```

[Congressional Bills 106th Congress]
[From the U.S. Government Publishing Office]
[S. 1464 Introduced in Senate (IS)]

106th CONGRESS
  1st Session
                                S. 1464

To amend the Federal Food, Drug, and Cosmetic Act to establish certain 
requirements regarding the Food Quality Protection Act of 1996, and for 
                            other purposes.

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                             July 29, 1999

 Mr. Hagel (for himself, Mrs. Lincoln, Mr. Roberts, Ms. Landrieu, Mr. 
 Hutchinson, Mr. Cochran, Mr. Grams, Mr. Abraham, Mr. Smith of Oregon, 
   Mr. Hollings, Mr. Craig, Mr. Gorton, Mr. Grassley, Mr. Crapo, Mr. 
 Burns, Mr. Frist, Mr. Breaux, Mr. Ashcroft, Mr. Coverdell, Mr. Helms, 
 and Mr. Lott) introduced the following bill; which was read twice and 
   referred to the Committee on Agriculture, Nutrition, and Forestry

_______________________________________________________________________

                                 A BILL

 
To amend the Federal Food, Drug, and Cosmetic Act to establish certain 
requirements regarding the Food Quality Protection Act of 1996, and for 
                            other purposes.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Regulatory 
Openness and Fairness Act of 1999''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
            TITLE I--ISSUANCE AND CONTINUATION OF TOLERANCES

Sec. 101. Transition analysis and description of basis for decisions 
                            relating to tolerance reviews. 
Sec. 102. Interim procedures for reviews of tolerances.
Sec. 103. Implementation rules and guidance.
Sec. 104. Data in support of tolerances and registrations.
Sec. 105. Expedited action.
                     TITLE II--STUDIES AND REPORTS

Sec. 201. Definitions.
Sec. 202. Priorities and resources.
Sec. 203. International trade effects.
Sec. 204. Advisory committee.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) The Food Quality Protection Act of 1996 (Public Law 
        104-170; 110 Stat. 1489), enacted on August 3, 1996, made many 
        major modifications to section 408 of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 346a) that require the 
        Administrator of the Environmental Protection Agency to 
        consider new kinds of information and use additional criteria 
        in regulating pesticide chemical residues and in reviewing 
        tolerances for pesticide chemical residues that had previously 
        been found to be adequate to protect the public health.
            (2)(A) Amendments made by the Food Quality Protection Act 
        of 1996 prescribe the use of a number of new risk assessment 
        criteria that require the development of major modifications to 
        regulatory policies and procedures used by the Administrator to 
        regulate pesticide chemical residues.
            (B) Since the enactment of the Food Quality Protection Act 
        of 1996, it has become clear that several of the new concepts 
        embodied in that Act involve a high degree of complexity.
            (C) Practical implementation of the concepts demands new 
        scientific tools in addition to the tools that were available 
        when the Food Quality Protection Act of 1996 was enacted.
            (3)(A) To reach sound, suitably protective decisions on 
        tolerance reviews under the new criteria, the Administrator 
        also will need a great deal of new data, not only on the newly 
        considered nondietary routes of exposure, but also, in some 
        cases, on dietary exposure and toxicity, so that the 
        Administrator can determine whether pesticide chemicals 
        residues that were found safe under the former criteria satisfy 
        the new criteria as well.
            (B) Some data collection efforts are underway to obtain new 
        data for tolerance reviews, but will not yield results for 1 or 
        more years.
            (C) In some areas, the need for new data depends on 
        decisions not yet made by the Administrator about what kinds of 
        tests should be conducted and which compounds should be tested, 
        for tolerance reviews.
            (4)(A) The Administrator has instituted public proceedings, 
        relating to the regulations and tolerance reviews, on such 
        topics as what new interpretations and policies are needed, 
        what new kinds of data are needed, how the new data would be 
        used, and how the needed regulatory transition can be achieved.
