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[104th Congress Public Law 170]
[From the U.S. Government Printing Office]

<DOC>
[DOCID: f:publ170.104]

[[Page 110 STAT. 1489]]

Public Law 104-170
104th Congress

                                 An Act

 
To amend the Federal Insecticide, Fungicide, and Rodenticide Act and the 
 Federal Food, Drug, and Cosmetic Act, and for other purposes. <<NOTE:  
                     Aug. 3, 1996 -  [H.R. 1627]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Food Quality 
Protection Act of 1996.>> 

SECTION 1. <<NOTE: 7 USC 136 note.>>  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''.

[[Page 110 STAT. 1490]]

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) <<NOTE: Federal Register, 
                      publication.>>  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) <<NOTE: Establishment.>>  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:

[[Page 110 STAT. 1491]]

    ``(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 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. <<NOTE: Regulations.>>  The 
        Administrator shall by regula

[[Page 110 STAT. 1492]]

        tion 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 <<NOTE: 7 USC 136x, 
        136y.>>  as sections 33 and 34, respectively; and
            (2) by adding after section 29 the following:

[[Page 110 STAT. 1493]]

``SEC. 30. <<NOTE: 7 USC 136w-5.>>  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.''.

[[Page 110 STAT. 1494]]

    (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 product 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) <<NOTE: Effective date.>>  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

[[Page 110 STAT. 1495]]

                      the period of 10 years following the date of 
                      submission of such data. <<NOTE: Notification.>>  
                      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. <<NOTE: Notice.>> In such 
                      circumstance, the Administrator shall provide, in 
                      writing to the reg

[[Page 110 STAT. 1496]]

                      istrant, 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 accordance 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

[[Page 110 STAT. 1497]]

            (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) <<NOTE: Review.>> 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

[[Page 110 STAT. 1498]]

                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. <<NOTE: Federal Register, 
                publication.>>  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. <<NOTE: Notice.>>  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

[[Page 110 STAT. 1499]]

                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 may refuse the request 
                for extension by the registrant. <<NOTE: Federal 
                Register, publication.>> 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. <<NOTE: Notice.>>  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

[[Page 110 STAT. 1500]]

                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. <<NOTE: Federal 
                Register, publication.>>  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. <<NOTE: Notice.>> 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:

[[Page 110 STAT. 1501]]

``SEC. 31. <<NOTE: 7 USC 136w-6.>>  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) <<NOTE: Public information. Reports.>>  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. <<NOTE: 7 USC 136w-7.>> 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, 
        tolerances, 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) <<NOTE: Nomenclature.>>  Establishment.--There is 
        established in the Treasury of the United States a revolving 
        fund to be known as the

[[Page 110 STAT. 1502]]

        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

[[Page 110 STAT. 1503]]

                    ``(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.

[[Page 110 STAT. 1504]]

                          ``(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) shall 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;

[[Page 110 STAT. 1505]]

                    ``(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) <<NOTE: Federal Register, 
                      publication.>> 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.

[[Page 110 STAT. 1506]]

                          ``(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 amendment 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) <<NOTE: Review.>> 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

[[Page 110 STAT. 1507]]

                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.''.

[[Page 110 STAT. 1508]]

                  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

[[Page 110 STAT. 1509]]

                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 followed 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.--

[[Page 110 STAT. 1510]]

            ``(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). <<NOTE: Regulations.>>  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) <<NOTE: Notification.>> 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. <<NOTE: Notification.>>  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:

[[Page 110 STAT. 1511]]

                    ``(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) <<NOTE: Guidelines.>>  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) <<NOTE: Notification.>>  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. <<NOTE: 21 USC 346a note.>>  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.

[[Page 110 STAT. 1512]]

    (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 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. <<NOTE: 7 USC 136i-2.>>  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. <<NOTE: 7 USC 136r-1.>> 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. <<NOTE: 7 USC 136i-2 note.>>  PESTICIDE USE INFORMATION 
            STUDY.

    (a) <<NOTE: Reports.>>  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

[[Page 110 STAT. 1513]]

        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-- <<NOTE: Food Quality Protection Act of 1996.>> AMENDMENTS TO 
THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

SEC 401. SHORT TITLE AND REFERENCE.

