```

[Congressional Bills 104th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1627 Introduced in House (IH)]

  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

                              May 12, 1995

 Mr. Bliley (for himself, Mr. Towns, Mr. Roberts, Mr. de la Garza, Mr. 
 Emerson, Mr. Condit, Mr. Bilirakis, Mr. Gunderson, Mr. Stenholm, Mr. 
 Combest, Mr. Montgomery, Mr. Allard, Mr. Young of Alaska, Mr. Johnson 
of South Dakota, Mr. Walker, Mr. Dooley, Mr. Fields of Texas, Mr. Hall 
   of Texas, Mr. Barrett of Nebraska, Mrs. Thurman, Mr. Hastert, Mr. 
 Pomeroy, Mr. Wolf, Mr. Bishop, Mr. Stump, Mrs. Lincoln, Mr. Everett, 
  Mr. Paxon, Mr. Goodlatte, Mr. Doolittle, Mr. Canady of Florida, Mr. 
 Pombo, Mr. Kingston, Mr. Walsh, Mr. Hoekstra, Mr. Baker of Louisiana, 
 Mr. Calvert, Mr. Smith of Michigan, Mr. Cox of California, Mr. Crapo, 
  Mr. Lucas, Mr. Lewis of Kentucky, Mr. Shadegg, Mr. Hostettler, Mrs. 
 Chenoweth, Mr. Hutchinson, Mr. Chambliss, Mr. Latham, Mr. LaHood, Mr. 
Taylor of North Carolina, Mr. Bereuter, Mr. Whitfield, Mr. Nethercutt, 
    Mr. Boucher, Mr. Oxley, Mr. Skeen, Mr. Boehner, Mr. Stupak, Mr. 
 Thornberry, Mr. Bryant of Tennessee, Mr. Hastings of Washington, Mr. 
   Poshard, Mr. Burr, Mr. Sensenbrenner, Mr. Talent, Ms. Danner, Mr. 
Hefley, Mr. Orton, Mr. Upton, Mr. Bilbray, Mr. Foley, Mr. McCrery, Mr. 
 Cooley, Mr. McHugh, Mr. Ganske, Mr. Ewing, Mr. Holden, Mr. Manzullo, 
 Mr. Hayworth, Mr. Chrysler, Mr. Gillmor, Mr. Metcalf, Mrs. Seastrand, 
 Mr. Minge, Mr. Dickey, Mr. Norwood, Mr. Duncan, Mr. Barton of Texas, 
 Mr. Gordon, Mr. Schaefer, Mr. Clinger, Mr. Moorhead, Mr. Radanovich, 
   Mr. Hancock, Mr. Rose, Mr. Buyer, and Mr. Quillen) introduced the 
following bill; Titles I-III, referred to the Committee on Agriculture; 
            Title IV, referred to the Committee on Commerce

_______________________________________________________________________

                                 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 
1995''.

                  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 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.--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.
            ``(3) Prenotice of rulemaking 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 within 
                the time limits of this paragraph.
                    ``(C) Not more than 60 days after issuing a notice 
                under this paragraph, the Administrator shall either--
                            ``(i) issue a notice of proposed rulemaking 
                        under paragraph (5); or
                            ``(ii) issue a notice of a decision not to 
                        initiate a rulemaking.
            ``(4) 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 the notice 
        of proposed rulemaking under paragraph (5), of each timely 
        comment filed with the Administrator, of the report of the 
        Scientific Advisory Panel under paragraph (7), of a record of 
        each hearing held by the Administrator in connection with the 
        rulemaking of the decision of the hearing examiner under 
        paragraph (6), 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.
            ``(5) Notice of proposed rulemaking.--
                    ``(A) 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 place 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, prices of agricultural commodities 
                and retail food prices, and any associated societal 
                impacts (including consumer nutrition and health and 
                low-income consumers).
            ``(6) 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 a hearing on 
                questions of fact, based on information submitted under 
                paragraph (5), and pertaining to the proposed rule or 
                comments thereon. Upon such request, the Administrator 
                shall schedule a hearing not to exceed 20 days 
                duration, to commence not later than 30 days and to 
                conclude not later than 90 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 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 hearing 
                examiner who shall have the authority to administer 
                oaths, issue subpoenas, regulate the course of the 
                hearing, conduct prehearing conferences, schedule 
                presentations, and exclude irrelevant, immaterial, or 
                unduly repetitious evidence, or evidence that should 
                have been submitted under subparagraph (5)(B).
                    ``(C) The hearing examiner shall conduct the 
                hearing in a manner that encourages discussion and 
                debate on questions of fact regarding the docket, and 
                conforms with the deadlines set in this paragraph. 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. The presentation of evidence and argument shall 
                not delay the conclusion of the hearing beyond 20 days 
                of its commencement.
