Text: S.1166 — 104th Congress (1995-1996)All Information (Except Text)

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Introduced in Senate (08/10/1995)

 
[Congressional Bills 104th Congress]
[From the U.S. Government Printing Office]
[S. 1166 Introduced in Senate (IS)]


104th CONGRESS
  1st Session
                                S. 1166

 To amend the Federal Insecticide, Fungicide, and Rodenticide Act, to 
   improve the registration of pesticides, to provide minor use crop 
 protection, to improve pesticide tolerances to safeguard infants and 
                   children, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

               August 10 (legislative day, July 10), 1995

  Mr. Lugar (for himself, Mr. Pryor, Mrs. Kassebaum, Mr. Inouye, Mr. 
Cochran, Mr. Kerrey, Mr. Dole, Mr. Heflin, Mr. Gorton, and Mr. Breaux) 
introduced the following bill; which was read twice and referred to the 
           Committee on Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL


 
 To amend the Federal Insecticide, Fungicide, and Rodenticide Act, to 
   improve the registration of pesticides, to provide minor use crop 
 protection, to improve pesticide tolerances to safeguard infants and 
                   children, and for other purposes.
    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Food Quality 
Protection Act of 1995''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
    TITLE I--AMENDMENTS TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND 
                            RODENTICIDE ACT

Sec. 101. Reference.
                 Subtitle A--Registration of Pesticides

Sec. 111. Tolerance reevaluation as part of reregistration.
Sec. 112. Scientific advisory panel.
Sec. 113. Coordination of cancellation.
                 Subtitle B--Minor Use Crop Protection

Sec. 121. Definition of minor use.
Sec. 122. Exclusive use of minor use pesticides.
Sec. 123. Time extensions for development of minor use data.
Sec. 124. Minor use waiver.
Sec. 125. Expedition of minor use registrations.
Sec. 126. Utilization of data for voluntarily canceled chemicals.
Sec. 127. Minor use programs.
                   Subtitle C--Conforming Amendments

Sec. 131. FIFRA table of contents.
   TITLE II--DATA COLLECTION AND IMPROVED PROCEDURES TO ENSURE THAT 
        TOLERANCES SAFEGUARD THE HEALTH OF INFANTS AND CHILDREN

Sec. 201. Implementation of NAS report.
Sec. 202. Collection of pesticide use information.
Sec. 203. Integrated pest management.
   TITLE III--AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

Sec. 301. Reference.
Sec. 302. Definitions.
Sec. 303. Prohibited acts.
Sec. 304. Adulterated food.
Sec. 305. Tolerances and exemptions for pesticide chemical residues.
Sec. 306. Authorization for increase monitoring.
    TITLE I--AMENDMENTS TO THE FEDERAL INSECTICIDE, FUNGICIDE, AND 
                            RODENTICIDE ACT

SEC. 101. REFERENCE.

    Except as otherwise expressly provided, 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 (7 U.S.C. 136 et seq.).

                 Subtitle A--Registration of Pesticides

SEC. 111. 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 not 
                later than the date on which the Administrator makes a 
                determination under subparagraph (C) or (D) with 
                respect to a pesticide 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), taking into account available 
                        information and reasonable assumptions 
                        concerning the dietary exposure levels of food 
                        consumers (and major identifiable subgroups of 
                        food consumers, including infants and children) 
                        to residue of the pesticide in food and 
                        available information and reasonable 
                        assumptions concerning the variability of the 
                        sensitivities of major identifiable groups, 
                        including infants and children;
                            ``(ii) determine whether the tolerance or 
                        exemption meets the requirements of the Act;
                            ``(iii) determine whether additional 
                        tolerances or exemptions should be issued;
                            ``(iv) publish in the Federal Register a 
                        notice setting forth the determinations made 
                        under this subparagraph; and
                            ``(v) commence promptly such proceedings 
                        under this Act and section 408 of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 346a) 
                        as are warranted by the determinations.''.

SEC. 112. SCIENTIFIC ADVISORY PANEL.

    Section 25(d) (7 U.S.C. 136w(d)) is amended--
            (1) in the first sentence, by striking ``(d) Scientific 
        Advisory Panel.--The Administrator shall'' and inserting the 
        following:
    ``(d) Scientific Advisory Panel.--
            ``(1) In general.--The Administrator shall''; and
            (2) by adding at the end the following:
            ``(2) Science review board.--
                    ``(A) There is established a science review board 
                consisting of 60 scientists who shall be available to 
                the scientific advisory panel to assist in reviews 
                conducted by the panel.
                    ``(B) The scientific advisory panel shall select 
                the scientists from 60 nominations submitted by each of 
                the National Science Foundation and the National 
                Institutes of Health.
                    ``(C) A member of the board shall be compensated in 
                the same manner as a member of the panel.''.

SEC. 113. COORDINATION OF CANCELLATION.

     Section 2(bb) (7 U.S.C. 136(bb)) is amended--
            (1) by striking ``means any unreasonable risk'' and 
        inserting ``means--
            ``(1) any unreasonable risk''; and
            (2) by striking the period at the end and inserting ``; 
        and''; and
            (3) by adding at the end the following:
            ``(2) a human dietary risk from residue that results from a 
        use of a pesticide in or on any food inconsistent with the 
        standard the Administrator determines is adequate to protect 
        the public health under section 408 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 346a).''.

                 Subtitle B--Minor Use Crop Protection

SEC. 121. DEFINITION OF MINOR USE.

    Section 2 (7 U.S.C. 136) is amended by adding at the end the 
following:
    ``(hh) 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 if--
            ``(1)(A) in the case of the use of the pesticide on a 
        commercial agricultural crop or site, the total quantity of 
        acreage devoted to the crop in the United States is less than 
        300,000 acres, as determined by the Secretary; or
            ``(B) the Administrator, in consultation with the Secretary 
        of Agriculture, determines that, based on information provided 
        by an applicant for registration or a registrant--
                    ``(i) the use does not provide a sufficient 
                economic incentive to support the initial registration 
                or continuing registration of a pesticide for the use; 
                and
                    ``(ii)(I) there are not a sufficient number of 
                efficacious alternative registered pesticides available 
                for the use; or
                    ``(II) any 1 of the alternatives to the pesticide 
                pose a greater risk to the environment or human health 
                than the pesticide; or
                    ``(III) the pesticide plays, or will play, a 
                significant part in managing pest resistance; or
                    ``(IV) the pesticide plays, or will play, a 
                significant part in an integrated pest management 
                program; and
            ``(2) the Administrator does not determine that, based on 
        data existing on the date of the determination, the use may 
        cause unreasonable adverse effects on the environment.''.

