I

107TH CONGRESS

1ST SESSION H. R. 1817

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

MAY 10, 2001

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 2001’’.

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

Sec. 104. Inspections of processors and importers.

Sec. 105. Tolerances for contaminants in food.

Sec. 106. State and Federal cooperation.

Sec. 107. 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.

22 SEC. 102. REGISTRATION OF PROCESSORS AND IMPORT23 ERS.

24 (a) IN GENERAL.—Any facility engaged in processing

25 of food products and any person who imports food prod-
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1 ucts shall register with the Secretary. Application for reg2 istration shall be made to the Secretary using such forms

3 and containing such information as the Secretary shall

4 prescribe by regulation within 24 months after the date

5 of enactment of this Act. Upon receipt and review of a

6 completed application, the Secretary shall issue to the ap7 plicant a certificate of registration unless good cause is

8 shown why such application should be denied. The Sec9 retary shall promptly notify any applicant of such denial,

10 include a written explanation of the reasons for such de11 nial, and provide an opportunity for a hearing or re12 application upon request.

13 (b) SUSPENSION OF REGISTRATION.—

14 (1) The registration may be suspended imme15 diately by the Secretary for—

16 (A) failure to permit access for inspection

17 under this Act;

18 (B) violation of this Act or regulation

19 issued under this Act, where the Secretary de20 termines that such suspension is likely to pre21 vent a significant risk of adverse health con22 sequences; or

23 (C) conviction of the applicant or reg24 istrant in any Federal or State court of—
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1 (i) any felony other than a felony

2 based upon the acquiring, handling, or dis3 tribution of adulterated or misbranded

4 food; or

5 (ii) more than one violation of any law

6 other than a violation involving any fraud

7 in connection with transactions in food.

8 (2) Any registration suspended under para9 graph (1) may be reinstated whenever the Secretary

10 determines that suspension is no longer necessary.

11 (c) EXEMPTION AUTHORITY.—The Secretary may by

12 regulation exempt classes of facilities from the require13 ments of subsection (a) if the Secretary determines that

14 the registration of such facilities or persons is not needed

15 for effective enforcement of this Act.

16 SEC. 103. PROCESS CONTROLS TO REDUCE THE ADULTERA17 TION OF FOOD PRODUCTS.

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

19 basis of the best available scientific and technological data,

20 prescribe regulations to—

21 (1) limit the presence of human pathogens and

22 other potentially harmful substances in food prod23 ucts;

24 (2) ensure that all registered facilities imple25 ment appropriate measures to control and reduce
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1 the presence and growth of human pathogens and

2 other potentially harmful substances on food prod3 ucts;

4 (3) ensure that all fully processed or ready-to5 eat food products are processed in a sanitary man6 ner, using reasonably available techniques and tech7 nologies to eliminate any human pathogens or other

8 potentially harmful substances likely to cause

9 foodborne illness; and

10 (4) ensure that food products intended for final

11 processing outside commercial establishments are la12 beled with instructions for handling and preparation

13 for consumption which, when adhered to, will de14 stroy any human pathogens or other potentially

15 harmful substance likely to cause foodborne illness.

16 (b) REGULATIONS.—The Secretary shall, within one

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

18 require all registered facilities to adopt processing controls

19 adequate to protect public health and to limit the presence

20 and growth of human pathogens and other potentially

21 harmful substances in food products prepared in any reg22 istered facility. Such regulations shall—

23 (1) set standards for sanitation;

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

25 physical hazards as appropriate;
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1 (3) require process controls to assure that food

2 is safe and that relevant regulatory and safety

3 standards are met;

4 (4) require recordkeeping to monitor compli5 ance;

6 (5) require sampling to assure that processing

7 controls are effective and that regulatory standards

8 are being met; and

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

10 official establishments and submission of copies of

11 such records to the Secretary as the Secretary

12 deems appropriate.