                    ``(D) Subject to subparagraph (B), an interested 
                person is entitled--
                            ``(i) to present such person's position 
                        orally or by documentary submissions (or both); 
                        and
                            ``(ii) if the Administrator determines that 
                        there are disputed issues of material fact 
                        necessary to resolve, to present such rebuttal 
                        submissions and to conduct such cross-
                        examination of persons as the hearing
                         examiner determines (I) to be appropriate, and 
(II) to be required for a full and true disclosure with respect to such 
issues.
                    ``(E) As soon as practicable after completion of 
                the hearing but not later than 180 days after the close 
                of the public comment period, the hearing examiner 
                shall issue a decision. Such decision shall be based 
                only on substantial evidence of record of such hearing 
                (including the report of the Scientific Advisory Panel) 
                and shall set forth detailed findings of fact upon 
                which the decision is based.
            ``(7) Review by scientific advisory panel.--At the time the 
        Administrator issues a notice of proposed rulemaking under 
        paragraph (5), the Administrator shall provide a copy of such 
        notice to the Scientific Advisory Panel established under 
        section 25(d). The hearing examiner (or Administrator if no 
        hearing is requested) 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 
        material issues of fact or scientific policy that appear to be 
        of significance in the hearing. The Panel may hold a public 
        hearing to discuss the proposed rule. The Panel shall provide a 
        report to the hearing examiner (or Administrator if no hearing 
        is requested) not later than 120 days after the close of 
        comment period. 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.
            ``(8) Final action.--Not later than 365 days after issuing 
        a notice of proposed rulemaking and 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, and 
        shall use the least burdensome requirements to achieve the 
        purposes of this Act. 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 
                        difference between the final rule and the 
                        proposed rule;
                            ``(ii) describes the impact of the final 
                        rule on production and prices of agricultural 
                        commodities, retail food prices, and otherwise 
                        on the agricultural economy; and
                            ``(iii) explains any significant 
                        disagreements the Administrator may
                         have with the comments, evaluations, or 
recommendations contained in the report under paragraph (7) or the 
benefits and use information described in paragraph (5)(A)(iii) and 
analysis in paragraph (5)(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.
            ``(9) 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.
                    ``(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.
            ``(10) 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.
            ``(11) 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 (5) through (8) apply. A denial of a petition shall 
        be judicially reviewable as provided in paragraph (12).
            ``(12) Judicial review.--A decision not to initiate a 
        rulemaking published under paragraph (3), a final rule or a 
        withdrawal of a proposed rule published under paragraph (8) or 
        a denial of a petition under paragraph (11) shall be judicially 
        reviewable in the manner specified by section 16(b)(2).''.

SEC. 103. PESTICIDES IN REVIEW.
    If the Administrator, on or before January 1, 1995, 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 
1995, 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 
1995.

SEC. 104. SUSPENSION.

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

SEC. 105. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

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

SEC. 106. SCIENTIFIC ADVISORY PANEL.

    The first sentence of section 25(d) (7 U.S.C. 136w(d)) is amended--
            (1) by striking ``The Administrator shall'' and inserting 
        ``(1) In general.--The Administrator shall''; and
            (2) by adding at the end the following:
            ``(2) Science review board.--There is established a Science 
        Review Board to consist of 60 scientists who shall be available 
        to the Scientific Advisory Panel to assist in reviews conducted 
        by the Panel. 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 unless 
                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(d)) is amended--
            (1) in paragraph (1)(A), by striking ``on the initial 
        classification and registered pesticides'' and inserting 
        ``under section 6(b) of this Act. Registered pesticides''; and
            (2) in paragraph (2), by striking ``the Administrator shall 
        notify the registrant'' and all that follows through the end of 
        the paragraph, and inserting ``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. 136a-
1(e)(3)(B)(iii)(III)) is amended--
            (1) by striking ``section 6(d), except that the'' and 
        inserting ``section 6(d). The''; and
            (2) by inserting after ``guidelines.'' the following: ``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 ``section 16'' and inserting ``section 
16(b)(1)''.
    (f) Section 6(d).--Section 6(d) (7 U.S.C. 136d(d)) is amended--
            (1) by amending 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(b), 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 the ninth sentence and all that follows 
        through the end of the subsection 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.''.
