[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 908 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Consumer Food 
Safety Act of 1999''.
    (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.
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.

SEC. 2. DEFINITIONS.

    In this Act:
            (1) Contaminant.--The term ``contaminant'' includes a 
        bacterium, a chemical contaminant, a natural toxin, a virus, a 
        parasite, and a physical hazard, that when found on or in food 
        can cause human illness or injury.
            (2) Facility.--The term ``facility'' includes any factory, 
        warehouse, or establishment (including a factory, warehouse, or 
        establishment of an importer), that handles or processes food.
            (3) Food.--The term ``food'' has the meaning given the term 
        in section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321).
            (4) Food safety law.--The term ``food safety law'' means 
        this Act and the provisions of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.) that relate to food.
            (5) Process.--The term ``process'' means the commercial 
        harvesting, preparation, manufacture, or transportation of a 
        food product.
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

                 TITLE I--NATIONAL FOOD SAFETY PROGRAM

SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.

    (a) In General.--
            (1) Finding.--Congress finds that persons who produce or 
        process food for human consumption have the responsibility to 
        prevent or minimize food safety hazards related to their 
        products.
            (2) National program.--The Secretary shall administer, in 
        accordance with the provisions of this Act, a national program 
        for the purpose of protecting public health by ensuring that 
        the food industry has effective programs in place to assure the 
        safety of food products consumed in the United States.
            (3) Basis for program.--The program shall--
                    (A) be based on a comprehensive analysis of the 
                hazards associated with different food products and 
                with the processing (including harvesting) and handling 
                of different food products, including the 
                identification and evaluation of--
                            (i) the severity of the potential public 
                        health hazards;
                            (ii) the sources and specific points of 
                        potential contamination that may render food 
                        products unsafe for human consumption; and
                            (iii) the potential for persistence, 
                        multiplication, or concentration of naturally 
                        occurring or added contaminants in foods, 
                        including food products; and
                    (B) take into consideration the distinctive 
                characteristics of food processing and handling.
    (b) Program Elements.--The program shall provide for--
            (1) implementation of a national system for the annual 
        registration of facilities (including facilities of importers) 
        with the Secretary;
            (2) development of a program to oversee the implementation 
        of process controls in facilities, including the establishment 
        and enforcement of health-based standards for--
                    (A) substances that may contaminate food; and
                    (B) safety and sanitation in the processing and 
                handling of food products;
            (3) establishment of inspection and oversight procedures to 
        monitor that facilities are utilizing preventive controls to 
        minimize or eliminate identifiable hazards in food;
            (4) implementation of a national system for quarterly 
        inspections of facilities (including facilities of importers), 
        except for facilities that meet the Secretary's standards for 
        exceptional or negligible-risk facilities;
            (5) implementation of procedures and requirements to ensure 
        the safety of imported food products;
            (6) coordination with other Federal agencies or State 
        governments in carrying out inspection, enforcement, and 
        monitoring relating to the safety of food products;
            (7) implementation of a national surveillance system to 
        assess the public health hazards associated with the human 
        consumption of food products, in cooperation with the Director 
        of the Centers for Disease Control and Prevention;
            (8) implementation of a sampling program to ensure that 
        industry programs to prevent food contamination are effective 
        and that food products meet the standards established in 
        paragraph (2);
            (9) development of public education and advisory programs 
        relating to the safety of food products; and
            (10) implementation of a research program to further the 
        objectives of this Act.

SEC. 102. REGISTRATION OF PROCESSORS AND IMPORTERS.

    (a) Registration.--
            (1) In general.--Any facility engaged in processing or 
        handling food products for consumption in the United States, 
        including any facility of an importer, shall be registered with 
        the Secretary. To obtain the registration--
                    (A) for a domestic facility not described in 
                subparagraph (B), the owner, operator, or agent in 
                charge of the facility shall submit an application to 
                the Secretary; and
                    (B) for a facility of an importer, or for a foreign 
                facility, the importer seeking to import the food 
                product processed or handled in the facility shall 
                submit the application.
            (2) Application.--
                    (A) In general.--The applicant shall submit the 
                application to the Secretary in such manner and 
                containing such information as the Secretary shall 
                prescribe by regulation.
                    (B) Submission.--The applicant shall submit the 
                application not later than 24 months after--
                            (i) the date of enactment of this Act; or
                            (ii) the date the facility first processed 
                        or handled food, if later than such date of 
                        enactment.
                    (C) Contents.--In the case of an application 
                submitted for a foreign facility, the application shall 
                contain, at a minimum, such information as the 
                Secretary may require demonstrating that the facility, 
                and the foreign nation involved, will permit 
                inspections described in this title.
            (3) Procedure.--Upon receipt and review of a completed 
        application described in paragraph (1), the Secretary shall 
        issue to the applicant a certificate of registration unless the 
        Secretary finds that there is good cause for denial of the 
        application. The Secretary shall promptly notify the applicant 
        of the denial, include in the notification a written 
        explanation of the reasons for such denial, and provide an 
        opportunity for a hearing or reapplication upon request.
    (b) Suspension of Registration.--
            (1) Basis.--The registration of a facility, including the 
        facility of an importer, may be suspended immediately by the 
        Secretary for--
                    (A) failure to permit access to the facility for 
                inspection under this Act;
                    (B) violation of a food safety law, including a 
                regulation issued under a food safety law, concerning 
                the facility, in a case in which the Secretary 
                determines that such suspension is likely to prevent a 
                significant risk of adverse health consequences; or
                    (C) conviction of the applicant or registrant in 
                any Federal or State court of--
                            (i) any felony relating to food, whether or 
                        not the felony is based upon the acquisition, 
                        handling, or distribution of adulterated or 
                        misbranded food; or
                            (ii) more than 1 violation of any law 
                        relating to food, whether or not the violation 
                        involves any fraud in connection with 
                        transactions in food.
            (2) Impact.--No person may introduce a food product into 
        interstate commerce, or offer a food product for import into 
        the United States, from a facility with a suspended 
        registration.
            (3) Reinstatement.--Any registration suspended under 
        paragraph (1) may be reinstated whenever the Secretary 
        determines that the suspension is no longer necessary.
    (c) Exemption Authority.--The Secretary may by regulation exempt 
classes of facilities from the requirements of subsection (a) if the 
Secretary determines that the registration of such facilities is not 
needed for effective enforcement of a food safety law.

