[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 2077 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 2077

 To establish a program to assure the safety of fresh produce intended 
             for human consumption, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 20, 2007

   Mr. Harkin (for himself, Mr. Kohl, and Mr. Durbin) introduced the 
 following bill; which was read twice and referred to the Committee on 
                  Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
 To establish a program to assure the safety of fresh produce intended 
             for human consumption, 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 ``Fresh Produce 
Safety Act''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Definitions.
                    TITLE I--FOOD SAFETY ACTIVITIES

Sec. 101. Administration of national program.
                Subtitle A--Minimally Processed Produce

Sec. 111. Good manufacturing practices.
Sec. 112. Inspections of processors.
                Subtitle B--Raw Agricultural Commodities

Sec. 121. Good agricultural practices.
Sec. 122. Inspections of facilities.
                    TITLE II--RESEARCH AND EDUCATION

Sec. 201. Public health assessment system.
Sec. 202. Public education system.
Sec. 203. Research.
            TITLE III--IMPORTED PRODUCE AND OTHER PROVISIONS

Sec. 301. Imported produce.
Sec. 302. Authorization of appropriations.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) consumption of fresh fruits and vegetables can promote 
        health and prevent disease, and should be encouraged;
            (2) an estimated 76,000,000 cases of foodborne disease 
        occur each year in the United States, causing about 325,000 
        hospitalizations and 5,000 deaths annually, according to the 
        Centers for Disease Control and Prevention (referred to in this 
        section as the ``CDC'');
            (3) data reported to the CDC indicate that outbreaks of 
        foodborne illness in the United States associated with fruits 
        and vegetables have increased in absolute numbers and as a 
        proportion of all reported foodborne outbreaks;
            (4) illnesses caused by E. coli O157: H7, Salmonella spp., 
        and norovirus have been traced to a wide variety of produce, 
        including lettuce, salads, melons, sprouts, tomatoes, and many 
        fruit- and vegetable-containing dishes;
            (5) outbreaks of food-borne illness associated with produce 
        in the United States have been documented from both imported 
        produce and domestically grown produce;
            (6) large scale processing of produce can easily spread 
        pathogens into minimally processed food and a single outbreak 
        can affect hundreds of people;
            (7) persons who process produce for human consumption have 
        the responsibility to prevent or minimize food safety hazards 
        related to their products;
            (8) rising consumer demand for minimally processed produce, 
        the growing market for various kinds of domestic and imported 
        minimally processed produce, and the increasing variety of 
        processing techniques for produce, are causing newly recognized 
        or unpredicted safety hazards; and
            (9) risk-based sanitation practices, and commodity-specific 
        good agricultural and manufacturing practices, tailored to the 
        hazards and the level of risk that a specific food product 
        presents, should be applied to the processing of produce to 
        minimize these hazards.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Contaminant.--The term ``contaminant'' includes a 
        bacterium, chemical, natural or manufactured toxin, virus, 
        parasite, physical hazard, or other human pathogen that, when 
        in food, can cause human illness, injury, or death.
            (2) Minimally process.--
                    (A) In general.--The term ``minimally process'' 
                means--
                            (i) to carry out the commercial preparation 
                        or manufacture of produce, including--
                                    (I) the peeling, coring, stemming, 
                                trimming, mashing, or shredding of 
                                produce;
                                    (II) the cutting of produce after 
                                harvesting;
                                    (III) the preparation of fresh 
                                produce so to as to appear ready for 
                                consumption without further washing or 
                                preparation; and
                                    (IV) the mixing or blending of 
                                minimally processed produce with other 
                                produce; and
                            (ii) does not include carrying out the 
                        harvesting, washing (except as provided in 
                        clause (i)(III)), waxing, packing, or sorting, 
                        of a raw agricultural commodity.
                    (B) Exception.--The term ``minimally process'' 
                shall not apply to a raw agricultural commodity that is 
                stemmed but not subject to further commercial 
                preparation.
            (3) Processor of produce.--The term ``processor of 
        produce'' means a person that minimally processes produce.
            (4) Produce.--
                    (A) In general.--The term ``produce'' means any 
                perishable agricultural commodity, as defined in 
                section 1(b) of the Perishable Agricultural Commodities 
                Act, 1930 (7 U.S.C. 499a(b)).
                    (B) Inclusions.--The term ``produce'' includes a 
                mixture of--
                            (i) a commodity described in subparagraph 
                        (A); and
                            (ii) any other food, as defined in section 
                        201 of the Federal Food, Drug, and Cosmetic Act 
                        (21 U.S.C. 321).
                    (C) Exclusions.--The term ``produce'' does not 
                include--
                            (i) other food in the mixture described in 
                        subparagraph (B)(ii); and
                            (ii) an article used for food or drink for 
                        animals, or an article used for a component of 
                        such an article.
            (5) Raw agricultural commodity.--The term ``raw 
        agricultural commodity'' means a perishable agricultural 
        commodity, as defined in section 1(b) of the Perishable 
        Agricultural Commodities Act, 1930 (7 U.S.C. 499a(b)) that is a 
        raw agricultural commodity, as defined in section 201 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).
            (6) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.

