise any part of the plan 

20 until that part of the plan becomes effective in accordance 

21 with subsection (d). 

22 (d) EFFECTIVE DATE.—

23 (1) IN GENERAL.—The reorganization plan de24 scribed in this section, including any modifications 
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1 or revisions of the plan under subsection (c), shall 

2 become effective for an agency on the earlier of—

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

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

5 except that such date may not be earlier than 

6 90 days after the date the President has trans7 mitted the reorganization plan to the appro8 priate congressional committees pursuant to 

9 subsection (a); or 

10 (B) the end of the transition period. 

11 (2) STATUTORY CONSTRUCTION.—Nothing in 

12 this subsection may be construed to require the 

13 transfer of functions, personnel, records, balances of 

14 appropriations, or other assets of an agency on a 

15 single date. 

16 (3) SUPERCEDES EXISTING LAW.—Paragraph 

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

18 title 5, United States Code. 

19 SEC. 503. TRANSITIONAL AUTHORITIES. 

20 (a) PROVISION OF ASSISTANCE BY OFFICIALS.—

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

22 official having authority over or function relating to the 

23 agency immediately before the effective date of this Act 

24 shall provide the Administrator such assistance, including 

25 the use of personnel and assets, as the Administrator may 
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1 request in preparing for the transfer and integration of 

2 the agency to the Administration. 

3 (b) SERVICES AND PERSONNEL.—During the transi4 tion period, upon the request of the Administrator, the 

5 head of any executive agency may, on a reimbursable 

6 basis, provide services or detail personnel to assist with 

7 the transition. 

8 (c) ACTING OFFICIALS.—

9 (1) IN GENERAL.—During the transition pe10 riod, pending the advice and consent of the Senate 

11 to the appointment of an officer required by this Act 

12 to be appointed by and with such advice and con13 sent, the President may designate any officer whose 

14 appointment was required to be made by and with 

15 such advice and consent and who was such an officer 

16 immediately before the effective date of this Act 

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

18 before such designation, to act in such office until 

19 the same is filled as provided in this Act. 

20 (2) COMPENSATION.—While acting pursuant to 

21 paragraph (1), such officers shall receive compensa22 tion at the higher of—

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

24 respective offices in which they act; or 
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1 (B) the rates provided for the offices held 

2 at the time of designation. 

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

4 construed to require the advice and consent of the 

5 Senate to the appointment by the President to a po6 sition in the Administration of any officer whose 

7 agency is transferred to the Administration pursuant 

8 to this Act and whose duties following such transfer 

9 are germane to those performed before such trans10 fer. 

11 (d) TRANSFER OF PERSONNEL, ASSETS, OBLIGA12 TIONS, AND FUNCTION.—

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

14 of title 31, United States Code, the personnel, as15 sets, liabilities, contracts, property, records, and un16 expended balances of appropriations, authorizations, 

17 allocations, and other funds that relate to the func18 tions transferred under subsection (a) from a Fed19 eral agency shall be transferred to the Administra20 tion.

21 (2) UNEXPENDED FUNDS.—Unexpended funds 

22 transferred under this subsection shall be used by 

23 the Administration only for the purposes for which 

24 the funds were originally authorized and appro25 priated.
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1 SEC. 504. SAVINGS PROVISIONS.

2 (a) COMPLETED ADMINISTRATIVE ACTIONS.—The 

3 enactment of this Act or the transfer of functions under 

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

5 regulation, permit, personnel action, agreement, grant, 

6 contract, certificate, license, registration, privilege, or 

7 other administrative action issued, made, granted, or oth8 erwise in effect or final with respect to that agency on 

9 the day before the transfer date with respect to the trans10 ferred functions

11 (b) PENDING PROCEEDINGS.—Subject to the author12 ity of the Administrator under this Act—

13 (1) pending proceedings in an agency, including 

14 notices of proposed rulemaking, and applications for 

15 licenses, permits, certificates, grants, and financial 

16 assistance, shall continue notwithstanding the enact17 ment of this Act or the transfer of the agency to the 

18 Administration, unless discontinued or modified 

19 under the same terms and conditions and to the 

20 same extent that such discontinuance could have oc21 curred if such enactment or transfer had not oc22 curred; and

23 (2) orders issued in such proceedings, and ap24 peals therefrom, and payments made pursuant to 

25 such orders, shall issue in the same manner on the 

26 same terms as if this Act had not been enacted or 
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1 the agency had not been transferred, and any such 

2 order shall continue in effect until amended, modi3 fied, superceded, terminated, set aside, or revoked by 

4 an officer of the United States or a court of com5 petent jurisdiction, or by operation of law.

6 (c) PENDING CIVIL ACTIONS.—Subject to the author7 ity of the Administrator under this Act, any civil action 

8 commenced with regard to that agency pending before 

9 that agency on the day before the transfer date with re10 spect to the transferred functions shall continue notwith11 standing the enactment of this Act or the transfer of an 

12 agency to the Administration.

13 (d) REFERENCES.—

14 (1) IN GENERAL.—After the transfer of func15 tions from a Federal agency under this Act, any ref16 erence in any other Federal law, Executive order, 

17 rule, regulation, directive, document, or other mate18 rial to that Federal agency or the head of that agen19 cy in connection with the administration or enforce20 ment of the food safety laws shall be deemed to be 

21 a reference to the Administration or the Adminis22 trator, respectively.

23 (2) STATUTORY REPORTING REQUIREMENTS.—

24 Statutory reporting requirements that applied in re25 lation to such an agency immediately before the ef-
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1 fective date of this Act shall continue to apply fol2 lowing such transfer if they refer to the agency by 

3 name. 

4 SEC. 505. CONFORMING AMENDMENTS. 

5 (a) EXECUTIVE SCHEDULE.—Section 5313 of title 5, 

6 United States Code, is amended by inserting at the end 

7 the following new item: 

8 ‘‘Administrator of Food Safety.’’. 

9 (b) REPEAL OF CERTAIN PROVISIONS.—Section 18 

10 of the Poultry Products Inspection Act (21 U.S.C. 467), 

11 section 401 of the Federal Meat Inspection Act (21 U.S.C. 

12 671), and section 18 of the Egg Products Inspection Act 

13 (21 U.S.C. 1047) are repealed. 

14 SEC. 506. ADDITIONAL TECHNICAL AND CONFORMING 

15 AMENDMENTS. 

16 Not later than 60 days after the submission of the 

17 reorganization plan under section 502, the President shall 

18 prepare and submit proposed legislation to Congress con19 taining necessary and appropriate technical and con20 forming amendments to the Acts listed in section 3(15) 

21 of this Act to reflect the changes made by this Act. 

22 SEC. 507. REGULATIONS. 

23 The Administrator may promulgate such regulations 

24 as the Administrator determines are necessary or appro25 priate to perform the duties of the Administrator. 
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1 SEC. 508. AUTHORIZATION OF APPROPRIATIONS. 

2 There are authorized to be appropriated such sums 

3 as are necessary to carry out this Act. 

4 SEC. 509. LIMITATION ON AUTHORIZATION OF APPROPRIA5 TIONS. 

6 For the fiscal year that includes the effective date 

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

8 carry out this Act shall not exceed—

9 (1) the amount appropriated for that fiscal year 

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

11 for the purpose of administering or enforcing the 

12 food safety law; or

13 (2) the amount appropriated for those agencies 

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

15 of the effective date of this Act, appropriations for 

16 those agencies for the fiscal year that includes the 

17 effective date have not yet been made. 

18 SEC. 510. EFFECTIVE DATE. 

19 This Act takes effect on the date of enactment of this 

20 Act.

Æ