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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1627 Introduced in House (IH)]

103d CONGRESS
  1st Session
                                H. R. 1627

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

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             April 1, 1993

Mr. Lehman (for himself, Mr. Bliley, Mr. Rowland, Mr. Smith of Oregon, 
   Mr. Roberts, Mr. Penny, Mr. English of Oklahoma, Mr. Holden, Mr. 
   Emerson, Mr. Kingston, Mr. Sarpalius, Mr. Ewing, Mr. Dooley, Mr. 
  Johnson of South Dakota, Mr. Barrett of Nebraska, Mr. Boehner, Mr. 
  Combest, Mr. Doolittle, Mr. Condit, Mr. Bishop, Mr. Gunderson, Mr. 
  Pomeroy, Mr. Allard, Mr. Towns, Mr. Cooper, Mr. Hall of Texas, Mr. 
 McMillan, Mr. Hastert, Mr. Upton, Mr. Paxon, Mr. Klug, Mr. Franks of 
 Connecticut, Mr. Manton, Mr. Boucher, Mr. Crapo, Mr. Barton of Texas, 
 Mr. Gillmor, Mr. Oxley, Mr. Tauzin, and Mr. Moorehead) introduced the 
    following bill; which was referred jointly to the Committees on 
                  Agriculture and Energy and Commerce

                            August 18, 1993

 Additional sponsors: Mr. Johnson of Georgia, Mr. Parker, Mr. Darden, 
  Mr. Lipinski, Mr. Stump, Mr. Hancock, Mr. Bereuter, Mr. Walsh, Mr. 
Dornan, Mr. Bateman, Mr. Hughes, Mr. Smith of Michigan, Mr. Herger, Mr. 
 Baker of Louisiana, Mr. Payne of Virginia, Mr. Inhofe, Mr. Coble, Mr. 
Sundquist, Mr. Ravenel, Mr. Pombo, Mr. Sisisky, Mr. Wise, Mr. LaRocco, 
Mr. Camp, Mr. Canady, Mr. Walker, Mr. Roth, Mr. Houghton, Mr. Coleman, 
   Mr. Stearns, Mr. Thomas of Wyoming, Mr. Hefner, Mr. McCrery, Ms. 
Danner, Mr. Goodling, Mr. McDade, Mr. Valentine, Mr. Burton of Indiana, 
Mr. Dreier, Mr. Lewis of Florida, Mr. Clyburn, Mr. Gekas, Mr. Deal, Mr. 
 Kanjorski, Mr. Gingrich, Mr. Shuster, Mr. Grams, Mr. Taylor of North 
 Carolina, Mr. Traficant, Mr. Schaefer, Mr. Gallegly, Mr. Hutchinson, 
  Mr. Andrews of New Jersey, Mr. Peterson of Minnesota, Ms. Dunn, Mr. 
     Gallo, Mr. Ballenger, Mr. Zeliff, Mr. Goodlatte, Mr. Baker of 
   California, Mr. Armey, Mr. Brewster, Mr. Peterson of Florida, Mr. 
   Hansen, Mrs. Lloyd, Mr. Solomon, Mr. Neal of North Carolina, Mr. 
   Bonilla, Mr. Gonzalez, Mr. Gutierrez, Mr. Collins of Georgia, Mr. 
 Duncan, Mr. Cox, Mr. Lightfoot, Ms. Kaptur, Mr. Young of Alaska, Mr. 
                        Gilchrest, and Mr. Fazio

_______________________________________________________________________

                                 A BILL

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

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

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

                  TITLE I--CANCELLATION AND SUSPENSION

SEC. 101. REFERENCE.

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

SEC. 102. CANCELLATION.