SEC. 122. EXCLUSIVE USE OF MINOR USE PESTICIDES.

    Section 3(c)(1)(F) (7 U.S.C. 136a(c)(1)(F)) is amended--
            (1) in clause (i)--
                    (A) by striking ``(i) With respect'' and inserting 
                ``(i)(I) With respect'';
                    (B) by striking ``a period of ten years following 
                the date the Administrator first registers the 
                pesticide'' and inserting ``the exclusive data use 
                period determined under subclause (II)''; and
                    (C) by adding at the end the following:
                            ``(II) Except as provided in subclauses 
                        (III) and (IV), the exclusive data use period 
                        under subclause (I) shall be 10 years beginning 
                        on the date the Administrator first registers 
                        the pesticide.
                            ``(III) Subject to subclauses (IV), (V), 
                        and (VI), the exclusive data use period under 
                        subclause (II) shall be extended 1 year for 
                        each 3 minor uses registered after the date of 
                        enactment of this subclause and before the date 
                        that is 7 years after the date the 
                        Administrator first registers the pesticide, if 
                        the Administrator in consultation with the 
                        Secretary of Agriculture, determines that, 
                        based on information provided by an applicant 
                        for registration or a registrant--
                                    ``(aa) there are not a sufficient 
                                number of efficacious alternative 
                                registered pesticides available for the 
                                use; or
                                    ``(bb) any 1 of the alternatives to 
                                the pesticide pose a greater risk to 
                                the environment or human health than 
                                the pesticide; or
                                    ``(cc) the pesticide plays, or will 
                                play, a significant part in managing 
                                pest resistance; or
                                    ``(dd) the pesticide plays, or will 
                                play, a significant part in an 
                                integrated pest management program.
                            ``(IV) Notwithstanding subclause (III), the 
                        exclusive data use period established under 
                        this clause may not exceed 13 years.
                            ``(V) For purposes of subclause (III), the 
                        registration of a pesticide for a minor use on 
                        a crop grouping established by the 
                        Administrator shall be considered 1 minor use 
                        for each representative crop for which data are 
                        provided in the crop grouping.
                            ``(VI) An extension under subclause (III) 
                        shall be reduced or terminated if the applicant 
                        for registration or the registrant voluntarily 
                        cancels the pesticide or deletes from the 
                        registration a minor use that formed the basis 
                        for the extension, or if the Administrator 
                        determines that the applicant or registrant is 
                        not actually marketing the pesticide for a 
                        minor use that formed the basis for the 
                        extension.''; and
            (2) by adding at the end the following:
                            ``(iv) The period of exclusive use provided 
                        under clause (i)(III) 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.
                            ``(v) 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 the data relate solely to a minor use 
                        of a pesticide, the data shall not, without the 
                        written permission of the original data 
                        submitter, be considered by the Administrator 
                        to support an application for a minor use by 
                        another person during the period of 10 years 
                        following the date of submission of the data. 
                        The applicant or registrant at the time at 
                        which the new minor use is requested shall 
                        notify the Administrator that, to the best of 
                        the applicant's or registrant's knowledge, the 
                        exclusive use period for the pesticide has 
                        expired and that the data pertaining solely to 
                        the minor use of a pesticide are eligible for 
                        exclusive use protection under this paragraph. 
                        If the minor use registration that is supported 
                        by data submitted pursuant to this subsection 
                        is voluntarily canceled or if the data are 
                        subsequently used to support a nonminor use, 
                        the data shall not be subject to the exclusive 
                        use protection provided under this paragraph 
                        but shall instead be considered by the 
                        Administrator in accordance with clause (i), as 
                        appropriate.''.

SEC. 123. TIME EXTENSIONS FOR DEVELOPMENT OF MINOR USE DATA.

    (a) In General.--Section 3 (7 U.S.C. 136a) is amended by adding at 
the end the following:
    ``(g) Time Extension for Development of Minor Use Data.--
            ``(1) Supported use.--In the case of a minor use, the 
        Administrator shall, on the request of a registrant and subject 
        to paragraph (3), extend the time for the production of residue 
        chemistry data under subsection (c)(2)(B) and subsections 
        (d)(4), (e)(2), and (f)(2) of section 4 for data required 
        solely to support the minor use until the final date under 
        section 4 for submitting data on any other use established not 
        later than the date of enactment of this subsection.
            ``(2) Nonsupported use.--
                    ``(A) If a registrant does not commit to support a 
                minor use of a pesticide, the Administrator shall, on 
                the request of the registrant and subject to paragraph 
                (3), extend the time for taking any action under 
                subsection (c)(2)(B) or subsection (d)(6), (e)(3)(A), 
                or (f)(3) of section 4 regarding the minor use until 
                the final date under section 4 for submitting data on 
                any other use established not later than the date of 
                enactment of this subsection.
                    ``(B) On 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 on which the uses not being 
                supported will be deleted from the registration under 
                section 6(f)(1).
            ``(3) Conditions.--Paragraphs (1) and (2) shall apply only 
        if--
                    ``(A) the registrant commits to support and provide 
                data for--
                            ``(i) any use of the pesticide on a food; 
                        or
                            ``(ii) any other use, if all uses of the 
                        pesticide are for uses other than food;
                    ``(B)(i) the registrant provides a schedule for 
                producing the data referred to in subparagraph (A) with 
                the request for an extension;
                    ``(ii) the schedule includes interim dates for 
                measuring progress; and
                    ``(iii) the Administrator determines that the 
                registrant is able to produce the data referred to in 
                subparagraph (A) before a final date established by the 
                Administrator;
                    ``(C) the Administrator determines that the 
                extension would not significantly delay issuance of a 
                determination of eligibility for reregistration under 
                section 4; and
                    ``(D) the Administrator determines that, based on 
                data existing on the date of the determination, the 
                extension would not significantly increase the risk of 
                unreasonable adverse effects on the environment.
            ``(4) Monitoring.--If the Administrator grants an extension 
        under paragraph (1) or (2), the Administrator shall--
                    ``(A) monitor the development of any data the 
                registrant committed to under paragraph (3)(A); and
                    ``(B) ensure that the registrant is meeting the 
                schedule provided under paragraph (3)(B) for producing 
                the data.
            ``(5) Noncompliance.--If the Administrator determines that 
        a registrant is not meeting a schedule provided by the 
        registrant under paragraph (3)(B), the Administrator may--
                    ``(A) revoke any extension to which the schedule 
                applies; and
                    ``(B) proceed in accordance with subsection 
                (c)(2)(B)(iv).
            ``(6) Modification or revocation.--The Administrator may 
        modify or revoke an extension under this subsection if the 
        Administrator determines that the extension could cause 
        unreasonable adverse effects on the environment. If the 
        Administrator modifies or revokes an extension under this 
        paragraph, the Administrator shall provide written notice to 
        the registrant of the modification or revocation.''.
    (b) Conforming Amendments.--
            (1) Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)) is amended 
        by adding at the end the following:
                    ``(vi) Subsection (g) shall apply to this 
                subparagraph.''.
            (2) Subsections (d)(4), (e)(2), and (f)(2) of section 4 (7 
        U.S.C. 136a-1) are each amended by adding at the end the 
        following:
                    ``(C) Section 3(g) shall apply to this 
                paragraph.''.
            (3) Subsections (d)(6) and (f)(3) of section 4 (7 U.S.C. 
        136a-1) are each amended by striking ``The Administrator 
        shall'' and inserting ``Subject to section 3(g), the 
        Administrator shall''.
            (4) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) is 
        amended by striking ``If the registrant'' and inserting 
        ``Subject to section 3(g), if the registrant''.