            (B) These proceedings are not yet finished, and on some 
        issues public notice and comment proceedings have been 
        scheduled but have not yet begun.
            (5)(A) The Food Quality Protection Act of 1996 amended the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) by 
        adding several provisions that provide flexibility to the 
        Administrator in making the transition to the new approach to 
        regulating pesticide chemical residues.
            (B) The Federal Food, Drug, and Cosmetic Act allows a 
        continuing process of refinement and improvement in tolerance 
        decisionmaking, as additional information is collected and as 
        new policies and methods are developed and adopted for the 
        practical implementation of the new requirements in that Act.
            (C) The Federal Food, Drug, and Cosmetic Act provides that 
        the data requirements for tolerances must be set out clearly in 
        regulations and guidelines, so that the regulated community 
        will know what types of information the Administrator requires 
        and what testing procedures should be used to develop the 
        information.
            (D) Amendments made by the Food Quality Protection Act of 
        1996 relating to risk assessments affecting tolerances allow 
        only the use of reliable information regarding nondietary 
        exposure routes, which were not previously considered in risk 
        assessments affecting tolerances.
            (E) Congress did not anticipate that a tolerance would be 
        revoked because of reliance by the Administrator on estimates 
        or assumptions stemming from absence of that information, 
        without first providing notice of what information is needed 
        and a reasonable opportunity to collect the information.
            (F) When a tolerance is under review and the Administrator 
        determines that additional information is needed to support the 
        continuation of the tolerance, the Federal Food, Drug, and 
        Cosmetic Act authorizes the Administrator to postpone the 
        effective date of any tolerance rule resulting from the review, 
        and this authority can be utilized as appropriate in cases in 
        which additional information is pertinent to a tolerance 
        review.
            (G) The Federal Food, Drug, and Cosmetic Act permits the 
        Administrator to conduct a tolerance review in stages, as 
        allowed by the available, reliable information.
            (6)(A) Although the authorities described in subparagraphs 
        (F) and (G) of paragraph (5) already are provided by law, it 
        appears that further congressional guidance is needed to ensure 
        that decisions of the Administrator relating to tolerance 
        reviews are reasonable, well supported, and balanced, and to 
        avoid disruptions in agriculture, other sectors of the economy, 
        and international trade.
            (B) During the transition to revised standards, procedures, 
        and requirements for the regulation of pesticide chemical 
        residues, the Administrator must ensure that decisions are 
        balanced, reasonable, and understandable, and are based on and 
        supported by sound information, in order to avoid unnecessary 
        disruptions in agriculture, the economy, and international 
        trade, and to maintain the public trust in the food supply.
            (7) Unless the Administrator implements section 408 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) carefully 
        and wisely, decisions made under that section could cause great 
        harm to--
                    (A) the safe and affordable food supply of the 
                United States;
                    (B) the agricultural system of the United States 
                (including food, fiber, nursery, and forestry 
                production, food storage, and transportation);
                    (C) related industries; and
                    (D) other private and public sector activities, 
                such as--
                            (i) public health protection against 
                        bacteria and other microorganisms;
                            (ii) control of insects and diseases; and
                            (iii) residential and business pest 
                        control.

            TITLE I--ISSUANCE AND CONTINUATION OF TOLERANCES

SEC. 101. TRANSITION ANALYSIS AND DESCRIPTION OF BASIS FOR DECISIONS 
              RELATING TO TOLERANCE REVIEWS.

    Section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
346a) is amended by adding at the end the following:
    ``(t) Transition Analysis and Descriptions of Basis for Decisions 
Relating to Tolerance Reviews.--
            ``(1) Application of requirements to certain documents.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), this subsection applies to any 
                proposed or final rule, order, notice, report, guidance 
                document, or risk assessment (referred to in this 
                subsection as a `document') that is--
                            ``(i) based on, or results from, any review 
                        (including a reassessment) by the Administrator 
                        of a tolerance or of the uses of a pesticide 
                        chemical for which a tolerance is in effect; 
                        and
                            ``(ii) issued or disclosed as described in 
                        paragraph (2).