    (g) Section 16(b).--Section 16(b) (17 U.S.C. 136n(b)) is amended--
            (1) by striking ``(b) Review by Court of Appeals.--In the 
        case of'' and inserting the following:
    ``(b) Review by Court of Appeals.--
            ``(1) Review of certain orders.--In the case of'';
            (2) 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)(8), any decision by the 
        Administrator under section 6(b)(8) 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)(11), any person who will be adversely affected by such 
        rule or decision who filed comments in the proceedings 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 issuance of such rule or decision. The court 
        shall hold unlawful and set aside such rule or decision if it 
        finds that a rule of, or ruling by, the hearing examiner under 
        section 6(b)(6), limiting such petitioner's cross-examination 
        or oral presentations, has precluded disclosure of disputed 
        material facts which was necessary to a full determination by 
        the Administrator of the rulemaking proceeding taken as a 
        whole. 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 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 of 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, 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.''.
    (h) Section 25(a).--Section 25(a) (7 U.S.C. 136w(a)) is amended by 
adding at the end the following:
            ``(5) Exception.--The requirements of this subsection shall 
        not apply to any rule or rulemaking proceeding under section 
        6(b).''.
    (i) Section 25(d).--Section 25(d) (7 U.S.C. 136w(d)) is amended--
            (1) in the first sentence by striking ``in notices of 
        intent issued under subsection 6(b) and''; and
            (2) in the second sentence by striking ``notices of intent 
        and'' and by striking ``6(b) or''.
    (j) Section 25(e).--Section 25(e) (7 U.S.C. 136w(e)) is amended--
            (1) by striking the period at the end of the second 
        sentence; and
            (2) by inserting at the end of the second sentence ``, 
        except for any action that may be taken under section 6(b).''.

            TITLE II--MINOR USE CROP PROTECTION ACT OF 1995

SEC. 201. SHORT TITLE.

    (a) Short Title.--This title may be cited as the ``Minor Use Crop 
Protection Act of 1995''.
    (b) Reference.--Whenever in this title an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Insecticide, Fungicide, and Rodenticide 
Act.

SEC. 202. MINOR CROP PROTECTION.

    (a) Definition.--Section 2 (7 U.S.C. 136) is amended by adding at 
the end the following:
    ``(hh) Minor Use.--The term `minor use' means the use of a 
pesticide on an animal, on a commercial agricultural crop or site, or 
for the protection of public health where--
            ``(1) the total United States acreage for the crop is less 
        than 300,000 acres; or
            ``(2) the Administrator, in consultation with the Secretary 
        of Agriculture, determines that, based on information provided 
        by an applicant for registration or a registrant, the use does 
        not provide sufficient economic incentive to support the 
        initial registration or continuing registration of a pesticide 
        for such use; and--
                    ``(A) there are insufficient efficacious 
                alternative registered pesticides available for the 
                use; or
                    ``(B) the alternatives to the pesticide pose 
                greater risks to the environment or human health; or
                    ``(C) the pesticide plays or will play, a 
                significant part in managing pest resistance; or
                    ``(D) the pesticide plays or will play a 
                significant part in an integrated pest management 
                program.
        The status as a minor use under this subsection shall continue 
        as long as the Administrator has not determined that, based on 
        existing data, such use may cause an unreasonable adverse 
        effect on the environment and the use otherwise qualifies for 
        such status.''.
    (b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7 
U.S.C. 136a(c)(1)(F)) is amended by redesignating clauses (ii) and 
(iii) as clauses (iii) and (iv), respectively, and by inserting after 
clause (i) the following:
                            ``(ii) The period of exclusive data use for 
                        data submitted to support the application for 
                        the original registration of a pesticide under 
                        clause (i) shall be extended one additional 
                        year for each 3 minor uses registered after the 
                        date of enactment of this clause and, before 
                        the expiration of the period of exclusive use 
                        under this clause, up to a total of 3 
                        additional years for all minor uses registered 
                        by the Administrator if the Administrator in 
                        consultation with the Secretary of Agriculture 
                        determines that, based on information provided 
                        by an applicant for registration or a 
                        registrant, that--
                                    ``(I) there are insufficient 
                                efficacious alternative registered 
                                pesticides available for the use; or
                                    ``(II) the alternatives to the 
                                pesticide pose greater risks to the 
                                environment or human health; or
                                    ``(III) the pesticide plays or will 
                                play a significant part in managing 
                                pest resistance; or
                                    ``(IV) the pesticide plays or will 
                                play a significant part in an 
                                integrated pest management program.
                        The registration of a pesticide for a minor use 
                        on a crop grouping established by the 
                        Administrator shall be considered for purposes 
                        of this clause one minor use for each 
                        representative crop for which data are provided 
                        in the crop grouping. Any additional exclusive 
                        use period under this clause shall be modified 
                        as appropriate or terminated if the registrant 
                        voluntarily cancels the product or deletes from 
                        the registration the minor uses which formed 
                        the basis for the extension of the additional 
                        exclusive use period or if the Administrator 
                        determines that the registrant is not actually 
                        marketing the product for such minor uses.''.
