I 

108TH CONGRESS 

1ST SESSION H. R. 1496

To establish a comprehensive program to ensure the safety of food products 

intended for human consumption which are regulated by the Food and 

Drug Administration. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 27, 2003

Mr. PALLONE introduced the following bill; which was referred to the 

Committee on Energy and Commerce 

A BILL

To establish a comprehensive program to ensure the safety 

of food products intended for human consumption which 

are regulated by the Food and Drug Administration.

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

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

5 ‘‘Consumer Food Safety Act of 2003’’. 

6 (b) TABLE OF CONTENTS.—

Sec. 1. Short title; table of contents. 

Sec. 2. Definitions. 

TITLE I—NATIONAL FOOD SAFETY PROGRAM 

Sec. 101. Administration of national program. 

Sec. 102. Process controls to reduce the adulteration of food products. 
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Sec. 103. Inspections of processors and importers. 

Sec. 104. Tolerances for contaminants in food. 

Sec. 104. State and Federal cooperation. 

Sec. 106. Imports. 

TITLE II—RESEARCH AND EDUCATION 

Sec. 201. Public health assessment system. 

Sec. 202. Public education and advisory system. 

Sec. 203. Research. 

TITLE III—ENFORCEMENT 

Sec. 301. Amendments to the Federal Food, Drug, and Cosmetic Act. 

TITLE IV—AUTHORIZATION 

Sec. 401. Authorization of appropriations.

1 SEC. 2. DEFINITIONS. 

2 For purposes of this Act: 

3 (1) The term ‘‘contaminants’’ includes bacteria, 

4 chemical contaminants, natural toxins, viruses, 

5 parasites, and physical hazards that when found on 

6 or in food can cause human illness or injury. 

7 (2) The term ‘‘facility’’ includes any factory, 

8 warehouse, establishment, or importer that handles 

9 or processes food. 

10 (3) The term ‘‘process’’ means the commercial 

11 harvesting, preparation, manufacture, or transpor12 tation of food products. 

13 (4) The term ‘‘Secretary’’ means the Secretary 

14 of Health and Human Services. 
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1 TITLE I—NATIONAL FOOD 

2 SAFETY PROGRAM 

3 SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM. 

4 (a) IN GENERAL.—

5 (1) Persons who produce or process food for 

6 human consumption have the responsibility to pre7 vent or minimize food safety hazards related to their 

8 products. The Secretary shall administer a national 

9 program for the purpose of protecting human health 

10 by ensuring that the food industry has effective pro11 grams in place to assure the safety of food products 

12 consumed in the United States. 

13 (2) The program shall—

14 (A) be based on a comprehensive analysis 

15 of the hazards associated with different food 

16 products and with the harvesting, processing, 

17 and handling of different food products, includ18 ing the identification and evaluation of—

19 (i) the severity of the potential health 

20 risks; 

21 (ii) the sources and specific points of 

22 potential contamination that may render 

23 food products unsafe for human consump24 tion; and 
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1 (iii) the potential for persistence, mul2 tiplication, or concentration of naturally 

3 occurring or added contaminants in foods 

4 and food products; 

5 (B) take into consideration the distinctive 

6 characteristics of food production and proc7 essing; 

8 (C) establish inspection and oversight pro9 cedures to monitor that facilities are utilizing 

10 preventive controls to minimize or eliminate 

11 identifiable hazards; and 

12 (D) require each food processing facility to 

13 annually register with the Secretary. 

14 (b) PROGRAM ELEMENTS.—The program shall pro15 vide for—

16 (1) implementation of a national system for the 

17 registration and quarterly inspection of facilities and 

18 importers. Quarterly inspections can be waived by 

19 plants that meet the Secretary’s standards for ex20 ceptional or negligible-risk facilities or importers; 

21 (2) development of a program to oversee the 

22 implementation of process controls in food proc23 essing facilities; 

24 (3) the establishment and enforcement of 

25 health-based standards for (A) substances which 
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1 may contaminate food and (B) safety and sanitation 

2 in the processing and handling of food products; 

3 (4) implementation of a sampling program to 

4 ensure that industry programs to prevent food con5 tamination are effective and that food products meet 

6 the standards established in paragraph (1); 

7 (5) implementation of procedures and require8 ments to ensure the safety of imported food prod9 ucts; 

10 (6) coordination with other Federal agencies or 

11 State governments in carrying out inspection, en12 forcement, and monitoring; 

13 (7) implementation of a national surveillance 

14 system to assess the health risks associated with the 

15 human consumption of food products, in cooperation 

16 with the Secretary of Agriculture and the Centers 

17 for Disease Control and Prevention; 

18 (8) development of public education and advi19 sory programs; and

20 (9) implementation of a research program in 

21 furtherance of the purposes of this Act. 
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1 SEC. 102. PROCESS CONTROLS TO REDUCE THE ADULTERA2 TION OF FOOD PRODUCTS. 