SEC. 124. MINOR USE WAIVER.

    Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is amended by adding at the 
end the following:
                    ``(E) In the case of 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 the data 
                will not prevent the Administrator from determining--
                            ``(i) the incremental risk presented by the 
                        minor use of the pesticide; and
                            ``(ii) whether the minor use of the 
                        pesticide would have unreasonable adverse 
                        effects on the environment.''.

SEC. 125. EXPEDITION OF MINOR USE REGISTRATIONS.

    Section 3(c)(3) (7 U.S.C. 136a(c)(3)) is amended by adding at the 
end the following:
                    ``(C)(i) As expeditiously as practicable after 
                receipt, the Administrator shall review and act on a 
                complete application that--
                            ``(I) proposes the initial registration of 
                        a new pesticide active ingredient, if the 
                        active ingredient is proposed to be registered 
                        solely for a minor use, or proposes a 
                        registration amendment to an existing 
                        registration solely for a minor use; or
                            ``(II) for a registration or a registration 
                        amendment, proposes a significant minor use.
                    ``(ii) As used in clause (i):
                            ``(I) The term `as expeditiously as 
                        practicable' means the Administrator shall, to 
                        the greatest extent practicable, complete a 
                        review and evaluation of all data submitted 
                        with the application not later than 1 year 
                        after submission of the application.
                            ``(II) The term `significant minor use' 
                        means--
                                    ``(aa) 3 or more proposed minor 
                                uses for each proposed use that is not 
                                minor;
                                    ``(bb) a minor use that the 
                                Administrator determines could replace 
                                a use that was canceled not earlier 
                                than 5 years preceding the receipt of 
                                the application; or
                                    ``(cc) a minor use that the 
                                Administrator determines would avoid 
                                the reissuance of an emergency 
                                exemption under section 18 for the 
                                minor use.
                    ``(iii) Review and action on an application under 
                clause (i) shall not be subject to judicial review.
                    ``(D) On receipt by the registrant of a denial of a 
                request to waive a data requirement under paragraph 
                (2)(E), the registrant shall have the full time period 
                originally established by the Administrator for 
                submission of the data, beginning on the date of 
                receipt by the registrant of the denial.''.

SEC. 126. UTILIZATION OF DATA FOR VOLUNTARILY CANCELED CHEMICALS.

    Section 6(f) (7 U.S.C. 136d) is amended--
            (1) in paragraph (1)(C)(ii) by striking ``90-day'' and 
        inserting ``180-day'' each place it appears;
            (2) in paragraph (3)(A) by striking ``90-day'' and 
        inserting ``180-day''; and
            (3) by adding at the end the following:
            ``(4) Utilization of data for voluntarily canceled 
        chemicals.--The Administrator shall process, review, and 
        evaluate the application for a voluntarily canceled pesticide 
        as if the registrant had not canceled the registration, if--
                    ``(A) another application is pending on the 
                effective date of the voluntary cancellation for the 
                registration of a pesticide that is--
                            ``(i) for a minor use;
                            ``(ii) identical or substantially similar 
                        to the canceled pesticide; and
                            ``(iii) for an identical or substantially 
                        similar use as the canceled pesticide;
                    ``(B) the Administrator determines that the minor 
                use will not cause unreasonable adverse effects on the 
                environment; and
                    ``(C) the applicant under subparagraph (A) 
                certifies that the applicant will satisfy any 
                outstanding data requirement necessary to support the 
                reregistration of the pesticide, in accordance with any 
                data submission schedule established by the 
                Administrator.''.

SEC. 127. MINOR USE PROGRAMS.

    The Act is amended--
            (1) by redesignating sections 30 and 31 (7 U.S.C. 136x and 
        136y) as sections 33 and 34, respectively; and
            (2) by inserting after section 29 (7 U.S.C. 136w-4) the 
        following:

``SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.

    ``(a) Establishment.--The Administrator shall establish a minor use 
program in the Office of Pesticide Programs.
    ``(b) Responsibilities.--In carrying out the program established 
under subsection (a), the Administrator shall--
            ``(1) coordinate the development of minor use programs and 
        policies; and
            ``(2) consult with growers regarding a minor use issue, 
        registration, or amendment that is submitted to the 
        Environmental Protection Agency.

``SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.

    ``(a) Establishment.--The Secretary of Agriculture shall establish 
a minor use program.
    ``(b) Responsibilities.--In carrying out the program established 
under subsection (a), the Secretary shall coordinate the 
responsibilities of the Department of Agriculture related to the minor 
use of a pesticide, including--
            ``(1) carrying out the Inter-Regional Research Project 
        Number 4 established under section 2(e) of Public Law 89-106 (7 
        U.S.C. 450i(e));
            ``(2) carrying out the national pesticide resistance 
        monitoring program established under section 1651(d) of the 
        Food, Agriculture, Conservation, and Trade Act of 1990 (7 
        U.S.C. 5882(d));
            ``(3) supporting integrated pest management research;
            ``(4) consulting with growers to develop data for minor 
        uses; and
            ``(5) providing assistance for minor use registrations, 
        tolerances, and reregistrations with the Environmental 
        Protection Agency.