13 Public access to records that relate to the adequacy of

14 measures taken by official establishments to protect the

15 public health and to limit the presence and growth of

16 human pathogens and other potentially harmful sub17 stances shall be governed by 5 U.S.C. 552 et seq. The

18 Secretary may, as the Secretary deems necessary, require

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

20 control over food ingredients to adopt processing controls,

21 where such processing controls are needed to assure the

22 protection of public health.

23 SEC. 104. INSPECTIONS OF PROCESSORS AND IMPORTERS.

24 (a) NATURE OF INSPECTIONS.—
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1 (1) The inspection system shall provide for fre2 quent unannounced inspections of food processing

3 and importing facilities to determine if such facilities

4 are operated in a sanitary manner and if food prod5 ucts are unsafe for human consumption, or adulter6 ated or misbranded under the Federal Food, Drug,

7 and Cosmetic Act (21 U.S.C. 301 et seq.). Inspec8 tions shall include review of processing records and

9 sampling of food products.

10 (2) Inspections shall be conducted at least quar11 terly, unless the Secretary determines that the facil12 ity is an exceptional or negligible-risk facility under

13 standards established by the Secretary.

14 (3) Standards for exceptional or negligible-risk

15 facilities shall consider the hazards associated with

16 the type of product being produced; and the facility’s

17 history of compliance, food safety problems and such

18 other factors as the Secretary may deem appro19 priate. The Secretary shall specify an alternative in20 spection frequency for each facility which is deemed

21 exceptional or negligible-risk. Each inspection shall

22 include an examination of whether the facility con23 tinues to meet the standards for exceptional or neg24 ligible-risk facilities.

25 (b) CONDUCT OF INSPECTIONS.—
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1 (1) An inspection under subsection (a) of any

2 domestic, foreign, or importing facility shall extend

3 to all things therein (including records required to

4 be maintained under subsection (e), processes, con5 trols, and premises) that bear on whether food prod6 ucts are in compliance with this Act or the Federal

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

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

9 such records.

10 (2) In conducting such inspections, officers or

11 employees duly designated by the Secretary, upon

12 presenting appropriate credentials to the owner, op13 erator, or agent in charge, are authorized—

14 (A) to enter at reasonable times any facil15 ity in which persons are engaged in the food

16 processing or importing of food products, or to

17 enter any vehicle being used to transport or

18 hold such food products;

19 (B) to inspect in a reasonable manner such

20 facility or vehicle and all pertinent equipment,

21 finished and unfinished materials, containers,

22 labeling, processes, controls, and premises; and

23 (C) to collect and retain samples of food

24 products or ingredients or of any other items

25 found during an inspection that may contribute
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1 to a finding of whether such food products are

2 unsafe for human consumption or adulterated

3 or misbranded under the Food, Drug, and Cos4 metic Act (21 U.S.C. 301 et seq.).

5 (3) Immediately after completion of inspection,

6 the officer or employee making the inspection shall

7 give to the owner, operator, or agent in charge a re8 port in writing setting forth any conditions or prac9 tices observed which indicate that either processing

10 controls are inadequate to prevent or minimize food

11 safety hazards or that any food from such facility is

12 unsafe for human consumption, or adulterated or

13 misbranded under the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 301 et seq.).

15 (c) PRODUCT DETENTION AND CONDEMNATION.—

16 (1) If, during an inspection conducted under

17 this section, an officer or employee making the in18 spection has reason to believe that a food product is

19 unsafe for human consumption, or adulterated or

20 misbranded under the Federal Food, Drug, and Cos21 metic Act (21 U.S.C. 301 et seq.), such officer or

22 employee may order the food product segregated,

23 impounded, and if objection is not made within 48

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

25 products that are in perishable form may be proc-
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1 essed to the extent necessary to prevent spoilage,

2 and a hearing shall be commenced expeditiously.

3 (2) If the Secretary determines that, through

4 relabeling or other action, such food products can be

5 brought into compliance with this Act and the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301

7 et seq.), the food may be released following a deter8 mination by the Secretary that such relabeling or

9 other action as specified by the Secretary has been

10 performed.

11 (3) Any food product condemned without objec12 tion, or after hearing and judicial review, shall be

13 destroyed under supervision of the Secretary.

