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





                                                 Union Calendar No. 364

104th CONGRESS

  2d Session

                               H. R. 1627

                  [Report No. 104-669, Parts I and II]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                             July 23, 1996

Reported from the Committee on Commerce with an amendment, committed to 
the Committee of the Whole House on the State of the Union, and ordered 
                             to be printed
                                                 Union Calendar No. 364
104th CONGRESS
  2d Session
                                H. R. 1627

                  [Report No. 104-669, Parts I and II]

 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

                             July 11, 1996

       Reported from the Committee on Agriculture with amendments
  [Omit the part struck through and insert the part printed in italic]

                             July 23, 1996

 Additional sponsors: Mr. Hayes, Mr. Peterson of Minnesota, Mr. Coble, 
  Mr. McIntosh, Mr. Ballenger, Mr. Bunn of Oregon, Mr. Laughlin, Mr. 
Funderburk, Mr. Pickett, Mr. Barr of Georgia, Mr. Fazio of California, 
 Mr. Collins of Georgia, Mr. Solomon, Mr. Gekas, Mr. Bono, Mr. Jones, 
  Mr. Baker of California, Mr. Gutknecht, Mr. Sisisky, Mr. Klug, Mr. 
Gallegly, Mr. Jacobs, Mr. Burton of Indiana, Mr. Archer, Mr. Camp, Mr. 
 Christensen, Mr. Coburn, Mr. Herger, Mr. Kanjorski, Mr. Costello, Mr. 
   Franks of Connecticut, Mr. Thornton, Mr. Hefner, Mr. Thomas, Mr. 
Brownback, Mr. Rogers, Mr. Heineman, Mr. Dornan, Mr. Watts of Oklahoma, 
  Mr. Linder, Mr. Goodling, Mr. Rohrabacher, Mr. Crane, Mr. Ford, Mr. 
 Spence, Mr. Parker, Mr. Lewis of California, Mr. Stockman, Mr. Davis, 
  Mr. McKeon, Mr. Wicker, Mr. Tiahrt, Mr. Hilliard, Mr. Thompson, Mr. 
Hobson, Mr. Houghton, Mr. Bonilla, Mr. Bunning of Kentucky, Mr. Leach, 
     Ms. Dunn of Washington, Mr. Matsui, Mr. Spratt, Mrs. Smith of 
Washington, Mr. Clyburn, Mr. Tanner, Mr. Peterson of Florida, Mr. Mica, 
  Mr. Packard, Mr. Pete Geren of Texas, Mr. Ehrlich, Mr. Bateman, Mr. 
 Chapman, Mr. Miller of Florida, Mr. Skelton, Mr. Riggs, Mr. Volkmer, 
Mr. McCollum, Mr. Farr of California, Mr. Tate, Mr. Payne of Virginia, 
  Mr. Hunter, Mr. Cramer, Mr. Brewster, Mr. Weller, Mr. McInnis, Mrs. 
   Myrick, Mr. Hilleary, Mrs. Cubin, Mr. Gilchrest, Mr. Nussle, Mr. 
 Wiliams, Mr. Knollenberg, Mr. Largent, Mr. Engel, Mr. Livingston, Mr. 
    Roth, Mr. Lightfoot, Mr. Callahan, Mr. Lipinski, Mr. DeLay, Mr. 
  Shuster, Mr. Goss, Mr. Royce, Mr. Bevill, Mr. Deal of Georgia, Mr. 
Weldon of Florida, Mr. Souder, Mr. Andrews, Mr. Dreier, Mr. Bartlett of 
  Maryland, Mr. Cunningham, Mr. Stearns, Mr. Bachus, Mr. Scarborough, 
   Mrs. Fowler, Mr. Traficant, Mr. Porter, Mr. Bass, Mr. English of 
Pennsylvania, Mrs. Vucanovich, Mr. Castle, Mr. Kim, Mr. Smith of Texas, 
    Ms. Pryce, Mr. Petri, Mr. Hansen, Mr. Istook, Mr. Watt of North 
Carolina, Mr. Longley, Mr. Hamilton, Mr. Manton, Mr. Myers of Indiana, 
Mr. LaTourette, Mrs. Clayton, Mr. Barcia of Michigan, Mr. Boehlert, Mr. 
   Dicks, Mr. Wamp, Mr. McDade, Mr. Graham, Mr. Kolbe, Mr. Ney, Mrs. 
     Roukema, Mr. Campbell, Mr. Gilman, Mr. Dingell, and Mr. Waxman

                             July 23, 1996

Reported from the Committee on Commerce with an amendment, committed to 
the Committee of the Whole House on the State of the Union, and ordered 
                             to be printed
[Omit the part in bold brackets and insert the part printed in boldface 
                                 roman]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Food Quality Protection Act 
of 1995''.</DELETED>

        <DELETED>TITLE I--CANCELLATION AND SUSPENSION</DELETED>

<DELETED>SEC. 101. REFERENCE.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 102. CANCELLATION.</DELETED>

<DELETED>    Section 6(b) (7 U.S.C. 136d(b)) is amended to read as 
follows:</DELETED>
<DELETED>    ``(b) Cancellation and Change in Classification or Other 
Terms or Conditions of Registration.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(3) Prenotice of rulemaking procedures.--
        </DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(C) Not more than 60 days after issuing 
                a notice under this paragraph, the Administrator shall 
                either--</DELETED>
                        <DELETED>    ``(i) issue a notice of proposed 
                        rulemaking under paragraph (5); or</DELETED>
                        <DELETED>    ``(ii) issue a notice of a 
                        decision not to initiate a 
                        rulemaking.</DELETED>
        <DELETED>    ``(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--
        </DELETED>
                <DELETED>    ``(A) information of which the 
                Administrator may properly take official notice; 
                or</DELETED>
                <DELETED>    ``(B) information of which a court may 
                properly take judicial notice.</DELETED>
        <DELETED>    ``(5) Notice of proposed rulemaking.--</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the factual data on which 
                        the proposed rule is based;</DELETED>
                        <DELETED>    ``(ii) the major scientific 
                        assumptions, legal interpretations, and policy 
                        considerations underlying the proposed 
                        rule;</DELETED>
                        <DELETED>    ``(iii) a summary of available 
                        risk-benefit information, including benefits 
                        and use information as provided by the 
                        Secretary of Agriculture; and</DELETED>
                        <DELETED>    ``(iv) the Administrator's 
                        analysis and tentative conclusions regarding 
                        the balancing of such risks and 
                        benefits.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(6) Hearing.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(D) Subject to subparagraph (B), an 
                interested person is entitled--</DELETED>
                        <DELETED>    ``(i) to present such person's 
                        position orally or by documentary submissions 
                        (or both); and</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) explains the reasons for the 
                action;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(C) responds to each significant comment 
                contained in the docket; and</DELETED>
                <DELETED>    ``(D) in the case of a final rule--
                </DELETED>
                        <DELETED>    ``(i) explains the reasons for any 
                        major difference between the final rule and the 
                        proposed rule;</DELETED>
                        <DELETED>    ``(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</DELETED>
                        <DELETED>    ``(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.</DELETED>
                <DELETED>A final rule issued under this subsection 
                shall be effective upon the date of its publication in 
                the Federal Register.</DELETED>
        <DELETED>    ``(9) Modification or cancellation.--</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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).</DELETED>
        <DELETED>    ``(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).''.</DELETED>

<DELETED>SEC. 103. PESTICIDES IN REVIEW.</DELETED>

<DELETED>    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.</DELETED>

<DELETED>SEC. 104. SUSPENSION.</DELETED>

<DELETED>    (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).''.</DELETED>
<DELETED>    (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.''.</DELETED>

<DELETED>SEC. 105. TOLERANCE REEVALUATION AS PART OF 
              REREGISTRATION.</DELETED>

<DELETED>    Section 4(g)(2) (7 U.S.C. 136a-1(g)(2)) is amended by 
adding at the end the following:</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(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);</DELETED>
                        <DELETED>    ``(ii) determine whether such 
                        tolerance or exemption meets the requirements 
                        of that Act;</DELETED>
                        <DELETED>    ``(iii) determine whether 
                        additional tolerances or exemptions should be 
                        issued;</DELETED>
                        <DELETED>    ``(iv) publish in the Federal 
                        Register a notice setting forth the 
                        determinations made under this subparagraph; 
                        and</DELETED>
                        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 106. SCIENTIFIC ADVISORY PANEL.</DELETED>

<DELETED>    The first sentence of section 25(d) (7 U.S.C. 136w(d)) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``The Administrator shall'' and 
        inserting ``(1) In general.--The Administrator shall''; 
        and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
        <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 107 CONFORMING AMENDMENTS.</DELETED>

<DELETED>    (a) Section 3(c)(6).--Section 3(c)(6) (7 U.S.C. 
136a(c)(6)) is amended to read as follows:</DELETED>
        <DELETED>    ``(6) Denial of application for registration.--
        </DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (b) Section 3(c)(8).--Section 3(c)(8) (7 U.S.C. 
136a(c)(8)) is repealed.</DELETED>
<DELETED>    (c) Section 3(d).--Section 3(d) (7 U.S.C. 136a(d)) is 
amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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.''.</DELETED>
<DELETED>    (d) Section 4(e).--Section 4(e)(3)(B)(iii)(III) (7 U.S.C. 
136a-1(e)(3)(B)(iii)(III)) is amended--</DELETED>
        <DELETED>    (1) by striking ``section 6(d), except that the'' 
        and inserting ``section 6(d). The''; and</DELETED>
        <DELETED>    (2) by inserting after ``guidelines.'' the 
        following: ``If a hearing is held, a decision after completion 
        of such hearing shall be final.''.</DELETED>
<DELETED>    (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)''.</DELETED>
<DELETED>    (f) Section 6(d).--Section 6(d) (7 U.S.C. 136d(d)) is 
amended--</DELETED>
        <DELETED>    (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</DELETED>
        <DELETED>    (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.''.</DELETED>
<DELETED>    (g) Section 16(b).--Section 16(b) (17 U.S.C. 136n(b)) is 
amended--</DELETED>
        <DELETED>    (1) by striking ``(b) Review by Court of 
        Appeals.--In the case of'' and inserting the 
        following:</DELETED>
<DELETED>    ``(b) Review by Court of Appeals.--</DELETED>
        <DELETED>    ``(1) Review of certain orders.--In the case 
        of'';</DELETED>
        <DELETED>    (2) by striking ``under this section'' in the 
        sixth sentence of paragraph (1) (as so designated) and 
        inserting ``under this paragraph'', and</DELETED>
        <DELETED>    (3) by adding at the end the following new 
        paragraph:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (h) Section 25(a).--Section 25(a) (7 U.S.C. 136w(a)) is 
amended by adding at the end the following:</DELETED>
        <DELETED>    ``(5) Exception.--The requirements of this 
        subsection shall not apply to any rule or rulemaking proceeding 
        under section 6(b).''.</DELETED>
<DELETED>    (i) Section 25(d).--Section 25(d) (7 U.S.C. 136w(d)) is 
amended--</DELETED>
        <DELETED>    (1) in the first sentence by striking ``in notices 
        of intent issued under subsection 6(b) and''; and</DELETED>
        <DELETED>    (2) in the second sentence by striking ``notices 
        of intent and'' and by striking ``6(b) or''.</DELETED>
<DELETED>    (j) Section 25(e).--Section 25(e) (7 U.S.C. 136w(e)) is 
amended--</DELETED>
        <DELETED>    (1) by striking the period at the end of the 
        second sentence; and</DELETED>
        <DELETED>    (2) by inserting at the end of the second sentence 
        ``, except for any action that may be taken under section 
        6(b).''.</DELETED>

   <DELETED>TITLE II--MINOR USE CROP PROTECTION ACT OF 1995</DELETED>

<DELETED>SEC. 201. SHORT TITLE.</DELETED>

<DELETED>    (a) Short Title.--This title may be cited as the ``Minor 
Use Crop Protection Act of 1995''.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 202. MINOR CROP PROTECTION.</DELETED>

<DELETED>    (a) Definition.--Section 2 (7 U.S.C. 136) is amended by 
adding at the end the following:</DELETED>
<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(1) the total United States acreage for the crop 
        is less than 300,000 acres; or</DELETED>
        <DELETED>    ``(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--</DELETED>
                <DELETED>    ``(A) there are insufficient efficacious 
                alternative registered pesticides available for the 
                use; or</DELETED>
                <DELETED>    ``(B) the alternatives to the pesticide 
                pose greater risks to the environment or human health; 
                or</DELETED>
                <DELETED>    ``(C) the pesticide plays or will play, a 
                significant part in managing pest resistance; 
                or</DELETED>
                <DELETED>    ``(D) the pesticide plays or will play a 
                significant part in an integrated pest management 
                program.</DELETED>
        <DELETED>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.''.</DELETED>
<DELETED>    (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:</DELETED>
                        <DELETED>    ``(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--</DELETED>
                                <DELETED>    ``(I) there are 
                                insufficient efficacious alternative 
                                registered pesticides available for the 
                                use; or</DELETED>
                                <DELETED>    ``(II) the alternatives to 
                                the pesticide pose greater risks to the 
                                environment or human health; 
                                or</DELETED>
                                <DELETED>    ``(III) the pesticide 
                                plays or will play a significant part 
                                in managing pest resistance; 
                                or</DELETED>
                                <DELETED>    ``(IV) the pesticide plays 
                                or will play a significant part in an 
                                integrated pest management 
                                program.</DELETED>
                        <DELETED>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.''.</DELETED>
<DELETED>    (c) Time Extensions for Development of Minor Use Data.--
</DELETED>
        <DELETED>    (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:</DELETED>
                        <DELETED>    ``(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 Food Quality 
                        Protection Act of 1995, if--</DELETED>
                                <DELETED>    ``(I) the data to support 
                                other uses of the pesticide on a food 
                                are being provided;</DELETED>
                                <DELETED>    ``(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;</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(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.''.</DELETED>
        <DELETED>    (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 Food Quality Protection Act of 
        1996 if--</DELETED>
                <DELETED>    ``(i) the data to support other uses of 
                the pesticide on a food are being provided;</DELETED>
                <DELETED>    ``(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;</DELETED>
                <DELETED>    ``(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</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 
136a(c)(2)) is amended--</DELETED>
        <DELETED>    (1) by inserting ``In general.--'' after 
        ``(A)'';</DELETED>
        <DELETED>    (2) by inserting ``Additional data.--'' after 
        ``(B)'';</DELETED>
        <DELETED>    (3) by inserting ``Simplified procedures.--'' 
        after ``(C)''; and</DELETED>
        <DELETED>    (4) by adding at the end the following:</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) the incremental risk 
                        presented by the minor use of the pesticide; 
                        and</DELETED>
                        <DELETED>    ``(ii) that such risk, if any, 
                        would not be an unreasonable adverse effect on 
                        the environment.''.</DELETED>
<DELETED>    (e) Expediting Minor Use Registrations.--Section 3(c)(3) 
(7 U.S.C. 136a(c)(3)) is amended--</DELETED>
        <DELETED>    (1) by inserting after ``(A)'' the following: ``In 
        general.--'';</DELETED>
        <DELETED>    (2) by inserting after ``(B)'' the following: 
        ``Identical or substantially similar.--''; and</DELETED>
        <DELETED>    (3) by adding at the end the following:</DELETED>
                <DELETED>    ``(C) Minor use registration.--</DELETED>
                        <DELETED>    ``(i) The Administrator shall, as 
                        expeditiously as possible, review and act on 
                        any complete application--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(II) for a registration 
                                or a registration amendment that 
                                proposes significant minor 
                                uses.</DELETED>
                        <DELETED>    ``(ii) For the purposes of clause 
                        (i)--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (f) Temporary Extension of Registration for Unsupported 
Minor Uses.--</DELETED>
        <DELETED>    (1) Reregistration.--</DELETED>
                <DELETED>    (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.''.</DELETED>
                <DELETED>    (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.''.</DELETED>
        <DELETED>    (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:</DELETED>
                <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>
        <DELETED>    ``(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.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 30. ENVIRONMENTAL PROTECTION AGENCY MINOR USE 
              PROGRAM.</DELETED>

<DELETED>    ``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.''.</DELETED>
<DELETED>    (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:</DELETED>

<DELETED>``SEC. 31. DEPARTMENT OF AGRICULTURE MINOR USE 
              PROGRAM.</DELETED>

<DELETED>    ``(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--</DELETED>
        <DELETED>    ``(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);</DELETED>
        <DELETED>    ``(2) supporting integrated pest management 
        research;</DELETED>
        <DELETED>    ``(3) consulting with growers to develop data for 
        minor uses; and</DELETED>
        <DELETED>    ``(4) providing assistance for minor use 
        registrations, tolerances, and reregistrations with the 
        Environmental Protection Agency.</DELETED>
<DELETED>    ``(b) Matching Fund Program.--</DELETED>
        <DELETED>    ``(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.</DELETED>
        <DELETED>    ``(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.''.</DELETED>

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

<DELETED>SEC. 301. DATA COLLECTION ACTIVITIES TO ASSURE THE HEALTH OF 
              INFANTS AND CHILDREN.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.</DELETED>

<DELETED>    (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.</DELETED>
<DELETED>    (b) Collection.--The data shall be collected by surveys of 
farmers or from other sources offering statistically reliable 
data.</DELETED>
<DELETED>    (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.</DELETED>

<DELETED>SEC. 303. INTEGRATED PEST MANAGEMENT.</DELETED>

<DELETED>    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.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food Quality Protection Act of 
1996''.