    Section 6(b) (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), 
        or may classify any such pesticide, or may prohibit the 
        registration or continued registration of any such pesticide 
        for some or all purposes, to the extent necessary to assure 
        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 prudent concerns of unreasonable 
                adverse effects to man or to 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 upon 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 paragraph (1) 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 any previous analysis of the validated test 
                or significant evidence presented to the committee and 
                who are expert 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 furnished to the registrant of each affected 
                pesticide a notice that includes a summary of the 
                validated test or other significant evidence upon which 
                the Administrator proposes to base the rulemaking and 
                the basis for a determination that such test or 
                evidence raises prudent concerns that the pesticide 
                causes unreasonable adverse risks to man or to the 
                environment. A registrant shall have 30 days after 
                receipt of a notice provided under this subparagraph to 
                respond to such notice.
                    ``(B) At the same time that the Administrator 
                furnishes notice to registrants of the pesticide under 
                subparagraph (A), the Administrator shall also furnish 
                such notice to the Secretary of Agriculture and the 
                Secretary of Health and Human Services. Upon receipt of 
                such notification, the Secretary of Agriculture, when 
                an agricultural commodity is affected, shall prepare an 
                analysis of the benefit and use data of the pesticide 
                and provide the analysis to the Administrator.
            ``(4) Advance notice to public.--
                    ``(A) The Administrator 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 any 
                registrant shall either--
                            ``(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 such notice 
                in the Federal Register and provide a period of not 
                less than 60 days for comment thereon. The notice shall 
                contain a statement of its basis and purpose, which 
                shall include a summary of--
                            ``(i) the factual data on which the notice 
                        is based,
                            ``(ii) the major scientific assumptions 
                        underlying the notice, and
                            ``(iii) a summary of the notice under 
                        paragraph (3) and any significant comments 
                        received from any 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 its basis.
            ``(5) Docket.--For each rulemaking under paragraph (1), the 
        Administrator shall establish a docket. The docket shall 
        include a copy of the notice under paragraph (3), of any notice 
        issued under paragraph (4), of the notice of proposed 
        rulemaking under paragraph (6), of each timely comment filed 
        with the Administrator, of the report of the Scientific 
        Advisory Panel under paragraph (8), of a record of each hearing 
        held by the Administrator in connection with the rulemaking, 
        and of the final rule or decision to withdraw the rule. 
        Information in the docket shall be made available to the public 
        consistent with the requirements of section 10. No factual 
        material that has not been entered into the docket in a timely 
        manner may be relied upon by the Administrator in issuing a 
        final rule or in withdrawing a proposed rule or by any person 
        in a judicial review proceeding, except for--
                    ``(A) information of which the Administrator may 
                properly take official notice, or
                    ``(B) 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 its basis and purpose, 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 Administrator's analysis and 
                        tentative conclusions regarding the balancing 
                        of such risks and benefits.
                    ``(B) Registrants of the pesticide and any person 
                who submits comments on the proposed rule shall make a 
                report to the Administrator of all scientific data and 
                studies in such person's possession concerning the 
                risks and benefits of the pesticide that are the 
                subject of the rulemaking and were not included in the 
                bibliography included in the notice required in 
                subparagraph (A). If such person receives additional 
                scientific data or studies pertinent to the rulemaking 
                that were not included in such bibliography, the person 
                shall make a report of such scientific data and studies 
                to the Administrator promptly after receipt. If the 
                Administrator receives reports containing additional 
                data concerning risks or benefits, the Administrator 
                shall revise the bibliography to reflect such data and 
                make the revised bibliography available to the public.
                    ``(C) The Administrator shall provide a comment 
                period of not less than 90 days after the publication 
                of the notice of proposed rulemaking. During such 
                period any person may submit comments, data, or 
                documentary information on the proposed rule. Promptly 
                upon receipt by the Administrator, all written comments 
                and documentary information on the proposed rule 
                received from any person for inclusion in the docket 
                during the comment period, shall be placed in the 
                docket.
                    ``(D) At the same time that 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. 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 such proposed rule. When 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 consumer nutrition and 
                health and low-income consumers).
            ``(7) Informal hearing.--
                    ``(A) Any person who has submitted a comment may, 