SEC. 103. PROCESS CONTROLS TO REDUCE THE CONTAMINATION OF FOOD 
              PRODUCTS.

    (a) In General.--The Secretary shall, on the basis of the best 
available scientific and technological data, prescribe regulations to--
            (1) limit the presence of contaminants and other 
        potentially harmful substances in food products;
            (2) ensure that all facilities registered under section 102 
        implement appropriate process controls to control and reduce 
the presence and growth of contaminants and other potentially harmful 
substances in food products;
            (3) ensure that all processed or ready-to-eat food products 
        are processed and handled in a sanitary manner, using 
        reasonably available techniques and technologies to minimize 
        any contaminants or other potentially harmful substances likely 
        to cause foodborne illness; and
            (4) ensure that food products intended for final processing 
        outside commercial establishments are labeled with instructions 
        for handling and preparation for consumption that, when adhered 
        to, will destroy any contaminant or other potentially harmful 
        substance likely to cause foodborne illness.
    (b) Regulations.--
            (1) In general.--In implementing subsection (a), the 
        Secretary shall, not later than 1 year after the date of 
        enactment of this Act, issue regulations that require each 
        facility registered under section 102 to adopt process controls 
        adequate to protect public health by controlling and reducing 
        the presence and growth of contaminants and other potentially 
        harmful substances in food products prepared in the facility.
            (2) Elements.--Such regulations shall--
                    (A) set standards for sanitation in food products;
                    (B) set tolerances for biological, chemical, and 
                physical contaminants in food products, as appropriate;
                    (C) require process controls to assure that food 
                products are safe and that relevant regulatory and 
                other safety standards, including the standards and 
                tolerances described in subparagraphs (A) and (B), are 
                met;
                    (D) require recordkeeping to monitor compliance 
                with the process controls;
                    (E) require sampling (in accordance with the 
                sampling guidelines described in section 201(b)) to 
                assure that the process controls are effective and that 
                regulatory and other safety standards are being met; 
                and
                    (F) provide for agency access to records kept under 
                subparagraph (D) and submission of copies of such 
                records to the Secretary as the Secretary determines to 
                be appropriate.
    (c) Records.--Public access to records kept under subsection 
(b)(2)(D) that relate to the adequacy of measures taken by facilities 
to protect public health by controlling and reducing the presence and 
growth of contaminants and other potentially harmful substances in food 
products shall be governed by section 552 of title 5, United States 
Code.
    (d) Process Controls for Use of Food Ingredients.--The Secretary 
may require any person, firm, or corporation that has responsibility 
for or control over food ingredients and that is registered under 
section 102 to adopt process controls, to the extent the Secretary 
determines that such process controls are needed to assure the 
protection of public health.

SEC. 104. TOLERANCES FOR CONTAMINANTS IN FOOD.

    (a) Tolerances.--In adopting, under section 103(b)(2), tolerances 
for facilities registered under section 102, the Secretary shall 
establish tolerances limiting the quantity, in food products, of 
contaminants, except for pesticide chemical residues regulated under 
section 408, or food additives regulated under section 409, of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a or 348), that, 
when found in food products, may render such products unsafe for human 
consumption. Such tolerances may include indicators (including 
indicator organisms) from which the presence of a contaminant in a food 
product may reasonably be inferred. In developing a tolerance for a 
contaminant, the Secretary shall take into account the extent to which 
consumers may be exposed to such contaminant from sources other than 
food, and the extent to which such contaminant can be avoided or 
minimized in the commercial processing and handling of such food.
    (b) Regulations.--
            (1) In general.--The Secretary, after notice and an 
        opportunity for comment, shall promulgate regulations to 
        implement subsection (a) not later than 48 months after the 
        date of enactment of this Act. In promulgating such 
        regulations, the Secretary shall establish tolerances for the 
        contaminants that the Secretary determines have the greatest 
        public health impact, as early as feasible after the date of 
        enactment of this Act.
            (2) Basis.--A tolerance established under this section 
        shall be based on--
                    (A) a scientific analysis of the public health 
                risks attributable to the contaminant for which the 
                tolerance is established; and
                    (B) analysis of the public health risks 
                attributable to the contaminant for sensitive groups, 
                such as children, elderly individuals, pregnant women, 
                and individuals with compromised immune systems.
            (3) Revisions.--The Secretary shall, in a timely manner, 
        issue revisions to the regulations under paragraph (1) that 
        take into account new information relating to the contaminants 
        involved.
            (4) Data or assistance.--The Secretary may enter into a 
        contract with the National Academy of Sciences to provide such 
        data or assistance as the Secretary of Health and Human 
        Services determines to be necessary to carry out this 
        subsection.
    (c) Report.--The Secretary shall prepare and submit to Congress a 
report on the progress of the Secretary in establishing tolerances 
under this section. The report shall include a description of the 
research that has been conducted with respect to such tolerances and 
the research that needs to be conducted before additional tolerances 
may be established under this section, the health significance of the 
lack of such additional tolerances, a timetable for the establishment 
of such tolerances, and the estimated costs, including costs of 
research, associated with the establishment of such tolerances. The 
report shall be submitted not later than 18 months after the date of 
enactment of this Act, and biennially thereafter during the 6-year 
period that begins on such date of enactment.

