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<PRE>[DOCID: f:h1627enr.txt]
        H.R.1627

                       One Hundred Fourth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

         Begun and held at the City of Washington on Wednesday,
   the third day of January, one thousand nine hundred and ninety-six


                                 An Act


 
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the 
      Federal Food, Drug, and Cosmetic Act, 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.

    This Act may be cited as the ``Food Quality Protection Act of 
1996''.

                    TITLE I--SUSPENSION-APPLICATORS

 SEC. 101. REFERENCE.

    Whenever in this title an amendment or repeal is expressed in terms 
of an amendment to, or repeal of, a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Insecticide, Fungicide, and Rodenticide Act.

                         Subtitle A--Suspension

 SEC. 102. SUSPENSION.

    (a) Section 6(c)(1).--The second sentence of section 6(c)(1) (7 
U.S.C. 136d(c)(1)) is amended to read: ``Except as provided in 
paragraph (3), no order of suspension may be issued under this 
subsection unless the Administrator has issued, or at the same time 
issues, a notice of intention to cancel the registration or change the 
classification of the pesticide under subsection (b).''.
    (b) Section 6(c)(3).--Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is 
amended--
        (1) by inserting after the first sentence the following new 
    sentence: ``The Administrator may issue an emergency order under 
    this paragraph before issuing a notice of intention to cancel the 
    registration or change the classification of the pesticide under 
    subsection (b) and the Administrator shall proceed to issue the 
    notice under subsection (b) within 90 days of issuing an emergency 
    order. If the Administrator does not issue a notice under 
    subsection (b) within 90 days of issuing an emergency order, the 
    emergency order shall expire.''; and
        (2) by striking ``In that case'' and inserting ``In the case of 
    an emergency order''.

SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

    Section 4(g)(2) (7 U.S.C. 136a-1(g)(2)) is amended by adding at the 
end the following:
            ``(E) As soon as the Administrator has sufficient 
        information with respect to the dietary risk of a particular 
        active ingredient, but in any event no later than the time the 
        Administrator makes a determination under subparagraph (C) or 
        (D) with respect to pesticides containing a particular active 
        ingredient, the Administrator shall--
                ``(i) reassess each associated tolerance and exemption 
            from the requirement for a tolerance issued under section 
            408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
            346a);
                ``(ii) determine whether such tolerance or exemption 
            meets the requirements of that Act;
                ``(iii) determine whether additional tolerances or 
            exemptions should be issued;
                ``(iv) publish in the Federal Register a notice setting 
            forth the determinations made under this subparagraph; and
                ``(v) commence promptly such proceedings under this Act 
            and section 408 of the Federal Food, Drug, and Cosmetic Act 
            as are warranted by such determinations.''.

SEC. 104. SCIENTIFIC ADVISORY PANEL.

    Section 25(d) (7 U.S.C. 136w(d)) is amended--
        (1) in the first sentence, by striking ``The Administrator 
    shall'' and inserting:
        ``(1) In general.--The Administrator shall''; and
        (2) by adding at the end the following:
        ``(2) Science review board.--There is established a Science 
    Review Board to consist of 60 scientists who shall be available to 
    the Scientific Advisory Panel to assist in reviews conducted by the 
    Panel. Members of the Board shall be selected in the same manner as 
    members of temporary subpanels created under paragraph (1). Members 
    of the Board shall be compensated in the same manner as members of 
    the Panel.''.

 SEC. 105. NITROGEN STABILIZER.

    (a) Section 2.--Section 2 (7 U.S.C. 136) is amended--
        (1) in subsection (a)--
            (A) in paragraph (1) by striking ``or'' after 
        ``defoliant,'' and inserting ``, or nitrogen stabilizer'' after 
        ``desiccant'';
            (B) at the end of paragraph (3) by striking ``and'';
            (C) at the end of paragraph (4) by striking the period and 
        inserting ``; and''; and
            (D) at the end by adding the following:
        ``(5) in the case of a nitrogen stabilizer, an ingredient which 
    will prevent or hinder the process of nitrification, 
    denitrification, ammonia volatilization, or urease production 
    through action affecting soil bacteria.'';
        (2) in subsection (u), by striking ``and'' before ``(2)'' and 
    by inserting ``and (3) any nitrogen stabilizer,'' after 
    ``desiccant,''; and
        (3) at the end by adding the following:
    ``(hh) Nitrogen Stabilizer.--The term `nitrogen stabilizer' means 
any substance or mixture of substances intended for preventing or 
hindering the process of nitrification, denitrification, ammonia 
volatilization, or urease production through action upon soil bacteria. 
Such term shall not include--
        ``(1) dicyandiamide;
        ``(2) ammonium thiosulfate; or
        ``(3) any substance or mixture of substances.--
            ``(A) that was not registered pursuant to section 3 prior 
        to January 1, 1992; and
            ``(B) that was in commercial agronomic use prior to January 
        1, 1992, with respect to which after January 1, 1992, the 
        distributor or seller of the substance or mixture has made no 
        specific claim of prevention or hindering of the process of 
        nitrification, denitrification, ammonia volatilization urease 
        production regardless of the actual use or purpose for, or 
        future use or purpose for, the substance or mixture.
Statements made in materials required to be submitted to any State 
legislative or regulatory authority, or required by such authority to 
be included in the labeling or other literature accompanying any such 
substance or mixture shall not be deemed a specific claim within the 
meaning of this subsection.''.
    (b) Section 3(f).--Section 3(f) (7 U.S.C. 136a(f)) is amended by 
adding at the end the following:
        ``(4) Mixtures of nitrogen stabilizers and fertilizer 
    products.--Any mixture or other combination of--
            ``(A) 1 or more nitrogen stabilizers registered under this 
        Act; and
            ``(B) 1 or more fertilizer products,
    shall not be subject to the provisions of this section or sections 
    4, 5, 7, 15, and 17(a)(2) if the mixture or other combination is 
    accompanied by the labeling required under this Act for the 
    nitrogen stabilizer contained in the mixture or other combination, 
    the mixture or combination is mixed or combined in accordance with 
    such labeling, and the mixture or combination does not contain any 
    active ingredient other than the nitrogen stabilizer.''.

SEC. 106. PERIODIC REGISTRATION REVIEW.

    (a) Section 6.--Section 6 (7 U.S.C. 136d) is amended--
        (1) in subsection (a), by striking the heading and inserting 
    the following:
    ``(a) Existing Stocks and Information.--''; and
        (2) by amending paragraph (1) of subsection (a) to read as 
    follows:
        ``(1) Existing stocks.--The Administrator may permit the 
    continued sale and use of existing stocks of a pesticide whose 
    registration is suspended or canceled under this section, or 
    section 3 or 4, to such extent, under such conditions, and for such 
    uses as
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 the Administrator determines that such sale or use is not 
    inconsistent with the purposes of this Act.''.
    (b) Section 3.--Section 3 (7 U.S.C. 136a) is amended by adding at 
the end the following:
    ``(g) Registration Review.--
        ``(1)(A) General rule.--The registrations of pesticides are to 
    be periodically reviewed. The Administrator shall by regulation 
    establish a procedure for accomplishing the periodic review of 
    registrations. The goal of these regulations shall be a review of a 
    pesticide's registration every 15 years. No registration shall be 
    canceled as a result of the registration review process unless the 
    Administrator follows the procedures and substantive requirements 
    of section 6.
        ``(B) Limitation.--Nothing in this subsection shall prohibit 
    the Administrator from undertaking any other review of a pesticide 
    pursuant to this Act.
        ``(2)(A) Data.--The Administrator shall use the authority in 
    subsection (c)(2)(B) to require the submission of data when such 
    data are necessary for a registration review.
        ``(B) Data submission, compensation, and exemption.--For 
    purposes of this subsection, the provisions of subsections (c)(1), 
    (c)(2)(B), and (c)(2)(D) shall be utilized for and be applicable to 
    any data required for registration review.''.

     Subtitle B--Training for Maintenance Applicators and Service 
                              Technicians

 SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS DEFINITIONS.

    Section 2 (7 U.S.C. 136), as amended by section 106, is amended by 
adding at the end the following:
    ``(jj) Maintenance Applicator.--The term `maintenance applicator' 
means any individual who, in the principal course of such individual's 
employment, uses, or supervises the use of, a pesticide not classified 
for restricted use (other than a ready to use consumer products 
pesticide); for the purpose of providing structural pest control or 
lawn pest control including janitors, general maintenance personnel, 
sanitation personnel, and grounds maintenance personnel. The term 
`maintenance applicator' does not include private applicators as 
defined in section 2(e)(2); individuals who use antimicrobial 
pesticides, sanitizers or disinfectants; individuals employed by 
Federal, State, and local governments or any political subdivisions 
thereof, or individuals who use pesticides not classified for 
restricted use in or around their homes, boats, sod farms, nurseries, 
greenhouses, or other noncommercial property.
    ``(kk) Service Technician.--The term `service technician' means any 
individual who uses or supervises the use of pesticides (other than a 
ready to use consumer products pesticide) for the purpose of providing 
structural pest control or lawn pest control on the property of another 
for a fee. The term `service technician' does not include individuals 
who use antimicrobial pesticides, sanitizers or disinfectants; or who 
otherwise apply ready to use consumer products pesticides.''.

 SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS 
              AND SERVICE TECHNICIANS.

    The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
136 et seq.) is amended--
        (1) by redesignating sections 30 and 31 as sections 33 and 34, 
    respectively; and
        (2) by adding after section 29 the following:

``SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS 
              AND SERVICE TECHNICIANS.

    ``Each State may establish minimum requirements for training of 
maintenance applicators and service technicians. Such training may 
include instruction in the safe and effective handling and use of 
pesticides in accordance with the Environmental Protection Agency 
approved labeling, and instruction in integrated pest management 
techniques. The authority of the Administrator with respect to minimum 
requirements for training of maintenance applicators and service 
technicians shall be limited to ensuring that each State understands 
the provisions of this section.''.

     TITLE II--MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE 
           REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

 SEC. 201. REFERENCE.

    Whenever in this title an amendment or repeal is expressed in terms 
of an amendment to, or repeal of, a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Insecticide, Fungicide, and Rodenticide Act.

                 Subtitle A--Minor Use Crop Protection

 SEC. 210. MINOR CROP PROTECTION.

    (a) Definition.--Section 2 (7 U.S.C. 136), as amended by section 
120, is further amended by adding at the end the following:
    ``(ll) Minor Use.--The term `minor use' means the use of a 
pesticide on an animal, on a commercial agricultural crop or site, or 
for the protection of public health where--
        ``(1) the total United States acreage for the crop is less than 
    300,000 acres, as determined by the Secretary of Agriculture; or
        ``(2) the Administrator, in consultation with the Secretary of 
    Agriculture, determines that, based on information provided by an 
    applicant for registration or a registrant, the use does not 
    provide sufficient economic incentive to support the initial 
    registration or continuing registration of a pesticide for such use 
    and--
            ``(A) there are insufficient efficacious alternative 
        registered pesticides available for the use;
            ``(B) the alternatives to the pesticide use pose greater 
        risks to the environment or human health;
            ``(C) the minor use pesticide plays or will play a 
        significant part in managing pest resistance; or
            ``(D) the minor use pesticide plays or will play a 
        significant part in an integrated pest management program.
The status as a minor use under this subsection shall continue as long 
as the Administrator has not determined that, based on existing data, 
such use may cause an unreasonable adverse effect on the environment 
and the use otherwise qualifies for such status.''.
    (b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7 
U.S.C. 136a(c)(1)(F)) is amended--
        (1) by redesignating clauses (ii) and (iii) as clauses (iii) 
    and (iv), respectively; and
        (2) by inserting after clause (i) the following:
                ``(ii) The period of exclusive data use provided under 
            clause (i) shall be extended 1 additional year for each 3 
            minor uses registered after the date of enactment of this 
            clause and within 7 years of the commencement of the 
            exclusive use period, up to a total of 3 additional years 
            for all minor uses registered by the Administrator if the 
            Administrator, in consultation with the Secretary of 
            Agriculture, determines that, based on information provided 
            by an applicant for registration or a registrant, that--

                    ``(I) there are insufficient efficacious 
                alternative registered pesticides available for the 
                use;
                    ``(II) the alternatives to the minor use pesticide 
                pose greater risks to the environment or human health;
                    ``(III) the minor use pesticide plays or will play 
                a significant part in managing pest resistance; or
                    ``(IV) the minor use pesticide plays or will play a 
                significant part in an integrated pest management 
                program.