                    TITLE I--FOOD SAFETY ACTIVITIES

SEC. 101. ADMINISTRATION OF NATIONAL PROGRAM.

    (a) In General.--
            (1) National program.--The Secretary shall administer a 
        national program for the purpose of protecting human health by 
        ensuring that--
                    (A) there are effective programs in place to assure 
                the safety of produce minimally processed in the United 
                States; and
                    (B) producers of raw agricultural commodities have 
                effective programs in place to assure the safety of 
                those commodities produced in the United States.
            (2) Basis for program.--The program shall take into 
        consideration the distinctive characteristics of minimal 
        processing of produce and the differing practices and levels of 
        risk associated with the production of different raw 
        agricultural commodities.
    (b) Program Elements.--The program shall provide for implementation 
of the authorities described in--
            (1) sections 402A, 402B, 704A, and 704B of the Federal 
        Food, Drug, and Cosmetic Act, as added by subtitles A and B; 
        and
            (2) title II.

                Subtitle A--Minimally Processed Produce

SEC. 111. GOOD MANUFACTURING PRACTICES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act is amended by inserting after section 402 (21 U.S.C. 342) the 
following:

``SEC. 402A. GOOD MANUFACTURING PRACTICES FOR PRODUCE.

    ``(a) Good Manufacturing Practice Regulations.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary shall by regulation 
        establish standards for good manufacturing practices for the 
        minimal processing of produce.
            ``(2) Content.--The regulations issued under paragraph (1) 
        shall include the following requirements:
                    ``(A) Sanitation.--Processors of produce shall--
                            ``(i) establish mandatory sanitation 
                        standard operating procedures, including 
                        cleaning procedures for equipment, storage 
                        areas, air systems, and water storage areas;
                            ``(ii) design processing facilities to 
                        facilitate maintenance and good sanitation 
                        practices so that contamination may be 
                        controlled throughout receiving, cooling, 
                        processing, packing, and storage operations; 
                        and
                            ``(iii) ensure--
                                    ``(I) controlled access to the 
                                facility and to processing areas;
                                    ``(II) adequate space for 
                                operations;
                                    ``(III) adequate drainage of 
                                processing and wash water;
                                    ``(IV) food contact surfaces that 
                                are easy to clean and maintain;
                                    ``(V) that areas and structures 
                                designed to protect the product and 
                                equipment from contamination; and
                                    ``(VI) that sanitation standards 
                                established in clause (i) are adhered 
                                to in the transportation of minimally 
                                processed produce to the extent 
                                practicable.
                    ``(B) Water.--
                            ``(i) In general.--Processors of produce 
                        shall ensure that--
                                    ``(I) the water supply used in food 
                                processing plants is suitable for its 
                                intended use;
                                    ``(II) facilities have an 
                                environmental monitoring program that 
                                includes sampling for pathogens to 
                                detect areas of harborage and to verify 
                                the effectiveness of cleaning and 
                                sanitizing programs in preventing 
                                cross-contamination; and
                                    ``(III) each sanitizer used for 
                                washing vegetables is appropriate for 
                                its intended use.
                            ``(ii) Sampling programs for water.--If the 
                        Secretary determines that effective sampling 
                        programs can be developed, processors of 
                        produce shall ensure that the water used for 
                        washing produce is monitored for the presence 
                        of pathogens at a rate adequate to ensure 
                        highly contaminated batches are identified and 
                        eliminated.
                    ``(C) Additional requirements.--Other requirements 
                as determined appropriate by the Secretary.
