II

106TH CONGRESS

1ST SESSION S. 908

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

intended for human consumption that are regulated by the Food and

Drug Administration, and for other purposes.

IN THE SENATE OF THE UNITED STATES

APRIL 28, 1999

Mr. DORGAN introduced the following bill; which was read twice and referred

to the Committee on Agriculture, Nutrition, and Forestry

A BILL

To establish a comprehensive program to ensure the safety

of food products intended for human consumption that

are regulated by the Food and Drug Administration,

and for other purposes.

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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

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

5 ‘‘Consumer Food Safety Act of 1999’’.

6 (b) TABLE OF CONTENTS.—

Sec. 1. Short title; table of contents.

Sec. 2. Definitions.
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TITLE I—NATIONAL FOOD SAFETY PROGRAM

Sec. 101. Administration of national program.

Sec. 102. Registration of processors and importers.

Sec. 103. Process controls to reduce the contamination of food products.

Sec. 104. Tolerances for contaminants in food.

Sec. 105. Inspections of processors and importers.

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 In this Act:

3 (1) CONTAMINANT.—The term ‘‘contaminant’’

4 includes a bacterium, a chemical contaminant, a nat5 ural toxin, a virus, a parasite, and a physical hazard,

6 that when found on or in food can cause human ill7 ness or injury.

8 (2) FACILITY.—The term ‘‘facility’’ includes

9 any factory, warehouse, or establishment (including

10 a factory, warehouse, or establishment of an im11 porter), that handles or processes food.

12 (3) FOOD.—The term ‘‘food’’ has the meaning

13 given the term in section 201 of the Federal Food,

14 Drug, and Cosmetic Act (21 U.S.C. 321).
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1 (4) FOOD SAFETY LAW.—The term ‘‘food safety

2 law’’ means this Act and the provisions of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 301

4 et seq.) that relate to food.

5 (5) PROCESS.—The term ‘‘process’’ means the

6 commercial harvesting, preparation, manufacture, or

7 transportation of a food product.

8 (6) SECRETARY.—The term ‘‘Secretary’’ means

9 the Secretary of Health and Human Services.

10 TITLE I—NATIONAL FOOD

11 SAFETY PROGRAM

12 SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.

13 (a) IN GENERAL.—

14 (1) FINDING.—Congress finds that persons who

15 produce or process food for human consumption

16 have the responsibility to prevent or minimize food

17 safety hazards related to their products.

18 (2) NATIONAL PROGRAM.—The Secretary shall

19 administer, in accordance with the provisions of this

20 Act, a national program for the purpose of pro21 tecting public health by ensuring that the food in22 dustry has effective programs in place to assure the

23 safety of food products consumed in the United

24 States.
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1 (3) BASIS FOR PROGRAM.—The program

2 shall—

3 (A) be based on a comprehensive analysis

4 of the hazards associated with different food

5 products and with the processing (including

6 harvesting) and handling of different food prod7 ucts, including the identification and evaluation

8 of—

9 (i) the severity of the potential public

10 health hazards;

11 (ii) the sources and specific points of

12 potential contamination that may render

13 food products unsafe for human consump14 tion; and

15 (iii) the potential for persistence, mul16 tiplication, or concentration of naturally

17 occurring or added contaminants in foods,

18 including food products; and

19 (B) take into consideration the distinctive

20 characteristics of food processing and handling.

21 (b) PROGRAM ELEMENTS.—The program shall pro22 vide for—

23 (1) implementation of a national system for the

24 annual registration of facilities (including facilities

25 of importers) with the Secretary;
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1 (2) development of a program to oversee the

2 implementation of process controls in facilities, in3 cluding the establishment and enforcement of health4 based standards for—

5 (A) substances that may contaminate food;

6 and

7 (B) safety and sanitation in the processing

8 and handling of food products;

9 (3) establishment of inspection and oversight

10 procedures to monitor that facilities are utilizing

11 preventive controls to minimize or eliminate identifi12 able hazards in food;

13 (4) implementation of a national system for

14 quarterly inspections of facilities (including facilities

15 of importers), except for facilities that meet the Sec16 retary’s standards for exceptional or negligible-risk

17 facilities;

18 (5) implementation of procedures and require19 ments to ensure the safety of imported food prod20 ucts;

21 (6) coordination with other Federal agencies or

22 State governments in carrying out inspection, en23 forcement, and monitoring relating to the safety of

24 food products;
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1 (7) implementation of a national surveillance

2 system to assess the public health hazards associated

3 with the human consumption of food products, in co4 operation with the Director of the Centers for Dis5 ease Control and Prevention;

6 (8) implementation of a sampling program to

7 ensure that industry programs to prevent food con8 tamination are effective and that food products meet

9 the standards established in paragraph (2);

10 (9) development of public education and advi11 sory programs relating to the safety of food prod12 ucts; and

13 (10) implementation of a research program to

14 further the objectives of this Act.

15 SEC. 102. REGISTRATION OF PROCESSORS AND IMPORT16 ERS.

17 (a) REGISTRATION.—

18 (1) IN GENERAL.—Any facility engaged in proc19 essing or handling food products for consumption in

20 the United States, including any facility of an im21 porter, shall be registered with the Secretary. To ob22 tain the registration—

23 (A) for a domestic facility not described in

24 subparagraph (B), the owner, operator, or
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1 agent in charge of the facility shall submit an

2 application to the Secretary; and

3 (B) for a facility of an importer, or for a

4 foreign facility, the importer seeking to import

5 the food product processed or handled in the fa6 cility shall submit the application.