                not later than 15 days after the close of the comment 
                period, request of the Administrator an informal 
                hearing on questions of fact pertaining to the proposed 
                rule or comments thereon. Upon such request, the 
                Administrator shall schedule an informal hearing not to 
                exceed 20 days duration, and to conduct not later than 
                60 days after the close of the comment period. The 
                Administrator shall announce the time, place, and 
                purpose of the hearing in the Federal Register. The 
                informal hearing shall be limited to addressing 
                questions of fact raised by materials in the docket. 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) The presiding officer shall conduct the 
                informal hearing in a manner that encourages discussion 
                and debate on questions of fact regarding the docket. 
                The Administrator shall designate one or more employees 
                of the Environmental Protection Agency to participate 
                in the hearing. Any 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 participant's position or rebut a contrary 
                position and may choose to present materials in oral or 
                written form.
            ``(8) Review by scientific advisory panel.--At the time the 
        Administrator issues a notice of proposed rulemaking under 
        paragraph (6), the Administrator shall provide a copy of such 
        notice to the Scientific Advisory Panel established under 
        section 25(d). If any 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. The 
        Panel may hold a public hearing to discuss the proposed rule. 
        The Panel shall provide a report to the Administrator not later 
        than 30 days after the close of comment period (or, if a 
        hearing has been requested under paragraph (7), not later than 
        30 days after the end of such hearing). The Administrator shall 
        allow a reasonable time for written public comment on the 
        Panel's report. A copy of the Panel's report and any comments 
        shall be included in the rulemaking docket.
            ``(9) Final action.--After considering all material in the 
        docket, the Administrator shall publish in the Federal Register 
        either a final rule or a withdrawal of the proposed rule. The 
        Administrator may not prohibit a use of a pesticide if 
        alternative requirements will assure that the pesticide, when 
        used in accordance with widespread and commonly recognized 
        practice, will not generally cause unreasonable adverse effects 
        on the environment. In taking any 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 agricultural economy. The final 
        rule or withdrawal of the proposal shall be accompanied by a 
        statement that--
                    ``(A) explains the reasons for the action;
                    ``(B) responds to any comments made by the 
                Secretary of Agriculture or the Secretary of Health and 
                Human Services, and responds to any report of the 
                Scientific Advisory Panel;
                    ``(C) responds to each significant comment 
                contained in the docket; and
                    ``(D) in the case of a final rule--
                            ``(i) explains the reasons for any major 
                        differences 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 
                        disagreements the Administrator may have with 
                        the comments, evaluations, or recommendations 
                        contained in the report under paragraph (8) or 
                        the benefits and use information described in 
                        paragraph (6)(A)(iii) and analysis in paragraph 
                        (6)(D) as it bears on the final rule.
        A final rule issued under this subsection shall be effective 
        upon the date of its publication in the Federal Register.
            ``(10) Modification or cancellation.--
                    ``(A) A final rule shall state any requirements, 
                classifications, or prohibitions imposed by the rule, 
                and shall state that each affected registrant shall 
                have a 30-day period from the date of 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. However, if the rule unconditionally 
                prohibits all uses of a pesticide, the rule may provide 
                that cancellation of the registration of the pesticide 
                is effective upon publication of the rule. The final 
                rule may prohibit or limit distribution or sale by the 
                registrant of the affected pesticide to any other 
                person in any State during such 30-day period.
                    ``(B) Notwithstanding any other provision of this 
                Act, if an application for an amendment to the 
                registration to make it comply with a rule issued under 
                subparagraph (A) is not submitted within such 30-day 
                period, the Administrator may issue and publish in the 
                Federal Register an order canceling the registration, 
                effective upon the date of 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 any 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 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. The petition shall state the 
        factual material and argument that form the basis for the 
        petition. The Administrator shall publish a notice of the 
        petition in the Federal Register and allow a 60-day comment 
        period thereon. 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 its basis in the Federal 
        Register. In making such a determination, the Administrator 
        shall give due regard to the desirability of finality, to the 
        opportunity that the petitioner had to present the factual 
        material and argument in question in the prior rulemaking 
        proceeding, and to any new evidence submitted by the 
        petitioner. If the Administrator proposes to amend or revoke 
        the rule, then the procedures established by paragraph (1) and 
        paragraphs (6) through (9) apply. 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 necessary to issue a suspension order under subsection 
        (c), the Administrator may waive the requirements of paragraphs 
        (3) and (4) of this subsection.''.