SEC. 105. INSPECTIONS OF PROCESSORS AND IMPORTERS.

    (a) Nature of Inspections.--
            (1) In general.--The inspection system referred to in 
        section 101(b)(4) shall provide for regular and unannounced 
        inspections of facilities (including facilities of importers) 
        registered under section 102 to determine if such facilities 
        are operated in a sanitary manner and if food products 
        processed or handled in the facilities is in violation of a 
        food safety law.
            (2) Schedule.--The Secretary shall inspect each facility 
        described in paragraph (1) at least quarterly, except that the 
        Secretary shall specify an alternative inspection frequency for 
        a facility that the Secretary determines to be an exceptional 
        or negligible-risk facility, under standards issued under 
        paragraph (3).
            (3) Standards.--The Secretary shall issue standards for 
        determining whether a facility is an exceptional or negligible-
        risk facility. In issuing the standards, the Secretary shall 
        classify facilities by considering the hazards associated with 
        the type of product being produced at a facility, the 
        facility's history of compliance and food safety problems, and 
        such other factors as the Secretary may determine to be 
        appropriate.
            (4) Examination of classifications.--Each inspection of a 
        facility classified as an exceptional or negligible-risk 
        facility shall include an examination of whether the facility 
        is appropriately classified under the standards issued under 
        paragraph (3).
    (b) Conduct of Inspections.--
            (1) Scope.--An inspection under subsection (a) of any 
        domestic or foreign facility (including a facility of an 
        importer) shall extend to all things in the facility (including 
        records required to be maintained under subsection (e), 
        processes, controls, and premises) that bear on whether food 
        products are in compliance with a food safety law. The 
        inspection shall include a review of processing or handling 
        records and sampling of food products. Access to records may 
        include the copying of such records.
            (2) Authorities.--In conducting such inspections, officers 
        or employees duly designated by the Secretary, on presenting 
        appropriate credentials to the owner, operator, or agent in 
        charge of a facility, are authorized--
                    (A) to enter at reasonable times any facility 
                described in subsection (a) in which persons are 
                engaged in the processing or handling of food products 
                (including a facility of an importer), which may 
                include entering any vehicle being used to transport or 
                hold food products for processing or handling;
                    (B) to inspect in a reasonable manner such facility 
                (which may include inspecting a vehicle described in 
                subparagraph (A)), including all pertinent equipment, 
                finished and unfinished materials, containers, 
                labeling, processes, controls, and premises; and
                    (C) to collect and retain samples of food products 
                or ingredients or of any other items found during an 
                inspection that may contribute to a finding of whether 
                such food products are in violation of a food safety 
                law.
            (3) Report.--Immediately after completion of the 
        inspection, the officer or employee making the inspection shall 
        give to the owner, operator, or agent in charge a report, in 
        writing, setting forth any conditions or practices observed 
        that indicate that either process controls are inadequate to 
        prevent or minimize food safety hazards or that any food 
        product from such facility is in violation of a food safety 
        law.
    (c) Product Detention and Condemnation.--
            (1) In general.--If, during an inspection conducted under 
        this section of a domestic facility, an officer or employee 
        making the inspection determines that a food product is in 
        violation of a food safety law, such officer or employee may 
        order the food product segregated, impounded, and if objection 
        is not made within 48 hours after the issuance of the 
        impoundment order, condemned. If objection is made within such 
        48 hours, food products that are in perishable form may be 
        processed to the extent necessary to prevent spoilage, and the 
        Secretary shall expeditiously commence a hearing regarding the 
        determination and any action required for compliance with the 
        food safety laws.
            (2) Release.--If the Secretary determines that, through 
        relabeling or other action, such food product can be brought 
        into compliance with the food safety laws, the food product may 
        be released following a determination by the Secretary that 
        such relabeling or other action as specified by the Secretary 
        has been performed.
            (3) Destruction.--Any food product condemned under 
        paragraph (1)--
                    (A) in a case in which no objection is made under 
                paragraph (1);
                    (B) after the hearing and any judicial review; or
                    (C) after failure of the owner, operator, or agent 
                to perform relabeling or other action described in 
                paragraph (2);
        shall be destroyed under supervision of the Secretary.
    (d) Official Mark.--The Secretary shall prescribe by regulation 
conditions under which any food product shall display an official mark, 
when needed to facilitate exports, that signifies that the food product 
has been processed and handled in accordance with standards approved by 
the Secretary. The Secretary may assess a fee for the use of such a 
mark. The Secretary shall deposit fees received under this subsection 
in an account, and may use the funds in the account to carry out 
enforcement activities under the food safety laws, or to carry out 
section 106.
    (e) Maintenance of Records.--The registrant for each facility 
registered under section 102 shall maintain and make available for 
inspection by the Secretary such records as the Secretary may 
prescribe. Such records shall be maintained for a reasonable period of 
time as determined by the Secretary. The records shall include 
information concerning--
            (1)(A) the origin, receipt, delivery, sale, movement, 
        holding, and disposition of food products, or ingredients for 
food products, processed or handled at the facility;
            (B) the identity and amount of ingredients used in the food 
        involved;
            (C) the processing or handling of the food;
            (D) the results of laboratory, sanitation, or other quality 
        control tests performed on the food or in the facility; and
            (E) consumer complaints concerning the food or the 
        packaging of the food; and
            (2) other matters reasonably related to whether food 
        products processed or handled at the facility may be in 
        violation of a food safety law.
    (f) Other Inspection Rights and Duties.--Section 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at 
the end the following new subsection:
    ``(g) Except as otherwise provided in section 106(b) of the 
Consumer Food Safety Act of 1999, the provisions of the last 2 
sentences of subsection (a)(1), and subsections (c) and (d), relating 
to the powers and duties of officers and employees to enforce this Act, 
and to the rights and duties of persons with respect to whom such 
powers are exercised, apply to the powers and duties of officers and 
employees designated by the Secretary to enforce the Consumer Food 
Safety Act of 1999, and to the rights and duties of persons with 
respect to whom such powers are exercised, respectively.''.