                    TITLE I--SUSPENSION-APPLICATORS

 SEC. 101. REFERENCE.

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

                         Subtitle A--Suspension

 SEC. 102. SUSPENSION.

    (a) Section 6(c)(1).--The second sentence of section 6(c)(1) (7 
U.S.C. 136d(c)(1)) is amended to read: ``Except as provided in 
paragraph (3), no order of suspension may be issued under this 
subsection unless the Administrator has issued, or at the same time 
issues, a notice of intention to cancel the registration or change the 
classification of the pesticide under subsection (b).''.
    (b) Section 6(c)(3).--Section 6(c)(3) (7 U.S.C. 136d(c)(3)) is 
amended by inserting after the first sentence the following new 
sentence: ``The Administrator may issue an emergency order under this 
paragraph before issuing a notice of intention to cancel the 
registration or change the classification of the pesticide under 
subsection (b) and the Administrator shall proceed to issue the notice 
under subsection (b) within 90 days of issuing an emergency order. If 
the Administrator does not issue a notice under subsection (b) within 
90 days of issuing an emergency order, the emergency order shall 
expire.''.

 SEC. 103. TOLERANCE REEVALUATION AS PART OF REREGISTRATION.

    Section 4(g)(2) (7 U.S.C. 136a-1(g)(2)) is amended by adding at the 
end the following:
                    ``(E) As soon as the Administrator has sufficient 
                information with respect to the dietary risk of a 
                particular active ingredient, but in any event no later 
                than the time the Administrator makes a determination 
                under subparagraph (C) or (D) with respect to 
                pesticides containing a particular active ingredient, 
                the Administrator shall--
                            ``(i) reassess each associated tolerance 
                        and exemption from the requirement for a 
                        tolerance issued under section 408 of the 
                        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                        346a) taking into account available information 
                        and reasonable assumptions concerning the 
                        dietary exposure levels of food consumers (and 
                        major identifiable subgroups of food consumers, 
                        including infants and children) to residue of 
                        the pesticide in food and available information 
                        and reasonable assumptions concerning the 
                        variability of the sensitivities of major 
                        identifiable groups, including infants and 
                        children;
                            ``(ii) determine whether 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. 104. SCIENTIFIC ADVISORY PANEL.

    Section 25(d) (7 U.S.C. 136w(d)) is amended--
            (1) in the first sentence, by striking ``The Administrator 
        shall'' and inserting:
            ``(1) In general.--The Administrator shall''; and
            (2) by adding at the end the following:
            ``(2) Science review board.--There is established a Science 
        Review Board to consist of 60 scientists who shall be available 
        to the Scientific Advisory Panel to assist in reviews conducted 
        by the Panel. Members of the Board shall be selected in the 
        same manner as members of temporary subpanels created under 
        paragraph (1). Members of the Board shall be compensated in the 
        same manner as members of the Panel.''.

 SEC. 105. NITROGEN STABILIZER.

    (a) Section 2.--Section 2 (7 U.S.C. 136) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1) by striking ``or'' after 
                ``defoliant,'' and inserting ``, or nitrogen 
                stabilizer'' after ``desiccant'';
                    (B) at the end of paragraph (3) by striking 
                ``and'';
                    (C) at the end of paragraph (4) by striking the 
                period and inserting ``; and''; and
                    (D) at the end by adding the following:
            ``(5) in the case of a nitrogen stabilizer, an ingredient 
        which will prevent or hinder the process of nitrification, 
        denitrification, ammonia volatilization, or urease production 
        through action affecting soil bacteria.'';
            (2) in subsection (u), by striking ``and'' before ``(2)'' 
        and by inserting ``and (3) any nitrogen stabilizer,'' after 
        ``desiccant,''; and
            (3) at the end by adding the following:
    ``(hh) Nitrogen Stabilizer.--The term `nitrogen stabilizer' means 
any substance or mixture of substances intended for preventing or 
hindering the process of nitrification, denitrification, ammonia 
volatilization, or urease production through action upon soil bacteria. 
Such term shall not include--
            ``(1) dicyandiamide;
            ``(2) ammonium thiosulfate; or
            ``(3) any substance or mixture of substances.--
                    ``(A) that was not registered pursuant to section 3 
                prior to January 1, 1992; and
                    ``(B) that was in commercial agronomic use prior to 
                January 1, 1992, with respect to which after January 1, 
                1992, the distributor or seller of the substance or 
                mixture has made no specific claim of prevention or 
                hindering of the process of nitrification, 
                denitrification, ammonia volatilization urease 
                production regardless of the actual use or purpose for, 
                or future use or purpose for, the substance or mixture.
Statements made in materials required to be submitted to any State 
legislative or regulatory authority, or required by such authority to 
be included in the labeling or other literature accompanying any such 
substance or mixture shall not be deemed a specific claim within the 
meaning of this subsection.''.
    (b) Section 3(f).--Section 3(f) (7 U.S.C. 136a(f)) is amended by 
adding at the end the following:
            ``(4) Mixtures of nitrogen stabilizers and fertilizer 
        products.--Any mixture or other combination of--
                    ``(A) 1 or more nitrogen stabilizers registered 
                under this Act; and
                    ``(B) 1 or more fertilizer products,
        shall not be subject to the provisions of this section or 
        sections 4, 5, 7, 15, and 17(a)(2) if the mixture or other 
        combination is accompanied by the labeling required under this 
        Act for the nitrogen stabilizer contained in the mixture or 
        other combination, the mixture or combination is mixed or 
        combined in accordance with such labeling, and the mixture or 
        combination does not contain any active ingredient other than 
        the nitrogen stabilizer.''.

 SEC. 106. AUTHORITY OF STATES.

    (a) Definitions.--Section 2 (7 U.S.C. 136), as amended by section 
105, is further amended--
            (1) in subsection (aa), by adding at the end the following 
        new sentence: ``The term `State' does not include a local 
        government, as defined in subsection (ii), and is not intended 
        to grant any authority or to otherwise refer to local 
        governments or political subdivisions of a State.''; and
            (2) by adding at the end the following:
    ``(ii) Local Government.--The term `local government' means any 
political subdivision of a State including counties, townships, cities, 
towns, parishes, and boroughs, whether home rule entities or not, or 
any local agency or body of any type which has an organized existence, 
governmental character, and substantial autonomy including independent 
or autonomous school districts, housing authorities, and other special 
districts.''.
    (b) Records.--Section 8(b) (7 U.S.C. 136f(b)) is amended by 
striking ``or political subdivision'' in the first sentence.
    (c) Delegation and Cooperation.--Section 22(b) (7 U.S.C. 136t(b)) 
is amended by striking ``or any political subdivision thereof''.
    (d) Authority of States.--Section 24 (7 U.S.C. 136v) is amended by 
adding at the end the following:
    ``(d) Local Regulation.--Subject to subsection (e), a local 
government shall not impose or continue in effect any requirement or 
regulation regarding pesticides or devices.
    ``(e) Locally Specific State Regulation.--Nothing in this section 
shall prohibit a State from enforcing laws, enacting laws, or 
implementing regulations applicable to local governments regarding the 
sale or use of any federally registered pesticide or device.''.
    (e) Authority of Administrator.--The first sentence of section 
25(e) (7 U.S.C. 136w(e)) is amended by striking ``or political 
subdivision thereof''.

 SEC. 107. PERIODIC REGISTRATION REVIEW.

    (a) Section 6.--Section 6 (7 U.S.C. 136d) is amended--
            (1) in subsection (a), by striking the heading and 
        inserting the following:
    ``(a) Existing Stocks and Information.--''; and
            (2) by amending paragraph (1) of subsection (a) to read as 
        follows:
            ``(1) Existing stocks.--The Administrator may permit the 
        continued sale and use of existing stocks of a pesticide whose 
        registration is suspended or canceled under this section, or 
        section 3 or 4, to such extent, under such conditions, and for 
        such uses as the Administrator determines that such sale or use 
        is not inconsistent with the purposes of this Act.''.
    (b) Section 3.--Section 3 (7 U.S.C. 136a) is amended by adding at 
the end the following:
    ``(g) Registration Review.--
            ``(1)(A) General rule.--The registrations of pesticides are 
        to be periodically reviewed. The Administrator shall by 
        regulation establish a procedure for accomplishing the periodic 
        review of registrations. The goal of these regulations shall be 
        a review of a pesticide's registration every 15 years. No 
        registration shall be canceled as a result of the registration 
        review process unless the Administrator follows the procedures 
        and substantive requirements of section 6.
            ``(B) Limitation.--Nothing in this subsection shall 
        prohibit the Administrator from undertaking any other review of 
        a pesticide pursuant to this Act.
            ``(2)(A) Data.--The Administrator shall use the authority 
        in subsection (c)(2)(B) to require the submission of data when 
        such data are necessary for a registration review.
            ``(B) Data submission, compensation, and exemption.--For 
        purposes of this subsection, the provisions of subsections 
        (c)(1), (c)(2)(B), and (c)(2)(D) shall be utilized for and be 
        applicable to any data required for registration review.''.

     Subtitle B--Training for Maintenance Applicators and Service 
                              Technicians

 SEC. 120. MAINTENANCE APPLICATORS AND SERVICE TECHNICIANS DEFINITIONS.

    Section 2 (7 U.S.C. 136), as amended by section 106, is amended by 
adding at the end the following:
    ``(jj) Maintenance Applicator.--The term `maintenance applicator' 
means any individual who, in the principal course of such individual's 
employment, uses, or supervises the use of, a pesticide not classified 
for restricted use (other than a ready to use consumer products 
pesticides); for the purpose of providing structural pest control or 
lawn pest control including janitors, general maintenance personnel, 
sanitation personnel, and grounds maintenance personnel. The term 
`maintenance applicator' does not include private applicators as 
defined in section 2(e)(2); individuals who use antimicrobial 
pesticides, sanitizers or disinfectants; individuals employed by 
Federal, State, and local governments or any political subdivisions 
thereof, or individuals who use pesticides not classified for 
restricted use in or around their homes, boats, sod farms, nurseries, 
greenhouses, or other noncommercial property.
    ``(kk) Service Technician.--The term `service technician' means any 
individual who uses or supervises the use of pesticides (other than a 
ready to use consumer products pesticide) for the purpose of providing 
structural pest control or lawn pest control on the property of another 
for a fee. The term `service technician' does not include individuals 
who use antimicrobial pesticides, sanitizers or disinfectants; or who 
otherwise apply ready to use consumer products pesticides.''.

 SEC. 121. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS 
              AND SERVICE TECHNICIANS.

    The Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
136 et seq.) is amended--
            (1) by redesignating sections 30 and 31 as sections 33 and 
        34, respectively; and
            (2) by adding after section 29 the following:

``SEC. 30. MINIMUM REQUIREMENTS FOR TRAINING OF MAINTENANCE APPLICATORS 
              AND SERVICE TECHNICIANS.

    ``Each State may establish minimum requirements for training of 
maintenance applicators and service technicians. Such training may 
include instruction in the safe and effective handling and use of 
pesticides in accordance with the Environmental Protection Agency 
approved labeling, and instruction in integrated pest management 
techniques. The authority of the Administrator with respect to minimum 
requirements for training of maintenance applicators and service 
technicians shall be limited to ensuring that each State understands 
the provisions of this section.''.

     TITLE II--MINOR USE CROP PROTECTION, ANTIMICROBIAL PESTICIDE 
           REGISTRATION REFORM, AND PUBLIC HEALTH PESTICIDES

 SEC. 201. REFERENCE.

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

                 Subtitle A--Minor Use Crop Protection

 SEC. 210. MINOR CROP PROTECTION.