SEC. 103. PESTICIDES IN REVIEW.

    If the Administrator, on or before January 1, 1993, has published a 
document instituting a special review proceeding or public interim 
administrative review proceeding with respect to a particular pesticide 
or active ingredient thereof, the Administrator may, in lieu of 
proceeding under section 6(b) of the Federal Insecticide, Fungicide, 
and Rodenticide Act as amended by the Food Quality Protection Act of 
1993, elect to continue such review proceeding and, upon its 
completion, take action as warranted in accordance with sections 
3(c)(6), 6(b), and 6(d) as those sections were in effect on the day 
before the date of enactment of the Food Quality Protection Act of 
1993.

SEC. 104. SUSPENSION.

    (a) Section 6(c)(1).--The second sentence of section 6(c)(1) (7 
U.S.C. 136d(c)(1)) is revised to read: ``Except as provided in 
paragraph (3), no order of suspension may be issued under this 
subsection unless the Administrator has issued, or at the same time 
issues, a proposed rule under subsection (b).''.
    (b) Section 6(c)(3).--Section 6(c)(3) (7 U.S.C. 136d(c)(1)) 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), provided 
that the Administrator shall proceed expeditiously to issue a proposed 
rule.''.

SEC. 105. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

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

SEC. 106. SCIENTIFIC ADVISORY PANEL.

    The first sentence of section 25(d) (7 U.S.C. 136w(d)) is amended 
by striking out ``The Administrator shall'' and inserting in lieu 
thereof ``(1) In general.--The Administrator shall'' and such section 
is amended by adding at the end the following:
            ``(2) Science review board.--There is established a Science 
        Review Board to consist of 60 scientists who shall be available 
        to the Scientific Advisory Panel to assist in reviews conducted 
        by the Panel. The Scientific Advisory Panel shall select the 
        scientists from 60 nominations submitted each by the National 
        Science Foundation and the National Institutes of Health. 
        Members of the Board shall be compensated in the same manner as 
        members of the Panel.''.

SEC. 107. CONFORMING AMENDMENTS.

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

                       TITLE II--DATA COLLECTION

SEC. 201. COLLECTION OF PESTICIDE USE INFORMATION.

    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. Such data shall be collected by surveys of 
farmers or from other sources offering statistically reliable data. The 
Secretary shall, as appropriate, coordinate with the Administrator of 
the Environmental Protection Agency in the design of such surveys and 
make available to the Administrator the aggregate results of such 
surveys to assist the Administrator in developing exposure calculations 
and benefits determinations with respect to pesticide regulatory 
decisions.

SEC. 202. 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 designating the text of such section as paragraph 
        (1) with the margin indented one em, and
            (2) by adding at the end the following:
    ``(2) The Administrator and the Secretary of Agriculture shall 
research, develop, and disseminate integrated pest management 
techniques and other pest control methods that enable producers to 
reduce or eliminate applications of pesticides which pose a greater 
than negligible dietary risk to humans, with a special focus on crops 
critical to a balanced, healthy diet and which are considered as minor 
crops in terms of acreage produced.''.

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

SEC. 301. REFERENCE.