``SEC. 32. MINOR USE MATCHING FUND PROGRAM.

    ``(a) Establishment.--The Secretary of Agriculture, in consultation 
with the Administrator, shall establish and administer a minor use 
matching fund program.
    ``(b) Responsibilities.--In carrying out the program, the Secretary 
shall--
            ``(1) ensure the continued availability of minor use 
        pesticides; and
            ``(2) develop data to support minor use pesticide 
        registrations and reregistrations.
    ``(c) Eligibility.--Any person that desires to develop data to 
support a minor use registration shall be eligible to participate in 
the program.
    ``(d) Priority.--In carrying out the program, the Secretary shall 
provide a priority for funding to a person that does not directly 
receive funds from the sale of a product registered for a minor use.
    ``(e) Matching Funds.--To be eligible for funds under the program, 
a person shall match the amount of funds provided under the program 
with an equal amount of non-Federal funds.
    ``(f) Ownership of Data.--Any data developed through the program 
shall be jointly owned by the Department of Agriculture and the person 
that receives funds under this section.
    ``(g) Statement.--Any data developed under this subsection shall be 
submitted in a statement that complies with section 3(c)(1)(F).
    ``(h) Compensation.--Any compensation received by the Department of 
Agriculture for the use of data developed under this section shall be 
placed in a revolving fund. The fund shall be available, without fiscal 
year limitation, to carry out the program.
    ``(i) Authorization for Appropriations.--There are authorized to be 
appropriated to carry out this section $10,000,000 for each fiscal 
year.''.

                   Subtitle C--Conforming Amendments

SEC. 131. FIFRA TABLE OF CONTENTS.

    The table of contents in section 1(b) (7 U.S.C. prec. 121) is 
amended--
            (1) by adding at the end of the items relating to section 2 
        the following:

        ``(hh) Minor use.'';
            (2) by adding at the end of the items relating to section 3 
        the following:

        ``(g) Time extension for development of minor use data.
            ``(1) Supported use.
            ``(2) Nonsupported use.
            ``(3) Conditions.
            ``(4) Monitoring.
            ``(5) Noncompliance.
            ``(6) Modification or revocation.'';
            (3) by adding at the end of the items relating to section 
        6(f) the following:

            ``(4) Utilization of data for voluntarily canceled 
                            chemicals.'';
            (4) by striking the item relating to section 25(d) and 
        inserting the following:

        ``(d) Scientific advisory panel.
            ``(1) In general.
            ``(2) Science review board.'';
        and
            (5) by striking the items relating to sections 30 and 31 
        and inserting the following:

        ``Sec. 30. Environmental Protection Agency minor use program.
            ``(a) Establishment.
            ``(b) Responsibilities.
        ``Sec. 31. Department of Agriculture minor use program.
            ``(a) Establishment.
            ``(b) Responsibilities.
        ``Sec. 32. Minor use matching fund program.
            ``(a) Establishment.
            ``(b) Responsibilities.
            ``(c) Eligibility.
            ``(d) Priority.
            ``(e) Matching funds.
            ``(f) Ownership of data.
            ``(g) Statement.
            ``(h) Compensation.
            ``(i) Authorization for appropriations.
        ``Sec. 33. Severability.
        ``Sec. 34. Authorization for appropriations.''.
   TITLE II--DATA COLLECTION AND IMPROVED PROCEDURES TO ENSURE THAT 
        TOLERANCES SAFEGUARD THE HEALTH OF INFANTS AND CHILDREN

SEC. 201. IMPLEMENTATION OF NAS REPORT.

    (a) In General.--The Administrator of the Environmental Protection 
Agency, the Secretary of Agriculture, and the Secretary of Health and 
Human Services shall coordinate the development and implementation of 
procedures to ensure that pesticide tolerances adequately safeguard the 
health of infants and children, based on the conclusions and 
recommendations contained in the report entitled ``Pesticides in the 
Diets of Infants and Children'' of the National Research Council of the 
National Academy of Sciences.
    (b) Procedures.--To the maximum extent practicable, the procedures 
referred to in subsection (a) shall include--
            (1) collection of data on food consumption patterns of 
        infants and children;
            (2) improved surveillance of pesticide residues, including 
        guidelines for the use of comparable analytical and 
        standardized reporting methods, the increased sampling of foods 
        most likely consumed by infants and children, and the 
        development of more complete information on the effects of food 
        processing on levels of pesticide residues;
            (3) toxicity testing procedures that take into account the 
        vulnerability of infants and children;
            (4) methods of risk assessment that take into account 
        unique characteristics of infants and children; and
            (5) other appropriate measures considered necessary by the 
        Administrator to ensure that pesticide tolerances adequately 
        safeguard the health of infants and children.

SEC. 202. 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 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 in 
developing exposure calculations and benefits determinations with 
respect to pesticide regulatory decisions.

SEC. 203. INTEGRATED PEST MANAGEMENT.

    (a) Definition.--In this section, the term ``integrated pest 
management'' means a sustainable approach to managing pests by 
combining biological, cultural, physical, and chemical tools in a way 
that minimizes economic, health, and environmental risks.
    (b) Implementation.--The Secretary of Agriculture, in cooperation 
with the Administrator of the Environmental Protection Agency, shall 
implement research, demonstration, and education programs to support 
adoption of integrated pest management.
    (c) Federal Agencies.--Federal agencies shall use integrated pest 
management techniques to carry out pest management activities and shall 
promote integrated pest management through procurement and regulatory 
policy and through other activities.
    (d) Information.--The Secretary of Agriculture and the 
Administrator of the Environmental Protection Agency shall make 
information on integrated pest management widely available to pesticide 
users, including Federal agencies that use pesticides.

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

SEC. 301. REFERENCE.

    Whenever in this title an amendment is expressed in terms of an 
amendment to a section or other provision, or refers to 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 
(21 U.S.C. 321 et seq.).
SEC. 302. DEFINITIONS.