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

15 by regulation the conditions under which any food product

16 shall display an official mark, when needed to facilitate

17 exports, that signifies that the food product has been proc18 essed in accordance with standards approved by the Sec19 retary. Such a mark may be subject to a fee.

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

21 person registered under this section shall maintain and

22 make available for inspection by the Secretary such

23 records as the Secretary may prescribe. Such records shall

24 be maintained for a reasonable period of time as deter-
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1 mined by the Secretary. The records shall include, but are

2 not limited to, information concerning—

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

4 holding, and disposition of food products or ingredi5 ents; the identity and amount of ingredients used in

6 the food; the processing of the food; the results of

7 laboratory, sanitation, or other quality control tests

8 performed on the food or in the facility; consumer

9 complaints concerning the food or its packaging; and

10 (2) other matters reasonably related to whether

11 food products may be unsafe for human consump12 tion, or adulterated or misbranded under the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301

14 et seq.).

15 (f) OTHER INSPECTION RIGHTS AND DUTIES.—Sec16 tion 704 of the Federal Food, Drug, and Cosmetic Act

17 (21 U.S.C. 374) is amended by adding at the end the fol18 lowing new subsection:

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

20 designated officers and employees and of other persons

21 shall apply to enforcement of the Consumer Food Safety

22 Act of 2001 to the same extent and in the same manner

23 as they apply to enforcement of this Act.’’.
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1 SEC. 105. TOLERANCES FOR CONTAMINANTS IN FOOD.

2 (a) TOLERANCES.—The Secretary shall establish tol3 erances limiting the quantity of contaminants, except for

4 pesticide residues regulated under section 408 or food ad5 ditives regulated under section 409 of the Federal Food,

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

7 when found in food products, may render such products

8 unsafe for human consumption. Contaminants include but

9 are not limited to bacteria, chemical contaminants, natural

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

11 can cause human illness. Such tolerances may include in12 dicators (including indicator organisms) from which it

13 may reasonably be inferred that a contaminant is present

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

15 shall take into account the extent to which consumers may

16 be exposed to such contaminant from sources other than

17 food, and the extent to which such contaminant can be

18 avoided or minimized in the commercial handling and

19 processing of such food.

20 (b) REGULATIONS.—

21 (1) The Secretary, after notice and an oppor22 tunity for comment, shall promulgate regulations to

23 implement subsection (a) within 48 months after the

24 date of enactment of this Act. In promulgating such

25 regulations, the Secretary shall establish tolerances

26 for the contaminants that the Secretary determines
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1 are having the greatest public health impact as early

2 as feasible after implementation of this Act.

3 (2) A tolerance established under this section

4 shall be based on—

5 (A) a scientific analysis of the health risks

6 attributable to the contaminant for which the

7 tolerance is established; and

8 (B) analysis of the risks for sensitive

9 groups, such as children, elderly, pregnant

10 women and the immune compromised.

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

12 issue revisions to the regulations under paragraph

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

14 Secretary may contract with the National Academy

15 of Sciences to provide such data or assistance as the

16 Secretary deems necessary.

17 (c) REPORT.—The Secretary shall report to the Con18 gress on the progress of the Secretary in establishing tol19 erances under this section. The report shall include a de20 scription of the research that has been conducted with re21 spect to such tolerances and the research that must be

22 conducted before additional tolerances may be established,

23 the health significance of the lack of such additional toler24 ances, a timetable for the establishment of such toler25 ances, and the estimated costs, including costs of research,
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1 associated with the establishment of such tolerances. The

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

3 month after the date of enactment of this Act, and bienni4 ally thereafter during the 6-year period that begins on

5 such date of enactment.

6 SEC. 106. STATE AND FEDERAL COOPERATION.

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

8 States in undertaking activities and programs that con9 tribute to the national food safety program so that State

10 and Federal programs function in a coordinated and cost11 effective manner. With the assistance provided in sub12 section (b), the Secretary shall encourage States to—

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

14 safety programs, especially with respect to the regu15 lation of retail commercial food establishments,

16 transportation, harvesting, and fresh markets; and

17 (2) establish procedures and requirements for

18 ensuring that food products under the jurisdiction of

19 the State are not unsafe for human consumption.