3 (a) IN GENERAL.—The Secretary shall, upon the 

4 basis of the best available scientific and technological data, 

5 prescribe regulations to—

6 (1) limit the presence of human pathogens and 

7 other potentially harmful substances in food prod8 ucts; 

9 (2) ensure that all registered facilities imple10 ment appropriate measures to control and reduce 

11 the presence and growth of human pathogens and 

12 other potentially harmful substances on food prod13 ucts; 

14 (3) ensure that all fully processed or ready-to15 eat food products are processed in a sanitary man16 ner, using reasonably available techniques and tech17 nologies to eliminate any human pathogens or other 

18 potentially harmful substances likely to cause 

19 foodborne illness; and 

20 (4) ensure that food products intended for final 

21 processing outside commercial establishments are la22 beled with instructions for handling and preparation 

23 for consumption which, when adhered to, will de24 stroy any human pathogens or other potentially 

25 harmful substance likely to cause foodborne illness. 
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1 (b) REGULATIONS.—The Secretary shall, within one 

2 year of the enactment of this Act, issue regulations that 

3 require all registered facilities to adopt processing controls 

4 adequate to protect public health and to limit the presence 

5 and growth of human pathogens and other potentially 

6 harmful substances in food products prepared in any reg7 istered facility. Such regulations shall—

8 (1) set standards for sanitation; 

9 (2) set tolerances for biological, chemical, and 

10 physical hazards as appropriate; 

11 (3) require process controls to assure that food 

12 is safe and that relevant regulatory and safety 

13 standards are met; 

14 (4) require recordkeeping to monitor compli15 ance; 

16 (5) require sampling to assure that processing 

17 controls are effective and that regulatory standards 

18 are being met; and 

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

20 official establishments and submission of copies of 

21 such records to the Secretary as the Secretary 

22 deems appropriate. 

23 Public access to records that relate to the adequacy of 

24 measures taken by official establishments to protect the 

25 public health and to limit the presence and growth of 
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1 human pathogens and other potentially harmful sub2 stances shall be governed by 5 U.S.C. 552 et seq. The 

3 Secretary may, as the Secretary deems necessary, require 

4 any person, firm, or corporation with responsibility for or 

5 control over food ingredients to adopt processing controls, 

6 where such processing controls are needed to assure the 

7 protection of public health.

8 SEC. 103. INSPECTIONS OF PROCESSORS AND IMPORTERS. 

9 (a) NATURE OF INSPECTIONS.—

10 (1) The inspection system shall provide for fre11 quent unannounced inspections of food processing 

12 and importing facilities to determine if such facilities 

13 are operated in a sanitary manner and if food prod14 ucts are unsafe for human consumption, or adulter15 ated or misbranded under the Federal Food, Drug, 

16 and Cosmetic Act (21 U.S.C. 301 et seq.). Inspec17 tions shall include review of processing records and 

18 sampling of food products. 

19 (2) Inspections shall be conducted at least quar20 terly, unless the Secretary determines that the facil21 ity is an exceptional or negligible-risk facility under 

22 standards established by the Secretary. 

23 (3) Standards for exceptional or negligible-risk 

24 facilities shall consider the hazards associated with 

25 the type of product being produced; and the facility’s 
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1 history of compliance, food safety problems and such 

2 other factors as the Secretary may deem appro3 priate. The Secretary shall specify an alternative in4 spection frequency for each facility which is deemed 

5 exceptional or negligible-risk. Each inspection shall 

6 include an examination of whether the facility con7 tinues to meet the standards for exceptional or neg8 ligible-risk facilities. 

9 (b) CONDUCT OF INSPECTIONS.—

10 (1) An inspection under subsection (a) of any 

11 domestic, foreign, or importing facility shall extend 

12 to all things therein (including records required to 

13 be maintained under subsection (e), processes, con14 trols, and premises) that bear on whether food prod15 ucts are in compliance with this Act or the Federal 

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

17 seq.). Access to records may include the copying of 

18 such records. 

19 (2) In conducting such inspections, officers or 

20 employees duly designated by the Secretary, upon 

21 presenting appropriate credentials to the owner, op22 erator, or agent in charge, are authorized—

23 (A) to enter at reasonable times any facil24 ity in which persons are engaged in the food 

25 processing or importing of food products, or to 
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1 enter any vehicle being used to transport or 

2 hold such food products; 

3 (B) to inspect in a reasonable manner such 

4 facility or vehicle and all pertinent equipment, 

5 finished and unfinished materials, containers, 

6 labeling, processes, controls, and premises; and 

7 (C) to collect and retain samples of food 

8 products or ingredients or of any other items 

9 found during an inspection that may contribute 

10 to a finding of whether such food products are 

11 unsafe for human consumption or adulterated 

12 or misbranded under the Food, Drug, and Cos13 metic Act (21 U.S.C. 301 et seq.). 

14 (3) Immediately after completion of inspection, 

15 the officer or employee making the inspection shall 

16 give to the owner, operator, or agent in charge a re17 port in writing setting forth any conditions or prac18 tices observed which indicate that either processing 

19 controls are inadequate to prevent or minimize food 

20 safety hazards or that any food from such facility is 

21 unsafe for human consumption, or adulterated or 

22 misbranded under the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 301 et seq.). 

