[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 823 Introduced in Senate (IS)]







106th CONGRESS
  1st Session
                                 S. 823

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


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 15, 1999

Mr. Harkin (for himself 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 processed 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 ``Fruit and 
Vegetable 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--Processed Produce

Sec. 111. Good manufacturing practices.
Sec. 112. Inspections of processors.
Sec. 113. State and Federal cooperation.
                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 and advisory system.
Sec. 203. Research.
                        TITLE III--IMPORTED FOOD

Sec. 301. Criteria for deeming imported food adulterated.

SEC. 2. FINDINGS.

    Congress finds that--
            (1) persons who process produce for human consumption have 
        the responsibility to prevent or minimize food safety hazards 
        related to their products;
            (2) consumption of fresh fruits and vegetables can promote 
        health and prevent disease, and should be encouraged;
            (3) rising consumer demand for processed produce, the 
        growing market for various kinds of domestic and imported 
        processed produce, and the increasing variety of processing 
        techniques for produce, are causing newly recognized or 
        unpredicted safety hazards; and
            (4) uniform sanitation practices, applied to processing of 
        produce, will minimize these hazards.

SEC. 3. DEFINITIONS.

    In this Act:
            (1) Contaminant.--The term ``contaminant'' includes a 
        bacterium, a chemical contaminant, a natural toxin, a virus, a 
        parasite, a physical hazard, or other substance, that when 
        found on or in produce can cause human illness or injury.
            (2) Process.--The term ``process''--
                    (A) means to carry out the commercial preparation 
                or manufacture of produce, including--
                            (i) the freezing, dehydration, salting, 
                        sprouting, peeling, coring, stemming, trimming, 
                        fermentation, mashing, or shredding of produce;
                            (ii) the cutting of produce after 
                        harvesting;
                            (iii) the final washing of produce that 
                        will be presented for sale so as appear to the 
                        average consumer to be ready for consumption 
                        without further washing or preparation; and
                            (iv) the mixing or blending of produce with 
                        other produce; and
                    (B) does not include carrying out the harvesting, 
                washing (except as provided in subparagraph (A)(iii)), 
                waxing, packing, or sorting, of a raw agricultural 
                commodity.
            (3) Produce.--The term ``produce''--
                    (A) 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)(i) includes, except as provided in clause (ii), 
                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); and
                    (ii) does not include the other food in the mixture 
                described in clause (i)(II); and
                    (C) does not include an article used for food or 
                drink for animals, or an article used for a component 
                of such an article.
            (4) 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).
            (5) 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--
                    (i) the produce processing industry has effective 
                programs in place to assure the safety of produce 
                processed in the United States; and
                    (ii) 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 produce 
        processing and the production of raw agricultural commodities.
    (b) Program Elements.--The program shall provide for implementation 
of the authorities described in--
            (1) sections 402A, 402B, 407A, and 407B of the Federal 
        Food, Drug, and Cosmetic Act, as added in subtitles A and B;
            (2) section 113; and
            (3) title II.

                     Subtitle A--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.--Not later than 1 
year after the date of enactment of this section, the Secretary shall 
by regulation issue standards for good manufacturing practices for the 
processing of produce.
    ``(b) Application.--
            ``(1) In general.--The regulations issued under subsection 
        (a) shall be the same as the provisions of the good 
        manufacturing practice regulations that apply to the processing 
        of food (notwithstanding any exclusions in Federal law relating 
        to establishments engaged solely in the harvesting, storage, or 
        distribution of raw agricultural commodities), except as 
        provided in paragraph (2).
            ``(2) Exceptions.--In issuing regulations under subsection 
        (a), the Secretary may modify the provisions described in 
        paragraph (1) if the Secretary determines, for good cause shown 
        and stated together with the regulations, that--
                    ``(A) a modification of such provisions would be 
                more effective to prevent the contamination of, or 
                promote the sanitation of, processed produce; or
                    ``(B) the application of a portion of such 
                provisions would not result in the prevention of 
                contamination of, or promotion of sanitation of, 
                processed produce.
    ``(c) Effective Date.--The regulations described in subsection (a) 
take effect 2 years after the date of enactment of this section.
    ``(d) Definitions.--In this section:
            ``(1) Contaminant; process; produce.--The terms 
        `contaminant', `process', and `produce' have the meanings given 
        the terms in section 3 of the Fruit and Vegetable Safety Act.
            ``(2) 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 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:
    ``(h) 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.--
                    ``(A) In general.--The Secretary shall establish a 
                schedule for the unannounced inspections, which shall 
                provide for--
                            ``(i) annual inspections for the 
                        facilities, except as provided in clause (ii); 
                        and
                            ``(ii) less frequent inspections for 
                        facilities classified as low-risk facilities 
                        under subparagraph (B).
                    ``(B) Low-risk facilities.--The Secretary may 
                classify processing facilities as low-risk facilities. 
                In making the classification, the Secretary shall 
                classify facilities by considering the hazards 
                associated with the type of produce being 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.
            ``(3) Examination of classifications.--Each such inspection 
        of a facility shall include an examination of whether the 
        facility is appropriately classified under paragraph (2).
    ``(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 (including records required to be maintained 
        under subsection (d)(1)(A)), processes, controls, and premises) 
        that bear on whether 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 establishments in which food is processed.
            ``(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 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 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 within 48 hours after the issuance of the 
impoundment order, condemned. If objection is made within that 48 
hours, processed produce that is perishable 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 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 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 processing 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 processed 
                at the facility;
                    ``(ii) the processing of the produce; and
                    ``(iii) other matters reasonably related to whether 
                produce 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 processed at the facility, including 
                sufficient information to permit lot identification to 
                facilitate traceback of produce found to be adulterated 
                under 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 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).
    ``(e) Definitions.--
            ``(1) Facility.--The term `facility' includes any factory, 
        warehouse, or establishment, in which produce is processed.
            ``(2) Process; produce.--The terms `process' and `produce' 
        have the meanings given the terms in section 3 of the Fruit and 
        Vegetable 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''.