7 (2) APPLICATION.—

8 (A) IN GENERAL.—The applicant shall

9 submit the application to the Secretary in such

10 manner and containing such information as the

11 Secretary shall prescribe by regulation.

12 (B) SUBMISSION.—The applicant shall

13 submit the application not later than 24 months

14 after—

15 (i) the date of enactment of this Act;

16 or

17 (ii) the date the facility first processed

18 or handled food, if later than such date of

19 enactment.

20 (C) CONTENTS.—In the case of an applica21 tion submitted for a foreign facility, the appli22 cation shall contain, at a minimum, such infor23 mation as the Secretary may require dem24 onstrating that the facility, and the foreign na-
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1 tion involved, will permit inspections described

2 in this title.

3 (3) PROCEDURE.—Upon receipt and review of a

4 completed application described in paragraph (1),

5 the Secretary shall issue to the applicant a certifi6 cate of registration unless the Secretary finds that

7 there is good cause for denial of the application. The

8 Secretary shall promptly notify the applicant of the

9 denial, include in the notification a written expla10 nation of the reasons for such denial, and provide an

11 opportunity for a hearing or reapplication upon re12 quest.

13 (b) SUSPENSION OF REGISTRATION.—

14 (1) BASIS.—The registration of a facility, in15 cluding the facility of an importer, may be sus16 pended immediately by the Secretary for—

17 (A) failure to permit access to the facility

18 for inspection under this Act;

19 (B) violation of a food safety law, includ20 ing a regulation issued under a food safety law,

21 concerning the facility, in a case in which the

22 Secretary determines that such suspension is

23 likely to prevent a significant risk of adverse

24 health consequences; or
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1 (C) conviction of the applicant or reg2 istrant in any Federal or State court of—

3 (i) any felony relating to food, wheth4 er or not the felony is based upon the ac5 quisition, handling, or distribution of adul6 terated or misbranded food; or

7 (ii) more than 1 violation of any law

8 relating to food, whether or not the viola9 tion involves any fraud in connection with

10 transactions in food.

11 (2) IMPACT.—No person may introduce a food

12 product into interstate commerce, or offer a food

13 product for import into the United States, from a

14 facility with a suspended registration.

15 (3) REINSTATEMENT.—Any registration sus16 pended under paragraph (1) may be reinstated

17 whenever the Secretary determines that the suspen18 sion is no longer necessary.

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

20 regulation exempt classes of facilities from the require21 ments of subsection (a) if the Secretary determines that

22 the registration of such facilities is not needed for effective

23 enforcement of a food safety law.
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1 SEC. 103. PROCESS CONTROLS TO REDUCE THE CONTAMI2 NATION OF FOOD PRODUCTS.

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

4 of the best available scientific and technological data, pre5 scribe regulations to—

6 (1) limit the presence of contaminants and

7 other potentially harmful substances in food prod8 ucts;

9 (2) ensure that all facilities registered under

10 section 102 implement appropriate process controls

11 to control and reduce the presence and growth of

12 contaminants and other potentially harmful sub13 stances in food products;

14 (3) ensure that all processed or ready-to-eat

15 food products are processed and handled in a sani16 tary manner, using reasonably available techniques

17 and technologies to minimize any contaminants or

18 other 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 that, when adhered to, will destroy

24 any contaminant or other potentially harmful sub25 stance likely to cause foodborne illness.

26 (b) REGULATIONS.—
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1 (1) IN GENERAL.—In implementing subsection

2 (a), the Secretary shall, not later than 1 year after

3 the date of enactment of this Act, issue regulations

4 that require each facility registered under section

5 102 to adopt process controls adequate to protect

6 public health by controlling and reducing the pres7 ence and growth of contaminants and other poten8 tially harmful substances in food products prepared

9 in the facility.

10 (2) ELEMENTS.—Such regulations shall—

11 (A) set standards for sanitation in food

12 products;

13 (B) set tolerances for biological, chemical,

14 and physical contaminants in food products, as

15 appropriate;

16 (C) require process controls to assure that

17 food products are safe and that relevant regu18 latory and other safety standards, including the

19 standards and tolerances described in subpara20 graphs (A) and (B), are met;

21 (D) require recordkeeping to monitor com22 pliance with the process controls;

23 (E) require sampling (in accordance with

24 the sampling guidelines described in section

25 201(b)) to assure that the process controls are
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1 effective and that regulatory and other safety

2 standards are being met; and

3 (F) provide for agency access to records

4 kept under subparagraph (D) and submission

5 of copies of such records to the Secretary as the

6 Secretary determines to be appropriate.

7 (c) RECORDS.—Public access to records kept under

8 subsection (b)(2)(D) that relate to the adequacy of meas9 ures taken by facilities to protect public health by control10 ling and reducing the presence and growth of contami11 nants and other potentially harmful substances in food

12 products shall be governed by section 552 of title 5,

13 United States Code.

14 (d) PROCESS CONTROLS FOR USE OF FOOD INGRE15 DIENTS.—The Secretary may require any person, firm, or

16 corporation that has responsibility for or control over food

17 ingredients and that is registered under section 102 to

18 adopt process controls, to the extent the Secretary deter19 mines that such process controls are needed to assure the

20 protection of public health.