24 (c) PRODUCT DETENTION AND CONDEMNATION.—
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1 (1) If, during an inspection conducted under 

2 this section, an officer or employee making the in3 spection has reason to believe that a food product is 

4 unsafe for human consumption, or adulterated or 

5 misbranded under the Federal Food, Drug, and Cos6 metic Act (21 U.S.C. 301 et seq.), such officer or 

7 employee may order the food product segregated, 

8 impounded, and if objection is not made within 48 

9 hours, condemned. If objection is made, such food 

10 products that are in perishable form may be proc11 essed to the extent necessary to prevent spoilage, 

12 and a hearing shall be commenced expeditiously. 

13 (2) If the Secretary determines that, through 

14 relabeling or other action, such food products can be 

15 brought into compliance with this Act and the Fed16 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 

17 et seq.), the food may be released following a deter18 mination by the Secretary that such relabeling or 

19 other action as specified by the Secretary has been 

20 performed. 

21 (3) Any food product condemned without objec22 tion, or after hearing and judicial review, shall be 

23 destroyed under supervision of the Secretary. 

24 (d) OFFICIAL MARK.—The Secretary shall prescribe 

25 by regulation the conditions under which any food product 
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1 shall display an official mark, when needed to facilitate 

2 exports, that signifies that the food product has been proc3 essed in accordance with standards approved by the Sec4 retary. Such a mark may be subject to a fee. 

5 (e) MAINTENANCE OF RECORDS.—Each facility or 

6 person registered under this section shall maintain and 

7 make available for inspection by the Secretary such 

8 records as the Secretary may prescribe. Such records shall 

9 be maintained for a reasonable period of time as deter10 mined by the Secretary. The records shall include, but are 

11 not limited to, information concerning—

12 (1) the origin, receipt, delivery, sale, movement, 

13 holding, and disposition of food products or ingredi14 ents; the identity and amount of ingredients used in 

15 the food; the processing of the food; the results of 

16 laboratory, sanitation, or other quality control tests 

17 performed on the food or in the facility; consumer 

18 complaints concerning the food or its packaging; and 

19 (2) other matters reasonably related to whether 

20 food products may be unsafe for human consump21 tion, or adulterated or misbranded under the Fed22 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301 

23 et seq.). 

24 (f) OTHER INSPECTION RIGHTS AND DUTIES.—Sec25 tion 704 of the Federal Food, Drug, and Cosmetic Act 
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1 (21 U.S.C. 374) is amended by adding at the end the fol2 lowing new subsection: 

3 ‘‘(f) The rights and duties under this section of duly 

4 designated officers and employees and of other persons 

5 shall apply to enforcement of the Consumer Food Safety 

6 Act of 2003 to the same extent and in the same manner 

7 as they apply to enforcement of this Act.’’.

8 SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD. 

9 (a) TOLERANCES.—The Secretary shall establish tol10 erances limiting the quantity of contaminants, except for 

11 pesticide residues regulated under section 408 or food ad12 ditives regulated under section 409 of the Federal Food, 

13 Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), that, 

14 when found in food products, may render such products 

15 unsafe for human consumption. Contaminants include but 

16 are not limited to bacteria, chemical contaminants, natural 

17 toxins, viruses and parasites that when found on or in food 

18 can cause human illness. Such tolerances may include in19 dicators (including indicator organisms) from which it 

20 may reasonably be inferred that a contaminant is present 

21 in a food product. In developing a tolerance, the Secretary 

22 shall take into account the extent to which consumers may 

23 be exposed to such contaminant from sources other than 

24 food, and the extent to which such contaminant can be 
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1 avoided or minimized in the commercial handling and 

2 processing of such food. 

3 (b) REGULATIONS.—

4 (1) The Secretary, after notice and an oppor5 tunity for comment, shall promulgate regulations to 

6 implement subsection (a) within 48 months after the 

7 date of enactment of this Act. In promulgating such 

8 regulations, the Secretary shall establish tolerances 

9 for the contaminants that the Secretary determines 

10 are having the greatest public health impact as early 

11 as feasible after implementation of this Act. 

12 (2) A tolerance established under this section 

13 shall be based on—

14 (A) a scientific analysis of the health risks 

15 attributable to the contaminant for which the 

16 tolerance is established; and 

17 (B) analysis of the risks for sensitive 

18 groups, such as children, elderly, pregnant 

19 women and the immune compromised. 

20 (3) The Secretary shall, in a timely manner, 

21 issue revisions to the regulations under paragraph 

22 (1) which take into account new information. The 

23 Secretary may contract with the National Academy 

24 of Sciences to provide such data or assistance as the 

25 Secretary deems necessary. 
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1 (c) REPORT.—The Secretary shall report to the Con2 gress on the progress of the Secretary in establishing tol3 erances under this section. The report shall include a de4 scription of the research that has been conducted with re5 spect to such tolerances and the research that must be 

6 conducted before additional tolerances may be established, 

7 the health significance of the lack of such additional toler8 ances, a timetable for the establishment of such toler9 ances, and the estimated costs, including costs of research, 

10 associated with the establishment of such tolerances. The 

11 report shall be transmitted on or about the end of the 18th 

12 month after the date of enactment of this Act, and bienni13 ally thereafter during the 6-year period that begins on 

14 such date of enactment.

