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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 1478 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                S. 1478

  To amend the Federal Insecticide, Fungicide, and Rodenticide Act to 
  ensure that pesticide tolerances adequately safeguard the health of 
             infants and children, and for other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

           September 21 (legislative day, September 7), 1993

   Mr. Pryor (for himself, Mr. Lugar, Mr. Johnston, Mr. Heflin, Mrs. 
 Kassebaum, Mr. Cochran, Mr. Nickles, Mr. Dole, Mr. Coats, Mr. Helms, 
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 
  ensure that pesticide tolerances adequately safeguard the health of 
             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.

    This Act may be cited as the ``Food Quality Protection Act of 
1993''.

   TITLE I--DATA COLLECTION AND PROCEDURES TO ENSURE THAT TOLERANCES 
              SAFEGUARD THE HEALTH OF INFANTS AND CHILDREN

SEC. 101. IMPLEMENTATION OF NRC 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 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 specifically evaluate 
        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. 102. 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. 103. INTEGRATED PEST MANAGEMENT.

    Section 28(c) of the Federal Insecticide, Fungicide, and 
Rodenticide Act (7 U.S.C. 136w-3(c)) is amended--
            (1) by striking ``(c) Integrated Pest Management.--The 
        Administrator,'' and inserting the following:
    ``(c) Integrated Pest Management.--
            ``(1) In general.--The Administrator,''; and
            (2) by adding at the end the following new paragraph:
            ``(2) Joint research and development.--The Administrator 
        and the Secretary of Agriculture shall research, develop, and 
        disseminate information concerning integrated pest management 
        techniques and other pest control methods that enable producers 
        to reduce or eliminate applications of pesticides that pose a 
        greater than negligible dietary risk to humans, with a special 
        focus on crops critical to a balanced, healthy diet and that 
        are considered as minor crops in terms of acreage produced.''.

                 TITLE II--CANCELLATION AND SUSPENSION

SEC. 201. REFERENCE.

    Whenever in this title an amendment or repeal is expressed in terms 
of an amendment to, or repeal of, a section or other provision, the 
reference shall be considered to be made to a section or other 
provision of the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C. 136 et seq.).

SEC. 202. CANCELLATION.