20 (b) ASSISTANCE.—

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

22 planning, developing, and implementing a food safe23 ty program—

24 (A) advisory assistance;
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1 (B) technical and laboratory assistance

2 and training (including necessary materials and

3 equipment); and

4 (C) financial and other aid.

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

6 under agreements entered into with Federal, State, or

7 local agencies, use on a reimbursable basis or otherwise

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

9 carrying out their responsibilities under this Act. Such an

10 agreement shall provide that any compliance records, no11 tices, or reports issued in connection with activities under

12 the agreement and in the possession of the agency or gov13 ernment which entered into the agreement shall be made

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

15 States Code. Agreements with a State under this sub16 section may provide for training of State employees.

17 SEC. 107. IMPORTS.

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

19 the date of enactment of this Act, the Secretary shall es20 tablish and administer a comprehensive and efficient sys21 tem to ensure the safety of food imported into the United

22 States. The Secretary shall routinely inspect processing

23 facilities in exporting nations and imports at ports of entry

24 into the United States. The Secretary shall assure the ef-
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1 fective operation through verification and other activities

2 as the Secretary considers necessary.

3 (b) IMPORT REQUIREMENTS.—

4 (1) No food product may enter the United

5 States, or be withdrawn from a warehouse, for con6 sumption in the United States if such food

7 product—

8 (A) appears unsafe for human consump9 tion, or adulterated or misbranded under the

10 Federal Food, Drug, and Cosmetic Act (21

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

12 (B) is not marked or labeled as required

13 by regulations for domestic or imported articles;

14 or

15 (C) does not comply with the requirements

16 of this section.

17 (2) Upon entry for consumption in the United

18 States, food products that are not prohibited from

19 entry or from withdrawal from a warehouse under

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

21 domestic food products, except that all labeling of

22 such products shall clearly identify the country of

23 origin to facilitate the identification of products

24 linked to outbreaks of illness.

25 (c) INSPECTION OF IMPORTS.—
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1 (1) Food products that are offered for importa2 tion, or withdrawn from a warehouse, for consump3 tion in the United States, shall be subject to exami4 nations inspections, sampling, and such other proce5 dures at the port of entry or in the exporting nation

6 by officers or employees duly designated by the Sec7 retary. Such procedures shall be conducted with

8 such frequency and in such manner as the Secretary

9 may prescribe by regulation.

10 (2) Food products from a nation that is cer11 tified for such food products under subsection (e)(3)

12 shall be subject to random examinations, inspections,

13 sampling, and other procedures. Food products from

14 a nation that is not certified for such food products

15 under subsection (e)(3) shall be subject to such in16 tensified examinations, inspections, sampling, and

17 other verification procedures, including inspection in

18 the country of origin, as the Secretary determines

19 are necessary to ensure compliance with this Act.

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

21 during an inspection or other verification procedure car22 ried out under this section, an officer or employee con23 ducting the procedure has reason to believe that a food

24 product is unsafe for human consumption, or adulterated

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

2 may order the food product segregated, impounded, and

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

4 objection is made, such food products that are in perish5 able form may be processed to the extent necessary to pre6 vent spoilage, and a hearing shall be commenced expedi7 tiously. The final condemnation or other disposition of

8 such food product shall be subject to the provisions of sec9 tion 104(c).

10 (e) AGREEMENTS WITH FOREIGN NATIONS.—

11 (1) The Secretary may enter into an agreement

12 with any nation desiring to export food products to

13 the United States. Prior to concluding such an

14 agreement, the Secretary shall evaluate the food

15 safety program of the foreign nation to determine if

16 such program provides at least the same level of pro17 tection, with respect to food products intended for

18 export to the United States, as domestic laws that

19 affect the safety of the food supply. In such evalua20 tion, the Secretary shall consider—

21 (A) the potential for health, sanitary, envi22 ronmental, or other conditions within the for23 eign nation to adversely affect the safety of

24 food products exported from such nation; and
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1 (B) how well the food safety programs of

2 the foreign nation functions to minimize any

3 adverse effects on such safety.