    (a) Definition.--Section 2 (7 U.S.C. 136), as amended by section 
120, is further amended by adding at the end the following:
    ``(ll) Minor Use.--The term `minor use' means the use of a 
pesticide on an animal, on a commercial agricultural crop or site, or 
for the protection of public health where--
            ``(1) the total United States acreage for the crop is less 
        than 300,000 acres, as determined by the Secretary of 
        Agriculture; or
            ``(2) the Administrator, in consultation with the Secretary 
        of Agriculture, determines that, based on information provided 
        by an applicant for registration or a registrant, the use does 
        not provide sufficient economic incentive to support the 
        initial registration or continuing registration of a pesticide 
        for such use and--
                    ``(A) there are insufficient efficacious 
                alternative registered pesticides available for the 
                use;
                    ``(B) the alternatives to the pesticide use pose 
                greater risks to the environment or human health;
                    ``(C) the minor use pesticide plays or will play a 
                significant part in managing pest resistance; or
                    ``(D) the minor use pesticide plays or will play a 
                significant part in an integrated pest management 
                program.
The status as a minor use under this subsection shall continue as long 
as the Administrator has not determined that, based on existing data, 
such use may cause an unreasonable adverse effect on the environment 
and the use otherwise qualifies for such status.''.
    (b) Exclusive Use of Minor Use Pesticides.--Section 3(c)(1)(F) (7 
U.S.C. 136a(c)(1)(F)) is amended--
            (1) by redesignating clauses (ii) and (iii) as clauses 
        (iii) and (iv), respectively; and
            (2) by inserting after clause (i) the following:
                            ``(ii) The period of exclusive data use 
                        provided under clause (i) shall be extended 1 
                        additional year for each 3 minor uses 
                        registered after the date of enactment of this 
                        clause and within 7 years of the commencement 
                        of the exclusive use period, up to a total of 3 
                        additional years for all minor uses registered 
                        by the Administrator if the Administrator, in 
                        consultation with the Secretary of Agriculture, 
                        determines that, based on information provided 
                        by an applicant for registration or a 
                        registrant, that--
                                    ``(I) there are insufficient 
                                efficacious alternative registered 
                                pesticides available for the use;
                                    ``(II) the alternatives to the 
                                minor use pesticide pose greater risks 
                                to the environment or human health;
                                    ``(III) the minor use pesticide 
                                plays or will play a significant part 
                                in managing pest resistance; or
                                    ``(IV) the minor use pesticide 
                                plays or will play a significant part 
                                in an integrated pest management 
                                program.
                        The registration of a pesticide for a minor use 
                        on a crop grouping established by the 
                        Administrator shall be considered for purposes 
                        of this clause 1 minor use for each 
                        representative crop for which data are provided 
                        in the crop grouping. Any additional exclusive 
                        use period under this clause shall be modified 
                        as appropriate or terminated if the registrant 
                        voluntarily cancels the product or deletes from 
                        the registration the minor uses which formed 
                        the basis for the extension of the additional 
                        exclusive use period or if the Administrator 
                        determines that the registrant is not actually 
                        marketing the product for such minor uses.'';
            (3) in clause (iv), as amended by paragraph (1), by 
        striking ``and (ii)'' and inserting ``, (ii), and (iii)''; and
            (4) at the end of the section, as amended by paragraph (1), 
        by adding the following:
                            ``(v) The period of exclusive use provided 
                        under clause (ii) shall not take into effect 
                        until 1 year after enactment of this clause, 
                        except where an applicant or registrant is 
                        applying for the registration of a pesticide 
                        containing an active ingredient not previously 
                        registered.
                            ``(vi) With respect to data submitted after 
                        the date of enactment of this clause by an 
                        applicant or registrant to support an amendment 
                        adding a new use to an existing registration 
                        that does not retain any period of exclusive 
                        use, if such data relates solely to a minor use 
                        of a pesticide, such data shall not, without 
                        the written permission of the original data 
                        submitter, be considered by the Administrator 
                        to support an application for a minor use by 
                        another person during the period of 10 years 
                        following the date of submission of such data. 
                        The applicant or registrant at the time the new 
                        minor use is requested shall notify the 
                        Administrator that to the best of their 
                        knowledge the exclusive use period for the 
                        pesticide has expired and that the data 
                        pertaining solely to the minor use of a 
                        pesticide is eligible for the provisions of 
                        this paragraph. If the minor use registration 
                        which is supported by data submitted pursuant 
                        to this subsection is voluntarily canceled or 
                        if such data are subsequently used to support a 
                        nonminor use, the data shall no longer be 
                        subject to the exclusive use provisions of this 
                        clause but shall instead be considered by the 
                        Administrator in accordance with the provisions 
                        of clause (i), as appropriate.''.
    (c) Time Extensions for Development of Minor Use Data.--
            (1) Data call-in.--Section 3(c)(2)(B) (7 U.S.C. 
        136a(c)(2)(B)) is amended by adding at the end the following:
                            ``(vi) Upon the request of a registrant the 
                        Administrator shall, in the case of a minor 
                        use, extend the deadline for the production of 
                        residue chemistry data under this subparagraph 
                        for data required solely to support that minor 
                        use until the final deadline for submission of 
                        data under section 4 for the other uses of the 
                        pesticide established as of the date of 
                        enactment of the Minor Use Crop Protection Act 
                        of 1996, if--
                                    ``(I) the data to support other 
                                uses of the pesticide on a food are 
                                being provided;
                                    ``(II) the registrant, in 
                                submitting a request for such an 
                                extension, provides a schedule, 
                                including interim dates to measure 
                                progress, to assure that the data 
                                production will be completed before the 
                                expiration of the extension period;
                                    ``(III) the Administrator has 
                                determined that such extension will not 
                                significantly delay the Administrator's 
                                schedule for issuing a reregistration 
                                eligibility determination required 
                                under section 4; and
                                    ``(IV) the Administrator has 
                                determined that based on existing data, 
                                such extension would not significantly 
                                increase the risk of any unreasonable 
                                adverse effect on the environment. If 
                                the Administrator grants an extension 
                                under this clause, the Administrator 
                                shall monitor the development of the 
                                data and shall ensure that the 
                                registrant is meeting the schedule for 
                                the production of the data. If the 
                                Administrator determines that the 
                                registrant is not meeting or has not 
                                met the schedule for the production of 
                                such data, the Administrator may 
                                proceed in accordance with clause (iv) 
                                regarding the continued registration of 
                                the affected products with the minor 
                                use and shall inform the public of such 
                                action. Notwithstanding the provisions 
                                of this clause, the Administrator may 
                                take action to modify or revoke the 
                                extension under this clause if the 
                                Administrator determines that the 
                                extension for the minor use may cause 
                                an unreasonable adverse effect on the 
                                environment. 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 Food Quality Protection Act of 1996 if--
                    ``(i) the data to support other uses of the 
                pesticide on a food are being provided;
                    ``(ii) the registrant, in submitting a request for 
                such an extension provides a schedule, including 
                interim dates to measure progress, to assure that the 
                data production will be completed before the expiration 
                of the extension period;
                            ``(iii) the Administrator has determined 
                        that such extension will not significantly 
                        delay the Administrator's schedule for issuing 
                        a reregistration eligibility determination 
                        required under this section; and
                            ``(iv) the Administrator has determined 
                        that based on existing data, such extension 
                        would not significantly increase the risk of 
                        any unreasonable adverse effect on the 
                        environment. If the Administrator grants an 
                        extension under this subparagraph, the 
                        Administrator shall monitor the development of 
                        the data and shall ensure that the registrant 
                        is meeting the schedule for the production of 
                        the data. If the Administrator determines that 
                        the registrant is not meeting or has not met 
                        the schedule for the production of such data, 
                        the Administrator may proceed in accordance 
                        with clause (iv) of section 3(c)(2)(B) or other 
                        provisions of this section, as appropriate, 
                        regarding the continued registration of the 
                        affected products with the minor use and shall 
                        inform the public of such action. 
                        Notwithstanding the provisions of this 
                        subparagraph, the Administrator may take action 
                        to modify or revoke the extension under this 
                        subparagraph if the Administrator determines 
                        that the extension for the minor use may cause 
                        an unreasonable adverse affect on the 
                        environment. In such circumstance, the 
                        Administrator shall provide written notice to 
                        the registrant revoking the extension of time 
                        for submission of data. Such data shall instead 
                        be due in accordance with the date then 
                        established by the Administrator for submission 
                        of the data.''.
    (d) Minor Use Waiver.--Section 3(c)(2) (7 U.S.C. 136a(c)(2)) is 
amended--
            (1) by inserting ``In general.--'' after ``(A)'';
            (2) by inserting ``Additional data.--'' after ``(B)'';
            (3) by inserting ``Simplified procedures.--'' after 
        ``(C)''; and
            (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 nonminor use, a 
                                minor use that would, in the judgment 
                                of the Administrator, serve as a 
                                replacement for any use which has been 
                                canceled in the 5 years preceding the 
                                receipt of the application, or a minor 
                                use that in the opinion of the 
                                Administrator would avoid the 
                                reissuance of an emergency exemption 
                                under section 18 for that minor use.
                    ``(D) Adequate time for submission of minor use 
                data.--If a registrant makes a request for a minor use 
                waiver, regarding data required by the Administrator, 
                pursuant to paragraph (2)(E), and if the Administrator 
                denies in whole or in part such data waiver request, 
                the registrant shall have a full-time period for 
                providing such data. For purposes of this subparagraph, 
                the term `full-time period' means the time period 
                originally established by the Administrator for 
                submission of such data, beginning with the date of 
                receipt by the registrant of the Administrator's notice 
                of denial.''.
    (f) Temporary Extension of Registration for Unsupported Minor 
Uses.--
            (1) Reregistration.--
                    (A) Sections 4(d)(6) and 4(f)(3) (7 U.S.C. 136a-
                1(d)(6) and (f)(3)) are each amended by adding at the 
                end the following: ``If the registrant does not commit 
                to support a specific minor use of the pesticide, but 
                is supporting and providing data in a timely and 
                adequate fashion to support uses of the pesticide on a 
                food, or if all uses of the pesticide are nonfood uses 
and the registrant does not commit to support a specific minor use of 
the pesticide but is supporting and providing data in a timely and 
adequate fashion to support other nonfood uses of the pesticide, the 
Administrator, at the written request of the registrant, shall not take 
any action pursuant to this paragraph in regard to such unsupported 
minor use until the final deadline established as of the date of 
enactment of the Food Quality Protection Act of 1996, for the 
submission of data under this section for the supported uses identified 
pursuant to this paragraph unless the Administrator determines that the 
absence of the data is significant enough to cause human health or 
environmental concerns. On such a determination the Administrator may 
refuse the request for extension by the registrant. 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 Food Quality Protection Act of 
                1996, for the submission of data under this section for 
                the supported uses identified pursuant to this 
                subparagraph unless the Administrator determines that 
                the absence of the data is significant enough to cause 
                human health or environmental concerns. On the basis of 
                such determination, the Administrator may refuse the 
                request for extension by the registrant. 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)(1), is further amended by adding at 
        the end the following:
                            ``(vii) If the registrant does not commit 
                        to support a specific minor use of the 
                        pesticide, but is supporting and providing data 
                        in a timely and adequate fashion to support 
                        uses of the pesticide on a food, or if all uses 
                        of the pesticide are nonfood uses and the 
                        registrant does not commit to support a 
                        specific minor use of the pesticide but is 
                        supporting and providing data in a timely and 
                        adequate fashion to support other nonfood uses 
                        of the pesticide, the Administrator, at the 
                        written request of the registrant, shall not 
                        take any action pursuant to this clause in 
                        regard to such unsupported minor use until the 
                        final deadline established as of the date of 
                        enactment of the Food Quality Protection Act of 
                        1996, for the submission of data under section 
                        4 for the supported use 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 the receipt of the request and the 
effective date upon which the uses not being supported will be 
voluntarily deleted from the registration pursuant to section 6(f)(1). 
If the Administrator grants an extension under this clause, the 
Administrator shall monitor the development of the data for the uses 
being supported and shall ensure that the registrant is meeting the 
schedule for the production of such data. If the Administrator 
determines that the registrant is not meeting or has not met the 
schedule for the production of such data, the Administrator may proceed 
in accordance with clause (iv) of this subparagraph regarding the 
continued registration of the affected products with the minor and 
other uses and shall inform the public of such action in accordance 
with section 6(f)(2). Notwithstanding the provisions of this clause, 
the Administrator may deny, modify, or revoke the temporary extension 
under this subparagraph if the Administrator determines that the 
continuation of the minor use may cause an unreasonable adverse effect 
on the environment. In the event of modification or revocation, the 
Administrator shall provide, in writing, to the registrant a notice 
revoking the temporary extension and establish a new effective date by 
which the minor use shall be deleted from the registration.''.
    (g) Section 6(f) (7 U.S.C. 136d(f)) is amended--
            (1) in paragraph (1)(C)(ii) by striking ``90-day'' each 
        place it appears and inserting ``180-day''; and
            (2) in paragraph (3)(A) by striking ``90-day'' and 
        inserting ``180-day''.
    (h) Utilization of Data for Voluntarily Canceled Chemicals.--
Section 6(f) (7 U.S.C. 136d(f)) is amended by adding at the end the 
following:
            ``(4) Utilization of data for voluntarily canceled 
        pesticide.--When an application is filed with the Administrator 
        for the registration of a pesticide for a minor use and another 
        registrant subsequently voluntarily cancels its registration 
        for an identical or substantially similar pesticide for an 
        identical or substantially similar use, the Administrator shall 
        process, review, and evaluate the pending application as if the 
        voluntary cancellation had not yet taken place except that the 
        Administrator shall not take such action if the Administrator 
        determines that such minor use may cause an unreasonable 
        adverse effect on the environment. In order to rely on this 
        subsection, the applicant must certify that it agrees to 
        satisfy any outstanding data requirements necessary to support 
        the reregistration of the pesticide in accordance with the data 
        submission schedule established by the Administrator.''.
    (i) Environmental Protection Agency Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by section 121, is amended by adding after section 30 the 
following:

``SEC. 31. ENVIRONMENTAL PROTECTION AGENCY MINOR USE PROGRAM.

    ``(a) The Administrator shall assure coordination of minor use 
issues through the establishment of a minor use program within the 
Office of Pesticide Programs. Such office shall be responsible for 
coordinating the development of minor use programs and policies and 
consulting with growers regarding minor use issues and registrations 
and amendments which are submitted to the Environmental Protection 
Agency.
    ``(b) The Office of Pesticide Programs shall prepare a public 
report concerning the progress made on the registration of minor uses, 
including implementation of the exclusive use as an incentive for 
registering new minor uses, within 3 years of the passage of the Food 
Quality Protection Act of 1996.''.
    (j) Department of Agriculture Minor Use Program.--The Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), as 
amended by subsection (i), is amended by adding after section 31 the 
following:

``SEC. 32. DEPARTMENT OF AGRICULTURE MINOR USE PROGRAM.

    ``(a) In General.--The Secretary of Agriculture (hereinafter in 
this section referred to as the `Secretary') shall assure the 
coordination of the responsibilities of the Department of Agriculture 
related to minor uses of pesticides, including--
            ``(1) carrying out the Inter-Regional Project Number 4 (IR-
        4) as described in section 2 of Public Law 89-106 (7 U.S.C. 
        450i(e)) and the national pesticide resistance monitoring 
        program established under section 1651 of the Food, 
        Agriculture, Conservation, and Trade Act of 1990 (7 U.S.C. 
        5882);
            ``(2) supporting integrated pest management research;
            ``(3) consulting with growers to develop data for minor 
        uses; and
            ``(4) providing assistance for minor use registrations, 
        tolerances, and reregistrations with the Environmental 
        Protection Agency.
    ``(b)(1) Minor Use Pesticide Data.--
            ``(A) Grant authority.--The Secretary, in consultation with 
        the Administrator, shall establish a program to make grants for 
        the development of data to support minor use pesticide 
        registrations and reregistrations. The amount of any such grant 
        shall not exceed \1/2\ of the cost of the project for which the 
        grant is made.
            ``(B) Applicants.--Any person who wants to develop data to 
        support minor use pesticide registrations and reregistrations 
        may apply for a grant under subparagraph (A). Priority shall be 
        given to an applicant for such a grant who does not directly 
        receive funds from the sale of pesticides registered for minor 
        uses.
            ``(C) Data ownership.--Any data that is developed under a 
        grant under subparagraph (A) shall be jointly owned by the 
        Department of Agriculture and the person who received the 
        grant. Such a person shall enter into an agreement with the 
        Secretary under which such person shall share any fee paid to 
        such person under section 3(c)(1)(F).
    ``(2) Minor use pesticide data revolving fund.--
            ``(A) Establishment.--There is established in the Treasury 
        of the United States a revolving fund to be known as the Minor 
        Use Pesticide Data Revolving Fund. The Fund shall be available 
        without fiscal year limitation to carry out the authorized 
        purposes of this subsection.
            ``(B) Contents of the fund.--There shall be deposited in 
        the Fund--
                    ``(i) such amounts as may be appropriated to 
                support the purposes of this subsection; and
                    ``(ii) fees collected by the Secretary for any data 
                developed under a grant under paragraph (1)(A).
            ``(C) Authorizations of appropriations.--There are 
        authorized to be appropriated for each fiscal year to carry out 
        the purposes of this subsection $10,000,000 to remain available 
        until expended.''.

        Subtitle B--Antimicrobial Pesticide Registration Reform

 SEC. 221. DEFINITIONS.

    Section 2 (7 U.S.C. 136), as amended by section 210(a) is further 
amended--
            (1) in subsection (u), by adding at the end the following: 
        ``The term `pesticide' does not include liquid chemical 
        sterilant products (including any sterilant or subordinate 
        disinfectant claims on such products) for use on a critical or 
        semi-critical device, as defined in section 201 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 321). For purposes of 
        the preceding sentence, the term `critical device' includes any 
        device which is introduced directly into the human body, either 
        into or in contact with the bloodstream or normally sterile 
        areas of the body and the term `semi-critical device' includes 
        any device which contacts intact mucous membranes but which 
        does not ordinarily penetrate the blood barrier or otherwise 
        enter normally sterile areas of the body.''; and
            (2) by adding at the end the following:
    ``(mm) Antimicrobial Pesticide.--
            ``(1) In general.--The term `antimicrobial pesticide' means 
        a pesticide that--
                    ``(A) is intended to--
                            ``(i) disinfect, sanitize, reduce, or 
                        mitigate growth or development of 
                        microbiological organisms; or
                            ``(ii) protect inanimate objects, 
                        industrial processes or systems, surfaces, 
                        water, or other chemical substances from 
                        contamination, fouling, or deterioration caused 
                        by bacteria, viruses, fungi, protozoa, algae, 
                        or slime; and
                    ``(B) in the intended use is exempt from, or 
                otherwise not subject to, a tolerance under section 408 
                of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                346a and 348) or a food additive regulation under 
                section 409 of such Act.
            ``(2) Excluded products.--The term `antimicrobial 
        pesticide' does not include --
                    ``(A) a wood preservative or antifouling paint 
                product for which a claim of pesticidal activity other 
                than or in addition to an activity described in 
                paragraph (1) is made;
                    ``(B) an agricultural fungicide product; or
                    ``(C) an aquatic herbicide product.
            ``(3) Included products.--The term `antimicrobial 
        pesticide' does include any other chemical sterilant product 
        (other than liquid chemical sterilant products exempt under 
        subsection (u)), any other disinfectant product, any other 
        industrial microbiocide product, and any other preservative 
        product that is not excluded by paragraph (2).''.

 SEC. 222. FEDERAL AND STATE DATA COORDINATION.

    Section 3(c)(2)(B) (7 U.S.C. 136a(c)(2)(B)), as amended by section 
210(f)(2), is amended by adding at the end the following:
                    ``(viii)(I) If data required to support 
                registration of a pesticide under subparagraph (A) is 
                requested by a Federal or State regulatory authority, 
                the Administrator shall, to the extent practicable, 
                coordinate data requirements, test protocols, 
                timetables, and standards of review and reduce burdens 
                and redundancy caused to the registrant by multiple 
                requirements on the registrant.
                    ``(II) The Administrator may enter into a 
                cooperative agreement with a State to carry out 
                subclause (I).
                    ``(III) Not later than 1 year after the date of 
                enactment of this clause, the Administrator shall 
                develop a process to identify and assist in alleviating 
                future disparities between Federal and State data 
                requirements.''.

 SEC. 223. LABEL AND LABELING.

    Section 3(c) (7 U.S.C. 136a(c)) is amended by adding at the end the 
following:
            ``(9) Labeling.--
                    ``(A) Additional statements.--Subject to 
                subparagraphs (B) and (C), it shall not be a violation 
                of this Act for a registrant to modify the labeling of 
                an antimicrobial pesticide product to include relevant 
                information on product efficacy, product composition, 
                container composition or design, or other 
                characteristics that do not relate to any pesticidal 
                claim or pesticidal activity.
                    ``(B) Requirements.--Proposed labeling information 
                under subparagraph (A) shall not be false or 
                misleading, shall not conflict with or detract from any 
                statement required by law or the Administrator as a 
                condition of registration, and shall be substantiated 
                on the request of the Administrator.
                    ``(C) Notification and disapproval.--
                            ``(i) Notification.--A registration may be 
                        modified under subparagraph (A) if--
                                    ``(I) the registrant notifies the 
                                Administrator in writing not later than 
                                60 days prior to distribution or sale 
                                of a product bearing the modified 
                                labeling; and
                                    ``(II) the Administrator does not 
                                disapprove of the modification under 
                                clause (ii).
                            ``(ii) Disapproval.--Not later than 30 days 
                        after receipt of a notification under clause 
                        (i), the Administrator may disapprove the 
                        modification by sending the registrant 
                        notification in writing stating that the 
                        proposed language is not acceptable and stating 
                        the reasons why the Administrator finds the 
                        proposed modification unacceptable.
                            ``(iii) Restriction on sale.--A registrant 
                        may not sell or distribute a product bearing a 
                        disapproved modification.
                            ``(iv) Objection.--A registrant may file an 
                        objection in writing to a disapproval under 
                        clause (ii) not later than 30 days after 
                        receipt of notification of the disapproval.
                            ``(v) Final action.--A decision by the 
                        Administrator following receipt and 
                        consideration of an objection filed under 
                        clause (iv) shall be considered a final agency 
                        action.
                    ``(D) Use dilution.--The label or labeling required 
                under this Act for an antimicrobial pesticide that is 
                or may be diluted for use may have a different 
                statement of caution or protective measures for use of 
                the recommended diluted solution of the pesticide than 
                for use of a concentrate of the pesticide if the 
                Administrator determines that--
                            ``(i) adequate data have been submitted to 
                        support the statement proposed for the diluted 
                        solution uses; and
                            ``(ii) the label or labeling provides 
                        adequate protection for exposure to the diluted 
                        solution of the pesticide.''.

 SEC. 224. REGISTRATION REQUIREMENTS FOR ANTIMICROBIAL PESTICIDES.