    Subsection (b) of section 6 (7 U.S.C. 136d(b)) is amended to read 
as follows:
    ``(b) Cancellation and Change in Classification or Other Terms or 
Conditions of Registration.--
            ``(1) Authority.--Notwithstanding any other provision of 
        this Act, the Administrator may, by use of informal rulemaking 
        under this subsection, prescribe requirements regarding the 
        composition, packaging, and labeling of a pesticide (or a group 
        of pesticides containing a common active or inert ingredient), 
        may classify the pesticide, or may prohibit the registration or 
        continued registration of the pesticide for some or all 
        purposes, to the extent necessary to ensure that the pesticide, 
        when used in accordance with widespread and commonly recognized 
        practice, does not generally cause unreasonable adverse effects 
        on the environment.
            ``(2) Basis for rule.--
                    ``(A) The Administrator may not initiate a 
                rulemaking under this subsection unless the rulemaking 
                is based on a validated test or other significant 
                evidence raising a prudent concern that the pesticide 
                causes unreasonable adverse effects on the environment.
                    ``(B)(i) The Administrator shall submit, to a 
                scientific peer review committee established by the 
                Administrator, the validated test or other significant 
                evidence on which the Administrator proposes to base a 
                rulemaking under paragraph (1).
                    ``(ii) The scientific peer review committee shall 
                provide written recommendations to the Administrator as 
                to whether the test or evidence reviewed satisfies the 
                criteria under subparagraph (A) for initiating a 
                rulemaking under paragraph (1).
                    ``(iii) The scientific peer review committee shall 
                consist of employees of or consultants to the 
                Environmental Protection Agency who have not been 
                involved in a previous analysis of the validated test 
                or significant evidence presented to the committee and 
                who are experts in the physical or biological 
                disciplines involved in the proposed rulemaking.
            ``(3) Prenotice procedures.--
                    ``(A) The Administrator may not initiate a 
                rulemaking under paragraph (1) until the Administrator 
                has provided, to the registrant of each affected 
                pesticide, a notice that includes a summary of the 
                validated test or other significant evidence on which 
                the Administrator proposes to base the rulemaking and 
                the basis for a determination that the test or evidence 
                raises a prudent concern that the pesticide causes 
                unreasonable adverse effects on the environment. A 
                registrant may respond to a notice provided under this 
                subparagraph not later than 30 days after receipt of 
                the notice.
                    ``(B) At the same time as the Administrator 
                provides the notice to a registrant of the pesticide 
                under subparagraph (A), the Administrator shall also 
                provide the notice to the Secretary of Agriculture and 
                the Secretary of Health and Human Services. If an 
                agricultural commodity is affected, on receipt of the 
                notice, the Secretary of Agriculture shall prepare an 
                analysis of the benefit and use of the pesticide and 
                provide the analysis to the Administrator.
            ``(4) Advance notice to public.--
                    ``(A) After receiving the recommendation of the 
                peer review committee established under paragraph 
                (2)(B), together with any comments submitted by the 
                Secretary of Agriculture, the Secretary of Health and 
                Human Services, and a registrant, the Administrator 
                shall--
                            ``(i) issue an advance notice of proposed 
                        rulemaking; or
                            ``(ii) issue a notice of a proposed 
                        decision not to initiate a rulemaking under 
                        paragraph (1).
                    ``(B) The Administrator shall publish the notice in 
                the Federal Register and provide a period of not less 
                than 60 days for comment on the notice. The notice 
                shall contain a statement of the basis and purpose of 
                the notice and a summary of--
                            ``(i) the factual data on which the notice 
                        is based;
                            ``(ii) the major scientific assumptions 
                        underlying the notice; and
                            ``(iii) the notice provided under paragraph 
                        (3) and any significant comments received from 
                        a registrant, the Secretary of Agriculture, and 
                        the Secretary of Health and Human Services.
                    ``(C) If the Administrator, after considering any 
                comments received, decides not to issue a notice of 
                proposed rulemaking, the Administrator shall publish in 
                the Federal Register a notice setting forth the 
                decision and the basis for the decision.
            ``(5) Docket.--
                    ``(A) For each rulemaking under paragraph (1), the 
                Administrator shall establish a docket.
                    ``(B) The docket shall include a copy of--
                            ``(i) the notice provided under paragraph 
                        (3);
                            ``(ii) any notice issued under paragraph 
                        (4);
                            ``(iii) the notice of proposed rulemaking 
                        issued under paragraph (6);
                            ``(iv) each timely comment filed with the 
                        Administrator;
                            ``(v) the report of the Scientific Advisory 
                        Panel under paragraph (8);
                            ``(vi) a record of each hearing held by the 
                        Administrator in connection with the 
                        rulemaking; and
                            ``(vii) the final rule or decision to 
                        withdraw the rule.
                    ``(C) Information in the docket shall be made 
                available to the public consistent with section 10.
                    ``(D) No factual material that has not been entered 
                into the docket in a timely manner may be relied on by 
                the Administrator in issuing a final rule or in 
                withdrawing a proposed rule or by a person in a 
                judicial review proceeding, except for--
                            ``(i) information of which the 
                        Administrator may properly take official 
                        notice; or
                            ``(ii) information of which a court may 
                        properly take judicial notice.
            ``(6) Notice of proposed rulemaking.--
                    ``(A) Not less than 60 days after an advance notice 
                of proposed rulemaking, except as provided in paragraph 
                (14), the Administrator may issue a notice of proposed 
                rulemaking. The notice of proposed rulemaking shall 
                include a statement of the basis and purpose of the 
                proposed rulemaking, a request for any additional data 
                needed, and a bibliography of all significant 
                scientific data and studies on which the proposed rule 
                is based. The statement of basis and purpose shall 
                include a summary of--
                            ``(i) the factual data on which the 
                        proposed rule is based;
                            ``(ii) the major scientific assumptions, 
                        legal interpretations, and policy 
                        considerations underlying the proposed rule;
                            ``(iii) a summary of available risk-benefit 
                        information, including benefits and use 
                        information as provided by the Secretary of 
                        Agriculture; and
                            ``(iv) the analysis and tentative 
                        conclusions of the Administrator regarding the 
                        balancing of the risks and benefits.
                    ``(B)(i) A registrant of the pesticide and a person 
                who submits comments on the proposed rule shall make a 
                report to the Administrator of all scientific data and 
                studies possessed by the person concerning the risks 
                and benefits of the pesticide that is the subject of 
                the rulemaking that were not included in the 
                bibliography included in the notice required under 
                subparagraph (A).
                    ``(ii) If, after the date of the report made under 
                clause (i), the registrant or the person receives 
                additional scientific data or studies pertinent to the 
                rulemaking that were not included in the bibliography, 
                the person shall make a report of the scientific data 
                and studies to the Administrator promptly after 
                receipt.
                    ``(iii) If the Administrator receives reports 
                containing additional data concerning risks or 
                benefits, the Administrator shall revise the 
                bibliography to reflect the data and make the revised 
                bibliography available to the public.
                    ``(C)(i) The Administrator shall provide a comment 
                period of not less than 90 days after the publication 
                of the notice of proposed rulemaking.
                    ``(ii) During the period, a person may submit 
                comments, data, or documentary information on the 
                proposed rule.
                    ``(iii) Promptly on receipt by the Administrator, 
                all written comments and documentary information on the 
                proposed rule received from a person for inclusion in 
                the docket during the comment period, shall be placed 
                in the docket.
                    ``(D)(i) At the same time as the Administrator 
                publishes notice under subparagraph (A), the 
                Administrator shall provide the Secretary of 
                Agriculture and the Secretary of Health and Human 
                Services with a copy of the proposed rule.
                    ``(ii) Not later than 90 days after the publication 
                of the notice of proposed rulemaking, the Secretary of 
                Agriculture and the Secretary of Health and Human 
                Services may provide comments on the proposed rule.
                    ``(iii) If an agricultural commodity is affected, 
                the Secretary of Agriculture shall provide to the 
                Administrator an analysis of the impact of the proposed 