            ``(3) Risk assessment.--The standards established under 
        paragraph (1) shall be based on risk assessment tools and 
        metrics developed by the Food and Drug Administration in 
        consultation with the Department of Agriculture and processors 
        of produce. The risk assessments shall include--
                    ``(A) identification of existing and potential 
                hazards at facilities;
                    ``(B) evaluation of human health risks posed by 
                hazards identified in subparagraph (A); and
                    ``(C) proposed controls to minimize hazards based 
                on subparagraph (B).
            ``(4) Risk classification.--The Secretary shall classify 
        facilities as high-, medium-, or low-risk according to the risk 
        assessments in paragraph (3), and by considering the hazards 
        associated with the type of produce being minimally processed 
        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. Such risk classification shall 
        determine the specific standards and controls required at each 
        facility.
            ``(5) Science-based standards.--The standards established 
        under paragraph (1) shall--
                    ``(A) reflect the best available science; and
                    ``(B) be subject to change through regulations 
                promulgated by the Secretary as new scientific evidence 
                on risk becomes available.
    ``(b) Implementation Plan for Processors.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of this section, the Secretary shall require every 
        processor of produce to have a written plan detailing the 
        controls utilized the processor of produce.
            ``(2) Content.--A plan under paragraph (1) shall--
                    ``(A) address good manufacturing standards set 
                forth by the Secretary;
                    ``(B) require recordkeeping to monitor compliance;
                    ``(C) require the sampling of products and process 
                to be tested, at a frequency and in a manner 
                commensurate with the risk presented by the facility 
                and produce processed, as determined in subsection 
                (a)(3), if the Secretary deems this appropriate, and 
                sufficient to ensure that the standards or process 
                controls are effective on an on-going basis and that 
                regulatory standards are met; and
                    ``(D) provide access to the Food and Drug 
                Administration to records maintained by the facility 
                pursuant to section 414.
            ``(3) Specific controls.--In addition to complying with 
        standards established under section 402A(a)(1), the Secretary 
        may require processors to adopt specific process controls 
        identified in section 402A(a)(3), if the process controls are 
        needed to ensure the protection of the public health.
            ``(4) Tiered implementation.--The Secretary shall require 
        such a plan for high-risk facilities first, and then for 
        medium-risk facilities, and then for low-risk facilities, as 
        classified under subsection (a)(4).
    ``(c) Exceptions.--In issuing regulations under subsection (a), the 
Secretary may modify the good manufacturing process regulations if the 
Secretary determines, for good cause shown and stated together with the 
regulations, that for a specific product--
            ``(1) a modification of such provisions would be more 
        effective to prevent the contamination of, or promote the 
        sanitation of, minimally processed produce; or
            ``(2) the application of a portion of such provisions would 
        not result in the prevention of contamination of, or promotion 
        of sanitation of, minimally processed produce.
    ``(d) Effective Date.--The regulations promulgated under subsection 
(a) shall take effect 2 years after the date of enactment of this 
section.
    ``(e) Definitions.--In this section:
            ``(1) Contaminant; minimally process; produce.--The terms 
        `contaminant', `minimally process', and `produce' have the 
        meanings given those terms in section 3 of the Fresh Produce 
        Safety Act.
            ``(2) Facility.--The term `facility' includes any factory, 
        warehouse, or establishment, in which produce is minimally 
        processed.
            ``(3) Good manufacturing practice regulations.--The term 
        `good manufacturing practice regulations' means the good 
        manufacturing practice regulations for manufacturing, packing, 
        or holding food, issued under sections 402, 701, and 704 of 
        this Act and under section 361 of the Public Health Service Act 
        (42 U.S.C. 264).''.
    (b) Violation.--Section 402 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 342) is amended by adding at the end the following:
    ``(j) It is an article of produce processed in violation of section 
402A.''.

SEC. 112. INSPECTIONS OF PROCESSORS.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act is amended by inserting after section 704 (21 U.S.C. 374) 
the following:

``SEC. 704A. INSPECTIONS OF PROCESSORS.