    (a) Pesticide, Chemical; Pesticide Chemical Residue.--Section 
201(q) (21 U.S.C. 321(q)) is amended to read as follows:
    ``(q)(1) The term `pesticide chemical' means--
            ``(A) any substance that is a pesticide within the meaning 
        of section 2(u) of the Federal Insecticide, Fungicide, and 
        Rodenticide Act (7 U.S.C. 136 (u)),
            ``(B) any active ingredient of a pesticide within the 
        meaning of section 2(a) of the Federal Insecticide, Fungicide, 
        and Rodenticide Act. (7 U.S.C. 136(a)), or
            ``(C) any inert ingredient of a pesticide within the 
        meaning of section 2(m) of the Federal Insecticide, Fungicide, 
        and Rodenticide Act. (7 U.S.C. 136 (m)).
    ``(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 in the 
        commodity or food primarily as a result of the metabolism or 
        other degradation of a pesticide chemical.
    ``(3) Notwithstanding subparagraphs (1) and (2), the Administrator 
may by regulation except a substance from the definition of `pesticide 
chemical' or `pesticide chemical residue' if--
            ``(A) the substance's occurrence as a residue on 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) Food Additive.--Subparagraphs (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) Processed Food; Administrator.--Section 201 (21 U.S.C. 321) is 
amended by adding at the end the following new subsections:
    ``(gg) The term `processed food' means any food other than a raw 
agricultural commodity and includes any raw agricultural commodity that 
has been subject to processing, such as canning, cooking, freezing, 
dehydration, or milling.
    ``(hh) The term `Administrator' means the Administrator of the 
United States Environmental Protection Agency.''.

SEC. 303. PROHIBITED ACTS.

    Section 301(j) (21 U.S.C. 331(j)) is amended by inserting before 
the period at the end of the first sentence the following: ``, or the 
violation of section 408(g) or any regulation issued under that 
subsection''.

SEC. 304. ADULTERATED FOOD.

    Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended to read as 
follows: ``(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; (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''.