    (c) Time Extensions for Development of Minor Use Data.--
            (1) Data call-in.--Section 3(c)(2)(B) (7 U.S.C. 
        136a(c)(2)(B)) is amended by adding at the end the following:
                            ``(vi) Upon the request of a registrant the 
                        Administrator shall, in the case of a minor 
                        use, extend the deadline for the production of 
                        residue chemistry data under this subparagraph 
                        for data required solely to support that minor 
                        use until the final deadline for submission of 
                        data under section 4 for the other use of the 
                        pesticide established as of the date of 
                        enactment of the Minor Use Crop Protection Act 
                        of 1995, if--
                                    ``(I) the data to support other 
                                uses of the pesticide on a food are 
                                being provided;
                                    ``(II) the registrant, in 
                                submitting a request for such an 
                                extension, provides a schedule, 
                                including interim dates to measure 
                                progress, to assure that the data 
                                production will be completed before the 
                                expiration of the extension period;
                                    ``(III) the Administrator has 
                                determined that such extension will not 
                                significantly delay the Administrator's 
                                schedule for issuing a reregistration 
                                eligibility determination required 
                                under section 4; and
                                    ``(IV) the Administrator has 
                                determined in writing that based on 
                                existing data, such extension would not 
                                significantly increase the risk of any 
                                unreasonable adverse effect on the 
                                environment. If the Administrator 
                                grants an extension under this clause, 
                                the Administrator shall monitor the 
                                development of the data and shall 
                                ensure that the registrant is meeting 
                                the schedule for the
                                 production of the data. If the 
Administrator determines that the registrant is not meeting or has not 
met the schedule for the production of such data, the Administrator may 
proceed in accordance with clause (iv) regarding the continued 
registration of the affected products with the minor use and shall 
inform the public of such action. Notwithstanding the provisions of 
this clause, the Administrator may take action to modify or revoke the 
extension under this clause if the Administrator determines that the 
extension for the minor use may cause an unreasonable adverse effect on 
the environment. In such circumstance, the Administrator shall provide, 
in writing to the registrant, a notice revoking the extension of time 
for submission of data. Such data shall instead be due in accordance 
with the date established by the Administrator for the submission of 
the data.''.
            (2) Reregistration.--Sections 4(d)(4)(B), 4(e)(2)(B), and 
        4(f)(2)(B) (7 U.S.C. 136a-1(d)(4)(B), (e)(2)(B), and (f)(2)(B)) 
        are each amended by adding at the end the following: ``Upon the 
        request of a registrant, the Administrator shall, in the case 
        of a minor use, extend the deadline for the production of 
        residue chemistry data under this subparagraph for data 
        required solely to support that minor use until the final 
        deadline for submission of data under this section for the 
        other uses of the pesticide established as of the date of 
        enactment of the Minor Use Crop Protection Act of 1995 if--
                    ``(i) the data to support other uses of the 
                pesticide on a food are being provided;
                    ``(ii) the registrant, in submitting a request for 
                such an extension provides a schedule, including 
                interim dates to measure progress, to assure that the 
                data production will be completed before the expiration 
                of the extension period;
                    ``(iii) the Administrator has determined that such 
                extension will not significantly delay the 
                Administrator's schedule for issuing a reregistration 
                eligibility determination required under this section; 
                and
                    ``(iv) the Administrator has determined in writing 
                that based on existing data, such extension would not 
                significantly increase the risk of any unreasonable 
                adverse effect on the environment. If the Administrator 
                grants an extension under this subparagraph, the 
                Administrator shall monitor the development of the data 
                and shall ensure that the registrant is meeting the 
                schedule for the production of the data. If the 
                Administrator determines that the registrant is not 
                meeting or has not met the schedule for the production 
                of such data, the Administrator may proceed in 
                accordance with clause (iv) of section 3(c)(2)(B) or 
                other provisions of this section, as appropriate, 
                regarding the continued registration of the affected 
                products with the minor use and shall inform the public 
                of such action. Notwithstanding the provisions of this 
                subparagraph, the Administrator may take action to 
                modify or revoke the extension under this subparagraph 
                if the Administrator determines that the extension for 
                the minor use may cause an unreasonable adverse effect 
                on the environment. In such circumstance, the 
                Administrator shall provide, in writing to the 
                registrant, a notice revoking the extension of time for 
                submission of data. Such data shall
                 instead be due in accordance with the date then 
established by the Administrator for submission of the data.''.