                    ``(B) Exception.--This subsection does not apply to 
                any document in which the Administrator determines or 
                recommends that no revocation or denial of a tolerance, 
                or other adverse action regarding a tolerance, is 
                required.
            ``(2) Period of applicability.--This subsection applies to 
        a document that the Administrator issues or otherwise discloses 
        to any member of the public during the period beginning on 
        January 1, 1999, and ending on the date of completion of the 
        process of reviewing tolerances under subsection (q).
            ``(3) Transition analysis report.--
                    ``(A) Transition analysis.--Before issuing any 
                document to which this subsection applies, the 
                Administrator shall conduct a transition analysis of 
                the findings and regulatory steps recommended by or set 
                forth in the document.
                    ``(B) Report.--The Administrator shall prepare a 
                report, to be issued with the document, that--
                            ``(i) describes the results of the 
                        analysis;
                            ``(ii) describes the extent to which the 
                        conclusions in the document are tentative, 
                        preliminary, or subject to possible 
                        modification because of policy reevaluation, 
                        correction of data deficiencies, or use of new 
                        data to replace assumptions; and
                            ``(iii) contains the information described 
                        in subparagraphs (C) and (D).
                    ``(C) Contents of report relating to basis for 
                findings and regulatory steps.--A transition analysis 
                report prepared under this paragraph shall describe the 
                extent to which any finding or regulatory step 
                recommended by or set forth in the analyzed document is 
                based in whole or in part on--
                            ``(i) any assumption, if the Administrator 
                        is in possession of data that would make use of 
                        the assumption unnecessary;
                            ``(ii) any information about possible 
                        exposure from drinking water, or another 
                        nonoccupational, nondietary exposure route, 
                        that is derived from use of--
                                    ``(I) a worst-case assumption;
                                    ``(II) a computation or modeling 
                                result that is--
                                            ``(aa) based on a high-end 
                                        or upper-bound input; or
                                            ``(bb) designed to be a 
                                        worst-case, high-end, or upper-
                                        bound estimate; or
                                    ``(III) information that otherwise 
                                is not reasonably representative of 
                                risks to consumers or to major 
                                identifiable subgroups of consumers, on 
                                a national or regional basis;
                            ``(iii) any assumption about exposure from 
                        drinking water, or another nonoccupational, 
                        nondietary exposure route, if data that would 
                        make use of the assumption unnecessary, and 
                        would likely demonstrate a lower level of 
                        exposure than that used in the assumption--
                                    ``(I) are being developed and will 
                                be submitted to the Administrator 
                                within a reasonable period--
                                            ``(aa) in accordance with a 
                                        request by the Administrator 
                                        under subsection (f) or any of 
                                        the authorities referred to in 
                                        that subsection; or
                                            ``(bb) at the initiative of 
                                        an interested person; or
                                    ``(II) could be obtained by the 
                                Administrator by an action taken in 
                                accordance with subsection (f);
                            ``(iv) any assumption regarding the method 
                        for determining the aggregate exposure to a 
                        pesticide chemical or the cumulative effect of 
                        exposure to 2 or more pesticide chemicals 
                        having a common mechanism of toxicity, if the 
                        use of the assumption is based in whole or in 
                        part on the absence of data that could be 
                        obtained by the Administrator by an action 
                        taken in accordance with subsection (f), unless 
                        the data that would eliminate the need for use 
                        of the assumption have been identified and made 
                        known by the Administrator to interested 
                        persons and sufficient time has been provided 
                        to allow the data to be developed, submitted, 
                        and subsequently evaluated by the 
                        Administrator;
                            ``(v) any calculation developed by use of 
                        the margin of safety described in subsection 
                        (b)(2)(C), if the use of the margin of safety 
                        is based in whole or in part on the absence of 
                        data that could be obtained by the 
                        Administrator by an action taken in accordance 
                        with subsection (f), unless the data that would 
                        eliminate the need for use of the margin of 
                        safety have been identified and made known by 
                        the Administrator to interested persons and 
                        sufficient time has been provided to allow the 
                        data to be developed, submitted, and 
                        subsequently evaluated by the Administrator; or
                            ``(vi) any information about an alleged 
                        adverse effect relating to a pesticide 
                        chemical, if the information is anecdotal, 
                        unverified, or scientifically implausible, or 
                        comes from any study whose design and conduct 
                        has not been found by the Administrator to be 
                        scientifically sound with regard to design, 
                        conduct, reporting, and data availability.