SEC. 305. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

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

``SEC. 408. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

    ``(a) Requirement for Tolerance or Exemption.--
            ``(1) Definition.--For the purposes of this section, the 
        term `food', when used as a noun without modification, means a 
        raw agricultural commodity or processed food.
            ``(2) General rule.--Except as provided in paragraph (3) or 
        (4), 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 concentration 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.
            ``(3) Processed food.--Notwithstanding paragraph (2), the 
        following provisions shall apply with respect to processed 
        food:
                    ``(A) Tolerance requirement.--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 concentration of the 
                pesticide chemical residue in the processed food when 
                ready for consumption or use is not greater than the 
                tolerance prescribed for the pesticide chemical residue 
                in the raw agricultural commodity.
                    ``(B) Exemption from tolerance requirement.--If an 
                exemption from 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).
            ``(4) Residues of degradation products.--If a pesticide 
        chemical residue is present in or on a food because the residue 
        is a metabolite or other degradation product of a precursor 
        substance that itself is a pesticide chemical or pesticide 
        chemical residue, the 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 the residue in or on the 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; and
                    ``(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 the 
                tolerance or exemption applies only to particular named 
                substances or states that the tolerance or exemption 
                does not apply to residues of the degradation product.
            ``(5) 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 Tolerances.--
            ``(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 initiative under 
                subsection (e).
            ``(2) Standard.--
                    ``(A) In general.--A tolerance may not be 
                established for a pesticide chemical residue in or on a 
                food at a level that is higher than a level that the 
                Administrator determines is adequate to protect the 
                public health.
                    ``(B) Modification or revocation of a tolerance.--
                The Administrator shall modify or revoke a tolerance if 
                the tolerance is at a level higher than the level that 
                the Administrator determines is adequate to protect the 
                public health.
                    ``(C) Determination factors.--In making a 
                determination under this paragraph, the Administrator 
                shall take into account, among other relevant factors, 
                the validity, completeness, and reliability of the 
                available data from studies of the pesticide chemical 
                residue, the nature of any toxic effects shown to be 
                caused by the pesticide chemical in the studies, 
                available information and reasonable assumptions 
                concerning the relationship of the results of the 
                studies to human risk, available information and 
                reasonable assumptions concerning the dietary exposure 
                levels of food consumers (and major identifiable 
                subgroups of food consumers, including infants and 
                children) to the pesticide chemical residue, and 
                available information and reasonable assumptions 
                concerning the variability of the sensitivities of 
                major identifiable subgroups, including infants and 
                children, and shall consider other factors to the 
                extent required by subparagraph (F).
                    ``(D) Negligible dietary risk standard.--For 
                purposes of subparagraph (A), a tolerance level for a 
                pesticide chemical residue in or on a food shall be 
                deemed to be adequate to protect the public health if 
                the dietary risk posed to food consumers by the level 
                of the pesticide chemical residue is negligible. The 
                Administrator shall by regulation set forth the factors 
                and methods, including tests that are appropriate for 
                the determination of dietary risk and most likely 
                dietary exposure, for the determination of negligible 
                dietary risk.
                    ``(E) Infants and children.--Procedures shall be 
                developed and implemented that ensure that pesticide 
                tolerances adequately safeguard the health of infants 
                and children.
                    ``(F) Calculation of dietary risk.--Where reliable 
                data are available, the Administrator shall calculate 
                the dietary risk posed to food consumers by a pesticide 
                chemical on the basis of the percent of food actually 
                treated with the pesticide chemical and the actual 
                residue levels of the pesticide chemical that occur in 
                food. In particular, the Administrator shall take into 
                account aggregate pesticide use and residue data 
                collected by the Department of Agriculture.
                    ``(G) Exceptions to the negligible dietary risk 
                standard.--For purposes of subparagraph (A), a level of 
                a pesticide chemical residue in or on a food that poses 
                a greater than negligible dietary risk to consumers of 
                the food shall be considered to be adequate to protect 
                the public health if the Administrator determines that 
                the risk is not unreasonable because--
                            ``(i) use of the pesticide that produces 
                        the residue protects humans or the environment 
                        from adverse effects on public health or 
                        welfare that would, directly or indirectly, 
                        result in a greater risk to the public or the 
                        environment than the dietary risk from the 
                        pesticide chemical residue;
                            ``(ii) use of the pesticide avoids risks--
                                    ``(I) to workers, the public, or 
                                the environment that would be expected 
                                to result from the use of another 
                                pesticide or pest control method on the 
                                same food; and
                                    ``(II) that are greater than the 
                                risks that result from dietary exposure 
                                to the pesticide chemical residue; or
                            ``(iii) the availability of the pesticide 
                        would maintain the availability to consumers of 
                        an adequate, wholesome, and economical food 
                        supply taking into account national and 
                        regional effects.
                In making the determination under this subparagraph, 
                the Administrator shall not consider the effects on any 
                pesticide registrant, manufacturer, or marketer of a 
                pesticide.
            ``(3) Limitations.--
                    ``(A) Issuance of tolerance.--A tolerance may be 
                issued under the authority of paragraph (2)(G) only if 
                the Administrator has assessed the extent to which 
                efforts are being made to develop either an alternative 
                method of pest control or an alternative pesticide 
                chemical for use on such commodity or food that would 
                meet the requirements of paragraph (2)(D).
                    ``(B) Establishment of a tolerance.--A tolerance 
                for a pesticide chemical residue in or on a food shall 
                not be established 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.
                    ``(C) Establishment of a tolerance level.--A 
                tolerance for a pesticide chemical residue in or on a 
                food shall not be established at a level lower than the 
                limit of detection of the method for detecting and 
                measuring the pesticide chemical residue as determined 
                by the Administrator under subparagraph (B).
            ``(4) International standards.--In establishing a tolerance 
        for a pesticide chemical residue in or on a food, the 
        Administrator shall take into account any maximum residue level 
        for the chemical in or on the food that has been established by 
        the Codex Alimentarius Commission. The Administrator shall 
        determine whether the Codex maximum residue level is adequate 
        to protect the health of consumers in the United States and 
        whether the data supporting the maximum residue level are 
        valid, complete, and reliable. If the Administrator determines 
        not to adopt a Codex level, the Administrator shall publish a 
        notice in the Federal Register setting forth the reasons for 
        the determination.
    ``(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 a food--
                    ``(A) in response to a petition filed under 
                subsection (d), or
                    ``(B) on the Administrator's initiative under 
                subsection (e).
            ``(2) Standard.--
                    ``(A) In general.--An exemption from the 
                requirement for a tolerance for a pesticide chemical 
                residue in or on a food may be established only if the 
                Administrator determines that a tolerance is not needed 
                to protect the public health, in view of the levels of 
                dietary exposure to the pesticide chemical residue that 
                could reasonably be expected to occur.
                    ``(B) Revocation of exemption.--An exemption from 
                the requirement for a tolerance for a pesticide 
                chemical residue in or on a food shall be revoked if 
                the Administrator, in response to a petition for the 
                revocation of the exemption, or at the Administrator's 
                own initiative, determines that the exemption does not 
                satisfy the criterion of subparagraph (A).
                    ``(C) Determination factors.--In making a 
                determination under this paragraph, the Administrator 
                shall take into account, among other relevant factors, 
                the factors set forth in subsection (b)(2)(C).
            ``(3) Limitation.--An exemption from the requirement for a 
        tolerance for a pesticide chemical residue in or on a food 
        shall not be established by the Administrator unless the 
        Administrator determines, after consultation with the 
        Secretary--
                    ``(A) that there is a practical method for 
                detecting and measuring the levels of the pesticide 
                chemical residue in or on the food; or
                    ``(B) that there is no need for such a method, and 
                states the reasons for the determination in the order 
                issuing the regulation establishing or modifying the 