                action on the domestic and global availability and 
                prices of agricultural commodities and retail food 
                prices and any associated societal impacts (including 
                impacts on consumer nutrition and health and low-income 
                consumers).
            ``(7) Informal hearing.--
                    ``(A)(i) A person who has submitted a comment may, 
                not later than 15 days after the close of the comment 
                period, request the Administrator to conduct an 
                informal hearing on questions of fact pertaining to the 
                proposed rule or comments on the rule.
                    ``(ii) The Administrator shall--
                            ``(I) on receipt of the request, schedule 
                        an informal hearing of not to exceed 20 days 
                        duration; and
                            ``(II) not later than 60 days after the 
                        close of the comment period, conduct the 
                        hearing.
                    ``(iii) The Administrator shall publish the time, 
                place, and purpose of the hearing in the Federal 
                Register.
                    ``(iv) The informal hearing shall be limited to 
                addressing questions of fact raised by materials in the 
                docket.
                    ``(v) A transcript shall be made of any oral 
                presentation, discussion, or debate and included in the 
                docket.
                    ``(B) The Administrator shall appoint a presiding 
                officer who shall have the authority to administer 
                oaths, regulate the course of the hearing, conduct 
                prehearing conferences, schedule presentations, and 
                exclude irrelevant, immaterial, or unduly repetitious 
                evidence.
                    ``(C)(i) The presiding officer shall conduct the 
                informal hearing in a manner that encourages discussion 
                and debate on questions of fact regarding the docket.
                    ``(ii) The Administrator shall designate 1 or more 
                employees of the Environmental Protection Agency to 
                participate in the hearing.
                    ``(iii) A person who submitted a comment on the 
                proposed rule may participate in the hearing and shall 
                be entitled to present evidence and argument to support 
                the position of the person or rebut a contrary position 
                and may choose to present materials in oral or written 
                form.
            ``(8) Review by scientific advisory panel.--
                    ``(A) At the time the Administrator issues a notice 
                of proposed rulemaking under paragraph (6), the 
                Administrator shall provide a copy of the notice to the 
                Scientific Advisory Panel established under section 
                25(d) (referred to in this paragraph as the `Panel').
                    ``(B) If a person submits comments under paragraph 
                (6) in opposition to the proposed rule, the 
                Administrator shall request the comments, evaluations, 
                and recommendations of the Panel as to the impact on 
                health and the environment of the proposed rule and on 
                any disputed issues of fact or scientific policy that 
                appear to be of significance in the rulemaking.
                    ``(C) The Panel may hold a public hearing to 
                discuss the proposed rule.
                    ``(D) The Panel shall provide a report to the 
                Administrator not later than 30 days after the close of 
                the comment period (or, if a hearing has been requested 
                under paragraph (7), not later than 30 days after the 
                end of the hearing).
                    ``(E) The Administrator shall allow a reasonable 
                time for written public comment on the report of the 
                Panel. A copy of the report of the Panel and any 
                comments on the report shall be included in the 
                rulemaking docket.
            ``(9) Final action.--
                    ``(A) After considering all material in the docket, 
                the Administrator shall publish in the Federal Register 
                a final rule or a withdrawal of the proposed rule.
                    ``(B) The Administrator may not prohibit a use of a 
                pesticide if an alternative requirement will ensure 
                that the pesticide, when used in accordance with 
                widespread and commonly recognized practice, will not 
                generally cause unreasonable adverse effects on the 
                environment.
                    ``(C) In taking a final action, the Administrator 
                shall take into account the impact of the action on 
                production and prices of agricultural commodities, 
                retail food prices, and otherwise on the agricultural 
                economy.
                    ``(D) The final rule or withdrawal of the proposed 
                rule shall be accompanied by a statement that--
                            ``(i) explains the reasons for the action;
                            ``(ii) responds to any comments made by the 
                        Secretary of Agriculture or the Secretary of 
                        Health and Human Services, and to any report of 
                        the Scientific Advisory Panel established under 
                        section 25(d);
                            ``(iii) responds to each significant 
                        comment contained in the docket; and
                            ``(iv) in the case of a final rule--
                                    ``(I) explains the reason for any 
                                major difference between the final rule 
                                and the proposed rule;
                                    ``(II) describes the impact of the 
                                final rule on production and prices of 
                                agricultural commodities, retail food 
                                prices, and otherwise on the 
                                agricultural economy; and
                                    ``(III) explains any significant 
                                disagreement the Administrator may have 
                                with any comment, evaluation, or 
                                recommendation contained in the report 
                                under paragraph (8), the benefits and 
                                use information described in paragraph 
                                (6)(A)(iii), or the analysis described 
                                in paragraph (6)(D) as the analysis 
                                bears on the final rule.
                    ``(E) A final rule issued under this subsection 
                shall become effective on the date of the publication 
                of the final rule in the Federal Register.
            ``(10) Modification or cancellation.--
                    ``(A)(i) Subject to clause (ii), a final rule shall 
                state any requirement, classification, or prohibition 
                imposed by the rule, and shall state that each affected 
                registrant shall have a 30-day period from the date of 
                the publication of the rule in the Federal Register to 
                apply for an amendment to the registration to comply 
                with the rule or to request voluntary cancellation of 
                the registration.
                    ``(ii) If the rule unconditionally prohibits all 
                uses of a pesticide, the rule may provide that 
                cancellation of the registration of the pesticide is 
                effective beginning on the date of the publication of 
                the rule.
                    ``(iii) The final rule may prohibit or limit 
                distribution or sale by the registrant of the affected 
                pesticide to any other person in a State during the 30-
                day period.
                    ``(B) Notwithstanding any other provision of this 
                Act, if an application for an amendment to the 
                registration to make the registration comply with a 
                rule issued under subparagraph (A) is not submitted 
                within the 30-day period, the Administrator may issue 
                and publish in the Federal Register an order canceling 
                the registration, effective beginning on the date of 
                the publication of the order in the Federal Register.
            ``(11) Denial of applications.--Notwithstanding any other 
        provision of this Act, no application for initial or amended 
        registration of a pesticide under section 3 or 24(c) may be 
        approved if the registration would be inconsistent with a rule 
        in effect under this subsection.
            ``(12) Amendment of rule.--
                    ``(A) A registrant, or other interested person with 
                the concurrence of the registrant, may petition for the 
                amendment or revocation of a rule that has been issued 
                under this subsection.
                    ``(B) The petition shall state the factual material 
                and argument that form the basis for the petition.
                    ``(C) The Administrator shall publish a notice of 
                the petition in the Federal Register and allow a 60-day 
                comment period on the petition.
                    ``(D) Not later than 180 days after publication of 
                the notice, the Administrator shall determine whether 
                to deny the petition or to propose to amend or revoke 
                the rule, and publish the determination and the basis 
                for the determination in the Federal Register.
                    ``(E) In making the determination, the 
                Administrator shall give due regard to--
                            ``(i) the desirability of finality;
                            ``(ii) the opportunity that the petitioner 
                        had to present the factual material and 
                        argument in question in the prior rulemaking 
                        proceeding; and
                            ``(iii) any new evidence submitted by the 
                        petitioner.
                    ``(F) If the Administrator proposes to amend or 
                revoke the rule, the procedures established by 
                paragraph (1) and paragraphs (6) through (9) shall 
                apply.
                    ``(G) A denial of a petition shall be judicially 
                reviewable as provided in paragraph (13).
            ``(13) Judicial review.--A decision not to initiate a 
        rulemaking published under paragraph (4), a final rule or a 
        withdrawal of a proposed rule published under paragraph (9), or 
        a denial of a petition under paragraph (12) shall be judicially 
        reviewable in the manner specified by section 16(b)(2).
            ``(14) Exception to requirements.--If the Administrator 
        finds it is necessary to issue a suspension order under 
        subsection (c), the Administrator may waive the requirements of 
        paragraphs (3) and (4).''.