            The registration of a pesticide for a minor use on a crop 
            grouping established by the Administrator shall be 
            considered for purposes of this clause 1 minor use for each 
            representative crop for which data are provided in the crop 
            grouping. Any additional exclusive use period under this 
            clause shall be modified as appropriate or terminated if 
            the registrant voluntarily cancels the pr
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oduct or deletes 
            from the registration the minor uses which formed the basis 
            for the extension of the additional exclusive use period or 
            if the Administrator determines that the registrant is not 
            actually marketing the product for such minor uses.'';
        (3) in clause (iv), as amended by paragraph (1), by striking 
    ``and (ii)'' and inserting ``, (ii), and (iii)''; and
        (4) at the end of the section, as amended by paragraph (1), by 
    adding the following:
                ``(v) The period of exclusive use provided under clause 
            (ii) shall not take effect until 1 year after enactment of 
            this clause, except where an applicant or registrant is 
            applying for the registration of a pesticide containing an 
            active ingredient not previously registered.
                ``(vi) With respect to data submitted after the date of 
            enactment of this clause by an applicant or registrant to 
            support an amendment adding a new use to an existing 
            registration that does not retain any period of exclusive 
            use, if such data relates solely to a minor use of a 
            pesticide, such data shall not, without the written 
            permission of the original data submitter, be considered by 
            the Administrator to support an application for a minor use 
            by another person during the period of 10 years following 
            the date of submission of such data. The applicant or 
            registrant at the time the new minor use is requested shall 
            notify the Administrator that to the best of their 
            knowledge the exclusive use period for the pesticide has 
            expired and that the data pertaining solely to the minor 
            use of a pesticide is eligible for the provisions of this 
            paragraph. If the minor use registration which is supported 
            by data submitted pursuant to this subsection is 
            voluntarily canceled or if such data are subsequently used 
            to support a nonminor use, the data shall no longer be 
            subject to the exclusive use provisions of this clause but 
            shall instead be considered by the Administrator in 
            accordance with the provisions of clause (i), as 
            appropriate.''.
    (c) Time Extensions for Development of Minor Use Data.--
        (1) Data call-in.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) 
    is amended by adding at the end the following:
            ``(vi) Upon the request of a registrant the Administrator 
        shall, in the case of a minor use, extend the deadline for the 
        production of residue chemistry data under this subparagraph 
        for data required solely to support that minor use until the 
        final deadline for submission of data under section 4 for the 
        other uses of the pesticide established as of the date of 
        enactment of the Food Quality Protection Act of 1996, if--
                ``(I) the data to support other uses of the pesticide 
            on a food are being provided;
                ``(II) the registrant, in submitting a request for such 
            an extension, provides a schedule, including interim dates 
            to measure progress, to assure that the data production 
            will be completed before the expiration of the extension 
            period;
                ``(III) the Administrator has determined that such 
            extension will not significantly delay the Administrator's 
            schedule for issuing a reregistration eligibility 
            determination required under section 4; and
                ``(IV) the Administrator has determined that based on 
            existing data, such extension would not significantly 
            increase the risk of any unreasonable adverse effect on the 
            environment. If the Administrator grants an extension under 
            this clause, the Administrator shall monitor the 
            development of the data and shall ensure that the 
            registrant is meeting the schedule for the production of 
            the data. If the Administrator determines that the 
            registrant is not meeting or has not met the schedule for 
            the production of such data, the Administrator may proceed 
            in accordance with clause (iv) regarding the continued 
            registration of the affected products with the minor use 
            and shall inform the public of such action. Notwithstanding 
            the provisions of this clause, the Administrator may take 
            action to modify or revoke the extension under this clause 
            if the Administrator determines that the extension for the 
            minor use may cause an unreasonable adverse effect on the 
            environment. In such circumstance, the Administrator shall 
            provide, in writing to the registrant, a notice revoking 
            the extension of time for submission of data. Such data 
            shall instead be due in accordance with the date 
            established by the Administrator for the submission of the 
            data.''.
        (2) Reregistration.--Sections 4(d)(4)(B), 4(e)(2)(B), and 
    4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) are 
    each amended by adding at the end the following: ``Upon application 
    of a registrant, the Administrator shall, in the case of a minor 
    use, extend the deadline for the production of residue chemistry 
    data under this subparagraph for data required solely to support 
    that minor use until the final deadline for submission of data 
    under this section for the other uses of the pesticide established 
    as of the date of enactment of the Food Quality Protection Act of 
    1996 if--
                ``(i) the data to support other uses of the pesticide 
            on a food are being provided;
                ``(ii) the registrant, in submitting a request for such 
            an extension provides a schedule, including interim dates 
            to measure progress, to assure that the data production 
            will be completed before the expiration of the extension 
            period;
                ``(iii) the Administrator has determined that such 
            extension will not significantly delay the Administrator's 
            schedule for issuing a reregistration eligibility 
            determination required under this section; and
                ``(iv) the Administrator has determined that based on 
            existing data, such extension would not significantly 
            increase the risk of any unreasonable adverse effect on the 
            environment. If the Administrator grants an extension under 
            this subparagraph, the Administrator shall monitor the 
            development of the data and shall ensure that the 
            registrant is meeting the schedule for the production of 
            the data. If the Administrator determines that the 
            registrant is not meeting or has not met the schedule for 
            the production of such data, the Administrator may proceed 
            in accordance with clause (iv) of section 3(c)(2)(B) or 
            other provisions of this section, as appropriate, regarding 
            the continued registration of the affected products with 
            the minor use and shall inform the public of such action. 
            Notwithstanding the provisions of this subparagraph, the 
            Administrator may take action to modify or revoke the 
            extension under this subparagraph if the Administrator 
            determines that the extension for the minor use may cause 
            an unreasonable adverse effect on the environment. In such 
            circumstance, the Administrator shall provide written 
            notice to the registrant revoking the extension of time for 
            submission of data. Such data shall instead be due in 
            accordanc
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e with the date then established by the 
            Administrator for submission of the data.''.
    (d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is 
amended--
        (1) by inserting ``In general.--'' after ``(A)'';
        (2) by inserting ``Additional data.--'' after ``(B)'';
        (3) by inserting ``Simplified procedures.--'' after ``(C)''; 
    and
        (4) by adding at the end the following:
            ``(E) Minor use waiver.--In handling the registration of a 
        pesticide for a minor use, the Administrator may waive 
        otherwise applicable data requirements if the Administrator 
        determines that the absence of such data will not prevent the 
        Administrator from determining--
                ``(i) the incremental risk presented by the minor use 
            of the pesticide; and
                ``(ii) that such risk, if any, would not be an 
            unreasonable adverse effect on the environment.''.
    (e) Expediting Minor Use Registrations.--Section 3(c)(3) (7 U.S.C. 
136a(c)(3)) is amended--
        (1) by inserting after ``(A)'' the following: ``In general.--
    '';
        (2) by inserting after ``(B)'' the following: ``Identical or 
    substantially similar.--''; and
        (3) by adding at the end the following:
            ``(C) Minor use registration.--
                ``(i) The Administrator shall, as expeditiously as 
            possible, review and act on any complete application--

                    ``(I) that proposes the initial registration of a 
                new pesticide active ingredient if the active 
                ingredient is proposed to be registered solely for 
                minor uses, or proposes a registration amendment solely 
                for minor uses to an existing registration; or
                    ``(II) for a registration or a registration 
                amendment that proposes significant minor uses.

                ``(ii) For the purposes of clause (i)--

                    ``(I) the term `as expeditiously as possible' means 
                that the Administrator shall, to the greatest extent 
                practicable, complete a review and evaluation of all 
                data, submitted with a complete application, within 12 
                months after the submission of the complete 
                application, and the failure of the Administrator to 
                complete such a review and evaluation under clause (i) 
                shall not be subject to judicial review; and
                    ``(II) the term `significant minor uses' means 3 or 
                more minor uses proposed for every nonminor use, a 
                minor use that would, in the judgment of the 
                Administrator, serve as a replacement for any use which 
                has been canceled in the 5 years preceding the receipt 
                of the application, or a minor use that in the opinion 
                of the Administrator would avoid the reissuance of an 
                emergency exemption under section 18 for that minor 
                use.

            ``(D) Adequate time for submission of minor use data.--If a 
        registrant makes a request for a minor use waiver, regarding 
        data required by the Administrator, pursuant to paragraph 
        (2)(E), and if the Administrator denies in whole or in part 
        such data waiver request, the registrant shall have a full-time 
        period for providing such data. For purposes of this 
        subparagraph, the term `full-time period' means the time period 
        originally established by the Administrator for submission of 
        such data, beginning with the date of receipt by the registrant 
        of the Administrator's notice of denial.''.
    (f) Temporary Extension of Registration for Unsupported Minor 
Uses.--
        (1) Reregistration.--
            (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-1(d)(6) and 
        (f)(3)) are each amended by adding at the end the following: 
        ``If the registrant does not commit to support a specific minor 
        use of the pesticide, but is supporting and providing data in a 
        timely and adequate fashion to support uses of the pesticide on 
        a food, or if all uses of the pesticide are nonfood uses and 
        the registrant does not commit to support a specific minor use 
        of the pesticide but is supporting and providing data in a 
        timely and adequate fashion to support other nonfood uses of 
        the pesticide, the Administrator, at the written request of the 
        registrant, shall not take any action pursuant to this 
        paragraph in regard to such unsupported minor use until the 
        final deadline established as of the date of enactment of the 
        Food Quality Protection Act of 1996, for the submission of data 
        under this section for the supported uses identified pursuant 
        to this paragraph unless the Administrator determines that the 
        absence of the data is significant enough to cause human health 
        or environmental concerns. On such a determination the 
        Administrator may refuse the request for extension by the 
        registrant. Upon receipt of the request from the registrant, 
        the Administrator shall publish in the Federal Register a 
        notice of the receipt of the request and the effective date 
        upon which the uses not being supported will be voluntarily 
        deleted from the registration pursuant to section 6(f)(1). If 
        the Administrator grants an extension under this paragraph, the 
        Administrator shall monitor the development of the data for the 
        uses being supported and shall ensure that the registrant is 
        meeting the schedule for the production of such data. If the 
        Administrator determines that the registrant is not meeting or 
        has not met the schedule for the production of such data, the 
        Administrator may proceed in accordance with section 
        3(c)(2)(B)(iv) regarding the continued registration of the 
        affected products with the minor and other uses and shall 
        inform the public of such action in accordance with section 
        6(f)(2). Notwithstanding this subparagraph, the Administrator 
        may deny, modify, or revoke the temporary extension under this 
        paragraph if the Administrator determines that the continuation 
        of the minor use may cause an unreasonable adverse effect on 
        the environment. In the event of modification or revocation, 
        the Administrator shall provide, in writing, to the registrant 
        a notice revoking the temporary extension and establish a new 
        effective date by which the minor use shall be deleted from the 
        registration.''.
            (B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) is 
        amended by adding at the end the following: ``If the registrant 
        does not commit to support a specific minor use of the 
        pesticide, but is supporting and providing data in a timely and 
        adequate fashion to support uses of the pesticide on a food, or 
        if all uses of the pesticide are nonfood uses and the 
        registrant does not commit to support a specific minor use of 
        the pesticide but is supporting and providing data in a timely 
        and adequate fashion to support other nonfood uses of the 
        pesticide, the Administrator, at the written request of the 
        registrant, shall not take any action pursuant to this 
        subparagraph in regard to such unsupported minor use until the 
        final deadline established as of the date of enactment of the 
        Food Quality Protection Act of 1996, for the submission of data 
        under this section for the supported uses identified pursuant 
        to this subparagraph unless the Administrator determines that 
        the absence of the data is significant enough to cause human 
        health or environmental concerns. On the basis of such 
        determination, the Administrator m
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ay refuse the request for 
        extension by the registrant. Upon receipt of the request from 
        the registrant, the Administrator shall publish in the Federal 
        Register a notice of the receipt of the request and the 
        effective date upon which the uses not being supported will be 
        voluntarily deleted from the registration pursuant to section 
        6(f)(1). If the Administrator grants an extension under this 
        subparagraph, the Administrator shall monitor the development 
        of the data for the uses being supported and shall ensure that 
        the registrant is meeting the schedule for the production of 
        such data. If the Administrator determines that the registrant 
        is not meeting or has not met the schedule for the production 
        of such data, the Administrator may proceed in accordance with 
        section 3(c)(2)(B)(iv) regarding the continued registration of 
        the affected products with the minor and other uses and shall 
        inform the public of such action in accordance with section 
        6(f)(2). Notwithstanding this subparagraph, the Administrator 
        may deny, modify, or revoke the temporary extension under this 
        subparagraph if the Administrator determines that the 
        continuation of the minor use may cause an unreasonable adverse 
        effect on the environment. In the event of modification or 
        revocation, the Administrator shall provide, in writing, to the 
        registrant a notice revoking the temporary extension and 
        establish a new effective date by which the minor use shall be 
        deleted from the registration.''.
        (2) Data.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as 
    amended by subsection (c)(1), is further amended by adding at the 
    end the following:
            ``(vii) If the registrant does not commit to support a 
        specific minor use of the pesticide, but is supporting and 
        providing data in a timely and adequate fashion to support uses 
        of the pesticide on a food, or if all uses of the pesticide are 
        nonfood uses and the registrant does not commit to support a 
        specific minor use of the pesticide but is supporting and 
        providing data in a timely and adequate fashion to support 
        other nonfood uses of the pesticide, the Administrator, at the 
        written request of the registrant, shall not take any action 
        pursuant to this clause in regard to such unsupported minor use 
        until the final deadline established as of the date of 
        enactment of the Food Quality Protection Act of 1996, for the 
        submission of data under section 4 for the supported uses 
        identified pursuant to this clause unless the Administrator 
        determines that the absence of the data is significant enough 
        to cause human health or environmental concerns. On the basis 
        of such determination, the Administrator may refuse the request 
        for extension by the registrant. Upon receipt of the request 
        from the registrant, the Administrator shall publish in the 
        Federal Register a notice of the receipt of the request and the 
        effective date upon which the uses not being supported will be 
        voluntarily deleted from the registration pursuant to section 
        6(f)(1). If the Administrator grants an extension under this 
        clause, the Administrator shall monitor the development of the 
        data for the uses being supported and shall ensure that the 
        registrant is meeting the schedule for the production of such 
        data. If the Administrator determines that the registrant is 
        not meeting or has not met the schedule for the production of 
        such data, the Administrator may proceed in accordance with 
        clause (iv) of this subparagraph regarding the continued 
        registration of the affected products with the minor and other 
        uses and shall inform the public of such action in accordance 
        with section 6(f)(2). Notwithstanding the provisions of this 
        clause, the Administrator may deny, modify, or revoke the 
        temporary extension under this subparagraph if the 
        Administrator determines that the continuation of the minor use 
        may cause an unreasonable adverse effect on the environment. In 
        the event of modification or revocation, the Administrator 
        shall provide, in writing, to the registrant a notice revoking 
        the temporary extension and establish a new effective date by 
        which the minor use shall be deleted from the registration.''.
    (g) Section 6(f) (7 U.S.C. 136d(f)) is amended--
        (1) in paragraph (1)(C)(ii) by striking ``90-day'' each place 
    it appears and inserting ``180-day''; and
        (2) in paragraph (3)(A) by striking ``90-day'' and inserting 
    ``180-day''.
    (h) Utilization of Data for Voluntarily Canceled Chemicals.--
Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at the end the 
following:
        ``(4) Utilization of data for voluntarily canceled pesticide.--
    When an application is filed with the Administrator for the 
    registration of a pesticide for a minor use and another registrant 
    subsequently voluntarily cancels its registration for an identical 
    or substantially similar pesticide for an identical or 
    substantially similar use, the Administrator shall process, review, 
    and evaluate the pending application as if the voluntary 
    cancellation had not yet taken place except that the Administrator 
    shall not take such action if the Administrator determines that 
    such minor use may cause an unreasonable adverse effect on the 
    environment. In order to rely on this subsection, the applicant 
    must certify that it agrees to satisfy any outstanding data 
    requirements necessary to support the reregistration of the 
    pesticide in accordance with the data submission schedule 
    established by the Administrator.''.
    (i) Environmental Protection Agency Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by section 121, is amended by adding after section 30 the 
following:

``SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.

    ``(a) The Administrator shall assure coordination of minor use 
issues through the establishment of a minor use program within the 
Office of Pesticide Programs. Such office shall be responsible for 
coordinating the development of minor use programs and policies and 
consulting with growers regarding minor use issues and registrations 
and amendments which are submitted to the Environmental Protection 
Agency.
    ``(b) The Office of Pesticide Programs shall prepare a public 
report concerning the progress made on the registration of minor uses, 
including implementation of the exclusive use as an incentive for 
registering new minor uses, within 3 years of the passage of the Food 
Quality Protection Act of 1996.''.
    (j) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by subsection (i), is amended by adding after section 31 the 
following:

``SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.

    ``(a) In General.--The Secretary of Agriculture (hereinafter in 
this section referred to as the `Secretary') shall assure the 
coordination of the responsibilities of the Department of Agriculture 
related to minor uses of pesticides, including--
        ``(1) carrying out the Inter-Regional Project Number 4 (IR-4) 
    as described in section 2 of Public Law 89-106 (7 U.S.C. 450i(e)) 
    and the national pesticide resistance monitoring program 
    established under section 1651 of the Food, Agriculture, 
    Conservation, and Trade Act of 1990 (7 U.S.C. 5882);
        ``(2) supporting integrated pest management research;
        ``(3) consulting with growers to develop data for minor uses; 
    and
        ``(4) providing assistance for minor use registrations, 
    t
2000
olerances, and reregistrations with the Environmental Protection 
    Agency.
    ``(b)(1) Minor Use Pesticide Data.--
        ``(A) Grant authority.--The Secretary, in consultation with the 
    Administrator, shall establish a program to make grants for the 
    development of data to support minor use pesticide registrations 
    and reregistrations. The amount of any such grant shall not exceed 
    \1/2\ of the cost of the project for which the grant is made.
        ``(B) Applicants.--Any person who wants to develop data to 
    support minor use pesticide registrations and reregistrations may 
    apply for a grant under subparagraph (A). Priority shall be given 
    to an applicant for such a grant who does not directly receive 
    funds from the sale of pesticides registered for minor uses.
        ``(C) Data ownership.--Any data that is developed under a grant 
    under subparagraph (A) shall be jointly owned by the Department of 
    Agriculture and the person who received the grant. Such a person 
    shall enter into an agreement with the Secretary under which such 
    person shall share any fee paid to such person under section 
    3(c)(1)(F).
    ``(2) Minor Use Pesticide Data Revolving Fund.--
        ``(A) Establishment.--There is established in the Treasury of 
    the United States a revolving fund to be known as the Minor Use 
    Pesticide Data Revolving Fund. The Fund shall be available without 
    fiscal year limitation to carry out the authorized purposes of this 
    subsection.
        ``(B) Contents of the fund.--There shall be deposited in the 
    Fund--
            ``(i) such amounts as may be appropriated to support the 
        purposes of this subsection; and
            ``(ii) fees collected by the Secretary for any data 
        developed under a grant under paragraph (1)(A).
        ``(C) Authorizations of appropriations.--There are authorized 
    to be appropriated for each fiscal year to carry out the purposes 
    of this subsection $10,000,000 to remain available until 
    expended.''.