    ``(a) Nature of Inspections.--
            ``(1) In general.--The Secretary shall provide for 
        unannounced inspections of processing facilities to determine 
        if produce processed in the facilities is in compliance with 
        the requirements of this Act that relate to produce.
            ``(2) Schedule.--The Secretary shall establish a schedule 
        for the unannounced inspections, which shall provide for--
                    ``(A) inspections at least once per growing season 
                for facilities classified as high-risk under section 
                402A(a)(4); and
                    ``(B) less frequent inspections, as determined by 
                the Secretary, for facilities classified as medium- or 
                low-risk facilities under section 402A(a)(4).
            ``(3) Examination of classifications.--Each such inspection 
        of a facility shall include an examination of whether the 
        facility is appropriately classified under section 402A(a)(4).
    ``(b) Conduct of Inspections.--
            ``(1) Scope.--An inspection under subsection (a) of any 
        facility described in subsection (a) shall extend to all things 
        in the facility, any required records, processes, controls, and 
        premises that bear on whether minimally processed produce is in 
        compliance with the requirements of this Act that relate to 
        produce. Access to records may include the copying of the 
        records.
            ``(2) Authorities.--In conducting such an inspection, an 
        officer or employee duly designated by the Secretary shall have 
        the same authorities and duties as the officer or employee 
        would have under subsection (a)(1), (c), or (d) of section 704 
        to inspect facilities in which food is minimally processed.
            ``(3) Report.--Not later than 48 hours after completion of 
        the inspection, the officer or employee making the inspection 
        shall give to the owner, operator, or agent in charge a written 
        report setting forth any conditions or practices observed that 
        indicate that any produce from the facility is in violation of 
        the requirements of this Act that relate to produce.
    ``(c) Product Detention and Condemnation.--
            ``(1) In general.--If, during an inspection conducted under 
        this section, an officer or employee making the inspection 
        determines that minimally processed produce is in violation of 
        the requirements of this Act that relate to produce, the 
        officer or employee may order the produce segregated, 
        impounded, and if objection is not made no later than 48 hours 
        after the issuance of the impoundment order, condemned. If 
        objection is made during such 48-hour period, minimally 
        processed produce that is perishable may be processed to the 
        extent necessary to prevent spoilage, and the Secretary shall 
        expeditiously commence a hearing within 24 hours after the 
        objection regarding the determination and any action required 
        for compliance with the requirements of this Act that relate to 
        produce. The decision of the Secretary following the hearing 
        shall be considered to be a final agency action.
            ``(2) Release.--If the Secretary determines that, through 
        relabeling or other action, the produce can be brought into 
        compliance with the requirements of this Act that relate to 
        produce, the produce may be released following a determination 
        by the Secretary that the relabeling or other action as 
        specified by the Secretary has been performed.
            ``(3) Destruction.--Any minimally processed produce 
        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) Maintenance of Records.--
            ``(1) In general.--The owner, operator, or agent in charge 
        of each facility shall maintain such records as the Secretary 
        may prescribe. The records shall be maintained for a reasonable 
        period of time as determined by the Secretary. The records 
        shall include information concerning--
                    ``(A)(i) the origin, receipt, delivery, sale, 
                movement, holding, and disposition of produce minimally 
                processed at the facility;
                    ``(ii) the minimal processing of the produce; and
                    ``(iii) other matters reasonably related to whether 
                produce minimally processed at the facility may be in 
                violation of the requirements of this Act that relate 
                to produce; and
                    ``(B)(i) the origin, receipt, delivery, sale, 
                movement, holding, and disposition of ingredients used 
                in the produce minimally processed at the facility, 
                including sufficient information to permit lot 
                identification to facilitate traceback of produce found 
                to be in violation of the requirements of this Act that 
                relate to produce, or to be causing human illness or 
                injury;
                    ``(ii) the identity and amount of ingredients used 
                in the produce;
                    ``(iii) the results of laboratory, sanitation, or 
                other quality control tests performed on the produce or 
                in the facility; and
                    ``(iv) consumer complaints concerning the safety of 
                the produce or the packaging of the produce.
            ``(2) Availability of records.--The owner, operator, or 
        agent shall--
                    ``(A) make available, during an inspection 
                conducted under subsection (a), the records described 
                in paragraph (1)(A); and
                    ``(B) at the request of the Secretary, if the 
                officer or employee finds as a result of the inspection 
                that produce from the facility is associated with 
                foodborne disease or poses an imminent health hazard, 
                make available for inspection the records described in 
                paragraph (1)(B).
            ``(3) Required disclosure.--The owner, operator, or agent 
        in charge of a facility shall have an affirmative obligation to 
        take corrective action, including ensuring the product is not 
        introduced into commerce, as approved by the Commissioner of 
        Food and Drugs or the Secretary, if the results of testing or 
        sampling of produce, equipment, or material in contact with 
        produce are positive for any contaminant, in accordance with 
        section 414. The owner, operator, or agent in charge of a 
        facility shall have an affirmative obligation to disclose to 
        the Commissioner of Food and Drugs or the Secretary if the 
        results of testing finds a positive test result and the product 
        is in commerce.
    ``(e) Definitions.--
            ``(1) Facility.--The term `facility' includes any factory, 
        warehouse, or establishment, in which produce is minimally 
        processed.
            ``(2) Minimally process; produce.--The terms `minimally 
        process' and `produce' have the meanings given those terms in 
        section 3 of the Fresh Produce Safety Act.''.
    (b) Remedies.--
            (1) In general.--Paragraphs (f) and (n) of section 301, and 
        section 304(g)(1), of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 331, 334(g)(1)) are amended by striking ``section 
        704'' and inserting ``section 704 or 704A''.
            (2) Prohibited disclosures.--Section 301(j) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 331(j)) is amended by 
        striking ``704,'' and inserting ``704, 704A,''.
    (c) Conforming Amendment.--Section 742(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379l(a)(2)) is amended by striking 
``section 704'' and inserting ``section 704 or 704A''.