    (a) <<NOTE: 21 USC 301 note.>>  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

[[Page 110 STAT. 1514]]

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) if 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

[[Page 110 STAT. 1515]]

                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.

[[Page 110 STAT. 1516]]

            ``(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

[[Page 110 STAT. 1517]]

                                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 exceed 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). <<NOTE: Regulations.>>  
                      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

[[Page 110 STAT. 1518]]

                                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) <<NOTE: Publication.>> publish a 
                                specific determination regarding the 
                                safety of the pesticide chemical residue 
                                for infants and children.
                <<NOTE: Surveys.>> 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 pro

[[Page 110 STAT. 1519]]

                      duced 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. <<NOTE: Regulations.>>  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 tolerance.
                    ``(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

[[Page 110 STAT. 1520]]

                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. <<NOTE: Publication.>>  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--

[[Page 110 STAT. 1521]]

                    ``(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) <<NOTE: Regulations.>>  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);

[[Page 110 STAT. 1522]]

                          ``(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 chemical 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) <<NOTE: Publication.>>  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) <<NOTE: Regulations.>> 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

[[Page 110 STAT. 1523]]

                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 <<NOTE: Regulations.>> 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) <<NOTE: Notice.>> 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;

[[Page 110 STAT. 1524]]

                    ``(B) <<NOTE: Rules.>>  issue a rule requiring that 
                testing be conducted on a substance or mixture under 
                section 4 of the Toxic Substances Control Act; or
                    ``(C) <<NOTE: Federal Register, 
                publication.>> 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 endocrine 
                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

[[Page 110 STAT. 1525]]

                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) <<NOTE: Orders.>> 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

[[Page 110 STAT. 1526]]

        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 Administrator 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

[[Page 110 STAT. 1527]]

        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. <<NOTE: Regulations.>>  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

[[Page 110 STAT. 1528]]

        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. <<NOTE: Effective date.>>  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. <<NOTE: Applicability.>>  
                Subsection (e) shall apply to actions taken under this 
                paragraph. <<NOTE: Effective date.>>  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. <<NOTE: Applicability.>> Subsection (e) shall apply to 
        the establishment of such tolerance. <<NOTE: Review.>> The 
        Adminis

[[Page 110 STAT. 1529]]

        trator 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 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. <<NOTE: Regulations.>>  
        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) <<NOTE: Regulations.>> 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;

[[Page 110 STAT. 1530]]

                    ``(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

[[Page 110 STAT. 1531]]

        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 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

[[Page 110 STAT. 1532]]

        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.

<<NOTE: Publication. Public information.>>     ``(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

[[Page 110 STAT. 1533]]

        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 <<NOTE: Orders.>> 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) <<NOTE: Notice.>> 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 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 comple

[[Page 110 STAT. 1534]]

                      tion 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.
        <<NOTE: Regulations.>> 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.

[[Page 110 STAT. 1535]]

            ``(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

[[Page 110 STAT. 1536]]

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 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) <<NOTE: Effective date. Rules and 
                      procedures.>> 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;

[[Page 110 STAT. 1537]]

                          ``(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) <<NOTE: Review.>> 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) <<NOTE: Contracts.>>  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 <<NOTE: Applicability.>>  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

[[Page 110 STAT. 1538]]

        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. <<NOTE: Reports.>> 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) <<NOTE: Federal Register, publication.>> 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.''.

    Approved August 3, 1996.

LEGISLATIVE HISTORY--H.R. 1627:
---------------------------------------------------------------------------

HOUSE REPORTS: No. 104-669, Pt. 1 (Comm. on Agriculture) and Pt. 2 
(Comm. on Commerce).
CONGRESSIONAL RECORD, Vol. 142 (1996):
            July 23, considered and passed House.
            July 24, considered and passed Senate.
WEEKLY COMPILATION OF PRESIDENTIAL DOCUMENTS, Vol. 32 (1996):
            Aug. 3, Presidential remarks and statement.

                                  <all>
```