4 (2) Any agreement under this subsection with a

5 nation desiring to export food products to the

6 United States shall—

7 (A) require that the exporting nation

8 shall—

9 (i) establish and maintain a food safe10 ty system that is adequate to ensure that

11 the food products intended for export to

12 the United States are safe for human con13 sumption, and not adulterated or mis14 branded under the Federal Food, Drug,

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

16 and

17 (ii) promptly notify the Secretary of

18 any violations affecting the safety of food

19 products exported or intended for export to

20 the United States;

21 (B) provide for such activities (whether in

22 the exporting nation or at the port of entry dur23 ing importation) by the Secretary, including ex24 aminations, inspections, sampling, and testing,

25 at such stages in the growth or harvest of food,
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1 or in the processing or handling of food prod2 ucts, as the Secretary considers appropriate to

3 ensure that the food safety program of the ex4 porting nation continues to provide at least the

5 same level of protection, with respect to food

6 products intended for export to the United

7 States, as domestic laws that affect the safety

8 of the food supply; and

9 (C) provide for reciprocity with respect to

10 the treatment of food imports and exports be11 tween the United States and the exporting na12 tion.

13 (3) If the Secretary determines that a nation

14 desiring to export food products to the United States

15 has a program that provides at least the saline level

16 of protection, with respect to food products intended

17 for export to the United States, as domestic laws

18 that affect the safety of the food supply, the Sec19 retary shall, upon entry into force of an agreement

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

21 products for which the nation maintains such a pro22 gram.

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

24 good cause, and not less than once every 3 years, re25 view certifications made under paragraph (3), and
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1 shall revoke the certification of any nation that the

2 Secretary determines is not maintaining a food safe3 ty program that provides at least the same level of

4 protection, with respect to food products intended

5 for export to the United States, as domestic laws

6 that affect the safety of the food supply.

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

8 needed, an agreement made under paragraph (1)

9 with any nation whose certification has been revoked

10 under subparagraph (A) of this paragraph.

11 TITLE II—RESEARCH AND

12 EDUCATION

13 SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

14 (a) COOPERATION WITH THE CENTERS FOR DISEASE

15 CONTROL AND PREVENTION.—The Secretary shall work,

16 through the Centers for Disease Control and Prevention,

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

18 a representative proportion of the population of the United

19 States, and to assess more accurately the frequency and

20 sources of human illness in the United States associated

21 with the consumption of food.

22 (b) PUBLIC HEALTH SAMPLING.—

23 (1) Within 12 months after the date of enact24 ment of this Act, the Secretary in cooperation with

25 the Secretary of Agriculture shall establish guide-
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1 lines for a sampling system under which the Sec2 retary and the Secretary of Agriculture shall take

3 and analyze samples of food products to assist the

4 Secretary in carrying out this Act and the Federal

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

6 seq.), and to more accurately assess the nature, fre7 quency of occurrence, and amounts of contaminants

8 in food products.

9 (2) Such sampling system shall provide—

10 (A) statistically valid monitoring, including

11 market-basket studies, on the nature, frequency

12 of occurrence, and amounts of contaminants in

13 food products available to consumers; and

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

15 other information, including analysis of moni16 toring and verification samples, as the Sec17 retary determines may be useful in assessing

18 the occurrence of contaminants in food prod19 ucts.

20 (c) ASSESSMENT OF HEALTH HAZARDS.—Through

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

22 the sampling system described in subsection (b), the Sec23 retary shall rank food categories based on their hazard

24 to human health and identify appropriate industry and
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1 regulatory approaches to minimize hazards in the food

2 supply. Such analysis could include—

3 (1) the safety of commercial harvesting and

4 processing, as compared with the health hazards as5 sociated with food products that are harvested for

6 recreational or subsistence purposes and prepared

7 noncommercially;

8 (2) the safety of food products that are domes9 tically harvested and processed, as compared with

10 the health hazards associated with food products

11 that are harvested or processed outside the United

12 States; and

13 (3) contamination originating from handling

14 practices that occur prior to or after sale of food

15 products to consumers.