15 SEC. 105. STATE AND FEDERAL COOPERATION. 

16 (a) IN GENERAL.—The Secretary shall work with the 

17 States in undertaking activities and programs that con18 tribute to the national food safety program so that State 

19 and Federal programs function in a coordinated and cost20 effective manner. With the assistance provided in sub21 section (b), the Secretary shall encourage States to—

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

23 safety programs, especially with respect to the regu24 lation of retail commercial food establishments, 

25 transportation, harvesting, and fresh markets; and 
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1 (2) establish procedures and requirements for 

2 ensuring that food products under the jurisdiction of 

3 the State are not unsafe for human consumption. 

4 (b) ASSISTANCE.—

5 (1) The Secretary may provide to a State, for 

6 planning, developing, and implementing a food safe7 ty program—

8 (A) advisory assistance; 

9 (B) technical and laboratory assistance 

10 and training (including necessary materials and 

11 equipment); and 

12 (C) financial and other aid. 

13 (c) SERVICE AGREEMENTS.—The Secretary may, 

14 under agreements entered into with Federal, State, or 

15 local agencies, use on a reimbursable basis or otherwise 

16 the personnel, services, and facilities of such agencies in 

17 carrying out their responsibilities under this Act. Such an 

18 agreement shall provide that any compliance records, no19 tices, or reports issued in connection with activities under 

20 the agreement and in the possession of the agency or gov21 ernment which entered into the agreement shall be made 

22 available in accordance with section 552 of title 5, United 

23 States Code. Agreements with a State under this sub24 section may provide for training of State employees. 
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1 SEC. 106. IMPORTS. 

2 (a) ROLE OF SECRETARY.—Within 24 months after 

3 the date of enactment of this Act, the Secretary shall es4 tablish and administer a comprehensive and efficient sys5 tem to ensure the safety of food imported into the United 

6 States. The Secretary shall routinely inspect processing 

7 facilities in exporting nations and imports at ports of entry 

8 into the United States. The Secretary shall assure the ef9 fective operation through verification and other activities 

10 as the Secretary considers necessary. 

11 (b) IMPORT REQUIREMENTS.—

12 (1) No food product may enter the United 

13 States, or be withdrawn from a warehouse, for con14 sumption in the United States if such food prod15 uct—

16 (A) appears unsafe for human consump17 tion, or adulterated or misbranded under the 

18 Federal Food, Drug, and Cosmetic Act (21 

19 U.S.C. 301 et seq.); 

20 (B) is not marked or labeled as required 

21 by regulations for domestic or imported articles; 

22 or 

23 (C) does not comply with the requirements 

24 of this section. 

25 (2) Upon entry for consumption in the United 

26 States, food products that are not prohibited from 
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1 entry or from withdrawal from a warehouse under 

2 paragraph (1) shall be deemed to be and treated as 

3 domestic food products, except that all labeling of 

4 such products shall clearly identify the country of 

5 origin to facilitate the identification of products 

6 linked to outbreaks of illness. 

7 (c) INSPECTION OF IMPORTS.—

8 (1) Food products that are offered for importa9 tion, or withdrawn from a warehouse, for consump10 tion in the United States, shall be subject to exami11 nations inspections, sampling, and such other proce12 dures at the port of entry or in the exporting nation 

13 by officers or employees duly designated by the Sec14 retary. Such procedures shall be conducted with 

15 such frequency and in such manner as the Secretary 

16 may prescribe by regulation. 

17 (2) Food products from a nation that is cer18 tified for such food products under subsection (e)(3) 

19 shall be subject to random examinations, inspections, 

20 sampling, and other procedures. Food products from 

21 a nation that is not certified for such food products 

22 under subsection (e)(3) shall be subject to such in23 tensified examinations, inspections, sampling, and 

24 other verification procedures, including inspection in 
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1 the country of origin, as the Secretary determines 

2 are necessary to ensure compliance with this Act. 

3 (d) DETENTION OF IMPORTED FOOD PRODUCT.—If 

4 during an inspection or other verification procedure car5 ried out under this section, an officer or employee con6 ducting the procedure has reason to believe that a food 

7 product is unsafe for human consumption, or adulterated 

8 or misbranded under the Federal Food, Drug, and Cos9 metic Act (21 U.S.C. 301 et seq.), such officer or employee 

10 may order the food product segregated, impounded, and 

11 if objection is not made within 48 hours, condemned. If 

12 objection is made, such food products that are in perish13 able form may be processed to the extent necessary to pre14 vent spoilage, and a hearing shall be commenced expedi15 tiously. The final condemnation or other disposition of 

16 such food product shall be subject to the provisions of sec17 tion 103(c). 