SEC. 203. PESTICIDES IN REVIEW.

    If the Administrator of the Environmental Protection Agency, on or 
before January 1, 1993, publishes a document instituting a special 
review proceeding or public interim administrative review proceeding 
with respect to a pesticide or an active ingredient of a pesticide, the 
Administrator may, in lieu of proceeding under section 6(b) of the 
Federal Insecticide, Fungicide, and Rodenticide Act (as amended by 
section 202 of this Act), elect to continue the review proceeding and, 
on completion of the proceeding, take such action as is warranted in 
accordance with section 3(c)(6) and subsections (b) and (d) of section 
6 of the Federal Insecticide, Fungicide, and Rodenticide Act (as in 
effect on the day before the date of enactment of this Act).

SEC. 204. SUSPENSION.

    (a) Order.--Section 6(c)(1) (7 U.S.C. 136d(c)(1)) is amended by 
striking the second sentence and inserting the following new sentence: 
``Except as provided in paragraph (3), no order of suspension may be 
issued under this subsection unless the Administrator has issued, or at 
the same time issues, a proposed rule under subsection (b).''.
    (b) Emergency Order.--Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is 
amended by inserting after the first sentence the following new 
sentence: ``The Administrator may issue an emergency order under this 
paragraph before issuing a proposed rule under subsection (b), if the 
Administrator proceeds expeditiously to issue a proposed rule.''.

SEC. 205. 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 new subparagraph:
                    ``(E) As soon as the Administrator has sufficient 
                information with respect to the dietary risk of a 
                particular active ingredient, but in any event no later 
                than the time the Administrator makes a determination 
                under subparagraph (C) or (D) with respect to 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);
                            ``(ii) determine whether the tolerance or 
                        exemption meets the requirements of such 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. 206. SCIENTIFIC ADVISORY PANEL.

    Section 25(d) (7 U.S.C. 136w(d)) is amended--
            (1) 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 new paragraph:
            ``(2) Science review board.--
                    ``(A) There is established a Science Review Board 
                to consist of 60 scientists who shall be available to 
                the Scientific Advisory Panel to assist in reviews 
                conducted by the Panel.
                    ``(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. 207. CONFORMING AMENDMENTS.