SEC. 113. 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 111 so that State food safety 
programs involving the safety of processed produce 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) establish, continue, or strengthen State food safety 
        programs, especially with respect to the regulation of retail 
        commercial food establishments; and
            (2) establish procedures and requirements for ensuring that 
        processed produce under the jurisdiction of the State food 
        safety programs is not unsafe for human consumption.
    (b) Assistance.--The Secretary may provide to a State, for 
planning, developing, and implementing such 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 an agreement 
entered into with a Federal, State, or local agency, use, on a 
reimbursable basis or otherwise, the personnel, services, and 
facilities of the agency to carry out the responsibilities of the 
agency under this Act. The 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.

                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.--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 standards for good agricultural practices for the production of 
raw agricultural commodities, in order to minimize the adulteration and 
maximize the safety of those commodities.
    ``(b) Implementation Plan.--Not later than 3 years after the date 
of enactment of this section, the Secretary, in consultation with the 
Secretary of Agriculture, shall issue and carry out an implementation 
plan for the implementation of the standards.
    ``(c) Effective Date.--The regulations described in subsection (a) 
take effect 3 years after the date of enactment of this section.
    ``(d) Definition.--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(h) 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 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 described 
in subsection (b) 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 produce.
    (b) Public Health Sampling.--
            (1) Guidelines.--Not later than 12 months 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 produce 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 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 processed as 
                described in subparagraph (A).

SEC. 202. PUBLIC EDUCATION AND ADVISORY SYSTEM.

    (a) Public Education.--The Commissioner of Food and Drugs, 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 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 the produce 
        processing industry, the food service and retail industry, 
        consumers, and other persons as the Commissioner determines 
        will promote the purposes of this Act.
    (b) Health Advisories.--The Commissioner of Food and Drugs, in 
cooperation with the Secretary of Agriculture, the Director of the 
Centers for Disease Control and Prevention, the Administrator of the 
Environmental Protection Agency, States, and other appropriate 
entities, shall--
            (1) develop and distribute regional and national advisories 
        concerning food safety relating to produce;
            (2) develop standardized formats for written and broadcast 
        advisories concerning food safety relating to produce; and
            (3) incorporate State and local advisories, at the election 
        of the States and local entities, concerning food safety 
        relating to produce into the national public education program 
        required under subsection (a).

SEC. 203. RESEARCH.

    (a) In General.--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 
        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 
        processing produce and post-processing contamination of 
        produce; and
            (5) developing consumption data with respect to produce 
        (including processed produce).
    (b) Contract Authority.--The Commissioner of Food and Drugs 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 FOOD

SEC. 301. CRITERIA FOR DEEMING IMPORTED FOOD ADULTERATED.

    (a) Amendment to the Federal Food, Drug, and Cosmetic Act.--Section 
402 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342), as 
amended by sections 111(b) and 121(b), is further amended by adding at 
the end the following:
    ``(i) If it is food consisting of processed produce or a raw 
agricultural commodity (as defined in section 402A or 402B) that is 
offered for import into the United States and that has not been 
prepared, packed, and held under a system or conditions, or subject to 
measures, that meet the requirements of this Act (including sections 
402A and 402B), or that otherwise achieve the level of protection 
required, as determined by the Secretary, for such food prepared, 
packed, or held in the United States. In determining whether a system, 
conditions, or measures meet the requirements of this Act or otherwise 
achieve the level of protection required, the Secretary may consider 
whether an officer or employee duly designated by the Secretary has 
requested, and has been refused, access to the establishment or 
location where such food was prepared, packed, or held for the purpose 
of inspection (including sample collection), including inspection under 
subsection (a)(1), (b), or (d) of section 704A or section 704B, 
testing, or other relevant procedures, at a reasonable time and in a 
reasonable manner, and may deny the importation of such food from such 
establishment or location on the basis of such refusal and other 
relevant factors.''.
    (b) Implementation of Authority; Plan.--The Secretary of Health and 
Human Services shall develop a plan for the initial implementation of 
the authority under section 402(i) of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), and shall carry out the 
authority of such section consistent with such plan.
                                 <all>