    (d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is 
amended--
            (1) by inserting ``In general.--'' after ``(A)'';
            (2) by inserting ``Additional data.--'' after ``(B)'';
            (3) by inserting ``Simplified procedures.--'' after 
        ``(C)''; and
            (4) by adding at the end the following:
                    ``(E) Minor use waiver.--In handling the 
                registration of a pesticide for a minor use, the 
                Administrator may waive otherwise applicable data 
                requirements if the Administrator determines that the 
                absence of such data will not prevent the Administrator 
                from determining--
                            ``(i) the incremental risk presented by the 
                        minor use of the pesticide; and
                            ``(ii) that such risk, if any, would not be 
                        an unreasonable adverse effect on the 
                        environment.''.
    (e) Expediting Minor Use Registrations.--Section 3(c)(3) (7 U.S.C. 
136a(c)(3)) is amended--
            (1) by inserting after ``(A)'' the following: ``In 
        general.--'';
            (2) by inserting after ``(B)'' the following: ``Identical 
        or substantially similar.--''; and
            (3) by adding at the end the following:
                    ``(C) Minor use registration.--
                            ``(i) The Administrator shall, as 
                        expeditiously as possible, review and act on 
                        any complete application--
                                    ``(I) that proposes the initial 
                                registration of a new pesticide active 
                                ingredient if the active ingredient is 
                                proposed to be registered solely for 
                                minor uses, or proposes a registration 
                                amendment solely for minor uses to an 
                                existing registration; or
                                    ``(II) for a registration or a 
                                registration amendment that proposes 
                                significant minor uses.
                            ``(ii) For the purposes of clause (i)--
                                    ``(I) the term `as expeditiously as 
                                possible' means that the Administrator 
                                shall to the greatest extent 
                                practicable complete a review and 
                                evaluation of all data, submitted with 
                                a complete application, within 12 
                                months after the submission of the 
                                complete application, and the failure 
                                of the Administrator to complete such a 
                                review and evaluation under clause (i) 
                                shall not be subject to judicial 
                                review; and
                                    ``(II) the term `significant minor 
                                uses' means 3 or more minor uses 
                                proposed for every non-minor use, a 
                                minor use that would, in the judgment 
                                of the Administrator, serve as a 
                                replacement for any use which has been 
                                canceled in the 5 years preceding the 
                                receipt of the application, or a minor 
                                use that in the opinion of the 
                                Administrator would avoid the 
                                reissuance of an emergency exemption 
                                under section 18 for that minor use.
                    ``(D) Adequate time for submission of minor use 
                data.--If a
                 registrant makes a request for a minor use waiver, 
regarding data required by the Administrator, pursuant to paragraph 
(2)(E), and if the Administrator denies in whole or in part such data 
waiver request, the registrant shall have a full time period for 
providing such data. For purposes of this subparagraph, the term `full 
time period' means the time period originally established by the 
Administrator for submission of such data, beginning with the data of 
receipt by the registrant of the Administrator's notice of denial.''.
    (f) Temporary Extension of Registration for Unsupported Minor 
Uses.--
            (1) Reregistration.--
                    (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-
                1(d)(6) and (f)(3)) are each amended by adding at the 
                end the following: ``If the registrant does not commit 
                to support a specific minor use of the pesticide, but 
                is supporting and providing data in a timely and 
                adequate fashion to support uses of the pesticide on a 
                food, or if all uses of the pesticide are nonfood uses 
                and the registrant does not commit to support a 
                specific minor use of the pesticide but is supporting 
                and providing data in a timely and adequate fashion to 
                support other nonfood uses of the pesticide, the 
                Administrator, at the written request of the 
                registrant, shall not take any action pursuant to this 
                paragraph in regard to such unsupported minor use until 
                the final deadline established as of the date of 
                enactment of the Minor Use Crop Protection Act of 1995, 
                for the submission of data under this section for the 
                supported uses identified pursuant to this paragraph 
                unless the Administrator determines that the absence of 
                the data is significant enough to cause human health or 
                environmental concerns. On such a determination the 
                Administrator may refuse the request for extension by 
                the registrant. Upon receipt of the request from the 
                registrant, the Administrator shall publish in the 
                Federal Register a notice of the receipt of the request 
                and the effective date upon which the uses not being 
                supported will be voluntarily deleted from the 
                registration pursuant to section 6(f)(1). If the 
                Administrator grants an extension under this paragraph, 
                the Administrator shall monitor the development of the 
                data for the uses being supported and shall ensure that 
                the registrant is meeting the schedule for the 
                production of such data. If the Administrator 
                determines that the registrant is not meeting or has 
                not met the schedule for the production of such data, 
                the Administrator may proceed in accordance with 
                section 3(c)(2)(B)(iv) regarding the continued 
                registration of the affected products with the minor 
                and other uses and shall inform the public of such 
                action in accordance with section 6(f)(2). 