    Section 3 (7 U.S.C. 136a), as amended by section 107(b), is further 
amended by adding at the end the following:
    ``(h) Registration Requirements for Antimicrobial Pesticides.--
            ``(1) Evaluation of process.--To the maximum extent 
        practicable consistent with the degrees of risk presented by a 
        antimicrobial pesticide and the type of review appropriate to 
        evaluate the risks, the Administrator shall identify and 
        evaluate reforms to the antimicrobial registration process that 
        would reduce review periods existing as of the date of 
        enactment of this subsection for antimicrobial pesticide 
        product registration applications and applications for amended 
        registration of antimicrobial pesticide products, including--
                    ``(A) new antimicrobial active ingredients;
                    ``(B) new antimicrobial end-use products;
                    ``(C) substantially similar or identical 
                antimicrobial pesticides; and
                    ``(D) amendments to antimicrobial pesticide 
                registrations.
            ``(2) Review time period reduction goal.--Each reform 
        identified under paragraph (1) shall be designed to achieve the 
        goal of reducing the review period following submission of a 
        complete application, consistent with the degree of risk, to a 
        period of not more than--
                    ``(A) 540 days for a new antimicrobial active 
                ingredient pesticide registration;
                    ``(B) 270 days for a new antimicrobial use of a 
                registered active ingredient;
                    ``(C) 120 days for any other new antimicrobial 
                product;
                    ``(D) 90 days for a substantially similar or 
                identical antimicrobial product;
                    ``(E) 90 days for an amendment to an antimicrobial 
                registration that does not require scientific review of 
                data; and
                    ``(F) 90 to 180 days for an amendment to an 
                antimicrobial registration that requires scientific 
                review of data and that is not otherwise described in 
                this paragraph.
            ``(3) Implementation.--
                    ``(A) Proposed rulemaking.--
                            ``(i) Issuance.--Not later than 270 days 
                        after the date of enactment of this subsection, 
                        the Administrator shall publish in the Federal 
                        Register proposed regulations to accelerate and 
                        improve the review of antimicrobial pesticide 
                        products designed to implement, to the extent 
                        practicable, the goals set forth in paragraph 
                        (2).
                            ``(ii) Requirements.--Proposed regulations 
                        issued under clause (i) shall--
                                    ``(I) define the various classes of 
                                antimicrobial use patterns, including 
                                household, industrial, and 
                                institutional disinfectants and 
                                sanitizing pesticides, preservatives, 
                                water treatment, and pulp and paper 
                                mill additives, and other such products 
                                intended to disinfect, sanitize, 
                                reduce, or mitigate growth or 
                                development of microbiological 
                                organisms, or protect inanimate 
                                objects, industrial processes or 
                                systems, surfaces, water, or other 
                                chemical substances from contamination, 
                                fouling, or deterioration caused by 
                                bacteria, viruses, fungi, protozoa, 
                                algae, or slime;
                                    ``(II) differentiate the types of 
                                review undertaken for antimicrobial 
                                pesticides;
                                    ``(III) conform the degree and type 
                                of review to the risks and benefits 
                                presented by antimicrobial pesticides 
                                and the function of review under this 
                                Act, considering the use patterns of 
                                the product, toxicity, expected 
                                exposure, and product type;
                                    ``(IV) ensure that the registration 
                                process is sufficient to maintain 
                                antimicrobial pesticide efficacy and 
                                that antimicrobial pesticide products 
                                continue to meet product performance 
                                standards and effectiveness levels for 
                                each type of label claim made; and
                                    ``(V) implement effective and 
                                reliable deadlines for process 
                                management.
                            ``(iii) Comments.--In developing the 
                        proposed regulations, the Administrator shall 
                        solicit the views from registrants and other 
                        affected parties to maximize the effectiveness 
                        of the rule development process.
                    ``(B) Final regulations.--
                            ``(i) Issuance.--The Administrator shall 
                        issue final regulations not later than 240 days 
                        after the close of the comment period for the 
                        proposed regulations.
                            ``(ii) Failure to meet goal.--If a goal 
                        described in paragraph (2) is not met by the 
                        final regulations, the Administrator shall 
                        identify the goal, explain why the goal was not 
                        attained, describe the element of the 
                        regulations included instead, and identify 
                        future steps to attain the goal.
                            ``(iii) Requirements.--In issuing final 
                        regulations, the Administrator shall--
                                    ``(I) consider the establishment of 
                                a certification process for regulatory 
                                actions involving risks that can be 
                                responsibly managed, consistent with 
                                the degree of risk, in the most cost-
                                efficient manner;
                                    ``(II) consider the establishment 
                                of a certification process by approved 
                                laboratories as an adjunct to the 
                                review process;
                                    ``(III) use all appropriate and 
                                cost-effective review mechanisms, 
                                including--
                                            ``(aa) expanded use of 
                                        notification and non-
                                        notification procedures;
                                            ``(bb) revised procedures 
                                        for application review; and
                                            ``(cc) allocation of 
                                        appropriate resources to ensure 
                                        streamlined management of 
                                        antimicrobial pesticide 
                                        registrations; and
                                    ``(IV) clarify criteria for 
                                determination of the completeness of an 
                                application.
                    ``(C) Expedited review.--This subsection does not 
                affect the requirements or extend the deadlines or 
                review periods contained in subsection (c)(3).
                    ``(D) Alternative review periods.--If the final 
                regulations to carry out this paragraph are not 
                effective 630 days after the date of enactment of this 
                subsection, until the final regulations become 
                effective, the review period, beginning on the date of 
                receipt by the Agency of a complete application, shall 
                be--
                            ``(i) 2 years for a new antimicrobial 
                        active ingredient pesticide registration;
                            ``(ii) 1 year for a new antimicrobial use 
                        of a registered active ingredient;
                            ``(iii) 180 days for any other new 
                        antimicrobial product;
                            ``(iv) 90 days for a substantially similar 
                        or identical antimicrobial product;
                            ``(v) 90 days for an amendment to an 
                        antimicrobial registration that does not 
                        require scientific review of data; and
                            ``(vi) 240 days for an amendment to an 
                        antimicrobial registration that requires 
                        scientific review of data and that is not 
                        otherwise described in this subparagraph.
                    ``(E) Wood preservatives.--An application for the 
                registration, or for an amendment to the registration, 
                of a wood preservative product for which a claim of 
                pesticidal activity listed in section 2(mm) is made 
                (regardless of any other pesticidal claim that is made 
                with respect to the product) shall be reviewed by the 
                Administrator within the same period as that 
                established under this paragraph for an antimicrobial 
                pesticide product application, consistent with the 
                degree of risk posed by the use of the wood 
                preservative product, if the application requires the 
                applicant to satisfy the same data requirements as are 
                required to support an application for a wood 
                preservative product that is an antimicrobial 
                pesticide.
                    ``(F) Notification.--
                            ``(i) In general.--Subject to clause (iii), 
                        the Administrator shall notify an applicant 
                        whether an application has been granted or 
                        denied not later than the final day of the 
                        appropriate review period under this paragraph, 
                        unless the applicant and the Administrator 
                        agree to a later date.
                            ``(ii) Final decision.--If the 
                        Administrator fails to notify an applicant 
                        within the period of time required under clause 
                        (i), the failure shall be considered an agency 
                        action unlawfully withheld or unreasonably 
                        delayed for purposes of judicial review under 
                        chapter 7 of title 5, United States Code.
                            ``(iii) Exemption.--This subparagraph does 
                        not apply to an application for an 
                        antimicrobial pesticide that is filed under 
                        subsection (c)(3)(B) prior to 90 days after the 
                        date of enactment of this subsection.
            ``(4) Annual report.--
                    ``(A) Submission.--Beginning on the date of 
                enactment of this subsection and ending on the date 
                that the goals under paragraph (2) are achieved, the 
                Administrator shall, not later than March 1 of each 
                year, prepare and submit an annual report to the 
                Committee on Agriculture of the House of 
                Representatives and the Committee on Agriculture, 
                Nutrition, and Forestry of the Senate.
                    ``(B) Requirements.--A report submitted under 
                subparagraph (A) shall include a description of--
                            ``(i) measures taken to reduce the backlog 
                        of pending registration applications;
                            ``(ii) progress toward achieving reforms 
                        under this subsection; and
                            ``(iii) recommendations to improve the 
                        activities of the Agency pertaining to 
                        antimicrobial registrations.''.

 SEC. 225. DISPOSAL OF HOUSEHOLD, INDUSTRIAL, OR INSTITUTIONAL 
              ANTIMICROBIAL PRODUCTS.

    Section 19(h) (7 U.S.C. 136q(h)) is amended--
            (1) by striking ``Nothing in'' and inserting the following:
            ``(1) In general.--Nothing in''; and
            (2) by adding at the end the following:
            ``(2) Antimicrobial products.--A household, industrial, or 
        institutional antimicrobial product that is not subject to 
        regulation under the Solid Waste Disposal Act (42 U.S.C. 6901 
        et seq.) shall not be subject to the provisions of subsections 
        (a), (e), and (f), unless the Administrator determines that 
        such product must be subject to such provisions to prevent an 
        unreasonable adverse effect on the environment.''.

                  Subtitle C--Public Health Pesticides

 SEC. 230. DEFINITIONS.

    (a) Adverse Effects.--Section 2(bb) (7 U.S.C. 136(bb)) is amended 
by adding at the end the following: ``The Administrator shall consider 
the risks and benefits of public health pesticides separate from the 
risks and benefits of other pesticides. In weighing any regulatory 
action concerning a public health pesticide under this Act, the 
Administrator shall weigh any risks of the pesticide against the health 
risks such as the diseases transmitted by the vector to be controlled 
by the pesticide.''.
    (b) New Definitions.--Section 2 (7 U.S.C. 136), as amended by 
section 221, is amended by adding at the end the following:
    ``(nn) Public Health Pesticide.--The term `public health pesticide' 
means any minor use pesticide product registered for use and used 
predominantly in public health programs for vector control or for other 
recognized health protection uses, including the prevention or 
mitigation of viruses, bacteria, or other microorganisms (other than 
viruses, bacteria, or other microorganisms on or in living man or other 
living animal) that pose a threat to public health.
    ``(oo) Vector.--The term `vector' means any organism capable of 
transmitting the causative agent of human disease or capable of 
producing human discomfort or injury, including mosquitoes, flies, 
fleas, cockroaches, or other insects and ticks, mites, or rats.''.

 SEC. 231. REGISTRATION.

    Section 3(c)(2)(A) (7 U.S.C. 136a(c)(2)(A)) is amended--
            (1) by inserting after ``pattern of use,'' the following: 
        ``the public health and agricultural need for such minor 
        use,''; and
            (2) by striking ``potential exposure of man and the 
        environment to the pesticide'' and inserting ``potential 
        beneficial or adverse effects on man and the environment''.

 SEC. 232. REREGISTRATION.

    Section 4 (7 U.S.C. 136a-1) is amended--
            (1) in subsection (i)(4), by redesignating subparagraphs 
        (B) and (C) as subparagraphs (C) and (D), respectively, and by 
adding after subparagraph (A) the following:
                    ``(B) The Administrator shall exempt any public 
                health pesticide from the payment of the fee prescribed 
                under paragraph (3) if, in consultation with the 
                Secretary of Health and Human Services, the 
                Administrator determines, based on information supplied 
                by the registrant, that the economic return to the 
                registrant from sales of the pesticide does not support 
                the registration or reregistration of the pesticide.'';
            (2) in subsection (i)(5), by redesignating subparagraphs 
        (F) and (G) as subparagraphs (G) and (H), respectively, and by 
        adding after subparagraph (E) the following:
                    ``(F) The Administrator shall exempt any public 
                health pesticide from the payment of the fee prescribed 
                under paragraph (3) if, in consultation with the 
                Secretary of Health and Humans Services, the 
                Administrator determines, based on information supplied 
                by the registrant, that the economic return to the 
                registrant from sales of the pesticide does not support 
                the registration or reregistration of the pesticide.'';
            (3) in subsection (i)(7)(B), by striking ``or to 
        determine'' and inserting ``, to determine'' and by inserting 
        before the period the following: ``, or to determine the volume 
        usage for public health pesticides''; and
            (4) in subsection (k)(3)(A), by striking ``or'' at the end 
        of clause (i), by striking the period at the end of clause (ii) 
        and inserting thereof ``; or'', and by adding after clause (ii) 
        the following:
                            ``(iii) proposes the initial or amended 
                        registration of an end use pesticide that, if 
                        registered as proposed, would be used for a 
                        public health pesticide.''.

 SEC. 233. CANCELLATION.

    Section 6(b) (7 U.S.C. 136d(b)) is amended by adding after the 
eighth sentence the following: ``When a public health use is affected, 
the Secretary of Health and Human Services should provide available 
benefits and use information, or an analysis thereof, in accordance 
with the procedures followed and subject to the same conditions as the 
Secretary of Agriculture in the case of agricultural pesticides.''.

 SEC. 234. VIEWS OF THE SECRETARY OF HEALTH AND HUMAN SERVICES.

    Section 21 (7 U.S.C. 136s) is amended by redesignating subsections 
(b) and (c) as subsections (c) and (d), respectively, and by adding 
after subsection (a) the following:
    ``(b) Secretary of Health and Human Services.--The Administrator, 
before publishing regulations under this Act for any public health 
pesticide, shall solicit the views of the Secretary of Health and Human 
Services in the same manner as the views of the Secretary of 
Agriculture are solicited under section 25(a)(2).''.

 SEC. 235. AUTHORITY OF ADMINISTRATOR.

    Section 25(a)(1) (7 U.S.C. 136w(a)(1)) is amended--
            (1) by inserting after ``various classes of pesticides'' 
        the following: ``, including public health pesticides,''; and
            (2) by striking ``and nonagricultural pesticides'' and 
        inserting ``, nonagricultural, and public health pesticides''.

 SEC. 236. IDENTIFICATION OF PESTS.

    Section 28 (7 U.S.C. 136w-3) is amended by adding at the end the 
following:
    ``(d) Public Health Pests.--The Administrator, in coordination with 
the Secretary of Agriculture and the Secretary of Health and Human 
Services, shall identify pests of significant public health importance 
and, in coordination with the Public Health Service, develop and 
implement programs to improve and facilitate the safe and necessary use 
of chemical, biological, and other methods to combat and control such 
pests of public health importance.''.

 SEC. 237. PUBLIC HEALTH DATA.

    Section 4 (7 U.S.C. 136a-1) is amended by adding at the end the 
following:
    ``(m) Authorization of Funds To Develop Public Health Data.--
            ``(1) Definition.--For the purposes of this section, 
        `Secretary' means the Secretary of Health and Human Services, 
        acting through the Public Health Service.
            ``(2) Consultation.--In the case of a pesticide registered 
        for use in public health programs for vector control or for 
        other uses the Administrator determines to be human health 
        protection uses, the Administrator shall, upon timely request 
        by the registrant or any other interested person, or on the 
        Administrator's own initiative may, consult with the Secretary 
        prior to taking final action to suspend registration under 
        section 3(c)(2)(B)(iv), or cancel a registration under section 
        4, 6(e), or 6(f). In consultation with the Secretary, the 
        Administrator shall prescribe the form and content of requests 
        under this section.
            ``(3) Benefits to support family.--The Administrator, after 
        consulting with the Secretary, shall make a determination 
        whether the potential benefits of continued use of the 
        pesticide for public health or health protection purposes are 
        of such significance as to warrant a commitment by the 
        Secretary to conduct or to arrange for the conduct of the 
        studies required by the Administrator to support continued 
        registration under section 3 or registration under section 4.
            ``(4) Additional time.--If the Administrator determines 
        that such a commitment is warranted and in the public interest, 
        the Administrator shall notify the Secretary and shall, to the 
        extent necessary, amend a notice issued under section 
        3(c)(2)(B) to specify additional reasonable time periods for 
        submission of the data.
            ``(5) Arrangements.--The Secretary shall make such 
        arrangements for the conduct of required studies as the 
        Secretary finds necessary and appropriate to permit submission 
        of data in accordance with the time periods prescribed by the 
        Administrator. Such arrangements may include Public Health 
        Service intramural research activities, grants, contracts, or 
        cooperative agreements with academic, public health, or other 
        organizations qualified by experience and training to conduct 
        such studies.
            ``(6) Support.--The Secretary may provide for support of 
        the required studies using funds authorized to be appropriated 
        under this section, the Public Health Service Act, or other 
        appropriate authorities. After a determination is made under 
        subsection (d), the Secretary shall notify the Committees on 
        Appropriations of the House Representatives and the Senate of 
        the sums required to conduct the necessary studies.
            ``(7) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out the purposes of this section 
        $12,000,000 for fiscal year 1997, and such sums as may be 
        necessary for succeeding fiscal years.''.

     Subtitle D--Expedited Registration of Reduced Risk Pesticides

 SEC. 250. EXPEDITED REGISTRATION OF PESTICIDES .