16 SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM.

17 (a) PUBLIC EDUCATION.—The Secretary, in coopera18 tion with private and public organizations, including the

19 cooperative extension services and appropriate State enti20 ties, shall design and implement a national public edu21 cation program on food safety. The program shall

22 provide—

23 (1) information to the public regarding Federal

24 standards and good practice requirements and pro-
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1 motion of public awareness understanding and ac2 ceptance of such standards and requirements;

3 (2) information to health professionals so that

4 they may improve diagnosis and treatment of food5 related illness and advise individuals whose health

6 conditions place them in particular risk; and

7 (3) such other information or advice to con8 sumers and other persons as the Secretary deter9 mines will promote the purposes of this Act.

10 (b) HEALTH ADVISORIES.—The Secretary, in con11 sultation with the Secretary of Agriculture and the Admin12 istrator of the Environmental Protection Agency, shall

13 work with the States and other appropriate entities to—

14 (1) develop and distribute regional and national

15 advisories concerning food safety;

16 (2) develop standardized formats for written

17 and broadcast advisories; and

18 (3) incorporate State and local advisories into

19 the national public education program required

20 under subsection (a).

21 SEC. 203. RESEARCH.

22 (a) IN GENERAL.—The Secretary shall conduct re23 search to assist in the implementation of this Act, includ24 ing studies to—
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1 (1) improve sanitation and food safety practices

2 in the processing of food products;

3 (2) develop improved techniques for the moni4 toring of food and inspection of food products;

5 (3) develop efficient, rapid, and sensitive meth6 ods for determining and detecting the presence of

7 contaminants in food products;

8 (4) determine the sources of contamination of

9 food and food products with contaminants; and

10 (5) develop consumption data with respect to

11 food products.

12 (b) CONTRACT AUTHORITY.—The Secretary is au13 thorized to enter into contracts and agreements with any

14 State, university, other government agencies or other per15 sons to carry out the activities under this section.

16 TITLE III—ENFORCEMENT

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

18 AND COSMETIC ACT.

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

20 Cosmetic Act (21 U.S.C. 301 et seq.) is amended by add21 ing after section 413 the following new sections:

22 ‘‘SEC. 414. NOTIFICATION AND RECALL.

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

24 MISBRANDING.—Any person (other than a household con25 sumer or other individual who is the intended consumer
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1 of an article of food) that has a reasonable basis for believ2 ing that any article of food introduced into or in interstate

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

4 after shipment in interstate commerce, may be adulterated

5 or misbranded or otherwise in violation of the Consumer

6 Food Safety Act of 2001 shall immediately notify the Sec7 retary, in such manner and by such means as the Sec8 retary may by regulation prescribe, of the identity and lo9 cation of such article.

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

11 ‘‘(1) VOLUNTARY PROCEDURES.—If the Sec12 retary finds, upon notification under subsection (a)

13 or otherwise, that any article of food is adulterated

14 or misbranded when introduced into or while in

15 interstate commerce or while held for sale (whether

16 or not the first sale) after shipment in interstate

17 commerce and there is a reasonable probability that

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

19 public health, as determined by the Secretary, the

20 Secretary shall provide the appropriate persons (in21 cluding the manufacturers, importers, distributors,

22 or retailers) with an opportunity to—

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

24 ‘‘(B) notify all persons—
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1 ‘‘(i) producing, manufacturing, pack2 ing, processing, preparing, treating, pack3 aging, distributing, or holding such article;

4 or

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

6 distributed, transported, or sold, to imme7 diately cease distribution of such article;

8 ‘‘(C) recall such article;

9 ‘‘(D) provide, in consultation with the Sec10 retary, notice to consumers to whom such arti11 cle was, or may have been, distributed; or

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

13 measures, as appropriate in the circumstances.