    (a) Paragraph (6) of section 3(c) (7 U.S.C. 136a(c)(6)) is amended 
to read as follows:
            ``(6) Denial of application for registration.--
                    ``(A)(i) Except as provided in subparagraph (B), if 
                the Administrator proposes to deny an application for 
                registration because the application does not satisfy 
                the requirements of paragraph (5), the Administrator 
                shall notify the applicant of the proposal and the 
                reasons for the denial (including the factual basis of 
                the proposal).
                    ``(ii) Unless the applicant makes the necessary 
                corrections to the application and notifies the 
                Administrator of the corrections during the 30-day 
                period beginning on the day after the date the 
                applicant receives the notice, or during the period the 
                applicant submits a request for a hearing, the 
                Administrator may issue an order denying the 
                application.
                    ``(iii) If during the period referred to in clause 
                (ii), the Administrator does not receive the 
                corrections to the application or a request for a 
                hearing, the Administrator may issue an order denying 
                the application.
                    ``(iv) The order denying the application shall be 
                published in the Federal Register and shall not be 
                subject to judicial review.
                    ``(v) If during the period referred to in clause 
                (ii), the Administrator receives a request for a 
                hearing, a hearing shall be conducted under section 
                6(d).
                    ``(vi) If a hearing is held, a decision after 
                completion of the hearing shall be final and shall be 
                subject to judicial review under section 16(b)(1).
                    ``(B)(i) The Administrator may deny an application 
                for registration because the application does not 
                comply with the requirements of a rule issued under 
                section 6(b).
                    ``(ii) The Administrator shall notify the applicant 
                of the denial.
                    ``(iii) The notice shall explain why the 
                application does not comply with the requirements and 
                shall state that the applicant may petition to amend or 
                revoke the rule under section 6(b)(12).''.
    (b) Section 3(c) (7 U.S.C. 136a(c)) is amended by striking 
paragraph (8).
    (c) Section 3(d) (7 U.S.C. 136a(d)) is amended--
            (1) in paragraph (1)(A), by striking ``on the initial 
        classification and registered pesticides'' and inserting 
        ``under section 6(b). A registered pesticide''; and
            (2) in paragraph (2), by striking all that follows ``on the 
        environment,'' and inserting ``the Administrator may initiate a 
        proceeding under section 6(b).''.
    (d) Section 4(e)(3)(B)(iii)(III) (7 U.S.C. 136a-
1(e)(3)(B)(iii)(III)) is amended--
            (1) by striking ``section 6(d), except that the'' and 
        inserting ``section 6(d). The''; and
            (2) by inserting after ``guidelines.'' the following new 
        sentence: ``If a hearing is held, a decision after completion 
        of the hearing shall be final.''.
    (e) Section 6(c)(4) (7 U.S.C. 136d(c)(4)) is amended by striking 
``Section 16 of this Act'' and inserting ``section 16(b)(1)''.
    (f) Section 6(d) (7 U.S.C. 136d(d)) is amended--
            (1) by striking the first sentence and inserting the 
        following new sentence: ``If a hearing is requested pursuant to 
        section 3(c)(2)(B)(iv), 3(c)(6), or 4(e)(3)(B)(iii)(III), or 
        subsection (c)(2) or (e)(2), the hearing shall be held for the 
        purpose of receiving evidence relevant and material to the 
        issues raised by the request for the hearing.''; and
            (2) by striking all that follows the eighth sentence and 
        inserting the following new sentence: ``A hearing under this 
        subsection shall be held in accordance with sections 554, 556, 
        and 557 of title 5, United States Code. As soon as practicable 
        after the completion of the hearing, the Administrator shall 
        issue a final order setting forth the decision of the 
        Administrator. The order and decision shall be based only on 
        substantial evidence of the record of the hearing, shall set 
        forth detailed findings of fact on which the order is based, 
        and shall be subject to judicial review under section 
        16(b)(1).''.
    (g) Section 16(a) (7 U.S.C. 136n(a)) is amended by inserting after 
``a hearing'' the following: ``or a proceeding under section 6(b)''.
    (h) Section 16(b) (17 U.S.C. 136n(b)) is amended--
            (1) by striking ``(b) Review by Court of Appeals.--In the 
        case of'' and inserting the following:
    ``(b) Review by Court of Appeals.--
            ``(1) Review of certain orders.--In the case of'';
            (2) in the last sentence of paragraph (1) (as so 
        designated), by striking ``under this section'' and inserting 
        ``under this paragraph''; and
            (3) by adding at the end the following new paragraph:
            ``(2) Review of certain rules.--
                    ``(A) In the case of actual controversy as to the 
                validity of a rule issued by the Administrator under 
                section 6(b)(9), a decision by the Administrator under 
                paragraph (4) or (9) of section 6(b) not to issue a 
                proposed rule or to withdraw a proposed rule, or a 
                denial of a petition to revoke or amend a final rule 
                under section 6(b)(12), a person who will be adversely 
                affected by the rule or decision and who has filed 
                comments in the proceeding leading to the rule or 
                decision may obtain judicial review by filing a 
                petition in the United States court of appeals for the 
                circuit in which the person resides or has a place of 
                business, not later than 60 days after the entry of the 
                order.
                    ``(B) A copy of the petition shall be transmitted 
                to the Administrator or an officer designated by the 
                Administrator.
                    ``(C) On receipt of the copy of the petition, the 
                Administrator shall file in court the record of the 
                proceedings on which the Administrator based the rule 
                or decision, as provided in section 2112 of title 28, 
                United States Code.
                    ``(D) On the filing of the petition, the court 
                shall have exclusive jurisdiction to affirm or set 
                aside the rule or decision in whole or in part.
                    ``(E) The standard of review shall be the standard 
                set forth in section 706 of title 5, United States 
                Code.
                    ``(F) The judgment of the court under this 
                paragraph shall be final, subject to review by the 
                Supreme Court on certiorari or certification as 
                provided in section 1254 of title 28, United States 
                Code.
                    ``(G) The commencement of proceedings under this 
                section shall not, unless specifically ordered by the 
                court to the contrary, operate as a stay of an 
                order.''.
    (i) Section 25(a) (7 U.S.C. 136w(a)) is amended by adding at the 
end the following new paragraph:
            ``(5) Exception.--The requirements of this subsection shall 
        not apply to a rule or rulemaking proceeding under section 
        6(b).''.
    (j) Section 25(d)(1) (as designated by section 206) is further 
amended--
            (1) in the first sentence, by striking ``of the action 
        proposed in notices of intent issued under section 6(b) and''; 
        and
            (2) in the second sentence--
                    (A) by striking ``notices of intent and''; and
                    (B) by striking ``6(b) or 25(a), as applicable,'' 
                and inserting ``25(a),''.
    (k) The second sentence of section 25(e) (7 U.S.C. 136w(e)) is 
amended by inserting before the period at the end the following: ``, 
except for an action that may be taken under section 6(b)''.