                Notwithstanding this subparagraph, the Administrator 
                may deny, modify, or revoke the temporary extension 
                under this paragraph if the Administrator determines 
                that the continuation of the minor use may cause an 
                unreasonable adverse effect on the environment. In the 
                event of modification or revocation the Administrator 
                shall provide, in writing, to the registrant, a notice 
                revoking the temporary extension and establish a new 
                effective date by which the minor use shall be deleted 
                from the registration.''.
                    (B) Section 4(e)(3)(A) (7 U.S.C. 136a-1(e)(3)(A)) 
                is amended by adding at the end the following: ``If the 
                registrant does not commit to support a specific minor 
                use of the pesticide, but
                 is supporting and providing data in a timely and 
adequate fashion to support uses of the pesticide on a food, or if all 
uses of the pesticide are nonfood uses and the registrant does not 
commit to support a specific minor use of the pesticide but is 
supporting and providing data in a timely and adequate fashion to 
support other nonfood uses of the pesticide, the Administrator, at the 
written request of the registrant, shall not take any action pursuant 
to this subparagraph in regard to such unsupported minor use until the 
final deadline established as of the date of enactment of the Minor Use 
Crop Protection Act of 1995, for the submission of data under this 
section for the support uses identified pursuant to this subparagraph 
unless the Administrator determines that the absence of the data is 
significant enough to cause human health or environmental concerns. On 
the basis of such determination the Administrator may refuse the 
request for extension by the registrant. Upon receipt of the request 
from the registrant, the Administrator shall publish in the Federal 
Register a notice of the receipt of the request and the effective date 
upon which the uses not being supported will be voluntarily deleted 
from the registration pursuant to section 6(f)(1). If the Administrator 
grants an extension under this subparagraph, the Administrator shall 
monitor the development of the data for the uses being supported and 
shall ensure that the registrant is meeting the schedule for the 
production of such data. If the Administrator determines that the 
registrant is not meeting or has not met the schedule for the 
production of such data, the Administrator may proceed in accordance 
with section 3(c)(2)(B)(iv) regarding the continued registration of the 
affected products with the minor and other uses and shall inform the 
public of such action in accordance with section 6(f)(2). 
Notwithstanding this subparagraph, the Administrator may deny, modify, 
or revoke the temporary extension under this subparagraph if the 
Administrator determines that the continuation of the minor use may 
cause an unreasonable adverse effect on the environment. In the event 
of modification or revocation, the Administrator shall provide, in 
writing, to the registrant, a notice revoking the temporary extension 
and establish a new effective date by which the minor use shall be 
deleted from the registration.''.
            (2) Data.--Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as 
        amended by subsection (c), is further amended by adding at the 
        end the following:
                    ``(vii) If the registrant does not commit to 
                support a specific minor use of the pesticide, but is 
                supporting and providing data in a timely and adequate 
                fashion to support uses of the pesticide on a food, or 
                if all uses of the pesticide are nonfood uses and the 
                registrant does not commit to support a specific minor 
                use of the pesticide but is supporting and providing 
                data in a timely and adequate fashion to support other 
                nonfood uses of the pesticide, the Administrator, at 
                the written request of the registrant, shall not take 
                any action pursuant to this clause in regard to such 
                unsupported minor use until the final deadline 
                established as of the date of enactment of the Minor 
                Use Crop Production Act of 1995, for the submission of 
                data under section 4 for the supported uses identified 
                pursuant to this clause unless the Administrator 
                determines that the absence of the data is significant 
                enough to cause human health or environmental concerns. 
                On the basis of such determination, the Administrator 
                may refuse the request for extension by the registrant. 
                Upon receipt of
                 the request from the registrant, the Administrator 
shall publish in the Federal Register a notice of receipt of the 
request and the effective date upon which the uses not being supported 
will be voluntarily deleted from the registration pursuant to section 
6(f)(1). If the Administrator grants an extension under this clause, 
the Administrator shall monitor the development of the data for the 
uses being supported and shall ensure that the registrant is meeting 
the schedule for the production of such data. If the Administrator 
determines that the registrant is not meeting or has not met the 
schedule for the production of such data, the Administrator may proceed 
in accordance with clause (iv) of this subparagraph regarding the 
continued registration of the affected products with the minor and 
other uses and shall inform the public of such action in accordance 
with section 6(f)(2). Notwithstanding the provisions of this clause, 
the Administrator may deny, modify, or revoke the temporary extension 
under this subparagraph if the Administrator determines that the 
continuation of the minor use may cause an unreasonable adverse effect 
on the environment. In the event of modification or revocation, the 
Administrator shall provide, in writing, to the registrant, a notice 
revoking the temporary extension and establish a new effective date by 
which the minor use shall be deleted from the registration.''.