14 ‘‘(2) PRE-HEARING ORDER TO CEASE DISTRIBU15 TION AND GIVE NOTICE.—If such person refuses to

16 or does not voluntarily cease distribution, make noti17 fication, recall such article, or provide notice to con18 sumers, as applicable, within the time and in the

19 manner prescribed by the Secretary, the Secretary

20 shall, by order, require, as the Secretary deems nec21 essary, such person to—

22 ‘‘(A) immediately cease distribution of

23 such article;

24 ‘‘(B) immediately notify all persons—
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1 ‘‘(i) producing, manufacturing, pack2 ing, processing, preparing, treating, pack3 aging, distributing, or holding such article;

4 or

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

6 distributed, transported, or sold, to imme7 diately cease distribution of such article; or

8 ‘‘(C) immediately take the actions specified

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

10 ‘‘(3) NOTIFICATION OF CONSUMERS BY SEC11 RETARY.—The Secretary shall, as the Secretary

12 deems necessary, provide notice to consumers to

13 whom such article was, or may have been, distrib14 uted.

15 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro16 vide any person subject to an order under subsection (b)

17 with an opportunity for a hearing, to be held as soon as

18 possible but not later than 2 days after the issuance of

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

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

21 be recalled.

22 ‘‘(d) POST-HEARING RECALL ORDER.—

23 ‘‘(1) AMENDMENT OF ORDER.—If, after pro24 viding opportunity for a hearing under subsection

25 (c), the Secretary determines that there is a reason-
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1 able probability that the article that is the subject

2 of an order under subsection (b), if consumed, pre3 sents a threat to public health, the Secretary, as the

4 Secretary deems necessary, may—

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

6 such article or other appropriate action;

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

8 shall occur;

9 ‘‘(C) require periodic reports to the Sec10 retary describing the progress of the recall; and

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

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

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

14 hearing, the Secretary determines that adequate

15 grounds do not exist to continue the actions required

16 by the order, the Secretary shall vacate the order.

17 ‘‘(e) REMEDIES NOT EXCLUSIVE.—The remedies

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

19 exclusive of other remedies that may be available.

20 ‘‘SEC. 415. CIVIL PENALTIES.

21 ‘‘(a) IN GENERAL.—

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

23 AMOUNT.—Any person that commits an act that vio24 lates this Act with respect to food or the Consumer

25 Food Safety Act of 2001 may be assessed a civil
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1 penalty by the Secretary of not more than $100,000

2 for each such act. Each such act and each day dur3 ing which such act continues shall be a separate of4 fense.

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

6 be assessed by the Secretary under this section un7 less such person is given notice and opportunity for

8 a hearing on the record before the Secretary in ac9 cordance with sections 554 and 556 of title 5,

10 United States Code.

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

12 such civil penalty shall be assessed by the Secretary

13 by written order, taking into account the gravity of

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

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

16 be reviewed only as provided in subsection (b).

17 ‘‘(b) JUDICIAL REVIEW.—An order assessing a civil

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

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

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

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

22 which such person resides or has its principal place of

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

24 District of Columbia Circuit by filing a notice of appeal

25 in such court and by simultaneously sending a copy of
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1 such notice by certified mail to the Secretary. The Sec2 retary shall promptly file in such court a certified copy

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

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

5 to be unsupported by substantial evidence on the record

6 as a whole.

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

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

9 a final and unappealable order, or after the appropriate

10 court of appeals has entered final judgment in favor of

11 the Secretary, the Secretary shall refer the matter to the

12 Attorney General, who shall institute a civil action to re13 cover the amount assessed in an appropriate district court

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

15 and appropriateness of the Secretary’s order imposing the

16 civil penalty shall not be subject to review.

17 ‘‘(d) PENALTIES PAID INTO TREASURY.—All pen18 alties collected under authority of this section shall be paid

19 into the Treasury of the United States.

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

21 Nothing in this Act shall be construed as requiring the

22 Secretary to report for prosecution, or for the institution

23 of libel or injunction proceedings, violations of this Act

24 whenever the Secretary believes that the public interest

25 will be adequately served by assessment of civil penalties.
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1 ‘‘(f) 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. 416. WHISTLEBLOWER PROTECTION.