                regulation.
    ``(d) Petition for Tolerance of Exemption.--
            ``(1) Filing.--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 or revoking an exemption from 
                the requirement of a tolerance for such a residue.
            ``(2) Petition contents.--
                    ``(A) In general.--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 the summary or any information the 
                        summary 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 the 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 a statement why 
                        such a method is not needed;
                            ``(vii) practical methods for removing any 
                        amount of the residue that would exceed any 
                        proposed tolerance;
                            ``(viii) a proposed tolerance for the 
                        pesticide chemical residue, if a tolerance is 
                        proposed;
                            ``(ix) all relevant data bearing on the 
                        physical or other technical effect that the 
                        pesticide chemical is intended to have and the 
                        quantity of the pesticide chemical that is 
                        required to produce the effect;
                            ``(x) if the petition relates to a 
                        tolerance for a processed food, reports of 
                        investigations conducted using the processing 
                        method or methods used to produce that food;
                            ``(xi) such information as the 
                        Administrator may require to make the 
                        determination under subsection (b)(2)(E); and
                            ``(xii) 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 the 
                information or data. 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 revoke 
                an exemption from the requirement for a tolerance.
            ``(3) Notice.--A notice of the filing of a petition that 
        the Administrator determines has met the requirements of 
        paragraph (2) shall be published by the Administrator within 30 
        days after such determination. The notice shall announce the 
        availability of a description of the analytical methods 
        available to the Administrator for the detection and 
        measurement of the pesticide chemical residue with respect to 
        which the petition is filed or shall set forth the statement of 
        the petitioner of why such a method is not needed. The notice 
        shall include the summary required by paragraph (2)(A)(i).
            ``(4) Actions by the administrator.--The Administrator 
        shall, after giving due consideration to a petition filed under 
        paragraph (1) and any other information available to the 
        Administrator--
                    ``(A) 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;
                    ``(B) issue a proposed regulation under subsection 
                (e), and thereafter either issue a final regulation 
                under subsection (e) or an order denying the petition; 
                or
                    ``(C) issue an order denying the petition.
            ``(5) Effective date.--A regulation issued under paragraph 
        (4) shall take effect upon publication.
            ``(6) Further proceedings.--
                    ``(A) Objections.--Not later than 60 days after a 
                regulation or order is issued under paragraph (4), 
                subsection (e)(1), or subsection (f)(1), any person may 
                file objections thereto with the Administrator, 
                specifying with particularity the provisions of the 
                regulation or order considered objectionable and 
                stating reasonable grounds therefore. If the regulation 
                or order was issued in response to a petition filed 
                under paragraph (1), a copy of each objection filed by 
                a person other than the petitioner shall be served by 
                the Administrator on the petitioner.
                    ``(B) Public evidentiary 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 the public hearing is 
                necessary to receive factual evidence relevant to 
                material issues of fact raised by the objections. The 
                presiding officer in the 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, the 
                subpoena may be enforced by a Federal district court.
                    ``(C) Issuance of an order.--After receiving the 
                arguments of the parties, the Administrator shall, as 
                soon as practicable, 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), the 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 the 
                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.
                    ``(D) Effective date of an order.--An order issued 
                under this paragraph ruling on an objection shall not 
                take effect before the 90th day after the publication 
                of the order unless the Administrator finds that 
                emergency conditions exist necessitating an earlier 
                effective date, in which event the Administrator shall 
                specify in the order the findings of the Administrator 
                as to such conditions.
            ``(7) Judicial review.--
                    ``(A) Filing.--In a case of actual controversy as 
                to the validity of any order issued under paragraph (6) 
                or any regulation that is the subject of such an order, 
                any person who will be adversely affected by the 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, not later than 60 
                days after publication of such order, a petition 
                praying that the order or regulation be set aside in 
                whole or in part.
                    ``(B) Filing of record of proceedings.--A copy of 
                the petition 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 the petition, the court shall have exclusive 
                jurisdiction to affirm or set aside the order or 
                regulation complained of in whole or in part. The 
                findings of the Administrator with respect to questions 
                of fact shall be sustained only if supported by 
                substantial evidence when considered on the record as a 
                whole.
                    ``(C) 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.
                    ``(D) Final judgment.--The judgment of the court 
                affirming or setting aside, in whole or in part, any 
                order under paragraph (6) and any regulation that is 
                the subject of the 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 
                paragraph shall not, unless specifically ordered by the 
                court to the contrary, operate as a stay of a 
                regulation or order.
                    ``(E) Limitations on judicial review.--Any issue as 
                to which review is or was obtainable under paragraph 
                (6) and this paragraph shall not be the subject of 
                judicial review under any other provision of law.
    ``(e) Action on Administrator's Own Initiative.--
            ``(1) General rule.--The Administrator may issue a 
        regulation--
                    ``(A) establishing, modifying, or revoking a 
                tolerance for a pesticide chemical or a pesticide 
                chemical residue;
                    ``(B) establishing 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.
        A regulation issued under this paragraph shall become effective 
        upon the publication of the regulation.
            ``(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. The Administrator shall 
        provide an opportunity for a public hearing during the 
        rulemaking under procedures provided in subsection (d)(6)(B).
    ``(f) Special Data Requirements.--
            ``(1) Requiring submission of additional data.--If the 
        Administrator determines that additional data or information is 
        reasonably required to support the continuation of a tolerance 
        or exemption that is in effect under this section for a 
        pesticide chemical residue on a food, the Administrator shall--
                    ``(A) issue a notice requiring the persons holding 
                the pesticide registrations associated with the 
                tolerance or exemption to submit the data or 
                information under section 3(c)(2)(B) of the Federal 
                Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
                136a(c)(2)(B));
                    ``(B) issue a rule requiring that testing be 
                conducted on a substance or mixture under section 4 of 
                the Toxic Substances Control Act (15 U.S.C. 2603); or
                    ``(C) publish in the Federal Register, after first 
                providing notice and an opportunity for comment of not 
                less than 90 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 (7 
                        U.S.C. 136a(c)(2)(B)) or section 4 of the Toxic 
                        Substances Control Act (15 U.S.C. 2603);
                            ``(iii) describing the reports to 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 revise any such order to correct an 
        error.
            ``(2) Noncompliance.--If a submission required by a notice 
        issued in accordance with paragraph (1)(A) or a rule issued 
        under paragraph (1)(B) is not made by the time specified in the 
        notice or the rule, the Administrator may by order published in 
        the Federal Register modify or revoke the tolerance or 
        exemption in question.
            ``(3) Review.--An order issued under this subsection shall 
        be effective upon publication and shall be subject to review in 
        accordance with paragraphs (6) and (7) of subsection (d).
    ``(g) Confidentiality and Use of Data.--
            ``(1) General rule.--Data and information that are 
        submitted to the Administrator under this section in support of 
        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 (7 U.S.C. 136a and 136h).
            ``(2) Exceptions.--Data that are entitled to confidential 
        treatment under paragraph (1) may nonetheless be disclosed to 
        the Congress, and may be disclosed, under such security 
        requirements as the Administrator may provide by regulation, 
        to--
                    ``(A) employees of the United States who are 
                authorized by the Administrator to examine the data in 
                the carrying out of their official duties under this 
                Act or other Federal statutes intended to protect the 
                public health; or
                    ``(B) contractors with the United States authorized 
                by the Administrator to examine the data in the 
                carrying out of contracts under such statutes.
            ``(3) Summaries.--Notwithstanding any provision of this 
        subsection or other law, the Administrator may publish the 
        informative summary required by subsection (d)(2)(A)(i) and 
        may, in issuing a proposed or final regulation or order under 
        this section, publish an informative summary of the data 
        relating to the regulation or order.
    ``(h) 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).
            ``(2) Regulations under section 409.--Regulations that 
        established tolerances for substances that are pesticide 
        chemical residues on or in 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).