        Subtitle B--Antimicrobial Pesticide Registration Reform

 SEC. 221. DEFINITIONS.

    Section 2 (7 U.S.C. 136), as amended by section 210(a) is further 
amended--
        (1) in subsection (u), by adding at the end the following: 
    ``The term `pesticide' does not include liquid chemical sterilant 
    products (including any sterilant or subordinate disinfectant 
    claims on such products) for use on a critical or semi-critical 
    device, as defined in section 201 of the Federal Food, Drug, and 
    Cosmetic Act (21 U.S.C. 321). For purposes of the preceding 
    sentence, the term `critical device' includes any device which is 
    introduced directly into the human body, either into or in contact 
    with the bloodstream or normally sterile areas of the body and the 
    term `semi-critical device' includes any device which contacts 
    intact mucous membranes but which does not ordinarily penetrate the 
    blood barrier or otherwise enter normally sterile areas of the 
    body.''; and
        (2) by adding at the end the following:
    ``(mm) Antimicrobial Pesticide.--
        ``(1) In general.--The term `antimicrobial pesticide' means a 
    pesticide that--
            ``(A) is intended to--
                ``(i) disinfect, sanitize, reduce, or mitigate growth 
            or development of microbiological organisms; or
                ``(ii) protect inanimate objects, industrial processes 
            or systems, surfaces, water, or other chemical substances 
            from contamination, fouling, or deterioration caused by 
            bacteria, viruses, fungi, protozoa, algae, or slime; and
            ``(B) in the intended use is exempt from, or otherwise not 
        subject to, a tolerance under section 408 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 346a and 348) or a food 
        additive regulation under section 409 of such Act.
        ``(2) Excluded products.--The term `antimicrobial pesticide' 
    does not include --
            ``(A) a wood preservative or antifouling paint product for 
        which a claim of pesticidal activity other than or in addition 
        to an activity described in paragraph (1) is made;
            ``(B) an agricultural fungicide product; or
            ``(C) an aquatic herbicide product.
        ``(3) Included products.--The term `antimicrobial pesticide' 
    does include any other chemical sterilant product (other than 
    liquid chemical sterilant products exempt under subsection (u)), 
    any other disinfectant product, any other industrial microbiocide 
    product, and any other preservative product that is not excluded by 
    paragraph (2).''.

 SEC. 222. FEDERAL AND STATE DATA COORDINATION.

    Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section 
210(f)(2), is amended by adding at the end the following:
            ``(viii)(I) If data required to support registration of a 
        pesticide under subparagraph (A) is requested by a Federal or 
        State regulatory authority, the Administrator shall, to the 
        extent practicable, coordinate data requirements, test 
        protocols, timetables, and standards of review and reduce 
        burdens and redundancy caused to the registrant by multiple 
        requirements on the registrant.
            ``(II) The Administrator may enter into a cooperative 
        agreement with a State to carry out subclause (I).
            ``(III) Not later than 1 year after the date of enactment 
        of this clause, the Administrator shall develop a process to 
        identify and assist in alleviating future disparities between 
        Federal and State data requirements.''.

 SEC. 223. LABEL AND LABELING.

    Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the end the 
following:
        ``(9) Labeling.--
            ``(A) Additional statements.--Subject to subparagraphs (B) 
        and (C), it shall not be a violation of this Act for a 
        registrant to modify the labeling of an antimicrobial pesticide 
        product to include relevant information on product efficacy, 
        product composition, container composition or design, or other 
        characteristics that do not relate to any pesticidal claim or 
        pesticidal activity.
            ``(B) Requirements.--Proposed labeling information under 
        subparagraph (A) shall not be false or misleading, shall not 
        conflict with or detract from any statement required by law or 
        the Administrator as a condition of registration, and shall be 
        substantiated on the request of the Administrator.
            ``(C) Notification and disapproval.--
                ``(i) Notification.--A registration may be modified 
            under subparagraph (A) if --

                    ``(I) the registrant notifies the Administrator in 
                writing not later than 60 days prior to distribution or 
                sale of a product bearing the modified labeling; and
                    ``(II) the Administrator does not disapprove of the 
                modification under clause (ii).

                ``(ii) Disapproval.--Not later than 30 days after 
            receipt of a notification under clause (i), the 
            Administrator may disapprove the modification by sending 
            the registrant notification in writing stating that the 
            proposed language is not acceptable and stating the reasons 
            why the Administrator finds the proposed modification 
            unacceptable.
                ``(iii) Restriction on sale.--A registrant may not sell 
            or distribute a product bearing a disapproved modification.
                ``(iv) Objection.--A registrant may file an objection 
            in writing to a disapproval under clause (ii) not later 
            than 30 days after receipt of notification of the 
            disapproval.
                ``(v) Final action.--A decision by the Administrator 
            following receipt and consideration of an objection filed 
            under clause (iv) shal
2000
l be considered a final agency 
            action.
            ``(D) Use dilution.--The label or labeling required under 
        this Act for an antimicrobial pesticide that is or may be 
        diluted for use may have a different statement of caution or 
        protective measures for use of the recommended diluted solution 
        of the pesticide than for use of a concentrate of the pesticide 
        if the Administrator determines that --
                ``(i) adequate data have been submitted to support the 
            statement proposed for the diluted solution uses; and
                ``(ii) the label or labeling provides adequate 
            protection for exposure to the diluted solution of the 
            pesticide.''.

SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

    Section 3 (7 U.S.C. 136a), as amended by section 106(b), is further 
amended by adding at the end the following:
    ``(h) Registration Requirements for Antimicrobial Pesticides.--
        ``(1) Evaluation of process.--To the maximum extent practicable 
    consistent with the degrees of risk presented by an antimicrobial 
    pesticide and the type of review appropriate to evaluate the risks, 
    the Administrator shall identify and evaluate reforms to the 
    antimicrobial registration process that would reduce review periods 
    existing as of the date of enactment of this subsection for 
    antimicrobial pesticide product registration applications and 
    applications for amended registration of antimicrobial pesticide 
    products, including--
            ``(A) new antimicrobial active ingredients;
            ``(B) new antimicrobial end-use products;
            ``(C) substantially similar or identical antimicrobial 
        pesticides; and
            ``(D) amendments to antimicrobial pesticide registrations.
        ``(2) Review time period reduction goal.--Each reform 
    identified under paragraph (1) shall be designed to achieve the 
    goal of reducing the review period following submission of a 
    complete application, consistent with the degree of risk, to a 
    period of not more than--
            ``(A) 540 days for a new antimicrobial active ingredient 
        pesticide registration;
            ``(B) 270 days for a new antimicrobial use of a registered 
        active ingredient;
            ``(C) 120 days for any other new antimicrobial product;
            ``(D) 90 days for a substantially similar or identical 
        antimicrobial product;
            ``(E) 90 days for an amendment to an antimicrobial 
        registration that does not require scientific review of data; 
        and
            ``(F) 90 to 180 days for an amendment to an antimicrobial 
        registration that requires scientific review of data and that 
        is not otherwise described in this paragraph.
        ``(3) Implementation.--
            ``(A) Proposed rulemaking.--
                ``(i) Issuance.--Not later than 270 days after the date 
            of enactment of this subsection, the Administrator shall 
            publish in the Federal Register proposed regulations to 
            accelerate and improve the review of antimicrobial 
            pesticide products designed to implement, to the extent 
            practicable, the goals set forth in paragraph (2).
                ``(ii) Requirements.--Proposed regulations issued under 
            clause (i) shall--

                    ``(I) define the various classes of antimicrobial 
                use patterns, including household, industrial, and 
                institutional disinfectants and sanitizing pesticides, 
                preservatives, water treatment, and pulp and paper mill 
                additives, and other such products intended to 
                disinfect, sanitize, reduce, or mitigate growth or 
                development of microbiological organisms, or protect 
                inanimate objects, industrial processes or systems, 
                surfaces, water, or other chemical substances from 
                contamination, fouling, or deterioration caused by 
                bacteria, viruses, fungi, protozoa, algae, or slime;
                    ``(II) differentiate the types of review undertaken 
                for antimicrobial pesticides;
                    ``(III) conform the degree and type of review to 
                the risks and benefits presented by antimicrobial 
                pesticides and the function of review under this Act, 
                considering the use patterns of the product, toxicity, 
                expected exposure, and product type;
                    ``(IV) ensure that the registration process is 
                sufficient to maintain antimicrobial pesticide efficacy 
                and that antimicrobial pesticide products continue to 
                meet product performance standards and effectiveness 
                levels for each type of label claim made; and
                    ``(V) implement effective and reliable deadlines 
                for process management.

                ``(iii) Comments.--In developing the proposed 
            regulations, the Administrator shall solicit the views from 
            registrants and other affected parties to maximize the 
            effectiveness of the rule development process.
            ``(B) Final regulations.--
                ``(i) Issuance.--The Administrator shall issue final 
            regulations not later than 240 days after the close of the 
            comment period for the proposed regulations.
                ``(ii) Failure to meet goal.--If a goal described in 
            paragraph (2) is not met by the final regulations, the 
            Administrator shall identify the goal, explain why the goal 
            was not attained, describe the element of the regulations 
            included instead, and identify future steps to attain the 
            goal.
                ``(iii) Requirements.--In issuing final regulations, 
            the Administrator shall--

                    ``(I) consider the establishment of a certification 
                process for regulatory actions involving risks that can 
                be responsibly managed, consistent with the degree of 
                risk, in the most cost-efficient manner;
                    ``(II) consider the establishment of a 
                certification process by approved laboratories as an 
                adjunct to the review process;
                    ``(III) use all appropriate and cost-effective 
                review mechanisms, including--

                        ``(aa) expanded use of notification and non-
                    notification procedures;
                        ``(bb) revised procedures for application 
                    review; and
                        ``(cc) allocation of appropriate resources to 
                    ensure streamlined management of antimicrobial 
                    pesticide registrations; and

                    ``(IV) clarify criteria for determination of the 
                completeness of an application.

            ``(C) Expedited review.--This subsection does not affect 
        the requirements or extend the deadlines or review periods 
        contained in subsection (c)(3).
            ``(D) Alternative review periods.--If the final regulations 
        to carry out this paragraph are not effective 630 days after 
        the date of enactment of this subsection, until the final 
        regulations become effective, the review period, beginning on 
        the date of receipt by the Agency of a complete application, 
        shall be--
                ``(i) 2 years for a new antimicrobial active ingredient 
            pesticide registration;
                ``(ii) 1 year for a new antimicrobial use of a 
            registered active ingredient;
                ``(iii) 180 days for any other new antimicrobial 
            product;
                ``(iv) 90 days for a substantially similar or identical 
            antimicrobial product;
                ``(v) 90 days for an amendmen
2000
t to an antimicrobial 
            registration that does not require scientific review of 
            data; and
                ``(vi) 240 days for an amendment to an antimicrobial 
            registration that requires scientific review of data and 
            that is not otherwise described in this subparagraph.
            ``(E) Wood preservatives.--An application for the 
        registration, or for an amendment to the registration, of a 
        wood preservative product for which a claim of pesticidal 
        activity listed in section 2(mm) is made (regardless of any 
        other pesticidal claim that is made with respect to the 
        product) shall be reviewed by the Administrator within the same 
        period as that established under this paragraph for an 
        antimicrobial pesticide product application, consistent with 
        the degree of risk posed by the use of the wood preservative 
        product, if the application requires the applicant to satisfy 
        the same data requirements as are required to support an 
        application for a wood preservative product that is an 
        antimicrobial pesticide.
            ``(F) Notification.--
                ``(i) In general.--Subject to clause (iii), the 
            Administrator shall notify an applicant whether an 
            application has been granted or denied not later than the 
            final day of the appropriate review period under this 
            paragraph, unless the applicant and the Administrator agree 
            to a later date.
                ``(ii) Final decision.--If the Administrator fails to 
            notify an applicant within the period of time required 
            under clause (i), the failure shall be considered an agency 
            action unlawfully withheld or unreasonably delayed for 
            purposes of judicial review under chapter 7 of title 5, 
            United States Code.
                ``(iii) Exemption.--This subparagraph does not apply to 
            an application for an antimicrobial pesticide that is filed 
            under subsection (c)(3)(B) prior to 90 days after the date 
            of enactment of this subsection.
        ``(4) Annual report.--
            ``(A) Submission.--Beginning on the date of enactment of 
        this subsection and ending on the date that the goals under 
        paragraph (2) are achieved, the Administrator shall, not later 
        than March 1 of each year, prepare and submit an annual report 
        to the Committee on Agriculture of the House of Representatives 
        and the Committee on Agriculture, Nutrition, and Forestry of 
        the Senate.
            ``(B) Requirements.--A report submitted under subparagraph 
        (A) shall include a description of--
                ``(i) measures taken to reduce the backlog of pending 
            registration applications;
                ``(ii) progress toward achieving reforms under this 
            subsection; and
                ``(iii) recommendations to improve the activities of 
            the Agency pertaining to antimicrobial registrations.''.

 SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTITUTIONAL 
              ANTIMICROBIAL PRODUCTS.

    Section 19(h) (7 U.S.C. 136q(h)) is amended--
        (1) by striking ``Nothing in'' and inserting the following:
        ``(1) In general.--Nothing in''; and
        (2) by adding at the end the following:
        ``(2) Antimicrobial products.--A household, industrial, or 
    institutional antimicrobial product that is not subject to 
    regulation under the Solid Waste Disposal Act (42 U.S.C. 6901 et 
    seq.) shall not be subject to the provisions of subsections (a), 
    (e), and (f), unless the Administrator determines that such product 
    must be subject to such provisions to prevent an unreasonable 
    adverse effect on the environment.''.

                  Subtitle C--Public Health Pesticides

 SEC. 230. DEFINITIONS.

    (a) Adverse Effects.--Section 2(bb) (7 U.S.C. 136(bb)) is amended 
by adding at the end the following: ``The Administrator shall consider 
the risks and benefits of public health pesticides separate from the 
risks and benefits of other pesticides. In weighing any regulatory 
action concerning a public health pesticide under this Act, the 
Administrator shall weigh any risks of the pesticide against the health 
risks such as the diseases transmitted by the vector to be controlled 
by the pesticide.''.
    (b) New Definitions.--Section 2 (7 U.S.C. 136), as amended by 
section 221, is amended by adding at the end the following:
    ``(nn) Public Health Pesticide.--The term `public health pesticide' 
means any minor use pesticide product registered for use and used 
predominantly in public health programs for vector control or for other 
recognized health protection uses, including the prevention or 
mitigation of viruses, bacteria, or other microorganisms (other than 
viruses, bacteria, or other microorganisms on or in living man or other 
living animal) that pose a threat to public health.
    ``(oo) Vector.--The term `vector' means any organism capable of 
transmitting the causative agent of human disease or capable of 
producing human discomfort or injury, including mosquitoes, flies, 
fleas, cockroaches, or other insects and ticks, mites, or rats.''.