SEC. 208. CONFORMING AMENDMENTS TO FIFRA TABLE OF CONTENTS.

    The table of contents in section 1(b) (7 U.S.C. prec. 121) is 
amended--
            (1) by striking the item relating to section 3(c)(6) and 
        inserting the following new item:

            ``(6) Denial of application for 
            registration.'';
            (2) by striking the item relating to section 3(c)(8);
            (3) by striking the item relating to section 6(b) and 
        inserting the following new items:

        ``(b) Cancellation and change in classification or 
            other terms or conditions of registration.
            ``(1) Authority.
            ``(2) Basis for rule.
            ``(3) Prenotice procedures.
            ``(4) Advance notice to public.
            ``(5) Docket.
            ``(6) Notice of proposed rulemaking.
            ``(7) Informal hearing.
            ``(8) Review by Scientific Advisory Panel.
            ``(9) Final action.
            ``(10) Modification or cancellation.
            ``(11) Denial of applications.
            ``(12) Amendment of rule.
            ``(13) Judicial review.
            ``(14) Exception to requirements.'';
            (4) by striking the item relating to section 16(b) and 
        inserting the following new items:

        ``(b) Review by court of appeals.
            ``(1) Review of certain orders.
            ``(2) Review of certain rules.'';
            (5) by adding at the end of the items relating to section 
        25(a) the following new item:

            ``(5) Exception.'';
            (6) by striking the item relating to section 25(d) and 
        inserting the following new items:

        ``(d) Scientific Advisory Panel.
            ``(1) In general.
            ``(2) Science Review Board.'';
        and
            (7) by striking the item relating to section 28(c) and 
        inserting the following new items:

        ``(c) Integrated pest management.
            ``(1) In general.
            ``(2) Joint research and development.''.

   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, 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.--Section 201 (21 U.S.C. 321) is amended by 
adding at the end the following:
    ``(gg) The term `processed food' means any food other than a raw 
agricultural commodity and includes any raw agricultural commodity that 
has been subject to processing, such as canning, cooking, freezing, 
dehydration, or milling.
    ``(hh) The term `Administrator' means the Administrator of the 
United States Environmental Protection Agency.''.

SEC. 303. PROHIBITED ACTS.

    Section 301(j) (21 U.S.C. 331(j)) is amended by inserting before 
the first period the following: ``, or the violation of section 
408(g)(2) or any regulation issued under such section.''.

SEC. 304. ADULTERATED FOOD.

    Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended to read as 
follows:
            ``(2) if--
                    ``(A) 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) it bears or contains a pesticide chemical 
                residue that is unsafe within the meaning of section 
                408(a); or
                    ``(C) 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, shall 
        mean 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) 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) 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 it is a 
        metabolite or other degradation product of a precursor 
        substance that itself is a pesticide chemical or pesticide 
        chemical residue, such a residue shall not be considered to be 
        unsafe within the meaning of section 402(a)(2)(B) despite the 
        lack of a tolerance or exemption from the need for a tolerance 
        for such residue in or on such food if--
                    ``(A) the Administrator has not determined that the 
                degradation product is likely to pose any potential 
                health risk from dietary exposure that is of a 
                different type than, or of a greater significance than, 
                any risk posed by dietary exposure to the precursor 
                substance;
                    ``(B) either--
                            ``(i) a tolerance is in effect under this 
                        section for residues of the precursor substance 
                        in or on the food, and the combined level of 
                        residues of the degradation product and the 
                        precursor substance in or on the food is at or 
                        below the stoichiometrically equivalent level 
                        that would be permitted by the tolerance if the 
                        residue consisted only of the precursor 
                        substance rather than the degradation product; 
                        or
                            ``(ii) an exemption from the need for a 
                        tolerance is in effect under this section for 
                        residues of the precursor substance in or on 
                        the food; and
                    ``(C) the tolerance or exemption for residues of 
                the precursor substance does not state that it applies 
                only to particular named substances or states that it 
                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 
                it 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 such studies, 
                available information and reasonable assumptions 
                concerning the relationship of the results of such 
                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 groups, 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 
                considered to be adequate to protect the public health 
                if the dietary risk posed to food consumers by such 
                level of the pesticide chemical residue is negligible. 
                The Administrator shall by regulation set forth the 
                factors and methods for determining whether such a risk 
                is negligible.
                    ``(E) 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.
                    ``(F) 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 
                such 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 greater risk to the public or the 
                        environment than the dietary risk from the 
                        pesticide chemical residue;
                            ``(ii) use of the pesticide avoids risks 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 that are greater than the risks 
                        that result from dietary exposure to the 
                        pesticide chemical residue; or
                            ``(iii) the unavailability of the pesticide 
                        would limit the availability to consumers of an 
                        adequate, wholesome, and economical food 
                        supply, taking into account regional and 
                        domestic effects, and such adverse effects are 
                        likely to outweigh the risk posed by the 
                        pesticide residue.
                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)(f) 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 specified 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 United States' consumers and whether 
        the data supporting the maximum residue level are valid, 
        complete, and reliable. If the Administrator determines not to 
        adopt a Codex maximum residue level, the Administrator shall 
        publish a notice in the Federal Register setting forth the 
        reasons.
    ``(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 subparagraph, 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 such pesticide 
                chemical residue in or on such food; or
                    ``(B) that there is no need for such a method, and 
                states the reasons for such determination in the order 
                issuing the regulation establishing or modifying the 
                regulation.
    ``(d) Petition for Tolerance or Exemption.--
            ``(1) Petitions and petitioners.--Any person may file with 
        the Administrator a petition proposing the issuance of a 
        regulation--
                    ``(A) establishing, modifying, or revoking a 
                tolerance for a pesticide chemical residue in or on a 
                food; or
                    ``(B) establishing or revoking an exemption from 
                the requirement of a tolerance for such a residue.
            ``(2) Petition contents.--
                    ``(A) Establishment.--A petition under paragraph 
                (1) to establish a tolerance or exemption for a 
                pesticide chemical residue shall be supported by such 
                data and information as are specified in regulations 
                issued by the Administrator, including--
                            ``(i)(I) an informative summary of the 
                        petition and of the data, information, and 
                        arguments submitted or cited in support of the 
                        petition; and
                            ``(II) a statement that the petitioner 
                        agrees that such summary or any information it 
                        contains may be published as a part of the 
                        notice of filing of the petition to be 
                        published under this subsection and as part of 
                        a proposed or final regulation issued under 
                        this section;
                            ``(ii) the name, chemical identity, and 
                        composition of the pesticide chemical residue 
                        and of the pesticide chemical that produces the 
                        residue;
                            ``(iii) data showing the recommended 
                        amount, frequency, method, and time of 
                        application of that pesticide chemical;
                            ``(iv) full reports of tests and 
                        investigations made with respect to the safety 
                        of the pesticide chemical, including full 
                        information as to the methods and controls used 
                        in conducting such 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 such 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 it. The 
                Administrator may require a petition to be accompanied 
                by samples of the pesticide chemical with respect to 
                which the petition is filed.
                    ``(B) Modification or revocation.--The 
                Administrator may by regulation establish the 
                requirements for information and data to support a 
                petition to modify or revoke a tolerance or to revoke 
                an exemption from the requirement for a tolerance.
            ``(3) Notice.--A notice of the filing of a petition that 
        the Administrator determines has met the requirements of 
        paragraph (2) shall be published by the Administrator within 30 
        days after such determination. The notice shall announce the 
        availability of a description of the analytical methods 
        available to the Administrator for the detection and 
        measurement of the pesticide chemical residue with respect to 
        which the petition is filed or shall set forth the petitioner's 
        statement of why such a method is not needed. The notice shall 
        include the summary required by paragraph (2)(A)(i).
            ``(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 to be objectionable and 
                stating reasonable grounds therefor. If the regulation 
                or order was issued in response to a petition under 
                paragraph (d)(1), a copy of each objection filed by a 
                person other than the petitioner shall be served by the 
                Administrator on the petitioner.
                    ``(B) 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 such a public hearing is 
                necessary to receive factual evidence relevant to 
                material issues of fact raised by the objections. The 
                presiding officer in such a hearing may authorize a 
                party to obtain discovery from other persons and may 
                upon a showing of good cause made by a party issue a 
                subpoena to compel testimony or production of documents 
                from any person. The presiding officer shall apply the 
                Federal Rules of Civil Procedure in making any order 
                for the protection of the witness or the content of 
                documents produced and shall order the payment of 
                reasonable fees and expenses as a condition to 
                requiring testimony of the witness. On contest, such a 
                subpoena may be enforced by a Federal district court.
                    ``(C) 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), such order and any 
                revision to the regulation or prior order shall, with 
                respect to questions of fact at issue in the hearing, 