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

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

7 against in any way because that person—

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

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

10 about to testify at a proceeding, or assisted or par11 ticipated or is about to assist or participate in any

12 manner in such a proceeding or in any other action

13 to carry out the purposes, functions, or responsibil14 ities of the Consumer Food Safety Act of 2001, the

15 Federal Food, Drug, and Cosmetic Act, the Meat

16 Inspection Act, or the Poultry Products Inspection

17 Act; or

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

19 of law, rule, or regulation.

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

21 with respect to prohibited discrimination under subsection

22 (a) shall be governed by the applicable provisions of sec23 tion 31105 of title 49, United States Code, unless the

24 party bringing an action under this subsection chooses al-
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1 ternative dispute resolution procedures such as mediation

2 or arbitration.

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

4 proof with respect to prohibited discrimination under sub5 section (a) shall be governed by the applicable provisions

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

7 ‘‘SEC. 417. ADMINISTRATION AND ENFORCEMENT; APPLICA8 BILITY OF PENALTY PROVISIONS; CONDUCT

9 OF INQUIRIES; POWER AND JURISDICTION OF

10 COURTS.

11 ‘‘For the efficient administration and enforcement of

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

13 46, 48, 49, and 50 of title 15 (except subsections (c)

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

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

16 the Secretary in administrating and enforcing the provi17 sions of this chapter and to any person with respect to

18 whom such authority is exercised. The Secretary, in per19 son or by such agents as he may designate, may prosecute

20 any inquiry necessary to his duties under this chapter in

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

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

23 of the United States may be exercised for the purposes

24 of this chapter by any appropriate court.
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1 ‘‘SEC. 418. TRACEBACK.

2 ‘‘The Secretary may impose on a food product re3 quirements for the traceability of such type or class of food

4 product whenever such requirements are necessary to as5 sure the protection of the public health. Traceability re6 quirements shall be established in accordance with regula7 tions and guidelines issued by the Secretary.

8 ‘‘SEC. 419. CITIZEN’S CIVIL ACTIONS.

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

10 ‘‘(1) any person who violated any rule, toler11 ance, order, or other action of the Secretary to en12 sure the safety of food products; or

13 ‘‘(2) the Secretary where there is alleged a fail14 ure of the Secretary to perform any act or duty to

15 ensure the safety of food products, which is not dis16 cretionary.

17 The district courts shall have jurisdiction, without regard

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

19 parties, to enforce such rule, tolerance, order, or other ac20 tion of the Secretary, or to order the Secretary to perform

21 such act or duty. The suit shall be commenced in the dis22 trict in which the defendant resides or is found or has

23 an agent. The court may award damages sustained and

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

25 may award the plaintiff the costs of suit, including reason26 able attorney’s fees, reasonable expert witness fees, and
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1 penalties. The remedies provided for in this section shall

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

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

4 (b) CONFORMING AMENDMENT; PROHIBITED ACT.—

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

6 (21 U.S.C. 331) is amended by adding at the end the fol7 lowing new subsections:

8 ‘‘(x) The failure or refusal to comply with an order

9 issued under section 414(b)(2) or 414(d).

10 ‘‘(y) The failure to comply with the Consumer Food

11 Safety Act of 2001.’’.

12 TITLE IV—AUTHORIZATION

13 SEC. 401. AUTHORIZATION OF APPROPRIATIONS.

14 (a) IN GENERAL.—There are authorized to be appro15 priated, to carry out this Act, such sums as may be nec16 essary for fiscal year 2001 and for fiscal year 2002.

17 (b) ASSISTANCE TO STATES.—Of the funds author18 ized to be appropriated under subsection (a), there are au19 thorized to be appropriated such sums as may be nec20 essary for fiscal year 2001 and for fiscal year 2002, for

21 carrying out State program assistance activities under sec22 tion 106.

23 (c) RESEARCH PROGRAM AUTHORIZATION.—Of the

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

25 there are authorized to be appropriated such sums as may
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1 be necessary for fiscal year 2001 and for fiscal year 2002,

2 for carrying out the research program authorized by sec3 tion 203.

Æ