            ``(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).
    ``(i) 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 section 408(a) or 201(s) as then in effect; or
            ``(2) regarded by the Secretary as a substance described by 
        section 201(s)(4),
such a pesticide chemical residue shall be regarded as exempt from the 
requirement for a tolerance, as of the date of enactment of this 
subsection. The Administrator shall by regulation indicate which 
substances are described by this subsection. An exemption under this 
subsection may be revoked or modified as if the exemption had been 
issued under subsection (c).
    ``(j) Harmonization With Action Under Other Laws.--
            ``(1) Limitation.--Notwithstanding any other provision of 
        this Act, a final rule under this section that revokes, 
        modifies, or suspends a tolerance or exemption for a pesticide 
        chemical residue in or on a food may be issued only if the 
        Administrator has first taken any necessary action under the 
        Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
        136 et seq.) with respect to the registration of the pesticide 
        or pesticides whose use results in the residue to ensure that 
        any authorized use of the pesticide in producing, storing, 
        processing, or transporting food that occurs after the issuance 
        of the final rule under this section will not result in 
        pesticide chemical residues on the food that are unsafe within 
        the meaning of subsection (a).
            ``(2) Revocation of tolerance or exemption following 
        cancellation of associated registrations.--
                    ``(A) In general.--If the Administrator, acting 
                under the Federal Insecticide, Fungicide, and 
                Rodenticide Act (7 U.S.C. 136 et seq.), cancels the 
                registration of each pesticide that contains a 
                particular pesticide chemical and that is labeled for 
                use on a particular food, or requires that the 
                registration of each such pesticide be modified to 
                prohibit the use of the pesticide in connection with 
                the production, storage, or transportation of the food, 
                due in whole
                 or in part to dietary risks to humans posed by 
residues of the 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 
the use of the pesticide chemical, in or on the food. The Administrator 
shall use the procedures set forth in subsection (e) in taking action 
under this paragraph.
                    ``(B) Effective date.--A revocation under this 
                paragraph shall become effective not later than 180 
                days after--
                            ``(i) the date by which each such 
                        cancellation of a registration has become 
                        effective; or
                            ``(ii) 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 (7 U.S.C. 136 et seq.), 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 the 
                pesticide chemical on the 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 the use of the 
                pesticide chemical, in or on that food. The 
                Administrator shall use the procedures set forth in 
                subsection (e) in taking action under this paragraph. A 
                suspension under this paragraph shall become effective 
                not later than 60 days after the date by which each 
                such suspension of use has become effective.
                    ``(B) Effect of suspension.--The suspension of a 
                tolerance or exemption under subparagraph (A) shall be 
                effective as long as the use of each associated 
                registration of a pesticide is suspended under the 
                Federal Insecticide, Fungicide, and Rodenticide Act (7 
                U.S.C. 136 et seq.). 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 such Act is 
                terminated, leaving the registration of the pesticide 
                for the use in effect under such Act, the Administrator 
                shall rescind any associated suspension of a 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 canceled prior to the 
        effective date of this paragraph, 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 at a 
        level that permits such unavoidable residue to remain in or on 
        the food. In establishing such a tolerance, the Administrator 
        shall take into account the factors set forth in subsection 
        (b)(2)(C) and shall use the procedures set forth in subsection 
        (e). The Administrator shall review a tolerance established 
        under this paragraph periodically and modify the tolerance as 
        necessary so that the tolerance allows only that level of the 
        pesticide chemical residue that 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 the food shall not be considered 
        unsafe solely because of the presence of the pesticide chemical 
        residue in or on the 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 (7 U.S.C. 136 et seq.); 
                and
                    ``(B) the residue does not exceed a level that was 
                authorized at the time of the 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 
        the likely availability of the food in commerce will pose an 
        unreasonable dietary risk.
    ``(k) Fees.--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 functions 
of the Administrator under this section. Under the regulations, the 
performance of the services or other functions of the Administrator 
under this section, including--
            ``(1) the acceptance for filing of a petition submitted 
        under subsection (d);
            ``(2) the promulgation of a regulation establishing, 
        modifying, or revoking a tolerance or establishing or revoking 
        an exemption from the requirement of a tolerance under this 
        section;
            ``(3) the acceptance for filing of objections under 
        subsection (d)(6); or
            ``(4) the certification and filing in court of a transcript 
        of the proceedings and the record under subsection (d)(7),
may be conditioned upon the payment of the fees. The regulations may 
further provide for waiver or refund of fees in whole or in part when 
in the judgment of the Administrator the waiver or refund is equitable 
and not contrary to the purposes of this subsection.
    ``(l) 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 (7 U.S.C. 136a(c)(5)) 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 such Act 
                on April 25, 1985; or
                    ``(B) was approved for such use in a reregistration 
                eligibility determination issued under section 4(g) of 
                such Act on or after the date of enactment of the Food 
                Quality Protection Act of 1995.
            ``(2) Qualifying federal determination.--For purposes of 
        this subsection, the term `qualifying Federal determination' 
        means--
                    ``(A) a tolerance or exemption from the requirement 
                for a tolerance for a qualifying pesticide chemical 
                residue that was--
                            ``(i) issued under this section after the 
                        date of enactment of the Food Quality 
                        Protection Act of 1995; or
                            ``(ii) issued (or, pursuant to subsection 
                        (h) or (i), deemed to have been issued) under 
                        this section prior to the date of enactment of 
                        the Food Quality Protection Act of 1995, and 
                        determined by the Administrator to meet the 
                        standard under subsection (b)(2) (in the case 
                        of a tolerance) or (c)(2) (in the case of an 
                        exemption); and
                    ``(B) any statement, issued by the Secretary, of 
                the residue level below which enforcement action will 
                not be taken under this Act with respect to any 
                qualifying pesticide chemical residue, if the Secretary 
                finds that the pesticide chemical residue level 
                permitted by the statement during the period to which 
                the statement applies protects human health.
            ``(3) Limitation.--The Administrator may make the 
        determination described in paragraph (2)(A)(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 paragraphs (6) and (7) of subsection (d).
            ``(4) State authority.--Except as provided in paragraph 
        (5), no State or political subdivision may establish or enforce 
        any regulatory limit on a qualifying pesticide chemical residue 
        in or on any food if a qualifying Federal determination applies 
        to the presence of the pesticide chemical residue in or on the 
        food, unless the State regulatory limit is identical to the 
        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 food 
        if the State or political subdivision purports to prohibit or 
        penalize the production, processing, shipping, or other 
        handling of a food because the food contains a pesticide 
        residue (in excess of a prescribed limit), or if the State or 
        political subdivision purports to require that a food 
        containing a pesticide residue be the subject of a warning or 
        other statement relating to the presence of the pesticide 
        residue in the food.
            ``(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 the qualifying pesticide chemical 
                residue.
                    ``(B) Petition requirements.--Any petition made by 
                a State 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 the State of food 
                        bearing the pesticide chemical residue, and 
                        data on exposure of humans within the State to 
                        the pesticide chemical residue.
                    ``(C) Order.--Subject to paragraph (6), 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;
                            ``(ii) would not unduly burden interstate 
                        commerce; and
                            ``(iii) would not cause any food to be in 
                        violation of Federal law.
                    ``(D) Consideration of petition as petition for 
                tolerance or exemptions.--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 revoke or modify a tolerance or 
                to revoke 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 of order.--Any order of the 
                Administrator granting or denying the authorization 
                described in subparagraph (A) shall be subject to 
                review in the manner described in paragraphs (6) and 
                (7) of subsection (d).
            ``(6) 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 the residue, the sale of the food with the 
        residue level was lawful under this Act and under the law of 
        the State, unless the State demonstrates that consumption of 
        the food containing the pesticide residue level during the 
        period of the likely availability of the food in the State will 
        pose an unreasonable dietary risk to the health of persons 
        within the State.''.

SEC. 306. AUTHORIZATION FOR INCREASE MONITORING.

    There are authorized to be appropriated an additional $12,000,000 
for increased monitoring by the Secretary of Health and Human Services 
of pesticide residues in imported and domestic food.
                                 <all>
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