18 (e) AGREEMENTS WITH FOREIGN NATIONS.—

19 (1) The Secretary may enter into an agreement 

20 with any nation desiring to export food products to 

21 the United States. Prior to concluding such an 

22 agreement, the Secretary shall evaluate the food 

23 safety program of the foreign nation to determine if 

24 such program provides at least the same level of pro25 tection, with respect to food products intended for 
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1 export to the United States, as domestic laws that 

2 affect the safety of the food supply. In such evalua3 tion, the Secretary shall consider—

4 (A) the potential for health, sanitary, envi5 ronmental, or other conditions within the for6 eign nation to adversely affect the safety of 

7 food products exported from such nation; and 

8 (B) how well the food safety programs of 

9 the foreign nation functions to minimize any 

10 adverse effects on such safety. 

11 (2) Any agreement under this subsection with a 

12 nation desiring to export food products to the 

13 United States shall—

14 (A) require that the exporting nation 

15 shall—

16 (i) establish and maintain a food safe17 ty system that is adequate to ensure that 

18 the food products intended for export to 

19 the United States are safe for human con20 sumption, and not adulterated or mis21 branded under the Federal Food, Drug, 

22 and Cosmetic Act (21 U.S.C. 301 et seq.); 

23 and 

24 (ii) promptly notify the Secretary of 

25 any violations affecting the safety of food 
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1 products exported or intended for export to 

2 the United States; 

3 (B) provide for such activities (whether in 

4 the exporting nation or at the port of entry dur5 ing importation) by the Secretary, including ex6 aminations, inspections, sampling, and testing, 

7 at such stages in the growth or harvest of food, 

8 or in the processing or handling of food prod9 ucts, as the Secretary considers appropriate to 

10 ensure that the food safety program of the ex11 porting nation continues to provide at least the 

12 same level of protection, with respect to food 

13 products intended for export to the United 

14 States, as domestic laws that affect the safety 

15 of the food supply; and 

16 (C) provide for reciprocity with respect to 

17 the treatment of food imports and exports be18 tween the United States and the exporting na19 tion. 

20 (3) If the Secretary determines that a nation 

21 desiring to export food products to the United States 

22 has a program that provides at least the saline level 

23 of protection, with respect to food products intended 

24 for export to the United States, as domestic laws 

25 that affect the safety of the food supply, the Sec-
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1 retary shall, upon entry into force of an agreement 

2 under subsection (e)(1), certify the types of food 

3 products for which the nation maintains such a pro4 gram. 

5 (4)(A) The Secretary shall periodically or for 

6 good cause, and not less than once every 3 years, re7 view certifications made under paragraph (3), and 

8 shall revoke the certification of any nation that the 

9 Secretary determines is not maintaining a food safe10 ty program that provides at least the same level of 

11 protection, with respect to food products intended 

12 for export to the United States, as domestic laws 

13 that affect the safety of the food supply. 

14 (B) The Secretary shall review and modify, as 

15 needed, an agreement made under paragraph (1) 

16 with any nation whose certification has been revoked 

17 under subparagraph (A) of this paragraph. 

18 TITLE II—RESEARCH AND 

19 EDUCATION 

20 SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM. 

21 (a) COOPERATION WITH THE CENTERS FOR DISEASE

22 CONTROL AND PREVENTION.—The Secretary shall work, 

23 through the Centers for Disease Control and Prevention, 

24 to include food in an active surveillance system, based on 

25 a representative proportion of the population of the United 
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1 States, and to assess more accurately the frequency and 

2 sources of human illness in the United States associated 

3 with the consumption of food. 

4 (b) PUBLIC HEALTH SAMPLING.—

5 (1) Within 12 months after the date of enact6 ment of this Act, the Secretary in cooperation with 

7 the Secretary of Agriculture shall establish guide8 lines for a sampling system under which the Sec9 retary and the Secretary of Agriculture shall take 

10 and analyze samples of food products to assist the 

11 Secretary in carrying out this Act and the Federal 

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

13 seq.), and to more accurately assess the nature, fre14 quency of occurrence, and amounts of contaminants 

15 in food products. 

16 (2) Such sampling system shall provide—

17 (A) statistically valid monitoring, including 

18 market-basket studies, on the nature, frequency 

19 of occurrence, and amounts of contaminants in 

20 food products available to consumers; and 

21 (B) at the request of the Secretary, such 

22 other information, including analysis of moni23 toring and verification samples, as the Sec24 retary determines may be useful in assessing 
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1 the occurrence of contaminants in food prod2 ucts. 

3 (c) ASSESSMENT OF HEALTH HAZARDS.—Through 

4 the surveillance system referred to in subsection (a) and 

5 the sampling system described in subsection (b), the Sec6 retary shall rank food categories based on their hazard 

7 to human health and identify appropriate industry and 

8 regulatory approaches to minimize hazards in the food 

9 supply. Such analysis could include—

10 (1) the safety of commercial harvesting and 

11 processing, as compared with the health hazards as12 sociated with food products that are harvested for 

13 recreational or subsistence purposes and prepared 

14 noncommercially; 

15 (2) the safety of food products that are domes16 tically harvested and processed, as compared with 

17 the health hazards associated with food products

18 that are harvested or processed outside the United 

19 States; and 

20 (3) contamination originating from handling 

21 practices that occur prior to or after sale of food 

22 products to consumers. 