    Whenever in this title an amendment is expressed in terms of an 
amendment to a section or other provision, or refers to a section or 
other provision, the reference shall be considered to be made to a 
section or other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 302. DEFINITIONS.

    (a) 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 the Federal Insecticide, Fungicide, and Rodenticide Act, or
            ``(B) any active or inert ingredient of a pesticide within 
        the meaning of the Federal Insecticide, Fungicide, and 
        Rodenticide Act.
    ``(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 paragraphs (1) and (2), the Administrator may 
by regulation except a substance from the definition of `pesticide 
chemical' or `pesticide chemical residue' if--
            ``(A) its occurrence as a residue on 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) Paragraphs (1) and (2) of section 201(s) (21 U.S.C. 321(s)) are 
amended to read as follows:
            ``(1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
            ``(2) a pesticide chemical; or''.
    (c) Section 201 (21 U.S.C. 321) is amended by adding at the end the 
following:
    ``(bb) 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.
    ``(cc) 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--
            (1) by striking the period at the end; and
            (2) by adding at the end ``, or the violation of section 
        408(g)(2) or any regulation issued under that section.''.

SEC. 304. ADULTERATED FOOD.

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

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

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

      ``tolerances and exemptions for pesticide chemical residues

    ``Sec. 408. (a) Requirement for Tolerance or Exemption.--
            ``(1) General rule.--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. Except as 
        provided in paragraph (2) or (3), any pesticide chemical 
        residue in or on a food shall be deemed unsafe for the purpose 
        of section 402(a)(2)(B) unless--
                    ``(A) a tolerance for such pesticide chemical 
                residue in or on such food is in effect under this 
                section and the 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.
            ``(2) Processed food.--Notwithstanding paragraph (1)--
                    ``(A) if a tolerance is in effect under this 
                section for a pesticide chemical residue in or on a raw 
                agricultural commodity, a pesticide chemical residue 
                that is present in or on a processed food because the 
                food is made from that raw agricultural commodity shall 
                not be considered unsafe within the meaning of section 
                402(a)(2)(B) despite the lack of a tolerance for the 
                pesticide chemical residue in or on the processed food 
                if the 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).
            ``(3) Residues of degradation products.--If a pesticide 
        chemical residue is present in or on a food because it is a 
        metabolite or other degradation product of a precursor 
        substance that itself is a pesticide chemical or pesticide 
        chemical residue, such a residue shall not be considered to be 
        unsafe within the meaning of section 402(a)(2)(B) despite the 
        lack of a tolerance or exemption from the need for a tolerance 
        for such residue in or on such food if--
                    ``(A) the Administrator has not determined that the 
                degradation product is likely to pose any potential 
                health risk from dietary exposure that is of a 
                different type than, or of a greater significance than, 
                any risk posed by dietary exposure to the precursor 
                substance, and
                    ``(B) either--
                            ``(i) a tolerance is in effect under this 
                        section for residues of the precursor substance 
                        in or on the food, and the combined level of 
                        residues of the degradation product and the 
                        precursor substance in or on the food is at or 
                        below the stoichiometrically equivalent level 
                        that would be permitted by the tolerance if the 
                        residue consisted only of the precursor 
                        substance rather than the degradation product, 
                        or
                            ``(ii) an exemption from the need for a 
                        tolerance is in effect under this section for 
                        residues of the precursor substance in or on 
                        the food, and
                    ``(C) the tolerance or exemption for residues of 
                the precursor substance does not state that it applies 
                only to particular named substances or states that it 
                does not apply to residues of the degradation product.
            ``(4) Effect of tolerance or exemption.--While a tolerance 
        or exemption from the requirement for a tolerance is in effect 
        under this section for a pesticide chemical residue with 
        respect to any food, the food shall not by reason of bearing or 
        containing any amount of such a residue be considered to be 
        adulterated within the meaning of section 402(a)(1).
    ``(b) Authority and Standard for 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) 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) 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) 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) to the pesticide chemical residue, and 
        available information and reasonable assumptions concerning the 
        variability of the sensitivities of major identifiable groups 
        and shall consider other factors to the extent required by 
        subparagraph (F).
            ``(D) For purposes of subparagraph (A), a tolerance level 
        for a pesticide chemical residue in or on a food shall be 
        deemed to be adequate to protect the public health if the 