21 SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD.

22 (a) TOLERANCES.—In adopting, under section

23 103(b)(2), tolerances for facilities registered under section

24 102, the Secretary shall establish tolerances limiting the

25 quantity, in food products, of contaminants, except for
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1 pesticide chemical residues regulated under section 408,

2 or food additives regulated under section 409, of the Fed3 eral Food, Drug, and Cosmetic Act (21 U.S.C. 346a or

4 348), that, when found in food products, may render such

5 products unsafe for human consumption. Such tolerances

6 may include indicators (including indicator organisms)

7 from which the presence of a contaminant in a food prod8 uct may reasonably be inferred. In developing a tolerance

9 for a contaminant, the Secretary shall take into account

10 the extent to which consumers may be exposed to such

11 contaminant from sources other than food, and the extent

12 to which such contaminant can be avoided or minimized

13 in the commercial processing and handling of such food.

14 (b) REGULATIONS.—

15 (1) IN GENERAL.—The Secretary, after notice

16 and an opportunity for comment, shall promulgate

17 regulations to implement subsection (a) not later

18 than 48 months after the date of enactment of this

19 Act. In promulgating such regulations, the Secretary

20 shall establish tolerances for the contaminants that

21 the Secretary determines have the greatest public

22 health impact, as early as feasible after the date of

23 enactment of this Act.

24 (2) BASIS.—A tolerance established under this

25 section shall be based on—
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1 (A) a scientific analysis of the public

2 health risks attributable to the contaminant for

3 which the tolerance is established; and

4 (B) analysis of the public health risks at5 tributable to the contaminant for sensitive

6 groups, such as children, elderly individuals,

7 pregnant women, and individuals with com8 promised immune systems.

9 (3) REVISIONS.—The Secretary shall, in a time10 ly manner, issue revisions to the regulations under

11 paragraph (1) that take into account new informa12 tion relating to the contaminants involved.

13 (4) DATA OR ASSISTANCE.—The Secretary may

14 enter into a contract with the National Academy of

15 Sciences to provide such data or assistance as the

16 Secretary of Health and Human Services determines

17 to be necessary to carry out this subsection.

18 (c) REPORT.—The Secretary shall prepare and sub19 mit to Congress a report on the progress of the Secretary

20 in establishing tolerances under this section. The report

21 shall include a description of the research that has been

22 conducted with respect to such tolerances and the research

23 that needs to be conducted before additional tolerances

24 may be established under this section, the health signifi25 cance of the lack of such additional tolerances, a timetable
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1 for the establishment of such tolerances, and the estimated

2 costs, including costs of research, associated with the es3 tablishment of such tolerances. The report shall be sub4 mitted not later than 18 months after the date of enact5 ment of this Act, and biennially thereafter during the 6-

6 year period that begins on such date of enactment.

7 SEC. 105. INSPECTIONS OF PROCESSORS AND IMPORTERS.

8 (a) NATURE OF INSPECTIONS.—

9 (1) IN GENERAL.—The inspection system re10 ferred to in section 101(b)(4) shall provide for reg11 ular and unannounced inspections of facilities (in12 cluding facilities of importers) registered under sec13 tion 102 to determine if such facilities are operated

14 in a sanitary manner and if food products processed

15 or handled in the facilities is in violation of a food

16 safety law.

17 (2) SCHEDULE.—The Secretary shall inspect

18 each facility described in paragraph (1) at least

19 quarterly, except that the Secretary shall specify an

20 alternative inspection frequency for a facility that

21 the Secretary determines to be an exceptional or

22 negligible-risk facility, under standards issued under

23 paragraph (3).

24 (3) STANDARDS.—The Secretary shall issue

25 standards for determining whether a facility is an
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1 exceptional or negligible-risk facility. In issuing the

2 standards, the Secretary shall classify facilities by

3 considering the hazards associated with the type of

4 product being produced at a facility, the facility’s

5 history of compliance and food safety problems, and

6 such other factors as the Secretary may determine

7 to be appropriate.

8 (4) EXAMINATION OF CLASSIFICATIONS.—Each

9 inspection of a facility classified as an exceptional or

10 negligible-risk facility shall include an examination

11 of whether the facility is appropriately classified

12 under the standards issued under paragraph (3).

13 (b) CONDUCT OF INSPECTIONS.—

14 (1) SCOPE.—An inspection under subsection (a)

15 of any domestic or foreign facility (including a facil16 ity of an importer) shall extend to all things in the

17 facility (including records required to be maintained

18 under subsection (e), processes, controls, and prem19 ises) that bear on whether food products are in com20 pliance with a food safety law. The inspection shall

21 include a review of processing or handling records

22 and sampling of food products. Access to records

23 may include the copying of such records.

24 (2) AUTHORITIES.—In conducting such inspec25 tions, officers or employees duly designated by the
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1 Secretary, on presenting appropriate credentials to

2 the owner, operator, or agent in charge of a facility,

3 are authorized—

4 (A) to enter at reasonable times any facil5 ity described in subsection (a) in which persons

6 are engaged in the processing or handling of

7 food products (including a facility of an im8 porter), which may include entering any vehicle

9 being used to transport or hold food products

10 for processing or handling;

11 (B) to inspect in a reasonable manner such

12 facility (which may include inspecting a vehicle

13 described in subparagraph (A)), including all

14 pertinent equipment, finished and unfinished

15 materials, containers, labeling, processes, con16 trols, and premises; and

17 (C) to collect and retain samples of food

18 products or ingredients or of any other items

19 found during an inspection that may contribute

20 to a finding of whether such food products are

21 in violation of a food safety law.

22 (3) REPORT.—Immediately after completion of

23 the inspection, the officer or employee making the

24 inspection shall give to the owner, operator, or agent

25 in charge a report, in writing, setting forth any con-
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1 ditions or practices observed that indicate that either

2 process controls are inadequate to prevent or mini3 mize food safety hazards or that any food product

4 from such facility is in violation of a food safety law.