23 SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM. 

24 (a) PUBLIC EDUCATION.—The Secretary, in coopera25 tion with private and public organizations, including the 
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1 cooperative extension services and appropriate State enti2 ties, shall design and implement a national public edu3 cation program on food safety. The program shall pro4 vide—

5 (1) information to the public regarding Federal 

6 standards and good practice requirements and pro7 motion of public awareness understanding and ac8 ceptance of such standards and requirements; 

9 (2) information to health professionals so that 

10 they may improve diagnosis and treatment of food11 related illness and advise individuals whose health 

12 conditions place them in particular risk; and 

13 (3) such other information or advice to con14 sumers and other persons as the Secretary deter15 mines will promote the purposes of this Act. 

16 (b) HEALTH ADVISORIES.—The Secretary, in con17 sultation with the Secretary of Agriculture and the Admin18 istrator of the Environmental Protection Agency, shall 

19 work with the States and other appropriate entities to—

20 (1) develop and distribute regional and national 

21 advisories concerning food safety; 

22 (2) develop standardized formats for written 

23 and broadcast advisories; and 
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1 (3) incorporate State and local advisories into 

2 the national public education program required 

3 under subsection (a). 

4 SEC. 203. RESEARCH. 

5 (a) IN GENERAL.—The Secretary shall conduct re6 search to assist in the implementation of this Act, includ7 ing studies to—

8 (1) improve sanitation and food safety practices 

9 in the processing of food products; 

10 (2) develop improved techniques for the moni11 toring of food and inspection of food products; 

12 (3) develop efficient, rapid, and sensitive meth13 ods for determining and detecting the presence of 

14 contaminants in food products; 

15 (4) determine the sources of contamination of 

16 food and food products with contaminants; and 

17 (5) develop consumption data with respect to 

18 food products. 

19 (b) CONTRACT AUTHORITY.—The Secretary is au20 thorized to enter into contracts and agreements with any 

21 State, university, other government agencies or other per22 sons to carry out the activities under this section. 
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1 TITLE III—ENFORCEMENT 

2 SEC. 301. AMENDMENTS TO THE FEDERAL FOOD, DRUG, 

3 AND COSMETIC ACT. 

4 (a) IN GENERAL.—The Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add6 ing after section 415 the following new sections: 

7 ‘‘SEC. 416. NOTIFICATION AND RECALL. 

8 ‘‘(a) NOTICE TO SECRETARY OF ADULTERATION OR

9 MISBRANDING.—Any person (other than a household con10 sumer or other individual who is the intended consumer 

11 of an article of food) that has a reasonable basis for believ12 ing that any article of food introduced into or in interstate 

13 commerce, or held for sale (whether or not the first sale) 

14 after shipment in interstate commerce, may be adulterated 

15 or misbranded or otherwise in violation of the Consumer 

16 Food Safety Act of 2003 shall immediately notify the Sec17 retary, in such manner and by such means as the Sec18 retary may by regulation prescribe, of the identity and lo19 cation of such article. 

20 ‘‘(b) RECALL AND CONSUMER NOTIFICATION.—

21 ‘‘(1) VOLUNTARY PROCEDURES.—If the Sec22 retary finds, upon notification under subsection (a) 

23 or otherwise, that any article of food is adulterated 

24 or misbranded when introduced into or while in 

25 interstate commerce or while held for sale (whether 
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1 or not the first sale) after shipment in interstate 

2 commerce and there is a reasonable probability that 

3 such article, if consumed, would present a threat to 

4 public health, as determined by the Secretary, the 

5 Secretary shall provide the appropriate persons (in6 cluding the manufacturers, importers, distributors, 

7 or retailers) with an opportunity to—

8 ‘‘(A) cease distribution of such article; 

9 ‘‘(B) notify all persons—

10 ‘‘(i) producing, manufacturing, pack11 ing, processing, preparing, treating, pack12 aging, distributing, or holding such article; 

13 or 

14 ‘‘(ii) to which such article has been 

15 distributed, transported, or sold, to imme16 diately cease distribution of such article; 

17 ‘‘(C) recall such article; 

18 ‘‘(D) provide, in consultation with the Sec19 retary, notice to consumers to whom such arti20 cle was, or may have been, distributed; or 

21 ‘‘(E) take any combination of the above 

22 measures, as appropriate in the circumstances. 

23 ‘‘(2) PRE-HEARING ORDER TO CEASE DISTRIBU24 TION AND GIVE NOTICE.—If such person refuses to 

25 or does not voluntarily cease distribution, make noti-
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•HR 1496 IH 

1 fication, recall such article, or provide notice to con2 sumers, as applicable, within the time and in the 

3 manner prescribed by the Secretary, the Secretary 

4 shall, by order, require, as the Secretary deems nec5 essary, such person to—

6 ‘‘(A) immediately cease distribution of 

7 such article; 

8 ‘‘(B) immediately notify all persons—

9 ‘‘(i) producing, manufacturing, pack10 ing, processing, preparing, treating, pack11 aging, distributing, or holding such article; 

12 or 

13 ‘‘(ii) to which such article has been 

14 distributed, transported, or sold, to imme15 diately cease distribution of such article; or 

16 ‘‘(C) immediately take the actions specified 

17 in both subparagraphs (A) and (B). 