 SEC. 231. REGISTRATION.

    Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended--
        (1) by inserting after ``pattern of use,'' the following: ``the 
    public health and agricultural need for such minor use,''; and
        (2) by striking ``potential exposure of man and the environment 
    to the pesticide'' and inserting ``potential beneficial or adverse 
    effects on man and the environment''.

 SEC. 232. REREGISTRATION.

    Section 4 (7 U.S.C. 136a-1) is amended--
        (1) in subsection (i)(4), by redesignating subparagraphs (B) 
    and (C) as subparagraphs (C) and (D), respectively, and by adding 
    after subparagraph (A) the following:
            ``(B) The Administrator shall exempt any public health 
        pesticide from the payment of the fee prescribed under 
        paragraph (3) if, in consultation with the Secretary of Health 
        and Human Services, the Administrator determines, based on 
        information supplied by the registrant, that the economic 
        return to the registrant from sales of the pesticide does not 
        support the registration or reregistration of the pesticide.'';
        (2) in subsection (i)(5), by redesignating subparagraphs (F) 
    and (G) as subparagraphs (G) and (H), respectively, and by adding 
    after subparagraph (E) the following:
            ``(F) The Administrator shall exempt any public health 
        pesticide from the payment of the fee prescribed under 
        paragraph (3) if, in consultation with the Secretary of Health 
        and Humans Services, the Administrator determines, based on 
        information supplied by the registrant, that the economic 
        return to the registrant from sales of the pesticide does not 
        support the registration or reregistration of the pesticide.'';
        (3) in subsection (i)(7)(B), by striking ``or to determine'' 
    and inserting ``, to determine'' and by inserting before the period 
    the following: ``, or to determine the volume usage for public 
    health pesticides''; and
        (4) in subsection (k)(3)(A), by striking ``or'' at the end of 
    clause (i), by striking the period at the end of clause (ii) and 
    inserting thereof ``; or'', and by adding after clause (ii) the 
    following:
                ``(iii) proposes the initial or amended registration of 
            an end use pesticide that, if registered as proposed, would 
            be used for a public health pesticide.''.

 SEC. 233. CANCELLATION.

    Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after the 
eighth sentence the following: ``When a public health use is affected, 
the Secretary of Health and Human Services should provide available 
benefits and use information, or an analysis thereof, in accordance 
with the procedures f
2000
ollowed and subject to the same conditions as the 
Secretary of Agriculture in the case of agricultural pesticides.''.

 SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.

    Section 21 (7 U.S.C. 136s) is amended by redesignating subsections 
(b) and (c) as subsections (c) and (d), respectively, and by adding 
after subsection (a) the following:
    ``(b) Secretary of Health and Human Services.--The Administrator, 
before publishing regulations under this Act for any public health 
pesticide, shall solicit the views of the Secretary of Health and Human 
Services in the same manner as the views of the Secretary of 
Agriculture are solicited under section 25(a)(2).''.

 SEC. 235. AUTHORITY OF ADMINISTRATOR.

    Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--
        (1) by inserting after ``various classes of pesticides'' the 
    following: ``, including public health pesticides,''; and
        (2) by striking ``and nonagricultural pesticides'' and 
    inserting ``, nonagricultural, and public health pesticides''.

 SEC. 236. IDENTIFICATION OF PESTS.

    Section 28 (7 U.S.C. 136w-3) is amended by adding at the end the 
following:
    ``(d) Public Health Pests.--The Administrator, in coordination with 
the Secretary of Agriculture and the Secretary of Health and Human 
Services, shall identify pests of significant public health importance 
and, in coordination with the Public Health Service, develop and 
implement programs to improve and facilitate the safe and necessary use 
of chemical, biological, and other methods to combat and control such 
pests of public health importance.''.

 SEC. 237. PUBLIC HEALTH DATA.

    Section 4 (7 U.S.C. 136a-1) is amended by adding at the end the 
following:
    ``(m) Authorization of Funds To Develop Public Health Data.--
        ``(1) Definition.--For the purposes of this section, 
    `Secretary' means the Secretary of Health and Human Services, 
    acting through the Public Health Service.
        ``(2) Consultation.--In the case of a pesticide registered for 
    use in public health programs for vector control or for other uses 
    the Administrator determines to be human health protection uses, 
    the Administrator shall, upon timely request by the registrant or 
    any other interested person, or on the Administrator's own 
    initiative may, consult with the Secretary prior to taking final 
    action to suspend registration under section 3(c)(2)(B)(iv), or 
    cancel a registration under section 4, 6(e), or 6(f). In 
    consultation with the Secretary, the Administrator shall prescribe 
    the form and content of requests under this section.
        ``(3) Benefits to support family.--The Administrator, after 
    consulting with the Secretary, shall make a determination whether 
    the potential benefits of continued use of the pesticide for public 
    health or health protection purposes are of such significance as to 
    warrant a commitment by the Secretary to conduct or to arrange for 
    the conduct of the studies required by the Administrator to support 
    continued registration under section 3 or reregistration under 
    section 4.
        ``(4) Additional time.--If the Administrator determines that 
    such a commitment is warranted and in the public interest, the 
    Administrator shall notify the Secretary and shall, to the extent 
    necessary, amend a notice issued under section 3(c)(2)(B) to 
    specify additional reasonable time periods for submission of the 
    data.
        ``(5) Arrangements.--The Secretary shall make such arrangements 
    for the conduct of required studies as the Secretary finds 
    necessary and appropriate to permit submission of data in 
    accordance with the time periods prescribed by the Administrator. 
    Such arrangements may include Public Health Service intramural 
    research activities, grants, contracts, or cooperative agreements 
    with academic, public health, or other organizations qualified by 
    experience and training to conduct such studies.
        ``(6) Support.--The Secretary may provide for support of the 
    required studies using funds authorized to be appropriated under 
    this section, the Public Health Service Act, or other appropriate 
    authorities. After a determination is made under subsection (d), 
    the Secretary shall notify the Committees on Appropriations of the 
    House of Representatives and the Senate of the sums required to 
    conduct the necessary studies.
        ``(7) Authorization of appropriations.--There is authorized to 
    be appropriated to carry out the purposes of this section 
    $12,000,000 for fiscal year 1997, and such sums as may be necessary 
    for succeeding fiscal years.''.

     Subtitle D--Expedited Registration of Reduced Risk Pesticides

 SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

    Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223, is 
amended--
        (1) by adding at the end of paragraph (1) the following:
            ``(G) If the applicant is requesting that the registration 
        or amendment to the registration of a pesticide be expedited, 
        an explanation of the basis for the request must be submitted, 
        in accordance with paragraph (10) of this subsection.''; and
        (2) by adding at the end the following:
        ``(10) Expedited registration of pesticides.--
            ``(A) Not later than 1 year after the date of enactment of 
        this paragraph, the Administrator shall, utilizing public 
        comment, develop procedures and guidelines, and expedite the 
        review of an application for registration of a pesticide or an 
        amendment to a registration that satisfies such guidelines.
            ``(B) Any application for registration or an amendment, 
        including biological and conventional pesticides, will be 
        considered for expedited review under this paragraph. An 
        application for registration or an amendment shall qualify for 
        expedited review if use of the pesticide proposed by the 
        application may reasonably be expected to accomplish 1 or more 
        of the following:
                ``(i) Reduce the risks of pesticides to human health.
                ``(ii) Reduce the risks of pesticides to nontarget 
            organisms.
                ``(iii) Reduce the potential for contamination of 
            groundwater, surface water, or other valued environmental 
            resources.
                ``(iv) Broaden the adoption of integrated pest 
            management strategies, or make such strategies more 
            available or more effective.
            ``(C) The Administrator, not later than 30 days after 
        receipt of an application for expedited review, shall notify 
        the applicant whether the application is complete. If it is 
        found to be incomplete, the Administrator may either reject the 
        request for expedited review or ask the applicant for 
        additional information to satisfy the guidelines developed 
        under subparagraph (A).''.

 TITLE III--DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS 
                    AND CHILDREN AND OTHER MEASURES

 SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF INFANTS 
              AND CHILDREN.

    (a) In General.--The Secretary of Agriculture, in consultation with 
the Administrator of the Environmental Protection Agency and the 
Secretary of Health and Human Services, shall coordinate the 
development and implementation of survey procedures to ensure that 
adequate data on food consumption patterns of infants and children are 
collected.
    (b) Procedures.--To the extent practicable, the procedures referred 
to in subsection (a) shall include the collection of data on food 
consumption patterns of a statistically valid sample of infants and 
children.
    (c) Residue Data Collection.--The Secretary of Agriculture shall 
ensure that the residue data collection activities conducted by the 
Department of Agriculture in cooperation with the Environmental 
Protection Agency and the Department of Health and 
2000
Human Services, 
provide for the improved data collection of pesticide residues, 
including guidelines for the use of comparable analytical and 
standardized reporting methods, and the increased sampling of foods 
most likely consumed by infants and children.

 SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

    (a) In General.--The Secretary of Agriculture shall collect data of 
statewide or regional significance on the use of pesticides to control 
pests and diseases of major crops and crops of dietary significance, 
including fruits and vegetables.
    (b) Collection.--The data shall be collected by surveys of farmers 
or from other sources offering statistically reliable data.
    (c) Coordination.--The Secretary of Agriculture shall, as 
appropriate, coordinate with the Administrator of the Environmental 
Protection Agency in the design of the surveys and make available to 
the Administrator the aggregate results of the surveys to assist the 
Administrator.

 SEC. 303. INTEGRATED PEST MANAGEMENT.

    The Secretary of Agriculture, in cooperation with the 
Administrator, shall implement research, demonstration, and education 
programs to support adoption of Integrated Pest Management. Integrated 
Pest Management is a sustainable approach to managing pests by 
combining biological, cultural, physical, and chemical tools in a way 
that minimizes economic, health, and environmental risks. The Secretary 
of Agriculture and the Administrator shall make information on 
Integrated Pest Management widely available to pesticide users, 
including Federal agencies. Federal agencies shall use Integrated Pest 
Management techniques in carrying out pest management activities and 
shall promote Integrated Pest Management through procurement and 
regulatory policies, and other activities.

SEC. 304. COORDINATION OF CANCELLATION.

    Section 2(bb) (7 U.S.C. 136(bb)) is amended--
        (1) by inserting ``(1)'' after ``means''; and
        (2) by striking the period at the end of the first sentence and 
    inserting ``, or (2) a human dietary risk from residues that result 
    from a use of a pesticide in or on any food inconsistent with the 
    standard under section 408 of the Federal Food, Drug, and Cosmetic 
    Act (21 U.S.C. 346a).''.

 SEC. 305. PESTICIDE USE INFORMATION STUDY.

    (a) The Secretary of Agriculture shall, in consultation with the 
Administrator of the Environmental Protection Agency, prepare a report 
to Congress evaluating the current status and potential improvements in 
Federal pesticide use information gathering activities. This report 
shall at least include--
        (1) an analysis of the quality and reliability of the 
    information collected by the Department of Agriculture, the 
    Environmental Protection Agency, and other Federal agencies 
    regarding the agricultural use of pesticides; and
        (2) an analysis of options to increase the effectiveness of 
    national pesticide use information collection, including an 
    analysis of costs, burdens placed on agricultural producers and 
    other pesticide users, and effectiveness in tracking risk reduction 
    by those options.
    (b) The Secretary shall submit this report to Congress not later 
than 1 year following the date of enactment of this section.

    TITLE IV--AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

SEC 401. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This title may be cited as the ``Food Quality 
Protection Act of 1996 ''.
    (b) Reference.--Whenever in this title an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 402. DEFINITIONS.

    (a) Section 201(q).--Section 201(q) (21 U.S.C. 321(q)) is amended 
to read as follows:
    ``(q)(1) The term `pesticide chemical' means any substance that is 
a pesticide within the meaning of the Federal Insecticide, Fungicide, 
and Rodenticide Act, including all active and inert ingredients of such 
pesticide.
    ``(2) The term `pesticide chemical residue' means a residue in or 
on raw agricultural commodity or processed food of--
        ``(A) a pesticide chemical; or
        ``(B) any other added substance that is present on or in the 
    commodity or food primarily as a result of the metabolism or other 
    degradation of a pesticide chemical.
    ``(3) Notwithstanding paragraphs (1) and (2), the Administrator may 
by regulation except a substance from the definition of `pesticide 
chemical' or `pesticide chemical residue' if--
        ``(A) its occurrence as a residue on or in a raw agricultural 
    commodity or processed food is attributable primarily to natural 
    causes or to human activities not involving the use of any 
    substances for a pesticidal purpose in the production, storage, 
    processing, or transportation of any raw agricultural commodity or 
    processed food; and
        ``(B) the Administrator, after consultation with the Secretary, 
    determines that the substance more appropriately should be 
    regulated under one or more provisions of this Act other than 
    sections 402(a)(2)(B) and 408.''.
    (b) Section 201(s).--Paragraphs (1) and (2) of section 201(s) (21 
U.S.C. 321(s)) are amended to read as follows:
        ``(1) a pesticide chemical residue in or on a raw agricultural 
    commodity or processed food; or
        ``(2) a pesticide chemical; or''.
    (c) Section 201.--Section 201 (21 U.S.C. 321) is amended by adding 
at the end the following:
    ``(gg) The term `processed food' means any food other than a raw 
agricultural commodity and includes any raw agricultural commodity that 
has been subject to processing, such as canning, cooking, freezing, 
dehydration, or milling.
    ``(hh) The term `Administrator' means the Administrator of the 
United States Environmental Protection Agency.''.

SEC. 403. PROHIBITED ACTS.

    Section 301(j) (21 U.S.C. 331(j)) is amended in the first sentence 
by inserting before the period the following: ``; or the violating of 
section 408(i)(2) or any regulation issued under that section.''.

SEC. 404. ADULTERATED FOOD.

    Section 402(a) (21 U.S.C. 342(a)) is amended by striking ``(2)(A) 
if it bears'' and all that follows through ``(3) if it consists'' and 
inserting the following: ``(2)(A) if it bears or contains any added 
poisonous or added deleterious substance (other than a substance that 
is a pesticide chemical residue in or on a raw agricultural commodity 
or processed food, a food additive, a color additive, or a new animal 
drug) that is unsafe within the meaning of section 406; or (B) if it 
bears or contains a pesticide chemical residue that is unsafe within 
the meaning of section 408(a); or (C) if it is or if it bears or 
contains (i) any food additive that is unsafe within the meaning of 
section 409; or (ii) a new animal drug (or conversion product thereof) 
that is unsafe within the meaning of section 512; or (3) if it 
consists''.

SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

    Section 408 (21 U.S.C. 346a) is amended to read as follows:


       ``tolerances and exemptions for pesticide chemical residues

    ``Sec. 408. (a) Requirement for Tolerance or Exemption.--
        ``(1) General rule.--Except as provided in paragraph (2) or 
    (3), any pesticide chemical residue in or on a food shall be deemed 
    unsafe for the purpose of section 402(a)(2)(B) unless--
            ``(A) a tolerance for such pesticide chemical residue in or 
        on such food is in effect under this section and the quantity 
        of the residue is within the limits of the tolerance; or
            ``(B) an exemption from the requirement of a tolerance is 
        in effect under this section for the pesticide chemical 
        residue.
    For the purposes of this section, the term `food', when used as a 
    noun without modification, shall mean a raw agricultural commodity 
    or processed food.
        ``(2) Processed food.--Notwithstanding paragraph (1)--
            ``(A) i
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f a tolerance is in effect under this section for a 
        pesticide chemical residue in or on a raw agricultural 
        commodity, a pesticide chemical residue that is present in or 
        on a processed food because the food is made from that raw 
        agricultural commodity shall not be considered unsafe within 
        the meaning of section 402(a)(2)(B) despite the lack of a 
        tolerance for the pesticide chemical residue in or on the 
        processed food if the pesticide chemical has been used in or on 
        the raw agricultural commodity in conformity with a tolerance 
        under this section, such residue in or on the raw agricultural 
        commodity has been removed to the extent possible in good 
        manufacturing practice, and the concentration of the pesticide 
        chemical residue in the processed food is not greater than the 
        tolerance prescribed for the pesticide chemical residue in the 
        raw agricultural commodity; or
            ``(B) if an exemption for the requirement for a tolerance 
        is in effect under this section for a pesticide chemical 
        residue in or on a raw agricultural commodity, a pesticide 
        chemical residue that is present in or on a processed food 
        because the food is made from that raw agricultural commodity 
        shall not be considered unsafe within the meaning of section 
        402(a)(2)(B).
        ``(3) Residues of degradation products.--If a pesticide 
    chemical residue is present in or on a food because it is a 
    metabolite or other degradation product of a precursor substance 
    that itself is a pesticide chemical or pesticide chemical residue, 
    such a residue shall not be considered to be unsafe within the 
    meaning of section 402(a)(2)(B) despite the lack of a tolerance or 
    exemption from the need for a tolerance for such residue in or on 
    such food if--
            ``(A) the Administrator has not determined that the 
        degradation product is likely to pose any potential health risk 
        from dietary exposure that is of a different type than, or of a 
        greater significance than, any risk posed by dietary exposure 
        to the precursor substance;
            ``(B) either--
                ``(i) a tolerance is in effect under this section for 
            residues of the precursor substance in or on the food, and 
            the combined level of residues of the degradation product 
            and the precursor substance in or on the food is at or 
            below the stoichiometrically equivalent level that would be 
            permitted by the tolerance if the residue consisted only of 
            the precursor substance rather than the degradation 
            product; or
                ``(ii) an exemption from the need for a tolerance is in 
            effect under this section for residues of the precursor 
            substance in or on the food; and
            ``(C) the tolerance or exemption for residues of the 
        precursor substance does not state that it applies only to 
        particular named substances and does not state that it does not 
        apply to residues of the degradation product.
        ``(4) Effect of tolerance or exemption.--While a tolerance or 
    exemption from the requirement for a tolerance is in effect under 
    this section for a pesticide chemical residue with respect to any 
    food, the food shall not by reason of bearing or containing any 
    amount of such a residue be considered to be adulterated within the 
    meaning of section 402(a)(1).
    ``(b) Authority and Standard for Tolerance.--
        ``(1) Authority.--The Administrator may issue regulations 
    establishing, modifying, or revoking a tolerance for a pesticide 
    chemical residue in or on a food--
            ``(A) in response to a petition filed under subsection (d); 
        or
            ``(B) on the Administrator's own initiative under 
        subsection (e).
    As used in this section, the term `modify' shall not mean expanding 
    the tolerance to cover additional foods.
        ``(2) Standard.--
            ``(A) General rule.--
                ``(i) Standard.--The Administrator may establish or 
            leave in effect a tolerance for a pesticide chemical 
            residue in or on a food only if the Administrator 
            determines that the tolerance is safe. The Administrator 
            shall modify or revoke a tolerance if the Administrator 
            determines it is not safe.
                ``(ii) Determination of safety.--As used in this 
            section, the term `safe', with respect to a tolerance for a 
            pesticide chemical residue, means that the Administrator 
            has determined that there is a reasonable certainty that no 
            harm will result from aggregate exposure to the pesticide 
            chemical residue, including all anticipated dietary 
            exposures and all other exposures for which there is 
            reliable information.
                ``(iii) Rule of construction.--With respect to a 
            tolerance, a pesticide chemical residue meeting the 
            standard under clause (i) is not an eligible pesticide 
            chemical residue for purposes of subparagraph (B).
            ``(B) Tolerances for eligible pesticide chemical 
        residues.--
                ``(i) Definition.--As used in this subparagraph, the 
            term `eligible pesticide chemical residue' means a 
            pesticide chemical residue as to which--

                    ``(I) the Administrator is not able to identify a 
                level of exposure to the residue at which the residue 
                will not cause or contribute to a known or anticipated 
                harm to human health (referred to in this section as a 
                `nonthreshold effect');
                    ``(II) the lifetime risk of experiencing the 
                nonthreshold effect is appropriately assessed by 
                quantitative risk assessment; and
                    ``(III) with regard to any known or anticipated 
                harm to human health for which the Administrator is 
                able to identify a level at which the residue will not 
                cause such harm (referred to in this section as a 
                `threshold effect'), the Administrator determines that 
                the level of aggregate exposure is safe.

                ``(ii) Determination of tolerance.--Notwithstanding 
            subparagraph (A)(i), a tolerance for an eligible pesticide 
            chemical residue may be left in effect or modified under 
            this subparagraph if--

                    ``(I) at least one of the conditions described in 
                clause (iii) is met; and
                    ``(II) both of the conditions described in clause 
                (iv) are met.

                ``(iii) Conditions regarding use.--For purposes of 
            clause (ii), the conditions described in this clause with 
            respect to a tolerance for an eligible pesticide chemical 
            residue are the following:

                    ``(I) Use of the pesticide chemical that produces 
                the residue protects consumers from adverse effects on 
                health that would pose a greater risk than the dietary 
                risk from the residue.
                    ``(II) Use of the pesticide chemical that produces 
                the residue is necessary to avoid a significant 
                disruption in domestic production of an adequate, 
                wholesome, and economical food supply.

                ``(iv) Conditions regarding risk.--For purposes of 
            clause (ii), the conditions described in this clause with 
            respect to a tolerance for an eligible pesticide chemical 
            residue are the following:

                    ``(I) The yearly risk associated with the 
                nonthreshold effect from aggregate exposure to the 
                residue does not ex
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ceed 10 times the yearly risk that 
                would be allowed under subparagraph (A) for such 
                effect.
                    ``(II) The tolerance is limited so as to ensure 
                that the risk over a lifetime associated with the 
                nonthreshold effect from aggregate exposure to the 
                residue is not greater than twice the lifetime risk 
                that would be allowed under subparagraph (A) for such 
                effect.

                ``(v) Review.--Five years after the date on which the 
            Administrator makes a determination to leave in effect or 
            modify a tolerance under this subparagraph, and thereafter 
            as the Administrator deems appropriate, the Administrator 
            shall determine, after notice and opportunity for comment, 
            whether it has been demonstrated to the Administrator that 
            a condition described in clause (iii)(I) or clause 
            (iii)(II) continues to exist with respect to the tolerance 
            and that the yearly and lifetime risks from aggregate 
            exposure to such residue continue to comply with the limits 
            specified in clause (iv). If the Administrator determines 
            by such date that such demonstration has not been made, the 
            Administrator shall, not later than 180 days after the date 
            of such determination, issue a regulation under subsection 
            (e)(1) to modify or revoke the tolerance.
                ``(vi) Infants and children.--Any tolerance under this 
            subparagraph shall meet the requirements of subparagraph 
            (C).
            ``(C) Exposure of infants and children.--In establishing, 
        modifying, leaving in effect, or revoking a tolerance or 
        exemption for a pesticide chemical residue, the Administrator--
                ``(i) shall assess the risk of the pesticide chemical 
            residue based on--

                    ``(I) available information about consumption 
                patterns among infants and children that are likely to 
                result in disproportionately high consumption of foods 
                containing or bearing such residue among infants and 
                children in comparison to the general population;
                    ``(II) available information concerning the special 
                susceptibility of infants and children to the pesticide 
                chemical residues, including neurological differences 
                between infants and children and adults, and effects of 
                in utero exposure to pesticide chemicals; and
                    ``(III) available information concerning the 
                cumulative effects on infants and children of such 
                residues and other substances that have a common 
                mechanism of toxicity; and

                ``(ii) shall--

                    ``(I) ensure that there is a reasonable certainty 
                that no harm will result to infants and children from 
                aggregate exposure to the pesticide chemical residue; 
                and
                    ``(II) publish a specific determination regarding 
                the safety of the pesticide chemical residue for 
                infants and children.