5 (c) PRODUCT DETENTION AND CONDEMNATION.—

6 (1) IN GENERAL.—If, during an inspection con7 ducted under this section of a domestic facility, an

8 officer or employee making the inspection deter9 mines that a food product is in violation of a food

10 safety law, such officer or employee may order the

11 food product segregated, impounded, and if objection

12 is not made within 48 hours after the issuance of

13 the impoundment order, condemned. If objection is

14 made within such 48 hours, food products that are

15 in perishable form may be processed to the extent

16 necessary to prevent spoilage, and the Secretary

17 shall expeditiously commence a hearing regarding

18 the determination and any action required for com19 pliance with the food safety laws.

20 (2) RELEASE.—If the Secretary determines

21 that, through relabeling or other action, such food

22 product can be brought into compliance with the

23 food safety laws, the food product may be released

24 following a determination by the Secretary that such
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1 relabeling or other action as specified by the Sec2 retary has been performed.

3 (3) DESTRUCTION.—Any food product con4 demned under paragraph (1)—

5 (A) in a case in which no objection is made

6 under paragraph (1);

7 (B) after the hearing and any judicial re8 view; or

9 (C) after failure of the owner, operator, or

10 agent to perform relabeling or other action de11 scribed in paragraph (2);

12 shall be destroyed under supervision of the Sec13 retary.

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

15 by regulation 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 and handled in accordance with standards approved

19 by the Secretary. The Secretary may assess a fee for the

20 use of such a mark. The Secretary shall deposit fees re21 ceived under this subsection in an account, and may use

22 the funds in the account to carry out enforcement activi23 ties under the food safety laws, or to carry out section

24 106.
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1 (e) MAINTENANCE OF RECORDS.—The registrant for

2 each facility registered under section 102 shall maintain

3 and make available for inspection by the Secretary such

4 records as the Secretary may prescribe. Such records shall

5 be maintained for a reasonable period of time as deter6 mined by the Secretary. The records shall include informa7 tion concerning—

8 (1)(A) the origin, receipt, delivery, sale, move9 ment, holding, and disposition of food products, or

10 ingredients for food products, processed or handled

11 at the facility;

12 (B) the identity and amount of ingredients used

13 in the food involved;

14 (C) the processing or handling of the food;

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

16 other quality control tests performed on the food or

17 in the facility; and

18 (E) consumer complaints concerning the food or

19 the packaging of the food; and

20 (2) other matters reasonably related to whether

21 food products processed or handled at the facility

22 may be in violation of a food safety law.

23 (f) OTHER INSPECTION RIGHTS AND DUTIES.—Sec24 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 ‘‘(g) Except as otherwise provided in section 106(b)

4 of the Consumer Food Safety Act of 1999, the provisions

5 of the last 2 sentences of subsection (a)(1), and sub6 sections (c) and (d), relating to the powers and duties of

7 officers and employees to enforce this Act, and to the

8 rights and duties of persons with respect to whom such

9 powers are exercised, apply to the powers and duties of

10 officers and employees designated by the Secretary to en11 force the Consumer Food Safety Act of 1999, and to the

12 rights and duties of persons with respect to whom such

13 powers are exercised, respectively.’’.

14 SEC. 106. STATE AND FEDERAL COOPERATION.

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

16 States in undertaking activities and programs that con17 tribute to the national program established under section

18 101 so that State food safety programs and the national

19 program function in a coordinated and cost-effective man20 ner. With the assistance provided under subsection (b),

21 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 food safety programs are not unsafe for

4 human consumption.

5 (b) ASSISTANCE.—The Secretary may provide to a

6 State, for planning, developing, and implementing a food

7 safety program—

8 (1) advisory assistance;

9 (2) technical assistance, training, and labora10 tory assistance (including necessary materials and

11 equipment); and

12 (3) financial and other assistance.

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 that are recorded or issued in connection

20 with activities under the agreement and are in the posses21 sion of the agency that entered into the agreement shall

22 be made available in accordance with section 552 of title

23 5, United States Code. An agreement entered into with

24 a State agency under this subsection may provide for

25 training of State employees.
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1 SEC. 107. IMPORTS.

2 (a) ROLE OF SECRETARY.—Not later than 24

3 months after the date of enactment of this Act, the Sec4 retary shall establish and administer a comprehensive and

5 efficient system to ensure the safety of food products im6 ported into the United States. In administering the sys7 tem, the Secretary shall routinely inspect facilities reg8 istered under section 102 in exporting nations and imports

9 at ports of entry into the United States, in accordance

10 with this section and section 105. The Secretary shall as11 sure that the facilities are operating in compliance with

12 the food safety laws, through such verification and other

13 activities as the Secretary considers to be necessary.

14 (b) IMPORT REQUIREMENTS.—

15 (1) SAFETY STANDARDS.—No food product

16 may enter the United States, or be withdrawn from

17 a facility for consumption in the United States if

18 such food product appears to be in violation of a

19 food safety law.

20 (2) TREATMENT.—Upon entry for consumption

21 in the United States, food products that are not pro22 hibited from entry or from withdrawal from a facil23 ity under paragraph (1) shall be considered to be

24 and treated as domestic food products for purposes

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

26 U.S.C. 301 et seq.), except that all labeling of such
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1 products shall clearly identify the country of origin

2 to facilitate the identification of products linked to

3 outbreaks of illness.