    Section 3(c) (7 U.S.C. 136a(c)), as amended by section 223, is 
amended--
            (1) by adding at the end of paragraph (1) the following:
                    ``(G) If the applicant is requesting that the 
                registration or amendment to the registration of a 
                pesticide be expedited, an explanation of the basis for 
                the request must be submitted, in accordance with 
                paragraph (10) of this subsection.''; and
            (2) by adding at the end the following:
            ``(10) Expedited registration of pesticides.--
                    ``(A) Not later than 1 year after the date of 
                enactment of this paragraph, the Administrator shall, 
                utilizing public comment, develop procedures and 
                guidelines, and expedite the review of an application 
                for registration of a pesticide or an amendment to a 
                registration that satisfies such guidelines.
                    ``(B) Any application for registration or an 
                amendment, including biological and conventional 
                pesticides, will be considered for expedited review 
                under this paragraph. An application for registration 
                or an amendment shall qualify for expedited review if 
                use of the pesticide proposed by the application may 
                reasonably be expected to accomplish 1 or more of the 
                following:
                            ``(i) Reduce the risks of pesticides to 
                        human health.
                            ``(ii) Reduce the risks of pesticides to 
                        nontarget organisms.
                            ``(iii) Reduce the potential for 
                        contamination of groundwater, surface water, or 
                        other valued environmental resources.
                            ``(iv) Broaden the adoption of integrated 
                        pest management strategies, or make such 
                        strategies more available or more effective.
                    ``(C) The Administrator, not later than 30 days 
                after receipt of an application for expedited review, 
                shall notify the applicant whether the application is 
                complete. If it is found to be incomplete, the 
                Administrator may either reject the request for 
                expedited review or ask the applicant for additional 
                information to satisfy the guidelines developed under 
                subparagraph (A).''.

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

 SEC. 301. 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 Data Collection.--The Secretary of Agriculture shall 
ensure that the residue data collection activities conducted by the 
Department of Agriculture in cooperation with the Environmental 
Protection Agency and the Department of Health and Human Services, 
provide for the improved data collection of pesticide residues, 
including guidelines for the use of comparable analytical and 
standardized reporting methods, and the increased sampling of foods 
most likely consumed by infants and children.

 SEC. 302. COLLECTION OF PESTICIDE USE INFORMATION.

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

 SEC. 303. INTEGRATED PEST MANAGEMENT.

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

 SEC. 304. COORDINATION OF CANCELLATION.

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

 SEC. 305. PESTICIDE USE INFORMATION STUDY.

    (a) The Secretary of Agriculture shall, in consultation with the 
Administrator of the Environmental Protection Agency, prepare a report 
to Congress evaluating the current status and potential improvements in 
Federal pesticide use information gathering activities. This report 
shall at least include--
            (1) an analysis of the quality and reliability of the 
        information collected by the Department of Agriculture, the 
        Environmental Protection Agency, and other Federal agencies 
        regarding the agricultural use of pesticides; and
            (2) an analysis of options to increase the effectiveness of 
        national pesticide use information collection, including an 
        analysis of costs, burdens placed on agricultural producers and 
        other pesticide users, and effectiveness in tracking risk 
        reduction by those options.
    (b) The Secretary shall submit this report to Congress not later 
than 1 year following the date of enactment of this section.

   [TITLE IV--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.]

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

SEC 401. SHORT TITLE AND REFERENCE.

    (a) Short Title.--This title may be cited as the ``Food Quality 
Protection Act of 1996 ''.
    (b) Reference.--Whenever in this title an amendment or repeal is 
expressed in terms of an amendment to, or repeal of, a section or other 
provision, the reference shall be considered to be made to a section or 
other provision of the Federal Food, Drug, and Cosmetic Act.

SEC. 402. DEFINITIONS.

    (a) Section 201(q).--Section 201(q) (21 U.S.C. 321(q)) is amended 
to read as follows:
    ``(q)(1) The term `pesticide chemical' means any substance that is 
a pesticide within the meaning of the Federal Insecticide, Fungicide, 
and Rodenticide Act, including all active and inert ingredients of such 
pesticide.
    ``(2) The term `pesticide chemical residue' means a residue in or 
on raw agricultural commodity or processed food of--
            ``(A) a pesticide chemical; or
            ``(B) any other added substance that is present on or in 
        the commodity or food primarily as a result of the metabolism 
        or other degradation of a pesticide chemical.
    ``(3) Notwithstanding paragraphs (1) and (2), the Administrator may 
by regulation except a substance from the definition of `pesticide 
chemical' or `pesticide chemical residue' if--
            ``(A) its occurrence as a residue on or in a raw 
        agricultural commodity or processed food is attributable 
        primarily to natural causes or to human activities not 
        involving the use of any substances for a pesticidal purpose in 
        the production, storage, processing, or transportation of any 
        raw agricultural commodity or processed food; and
            ``(B) the Administrator, after consultation with the 
        Secretary, determines that the substance more appropriately 
        should be regulated under one or more provisions of this Act 
        other than sections 402(a)(2)(B) and 408.''.
    (b) Section 201(s).--Paragraphs (1) and (2) of section 201(s) (21 
U.S.C. 321(s)) are amended to read as follows:
            ``(1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
            ``(2) a pesticide chemical; or''.
    (c) Section 201.--Section 201 (21 U.S.C. 321) is amended by adding 
at the end the following:
    ``(gg) The term `processed food' means any food other than a raw 
agricultural commodity and includes any raw agricultural commodity that 
has been subject to processing, such as canning, cooking, freezing, 
dehydration, or milling.
    ``(hh) The term `Administrator' means the Administrator of the 
United States Environmental Protection Agency.''.

SEC. 403. PROHIBITED ACTS.

    Section 301(j) (21 U.S.C. 331(j)) is amended in the first sentence 
by inserting before the period the following: ``; or the violating of 
section 408(i)(2) or any regulation issued under that section.''.

SEC. 404. ADULTERATED FOOD.

    Section 402(a) (21 U.S.C. 342(a)) is amended by striking ``(2)(A) 
if it bears'' and all that follows through ``(3) if it consists'' and 
inserting the following: ``(2)(A) if it bears or contains any added 
poisonous or added deleterious substance (other than a substance that 
is a pesticide chemical residue in or on a raw agricultural commodity 
or processed food, a food additive, a color additive, or a new animal 
drug) that is unsafe within the meaning of section 406; or (B) if it 
bears or contains a pesticide chemical residue that is unsafe within 
the meaning of section 408(a); or (C) if it is or if it bears or 
contains (i) any food additive that is unsafe within the meaning of 
section 409; or (ii) a new animal drug (or conversion product thereof) 
that is unsafe within the meaning of section 512; or (3) if it 
consists''.