        dietary risk posed to food consumers by 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) 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) 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 
        deemed 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; or
                    ``(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) A tolerance may be issued under the 
        authority of paragraph (2)(E) 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) 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) 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) 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) 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) 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,
                            ``(II) a statement that the petitioner 
                        agrees that such summary or any information it 
                        contains may be published as a part of the 
                        notice of filing of the petition to be 
                        published under this subsection and as part of 
                        a proposed or final regulation issued under 
                        this section,
                            ``(ii) the name, chemical identity, and 
                        composition of the pesticide chemical residue 
                        and of the pesticide chemical that produces the 
                        residue,
                            ``(iii) data showing the recommended 
                        amount, frequency, method, and time of 
                        application of that pesticide chemical,
                            ``(iv) full reports of tests and 
                        investigations made with respect to the safety 
                        of the pesticide chemical, including full 
                        information as to the methods and controls used 
                        in conducting those tests and investigations,
                            ``(v) full reports of tests and 
                        investigations made with respect to the nature 
                        and amount of the pesticide chemical residue 
                        that is likely to remain in or on the food, 
                        including a description of the analytical 
                        methods used,
                            ``(vi) a practical method for detecting and 
                        measuring the levels of the pesticide chemical 
                        residue in or on the food, or 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(s) used to produce that food,
                            ``(xi) such information as the 
                        Administrator may require to make the 
                        determination under subsection (b)(2)(E), and
                            ``(xii) such other data and information as 
                        the Administrator requires by regulation to 
                        support the petition.
                If information or data required by this subparagraph is 
                available to the Administrator, the person submitting 
                the petition may cite the availability of the 
                information or data in lieu of submitting 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) Within 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 
                deemed 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) An objection may include a request for a 
                public evidentiary hearing upon the objection. The 
                Administrator shall, upon the initiative of the 
                Administrator or upon the request of an interested 
                person and after due notice, hold a public evidentiary 
                hearing if and to the extent the Administrator 
                determines that such a public hearing is necessary to 
                receive factual evidence relevant to material issues of 
                fact raised by the objections. The presiding officer in 
                such a hearing may authorize a party to obtain 
                discovery from other persons and may upon a showing of 
                good cause made by a party issue a subpoena to compel 
                testimony or production of documents from any person. 
                The presiding officer shall be governed by the Federal 
                Rules of Civil Procedure in making any order for the 
                protection of the witness or the content of documents 
                produced and shall order the payment of reasonable fees 
                and expenses as a condition to requiring testimony of 
                the witness. On contest, such a subpoena may be 
                enforced by a Federal district court.
                    ``(C) As soon as practicable after receiving the 
                arguments of the parties, the Administrator shall issue 
                an order stating the action taken upon each such 
                objection and setting forth any revision to the 
                regulation or prior order that the Administrator has 
                found to be warranted. If a hearing was held under 
                subparagraph (B), such order and any revision to the 
                regulation or prior order shall, with respect to 
                questions of fact at issue in the hearing, be based 
                only on substantial evidence of record at such hearing, 
                and shall set forth in detail the findings of facts and 
                the conclusions of law or policy upon which the order 
                or regulation is based.
                    ``(D) 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) 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 that person resides or has its 
        principal place of business, or in the United States Court of 
        Appeals for the District of Columbia Circuit, within 60 days 
        after publication of such order, a petition praying that the 
        order or regulation be set aside in whole or in part.
            ``(B) 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) 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) The judgment of the court affirming or setting aside, 
        in whole or in part, any order under paragraph (6) and any 