4 (c) INSPECTION OF IMPORTS.—

5 (1) EXAMINATIONS, INSPECTIONS, SAMPLING

6 AND OTHER PROCEDURES.—Food products that are

7 offered for importation, or withdrawn from a facil8 ity, for consumption in the United States, shall be

9 subject to examinations, inspections, sampling, and

10 such other procedures as the Secretary may deter11 mine to be appropriate at the port of entry or at the

12 facility registered under section 102 in the exporting

13 nation by officers or employees duly designated by

14 the Secretary. Such procedures shall be conducted

15 with such frequency and in such manner as the Sec16 retary may prescribe by regulation.

17 (2) RANDOM OR INTENSIFIED PROCEDURES.—

18 Food products from a nation that is certified for

19 such food products under subsection (e)(3) shall be

20 subject to random examinations, inspections, sam21 pling, and other procedures under paragraph (1).

22 Food products from a nation that is not certified for

23 such food products under subsection (e)(3) shall be

24 subject to such intensified examinations, inspections,

25 sampling, and other verification procedures, includ-
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1 ing inspection in the exporting nation, under para2 graph (1), as the Secretary determines are necessary

3 to ensure compliance with the food safety laws.

4 (d) DETENTION OF IMPORTED FOOD PRODUCT.—If,

5 during an inspection or other verification procedure car6 ried out under this section at a port of entry, an officer

7 or employee conducting the procedure determines that a

8 food product is in violation of a food safety law, such offi9 cer or employee may order the food product segregated,

10 impounded, and if objection is not made within such 48

11 hours, condemned. If objection is made, within such 48

12 hours such food products that are in perishable form may

13 be processed to the extent necessary to prevent spoilage,

14 and the Secretary shall expeditiously commerce a hearing

15 regarding the determination and any action required for

16 compliance with the food safety laws. The final condemna17 tion or other disposition of such food product shall be sub18 ject to the provisions of paragraphs (2) and (3) of section

19 105(c).

20 (e) AGREEMENTS WITH FOREIGN NATIONS.—

21 (1) EVALUATION.—The Secretary may enter

22 into an agreement described in paragraph (2) with

23 any nation desiring to export food products to the

24 United States. Prior to concluding such an agree25 ment, the Secretary shall evaluate the food safety
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1 program of the foreign nation to determine if such

2 program provides at least the same level of protec3 tion, with respect to food products intended for ex4 port to the United States, as domestic laws that af5 fect the safety of the food supply. In such evalua6 tion, the Secretary shall consider—

7 (A) the potential for health, sanitary, envi8 ronmental, or other conditions within the for9 eign nation to adversely affect the safety of

10 food products exported from such nation; and

11 (B) how well the food safety programs of

12 the foreign nation function to minimize any ad13 verse effects on such safety.

14 (2) REQUIREMENTS.—Any agreement under

15 this subsection with a nation desiring to export food

16 products to the United States shall—

17 (A) require that the exporting nation

18 shall—

19 (i) establish and maintain a food safe20 ty system that is adequate to ensure that

21 the food products intended for export to

22 the United States are not in violation of

23 the food safety laws; 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 other

7 procedures, at such stages in the growth or har8 vest of food, or in the processing or handling of

9 food products, as the Secretary considers to be

10 appropriate to ensure that the food safety pro11 gram of the exporting nation continues to pro12 vide at least the same level of protection, with

13 respect to food products intended for export to

14 the United States, as domestic laws that affect

15 the safety 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) CERTIFICATION.—If the Secretary deter21 mines that a nation desiring to export food products

22 to the United States has a program that provides at

23 least the same level of protection, with respect to

24 food products intended for export to the United

25 States, as domestic laws that affect the safety of the
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1 food supply, the Secretary shall, upon entry into

2 force of an agreement under paragraph (1), certify

3 the types of food products for which the nation

4 maintains such a program.

5 (4) REVIEWS OF CERTIFICATIONS.—

6 (A) IN GENERAL.—The Secretary shall pe7 riodically or for good cause, and not less than

8 once every 3 years, review certifications made

9 under paragraph (3), and shall revoke the cer10 tification of any nation that the Secretary de11 termines is not maintaining a food safety pro12 gram that provides at least the same level of

13 protection, with respect to food products in14 tended for export to the United States, as do15 mestic laws that affect the safety of the food

16 supply.

17 (B) IMPACT ON AGREEMENTS.—The Sec18 retary shall review and modify, as needed, an

19 agreement made under paragraph (1) with any

20 nation whose certification has been revoked

21 under subparagraph (A).
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1 TITLE II—RESEARCH AND

2 EDUCATION

3 SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

4 (a) COOPERATION WITH THE CENTERS FOR DISEASE

5 CONTROL AND PREVENTION.—The Secretary, acting

6 through the Director of the Centers for Disease Control

7 and Prevention, shall maintain an active surveillance sys8 tem for food, to include on a representative proportion of

9 the population of the United States, to assess more accu10 rately the frequency and sources of human illness in the

11 United States associated with the consumption of food.

12 (b) PUBLIC HEALTH SAMPLING.—

13 (1) GUIDELINES.—Not later than 12 months

14 after the date of enactment of this Act, the Sec15 retary, in cooperation with the Secretary of Agri16 culture, shall establish guidelines for a sampling sys17 tem under which the Secretary and the Secretary of

18 Agriculture shall collect and analyze samples of food

19 products to assist the Secretary in carrying out the

20 food safety laws, and to assess more accurately the

21 nature, frequency of occurrence, and amounts of

22 contaminants in food products.