SEC. 106. STATE AND FEDERAL COOPERATION.

    (a) In General.--The Secretary shall work with the States in 
undertaking activities and programs that contribute to the national 
program established under section 101 so that State food safety 
programs and the national program function in a coordinated and cost-
effective manner. With the assistance provided under subsection (b), 
the Secretary shall encourage States to--
            (1) continue, strengthen, or establish State food safety 
        programs, especially with respect to the regulation of retail 
        commercial food establishments, transportation, harvesting, and 
        fresh markets; and
            (2) establish procedures and requirements for ensuring that 
        food products under the jurisdiction of the State food safety 
        programs are not unsafe for human consumption.
    (b) Assistance.--The Secretary may provide to a State, for 
planning, developing, and implementing a food safety program--
            (1) advisory assistance;
            (2) technical assistance, training, and laboratory 
        assistance (including necessary materials and equipment); and
            (3) financial and other assistance.
    (c) Service Agreements.--The Secretary may, under agreements 
entered into with Federal, State, or local agencies, use on a 
reimbursable basis or otherwise, the personnel, services, and 
facilities of such agencies in carrying out their responsibilities 
under this Act. Such an agreement shall provide that any compliance 
records, notices, or reports that are recorded or issued in connection 
with activities under the agreement and are in the possession of the 
agency that entered into the agreement shall be made available in 
accordance with section 552 of title 5, United States Code. An 
agreement entered into with a State agency under this subsection may 
provide for training of State employees.

SEC. 107. IMPORTS.