    (g) Utilization of Data for Voluntarily Canceled Chemicals.--
Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at the end the 
following:
            ``(4) Utilization of data for voluntarily canceled 
        chemicals.--When an application is filed with the Administrator 
        for the registration of a pesticide for a minor use and another 
        registrant subsequently voluntarily cancels its registration 
        for an identical or substantially similar pesticide for an 
        identical or substantially similar use, the Administrator shall 
        process, review, and evaluate the pending application as if the 
        voluntary cancellation had not yet taken place, except that the 
        Administrator shall not take such action if the Administrator 
        determines that such minor use may cause an unreasonable 
        adverse effect on the environment. In order to rely on this 
        paragraph, the applicant must certify that it agrees to satisfy 
        any outstanding data requirements necessary to support the 
        reregistration of the pesticide in accordance with the data 
        submission schedule established by the Administrator.''.
    (h) Environmental Protection Agency Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.) is 
amended by redesignating sections 30 and 31 as sections 32 and 33, 
respectively, and adding after section 29 the following:

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

    ``The Administrator shall assure coordination of minor use issues 
through the establishment of a minor use program within the Office of 
Pesticide Programs. Such office shall be responsible for coordinating 
the development of minor use programs and policies and consulting with 
growers regarding minor use issues and registrations and amendments 
which are submitted to the Environmental Protection Agency.''.
    (i) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by subsection (h), is amended by adding after section 30 the 
following:

``SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.
    ``(a) In General.--The Secretary of Agriculture (hereinafter in 
this section referred to as the `Secretary') shall ensure the 
coordination of the responsibilities of the Department of Agriculture 
related to minor uses of pesticides, including--
            ``(1) carrying out the Inter-Regional Project Number 4 (IR-
        4) as described in section 2(e) of the Act entitled `An Act to 
        facilitate the work of the Department of Agriculture, and for 
        other purposes' (7 U.S.C. 4501(e)) and the national pesticide 
        resistance monitoring program established under section 1651 of 
        the Food, Agriculture, Conservation, and Trade Act of 1990 (7 
        U.S.C. 5882);
            ``(2) supporting integrated pest management research;
            ``(3) consulting with growers to develop data for minor 
        uses; and
            ``(4) providing assistance for minor use registrations, 
        tolerances, and reregistrations with the Environmental 
        Protection Agency.
    ``(b) Matching Fund Program.--
            ``(1) Establishment.--The Secretary of Agriculture, in 
        consultation with the Administrator, shall establish and 
        administer a minor use matching fund program. The matching fund 
        program shall be utilized to ensure the continued availability 
        of minor use crop protection chemicals, including the 
        development of data to support minor use pesticide 
        registrations and reregistrations. Access to the matching fund 
        program shall be available to any entity which desires to 
        develop data to support minor use registrations. Priority for 
        access to the fund shall be given those entities that do not 
        directly receive funds from the sale of products registered on 
        minor uses. Any entity that seeks such funding under this 
        paragraph shall be required to match such funds with an equal 
        amount of its own funds. Any data developed through the 
        matching fund program shall be jointly owned by the Department 
        of Agriculture and by the entity that receives such funding. 
        Any data developed under this subsection shall be subject to 
        the provisions of section 3(c)(1)(F). All compensation received 
        by the Department of Agriculture in return for the use of such 
        data under the matching fund program shall be returned to a 
        revolving fund which will support the matching fund program.
            ``(2) Authorization.--There is authorized to be 
        appropriated for the revolving fund for the matching fund 
        program an annual sum not to exceed $10,000,000.''.

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

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

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

SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

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

SEC. 303. INTEGRATED PEST MANAGEMENT.

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

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

SEC. 401. 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. 402. 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 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. 403. PROHIBITED ACTS.

    Section 301(j) (21 U.S.C. 331(j)) is amended--
            (1) by striking the period at the end; and
            (2) by inserting at the end ``, or the violation of section 
        408(g)(2) or any regulation issued under that section.''.

SEC. 404. 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. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

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

``TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES

    ``Sec. 408. (a) Requirement for Tolerance or Exemption.--
            ``(1) General rule.--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 for the requirement for a 
                tolerance is in effect under this section for a 
                pesticide chemical residue in or on a raw agricultural 
                commodity, a pesticide chemical residue that is present 
                in or on a processed food because the food is made from 
                that raw agricultural commodity shall not be considered 
                unsafe within the meaning of section 402(a)(2)(B).