23 (2) MONITORING AND OTHER INFORMATION.—

24 In carrying out the sampling system, the Secretary

25 and the Secretary of Agriculture shall provide for—
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1 (A) statistically valid monitoring, including

2 the conduct of market-basket studies, on the

3 nature, frequency of occurrence, and amounts

4 of contaminants in food products available to

5 consumers; and

6 (B) at the request of the Secretary of

7 Health and Human Services, the collection and

8 analysis of such other information, including

9 analysis of information from monitoring and

10 verification samples, as the Secretary deter11 mines may be useful in assessing the occurrence

12 of contaminants in food products.

13 (c) ASSESSMENT OF PUBLIC HEALTH HAZARDS.—

14 Using information obtained through the surveillance sys15 tem referred to in subsection (a) and the sampling system

16 described in subsection (b), the Secretary shall rank food

17 categories based on their hazard to public health and iden18 tify appropriate industry and regulatory approaches to

19 minimize hazards in the food supply. In conducting the

20 ranking and identification, the Secretary may determine—

21 (1) the public health hazards associated with

22 food products that are commercially harvested and

23 prepared, as compared with the public health haz24 ards associated with food products that are har-
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1 vested for recreational or subsistence purposes and

2 prepared noncommercially;

3 (2) the public health hazards associated with

4 food products that are domestically harvested and

5 processed, as compared with the public health haz6 ards associated with food products that are har7 vested or processed outside the United States; and

8 (3) the extent of contamination originating

9 from handling practices that occur prior to or after

10 sale of food products to consumers.

11 SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM.

12 (a) PUBLIC EDUCATION.—The Secretary, in coopera13 tion with private and public organizations, including the

14 State cooperative extension services and appropriate State

15 entities, shall design and implement a national public edu16 cation program on food safety. In carrying out the pro17 gram, the Secretary shall—

18 (1) provide information to the public regarding

19 Federal standards and good practice requirements

20 relating to food safety, and promote public aware21 ness, understanding, and acceptance of such stand22 ards and requirements;

23 (2) provide information to health professionals

24 so that the health professionals may improve diag25 nosis and treatment of food-related illness and ad-
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1 vise individuals whose health conditions place the in2 dividuals at particular risk for that illness; and

3 (3) provide such other information or advice to

4 consumers and other persons as the Secretary deter5 mines will promote the objectives of this Act.

6 (b) HEALTH ADVISORIES.—The Secretary, in con7 sultation with the Secretary of Agriculture and the Admin8 istrator of the Environmental Protection Agency, and in

9 cooperation with States and other appropriate entities,

10 shall—

11 (1) develop and distribute regional and national

12 advisories concerning food safety;

13 (2) develop standardized formats for written

14 and broadcast advisories concerning food safety; and

15 (3) incorporate State and local advisories, con16 cerning food safety into the national public edu17 cation program required under subsection (a).

18 SEC. 203. RESEARCH.

19 (a) IN GENERAL.—The Secretary shall conduct re20 search to assist in the implementation of this Act, includ21 ing studies relating to—

22 (1) improving sanitation and food safety prac23 tices in the processing and handling of food prod24 ucts;
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1 (2) developing improved techniques for the

2 monitoring of food and inspection of food products;

3 (3) developing efficient, rapid, and sensitive

4 methods for determining and detecting the presence

5 of contaminants in food products;

6 (4) determining the sources of contamination of

7 food (including food products); and

8 (5) developing consumption data with respect to

9 food products.

10 (b) CONTRACT AUTHORITY.—The Secretary is au11 thorized to enter into contracts and agreements with any

12 State, institution of higher education, other government

13 agency, or other person to carry out the activities de14 scribed in this section.

15 TITLE III—ENFORCEMENT

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

17 AND COSMETIC ACT.

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

19 Cosmetic Act (21 U.S.C. 301 et seq.) is amended—

20 (1) by inserting after the chapter heading for

21 chapter IV the following:

22 ‘‘SUBCHAPTER A—FOOD STANDARDS’’; and

23 (2) by adding at the end the following:
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1 ‘‘SUBCHAPTER B—REMEDIES

2 ‘‘SEC. 421. DEFINITIONS.

3 ‘‘In this subchapter, the term ‘food safety law’ means

4 the Consumer Food Safety Act of 1999 and the provisions

5 of this Act that relate to food.

6 ‘‘SEC. 422. NOTIFICATION AND RECALL.

7 ‘‘(a) NOTICE TO SECRETARY OF VIOLATION.—Any

8 person (other than a household consumer or other indi9 vidual who is the intended consumer of an article of food)

10 that has a reasonable basis for believing that any article

11 of food introduced into or in interstate commerce, or held

12 for sale (whether or not the first sale) after shipment in

13 interstate commerce, may be in violation of a food safety

14 law shall immediately notify the Secretary, in such manner

15 and by such means as the Secretary may by regulation

16 prescribe, of the identity and location of such article.

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

18 ‘‘(1) VOLUNTARY PROCEDURES.—If the Sec19 retary finds, on notification under subsection (a) or

20 otherwise, that any article of food is in violation of

21 a food safety law when introduced into or while in

22 interstate commerce or while held for sale (whether

23 or not the first sale) after shipment in interstate

24 commerce and there is a reasonable probability that

25 such article, if consumed, would present a threat to
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1 public health, as determined by the Secretary, the

2 Secretary shall provide the appropriate persons (in3 cluding the manufacturers, importers, distributors,

4 or retailers of the article) with an opportunity to—

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

6 ‘‘(B) notify all persons—

7 ‘‘(i) producing, manufacturing, pack8 ing, processing, preparing, treating, pack9 aging, distributing, or holding such article

10 to immediately cease such activities with

11 respect to such article; or

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

13 distributed, transported, or sold, to imme14 diately cease distribution of such article;

15 ‘‘(C) recall such article;

16 ‘‘(D) provide, in consultation with the Sec17 retary, notice of the finding of the Secretary to

18 consumers to whom such article was, or may

19 have been, distributed; or

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

21 measures, as determined by the Secretary to be

22 appropriate in the circumstances.