                be based only on substantial evidence of record at such 
                hearing, and shall set forth in detail the findings of 
                facts and the conclusions of law or policy upon which 
                the order or regulation is based.
                    ``(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 its publication 
                unless the Administrator finds that emergency 
                conditions exist necessitating an earlier effective 
                date, in which event the Administrator shall specify in 
                the order the Administrator's findings as to such 
                conditions.
            ``(7) Judicial review.--
                    ``(A) Filing of petition.--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 such order or regulation may 
                obtain judicial review by filing in the United States 
                Court of Appeals for the circuit wherein such 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 such a petition, the court shall have exclusive 
                jurisdiction to affirm or set aside the order or 
                regulation complained of in whole or in part. 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 such an order shall be final, subject to 
                review by the Supreme Court of the United States as 
                provided in section 1254 of title 28 of the United 
                States Code. The commencement of proceedings under this 
                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 its publication.
            ``(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 contrary to 
        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 
        are reasonably required to support the continuation of a 
        tolerance or exemption that is in effect under this section for 
        a pesticide chemical residue on a food, the Administrator 
        shall--
                    ``(A) issue a notice requiring the persons holding 
                the pesticide registrations associated with such 
                tolerance or exemption to submit the data or 
                information under section 3(c)(2)(B) of the Federal 
                Insecticide, Fungicide, and Rodenticide Act (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 an order issued 
        under paragraph (1)(B) is not made by the time specified in 
        such notice or order, 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 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 such data in 
                the carrying out of their official duties under this 
                Act or other Federal laws intended to protect the 
                public health; or
                    ``(B) contractors with the United States authorized 
                by the Administrator to examine such 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 it 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 
        whose use results in such residue to ensure that any authorized 
        use of the pesticide in producing, storing, processing, or 
        transporting food that occurs after the issuance of such final 
        rule under this section will not result in pesticide chemical 
        residues on such food that are unsafe within the meaning of 
        subsection (a).
            ``(2) Revocation of tolerance or exemption following 
        cancellation of associated registrations.--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 its use in connection with the 
        production, storage, or transportation of such food, due in 
        whole or in part to dietary risks to humans posed by residues 
        of such pesticide chemical on such food, the Administrator 
        shall revoke any tolerance or exemption that allows the 
        presence of such pesticide chemical, or any pesticide chemical 
        residue that results from its use, in or on such food. The 
        Administrator shall use the procedures set forth in subsection 
        (e) in taking action under this paragraph. A revocation under 
        this paragraph shall become effective not later than 180 days 
        after--
                    ``(A) the date by which each such cancellation of a 
                registration has become effective; or
                    ``(B) the date on which the use of the canceled 
                pesticide becomes unlawful under the terms of the 
                cancellation,
        whichever is later.
            ``(3) Suspension of tolerance or exemption following 
        suspension of associated registrations.--
                    ``(A) Suspension.--If the Administrator, acting 
                under the Federal Insecticide, Fungicide, and 
                Rodenticide Act (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 such 
                pesticide chemical on such food, the Administrator 
                shall suspend any tolerance or exemption that allows 
                the presence of such pesticide chemical, or any 
                pesticide chemical residue that results from its use, 
                in or on such 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 such 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 such 
        food. In establishing such a tolerance, the Administrator shall 
        take into account the factors set forth in subsection 
        (b)(2)(F)(iii) and shall use the procedures set forth in 
        subsection (e). The Administrator shall review any such 
        tolerance periodically and modify it as necessary so that it 
        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 that food shall not be considered 
        unsafe solely because of the presence of such pesticide 
        chemical residue in or on such food if it is shown to the 
        satisfaction of the Secretary that--
                    ``(A) the residue is present as the result of an 
                application or use of a pesticide at a time and in a 
                manner that was lawful under the Federal Insecticide, 
                Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.); 
                and
                    ``(B) the residue does not exceed a level that was 
                authorized at the time of that application or use to be 
                present on the food under a tolerance, exemption, food 
                additive regulation, or other sanction then in effect 
                under this Act,
        unless, in the case of any tolerance or exemption revoked, 
        suspended, or modified under this subsection or subsection (d) 
        or (e), the Administrator has issued a determination that 
        consumption of the legally treated food during the period of 
        its likely availability in commerce will pose an unreasonable 
        dietary risk.
    ``(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 
Administrator's functions under this section. Under the regulations, 
the performance of the Administrator's services or other functions 
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 such fees. The regulations may 
further provide for waiver or refund of fees in whole or in part when 
in the judgment of the Administrator such a waiver or refund is 
equitable and not contrary to the purposes of this subsection.
    ``(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, 
                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 
                the Federal Insecticide, Fungicide, and Rodenticide Act 
                (7 U.S.C. 136a-1(g)) on or after the date of enactment 
                of the Food Quality Protection Act of 1993.
            ``(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 1993; and
                            ``(ii) issued (or, pursuant to subsection 
                        (h) or (i), deemed to have been issued) under 
                        this section, 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 such pesticide chemical residue level 
                permitted by such statement during the period to which 
                such 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 such pesticide chemical residue in or on 
        such food, unless such State regulatory limit is identical to 
        such qualifying Federal determination. A State or political 
        subdivision shall be considered to establish or enforce a 
        regulatory limit on a pesticide chemical residue in or on food 
        if it purports to prohibit or penalize the production, 
        processing, shipping, or other handling of a food because it 
        contains a pesticide residue (in excess of a prescribed limit), 
        or if it 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 such qualifying pesticide chemical 
                residue.
                    ``(B) Petition requirements.--Any petition under 
                subparagraph (A) shall--
                            ``(i) satisfy any requirements prescribed, 
                        by rule, by the Administrator; and
                            ``(ii) be supported by scientific data 
                        about the pesticide chemical residue that is 
                        the subject of the petition or about chemically 
                        related pesticide chemical residues, data on 
                        the consumption within such State of food 
                        bearing the pesticide chemical residue, and 
                        data on exposure of humans within such State to 
                        the pesticide chemical residue.
                    ``(C) 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 subsections (d)(6) 
                and (d)(7).
            ``(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 such residue, the sale of such food with such 
        residue level was lawful under this Act and under the law of 
        such State, unless the State demonstrates that consumption of 
        the food containing such pesticide residue level during the 
        period of the food's likely availability in the State will pose 
        an unreasonable dietary risk to the health of persons within 
        such State.''.

SEC. 305. CONFORMING AMENDMENT.

    Section 512(a)(1) (21 U.S.C. 360b(a)(1)) is amended by striking 
``section 402(a)(2)(D)'' and inserting ``section 402(a)(2)(C)(ii)''.

SEC. 306. AUTHORIZATION FOR INCREASE MONITORING.

    There is authorized to be appropriated $12,000,000 in addition to 
other amounts appropriated for increased monitoring by the Secretary of 
Health and Human Services of pesticide residues in imported and 
domestic food.

                                 <all>

S 1478 IS----2
S 1478 IS----3
S 1478 IS----4
S 1478 IS----5
```