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

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

      ``tolerances and exemptions for pesticide chemical residues

    ``Sec. 408. (a) Requirement for Tolerance or Exemption.--
            ``(1) General rule.--Except as provided in paragraph (2) or 
        (3), any pesticide chemical residue in or on a food shall be 
        deemed unsafe for the purpose of section 402(a)(2)(B) unless--
                    ``(A) a tolerance for such pesticide chemical 
                residue in or on such food is in effect under this 
                section and the quantity of the residue is within the 
                limits of the tolerance; or
                    ``(B) an exemption from the requirement of a 
                tolerance is in effect under this section for the 
                pesticide chemical residue.
        For the purposes of this section, the term `food', when used as 
        a noun without modification, shall mean a raw agricultural 
        commodity or processed food.
            ``(2) Processed food.--Notwithstanding paragraph (1)--
                    ``(A) if a tolerance is in effect under this 
                section for a pesticide chemical residue in or on a raw 
                agricultural commodity, a pesticide chemical residue 
                that is present in or on a processed food because the 
                food is made from that raw agricultural commodity shall 
                not be considered unsafe within the meaning of section 
                402(a)(2)(B) despite the lack of a tolerance for the 
                pesticide chemical residue in or on the processed food 
                if the pesticide chemical has been used in or on the 
                raw agricultural commodity in conformity with a 
                tolerance under this section, such residue in or on the 
                raw agricultural commodity has been removed to the 
                extent possible in good manufacturing practice, and the 
                concentration of the pesticide chemical residue in the 
                processed food is not greater than the tolerance 
                prescribed for the pesticide chemical residue in the 
                raw agricultural commodity; or
                    ``(B) if an exemption for the requirement for a 
                tolerance is in effect under this section for a 
                pesticide chemical residue in or on a raw agricultural 
                commodity, a pesticide chemical residue that is present 
                in or on a processed food because the food is made from 
                that raw agricultural commodity shall not be considered 
                unsafe within the meaning of section 402(a)(2)(B).
            ``(3) Residues of degradation products.--If a pesticide 
        chemical residue is present in or on a food because it is a 
        metabolite or other degradation product of a precursor 
        substance that itself is a pesticide chemical or pesticide 
        chemical residue, such a residue shall not be considered to be 
        unsafe within the meaning of section 402(a)(2)(B) despite the 
        lack of a tolerance or exemption from the need for a tolerance 
        for such residue in or on such food if--
                    ``(A) the Administrator has not determined that the 
                degradation product is likely to pose any potential 
                health risk from dietary exposure that is of a 
                different type than, or of a greater significance than, 
                any risk posed by dietary exposure to the precursor 
                substance;
                    ``(B) either--
                            ``(i) a tolerance is in effect under this 
                        section for residues of the precursor substance 
                        in or on the food, and the combined level of 
                        residues of the degradation product and the 
                        precursor substance in or on the food is at or 
                        below the stoichiometrically equivalent level 
                        that would be permitted by the tolerance if the 
                        residue consisted only of the precursor 
                        substance rather than the degradation product; 
                        or
                            ``(ii) an exemption from the need for a 
                        tolerance is in effect under this section for 
                        residues of the precursor substance in or on 
                        the food; and
                    ``(C) the tolerance or exemption for residues of 
                the precursor substance does not state that it applies 
                only to particular named substances and does not state 
                that it does not apply to residues of the degradation 
                product.
            ``(4) Effect of tolerance or exemption.--While a tolerance 
        or exemption from the requirement for a tolerance is in effect 
        under this section for a pesticide chemical residue with 
        respect to any food, the food shall not by reason of bearing or 
        containing any amount of such a residue be considered to be 
        adulterated within the meaning of section 402(a)(1).
    ``(b) Authority and Standard for Tolerance.--
            ``(1) Authority.--The Administrator may issue regulations 
        establishing, modifying, or revoking a tolerance for a 
        pesticide chemical residue in or on a food--
                    ``(A) in response to a petition filed under 
                subsection (d); or
                    ``(B) on the Administrator's own initiative under 
                subsection (e).
        As used in this section, the term `modify' shall not mean 
        expanding the tolerance to cover additional foods.
            ``(2) Standard.--
                    ``(A) General rule.--
                            ``(i) Standard.--The Administrator may 
                        establish or leave in effect a tolerance for a 
                        pesticide chemical residue in or on a food only 
                        if the Administrator determines that the 
                        tolerance is safe. The Administrator shall 
                        modify or revoke a tolerance if the 
                        Administrator determines it is not safe.
                            ``(ii) Determination of safety.--As used in 
                        this section, the term `safe', with respect to 
                        a tolerance for a pesticide chemical residue', 
                        means that the Administrator has determined 
                        that there is a reasonable certainty that no 
                        harm will result from aggregate exposure to the 
                        pesticide chemical residue, including all 
                        anticipated dietary exposures and all other 
                        exposures for which there is reliable 
                        information.
                            ``(iii) Rule of construction.--With respect 
                        to a tolerance, a pesticide chemical residue 
                        meeting the standard under clause (i) is not an 
                        eligible pesticide chemical residue for 
                        purposes of subparagraph (B).
                    ``(B) Tolerances for eligible pesticide chemical 
                residues.--
                            ``(i) Definition.--As used in this 
                        subparagraph, the term `eligible pesticide 
                        chemical residue' means a pesticide chemical 
                        residue as to which--
                                    ``(I) the Administrator is not able 
                                to identify a level of exposure to the 
                                residue at which the residue will not 
                                cause or contribute to a known or 
                                anticipated harm to human health 
                                (referred to in this section as a 
                                `nonthreshold effect');
                                    ``(II) the lifetime risk of 
                                experiencing the nonthreshold effect is 
                                appropriately assessed by quantitative 
                                risk assessment; and
                                    ``(III) with regard to any known or 
                                anticipated harm to human health for 
                                which the Administrator is able to 
                                identify a level at which the residue 
                                will not cause such harm (referred to 
                                in this section as a `threshold 
                                effect'), the Administrator determines 
                                that the level of aggregate exposure is 
                                safe.
                            ``(ii) Determination of tolerance.--
                        Notwithstanding subparagraph (A)(i), a 
                        tolerance for an eligible pesticide chemical 
                        residue may be left in effect or modified under 
                        this subparagraph if--
                                    ``(I) at least one of the 
                                conditions described in clause (iii) is 
                                met; and
                                    ``(II) both of the conditions 
                                described in clause (iv) are met.
                            ``(iii) Conditions regarding use.--For 
                        purposes of clause (ii), the conditions 
                        described in this clause with respect to a 
                        tolerance for an eligible pesticide chemical 
                        residue are the following:
                                    ``(I) Use of the pesticide chemical 
                                that produces the residue protects 
                                consumers from adverse effects on 
                                health that would pose a greater risk 
                                than the dietary risk from the residue.
                                    ``(II) Use of the pesticide 
                                chemical that produces the residue is 
                                necessary to avoid a significant 
                                disruption in domestic production of an 
                                adequate, wholesome, and economical 
                                food supply.
                            ``(iv) Conditions regarding risk.--For 
                        purposes of clause (ii), the conditions 
                        described in this clause with respect to a 
                        tolerance for an eligible pesticide chemical 
                        residue are the following:
                                    ``(I) The yearly risk associated 
                                with the nonthreshold effect from 
                                aggregate exposure to the residue does 
                                not exceed 10 times the yearly risk 
                                that would be allowed under 
                                subparagraph (A) for such effect.
                                    ``(II) The tolerance is limited so 
                                as to ensure that the risk over a 
                                lifetime associated with the 
                                nonthreshold effect from aggregate 
                                exposure to the residue is not greater 
                                than twice the lifetime risk that would 
                                be allowed under subparagraph (A) for 
                                such effect.
                            ``(v) Review.--Five years after the date on 
                        which the Administrator makes a determination 
                        to leave in effect or modify a tolerance under 
                        this subparagraph, and thereafter as the 
                        Administrator deems appropriate, the 
                        Administrator shall determine, after notice and 
                        opportunity for comment, whether it has been 
                        demonstrated to the Administrator that a 
                        condition described in clause (iii)(I) or 
                        clause (iii)(II) continues to exist with 
                        respect to the tolerance and that the yearly 
                        and lifetime risks from aggregate exposure to 
                        such residue continue to comply with the limits 
                        specified in clause (iv). If the Administrator 
                        determines by such date that such demonstration 
                        has not been made, the Administrator shall, not 
                        later than 180 days after the date of such 
                        determination, issue a regulation under 
                        subsection (e)(1) to modify or revoke the 
                        tolerance.
                            ``(vi) Infants and children.--Any tolerance 
                        under this subparagraph shall meet the 
                        requirements of subparagraph (C).
                    ``(C) Exposure of infants and children.--In 
                establishing, modifying, leaving in effect, or revoking 
                a tolerance or exemption for a pesticide chemical 
                residue, the Administrator--
                            ``(i) shall assess the risk of the 
                        pesticide chemical residue based on--
                                    ``(I) available information about 
                                consumption patterns among infants and 
                                children that are likely to result in 
                                disproportionately high consumption of 
                                foods containing or bearing such 
                                residue among infants and children in 
                                comparison to the general population;
                                    ``(II) available information 
                                concerning the special susceptibility 
                                of infants and children to the 
                                pesticide chemical residues, including 
                                neurological differences between 
                                infants and children and adults, and 
                                effects of in utero exposure to 
                                pesticide chemicals; and
                                    ``(III) available information 
                                concerning the cumulative effects on 
                                infants and children of such residues 
                                and other substances that have a common 
                                mechanism of toxicity; and
                            ``(ii) shall--
                                    ``(I) ensure that there is a 
                                reasonable certainty that no harm will 
                                result to infants and children from 
                                aggregate exposure to the pesticide 
                                chemical residue; and
                                    ``(II) publish a specific 
                                determination regarding the safety of 
                                the pesticide chemical residue for 
                                infants and children.
                The Secretary of Health and Human Services and the 
                Secretary of Agriculture, in consultation with the 
                Administrator, shall conduct surveys to document 
                dietary exposure to pesticides among infants and 
                children. In the case of threshold effects, for 
                purposes of clause (ii)(I) an additional tenfold margin 
                of safety for the pesticide chemical residue and other 
                sources of exposure shall be applied for infants and 
                children to take into account potential pre- and post-
                natal toxicity and completeness of the data with 
                respect to exposure and toxicity to infants and 
                children. Notwithstanding such requirement for an 
                additional margin of safety, the Administrator may use 
                a different margin of safety for the pesticide chemical 
                residue only if, on the basis of reliable data, such 
                margin will be safe for infants and children.
                    ``(D) Factors.--In establishing, modifying, leaving 
                in effect, or revoking a tolerance or exemption for a 
                pesticide chemical residue, the Administrator shall 
                consider, among other relevant factors--
                            ``(i) the validity, completeness, and 
                        reliability of the available data from studies 
                        of the pesticide chemical and pesticide 
                        chemical residue;
                            ``(ii) the nature of any toxic effect shown 
                        to be caused by the pesticide chemical or 
                        pesticide chemical residue in such studies;
                            ``(iii) available information concerning 
                        the relationship of the results of such studies 
                        to human risk;
                            ``(iv) available information concerning the 
                        dietary consumption patterns of consumers (and 
                        major identifiable subgroups of consumers);
                            ``(v) available information concerning the 
                        cumulative effects of such residues and other 
                        substances that have a common mechanism of 
                        toxicity;
                            ``(vi) available information concerning the 
                        aggregate exposure levels of consumers (and 
                        major identifiable subgroups of consumers) to 
                        the pesticide chemical residue and to other 
                        related substances, including dietary exposure 
                        under the tolerance and all other tolerances in 
                        effect for the pesticide chemical residue, and 
                        exposure from other non-occupational sources;
                            ``(vii) available information concerning 
                        the variability of the sensitivities of major 
                        identifiable subgroups of consumers;
                            ``(viii) such information as the 
                        Administrator may require on whether the 
pesticide chemical may have an effect in humans that is similar to an 
effect produced by a naturally occurring estrogen or other endocrine 
effects; and
                            ``(ix) safety factors which in the opinion 
                        of experts qualified by scientific training and 
                        experience to evaluate the safety of food 
                        additives are generally recognized as 
                        appropriate for the use of animal 
                        experimentation data.
                    ``(E) Data and information regarding anticipated 
                and actual residue levels.--
                    ``(i) Authority.--In establishing, modifying, 
                leaving in effect, or revoking a tolerance for a 
                pesticide chemical residue, the Administrator may 
                consider available data and information on the 
                anticipated residue levels of the pesticide chemical in 
                or on food and the actual residue levels of the 
                pesticide chemical that have been measured in food, 
                including residue data collected by the Food and Drug 
                Administration.
                    ``(ii) Requirement.--If the Administrator relies on 
                anticipated or actual residue levels in establishing, 
                modifying, or leaving in effect a tolerance, the 
                Administrator shall pursuant to subsection (f)(1) 
                require that data be provided five years after the date 
                on which the tolerance is established, modified, or 
                left in effect, and thereafter as the Administrator 
                deems appropriate, demonstrating that such residue 
                levels are not above the levels so relied on. If such 
                data are not so provided, or if the data do not 
                demonstrate that the residue levels are not above the 
                levels so relied on, the Administrator shall, not later 
                than 180 days after the date on which the data were 
                required to be provided, issue a regulation under 
                subsection (e)(1), or an order under subsection (f)(2), 
                as appropriate, to modify or revoke the tolerance.
                    ``(F) Percent of food actually treated.--In 
                establishing, modifying, leaving in effect, or revoking 
                a tolerance for a pesticide chemical residue, the 
                Administrator may, when assessing chronic dietary risk, 
                consider available data and information on the percent 
                of food actually treated with the pesticide chemical 
                (including aggregate pesticide use data collected by 
                the Department of Agriculture) only if the 
                Administrator--
                            ``(i) finds that the data are reliable and 
                        provide a valid basis to show what percentage 
                        of the food derived from such crop is likely to 
                        contain such pesticide chemical residue;
                            ``(ii) finds that the exposure estimate 
                        does not understate exposure for any 
                        significant subpopulation group;
                            ``(iii) finds that, if data are available 
                        on pesticide use and consumption of food in a 
                        particular area, the population in such area is 
                        not dietarily exposed to residues above those 
                        estimated by the Administrator; and
                            ``(iv) provides for the periodic 
                        reevaluation of the estimate of anticipated 
                        dietary exposure.
            ``(3) Detection methods.--
                    ``(A) General rule.--A tolerance for a pesticide 
                chemical residue in or on a food shall not be 
                established or modified by the Administrator unless the 
                Administrator determines, after consultation with the 
                Secretary, that there is a practical method for 
                detecting and measuring the levels of the pesticide 
                chemical residue in or on the food.
                    ``(B) Detection limit.--A tolerance for a pesticide 
                chemical residue in or on a food shall not be 
                established at or modified to a level lower than the 
                limit of detection of the method for detecting and 
                measuring the pesticide chemical residue specified by 
                the Administrator under subparagraph (A).
            ``(4) International standards.--In establishing a tolerance 
        for a pesticide chemical residue in or on a food, the 
        Administrator shall determine whether a maximum residue level 
        for the pesticide chemical has been established by the Codex 
        Alimentarius Commission. If a Codex maximum residue level has 
        been established for the pesticide chemical and the 
        Administrator does not propose to adopt the Codex level, the 
        Administrator shall publish for public comment a notice 
        explaining the reasons for departing from the Codex level.
    ``(c) Authority and Standard for Exemptions.--
            ``(1) Authority.--The Administrator may issue a regulation 
        establishing, modifying, or revoking an exemption from the 
        requirement for a tolerance for a pesticide chemical residue in 
        or on food--
                    ``(A) in response to a petition filed under 
                subsection (d); or
                    ``(B) on the Administrator's initiative under 
                subsection (e).
            ``(2) Standard.--
                    ``(A) General rule.--
                            ``(i) Standard.--The Administrator may 
                        establish or leave in effect an exemption from 
                        the requirement for a tolerance for a pesticide 
                        chemical residue in or on food only if the 
                        Administrator determines that the exemption is 
                        safe. The Administrator shall modify or revoke 
                        an exemption if the Administrator determines it 
                        is not safe.
                            ``(ii) Determination of safety.--The term 
                        `safe', with respect to an exemption for a 
                        pesticide chemical residue, means that the 
                        Administrator has determined that there is a 
                        reasonable certainty that no harm will result 
                        from aggregate exposure to the pesticide 
                        chemical residue, including all anticipated 
                        dietary exposures and all other exposures for 
                        which there is reliable information.
                    ``(B) Factors.--In making a determination under 
                this paragraph, the Administrator shall take into 
                account, among other relevant considerations, the 
                considerations set forth in subparagraphs (C) and (D) 
                of subsection (b)(2).
            ``(3) Limitation.--An exemption from the requirement for a 
        tolerance for a pesticide chemical residue in or on food shall 
        not be established or modified by the Administrator unless the 
        Administrator determines, after consultation with the 
        Secretary--
                    ``(A) that there is a practical method for 
                detecting and measuring the levels of such pesticide 
                chemical residue in or on food; or
                    ``(B) that there is no need for such a method, and 
                states the reasons for such determination in issuing 
                the regulation establishing or modifying the exemption.
    ``(d) Petition for Tolerance or Exemption.--
            ``(1) Petitions and petitioners.--Any person may file with 
        the Administrator a petition proposing the issuance of a 
        regulation--
                    ``(A) establishing, modifying, or revoking a 
                tolerance for a pesticide chemical residue in or on a 
                food; or
                    ``(B) establishing, modifying, or revoking an 
                exemption from the requirement of a tolerance for such 
                a residue.
            ``(2) Petition contents.--
                    ``(A) Establishment.--A petition under paragraph 
                (1) to establish a tolerance or exemption for a 
                pesticide chemical residue shall be supported by such 
                data and information as are specified in regulations 
                issued by the Administrator, including--
                            ``(i)(I) an informative summary of the 
                        petition and of the data, information, and 
                        arguments submitted or cited in support of the 
                        petition; and
                            ``(II) a statement that the petitioner 
                        agrees that such summary or any information it 
                        contains may be published as a part of the 
                        notice of filing of the petition to be 
                        published under this subsection and as part of 
                        a proposed or final regulation issued under 
                        this section;
                            ``(ii) the name, chemical identity, and 
                        composition of the pesticide chemical residue 
                        and of the pesticide chemical that produces the 
                        residue;
                            ``(iii) data showing the recommended 
                        amount, frequency, method, and time of 
                        application of that pesticide chemical;
                            ``(iv) full reports of tests and 
                        investigations made with respect to the safety 
                        of the pesticide chemical, including full 
                        information as to the methods and controls used 
                        in conducting those tests and investigations;
                            ``(v) full reports of tests and 
                        investigations made with respect to the nature 
                        and amount of the pesticide chemical residue 
                        that is likely to remain in or on the food, 
                        including a description of the analytical 
                        methods used;
                            ``(vi) a practical method for detecting and 
                        measuring the levels of the pesticide chemical 
                        residue in or on the food, or for exemptions, a 
                        statement why such a method is not needed;
                            ``(vii) a proposed tolerance for the 
                        pesticide chemical residue, if a tolerance is 
                        proposed;
                            ``(viii) if the petition relates to a 
                        tolerance for a processed food, reports of 
                        investigations conducted using the processing 
                        method(s) used to produce that food;
                            ``(ix) such information as the 
                        Administrator may require to make the 
                        determination under subsection (b)(2)(C);
                            ``(x) such information as the Administrator 
                        may require on whether the pesticide chemical 
                        may have an effect in humans that is similar to 
                        an effect produced by a naturally occurring 
                        estrogen or other endocrine effects;
                            ``(xi) information regarding exposure to 
                        the pesticide chemical residue due to any 
                        tolerance or exemption already granted for such 
                        residue;
                            ``(xii) practical methods for removing any 
                        amount of the residue that would exceed any 
                        proposed tolerance; and
                            ``(xiii) such other data and information as 
                        the Administrator requires by regulation to 
                        support the petition.
                If information or data required by this subparagraph is 
                available to the Administrator, the person submitting 
                the petition may cite the availability of the 
                information or data in lieu of submitting it. The 
                Administrator may require a petition to be accompanied 
                by samples of the pesticide chemical with respect to 
                which the petition is filed.
                    ``(B) Modification or revocation.--The 
                Administrator may by regulation establish the 
                requirements for information and data to support a 
                petition to modify or revoke a tolerance or to modify 
                or revoke an exemption from the requirement for a 
                tolerance.
            ``(3) Notice.--A notice of the filing of a petition that 
        the Administrator determines has met the requirements of 
        paragraph (2) shall be published by the Administrator within 30 
        days after such determination. The notice shall announce the 
        availability of a description of the analytical methods 
        available to the Administrator for the detection and 
        measurement of the pesticide chemical residue with respect to 
        which the petition is filed or shall set forth the petitioner's 
        statement of why such a method is not needed. The notice shall 
        include the summary required by paragraph (2)(A)(i)(I).
            ``(4) Actions by the administrator.--
                    ``(A) In general.--The Administrator shall, after 
                giving due consideration to a petition filed under 
                paragraph (1) and any other information available to 
                the Administrator--
                            ``(i) issue a final regulation (which may 
                        vary from that sought by the petition) 
                        establishing, modifying, or revoking a 
                        tolerance for the pesticide chemical residue or 
                        an exemption of the pesticide chemical residue 
                        from the requirement of a tolerance (which 
final regulation shall be issued without further notice and without 
further period for public comment);
                            ``(ii) issue a proposed regulation under 
                        subsection (e), and thereafter issue a final 
                        regulation under such subsection; or
                            ``(iii) issue an order denying the 
                        petition.
                    ``(B) Priorities.--The Administrator shall give 
                priority to petitions for the establishment or 
                modification of a tolerance or exemption for a 
                pesticide chemical residue that appears to pose a 
                significantly lower risk to human health from dietary 
                exposure than pesticide chemical residues that have 
                tolerances in effect for the same or similar uses.
                    ``(C) Expedited review of certain petitions.--
                            ``(i) Date certain for review.--If a person 
                        files a complete petition with the 
                        Administrator proposing the issuance of a 
                        regulation establishing a tolerance or 
                        exemption for a pesticide chemical residue that 
                        presents a lower risk to human health than a 
                        pesticide chemical residue for which a 
                        tolerance has been left in effect or modified 
                        under subsection (b)(2)(B), the Administrator 
                        shall complete action on such petition under 
                        this paragraph within 1 year.
                            ``(ii) Required determinations.--If the 
                        Administrator issues a final regulation 
                        establishing a tolerance or exemption for a 
                        safer pesticide chemical residue under clause 
                        (i), the Administrator shall, not later than 
                        180 days after the date on which the regulation 
                        is issued, determine whether a condition 
                        described in subclause (I) or (II) of 
                        subsection (b)(2)(B)(iii) continues to exist 
                        with respect to a tolerance that has been left 
                        in effect or modified under subsection 
                        (b)(2)(B). If such condition does not continue 
                        to exist, the Administrator shall, not later 
                        than 180 days after the date on which the 
                        determination under the preceding sentence is 
                        made, issue a regulation under subsection 
                        (e)(1) to modify or revoke the tolerance.
    ``(e) Action on Administrator's Own Initiative.--
            ``(1) General rule.--The Administrator may issue a 
        regulation--
                    ``(A) establishing, modifying, suspending under 
                subsection (l)(3), or revoking a tolerance for a 
                pesticide chemical or a pesticide chemical residue;
                    ``(B) establishing, modifying, suspending under 
                subsection (l)(3), or revoking an exemption of a 
                pesticide chemical residue from the requirement of a 
                tolerance; or
                    ``(C) establishing general procedures and 
                requirements to implement this section.
            ``(2) Notice.--Before issuing a final regulation under 
        paragraph (1), the Administrator shall issue a notice of 
        proposed rulemaking and provide a period of not less than 60 
        days for public comment on the proposed regulation, except that 
        a shorter period for comment may be provided if the 
        Administrator for good cause finds that it would be in the 
        public interest to do so and states the reasons for the finding 
        in the notice of proposed rulemaking.
    ``(f) Special Data Requirements.--
            ``(1) Requiring submission of additional data.--If the 
        Administrator determines that additional data or information 
        are reasonably required to support the continuation of a 
        tolerance or exemption that is in effect under this section for 
        a pesticide chemical residue on a food, the Administrator 
        shall--
                    ``(A) issue a notice requiring the person holding 
                the pesticide registrations associated with such 
                tolerance or exemption to submit the data or 
                information under section 3(c)(2)(B) of the Federal 
                Insecticide, Fungicide, and Rodenticide Act;
                    ``(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 60 days' duration, an order--
                            ``(i) requiring the submission to the 
                        Administrator by one or more interested persons 
                        of a notice identifying the person or persons 
                        who will submit the required data and 
                        information;
                            ``(ii) describing the type of data and 
                        information required to be submitted to the 
                        Administrator and stating why the data and 
                        information could not be obtained under the 
                        authority of section 3(c)(2)(B) of the Federal 
                        Insecticide, Fungicide, and Rodenticide Act or 
                        section 4 of the Toxic Substances Control Act;
                            ``(iii) describing the reports of the 
                        Administrator required to be prepared during 