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

25 refuses to or does not voluntarily cease distribution,
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1 make notification, recall such article, or provide no2 tice to consumers, as applicable, within the time and

3 in the manner prescribed by the Secretary, the Sec4 retary shall, by order, require, as the Secretary de5 termines to be necessary, 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 to immediately cease such activities with

13 respect to such article; or

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

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

17 ‘‘(C) immediately take the actions specified

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

19 ‘‘(3) NOTIFICATION OF CONSUMERS BY SEC20 RETARY.—The Secretary shall, as the Secretary de21 termines to be necessary, provide notice of the find22 ing of the Secretary under paragraph (1) to con23 sumers to whom such article was, or may have been,

24 distributed.
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1 ‘‘(c) HEARING ON ORDER.—The Secretary shall pro2 vide any person subject to an order under subsection (b)

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

4 practicable but not later than 2 days after the issuance

5 of the order, on the actions required by the order and on

6 whether the article that is the subject of the order should

7 be recalled.

8 ‘‘(d) POST-HEARING RECALL ORDER.—

9 ‘‘(1) AMENDMENT OF ORDER.—If, after pro10 viding an opportunity for a hearing under subsection

11 (c), the Secretary determines that there is a reason12 able probability that the article that is the subject

13 of an order under subsection (b), if consumed, pre14 sents a threat to public health, the Secretary, as the

15 Secretary determines to be necessary, may—

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

17 such article or other appropriate action;

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

19 shall occur;

20 ‘‘(C) require periodic reports to the Sec21 retary describing the progress of the recall; and

22 ‘‘(D) provide notice of the recall to con23 sumers to whom such article was, or may have

24 been, distributed.
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1 ‘‘(2) VACATION OF ORDER.—If, after such a

2 hearing, the Secretary determines that adequate

3 grounds do not exist to continue the actions required

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

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

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

7 exclusive of other remedies that may be available.

8 ‘‘SEC. 423. CIVIL PENALTIES.

9 ‘‘(a) IN GENERAL.—

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

11 AMOUNT.—Any person that commits an act that vio12 lates a food safety law may be assessed a civil pen13 alty by the Secretary of not more than $100,000 for

14 each such act. Each such act and each day during

15 which such act continues shall be a separate offense.

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

17 be assessed by the Secretary under this section un18 less such person is given notice and an opportunity

19 for a hearing on the record before the Secretary in

20 accordance with sections 554 and 556 of title 5,

21 United States Code.

22 ‘‘(3) OTHER REQUIREMENTS.—Such civil pen23 alty shall be assessed by the Secretary by written

24 order. The amount of the civil penalty shall be deter25 mined by the Secretary, taking into account the
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1 gravity of the violation, degree of culpability of the

2 person, size and type of business of the person, and

3 any history of prior offenses by the person, and shall

4 be specified in the order. The order may be reviewed

5 only as provided in subsection (b).

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

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

8 unless the person files, within 30 days after the effective

9 date of the order, an application for judicial review of the

10 order in the United States Court of Appeals for the circuit

11 in which such person resides or has its principal place of

12 business, or in the United States Court of Appeals for the

13 District of Columbia Circuit. The person shall file the ap14 plication by filing a notice of appeal in such court and

15 by simultaneously sending a copy of such notice by cer16 tified mail to the Secretary. The Secretary shall promptly

17 file in such court a certified copy of the record upon which

18 such order was issued. The findings of the Secretary relat19 ing to the order shall be set aside only if found to be un20 supported by substantial evidence on the record as a

21 whole.

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

23 pay a civil penalty assessed under subsection (a) after the

24 order assessing the penalty has become a final and conclu25 sive order, or after the court of appeals described in sub-
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1 section (b) has entered final judgment in favor of the Sec2 retary, the Secretary shall refer the matter to the Attorney

3 General, who shall institute a civil action to recover the

4 amount assessed in a United States district court of com5 petent jurisdiction. In such action, the validity and appro6 priateness of the Secretary’s order assessing the civil pen7 alty shall not be subject to review.

8 ‘‘(d) PENALTIES PAID INTO ACCOUNT.—The Sec9 retary shall deposit penalties collected under this section

10 in an account, and may use the funds in the account to

11 carry out enforcement activities under the food safety

12 laws, or to carry out section 106 of the Consumer Food

13 Safety Act of 1999.

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

15 Nothing in this Act shall be construed as requiring the

16 Secretary to report for prosecution, or for the institution

17 of libel or injunction proceedings, violations of a food safe18 ty law whenever the Secretary believes that the public in19 terest will be adequately served by assessment of civil pen20 alties under this section.

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

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

23 exclusive of other remedies that may be available.
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1 ‘‘SEC. 424. WHISTLEBLOWER PROTECTION.

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

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

4 against in any way because that person—

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

6 or is about to commence a proceeding, has testified

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

8 or participated or is about to assist or participate in

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

10 out the objectives, functions, or responsibilities spec11 ified in the Consumer Food Safety Act of 1999, the

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

13 301 et seq.), the Federal Meat Inspection Act (21

14 U.S.C. 601 et seq.), or the Poultry Products Inspec15 tion Act (21 U.S.C. 451 et seq.); or

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

17 of a law described in paragraph (1), including a reg18 ulation issued under that law.