                Subtitle B--Raw Agricultural Commodities

SEC. 121. GOOD AGRICULTURAL PRACTICES.

    (a) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act, as amended by section 111(a), is further amended by inserting 
after section 402A the following:

``SEC. 402B. GOOD AGRICULTURAL PRACTICES FOR RAW AGRICULTURAL 
              COMMODITIES.

    ``(a) Good Agricultural Practice Regulations.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of this section, the Secretary, in consultation with 
        the Secretary of Agriculture, shall by regulation establish 
        general standards for good agricultural practices for the 
        production of raw agricultural commodities, in order to 
        minimize the violations of this Act and maximize the safety of 
        those commodities.
            ``(2) Contents.--The regulations issued under paragraph (1) 
        shall include the following requirements:
                    ``(A) Manure.--Growers of a raw agriculture 
                commodity shall--
                            ``(i) manage the application of manure to 
                        ensure that it does not contribute to the 
                        contamination of crops, including limitations 
                        on the crops where and when manure may be 
                        applied; and
                            ``(ii) monitor and maintain records 
                        relating to use of manure in composting 
                        intended for use on food crops to ensure 
                        effective controls are used to destroy 
                        pathogens.
                    ``(B) Animals, domestic and wildlife.--Growers of a 
                raw agricultural commodity shall ensure that domestic 
                animals should be excluded, to the extent reasonably 
                practicable, from fields and orchards during the 
                growing and harvesting season, and growing areas should 
                have wildlife deterrents.
                    ``(C) Water.--Growers of a raw agricultural 
                commodity shall ensure that the water supply used for 
                irrigation and for washing is suitable for its intended 
                use and that ground water is regularly monitored for 
                the presence of pathogens at a rate adequate to ensure 
                that contaminated water is identified and diverted from 
                use on food crops.
                    ``(D) Environmental conditions.--Growers of a raw 
                agricultural commodity shall consider the unique 
                environmental conditions that might increase the 
                likelihood of crop contamination, including flooding, 
                runoff, drought, and other conditions and develop 
                safety plans to ensure contaminated crops are not 
                distributed.
                    ``(E) Additional requirements.--Other requirements 
                as determined appropriate by the Secretary.
            ``(3) Risk assessment.--The standards established under 
        paragraph (1) shall be based on risk assessment tools and 
        metrics developed by the Food and Drug Administration in 
        consultation with the Department of Agriculture and growers of 
        produce. The risk assessments shall include--
                    ``(A) identification of existing and potential 
                hazards at facilities;
                    ``(B) evaluation of human health risks posed by 
                hazards identified in subparagraph (A); and
                    ``(C) proposed controls to minimize hazards based 
                on subparagraph (B).
            ``(4) Risk classification.--The Secretary shall classify 
        facilities as high-, medium-, or low-risk according to the risk 
        assessments in paragraph (3), and by considering the hazards 
        associated with the type of produce being grown 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. Such risk classification shall determine the 
        specific standards and controls required at each facility.
            ``(5) Science-based standards.--The standards established 
        under paragraph (1) shall--
                    ``(A) reflect the best available science; and
                    ``(B) be subject to change as new scientific 
                evidence on risk becomes available.