                        and after the collection of the data and 
                        information;
                            ``(iv) requiring the submission to the 
                        Administrator of the data, information, and 
                        reports referred to in clauses (ii) and (iii); 
                        and
                            ``(v) establishing dates by which the 
                        submissions described in clauses (i) and (iv) 
                        must be made.
                The Administrator may under subparagraph (C) revise any 
                such order to correct an error. The Administrator may 
                under this paragraph require data or information 
                pertaining to whether the pesticide chemical may have 
                an effect in humans that is similar to an effect 
                produced by a naturally occurring estrogen or other 
                endocrine effects.
            ``(2) Noncompliance.--If a submission required by a notice 
        issued in accordance with paragraph (1)(A), a rule issued under 
        paragraph (1)(B), or an order issued under paragraph (1)(C) is 
        not made by the time specified in such notice, rule, or order, 
        the Administrator may by order published in the Federal 
        Register modify or revoke the tolerance or exemption in 
        question. In any review of such an order under subsection 
        (g)(2), the only material issue shall be whether a submission 
        required under paragraph (1) was not made by the time 
        specified.
    ``(g) Effective Date, Objections, Hearings, and Administrative 
Review.--
            ``(1) Effective date.--A regulation or order issued under 
        subsection (d)(4), (e)(1), or (f)(2) shall take effect upon 
        publication unless the regulation or order specifies otherwise. 
        The Administrator may stay the effectiveness of the regulation 
        or order if, after issuance of such regulation or order, 
        objections are filed with respect to such regulation or order 
        pursuant to paragraph (2).
            ``(2) Further proceedings.--
                    ``(A) Objections.--Within 60 days after a 
                regulation or order is issued under subsection (d)(4), 
                (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C), any 
                person may file objections thereto with the 
                Administrator, specifying with particularity the 
                provisions of the regulation or order deemed 
                objectionable and stating reasonable grounds therefor. 
                If the regulation or order was issued in response to a 
                petition under subsection (d)(1), a copy of each 
                objection filed by a person other than the petitioner 
                shall be served by the Administrator on the petitioner.
                    ``(B) Hearing.--An objection may include a request 
                for a public evidentiary hearing upon the objection. 
                The Administrator shall, upon the initiative of the 
                Administrator or upon the request of an interested 
                person and after due notice, hold a public evidentiary 
                hearing if and to the extent the Administrator 
                determines that such a public hearing is necessary to 
                receive factual evidence relevant to material issues of 
                fact raised by the objections. The presiding officer in 
                such a hearing may authorize a party to obtain 
                discovery from other persons and may upon a showing of 
                good cause made by a party issue a subpoena to compel 
                testimony or production of documents from any person. 
                The presiding officer shall be governed by the Federal 
                Rules of Civil Procedure in making any order for the 
                protection of the witness or the content of documents 
                produced and shall order the payment of 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) Final decision.--As soon as practicable after 
                receiving the arguments of the parties, the 
                Administrator shall issue an order stating the action 
                taken upon each such objection and setting forth any 
                revision to the regulation or prior order that the 
                Administrator has found to be warranted. If a hearing 
                was held under subparagraph (B), such order and any 
                revision to the regulation or prior order shall, with 
                respect to questions of fact at issue in the hearing, 
                be based only on substantial evidence of record at such 
                hearing, and shall set forth in detail the findings of 
                facts and the conclusions of law or policy upon which 
                the order or regulation is based.
    ``(h) Judicial Review.--
            ``(1) Petition.--In a case of actual controversy as to the 
        validity of any regulation issued under subsection (e)(1)(C), 
or any order issued under subsection (f)(1)(C) or (g)(2)(C), or any 
regulation that is the subject of such an order, any person who will be 
adversely affected by such order or regulation may obtain judicial 
review by filing in the United States Court of Appeals for the circuit 
wherein that person resides or has its principal place of business, or 
in the United States Court of Appeals for the District of Columbia 
Circuit, within 60 days after publication of such order or regulation, 
a petition praying that the order or regulation be set aside in whole 
or in part.
            ``(2) Record and jurisdiction.--A copy of the petition 
        under paragraph (1) shall be forthwith transmitted by the clerk 
        of the court to the Administrator, or any officer designated by 
        the Administrator for that purpose, and thereupon the 
        Administrator shall file in the court the record of the 
        proceedings on which the Administrator based the order or 
        regulation, as provided in section 2112 of title 28, United 
        States Code. Upon the filing of such a petition, the court 
        shall have exclusive jurisdiction to affirm or set aside the 
        order or regulation complained of in whole or in part. As to 
        orders issued following a public evidentiary hearing, the 
        findings of the Administrator with respect to questions of fact 
        shall be sustained only if supported by substantial evidence 
        when considered on the record as a whole.
            ``(3) Additional evidence.--If a party applies to the court 
        for leave to adduce additional evidence and shows to the 
        satisfaction of the court that the additional evidence is 
        material and that there were reasonable grounds for the failure 
        to adduce the evidence in the proceeding before the 
        Administrator, the court may order that the additional evidence 
        (and evidence in rebuttal thereof) shall be taken before the 
        Administrator in the manner and upon the terms and conditions 
        the court deems proper. The Administrator may modify prior 
        findings as to the facts by reason of the additional evidence 
        so taken and may modify the order or regulation accordingly. 
        The Administrator shall file with the court any such modified 
        finding, order, or regulation.
            ``(4) Final judgment; supreme court review.--The judgment 
        of the court affirming or setting aside, in whole or in part, 
        any regulation or any order and any regulation which is the 
        subject of such an order shall be final, subject to review by 
        the Supreme Court of the United States as provided in section 
        1254 of title 28 of the United States Code. The commencement of 
        proceedings under this subsection shall not, unless 
        specifically ordered by the court to the contrary, operate as a 
        stay of a regulation or order.
            ``(5) Application.--Any issue as to which review is or was 
        obtainable under this subsection shall not be the subject of 
        judicial review under any other provision of law.
    ``(i) Confidentiality and Use of Data.--
            ``(1) General rule.--Data and information that are or have 
        been submitted to the Administrator under this section or 
        section 409 in support of a tolerance or an exemption from a 
        tolerance shall be entitled to confidential treatment for 
        reasons of business confidentiality and to exclusive use and 
        data compensation to the same extent provided by sections 3 and 
        10 of the Federal Insecticide, Fungicide, and Rodenticide Act.
            ``(2) Exceptions.--
                    ``(A) In general.--Data and information that are 
                entitled to confidential treatment under paragraph (1) 
                may be disclosed, under such security requirements as 
                the Administrator may provide by regulation, to--
                            ``(i) employees of the United States 
                        authorized by the Administrator to examine such 
                        data and information in the carrying out of 
                        their official duties under this Act or other 
                        Federal statutes intended to protect the public 
                        health; or
                            ``(ii) contractors with the United States 
                        authorized by the Administrator to examine such 
                        data and information in the carrying out of 
                        contracts under this Act or such statutes.
                    ``(B) Congress.--This subsection does not authorize 
                the withholding of data or information from either 
                House of Congress or from, to the extent of matter 
                within its jurisdiction, any committee or subcommittee 
                of such committee or any joint committee of Congress or 
                any subcommittee of such joint committee.
            ``(3) Summaries.--Notwithstanding any provision of this 
        subsection or other law, the Administrator may publish the 
        informative summary required by subsection (d)(2)(A)(i) and 
        may, in issuing a proposed or final regulation or order under 
        this section, publish an informative summary of the data 
        relating to the regulation or order.
    ``(j) Status of Previously Issued Regulations.--
            ``(1) Regulations under section 406.--Regulations affecting 
        pesticide chemical residues in or on raw agricultural 
        commodities promulgated, in accordance with section 701(e), 
        under the authority of section 406(a) upon the basis of public 
        hearings instituted before January 1, 1953, shall be deemed to 
        be regulations issued under this section and shall be subject 
        to modification or revocation under subsections (d) and (e), 
        and shall be subject to review under subsection (q).
            ``(2) Regulations under section 409.--Regulations that 
        established tolerances for substances that are pesticide 
        chemical residues in or on processed food, or that otherwise 
        stated the conditions under which such pesticide chemicals 
        could be safely used, and that were issued under section 409 on 
        or before the date of the enactment of this paragraph, shall be 
deemed to be regulations issued under this section and shall be subject 
to modification or revocation under subsection (d) or (e), and shall be 
subject to review under subsection (q).
            ``(3) Regulations under section 408.--Regulations that 
        established tolerances or exemptions under this section that 
        were issued on or before the date of the enactment of this 
        paragraph shall remain in effect unless modified or revoked 
        under subsection (d) or (e), and shall be subject to review 
        under subsection (q).
    ``(k) Transitional Provision.--If, on the day before the date of 
the enactment of this subsection, a substance that is a pesticide 
chemical was, with respect to a particular pesticidal use of the 
substance and any resulting pesticide chemical residue in or on a 
particular food--
            ``(1) regarded by the Administrator or the Secretary as 
        generally recognized as safe for use within the meaning of the 
        provisions of subsection (a) or section 201(s) as then in 
        effect; or
            ``(2) regarded by the Secretary as a substance described by 
        section 201(s)(4);
such a pesticide chemical residue shall be regarded as exempt from the 
requirement for a tolerance, as of the date of enactment of this 
subsection. The Administrator shall by regulation indicate which 
substances are described by this subsection. Any exemption under this 
subsection may be modified or revoked as if it had been issued under 
subsection (c).
    ``(l) Harmonization With Action Under Other Laws.--
            ``(1) Coordination with fifra.--To the extent practicable 
        and consistent with the review deadlines in subsection (q), in 
        issuing a final rule under this subsection that suspends or 
        revokes a tolerance or exemption for a pesticide chemical 
        residue in or on food, the Administrator shall coordinate such 
        action with any related necessary action under the Federal 
        Insecticide, Fungicide, and Rodenticide Act.
            ``(2) Revocation of tolerance or exemption following 
        cancellation of associated registrations.--If the 
        Administrator, acting under the Federal Insecticide, Fungicide, 
        and Rodenticide Act, cancels the registration of each pesticide 
        that contains a particular pesticide chemical and that is 
        labeled for use on a particular food, or requires that the 
        registration of each such pesticide be modified to prohibit its 
        use in connection with the production, storage, or 
        transportation of such food, due in whole or in part to dietary 
        risks to humans posed by residues of that pesticide chemical on 
        that food, the Administrator shall revoke any tolerance or 
        exemption that allows the presence of the pesticide chemical, 
        or any pesticide chemical residue that results from its use, in 
        or on that food. Subsection (e) shall apply to actions taken 
        under this paragraph. 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. Subsection (e) shall apply to 
                actions taken 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 suspended or canceled 
prior to the date of the enactment of this paragraph under the Federal 
Insecticide, Fungicide, and Rodenticide Act, if the Administrator 
determines that a residue of the canceled or suspended pesticide 
chemical will unavoidably persist in the environment and thereby be 
present in or on a food, the Administrator may establish a tolerance 
for the pesticide chemical residue. In establishing such a tolerance, 
the Administrator shall take into account both the factors set forth in 
subsection (b)(2) and the unavoidability of the residue. Subsection (e) 
shall apply to the establishment of such tolerance. The Administrator 
shall review any such tolerance periodically and modify it as necessary 
so that it allows no greater level of the pesticide chemical residue 
than is unavoidable.
            ``(5) Pesticide residues resulting from lawful application 
        of pesticide.--Notwithstanding any other provision of this Act, 
        if a tolerance or exemption for a pesticide chemical residue in 
        or on a food has been revoked, suspended, or modified under 
        this section, an article of that food shall not be deemed 
        unsafe solely because of the presence of such pesticide 
        chemical residue in or on such food if it is shown to the 
        satisfaction of the Secretary that--
                    ``(A) the residue is present as the result of an 
                application or use of a pesticide at a time and in a 
                manner that was lawful under the Federal Insecticide, 
                Fungicide, and Rodenticide Act; and
                    ``(B) the residue does not exceed a level that was 
                authorized at the time of that application or use to be 
                present on the food under a tolerance, exemption, food 
                additive regulation, or other sanction then in effect 
                under this Act;
        unless, in the case of any tolerance or exemption revoked, 
        suspended, or modified under this subsection or subsection (d) 
        or (e), the Administrator has issued a determination that 
        consumption of the legally treated food during the period of 
        its likely availability in commerce will pose an unreasonable 
        dietary risk.
            ``(6) Tolerance for use of pesticides under an emergency 
        exemption.--If the Administrator grants an exemption under 
        section 18 of the Federal Insecticide, Fungicide, and 
        Rodenticide Act (7 U.S.C. 136p) for a pesticide chemical, the 
        Administrator shall establish a tolerance or exemption from the 
        requirement for a tolerance for the pesticide chemical residue. 
        Such a tolerance or exemption from a tolerance shall have an 
        expiration date. The Administrator may establish such a 
        tolerance or exemption without providing notice or a period for 
        comment on the tolerance or exemption. The Administrator shall 
        promulgate regulations within 365 days after the date of the 
        enactment of this paragraph governing the establishment of 
        tolerances and exemptions under this paragraph. Such 
        regulations shall be consistent with the safety standard under 
        subsections (b)(2) and (c)(2) and with section 18 of the 
        Federal Insecticide, Fungicide, and Rodenticide Act.
    ``(m) Fees.--
            ``(1) Amount.--The Administrator shall by regulation 
        require the payment of such fees as will in the aggregate, in 
        the judgment of the Administrator, be sufficient over a 
        reasonable term to provide, equip, and maintain an adequate 
        service for the performance of the Administrator's functions 
        under this section. Under the regulations, the performance of 
        the Administrator's services or other functions under this 
        section, including--
                    ``(A) the acceptance for filing of a petition 
                submitted under subsection (d);
                    ``(B) establishing, modifying, leaving in effect, 
                or revoking a tolerance or establishing, modifying, 
                leaving in effect, or revoking an exemption from the 
                requirement for a tolerance under this section;
                    ``(C) the acceptance for filing of objections under 
                subsection (g); or
                    ``(D) the certification and filing in court of a 
                transcript of the proceedings and the record under 
                subsection (h);
        may be conditioned upon the payment of such fees. The 
        regulations may further provide for waiver or refund of fees in 
        whole or in part when in the judgment of the Administrator such 
        a waiver or refund is equitable and not contrary to the 
        purposes of this subsection.
            ``(2) Deposit.--All fees collected under paragraph (1) 
        shall be deposited in the Reregistration and Expedited 
        Processing Fund created by section 4(k) of the Federal 
        Insecticide, Fungicide, and Rodenticide Act. Such fees shall be 
        available to the Administrator, without fiscal year limitation, 
        for the performance of the Administrator's services or 
        functions as specified in paragraph (1).
    ``(n) National Uniformity of Tolerances.--
            ``(1) Qualifying pesticide chemical residue.--For purposes 
        of this subsection, the term `qualifying pesticide chemical 
        residue' means a pesticide chemical residue resulting from the 
        use, in production, processing, or storage of a food, of a 
        pesticide chemical that is an active ingredient and that--
                    ``(A) was first approved for such use in a 
                registration of a pesticide issued under section 
                3(c)(5) of the Federal Insecticide, Fungicide, 
                Rodenticide Act on or after April 25, 1985, on the 
                basis of data determined by the Administrator to meet 
                all applicable requirements for data prescribed by 
                regulations in effect under that Act on April 25, 1985; 
                or
                    ``(B) was approved for such use in a reregistration 
                eligibility determination issued under section 4(g) of 
                that Act on or after the date of enactment of this 
                subsection.
            ``(2) Qualifying federal determination.--For purposes of 
        this subsection, the term `qualifying Federal determination' 
        means a tolerance or exemption from the requirement for a 
        tolerance for a qualifying pesticide chemical residue that--
                    ``(A) is issued under this section after the date 
                of the enactment of this subsection and determined by 
                the Administrator to meet the standard under subsection 
                (b)(2)(A) (in the case of a tolerance) or (c)(2) (in 
                the case of an exemption); or
                    ``(B)(i) pursuant to subsection (j) is remaining in 
                effect or is deemed to have been issued under this 
                section, or is regarded under subsection (k) as exempt 
                from the requirement for a tolerance; and
                    ``(ii) is determined by the Administrator to meet 
                the standard under subsection (b)(2)(A) (in the case of 
                a tolerance) or (c)(2) (in the case of an exemption).
            ``(3) Limitation.--The Administrator may make the 
        determination described in paragraph (2)(B)(ii) only by issuing 
        a rule in accordance with the procedure set forth in subsection 
        (d) or (e) and only if the Administrator issues a proposed rule 
        and allows a period of not less than 30 days for comment on the 
        proposed rule. Any such rule shall be reviewable in accordance 
        with subsections (g) and (h).
            ``(4) State authority.--Except as provided in paragraphs 
        (5), (6), and (8) no State or political subdivision may 
        establish or enforce any regulatory limit on a qualifying 
        pesticide chemical residue in or on any food if a qualifying 
        Federal determination applies to the presence of such pesticide 
        chemical residue in or on such food, unless such State 
        regulatory limit is identical to such qualifying Federal 
        determination. A State or political subdivision shall be deemed 
        to establish or enforce a regulatory limit on a pesticide 
        chemical residue in or on a food if it purports to prohibit or 
        penalize the production, processing, shipping, or other 
        handling of a food because it contains a pesticide residue (in 
        excess of a prescribed limit).
            ``(5) Petition procedure.--
                    ``(A) In general.--Any State may petition the 
                Administrator for authorization to establish in such 
                State a regulatory limit on a qualifying pesticide 
                chemical residue in or on any food that is not 
                identical to the qualifying Federal determination 
                applicable to such qualifying pesticide chemical 
                residue.
                    ``(B) Petition requirements.--Any petition under 
                subparagraph (A) shall--
                            ``(i) satisfy any requirements prescribed, 
                        by rule, by the Administrator; and
                            ``(ii) be supported by scientific data 
                        about the pesticide chemical residue that is 
                        the subject of the petition or about chemically 
                        related pesticide chemical residues, data on 
                        the consumption within such State of food 
                        bearing the pesticide chemical residue, and 
                        data on exposure of humans within such State to 
                        the pesticide chemical residue.
                    ``(C) Authorization.--The Administrator may, by 
                order, grant the authorization described in 
                subparagraph (A) if the Administrator determines that 
                the proposed State regulatory limit--
                            ``(i) is justified by compelling local 
                        conditions; and
                            ``(ii) would not cause any food to be a 
                        violation of Federal law.
                    ``(D) Treatment.--In lieu of any action authorized 
                under subparagraph (C), the Administrator may treat a 
                petition under this paragraph as a petition under 
                subsection (d) to modify or revoke a tolerance or an 
                exemption. If the Administrator determines to treat a 
                petition under this paragraph as a petition under 
                subsection (d), the Administrator shall thereafter act 
                on the petition pursuant to subsection (d).
                    ``(E) Review.--Any order of the Administrator 
                granting or denying the authorization described in 
                subparagraph (A) shall be subject to review in the 
                manner described in subsections (g) and (h).
            ``(6) Urgent petition procedure.--Any State petition to the 
        Administrator pursuant to paragraph (5) that demonstrates that 
        consumption of a food containing such pesticide residue level 
        during the period of the food's likely availability in the 
        State will pose a significant public health threat from acute 
        exposure shall be considered an urgent petition. If an order by 
        the Administrator to grant or deny the requested authorization 
        in an urgent petition is not made within 30 days of receipt of 
        the petition, the petitioning State may establish and enforce a 
        temporary regulatory limit on a qualifying pesticide chemical 
        residue in or on the food. The temporary regulatory limit shall 
be validated or terminated by the Administrator's final order on the 
petition.
            ``(7) Residues from lawful application.--No State or 
        political subdivision may enforce any regulatory limit on the 
        level of a pesticide chemical residue that may appear in or on 
        any food if, at the time of the application of the pesticide 
        that resulted in such residue, the sale of such food with such 
        residue level was lawful under this section and under the law 
        of such State, unless the State demonstrates that consumption 
        of the food containing such pesticide residue level during the 
        period of the food's likely availability in the State will pose 
        an unreasonable dietary risk to the health of persons within 
        such State.
            ``(8) Savings.--Nothing in this Act preempts the authority 
        of any State or political subdivision to require that a food 
        containing a pesticide chemical residue bear or be the subject 
        of a warning or other statement relating to the presence of the 
        pesticide chemical residue in or on such food.
    ``(o) Consumer Right to Know.--Not later than 2 years after the 
date of the enactment of the Food Quality Protection Act of 1996, and 
annually thereafter, the Administrator shall, in consultation with the 
Secretary of Agriculture and the Secretary of Health and Human 
Services, publish in a format understandable to a lay person, and 
distribute to large retail grocers for public display (in a manner 
determined by the grocer), the following information, at a minimum:
            ``(1) A discussion of the risks and benefits of pesticide 
        chemical residues in or on food purchased by consumers.
            ``(2) A listing of actions taken under subparagraph (B) of 
        subsection (b)(2) that may result in pesticide chemical 
        residues in or on food that present a yearly or lifetime risk 
        above the risk allowed under subparagraph (A) of such 
        subsection, and the food on which the pesticide chemicals 
        producing the residues are used.
            ``(3) Recommendations to consumers for reducing dietary 
        exposure to pesticide chemical residues in a manner consistent 
        with maintaining a healthy diet, including a list of food that 
        may reasonably substitute for food listed under paragraph (2).
Nothing in this subsection shall prevent retail grocers from providing 
additional information.
    ``(p) Estrogenic Substances Screening Program.--
            ``(1) Development.--Not later than 2 years after the date 
        of enactment of this section, the Administrator shall in 
        consultation with the Secretary of Health and Human Services 
        develop a screening program, using appropriate validated test 
        systems and other scientifically relevant information, to 
        determine whether certain substances may have an effect in 
        humans that is similar to an effect produced by a naturally 
        occurring estrogen, or such other endocrine effect as the 
        Administrator may designate.
            ``(2) Implementation.--Not later than 3 years after the 
        date of enactment of this section, after obtaining public 
        comment and review of the screening program described in 
        paragraph (1) by the scientific advisory panel established 
        under section 25(d) of the Federal Insecticide, Fungicide, and 
        Rodenticide Act or the science advisory board established by 
        section 8 of the Environmental Research, Development, and 
        Demonstration Act of 1978 (42 U.S.C. 4365), the Administrator 
        shall implement the program.
            ``(3) Substances.--In carrying out the screening program 
        described in paragraph (1), the Administrator--
                    ``(A) shall provide for the testing of all 
                pesticide chemicals; and
                    ``(B) may provide for the testing of any other 
                substance that may have an effect that is cumulative to 
                an effect of a pesticide chemical if the Administrator 
                determines that a substantial population may be exposed 
                to such substance.
            ``(4) Exemption.--Notwithstanding paragraph (3), the 
        Administrator may, by order, exempt from the requirements of 
        this section a biologic substance or other substance if the 
        Administrator determines that the substance is anticipated not 
        to produce any effect in humans similar to an effect produced 
        by a naturally occurring estrogen.
            ``(5) Collection of information.--
                    ``(A) In general.--The Administrator shall issue an 
                order to a registrant of a substance for which testing 
                is required under this subsection, or to a person who 
                manufactures or imports a substance for which testing 
                is required under this subsection, to conduct testing 
                in accordance with the screening program described in 
                paragraph (1), and submit information obtained from the 
                testing to the Administrator, within a reasonable time 
                period that the Administrator determines is sufficient 
                for the generation of the information.
                    ``(B) Procedures.--To the extent practicable the 
                Administrator shall minimize duplicative testing of the 
                same substance for the same endocrine effect, develop, 
                as appropriate, procedures for fair and equitable 
                sharing of test costs, and develop, as necessary, 
                procedures for handling of confidential business 
                information.
                    ``(C) Failure of registrants to submit 
                information.--
                            ``(i) Suspension.--If a registrant of a 
                        substance referred to in paragraph (3)(A) fails 
                        to comply with an order under subparagraph (A) 
                        of this paragraph, the Administrator shall 
                        issue a notice of intent to suspend the sale or 
                        distribution of the substance by the 
                        registrant. Any suspension proposed under this 
                        paragraph shall become final at the end of the 
                        30-day period beginning on the date that the 
                        registrant receives the notice of intent to 
                        suspend, unless during that period a person 
                        adversely affected by the notice requests a 
                        hearing or the Administrator determines that 
                        the registrant has complied fully with this 
                        paragraph.
                            ``(ii) Hearing.--If a person requests a 
                        hearing under clause (i), the hearing shall be 
                        conducted in accordance with section 554 of 
                        title 5, United States Code. The only matter 
                        for resolution at the hearing shall be whether 
                        the registrant has failed to comply with an 
                        order under subparagraph (A) of this paragraph. 
                        A decision by the Administrator after 
                        completion of a hearing shall be considered to 
                        be a final agency action.
                            ``(iii) Termination of suspensions.--The 
                        Administrator shall terminate a suspension 
                        under this subparagraph issued with respect to 
                        a registrant if the Administrator determines 
                        that the registrant has complied fully with 
                        this paragraph.
                    ``(D) Noncompliance by other persons.--Any person 
                (other than a registrant) who fails to comply with an 
                order under subparagraph (A) shall be liable for the 
                same penalties and sanctions as are provided under 
                section 16 of the Toxic Substances Control Act (15 
                U.S.C. 2601 and following) in the case of a violation 
                referred to in that section. Such penalties and 
                sanctions shall be assessed and imposed in the same 
                manner as provided in such section 16.
            ``(6) Agency action.--In the case of any substance that is 
        found, as a result of testing and evaluation under this 
        section, to have an endocrine effect on humans, the 
        Administrator shall, as appropriate, take action under such 
        statutory authority as is available to the Administrator, 
        including consideration under other sections of this Act, as is 
        necessary to ensure the protection of public health.
            ``(7) Report to congress.--Not later than 4 years after the 
        date of enactment of this section, the Administrator shall 
        prepare and submit to Congress a report containing--
                    ``(A) the findings of the Administrator resulting 
                from the screening program described in paragraph (1);
                    ``(B) recommendations for further testing needed to 
                evaluate the impact on human health of the substances 
                tested under the screening program; and
                    ``(C) recommendations for any further actions 
                (including any action described in paragraph (6)) that 
                the Administrator determines are appropriate based on 
                the findings.
    ``(q) Schedule for Review.--
            ``(1) In general.--The Administrator shall review 
        tolerances and exemptions for pesticide chemical residues in 
        effect on the day before the date of the enactment of the Food 
        Quality Protection Act of 1996, as expeditiously as 
        practicable, assuring that--
                    ``(A) 33 percent of such tolerances and exemptions 
                are reviewed within 3 years of the date of enactment of 
                such Act;
                    ``(B) 66 percent of such tolerances and exemptions 
                are reviewed within 6 years of the date of enactment of 
                such Act; and
                    ``(C) 100 percent of such tolerances and exemptions 
                are reviewed within 10 years of the date of enactment 
                of such Act.
        In conducting a review of a tolerance or exemption, the 
        Administrator shall determine whether the tolerance or 
        exemption meets the requirements of subsection (b)(2) or (c)(2) 
        and shall, by the deadline for the review of the tolerance or 
        exemption, issue a regulation under subsection (d)(4) or (e)(1) 
        to modify or revoke the tolerance or exemption if the tolerance 
        or exemption does not meet such requirements.
            ``(2) Priorities.--In determining priorities for reviewing 
        tolerances and exemptions under paragraph (1), the 
        Administrator shall give priority to the review of the 
        tolerances or exemptions that appear to pose the greatest risk 
        to public health.
            ``(3) Publication of schedule.--Not later than 12 months 
        after the date of the enactment of the Food Quality Protection 
        Act of 1996, the Administrator shall publish a schedule for 
        review of tolerances and exemptions established prior to the 
        date of the enactment of the Food Quality Protection Act of 
        1996. The determination of priorities for the review of 
        tolerances and exemptions pursuant to this subsection is not a 
        rulemaking and shall not be subject to judicial review, except 
        that failure to take final action pursuant to the schedule 
        established by this paragraph shall be subject to judicial 
        review.
    ``(r) Temporary tolerance or exemption.--The Administrator may, 
upon the request of any person who has obtained an experimental permit 
for a pesticide chemical under the Federal Insecticide, Fungicide, and 
Rodenticide Act or upon the Administrator's own initiative, establish a 
temporary tolerance or exemption for the pesticide chemical residue for 
the uses covered by the permit. Subsections (b)(2), (d) and (c)(2), (e) 
shall apply to actions taken under this subsection.
    ``(s) Savings Clause.--Nothing in this section shall be construed 
to amend or modify the provisions of the Toxic Substances Control Act 
or the Federal Insecticide, Fungicide, and Rodenticide Act.''.