    (a) Role of Secretary.--Not later than 24 months after the date of 
enactment of this Act, the Secretary shall establish and administer a 
comprehensive and efficient system to ensure the safety of food 
products imported into the United States. In administering the system, 
the Secretary shall routinely inspect facilities registered under 
section 102 in exporting nations and imports at ports of entry into the 
United States, in accordance with this section and section 105. The 
Secretary shall assure that the facilities are operating in compliance 
with the food safety laws, through such verification and other 
activities as the Secretary considers to be necessary.
    (b) Import Requirements.--
            (1) Safety standards.--No food product may enter the United 
        States, or be withdrawn from a facility for consumption in the 
        United States if such food product appears to be in violation 
        of a food safety law.
            (2) Treatment.--Upon entry for consumption in the United 
        States, food products that are not prohibited from entry or 
        from withdrawal from a facility under paragraph (1) shall be 
        considered to be and treated as domestic food products for 
        purposes of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        301 et seq.), except that all labeling of such products shall 
        clearly identify the country of origin to facilitate the 
        identification of products linked to outbreaks of illness.
    (c) Inspection of Imports.--
            (1) Examinations, inspections, sampling and other 
        procedures.--Food products that are offered for importation, or 
        withdrawn from a facility, for consumption in the United 
        States, shall be subject to examinations, inspections, 
        sampling, and such other procedures as the Secretary may 
        determine to be appropriate at the port of entry or at the 
        facility registered under section 102 in the exporting nation 
        by officers or employees duly designated by the Secretary. Such 
        procedures shall be conducted with such frequency and in such 
        manner as the Secretary may prescribe by regulation.
            (2) Random or intensified procedures.--Food products from a 
        nation that is certified for such food products under 
        subsection (e)(3) shall be subject to random examinations, 
        inspections, sampling, and other procedures under paragraph 
        (1). Food products from a nation that is not certified for such 
        food products under subsection (e)(3) shall be subject to such 
        intensified examinations, inspections, sampling, and other 
        verification procedures, including inspection in the exporting 
        nation, under paragraph (1), as the Secretary determines are 
        necessary to ensure compliance with the food safety laws.
    (d) Detention of Imported Food Product.--If, during an inspection 
or other verification procedure carried out under this section at a 
port of entry, an officer or employee conducting the procedure 
determines that a food product is in violation of a food safety law, 
such officer or employee may order the food product segregated, 
impounded, and if objection is not made within such 48 hours, 
condemned. If objection is made, within such 48 hours such food 
products that are in perishable form may be processed to the extent 
necessary to prevent spoilage, and the Secretary shall expeditiously 
commerce a hearing regarding the determination and any action required 
for compliance with the food safety laws. The final condemnation or 
other disposition of such food product shall be subject to the 
provisions of paragraphs (2) and (3) of section 105(c).
    (e) Agreements With Foreign Nations.--
            (1) Evaluation.--The Secretary may enter into an agreement 
        described in paragraph (2) with any nation desiring to export 
        food products to the United States. Prior to concluding such an 
        agreement, the Secretary shall evaluate the food safety program 
        of the foreign nation to determine if such program provides at 
        least the same level of protection, with respect to food 
        products intended for export to the United States, as domestic 
        laws that affect the safety of the food supply. In such 
        evaluation, the Secretary shall consider--
                    (A) the potential for health, sanitary, 
                environmental, or other conditions within the foreign 
                nation to adversely affect the safety of food products 
                exported from such nation; and
                    (B) how well the food safety programs of the 
                foreign nation function to minimize any adverse effects 
                on such safety.
            (2) Requirements.--Any agreement under this subsection with 
        a nation desiring to export food products to the United States 
        shall--
                    (A) require that the exporting nation shall--
                            (i) establish and maintain a food safety 
                        system that is adequate to ensure that the food 
                        products intended for export to the United 
                        States are not in violation of the food safety 
                        laws; and
                            (ii) promptly notify the Secretary of any 
                        violations affecting the safety of food 
                        products exported or intended for export to the 
                        United States;
                    (B) provide for such activities (whether in the 
                exporting nation or at the port of entry during 
                importation) by the Secretary, including examinations, 
                inspections, sampling, and other procedures, at such 
                stages in the growth or harvest of food, or in the 
                processing or handling of food products, as the 
                Secretary considers to be appropriate to ensure that 
                the food safety program of the exporting nation 
                continues to provide at least the same level of 
                protection, with respect to food products intended for 
                export to the United States, as domestic laws that 
                affect the safety of the food supply; and
                    (C) provide for reciprocity with respect to the 
                treatment of food imports and exports between the 
                United States and the exporting nation.
            (3) Certification.--If the Secretary determines that a 
        nation desiring to export food products to the United States 
        has a program that provides at least the same level of 
        protection, with respect to food products intended for export 
        to the United States, as domestic laws that affect the safety 
        of the food supply, the Secretary shall, upon entry into force 
        of an agreement under paragraph (1), certify the types of food 
        products for which the nation maintains such a program.
            (4) Reviews of certifications.--
                    (A) In general.--The Secretary shall periodically 
                or for good cause, and not less than once every 3 
                years, review certifications made under paragraph (3), 
                and shall revoke the certification of any nation that 
the Secretary determines is not maintaining a food safety program that 
provides at least the same level of protection, with respect to food 
products intended for export to the United States, as domestic laws 
that affect the safety of the food supply.
                    (B) Impact on agreements.--The Secretary shall 
                review and modify, as needed, an agreement made under 
                paragraph (1) with any nation whose certification has 
                been revoked under subparagraph (A).

                    TITLE II--RESEARCH AND EDUCATION

SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

    (a) Cooperation With the Centers for Disease Control and 
Prevention.--The Secretary, acting through the Director of the Centers 
for Disease Control and Prevention, shall maintain an active 
surveillance system for food, to include on a representative proportion 
of the population of the United States, to assess more accurately the 
frequency and sources of human illness in the United States associated 
with the consumption of food.
    (b) Public Health Sampling.--
            (1) Guidelines.--Not later than 12 months after the date of 
        enactment of this Act, the Secretary, in cooperation with the 
        Secretary of Agriculture, shall establish guidelines for a 
        sampling system under which the Secretary and the Secretary of 
        Agriculture shall collect and analyze samples of food products 
        to assist the Secretary in carrying out the food safety laws, 
        and to assess more accurately the nature, frequency of 
        occurrence, and amounts of contaminants in food products.
            (2) Monitoring and other information.--In carrying out the 
        sampling system, the Secretary and the Secretary of Agriculture 
        shall provide for--
                    (A) statistically valid monitoring, including the 
                conduct of market-basket studies, on the nature, 
                frequency of occurrence, and amounts of contaminants in 
                food products available to consumers; and
                    (B) at the request of the Secretary of Health and 
                Human Services, the collection and analysis of such 
                other information, including analysis of information 
                from monitoring and verification samples, as the 
Secretary determines may be useful in assessing the occurrence of 
contaminants in food products.
    (c) Assessment of Public Health Hazards.--Using information 
obtained through the surveillance system referred to in subsection (a) 
and the sampling system described in subsection (b), the Secretary 
shall rank food categories based on their hazard to public health and 
identify appropriate industry and regulatory approaches to minimize 
hazards in the food supply. In conducting the ranking and 
identification, the Secretary may determine--
            (1) the public health hazards associated with food products 
        that are commercially harvested and prepared, as compared with 
        the public health hazards associated with food products that 
        are harvested for recreational or subsistence purposes and 
        prepared noncommercially;
            (2) the public health hazards associated with food products 
        that are domestically harvested and processed, as compared with 
        the public health hazards associated with food products that 
        are harvested or processed outside the United States; and
            (3) the extent of contamination originating from handling 
        practices that occur prior to or after sale of food products to 
        consumers.

SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM.

    (a) Public Education.--The Secretary, in cooperation with private 
and public organizations, including the State cooperative extension 
services and appropriate State entities, shall design and implement a 
national public education program on food safety. In carrying out the 
program, the Secretary shall--
            (1) provide information to the public regarding Federal 
        standards and good practice requirements relating to food 
        safety, and promote public awareness, understanding, and 
        acceptance of such standards and requirements;
            (2) provide information to health professionals so that the 
        health professionals may improve diagnosis and treatment of 
        food-related illness and advise individuals whose health 
        conditions place the individuals at particular risk for that 
        illness; and
            (3) provide such other information or advice to consumers 
        and other persons as the Secretary determines will promote the 
        objectives of this Act.
    (b) Health Advisories.--The Secretary, in consultation with the 
Secretary of Agriculture and the Administrator of the Environmental 
Protection Agency, and in cooperation with States and other appropriate 
entities, shall--
            (1) develop and distribute regional and national advisories 
        concerning food safety;
            (2) develop standardized formats for written and broadcast 
        advisories concerning food safety; and
            (3) incorporate State and local advisories, concerning food 
        safety into the national public education program required 
        under subsection (a).

SEC. 203. RESEARCH.

    (a) In General.--The Secretary shall conduct research to assist in 
the implementation of this Act, including studies relating to--
            (1) improving sanitation and food safety practices in the 
        processing and handling of food products;
            (2) developing improved techniques for the monitoring of 
        food and inspection of food products;
            (3) developing efficient, rapid, and sensitive methods for 
        determining and detecting the presence of contaminants in food 
        products;
            (4) determining the sources of contamination of food 
        (including food products); and
            (5) developing consumption data with respect to food 
        products.
    (b) Contract Authority.--The Secretary is authorized to enter into 
contracts and agreements with any State, institution of higher 
education, other government agency, or other person to carry out the 
activities described in this section.

                         TITLE III--ENFORCEMENT

SEC. 301. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 301 et seq.) is amended--
            (1) by inserting after the chapter heading for chapter IV 
        the following:

                 ``Subchapter A--Food Standards''; and

            (2) by adding at the end the following:

                        ``Subchapter B--Remedies

``SEC. 421. DEFINITIONS.

    ``In this subchapter, the term `food safety law' means the Consumer 
Food Safety Act of 1999 and the provisions of this Act that relate to 
food.

``SEC. 422. NOTIFICATION AND RECALL.

    ``(a) Notice to Secretary of Violation.--Any person (other than a 
household consumer or other individual who is the intended consumer of 
an article of food) that has a reasonable basis for believing that any 
article of food introduced into or in interstate commerce, or held for 
sale (whether or not the first sale) after shipment in interstate 
commerce, may be in violation of a food safety law shall immediately 
notify the Secretary, in such manner and by such means as the Secretary 
may by regulation prescribe, of the identity and location of such 
article.
    ``(b) Recall and Consumer Notification.--
            ``(1) Voluntary procedures.--If the Secretary finds, on 
        notification under subsection (a) or otherwise, that any 
        article of food is in violation of a food safety law when 
        introduced into or while in interstate commerce or while held 
        for sale (whether or not the first sale) after shipment in 
        interstate commerce and there is a reasonable probability that 
        such article, if consumed, would present a threat to public 
        health, as determined by the Secretary, the Secretary shall 
        provide the appropriate persons (including the manufacturers, 
        importers, distributors, or retailers of the article) with an 
        opportunity to--
                    ``(A) cease distribution of such article;
                    ``(B) notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such article to 
                        immediately cease such activities with respect 
                        to such article; or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of such article;
                    ``(C) recall such article;
                    ``(D) provide, in consultation with the Secretary, 
                notice of the finding of the Secretary to consumers to 
                whom such article was, or may have been, distributed; 
                or
                    ``(E) take any combination of the above measures, 
                as determined by the Secretary to be appropriate in the 
                circumstances.
            ``(2) Pre-hearing order to cease distribution and give 
        notice.--If such appropriate person refuses to or does not 
        voluntarily cease distribution, make notification, recall such 
        article, or provide notice to consumers, as applicable, within 
        the time and in the manner prescribed by the Secretary, the 
        Secretary shall, by order, require, as the Secretary determines 
        to be necessary, such person to--
                    ``(A) immediately cease distribution of such 
                article;
                    ``(B) immediately notify all persons--
                            ``(i) producing, manufacturing, packing, 
                        processing, preparing, treating, packaging, 
                        distributing, or holding such article to 
                        immediately cease such activities with respect 
                        to such article; or
                            ``(ii) to which such article has been 
                        distributed, transported, or sold, to 
                        immediately cease distribution of such article; 
                        or
                    ``(C) immediately take the actions specified in 
                both subparagraphs (A) and (B).
            ``(3) Notification of consumers by secretary.--The 
        Secretary shall, as the Secretary determines to be necessary, 
        provide notice of the finding of the Secretary under paragraph 
        (1) to consumers to whom such article was, or may have been, 
        distributed.
    ``(c) Hearing on Order.--The Secretary shall provide any person 
subject to an order under subsection (b) with an opportunity for a 
hearing, to be held as soon as practicable but not later than 2 days 
after the issuance of the order, on the actions required by the order 
and on whether the article that is the subject of the order should be 
recalled.
    ``(d) Post-Hearing Recall Order.--
            ``(1) Amendment of order.--If, after providing an 
        opportunity for a hearing under subsection (c), the Secretary 
        determines that there is a reasonable probability that the 
        article that is the subject of an order under subsection (b), 
        if consumed, presents a threat to public health, the Secretary, 
        as the Secretary determines to be necessary, may--
                    ``(A) amend the order to require recall of such 
                article or other appropriate action;
                    ``(B) specify a timetable in which the recall shall 
                occur;
                    ``(C) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(D) provide notice of the recall to consumers to 
                whom such article was, or may have been, distributed.
            ``(2) Vacation of order.--If, after such a hearing, the 
        Secretary determines that adequate grounds do not exist to 
        continue the actions required by the order, the Secretary shall 
        vacate the order.
    ``(e) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.