18 ‘‘(3) NOTIFICATION OF CONSUMERS BY SEC19 RETARY.—The Secretary shall, as the Secretary 

20 deems necessary, provide notice to consumers to 

21 whom such article was, or may have been, distrib22 uted. 

23 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro24 vide any person subject to an order under subsection (b) 

25 with an opportunity for a hearing, to be held as soon as 
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1 possible but not later than 2 days after the issuance of 

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

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

4 be recalled. 

5 ‘‘(d) POST-HEARING RECALL ORDER.—

6 ‘‘(1) AMENDMENT OF ORDER.—If, after pro7 viding opportunity for a hearing under subsection 

8 (c), the Secretary determines that there is a reason9 able probability that the article that is the subject 

10 of an order under subsection (b), if consumed, pre11 sents a threat to public health, the Secretary, as the 

12 Secretary deems necessary, may—

13 ‘‘(A) amend the order to require recall of 

14 such article or other appropriate action; 

15 ‘‘(B) specify a timetable in which the recall 

16 shall occur; 

17 ‘‘(C) require periodic reports to the Sec18 retary describing the progress of the recall; and 

19 ‘‘(D) provide notice to consumers to whom 

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

21 ‘‘(2) VACATION OF ORDER.—If, after such a 

22 hearing, the Secretary determines that adequate 

23 grounds do not exist to continue the actions required 

24 by the order, the Secretary shall vacate the order. 
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1 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies 

2 provided in this section shall be in addition to and not 

3 exclusive of other remedies that may be available. 

4 ‘‘SEC. 417. CIVIL PENALTIES. 

5 ‘‘(a) IN GENERAL.—

6 ‘‘(1) ACTS SUBJECT TO PENALTY; PENALTY

7 AMOUNT.—Any person that commits an act that vio8 lates this Act with respect to food or the Consumer 

9 Food Safety Act of 2003 may be assessed a civil 

10 penalty by the Secretary of not more than $100,000 

11 for each such act. Each such act and each day dur12 ing which such act continues shall be a separate of13 fense. 

14 ‘‘(2) NOTICE AND HEARING.—No penalty shall 

15 be assessed by the Secretary under this section un16 less such person is given notice and opportunity for 

17 a hearing on the record before the Secretary in ac18 cordance with sections 554 and 556 of title 5, 

19 United States Code. 

20 ‘‘(3) OTHER REQUIREMENTS.—The amount of 

21 such civil penalty shall be assessed by the Secretary 

22 by written order, taking into account the gravity of 

23 the violation, degree of culpability, size and type of 

24 business, and any history of prior offenses; and may 

25 be reviewed only as provided in subsection (b). 
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1 ‘‘(b) JUDICIAL REVIEW.—An order assessing a civil 

2 penalty under subsection (a) shall be final and conclusive 

3 unless the person files, within 30 days from the effective 

4 date of the order, an application for judicial review in the 

5 Court of Appeals of the United States for the circuit in 

6 which such person resides or has its principal place of 

7 business or in the United States Court of Appeals for the 

8 District of Columbia Circuit by filing a notice of appeal 

9 in such court and by simultaneously sending a copy of 

10 such notice by certified mail to the Secretary. The Sec11 retary shall promptly file in such court a certified copy 

12 of the record upon which such penalty was assessed. The 

13 findings of the Secretary shall be set aside only if found 

14 to be unsupported by substantial evidence on the record 

15 as a whole. 

16 ‘‘(c) COLLECTION ACTIONS.—If any person fails to 

17 pay an assessment of a civil penalty after it has become 

18 a final and unappealable order, or after the appropriate 

19 court of appeals has entered final judgment in favor of 

20 the Secretary, the Secretary shall refer the matter to the 

21 Attorney General, who shall institute a civil action to re22 cover the amount assessed in an appropriate district court 

23 of the United States. In such collection action, the validity 

24 and appropriateness of the Secretary’s order imposing the 

25 civil penalty shall not be subject to review. 
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1 ‘‘(d) PENALTIES PAID INTO TREASURY.—All pen2 alties collected under authority of this section shall be paid 

3 into the Treasury of the United States. 

4 ‘‘(e) SECRETARY’S DISCRETION TO PROSECUTE.—

5 Nothing in this Act shall be construed as requiring the 

6 Secretary to report for prosecution, or for the institution 

7 of libel or injunction proceedings, violations of this Act 

8 whenever the Secretary believes that the public interest 

9 will be adequately served by assessment of civil penalties. 

10 ‘‘(f) REMEDIES NOT EXCLUSIVE.—The remedies 

11 provided in this section shall be in addition to and not 

12 exclusive of other remedies that may be available. 

13 ‘‘SEC. 418. WHISTLEBLOWER PROTECTION. 