    ``(b) Implementation Plan.--
            ``(1) In general.--Not later than 2 years after the date of 
        enactment of this section, the Secretary shall require growers 
        of a raw agricultural commodity to have a written plan 
        detailing the controls utilized by the grower that limit the 
        presence and growth of contaminants.
            ``(2) Content.--A plan under paragraph (1) shall--
                    ``(A) address standards for good agricultural 
                practices developed under subsection (a);
                    ``(B) require recordkeeping to monitor compliance;
                    ``(C) require sampling of product to be tested at a 
                frequency and in a manner commensurate with the risk 
                presented by the facility and produce grown as 
                determined in subsection (a)(3), if the Secretary deems 
                this appropriate, and sufficient to ensure that the 
                standards or process controls are effective on an on-
                going basis and that regulatory standards are met; and
                    ``(D) provide access to the Food and Drug 
                Administration to records maintained by the facility.
            ``(3) Specific controls.--The Secretary may require growers 
        of a raw agricultural commodity to adopt as part of a plan 
        under paragraph (1) specific process controls, if the process 
        controls are needed to ensure the protection of the public 
        health.
            ``(4) Tiered implementation.--The Secretary shall require 
        such a plan for high-risk facilities first, and then for 
        medium-risk facilities, and then for low-risk facilities, as 
        classified under subsection (a)(4).
    ``(c) Effective Date.--The regulations described in subsection (a) 
shall take effect 2 years after the date of enactment of this section.
    ``(d) Definitions.--In this section:
            ``(1) Facility.--The term `facility' means a farm or other 
        facility of a grower of a raw agricultural commodity.
            ``(2) Raw agricultural commodity.--The term `raw 
        agricultural commodity' means a perishable agricultural 
        commodity, as defined in section 1(b) of the Perishable 
        Agricultural Commodities Act, 1930 (7 U.S.C. 499a(b)) that is a 
        raw agricultural commodity, as defined in section 201.''.
    (b) Violation.--Section 402(j) of the Federal Food, Drug, and 
Cosmetic Act, as added by section 111(b), is amended by inserting 
before the period the following: ``or a raw agricultural commodity 
produced in violation of section 402B''.

SEC. 122. INSPECTIONS OF FACILITIES.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act, as amended by section 112(a), is further amended by 
inserting after section 704A the following:

``SEC. 704B. INSPECTIONS OF FACILITIES.

    ``(a) Nature of Inspections.--Officers and employees duly 
designated by the Secretary shall have the authority to inspect 
appropriate facilities (as defined in section 402B) to determine 
compliance with the standards described in section 402B.
    ``(b) Regulations.--Not later than 2 years after the date of 
enactment of this section, the Secretary, in consultation with the 
Secretary of Agriculture, shall by regulation issue procedures for 
conducting the inspections.
    ``(c) Effective Date.--Subsection (a) and the regulations 
promulgated under subsection (b) shall take effect 3 years after the 
date of enactment of this section.''.
    (b) Remedies.--
            (1) In general.--Paragraphs (f) and (n) of section 301, and 
        section 304(g)(1), of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 331(j)), as amended in section 112(b), are further 
        amended by striking ``or 704A'' and inserting ``, 704A, or 
        704B''.
            (2) Prohibited disclosures.--Section 301(j) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(j)), as amended in 
        section 112(b), is further amended by inserting ``704B,'' after 
        ``704A,''.
    (c) Conforming Amendment.--Section 742(a)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379l(a)(2)), as amended in section 
112(c), is further amended by striking ``or 704A'' and inserting ``, 
704A, or 704B''.

                    TITLE II--RESEARCH AND EDUCATION

SEC. 201. PUBLIC HEALTH ASSESSMENT SYSTEM.