``SEC. 423. CIVIL PENALTIES.

    ``(a) In General.--
            ``(1) Acts subject to penalty; penalty amount.--Any person 
        that commits an act that violates a food safety law may be 
        assessed a civil penalty by the Secretary of not more than 
        $100,000 for each such act. Each such act and each day during 
        which such act continues shall be a separate offense.
            ``(2) Notice and hearing.--No penalty shall be assessed by 
        the Secretary under this section unless such person is given 
        notice and an opportunity for a hearing on the record before 
        the Secretary in accordance with sections 554 and 556 of title 
        5, United States Code.
            ``(3) Other requirements.--Such civil penalty shall be 
        assessed by the Secretary by written order. The amount of the 
        civil penalty shall be determined by the Secretary, taking into 
        account the gravity of the violation, degree of culpability of 
        the person, size and type of business of the person, and any 
        history of prior offenses by the person, and shall be specified 
        in the order. The order may be reviewed only as provided in 
        subsection (b).
    ``(b) Judicial Review.--An order assessing a civil penalty under 
subsection (a) shall be final and conclusive unless the person files, 
within 30 days after the effective date of the order, an application 
for judicial review of the order in the United States Court of Appeals 
for the circuit in which such person resides or has its principal place 
of business, or in the United States Court of Appeals for the District 
of Columbia Circuit. The person shall file the application by filing a 
notice of appeal in such court and by simultaneously sending a copy of 
such notice by certified mail to the Secretary. The Secretary shall 
promptly file in such court a certified copy of the record upon which 
such order was issued. The findings of the Secretary relating to the 
order shall be set aside only if found to be unsupported by substantial 
evidence on the record as a whole.
    ``(c) Collection Actions.--If any person fails to pay a civil 
penalty assessed under subsection (a) after the order assessing the 
penalty has become a final and conclusive order, or after the court of 
appeals described in subsection (b) has entered final judgment in favor 
of the Secretary, the Secretary shall refer the matter to the Attorney 
General, who shall institute a civil action to recover the amount 
assessed in a United States district court of competent jurisdiction. 
In such action, the validity and appropriateness of the Secretary's 
order assessing the civil penalty shall not be subject to review.
    ``(d) Penalties Paid Into Account.--The Secretary shall deposit 
penalties collected under this section in an account, and may use the 
funds in the account to carry out enforcement activities under the food 
safety laws, or to carry out section 106 of the Consumer Food Safety 
Act of 1999.
    ``(e) Secretary's Discretion To Prosecute.--Nothing in this Act 
shall be construed as requiring the Secretary to report for 
prosecution, or for the institution of libel or injunction proceedings, 
violations of a food safety law whenever the Secretary believes that 
the public interest will be adequately served by assessment of civil 
penalties under this section.
    ``(f) Remedies Not Exclusive.--The remedies provided in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.

``SEC. 424. WHISTLEBLOWER PROTECTION.