14 ‘‘(a) IN GENERAL.—No employee or other person 

15 may be harassed, prosecuted, held liable, or discriminated 

16 against in any way because that person—

17 ‘‘(1) has commenced, caused to be commenced, 

18 or is about to commence a proceeding, testified or is 

19 about to testify at a proceeding, or assisted or par20 ticipated or is about to assist or participate in any 

21 manner in such a proceeding or in any other action

22 to carry out the purposes, functions, or responsibil23 ities of the Consumer Food Safety Act of 2003, the 

24 Federal Food, Drug, and Cosmetic Act, the Meat 
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1 Inspection Act, or the Poultry Products Inspection 

2 Act; or 

3 ‘‘(2) is refusing to violate or assist in violation 

4 of law, rule, or regulation. 

5 ‘‘(b) PROCEDURES.—The process and procedures 

6 with respect to prohibited discrimination under subsection 

7 (a) shall be governed by the applicable provisions of sec8 tion 31105 of title 49, United States Code, unless the 

9 party bringing an action under this subsection chooses al10 ternative dispute resolution procedures such as mediation 

11 or arbitration. 

12 ‘‘(c) BURDENS OF PROOF.—The legal burdens of 

13 proof with respect to prohibited discrimination under sub14 section (a) shall be governed by the applicable provisions 

15 of sections 1214 and 1221 of title 5, United States Code. 

16 ‘‘SEC. 419. ADMINISTRATION AND ENFORCEMENT; APPLICA17 BILITY OF PENALTY PROVISIONS; CONDUCT 

18 OF INQUIRIES; POWER AND JURISDICTION OF 

19 COURTS. 

20 ‘‘For the efficient administration and enforcement of 

21 this chapter, the provision (including penalties) of sections 

22 46, 48, 49, and 50 of title 15 (except subsections (c) 

23 through (h) of section 46 and section 49 of title 15), are 

24 made applicable to the jurisdiction, powers, and duties of 

25 the Secretary in administrating and enforcing the provi-
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1 sions of this chapter and to any person with respect to 

2 whom such authority is exercised. The Secretary, in per3 son or by such agents as he may designate, may prosecute 

4 any inquiry necessary to his duties under this chapter in 

5 any part of the United States, and the powers conferred 

6 by said sections 49 and 50 of title 15 on the district courts 

7 of the United States may be exercised for the purposes 

8 of this chapter by any appropriate court. 

9 ‘‘SEC. 420. TRACEBACK. 

10 ‘‘The Secretary may impose on a food product re11 quirements for the traceability of such type or class of food 

12 product whenever such requirements are necessary to as13 sure the protection of the public health. Traceability re14 quirements shall be established in accordance with regula15 tions and guidelines issued by the Secretary. 

16 ‘‘SEC. 421. CITIZEN’S CIVIL ACTIONS. 

17 ‘‘Any person may commence a civil action against—

18 ‘‘(1) any person who violated any rule, toler19 ance, order, or other action of the Secretary to en20 sure the safety of food products; or 

21 ‘‘(2) the Secretary where there is alleged a fail22 ure of the Secretary to perform any act or duty to 

23 ensure the safety of food products, which is not dis24 cretionary. 
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1 The district courts shall have jurisdiction, without regard 

2 for the amount in controversy, or the citizenship of the 

3 parties, to enforce such rule, tolerance, order, or other ac4 tion of the Secretary, or to order the Secretary to perform 

5 such act or duty. The suit shall be commenced in the dis6 trict in which the defendant resides or is found or has 

7 an agent. The court may award damages sustained and 

8 if the court determines it to be in the interest of justice, 

9 may award the plaintiff the costs of suit, including reason10 able attorney’s fees, reasonable expert witness fees, and 

11 penalties. The remedies provided for in this section shall 

12 be in addition to and not in lieu of any other remedies 

13 provided by common law or under Federal or State law.’’. 

14 (b) CONFORMING AMENDMENT; PROHIBITED ACT.—

15 Section 301 of the Federal Food, Drug, and Cosmetic Act 

16 (21 U.S.C. 331) is amended by adding at the end the fol17 lowing: 

18 ‘‘(hh) The failure or refusal to comply with an order 

19 issued under section 416(b)(2) or 416(d). 

20 ‘‘(ii) The failure to comply with the Consumer Food 

21 Safety Act of 2003.’’. 
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1 TITLE IV—AUTHORIZATION 

2 SEC. 401. AUTHORIZATION OF APPROPRIATIONS. 

3 (a) IN GENERAL.—There are authorized to be appro4 priated, to carry out this Act, such sums as may be nec5 essary for fiscal year 2004 and for fiscal year 2005. 

6 (b) ASSISTANCE TO STATES.—Of the funds author7 ized to be appropriated under subsection (a), there are au8 thorized to be appropriated such sums as may be nec9 essary for fiscal year 2004 and for fiscal year 2005, for 

10 carrying out State program assistance activities under sec11 tion 105. 

12 (c) RESEARCH PROGRAM AUTHORIZATION.—Of the 

13 funds authorized to be appropriated under subsection (a), 

14 there are authorized to be appropriated such sums as may 

15 be necessary for fiscal year 2004 and for fiscal year 2005, 

16 for carrying out the research program authorized by sec17 tion 203.

Æ