19 ‘‘(b) PROCEDURES.—

20 ‘‘(1) IN GENERAL.—A person alleging a viola21 tion of subsection (a) may file a complaint as de22 scribed in subsection (b) of section 31105 of title 49,

23 United States Code.

24 ‘‘(2) ADMINISTRATION.—The process, proce25 dures, and remedies that apply under subsections

26 (b), (c), and (d) of that section 31105 with respect
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1 to allegations of violations of subsection (a) of that

2 section shall be the process, procedures, and rem3 edies that apply with respect to allegations of viola4 tions of subsection (a), except as provided in para5 graphs (3) and (4).

6 ‘‘(3) ALTERNATIVE PROCESS.—The person fil7 ing a complaint under paragraph (1) may elect to

8 use an alternative dispute resolution procedure, such

9 as mediation or arbitration, in lieu of the hearing

10 described in subsection (b) of that section 31105.

11 ‘‘(4) SECRETARY.—The powers and duties that

12 apply to the Secretary of Labor under that section

13 31105 shall apply to the Secretary of Health and

14 Human Services.

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

16 proof with respect to a violation of subsection (a) shall

17 be governed by the applicable provisions of sections 1214

18 and 1221 of title 5, United States Code.

19 ‘‘SEC. 425. ADMINISTRATION AND ENFORCEMENT; APPLICA20 BILITY OF PENALTY PROVISIONS; CONDUCT

21 OF INQUIRIES; POWER AND JURISDICTION OF

22 COURTS.

23 ‘‘(a) IN GENERAL.—For the efficient administration

24 and enforcement of the food safety laws, the provisions

25 (including provisions relating to penalties) of sections 6,
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1 8, 9, and 10 of the Federal Trade Commission Act (15

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

3 (h) of such section 6), relating to the jurisdiction, powers,

4 and duties of the Federal Trade Commission and the At5 torney General to administer and enforce that Act, and

6 to the rights and duties of persons with respect to whom

7 such powers are exercised, apply to the jurisdiction, pow8 ers, and duties of the Secretary and the Attorney General

9 in administering and enforcing the provisions of this chap10 ter and the Consumer Food Safety Act of 1999 and to

11 the rights and duties of persons with respect to whom such

12 powers are exercised, respectively.

13 ‘‘(b) INQUIRIES AND ACTIONS.—The Secretary, in

14 person or by such agents as the Secretary may designate,

15 may prosecute any inquiry necessary to carry out the du16 ties of the Secretary under this chapter and the Consumer

17 Food Safety Act of 1999 in any part of the United States,

18 and the powers conferred by sections 9 and 10 of the Fed19 eral Trade Commission Act (15 U.S.C. 49 and 50) on the

20 United States district courts may be exercised for the pur21 poses of this chapter by any United States district court

22 of competent jurisdiction.

23 ‘‘SEC. 426. TRACEBACK.

24 ‘‘The Secretary may impose on a food product re25 quirements for the traceability of such type or class of food
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1 product whenever such requirements are necessary to as2 sure the protection of public health. Traceability require3 ments shall be established in accordance with regulations

4 and guidelines issued by the Secretary and shall apply to

5 persons registered under section 102 of the Consumer

6 Food Safety Act of 1999.

7 ‘‘SEC. 427. CITIZEN’S CIVIL ACTIONS.

8 ‘‘(a) CIVIL ACTIONS.—Any person may commence a

9 civil action against—

10 ‘‘(1) any person who violates any rule (includ11 ing a rule establishing a tolerance), order, or other

12 action of the Secretary to ensure the safety of food

13 products; or

14 ‘‘(2) the Secretary, if the Secretary fails to per15 form any act or duty to ensure the safety of food

16 products that is not discretionary under a food safe17 ty law.

18 ‘‘(b) COURT.—The action shall be commenced in the

19 United States district court for the district in which the

20 defendant resides or is found or has an agent. The court

21 shall have jurisdiction, without regard to the amount in

22 controversy, or the citizenship of the parties, to enforce

23 such rule (including a rule establishing a tolerance), order,

24 or other action of the Secretary, or to order the Secretary

25 to perform such act or duty. The court may award dam-
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1 ages, in the amount of damages actually sustained, and,

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

3 may award the plaintiff the costs of suit, including reason4 able attorney’s fees, reasonable expert witness fees, and

5 penalties.

6 ‘‘(c) REMEDIES NOT EXCLUSIVE.—The remedies

7 provided for in this section shall be in addition to and not

8 exclusive of other remedies that may be available.’’.

9 ‘‘SEC. 428. ADMINISTRATION.

10 ‘‘Notwithstanding any other provision of this Act, the

11 remedy for any foreign facility that violates a food safety

12 law shall be suspension of registration under section 102

13 of the Consumer Food Safety Act of 1999.’’.

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

19 issued under section 422(b)(2) or 422(d).

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

21 Safety Act of 1999.’’.

22 TITLE IV—AUTHORIZATION

23 SEC. 401. AUTHORIZATION OF APPROPRIATIONS.

24 (a) IN GENERAL.—There are authorized to be appro25 priated to carry out this Act, other than sections 106 and
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1 203, such sums as may be necessary for each of fiscal

2 years 2000 and 2001.

3 (b) ASSISTANCE TO STATES.—There are authorized

4 to be appropriated such sums as may be necessary for

5 each of fiscal years 2000 and 2001, for carrying out sec6 tion 106 (relating to State program assistance).

7 (c) RESEARCH PROGRAM AUTHORIZATION.—There

8 are authorized to be appropriated such sums as may be

9 necessary for each of fiscal years 2000 and 2001, for car10 rying out section 203 (relating to research).

Æ