SEC. 406. AUTHORIZATION FOR INCREASED MONITORING.

    For the fiscal years 1997 through 1999, there is authorized to be 
appropriated in the aggregate an additional $12,000,000 for increased 
monitoring by the Secretary of Health and Human Services of pesticide 
residues in imported and domestic food.

SEC. 407. ALTERNATIVE ENFORCEMENT.

    Section 303(g) (21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (2), (3), and (4) as 
        paragraphs (3), (4), and (5), respectively,
            (2) by inserting after paragraph (1) the following:
    ``(2)(A) Any person who introduces into interstate commerce or 
delivers for introduction into interstate commerce an article of food 
that is adulterated within the meaning of section 402(a)(2)(B) shall be 
subject to a civil money penalty of not more than $50,000 in the case 
of an individual and $250,000 in the case of any other person for such 
introduction or delivery, not to exceed $500,000 for all such 
violations adjudicated in a single proceeding.
    ``(B) This paragraph shall not apply to any person who grew the 
article of food that is adulterated. If the Secretary assesses a civil 
penalty against any person under this paragraph, the Secretary may not 
use the criminal authorities under this section to sanction such person 
for the introduction or delivery for introduction into interstate 
commerce of the article of food that is adulterated. If the Secretary 
assesses a civil penalty against any person under this paragraph, the 
Secretary may not use the seizure authorities of section 304 or the 
injunction authorities of section 302 with respect to the article of 
food that is adulterated.
    ``(C) In a hearing to assess a civil penalty under this paragraph, 
the presiding officer shall have the same authority with regard to 
compelling testimony or production of documents as a presiding officer 
has under section 408(g)(2)(B). The third sentence of paragraph (3)(A) 
shall not apply to any investigation under this paragraph.'';
            (3) in paragraph (3), as so redesignated, by striking 
        ``paragraph (1)'' each place it occurs and inserting 
        ``paragraph (1) or (2)'';
            (4) in paragraph (4), as so redesignated, by striking 
        ``(2)(A)'' and inserting ``(3)(A)''; and
            (5) in paragraph (5), as so redesignated, by striking 
        ``(3)'' each place it occurs and inserting ``(4)''.

                             TITLE V--FEES

SEC. 501. REREGISTRATION FEES.

    (a) Section 4(i).--Section 4(i) (7 U.S.C. 136a-1(i)), as amended by 
section 232(2), is amended--
            (1) in paragraphs (5)(H) and (6), by striking ``1997'' and 
        inserting ``2001''; and
            (2) in paragraph (5)(C), by inserting ``(i)'' after ``(C)'' 
        and by adding at the end the following:
                    ``(ii) in each of the fiscal years 1998, 1999, and 
                2000, the Administrator is authorized to collect up to 
                an additional $2,000,000 in a manner consistent with 
                subsection (k)(5) and the recommendations of the 
                Inspector General of the Environmental Protection 
                Agency. The total fees that may be collected under this 
                clause shall not exceed $6,000,000.''.
    (b) Section 4(k)(1).--Section 4(k)(1) (7 U.S.C. 136a-1(k)(1) is 
amended by inserting before the period the following: ``which shall be 
known as the Reregistration and Expedited Processing Fund''.
    (c) Section 4(k)(2).--Section 4(k)(2) (7 136a-1(k)(2)) is amended 
to read as follows:
            ``(2) Source and use.--
                    ``(A) All moneys derived from fees collected by the 
                Administrator under subsection (i) shall be deposited 
                in the fund and shall be available to the 
                Administrator, without fiscal year limitation, 
                specifically to offset the costs of reregistration and 
                expedited processing of the applications specified in 
                paragraph (3). Such moneys derived from fees may not be 
                expended in any fiscal year to the extent such moneys 
                derived from fees would exceed money appropriated for 
                use by the Administrator and expended in such year for 
                such costs of reregistration and expedited processing 
                of such applications. The Administrator shall, prior to 
                expending any such moneys derived from fees--
                            ``(i) effective October 1, 1997, adopt 
                        specific and cost accounting rules and 
                        procedures as approved by the General 
                        Accounting Office and the Inspector General of 
                        the Environmental Protection Agency to ensure 
                        that moneys derived from fees are allocated 
                        solely to the costs of reregistration and 
                        expedited processing of the applications 
                        specified in paragraph (3) in the same portion 
                        as appropriated funds;
                            ``(ii) prohibit the use of such moneys 
                        derived from fees to pay for any costs other 
                        than those necessary to achieve reregistration 
                        and expedited processing of the applications 
                        specified in paragraph (3); and
                            ``(iii) ensure that personnel and facility 
                        costs associated with the functions to be 
                        carried out under this paragraph do not exceed 
                        agency averages for comparable personnel and 
                        facility costs.
                    ``(B) The Administrator shall also--
                            ``(i) complete the review of unreviewed 
                        reregistration studies required to support the 
                        reregistration eligibility decisions scheduled 
                        for completion in accordance with subsection 
                        (l)(2); and
                            ``(ii) contract for such outside assistance 
                        as may be necessary for review of required 
                        studies, using a generally accepted competitive 
                        process for the selection of vendors of such 
                        assistance.''.
    (d) Section 4(k)(3).--Section 4(k)(3) (7 U.S.C. 136a-1(k)(3)) is 
amended--
            (1) in subparagraph (A), by striking out ``for each of the 
        fiscal years 1992, 1993, and 1994, \1/7\th of the maintenance 
        fees collected, up to 2 million each year'' and inserting in 
        lieu thereof ``for each of the fiscal years 1997 through 2001, 
        not more than \1/7\ of the maintenance fees collected in such 
        fiscal year''; and
            (2) by adding a new subparagraph (C) to read as follows:
                    ``(C) The Administrator shall complete the 
                processing of the unprocessed expedited review 
                applications within 5 years from the date of enactment 
                of the Food Quality Protection Act of 1996.''.
    (e) Section 4(k)(5).--Section 4(k)(5) (7 U.S.C. 136a-1(k)(5)) is 
amended to read as follows:
            ``(5) Accounting and performance.--The Administrator shall 
        take all steps necessary to ensure that expenditures from fees 
        authorized by subsection (i)(5)(C)(ii) are used only to carry 
        out the goals established under subsection (l). The 
        Reregistration and Expedited Processing Fund shall be 
        designated as an Environmental Protection Agency component for 
        purposes of section 3515(c) of title 31, United States Code. 
        The annual audit required under section 3521 of such title of 
        the financial statements of activities under this Act under 
        section 3515(b) of such title shall include an audit of the 
        fees collected under subsection (i)(5)(C) and disbursed, of the 
        amount appropriated to match such fees, and of the 
        Administrator's attainment of performance measure and goals 
        established under subsection (l). Such an audit shall also 
        include a review of the reasonableness of the overhead 
        allocation and adequacy of disclosures of direct and indirect 
        costs associated with carrying out the reregistration and 
        expedited processing of the applications specified in paragraph 
        (3), and the basis for and accuracy of all costs paid with 
        moneys derived from such fees. The Inspector General shall 
        conduct the annual audit and report the findings and 
        recommendations of such audit to the Administrator and to the 
        Committees on Agriculture of the House of Representatives and 
        the Senate. The cost of such audit shall be paid for out of the 
        fees collected under subsection (i)(5)(C).''.
    (f) Goals.--Subsections (l) and (m) of section 4 (7 U.S.C. 136a-1), 
as amended by section 237, are redesignated as subsections (m) and (n) 
respectively and the following is inserted after subsection (k):
    ``(l) Performance Measures and Goal.--The Administrator shall 
establish and publish annually in the Federal Register performance 
measures and goals. Such measures and goals shall include--
            ``(1) the number of products reregistered, canceled, or 
        amended, the status of reregistration, the number and type of 
        data requests under section 3(c)(2)(B) issued to support 
        product reregistration by active ingredient, the progress in 
        reducing the number of unreviewed, required reregistration 
        studies, the aggregate status of tolerances reassessed, and the 
        number of applications for registration submitted under 
        subsection (k)(3) that were approved or disapproved;
            ``(2) the future schedule for reregistrations, including 
        the projection for such schedules that will be issued under 
        subsection (g)(2) (A) and (B) in the current fiscal year and 
        the succeeding fiscal year; and
            ``(3) the projected year of completion of the 
        reregistrations under this section.''.

                        TITLE VI--INDIAN TRIBES

 SEC. 601. AUTHORITY OF INDIAN TRIBES.

    (a) In General.--Section 24 (7 U.S.C. 136v) is amended--
            (1) in subsection (a), by inserting before the comma the 
        following: ``and an Indian tribe may only regulate the sale or 
        use of any federally registered pesticide or device within the 
        boundaries of a Federal Indian reservation for such tribe if at 
        least 50 percent of the lands in such reservation are owned by 
        members of the tribe or the tribe'';
            (2) in subsections (b) and (c), by inserting ``or Indian 
        tribe'' after ``State'' each time it occurs; and
            (3) in the section heading, by inserting before the period 
        the following: ``and indian tribes''.
    (b) Enforcement.--Section 26 (7 U.S.C. 136w-1) is amended--
            (1) in subsection (a), by inserting ``and an Indian tribe 
        with respect to violations which occur within the boundaries of 
        a Federal Indian reservation for such tribe, but only if at 
        least 50 percent of the lands in such reservation are owned by 
        members of the tribe or the tribe'' after ``violations'' and by 
        inserting ``or Indian tribe'' after ``State'' each place it 
        occurs;
            (2) in subsection (b), by inserting ``or Indian tribe'' 
        after ``State'' in the first sentence;
            (3) in subsection (c), by inserting ``or Indian tribes'' 
        after ``States''; and
            (4) in the section heading, by inserting ``and indian 
        tribe'' after ``state''.