        The Secretary of Health and Human Services and the Secretary of 
        Agriculture, in consultation with the Administrator, shall 
        conduct surveys to document dietary exposure to pesticides 
        among infants and children. In the case of threshold effects, 
        for purposes of clause (ii)(I) an additional tenfold margin of 
        safety for the pesticide chemical residue and other sources of 
        exposure shall be applied for infants and children to take into 
        account potential pre- and post-natal toxicity and completeness 
        of the data with respect to exposure and toxicity to infants 
        and children. Notwithstanding such requirement for an 
        additional margin of safety, the Administrator may use a 
        different margin of safety for the pesticide chemical residue 
        only if, on the basis of reliable data, such margin will be 
        safe for infants and children.
            ``(D) Factors.--In establishing, modifying, leaving in 
        effect, or revoking a tolerance or exemption for a pesticide 
        chemical residue, the Administrator shall consider, among other 
        relevant factors--
                ``(i) the validity, completeness, and reliability of 
            the available data from studies of the pesticide chemical 
            and pesticide chemical residue;
                ``(ii) the nature of any toxic effect shown to be 
            caused by the pesticide chemical or pesticide chemical 
            residue in such studies;
                ``(iii) available information concerning the 
            relationship of the results of such studies to human risk;
                ``(iv) available information concerning the dietary 
            consumption patterns of consumers (and major identifiable 
            subgroups of consumers);
                ``(v) available information concerning the cumulative 
            effects of such residues and other substances that have a 
            common mechanism of toxicity;
                ``(vi) available information concerning the aggregate 
            exposure levels of consumers (and major identifiable 
            subgroups of consumers) to the pesticide chemical residue 
            and to other related substances, including dietary exposure 
            under the tolerance and all other tolerances in effect for 
            the pesticide chemical residue, and exposure from other 
            non-occupational sources;
                ``(vii) available information concerning the 
            variability of the sensitivities of major identifiable 
            subgroups of consumers;
                ``(viii) such information as the Administrator may 
            require on whether the pesticide chemical may have an 
            effect in humans that is similar to an effect produced by a 
            naturally occurring estrogen or other endocrine effects; 
            and
                ``(ix) safety factors which in the opinion of experts 
            qualified by scientific training and experience to evaluate 
            the safety of food additives are generally recognized as 
            appropriate for the use of animal experimentation data.
            ``(E) Data and information regarding anticipated and actual 
        residue levels.--
            ``(i) Authority.--In establishing, modifying, leaving in 
        effect, or revoking a tolerance for a pesticide chemical 
        residue, the Administrator may consider available data and 
        information on the anticipated residue levels of the pesticide 
        chemical in or on food and the actual residue levels of the 
        pesticide chemical that have been measured in food, including 
        residue data collected by the Food and Drug Administration.
            ``(ii) Requirement.--If the Administrator relies on 
        anticipated or actual residue levels in establishing, 
        modifying, or leaving in effect a tolerance, the Administrator 
        shall pursuant to subsection (f)(1) require that data be 
        provided five years after the date on which the tolerance is 
        established, modified, or left in effect, and thereafter as the 
        Administrator deems appropriate, demonstrating that such 
        residue levels are not above the levels so relied on. If such 
        data are not so provided, or if the data do not demonstrate 
        that the residue levels are not above the levels so relied on, 
        the Administrator shall, not later than 180 days after the date 
        on which the data were required to be provided, issue a 
        regulation under subsection (e)(1), or an order under 
        subsection (f)(2), as appropriate, to modify or revoke the 
        toleranc
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e.
            ``(F) Percent of food actually treated.--In establishing, 
        modifying, leaving in effect, or revoking a tolerance for a 
        pesticide chemical residue, the Administrator may, when 
        assessing chronic dietary risk, consider available data and 
        information on the percent of food actually treated with the 
        pesticide chemical (including aggregate pesticide use data 
        collected by the Department of Agriculture) only if the 
        Administrator--
                ``(i) finds that the data are reliable and provide a 
            valid basis to show what percentage of the food derived 
            from such crop is likely to contain such pesticide chemical 
            residue;
                ``(ii) finds that the exposure estimate does not 
            understate exposure for any significant subpopulation 
            group;
                ``(iii) finds that, if data are available on pesticide 
            use and consumption of food in a particular area, the 
            population in such area is not dietarily exposed to 
            residues above those estimated by the Administrator; and
                ``(iv) provides for the periodic reevaluation of the 
            estimate of anticipated dietary exposure.
        ``(3) Detection methods.--
            ``(A) General rule.--A tolerance for a pesticide chemical 
        residue in or on a food shall not be established or modified by 
        the Administrator unless the Administrator determines, after 
        consultation with the Secretary, that there is a practical 
        method for detecting and measuring the levels of the pesticide 
        chemical residue in or on the food.
            ``(B) Detection limit.--A tolerance for a pesticide 
        chemical residue in or on a food shall not be established at or 
        modified to a level lower than the limit of detection of the 
        method for detecting and measuring the pesticide chemical 
        residue specified by the Administrator under subparagraph (A).
        ``(4) International standards.--In establishing a tolerance for 
    a pesticide chemical residue in or on a food, the Administrator 
    shall determine whether a maximum residue level for the pesticide 
    chemical has been established by the Codex Alimentarius Commission. 
    If a Codex maximum residue level has been established for the 
    pesticide chemical and the Administrator does not propose to adopt 
    the Codex level, the Administrator shall publish for public comment 
    a notice explaining the reasons for departing from the Codex level.
    ``(c) Authority and Standard for Exemptions.--
        ``(1) Authority.--The Administrator may issue a regulation 
    establishing, modifying, or revoking an exemption from the 
    requirement for a tolerance for a pesticide chemical residue in or 
    on food--
            ``(A) in response to a petition filed under subsection (d); 
        or
            ``(B) on the Administrator's initiative under subsection 
        (e).
        ``(2) Standard.--
            ``(A) General rule.--
                ``(i) Standard.--The Administrator may establish or 
            leave in effect an exemption from the requirement for a 
            tolerance for a pesticide chemical residue in or on food 
            only if the Administrator determines that the exemption is 
            safe. The Administrator shall modify or revoke an exemption 
            if the Administrator determines it is not safe.
                ``(ii) Determination of safety.--The term `safe', with 
            respect to an exemption for a pesticide chemical residue, 
            means that the Administrator has determined that there is a 
            reasonable certainty that no harm will result from 
            aggregate exposure to the pesticide chemical residue, 
            including all anticipated dietary exposures and all other 
            exposures for which there is reliable information.
            ``(B) Factors.--In making a determination under this 
        paragraph, the Administrator shall take into account, among 
        other relevant considerations, the considerations set forth in 
        subparagraphs (C) and (D) of subsection (b)(2).
        ``(3) Limitation.--An exemption from the requirement for a 
    tolerance for a pesticide chemical residue in or on food shall not 
    be established or modified by the Administrator unless the 
    Administrator determines, after consultation with the Secretary--
            ``(A) that there is a practical method for detecting and 
        measuring the levels of such pesticide chemical residue in or 
        on food; or
            ``(B) that there is no need for such a method, and states 
        the reasons for such determination in issuing the regulation 
        establishing or modifying the exemption.
    ``(d) Petition for Tolerance or Exemption.--
        ``(1) Petitions and petitioners.--Any person may file with the 
    Administrator a petition proposing the issuance of a regulation--
            ``(A) establishing, modifying, or revoking a tolerance for 
        a pesticide chemical residue in or on a food; or
            ``(B) establishing, modifying, or revoking an exemption 
        from the requirement of a tolerance for such a residue.
        ``(2) Petition contents.--
            ``(A) Establishment.--A petition under paragraph (1) to 
        establish a tolerance or exemption for a pesticide chemical 
        residue shall be supported by such data and information as are 
        specified in regulations issued by the Administrator, 
        including--
                ``(i)(I) an informative summary of the petition and of 
            the data, information, and arguments submitted or cited in 
            support of the petition; and
                ``(II) a statement that the petitioner agrees that such 
            summary or any information it contains may be published as 
            a part of the notice of filing of the petition to be 
            published under this subsection and as part of a proposed 
            or final regulation issued under this section;
                ``(ii) the name, chemical identity, and composition of 
            the pesticide chemical residue and of the pesticide 
            chemical that produces the residue;
                ``(iii) data showing the recommended amount, frequency, 
            method, and time of application of that pesticide chemical;
                ``(iv) full reports of tests and investigations made 
            with respect to the safety of the pesticide chemical, 
            including full information as to the methods and controls 
            used in conducting those tests and investigations;
                ``(v) full reports of tests and investigations made 
            with respect to the nature and amount of the pesticide 
            chemical residue that is likely to remain in or on the 
            food, including a description of the analytical methods 
            used;
                ``(vi) a practical method for detecting and measuring 
            the levels of the pesticide chemical residue in or on the 
            food, or for exemptions, a statement why such a method is 
            not needed;
                ``(vii) a proposed tolerance for the pesticide chemical 
            residue, if a tolerance is proposed;
                ``(viii) if the petition relates to a tolerance for a 
            processed food, reports of investigations conducted using 
            the processing method(s) used to produce that food;
                ``(ix) such information as the Administrator may 
            require to make the determination under subsection 
            (b)(2)(C);
                ``(x) such information as the Administrator may require 
            on whether the pesticide chemical may have an effect in 
            humans that is similar to an effect produced by a naturally 
            occurring estrogen or other endocrine effects;
                ``(xi) information regarding exposure to the pesticide 
            che
2000
mical residue due to any tolerance or exemption already 
            granted for such residue;
                ``(xii) practical methods for removing any amount of 
            the residue that would exceed any proposed tolerance; and
                ``(xiii) such other data and information as the 
            Administrator requires by regulation to support the 
            petition.
        If information or data required by this subparagraph is 
        available to the Administrator, the person submitting the 
        petition may cite the availability of the information or data 
        in lieu of submitting it. The Administrator may require a 
        petition to be accompanied by samples of the pesticide chemical 
        with respect to which the petition is filed.
            ``(B) Modification or revocation.--The Administrator may by 
        regulation establish the requirements for information and data 
        to support a petition to modify or revoke a tolerance or to 
        modify or revoke an exemption from the requirement for a 
        tolerance.
        ``(3) Notice.--A notice of the filing of a petition that the 
    Administrator determines has met the requirements of paragraph (2) 
    shall be published by the Administrator within 30 days after such 
    determination. The notice shall announce the availability of a 
    description of the analytical methods available to the 
    Administrator for the detection and measurement of the pesticide 
    chemical residue with respect to which the petition is filed or 
    shall set forth the petitioner's statement of why such a method is 
    not needed. The notice shall include the summary required by 
    paragraph (2)(A)(i)(I).
        ``(4) Actions by the administrator.--
            ``(A) In general.--The Administrator shall, after giving 
        due consideration to a petition filed under paragraph (1) and 
        any other information available to the Administrator--
                ``(i) issue a final regulation (which may vary from 
            that sought by the petition) establishing, modifying, or 
            revoking a tolerance for the pesticide chemical residue or 
            an exemption of the pesticide chemical residue from the 
            requirement of a tolerance (which final regulation shall be 
            issued without further notice and without further period 
            for public comment);
                ``(ii) issue a proposed regulation under subsection 
            (e), and thereafter issue a final regulation under such 
            subsection; or
                ``(iii) issue an order denying the petition.
            ``(B) Priorities.--The Administrator shall give priority to 
        petitions for the establishment or modification of a tolerance 
        or exemption for a pesticide chemical residue that appears to 
        pose a significantly lower risk to human health from dietary 
        exposure than pesticide chemical residues that have tolerances 
        in effect for the same or similar uses.
            ``(C) Expedited review of certain petitions.--
                ``(i) Date certain for review.--If a person files a 
            complete petition with the Administrator proposing the 
            issuance of a regulation establishing a tolerance or 
            exemption for a pesticide chemical residue that presents a 
            lower risk to human health than a pesticide chemical 
            residue for which a tolerance has been left in effect or 
            modified under subsection (b)(2)(B), the Administrator 
            shall complete action on such petition under this paragraph 
            within 1 year.
                ``(ii) Required determinations.--If the Administrator 
            issues a final regulation establishing a tolerance or 
            exemption for a safer pesticide chemical residue under 
            clause (i), the Administrator shall, not later than 180 
            days after the date on which the regulation is issued, 
            determine whether a condition described in subclause (I) or 
            (II) of subsection (b)(2)(B)(iii) continues to exist with 
            respect to a tolerance that has been left in effect or 
            modified under subsection (b)(2)(B). If such condition does 
            not continue to exist, the Administrator shall, not later 
            than 180 days after the date on which the determination 
            under the preceding sentence is made, issue a regulation 
            under subsection (e)(1) to modify or revoke the tolerance.
    ``(e) Action on Administrator's Own Initiative.--
        ``(1) General rule.--The Administrator may issue a regulation--
            ``(A) establishing, modifying, suspending under subsection 
        (l)(3), or revoking a tolerance for a pesticide chemical or a 
        pesticide chemical residue;
            ``(B) establishing, modifying, suspending under subsection 
        (l)(3), or revoking an exemption of a pesticide chemical 
        residue from the requirement of a tolerance; or
            ``(C) establishing general procedures and requirements to 
        implement this section.
        ``(2) Notice.--Before issuing a final regulation under 
    paragraph (1), the Administrator shall issue a notice of proposed 
    rulemaking and provide a period of not less than 60 days for public 
    comment on the proposed regulation, except that a shorter period 
    for comment may be provided if the Administrator for good cause 
    finds that it would be in the public interest to do so and states 
    the reasons for the finding in the notice of proposed rulemaking.
    ``(f) Special Data Requirements.--
        ``(1) Requiring submission of additional data.--If the 
    Administrator determines that additional data or information are 
    reasonably required to support the continuation of a tolerance or 
    exemption that is in effect under this section for a pesticide 
    chemical residue on a food, the Administrator shall--
            ``(A) issue a notice requiring the person holding the 
        pesticide registrations associated with such tolerance or 
        exemption to submit the data or information under section 
        3(c)(2)(B) of the Federal Insecticide, Fungicide, and 
        Rodenticide Act;
            ``(B) issue a rule requiring that testing be conducted on a 
        substance or mixture under section 4 of the Toxic Substances 
        Control Act; or
            ``(C) publish in the Federal Register, after first 
        providing notice and an opportunity for comment of not less 
        than 60 days' duration, an order--
                ``(i) requiring the submission to the Administrator by 
            one or more interested persons of a notice identifying the 
            person or persons who will submit the required data and 
            information;
                ``(ii) describing the type of data and information 
            required to be submitted to the Administrator and stating 
            why the data and information could not be obtained under 
            the authority of section 3(c)(2)(B) of the Federal 
            Insecticide, Fungicide, and Rodenticide Act or section 4 of 
            the Toxic Substances Control Act;
                ``(iii) describing the reports of the Administrator 
            required to be prepared during and after the collection of 
            the data and information;
                ``(iv) requiring the submission to the Administrator of 
            the data, information, and reports referred to in clauses 
            (ii) and (iii); and
                ``(v) establishing dates by which the submissions 
            described in clauses (i) and (iv) must be made.
        The Administrator may under subparagraph (C) revise any such 
        order to correct an error. The Administrator may under this 
        paragraph require data or information pertaining to whether the 
        pesticide chemical may have an effect in humans that is similar 
        to an effect produced by a naturally occurring estrogen or 
        other endocrin
2000
e effects.
        ``(2) Noncompliance.--If a submission required by a notice 
    issued in accordance with paragraph (1)(A), a rule issued under 
    paragraph (1)(B), or an order issued under paragraph (1)(C) is not 
    made by the time specified in such notice, rule, or order, the 
    Administrator may by order published in the Federal Register modify 
    or revoke the tolerance or exemption in question. In any review of 
    such an order under subsection (g)(2), the only material issue 
    shall be whether a submission required under paragraph (1) was not 
    made by the time specified.
    ``(g) Effective Date, Objections, Hearings, and Administrative 
Review.--
        ``(1) Effective date.--A regulation or order issued under 
    subsection (d)(4), (e)(1), or (f)(2) shall take effect upon 
    publication unless the regulation or order specifies otherwise. The 
    Administrator may stay the effectiveness of the regulation or order 
    if, after issuance of such regulation or order, objections are 
    filed with respect to such regulation or order pursuant to 
    paragraph (2).
        ``(2) Further proceedings.--
            ``(A) Objections.--Within 60 days after a regulation or 
        order is issued under subsection (d)(4), (e)(1)(A), (e)(1)(B), 
        (f)(2), (n)(3), or (n)(5)(C), any person may file objections 
        thereto with the Administrator, specifying with particularity 
        the provisions of the regulation or order deemed objectionable 
        and stating reasonable grounds therefor. If the regulation or 
        order was issued in response to a petition under subsection 
        (d)(1), a copy of each objection filed by a person other than 
        the petitioner shall be served by the Administrator on the 
        petitioner.
            ``(B) Hearing.--An objection may include a request for a 
        public evidentiary hearing upon the objection. The 
        Administrator shall, upon the initiative of the Administrator 
        or upon the request of an interested person and after due 
        notice, hold a public evidentiary hearing if and to the extent 
        the Administrator determines that such a public hearing is 
        necessary to receive factual evidence relevant to material 
        issues of fact raised by the objections. The presiding officer 
        in such a hearing may authorize a party to obtain discovery 
        from other persons and may upon a showing of good cause made by 
        a party issue a subpoena to compel testimony or production of 
        documents from any person. The presiding officer shall be 
        governed by the Federal Rules of Civil Procedure in making any 
        order for the protection of the witness or the content of 
        documents produced and shall order the payment of reasonable 
        fees and expenses as a condition to requiring testimony of the 
        witness. On contest, such a subpoena may be enforced by a 
        Federal district court.
            ``(C) Final decision.--As soon as practicable after 
        receiving the arguments of the parties, the Administrator shall 
        issue an order stating the action taken upon each such 
        objection and setting forth any revision to the regulation or 
        prior order that the Administrator has found to be warranted. 
        If a hearing was held under subparagraph (B), such order and 
        any revision to the regulation or prior order shall, with 
        respect to questions of fact at issue in the hearing, be based 
        only on substantial evidence of record at such hearing, and 
        shall set forth in detail the findings of facts and the 
        conclusions of law or policy upon which the order or regulation 
        is based.
    ``(h) Judicial Review.--
        ``(1) Petition.--In a case of actual controversy as to the 
    validity of any regulation issued under subsection (e)(1)(C), or 
    any order issued under subsection (f)(1)(C) or (g)(2)(C), or any 
    regulation that is the subject of such an order, any person who 
    will be adversely affected by such order or regulation may obtain 
    judicial review by filing in the United States Court of Appeals for 
    the circuit wherein that person resides or has its principal place 
    of business, or in the United States Court of Appeals for the 
    District of Columbia Circuit, within 60 days after publication of 
    such order or regulation, a petition praying that the order or 
    regulation be set aside in whole or in part.
        ``(2) Record and jurisdiction.--A copy of the petition under 
    paragraph (1) shall be forthwith transmitted by the clerk of the 
    court to the Administrator, or any officer designated by the 
    Administrator for that purpose, and thereupon the Administrator 
    shall file in the court the record of the proceedings on which the 
    Administrator based the order or regulation, as provided in section 
    2112 of title 28, United States Code. Upon the filing of such a 
    petition, the court shall have exclusive jurisdiction to affirm or 
    set aside the order or regulation complained of in whole or in 
    part. As to orders issued following a public evidentiary hearing, 
    the findings of the Administrator with respect to questions of fact 
    shall be sustained only if supported by substantial evidence when 
    considered on the record as a whole.
        ``(3) Additional evidence.--If a party applies to the court for 
    leave to adduce additional evidence and shows to the satisfaction 
    of the court that the additional evidence is material and that 
    there were reasonable grounds for the failure to adduce the 
    evidence in the proceeding before the Administrator, the court may 
    order that the additional evidence (and evidence in rebuttal 
    thereof) shall be taken before the Administrator in the manner and 
    upon the terms and conditions the court deems proper. The 
    Administrator may modify prior findings as to the facts by reason 
    of the additional evidence so taken and may modify the order or 
    regulation accordingly. The Administrator shall file with the court 
    any such modified finding, order, or regulation.
        ``(4) Final judgment; supreme court review.--The judgment of 
    the court affirming or setting aside, in whole or in part, any 
    regulation or any order and any regulation which is the subject of 
    such an order shall be final, subject to review by the Supreme 
    Court of the United States as provided in section 1254 of title 28 
    of the United States Code. The commencement of proceedings under 
    this subsection shall not, unless specifically ordered by the court 
    to the contrary, operate as a stay of a regulation or order.
        ``(5) Application.--Any issue as to which review is or was 
    obtainable under this subsection shall not be the subject of 
    judicial review under any other provision of law.
    ``(i) Confidentiality and Use of Data.--
        ``(1) General rule.--Data and information that are or have been 
    submitted to the Administrator under this section or section 409 in 
    support of a tolerance or an exemption from a tolerance shall be 
    entitled to confidential treatment for reasons of business 
    confidentiality and to exclusive use and data compensation to the 
    same extent provided by sections 3 and 10 of the Federal 
    Insecticide, Fungicide, and Rodenticide Act.
        ``(2) Exceptions.--
            ``(A) In general.--Data and information that are entitled 
        to confidential treatment under paragraph (1) may be disclosed, 
        under such security requirements as the Administrator may 
        provide by regulation, to--
                ``(i) employees of the United States authorized by the 
            Administrator to examine such data and information in the 
            carrying out of their official duties under this Act or 
            other Federal statutes intended to protect the public 
            health; or
                ``(ii) contractors with the United States authorized by 
            the Adminis
2000
trator to examine such data and information in 
            the carrying out of contracts under this Act or such 
            statutes.
            ``(B) Congress.--This subsection does not authorize the 
        withholding of data or information from either House of 
        Congress or from, to the extent of matter within its 
        jurisdiction, any committee or subcommittee of such committee 
        or any joint committee of Congress or any subcommittee of such 
        joint committee.
        ``(3) Summaries.--Notwithstanding any provision of this 
    subsection or other law, the Administrator may publish the 
    informative summary required by subsection (d)(2)(A)(i) and may, in 
    issuing a proposed or final regulation or order under this section, 
    publish an informative summary of the data relating to the 
    regulation or order.
    ``(j) Status of Previously Issued Regulations.--
        ``(1) Regulations under section 406.--Regulations affecting 
    pesticide chemical residues in or on raw agricultural commodities 
    promulgated, in accordance with section 701(e), under the authority 
    of section 406(a) upon the basis of public hearings instituted 
    before January 1, 1953, shall be deemed to be regulations issued 
    under this section and shall be subject to modification or 
    revocation under subsections (d) and (e), and shall be subject to 
    review under subsection (q).
        ``(2) Regulations under section 409.--Regulations that 
    established tolerances for substances that are pesticide chemical 
    residues in or on processed food, or that otherwise stated the 
    conditions under which such pesticide chemicals could be safely 
    used, and that were issued under section 409 on or before the date 
    of the enactment of this paragraph, shall be deemed to be 
    regulations issued under this section and shall be subject to 
    modification or revocation under subsection (d) or (e), and shall 
    be subject to review under subsection (q).
        ``(3) Regulations under section 408.--Regulations that 
    established tolerances or exemptions under this section that were 
    issued on or before the date of the enactment of this paragraph 
    shall remain in effect unless modified or revoked under subsection 
    (d) or (e), and shall be subject to review under subsection (q).
    ``(k) Transitional Provision.--If, on the day before the date of 
the enactment of this subsection, a substance that is a pesticide 
chemical was, with respect to a particular pesticidal use of the 
substance and any resulting pesticide chemical residue in or on a 
particular food--
        ``(1) regarded by the Administrator or the Secretary as 
    generally recognized as safe for use within the meaning of the 
    provisions of subsection (a) or section 201(s) as then in effect; 
    or
        ``(2) regarded by the Secretary as a substance described by 
    section 201(s)(4);
such a pesticide chemical residue shall be regarded as exempt from the 
requirement for a tolerance, as of the date of enactment of this 
subsection. The Administrator shall by regulation indicate which 
substances are described by this subsection. Any exemption under this 
subsection may be modified or revoked as if it had been issued under 
subsection (c).
    ``(l) Harmonization With Action Under Other Laws.--
        ``(1) Coordination with fifra.--To the extent practicable and 
    consistent with the review deadlines in subsection (q), in issuing 
    a final rule under this subsection that suspends or revokes a 
    tolerance or exemption for a pesticide chemical residue in or on 
    food, the Administrator shall coordinate such action with any 
    related necessary action under the Federal Insecticide, Fungicide, 
    and Rodenticide Act.
        ``(2) Revocation of tolerance or exemption following 
    cancellation of associated registrations.--If the Administrator, 
    acting under the Federal Insecticide, Fungicide, and Rodenticide 
    Act, cancels the registration of each pesticide that contains a 
    particular pesticide chemical and that is labeled for use on a 
    particular food, or requires that the registration of each such 
    pesticide be modified to prohibit its use in connection with the 
    production, storage, or transportation of such food, due in whole 
    or in part to dietary risks to humans posed by residues of that 
    pesticide chemical on that food, the Administrator shall revoke any 
    tolerance or exemption that allows the presence of the pesticide 
    chemical, or any pesticide chemical residue that results from its 
    use, in or on that food. Subsection (e) shall apply to actions 
    taken under this paragraph. A revocation under this paragraph shall 
    become effective not later than 180 days after--
            ``(A) the date by which each such cancellation of a 
        registration has become effective; or
            ``(B) the date on which the use of the canceled pesticide 
        becomes unlawful under the terms of the cancellation, whichever 
        is later.
        ``(3) Suspension of tolerance or exemption following suspension 
    of associated registrations.--
            ``(A) Suspension.--If the Administrator, acting under the 
        Federal Insecticide, Fungicide, and Rodenticide Act, suspends 
        the use of each registered pesticide that contains a particular 
        pesticide chemical and that is labeled for use on a particular 
        food, due in whole or in part to dietary risks to humans posed 
        by residues of that pesticide chemical on that food, the 
        Administrator shall suspend any tolerance or exemption that 
        allows the presence of the pesticide chemical, or any pesticide 
        chemical residue that results from its use, in or on that food. 
        Subsection (e) shall apply to actions taken under this 
        paragraph. A suspension under this paragraph shall become 
        effective not later than 60 days after the date by which each 
        such suspension of use has become effective.
            ``(B) Effect of suspension.--The suspension of a tolerance 
        or exemption under subparagraph (A) shall be effective as long 
        as the use of each associated registration of a pesticide is 
        suspended under the Federal Insecticide, Fungicide, and 
        Rodenticide Act. While a suspension of a tolerance or exemption 
        is effective the tolerance or exemption shall not be considered 
        to be in effect. If the suspension of use of the pesticide 
        under that Act is terminated, leaving the registration of the 
        pesticide for such use in effect under that Act, the 
        Administrator shall rescind any associated suspension of 
        tolerance or exemption.
        ``(4) Tolerances for unavoidable residues.--In connection with 
    action taken under paragraph (2) or (3), or with respect to 
    pesticides whose registrations were suspended or canceled prior to 
    the date of the enactment of this paragraph under the Federal 
    Insecticide, Fungicide, and Rodenticide Act, if the Administrator 
    determines that a residue of the canceled or suspended pesticide 
    chemical will unavoidably persist in the environment and thereby be 
    present in or on a food, the Administrator may establish a 
    tolerance for the pesticide chemical residue. In establishing such 
    a tolerance, the Administrator shall take into account both the 
    factors set forth in subsection (b)(2) and the unavoidability of 
    the residue. Subsection (e) shall apply to the establishment of 
    such tolerance. The Administrator shall review any such tolerance 
    periodically and modify it as necessary so that it allows no 
    greater level of the pesticide chemical residue than is 
    unavoidable.
        ``(5) Pesticide residues resulting from lawful application of 
    pesticide.--Notwithstanding any other provision of this Act, if a 
    tolerance or exemption for a pesticide chemical residue in or on a 
    food has been revoked, suspended, or modified under this section, 
    an 
2000
article of that food shall not be deemed unsafe solely because 
    of the presence of such pesticide chemical residue in or on such 
    food if it is shown to the satisfaction of the Secretary that--
            ``(A) the residue is present as the result of an 
        application or use of a pesticide at a time and in a manner 
        that was lawful under the Federal Insecticide, Fungicide, and 
        Rodenticide Act; and
            ``(B) the residue does not exceed a level that was 
        authorized at the time of that application or use to be present 
        on the food under a tolerance, exemption, food additive 
        regulation, or other sanction then in effect under this Act;
    unless, in the case of any tolerance or exemption revoked, 
    suspended, or modified under this subsection or subsection (d) or 
    (e), the Administrator has issued a determination that consumption 
    of the legally treated food during the period of its likely 
    availability in commerce will pose an unreasonable dietary risk.
        ``(6) Tolerance for use of pesticides under an emergency 
    exemption.--If the Administrator grants an exemption under section 
    18 of the Federal Insecticide, Fungicide, and Rodenticide Act (7 
    U.S.C. 136p) for a pesticide chemical, the Administrator shall 
    establish a tolerance or exemption from the requirement for a 
    tolerance for the pesticide chemical residue. Such a tolerance or 
    exemption from a tolerance shall have an expiration date. The 
    Administrator may establish such a tolerance or exemption without 
    providing notice or a period for comment on the tolerance or 
    exemption. The Administrator shall promulgate regulations within 
    365 days after the date of the enactment of this paragraph 
    governing the establishment of tolerances and exemptions under this 
    paragraph. Such regulations shall be consistent with the safety 
    standard under subsections (b)(2) and (c)(2) and with section 18 of 
    the Federal Insecticide, Fungicide, and Rodenticide Act.
    ``(m) Fees.--
        ``(1) Amount.--The Administrator shall by regulation require 
    the payment of such fees as will in the aggregate, in the judgment 
    of the Administrator, be sufficient over a reasonable term to 
    provide, equip, and maintain an adequate service for the 
    performance of the Administrator's functions under this section. 
    Under the regulations, the performance of the Administrator's 
    services or other functions under this section, including--
            ``(A) the acceptance for filing of a petition submitted 
        under subsection (d);
            ``(B) establishing, modifying, leaving in effect, or 
        revoking a tolerance or establishing, modifying, leaving in 
        effect, or revoking an exemption from the requirement for a 
        tolerance under this section;
            ``(C) the acceptance for filing of objections under 
        subsection (g); or
            ``(D) the certification and filing in court of a transcript 
        of the proceedings and the record under subsection (h);
    may be conditioned upon the payment of such fees. The regulations 
    may further provide for waiver or refund of fees in whole or in 
    part when in the judgment of the Administrator such a waiver or 
    refund is equitable and not contrary to the purposes of this 
    subsection.
        ``(2) Deposit.--All fees collected under paragraph (1) shall be 
    deposited in the Reregistration and Expedited Processing Fund 
    created by section 4(k) of the Federal Insecticide, Fungicide, and 
    Rodenticide Act. Such fees shall be available to the Administrator, 
    without fiscal year limitation, for the performance of the 
    Administrator's services or functions as specified in paragraph 
    (1).
    ``(n) National Uniformity of Tolerances.--
        ``(1) Qualifying pesticide chemical residue.--For purposes of 
    this subsection, the term `qualifying pesticide chemical residue' 
    means a pesticide chemical residue resulting from the use, in 
    production, processing, or storage of a food, of a pesticide 
    chemical that is an active ingredient and that--
            ``(A) was first approved for such use in a registration of 
        a pesticide issued under section 3(c)(5) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act on or after April 
        25, 1985, on the basis of data determined by the Administrator 
        to meet all applicable requirements for data prescribed by 
        regulations in effect under that Act on April 25, 1985; or
            ``(B) was approved for such use in a reregistration 
        eligibility determination issued under section 4(g) of that Act 
        on or after the date of enactment of this subsection.
        ``(2) Qualifying federal determination.--For purposes of this 
    subsection, the term `qualifying Federal determination' means a 
    tolerance or exemption from the requirement for a tolerance for a 
    qualifying pesticide chemical residue that--
            ``(A) is issued under this section after the date of the 
        enactment of this subsection and determined by the 
        Administrator to meet the standard under subsection (b)(2)(A) 
        (in the case of a tolerance) or (c)(2) (in the case of an 
        exemption); or
            ``(B)(i) pursuant to subsection (j) is remaining in effect 
        or is deemed to have been issued under this section, or is 
        regarded under subsection (k) as exempt from the requirement 
        for a tolerance; and
            ``(ii) is determined by the Administrator to meet the 
        standard under subsection (b)(2)(A) (in the case of a 
        tolerance) or (c)(2) (in the case of an exemption).
        ``(3) Limitation.--The Administrator may make the determination 
    described in paragraph (2)(B)(ii) only by issuing a rule in 
    accordance with the procedure set forth in subsection (d) or (e) 
    and only if the Administrator issues a proposed rule and allows a 
    period of not less than 30 days for comment on the proposed rule. 
    Any such rule shall be reviewable in accordance with subsections 
    (g) and (h).
        ``(4) State authority.--Except as provided in paragraphs (5), 
    (6), and (8) no State or political subdivision may establish or 
    enforce any regulatory limit on a qualifying pesticide chemical 
    residue in or on any food if a qualifying Federal determination 
    applies to the presence of such pesticide chemical residue in or on 
    such food, unless such State regulatory limit is identical to such 
    qualifying Federal determination. A State or political subdivision 
    shall be deemed to establish or enforce a regulatory limit on a 
    pesticide chemical residue in or on a food if it purports to 
    prohibit or penalize the production, processing, shipping, or other 
    handling of a food because it contains a pesticide residue (in 
    excess of a prescribed limit).
        ``(5) Petition procedure.--
            ``(A) In general.--Any State may petition the Administrator 
        for authorization to establish in such State a regulatory limit 
        on a qualifying pesticide chemical residue in or on any food 
        that is not identical to the qualifying Federal determination 
        applicable to such qualifying pesticide chemical residue.
            ``(B) Petition requirements.--Any petition under 
        subparagraph (A) shall--
                ``(i) satisfy any requirements prescribed, by rule, by 
            the Administrator; and
                ``(ii) be supported by scientific data about the 
            pesticide chemical residue that is the subject of the 
            petition or about chemically related pesticide chemical 
            residues, data on the consumption within such State of food 
            bearing the pesticide chemical residue, and data on 
            exposure of humans within such State to the pesticide 
            chemical residue.
            ``(C) Authorization.--The Administrator may, by order, 
        grant the authorization 
2000
described in subparagraph (A) if the 
        Administrator determines that the proposed State regulatory 
        limit--
                ``(i) is justified by compelling local conditions; and
                ``(ii) would not cause any food to be a violation of 
            Federal law.
            ``(D) Treatment.--In lieu of any action authorized under 
        subparagraph (C), the Administrator may treat a petition under 
        this paragraph as a petition under subsection (d) to modify or 
        revoke a tolerance or an exemption. If the Administrator 
        determines to treat a petition under this paragraph as a 
        petition under subsection (d), the Administrator shall 
        thereafter act on the petition pursuant to subsection (d).
            ``(E) Review.--Any order of the Administrator granting or 
        denying the authorization described in subparagraph (A) shall 
        be subject to review in the manner described in subsections (g) 
        and (h).
        ``(6) Urgent petition procedure.--Any State petition to the 
    Administrator pursuant to paragraph (5) that demonstrates that 
    consumption of a food containing such pesticide residue level 
    during the period of the food's likely availability in the State 
    will pose a significant public health threat from acute exposure 
    shall be considered an urgent petition. If an order by the 
    Administrator to grant or deny the requested authorization in an 
    urgent petition is not made within 30 days of receipt of the 
    petition, the petitioning State may establish and enforce a 
    temporary regulatory limit on a qualifying pesticide chemical 
    residue in or on the food. The temporary regulatory limit shall be 
    validated or terminated by the Administrator's final order on the 
    petition.
        ``(7) Residues from lawful application.--No State or political 
    subdivision may enforce any regulatory limit on the level of a 
    pesticide chemical residue that may appear in or on any food if, at 
    the time of the application of the pesticide that resulted in such 
    residue, the sale of such food with such residue level was lawful 
    under this section and under the law of such State, unless the 
    State demonstrates that consumption of the food containing such 
    pesticide residue level during the period of the food's likely 
    availability in the State will pose an unreasonable dietary risk to 
    the health of persons within such State.
        ``(8) Savings.--Nothing in this Act preempts the authority of 
    any State or political subdivision to require that a food 
    containing a pesticide chemical residue bear or be the subject of a 
    warning or other statement relating to the presence of the 
    pesticide chemical residue in or on such food.
    ``(o) Consumer Right To Know.--Not later than 2 years after the 
date of the enactment of the Food Quality Protection Act of 1996, and 
annually thereafter, the Administrator shall, in consultation with the 
Secretary of Agriculture and the Secretary of Health and Human 
Services, publish in a format understandable to a lay person, and 
distribute to large retail grocers for public display (in a manner 
determined by the grocer), the following information, at a minimum:
        ``(1) A discussion of the risks and benefits of pesticide 
    chemical residues in or on food purchased by consumers.
        ``(2) A listing of actions taken under subparagraph (B) of 
    subsection (b)(2) that may result in pesticide chemical residues in 
    or on food that present a yearly or lifetime risk above the risk 
    allowed under subparagraph (A) of such subsection, and the food on 
    which the pesticide chemicals producing the residues are used.
        ``(3) Recommendations to consumers for reducing dietary 
    exposure to pesticide chemical residues in a manner consistent with 
    maintaining a healthy diet, including a list of food that may 
    reasonably substitute for food listed under paragraph (2).
    Nothing in this subsection shall prevent retail grocers from 
providing additional information.
    ``(p) Estrogenic substances screening program.--
        ``(1) Development.--Not later than 2 years after the date of 
    enactment of this section, the Administrator shall in consultation 
    with the Secretary of Health and Human Services develop a screening 
    program, using appropriate validated test systems and other 
    scientifically relevant information, to determine whether certain 
    substances may have an effect in humans that is similar to an 
    effect produced by a naturally occurring estrogen, or such other 
    endocrine effect as the Administrator may designate.
        ``(2) Implementation.--Not later than 3 years after the date of 
    enactment of this section, after obtaining public comment and 
    review of the screening program described in paragraph (1) by the 
    scientific advisory panel established under section 25(d) of the 
    Federal Insecticide, Fungicide, and Rodenticide Act or the science 
    advisory board established by section 8 of the Environmental 
    Research, Development, and Demonstration Act of 1978 (42 U.S.C. 
    4365), the Administrator shall implement the program.
        ``(3) Substances.--In carrying out the screening program 
    described in paragraph (1), the Administrator--
            ``(A) shall provide for the testing of all pesticide 
        chemicals; and
            ``(B) may provide for the testing of any other substance 
        that may have an effect that is cumulative to an effect of a 
        pesticide chemical if the Administrator determines that a 
        substantial population may be exposed to such substance.
        ``(4) Exemption.--Notwithstanding paragraph (3), the 
    Administrator may, by order, exempt from the requirements of this 
    section a biologic substance or other substance if the 
    Administrator determines that the substance is anticipated not to 
    produce any effect in humans similar to an effect produced by a 
    naturally occurring estrogen.
        ``(5) Collection of information.--
            ``(A) In general.--The Administrator shall issue an order 
        to a registrant of a substance for which testing is required 
        under this subsection, or to a person who manufactures or 
        imports a substance for which testing is required under this 
        subsection, to conduct testing in accordance with the screening 
        program described in paragraph (1), and submit information 
        obtained from the testing to the Administrator, within a 
        reasonable time period that the Administrator determines is 
        sufficient for the generation of the information.
            ``(B) Procedures.--To the extent practicable the 
        Administrator shall minimize duplicative testing of the same 
        substance for the same endocrine effect, develop, as 
        appropriate, procedures for fair and equitable sharing of test 
        costs, and develop, as necessary, procedures for handling of 
        confidential business information.
            ``(C) Failure of registrants to submit information.--
                ``(i) Suspension.--If a registrant of a substance 
            referred to in paragraph (3)(A) fails to comply with an 
            order under subparagraph (A) of this paragraph, the 
            Administrator shall issue a notice of intent to suspend the 
            sale or distribution of the substance by the registrant. 
            Any suspension proposed under this paragraph shall become 
            final at the end of the 30-day period beginning on the date 
            that the registrant receives the notice of intent to 
            suspend, unless during that period a person adversely 
            affected by the notice requests a hearing or the 
            Administrator determines that the registrant has complied 
            fully with this paragraph.
                ``(ii) Hearing.--If a person requests a hearing under 
            clause (i), the hearing shall be conducted in accordance 
            