        regulation which is the subject of such an order shall be 
        final, subject to review by the Supreme Court of the United 
        States as provided in section 1254 of title 28 of the United 
        States Code. The commencement of proceedings under this 
        paragraph shall not, unless specifically ordered by the court 
        to the contrary, operate as a stay of a regulation or order.
            ``(E) 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,
                    ``(B) issue a rule requiring that testing be 
                conducted on a substance or mixture under section 4 of 
                the Toxic Substances Control Act, or
                    ``(C) publish in the Federal Register, after first 
                providing notice and an opportunity for comment of not 
                less than 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 or 
                        section 4 of the Toxic Substances Control Act,
                            ``(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.
            ``(2) Exceptions.--Data that are entitled to confidential 
        treatment under paragraph (1) may nonetheless be disclosed to 
        the Congress of the United States, and may be disclosed, under 
        such security requirements as the Administrator may provide by 
        regulation, to--
                    ``(A) employees of the United States authorized by 
                the Administrator to examine such data in the carrying 
                out of their official duties under this Act or other 
                Federal statutes intended to protect the public health, 
                or
                    ``(B) contractors with the United States authorized 
                by the Administrator to examine 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 with 
        respect to the registration of the pesticide(s) 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, cancels the registration of each pesticide 
        that contains a particular pesticide chemical and that is 
        labeled for use on a particular food, or requires that the 
        registration of each such pesticide be modified to prohibit its 
        use in connection with the production, storage, or 
        transportation of such food, due in whole or in part to dietary 
        risks to humans posed by residues of that pesticide chemical on 
        that food, the Administrator shall revoke any tolerance or 
        exemption that allows the presence of the pesticide chemical, 
        or any pesticide chemical residue that results from its use, in 
        or on that food. 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, suspends the use of each registered 
                pesticide that contains a particular pesticide chemical 
                and that is labeled for use on a particular food, due 
                in whole or in part to dietary risks to humans posed by 
                residues of that pesticide chemical on that food, the 
                Administrator shall suspend any tolerance or exemption 
                that allows the presence of the pesticide chemical, or 
                any pesticide chemical residue that results from its 
                use, in or on that food. 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. 
                While a suspension of a tolerance or exemption is 
                effective the tolerance or exemption shall not be 
                considered to be in effect. If the suspension of use of 
                the pesticide under that Act is terminated, leaving the 
                registration of the pesticide for such use in effect 
                under that Act, the Administrator shall rescind any 
                associated suspension of 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)(A)(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 deemed 
        unsafe solely because of the presence of such pesticide 
        chemical residue in or on such food if it is shown to the 
        satisfaction of the Secretary that--
                    ``(A) the residue is present as the result of an 
                application or use of a pesticide at a time and in a 
                manner that was lawful under the Federal Insecticide, 
                Fungicide, and Rodenticide Act; and
                    ``(B) the residue does not exceed a level that was 
                authorized at the time of that application or use to be 
                present on the food under a tolerance, exemption, food 
                additive regulation, or other sanction then in effect 
                under this Act;
        unless, in the case of any tolerance or exemption revoked, 
        suspended, or modified under this subsection or subsection (d) 
        or (e), the Administrator has issued a determination that 
        consumption of the legally treated food during the period of 
        its likely availability in commerce will pose an unreasonable 
        dietary risk.
    ``(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 on or after April 25, 1985, on the 
                basis of data determined by the Administrator to meet 
                all applicable requirements for data prescribed by 
                regulations in effect under that Act on April 25, 1985; 
                or
                    ``(B) was approved for such use in a reregistration 
                eligibility determination issued under section 4(g) of 
                that Act on or after the date of enactment of 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;
                            ``(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 subsections (d)(6) and (d)(7).
            ``(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 deemed 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) 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) 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) 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) 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) 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. 306. AUTHORIZATION FOR INCREASE MONITORING.

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

                                 <all>

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