            ``(3) Residues of degradation products.--If a pesticide 
        chemical residue is present in or on a food because it is a 
        metabolite or other degradation product of a precursor 
        substance that itself is a pesticide chemical or pesticide 
        chemical residue, such a residue shall not be considered to be 
        unsafe within the meaning of section 402(a)(2)(B) despite the 
        lack of a tolerance or exemption from the need for a tolerance 
        for such residue in or on such food if--
                    ``(A) the Administrator has not determined that the 
                degradation product is likely to pose any potential 
                health risk from dietary exposure that is of a 
                different type than, or of a greater significance than, 
                any risk posed by dietary exposure to the precursor 
                substance; 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, including infants and children) to the 
        pesticide chemical residue, and available information and 
        reasonable assumptions concerning the variability of the 
        sensitivities of major identifiable groups, including infants 
        and children, and shall consider other factors to the extent 
        required by subparagraph (F).
            ``(D) 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, 
        including tests which are appropriate for the determination of 
        dietary risk and most likely dietary exposure, for the 
        determination of negligible dietary risk.
            ``(E) Procedures shall be developed and implemented that 
        ensure that pesticide tolerances adequately safeguard the 
        health of infants and children.
            ``(F) Where reliable data are available, the Administrator 
        shall calculate the dietary risk posed to food consumers by a 
        pesticide chemical on the basis of the percent of food actually 
        treated with the pesticide chemical and the actual residue 
        levels of the
         pesticide chemical that occur in food. In particular, the 
Administrator shall take into account aggregate pesticide use and 
residue data collected by the Department of Agriculture.
            ``(G) 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 that are 
                considered to be greater than the risks that result 
                from dietary exposure to the pesticide chemical 
                residue; or
                    ``(iii) the availability of the pesticide would 
                enable domestic growers to maintain the availability of 
                an adequate, wholesome, and economical food supply for 
                consumers, taking into account national and regional 
                effects.
        In making the determination under this subparagraph, the 
        Administrator shall not consider the effects on any pesticide 
        registrant, manufacturer, or marketer of a pesticide.
            ``(3) Limitations.--(A) 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, or that a practical method is unavailable or not 
        feasible.
            ``(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 determine whether a maximum residue level 
        for the chemical has been established by the Codex Alimentarius 
        Commission. If a Codex maximum residue level has been 
        established for the chemical and the Administrator does not 
        propose to adopt the Codex level, the Administrator shall 
        publish for public comment a notice explaining the reasons for 
        departing from the Codex level. If the Administrator determines 
        not to adopt a Codex level, the Administrator shall publish as 
        part of the final tolerance decision a determination with 
        supporting data that the Codex level is not supported by 
        adequate and reliable
         scientific data, or is inadequate to protect the health of the 
United States' consumers and that the effect of the tolerance on the 
availability to consumers of an adequate, wholesome and economical food 
supply, does not outweigh the risk posed by the pesticide residue.
    ``(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 paragraph, the 
        Administrator shall take into account, among other relevant 
        factors, the factors set forth in subsection (b)(2)(C).
            ``(3) Limitation.--An exemption from the requirement for a 
        tolerance for a pesticide chemical residue in or on a food 
        shall not be established by the Administrator unless the 
        Administrator determines, after consultation with the 
        Secretary--
                    ``(A) that there is a practical method for 
                detecting and measuring the levels of 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 a 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 requiring to be submitted to the 
                        Administrator and stating why the data and 
                        information could not be obtained under the 
                        authority of section 3(c)(2)(B) of the Federal 
                        Insecticide, Fungicide, and Rodenticide Act or 
                        section 4 of the Toxic Substances Control Act;
                            ``(iii) describing the reports of the 
                        Administrator required to be prepared during 
                        and after the collection of the data and 
                        information;
                            ``(iv) requiring the submission to the 
                        Administrator of the data, information, and 
                        reports referred to in clauses (ii) and (iii); 
                        and
                            ``(v) establishing dates by which the 
                        submissions described in clauses (i) and (iv) 
                        must be made.
                The Administrator may 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 or an exemption from a tolerance shall be entitled 
        to confidential treatment for reasons of business 
        confidentiality and to exclusive use and data compensation, to 
        the same extent provided by sections 3 and 10 of the Federal 
        Insecticide, Fungicide, and Rodenticide Act.
            ``(2) Exceptions.--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. All 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 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 1995.
            ``(2) Qualifying federal determination.--For purposes of 
        this subsection, the term `qualifying Federal determination' 
        means--
                    ``(A) a tolerance or exemption from the requirement 
                for a tolerance for a qualifying pesticide chemical 
                residue that was--
                            ``(i) issued under this section after the 
                        date of enactment of the Food Quality 
                        Protection Act of 1995; (or)
                            ``(ii) issued (or, pursuant to subsection 
                        (h) or (i), deemed to have been issued) under 
                        this section, 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. 406. 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>
HR 1627 IH----2
HR 1627 IH----3
HR 1627 IH----4
HR 1627 IH----5
```