    (a) Cooperation With the Centers for Disease Control and 
Prevention.--The Commissioner of Food and Drugs, in cooperation with 
the Secretary of Agriculture, the Director of the Centers for Disease 
Control and Prevention, and the Administrator of the Environmental 
Protection Agency, shall establish and maintain an active surveillance 
system, for surveillance of 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 fresh produce.
    (b) Public Health Sampling.--
            (1) Guidelines.--Not later than 3 years after the date of 
        enactment of this Act, the Commissioner of Food and Drugs, in 
        cooperation with the Secretary of Agriculture, the Director of 
        the Centers for Disease Control and Prevention, and the 
        Administrator of the Environmental Protection Agency, shall 
        establish guidelines for a sampling system under which the 
        Commissioner and the Secretary of Agriculture shall collect and 
        analyze samples of fresh produce, both minimally processed and 
        unprocessed, to assist the Commissioner in carrying out this 
        Act and the requirements of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 301 et seq.) that relate to produce, 
        and to assess more accurately the nature, frequency of 
        occurrence, and amounts of contaminants in the produce.
            (2) Monitoring and other information.--In carrying out the 
        sampling system, the Commissioner of Food and Drugs 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 
                produce available to consumers; and
                    (B) at the request of the Commissioner, the 
                collection and analysis of such other information, 
                including analysis of information from monitoring and 
                verification samples, as the Commissioner determines 
                may be useful in assessing the occurrence of 
                contaminants in produce.
            (3) Process verification standard.--The Commissioner of 
        Food and Drugs and the Secretary of Agriculture shall conduct 
        sampling to identify--
                    (A) a contaminant, or other substance, that is 
                commonly found on minimally processed produce and, when 
                present at low levels, accurately indicates that the 
                produce has been appropriately processed, with adequate 
                sanitation; and
                    (B) a standard for the level of that substance that 
                indicates that the produce has been minimally processed 
                as described in subparagraph (A).

SEC. 202. PUBLIC EDUCATION SYSTEM.

    The Commissioner of Food and Drugs and the Secretary of 
Agriculture, 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 relating to produce. In carrying out the 
program, the Commissioner shall--
            (1) provide information to the public regarding Federal 
        standards and good agricultural and manufacturing practice 
        requirements relating to food safety and promote public 
        awareness, understanding, and acceptance of the standards and 
        requirements; and
            (2) provide such other information or advice to persons 
        that work with the growing and minimal processing of produce, 
        the food service and retail industry, consumers, and other 
        persons as the Commissioner determines will promote the 
        purposes of this Act.

SEC. 203. RESEARCH.

    (a) In General.--The Secretary of Agriculture, in consultation with 
the Commissioner of Food and Drugs, shall conduct research to assist in 
the implementation of this Act and the requirements of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) that relate to 
produce, including studies relating to--
            (1) improving sanitation and food safety practices in the 
        minimal processing of produce;
            (2) developing improved techniques for the monitoring of 
        produce and inspection of produce;
            (3) developing efficient, rapid, and sensitive methods for 
        determining and detecting the presence of contaminants in 
        produce;
            (4) determining the sources of contamination of produce, 
        including contamination from growing, harvesting, and minimal 
        processing produce and post-processing contamination of 
        produce;
            (5) developing consumption data with respect to produce 
        (including minimally processed produce); and
            (6) mitigation strategies to aid produce processors and 
        produce growers in deciding what actions to take when 
        contamination is found.
    (b) Contract Authority.--The Secretary of Agriculture is authorized 
to enter into contracts and agreements with States, institutions of 
higher education, other government agencies, and other persons to carry 
out the activities described in this section.

            TITLE III--IMPORTED PRODUCE AND OTHER PROVISIONS

SEC. 301. IMPORTED PRODUCE.

    (a) Equivalency Procedures.--Not later than 1 year after the date 
of enactment of this Act, the Secretary, in consultation with the 
Secretary of Agriculture, shall by regulation establish procedures for 
equivalency with foreign countries that intend to export raw 
agricultural commodities and minimally processed produce to the United 
States.
    (b) Content.--The Secretary, in consultation with the Secretary of 
Agriculture, shall establish procedures to require that imported raw 
agricultural commodities and minimally processed produce meet the 
criteria established in this Act (and the amendments made by this Act).

SEC. 302. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as may be 
necessary to carry out this Act (and the amendments made by this Act) 
for each fiscal year.
                                 <all>