2000
with section 554 of title 5, United States Code. The only 
            matter for resolution at the hearing shall be whether the 
            registrant has failed to comply with an order under 
            subparagraph (A) of this paragraph. A decision by the 
            Administrator after completion of a hearing shall be 
            considered to be a final agency action.
                ``(iii) Termination of suspensions.--The Administrator 
            shall terminate a suspension under this subparagraph issued 
            with respect to a registrant if the Administrator 
            determines that the registrant has complied fully with this 
            paragraph.
            ``(D) Noncompliance by other persons.--Any person (other 
        than a registrant) who fails to comply with an order under 
        subparagraph (A) shall be liable for the same penalties and 
        sanctions as are provided under section 16 of the Toxic 
        Substances Control Act (15 U.S.C. 2601 and following) in the 
        case of a violation referred to in that section. Such penalties 
        and sanctions shall be assessed and imposed in the same manner 
        as provided in such section 16.
        ``(6) Agency action.--In the case of any substance that is 
    found, as a result of testing and evaluation under this section, to 
    have an endocrine effect on humans, the Administrator shall, as 
    appropriate, take action under such statutory authority as is 
    available to the Administrator, including consideration under other 
    sections of this Act, as is necessary to ensure the protection of 
    public health.
        ``(7) Report to congress.--Not later than 4 years after the 
    date of enactment of this section, the Administrator shall prepare 
    and submit to Congress a report containing--
            ``(A) the findings of the Administrator resulting from the 
        screening program described in paragraph (1);
            ``(B) recommendations for further testing needed to 
        evaluate the impact on human health of the substances tested 
        under the screening program; and
            ``(C) recommendations for any further actions (including 
        any action described in paragraph (6)) that the Administrator 
        determines are appropriate based on the findings.
    ``(q) Schedule for Review.--
        ``(1) In general.--The Administrator shall review tolerances 
    and exemptions for pesticide chemical residues in effect on the day 
    before the date of the enactment of the Food Quality Protection Act 
    of 1996, as expeditiously as practicable, assuring that--
            ``(A) 33 percent of such tolerances and exemptions are 
        reviewed within 3 years of the date of enactment of such Act;
            ``(B) 66 percent of such tolerances and exemptions are 
        reviewed within 6 years of the date of enactment of such Act; 
        and
            ``(C) 100 percent of such tolerances and exemptions are 
        reviewed within 10 years of the date of enactment of such Act.
    In conducting a review of a tolerance or exemption, the 
    Administrator shall determine whether the tolerance or exemption 
    meets the requirements of subsections (b)(2) or (c)(2) and shall, 
    by the deadline for the review of the tolerance or exemption, issue 
    a regulation under subsection (d)(4) or (e)(1) to modify or revoke 
    the tolerance or exemption if the tolerance or exemption does not 
    meet such requirements.
        ``(2) Priorities.--In determining priorities for reviewing 
    tolerances and exemptions under paragraph (1), the Administrator 
    shall give priority to the review of the tolerances or exemptions 
    that appear to pose the greatest risk to public health.
        ``(3) Publication of schedule.--Not later than 12 months after 
    the date of the enactment of the Food Quality Protection Act of 
    1996, the Administrator shall publish a schedule for review of 
    tolerances and exemptions established prior to the date of the 
    enactment of the Food Quality Protection Act of 1996. The 
    determination of priorities for the review of tolerances and 
    exemptions pursuant to this subsection is not a rulemaking and 
    shall not be subject to judicial review, except that failure to 
    take final action pursuant to the schedule established by this 
    paragraph shall be subject to judicial review.
    ``(r) Temporary Tolerance or Exemption.--The Administrator may, 
upon the request of any person who has obtained an experimental permit 
for a pesticide chemical under the Federal Insecticide, Fungicide, and 
Rodenticide Act or upon the Administrator's own initiative, establish a 
temporary tolerance or exemption for the pesticide chemical residue for 
the uses covered by the permit. Subsections (b)(2), (c)(2), (d), and 
(e) shall apply to actions taken under this subsection.
    ``(s) Savings Clause.--Nothing in this section shall be construed 
to amend or modify the provisions of the Toxic Substances Control Act 
or the Federal Insecticide, Fungicide, and Rodenticide Act.''.

SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

    For the fiscal years 1997 through 1999, there is authorized to be 
appropriated in the aggregate an additional $12,000,000 for increased 
monitoring by the Secretary of Health and Human Services of pesticide 
residues in imported and domestic food.

SEC. 407. ALTERNATIVE ENFORCEMENT.

    Section 303(g) (21 U.S.C. 333(f)) is amended--
        (1) by redesignating paragraphs (2), (3), and (4) as paragraphs 
    (3), (4), and (5), respectively;
        (2) by inserting after paragraph (1) the following:
    ``(2)(A) Any person who introduces into interstate commerce or 
delivers for introduction into interstate commerce an article of food 
that is adulterated within the meaning of section 402(a)(2)(B) shall be 
subject to a civil money penalty of not more than $50,000 in the case 
of an individual and $250,000 in the case of any other person for such 
introduction or delivery, not to exceed $500,000 for all such 
violations adjudicated in a single proceeding.
    ``(B) This paragraph shall not apply to any person who grew the 
article of food that is adulterated. If the Secretary assesses a civil 
penalty against any person under this paragraph, the Secretary may not 
use the criminal authorities under this section to sanction such person 
for the introduction or delivery for introduction into interstate 
commerce of the article of food that is adulterated. If the Secretary 
assesses a civil penalty against any person under this paragraph, the 
Secretary may not use the seizure authorities of section 304 or the 
injunction authorities of section 302 with respect to the article of 
food that is adulterated.
    ``(C) In a hearing to assess a civil penalty under this paragraph, 
the presiding officer shall have the same authority with regard to 
compelling testimony or production of documents as a presiding officer 
has under section 408(g)(2)(B). The third sentence of paragraph (3)(A) 
shall not apply to any investigation under this paragraph.'';
        (3) in paragraph (3), as so redesignated, by striking 
    ``paragraph (1)'' each place it occurs and inserting ``paragraph 
    (1) or (2)'';
        (4) in paragraph (4), as so redesignated, by striking 
    ``(2)(A)'' and inserting ``(3)(A)''; and
        (5) in paragraph (5), as so redesignated, by striking ``(3)'' 
    each place it occurs and inserting ``(4)''.

                             TITLE V--FEES

SEC. 501. REREGISTRATION FEES.

    (a) Section 4(i).--Section 4(i) (7 U.S.C. 136a-1(i)), as amended by 
section 232(2), is amended--
        (1) in paragraphs (5)(H) and (6), by striking ``1997'' and 
    inserting ``2001''; and
        (2) in paragraph (5)(C), by inserting ``(i)'' after ``(C)'' and 
    by adding at the end the following:
            ``(ii) in each of the fiscal years 1998, 1999, and 2000, 
        the Administrator is authorized to collect up to an additional 
        $2,000,000 in a manner consistent with subsection (k)(5) and 
        the recommendations of 
1ddc
the Inspector General of the 
        Environmental Protection Agency. The total fees that may be 
        collected under this clause shall not exceed $6,000,000.''.
    (b) Section 4(k)(1).--Section 4(k)(1) (7 U.S.C. 136a-1(k)(1)) is 
amended by inserting before the period the following: ``which shall be 
known as the Reregistration and Expedited Processing Fund''.
    (c) Section 4(k)(2).--Section 4(k)(2) (7 U.S.C. 136a-1(k)(2)) is 
amended to read as follows:
        ``(2) Source and use.--
            ``(A) All moneys derived from fees collected by the 
        Administrator under subsection (i) shall be deposited in the 
        fund and shall be available to the Administrator, without 
        fiscal year limitation, specifically to offset the costs of 
        reregistration and expedited processing of the applications 
        specified in paragraph (3). Such moneys derived from fees may 
        not be expended in any fiscal year to the extent such moneys 
        derived from fees would exceed money appropriated for use by 
        the Administrator and expended in such year for such costs of 
        reregistration and expedited processing of such applications. 
        The Administrator shall, prior to expending any such moneys 
        derived from fees--
                ``(i) effective October 1, 1997, adopt specific and 
            cost accounting rules and procedures as approved by the 
            General Accounting Office and the Inspector General of the 
            Environmental Protection Agency to ensure that moneys 
            derived from fees are allocated solely to the costs of 
            reregistration and expedited processing of the applications 
            specified in paragraph (3) in the same portion as 
            appropriated funds;
                ``(ii) prohibit the use of such moneys derived from 
            fees to pay for any costs other than those necessary to 
            achieve reregistration and expedited processing of the 
            applications specified in paragraph (3); and
                ``(iii) ensure that personnel and facility costs 
            associated with the functions to be carried out under this 
            paragraph do not exceed agency averages for comparable 
            personnel and facility costs.
            ``(B) The Administrator shall also--
                ``(i) complete the review of unreviewed reregistration 
            studies required to support the reregistration eligibility 
            decisions scheduled for completion in accordance with 
            subsection (l)(2); and
                ``(ii) contract for such outside assistance as may be 
            necessary for review of required studies, using a generally 
            accepted competitive process for the selection of vendors 
            of such assistance.''.
    (d) Section 4(k)(3).--Section 4(k)(3) (7 U.S.C. 136a-1(k)(3)) is 
amended--
        (1) in subparagraph (A), by striking out ``for each of the 
    fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance fees 
    collected, up to 2 million each year'' and inserting in lieu 
    thereof ``for each of the fiscal years 1997 through 2001, not more 
    than \1/7\ of the maintenance fees collected in such fiscal year''; 
    and
        (2) by adding a new subparagraph (C) to read as follows:
            ``(C) So long as the Administrator has not met the time 
        frames specified in clause (ii) of section 3(c)(3)(B) with 
        respect to any application subject to section 3(c)(3)(B) that 
        was received prior to the date of enactment of the Food Quality 
        Protection Act of 1996, the Administrator shall use the full 
        amount of the fees specified in subparagraph (A) for the 
        purposes specified therein. Once all applications subject to 
        section 3(c)(3)(B) that were received prior to such date of 
        enactment have been acted upon, no limitation shall be imposed 
        by the preceding sentence of this subparagraph so long as the 
        Administrator meets the time frames specified in clause (ii) of 
        section 3(c)(3)(B) on 90 percent of affected applications in a 
        fiscal year. Should the Administrator not meet such time frames 
        in a fiscal year, the limitations imposed by the first sentence 
        of this subparagraph shall apply until all overdue applications 
        subject to section 3(c)(3)(B) have been acted upon.''.
    (e) Section 4(k)(5).--Section 4(k)(5) (7 U.S.C. 136a-1(k)(5)) is 
amended to read as follows:
        ``(5) Accounting and performance.--The Administrator shall take 
    all steps necessary to ensure that expenditures from fees 
    authorized by subsection (i)(5)(C)(ii) are used only to carry out 
    the goals established under subsection (l). The Reregistration and 
    Expedited Processing Fund shall be designated as an Environmental 
    Protection Agency component for purposes of section 3515(c) of 
    title 31, United States Code. The annual audit required under 
    section 3521 of such title of the financial statements of 
    activities under this Act under section 3515(b) of such title shall 
    include an audit of the fees collected under subsection (i)(5)(C) 
    and disbursed, of the amount appropriated to match such fees, and 
    of the Administrator's attainment of performance measures and goals 
    established under subsection (l). Such an audit shall also include 
    a review of the reasonableness of the overhead allocation and 
    adequacy of disclosures of direct and indirect costs associated 
    with carrying out the reregistration and expedited processing of 
    the applications specified in paragraph (3), and the basis for and 
    accuracy of all costs paid with moneys derived from such fees. The 
    Inspector General shall conduct the annual audit and report the 
    findings and recommendations of such audit to the Administrator and 
    to the Committees on Agriculture of the House of Representatives 
    and the Senate. The cost of such audit shall be paid for out of the 
    fees collected under subsection (i)(5)(C).''.
    (f) Goals.--Subsections (l) and (m) of section 4 (7 U.S.C. 136a-1), 
as amended by section 237, are redesignated as subsections (m) and (n) 
respectively and the following is inserted after subsection (k):
    ``(l) Performance Measures and Goal.--The Administrator shall 
establish and publish annually in the Federal Register performance 
measures and goals. Such measures and goals shall include--
        ``(1) the number of products reregistered, canceled, or 
    amended, the status of reregistration, the number and type of data 
    requests under section 3(c)(2)(B) issued to support product 
    reregistration by active ingredient, the progress in reducing the 
    number of unreviewed, required reregistration studies, the 
    aggregate status of tolerances reassessed, and the number of 
    applications for registration submitted under subsection (k)(3) 
    that were approved or disapproved;
        ``(2) the future schedule for reregistrations, including the 
    projection for such schedules that will be issued under subsection 
    (g)(2)(A) and (B) in the current fiscal year and the succeeding 
    fiscal year; and
        ``(3) the projected year of completion of the reregistrations 
    under this section.''.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.

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