    ``(a) In General.--No employee or other person may be harassed, 
prosecuted, held liable, or discriminated against in any way because 
that person--
            ``(1) has commenced, caused to be commenced, or is about to 
        commence a proceeding, has testified or is about to testify at 
        a proceeding, or has assisted or participated or is about to 
        assist or participate in any manner in a proceeding or other 
        action, to carry out the objectives, functions, or 
        responsibilities specified in the Consumer Food Safety Act of 
        1999, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et 
        seq.), or the Poultry Products Inspection Act (21 U.S.C. 451 et 
        seq.); or
            ``(2) is refusing to violate or assist in violation of a 
        law described in paragraph (1), including a regulation issued 
        under that law.
    ``(b) Procedures.--
            ``(1) In general.--A person alleging a violation of 
        subsection (a) may file a complaint as described in subsection 
        (b) of section 31105 of title 49, United States Code.
            ``(2) Administration.--The process, procedures, and 
        remedies that apply under subsections (b), (c), and (d) of that 
        section 31105 with respect to allegations of violations of 
        subsection (a) of that section shall be the process, 
        procedures, and remedies that apply with respect to allegations 
        of violations of subsection (a), except as provided in 
        paragraphs (3) and (4).
            ``(3) Alternative process.--The person filing a complaint 
        under paragraph (1) may elect to use an alternative dispute 
        resolution procedure, such as mediation or arbitration, in lieu 
        of the hearing described in subsection (b) of that section 
        31105.
            ``(4) Secretary.--The powers and duties that apply to the 
        Secretary of Labor under that section 31105 shall apply to the 
        Secretary of Health and Human Services.
    ``(c) Burdens of Proof.--The legal burdens of proof with respect to 
a violation of subsection (a) shall be governed by the applicable 
provisions of sections 1214 and 1221 of title 5, United States Code.

``SEC. 425. ADMINISTRATION AND ENFORCEMENT; APPLICABILITY OF PENALTY 
              PROVISIONS; CONDUCT OF INQUIRIES; POWER AND JURISDICTION 
              OF COURTS.

    ``(a) In General.--For the efficient administration and enforcement 
of the food safety laws, the provisions (including provisions relating 
to penalties) of sections 6, 8, 9, and 10 of the Federal Trade 
Commission Act (15 U.S.C. 46, 48, 49, and 50) (except subsections (c) 
through (h) of such section 6), relating to the jurisdiction, powers, 
and duties of the Federal Trade Commission and the Attorney General to 
administer and enforce that Act, and to the rights and duties of 
persons with respect to whom such powers are exercised, apply to the 
jurisdiction, powers, and duties of the Secretary and the Attorney 
General in administering and enforcing the provisions of this chapter 
and the Consumer Food Safety Act of 1999 and to the rights and duties 
of persons with respect to whom such powers are exercised, 
respectively.
    ``(b) Inquiries and Actions.--The Secretary, in person or by such 
agents as the Secretary may designate, may prosecute any inquiry 
necessary to carry out the duties of the Secretary under this chapter 
and the Consumer Food Safety Act of 1999 in any part of the United 
States, and the powers conferred by sections 9 and 10 of the Federal 
Trade Commission Act (15 U.S.C. 49 and 50) on the United States 
district courts may be exercised for the purposes of this chapter by 
any United States district court of competent jurisdiction.

``SEC. 426. TRACEBACK.

    ``The Secretary may impose on a food product requirements for the 
traceability of such type or class of food product whenever such 
requirements are necessary to assure the protection of public health. 
Traceability requirements shall be established in accordance with 
regulations and guidelines issued by the Secretary and shall apply to 
persons registered under section 102 of the Consumer Food Safety Act of 
1999.

``SEC. 427. CITIZEN'S CIVIL ACTIONS.

    ``(a) Civil Actions.--Any person may commence a civil action 
against--
            ``(1) any person who violates any rule (including a rule 
        establishing a tolerance), order, or other action of the 
        Secretary to ensure the safety of food products; or
            ``(2) the Secretary, if the Secretary fails to perform any 
        act or duty to ensure the safety of food products that is not 
        discretionary under a food safety law.
    ``(b) Court.--The action shall be commenced in the United States 
district court for the district in which the defendant resides or is 
found or has an agent. The court shall have jurisdiction, without 
regard to the amount in controversy, or the citizenship of the parties, 
to enforce such rule (including a rule establishing a tolerance), 
order, or other action of the Secretary, or to order the Secretary to 
perform such act or duty. The court may award damages, in the amount of 
damages actually sustained, and, if the court determines it to be in 
the interest of justice, may award the plaintiff the costs of suit, 
including reasonable attorney's fees, reasonable expert witness fees, 
and penalties.
    ``(c) Remedies Not Exclusive.--The remedies provided for in this 
section shall be in addition to and not exclusive of other remedies 
that may be available.''.

``SEC. 428. ADMINISTRATION.

    ``Notwithstanding any other provision of this Act, the remedy for 
any foreign facility that violates a food safety law shall be 
suspension of registration under section 102 of the Consumer Food 
Safety Act of 1999.''.
    (b) Conforming Amendment; Prohibited Act.--Section 301 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(aa) The failure or refusal to comply with an order issued under 
section 422(b)(2) or 422(d).
    ``(bb) The failure to comply with the Consumer Food Safety Act of 
1999.''.

                        TITLE IV--AUTHORIZATION

SEC. 401. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--There are authorized to be appropriated to carry 
out this Act, other than sections 106 and 203, such sums as may be 
necessary for each of fiscal years 2000 and 2001.
    (b) Assistance to States.--There are authorized to be appropriated 
such sums as may be necessary for each of fiscal years 2000 and 2001, 
for carrying out section 106 (relating to State program assistance).
    (c) Research Program Authorization.--There are authorized to be 
appropriated such sums as may be necessary for each of fiscal years 
2000 and 2001, for carrying out section 203 (relating to research).
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