                    ``(D) Additional contents of report.--A transition 
                analysis report prepared under this paragraph shall 
                contain information--
                            ``(i) summarizing and responding briefly to 
                        comments received by the Administrator from any 
                        other person regarding the applicability of any 
                        provision of subparagraph (C) to the document 
                        analyzed under this subsection;
                            ``(ii) describing briefly the availability 
                        and suitability of pesticidal and nonpesticidal 
                        alternatives to the pesticide chemical uses 
                        being reviewed, including a description of--
                                    ``(I) the extent to which (as 
                                determined by the Administrator, in 
                                consultation with the Secretary of 
                                Agriculture) an alternative to the use 
                                for which the tolerance under review 
                                has been approved that is effective and 
                                economical; and
                                    ``(II) whether revocation or 
                                modification of the tolerance will 
                                result in--
                                            ``(aa) a significant 
                                        regional shift of production of 
                                        food within the United States;
                                            ``(bb) an increase in 
                                        imports of corresponding 
                                        commodities;
                                            ``(cc) an increase in pest 
                                        control costs;
                                            ``(dd) an increase in pest 
                                        crop damage and yield loss, 
                                        including quality degradation, 
                                        due to the lack of an effective 
                                        alternative; or
                                            ``(ee) a disruption of 
                                        domestic production of an 
                                        adequate, wholesome, and 
                                        economical food supply;
                            ``(iii) identifying the data that, if 
                        available, would make unnecessary any reliance 
                        on any information, assumption, or calculation 
                        that is described in clause (ii), (iii), (iv), 
                        or (v) of subparagraph (C) and identified in 
                        the report;
                            ``(iv) describing the extent to which any 
                        finding or regulatory step recommended by or 
                        set forth in the document is based in whole or 
                        in part on any assumption about toxicity, 
                        dietary exposure, or risk from dietary 
                        exposure, if data that would make use of the 
                        assumption unnecessary--
                                    ``(I) are being developed and will 
                                be submitted to the Administrator 
                                within a reasonable period--
                                            ``(aa) in accordance with a 
                                        request by the Administrator 
                                        under subsection (f) or any of 
                                        the authorities referred to in 
                                        that subsection; or
                                            ``(bb) at the initiative of 
                                        an interested person; or
                                    ``(II) could be obtained by the 
                                Administrator by an action taken in 
                                accordance with subsection (f); and
                            ``(v) describing the extent to which any 
                        finding or regulatory step recommended by or 
                        set forth in the document is based in whole or 
                        in part on--
                                    ``(I) any use of data on the 
                                presence or absence of nonadverse 
                                effects, rather than data on the 
                                presence or absence of adverse effects, 
                                as the basis for calculation of 
                                allowable exposure levels; or
                                    ``(II) any policy that the 
                                Administrator may revise after 
                                completion of any reevaluation of that 
                                policy that is being conducted or is 
                                scheduled to be conducted.
            ``(4) Definition.--In this subsection and subsection (u), 
        the term `tolerance' has the meaning given the term in section 
        201 of the Regulatory Openness and Fairness Act of 1999.''.

SEC. 102. INTERIM PROCEDURES FOR REVIEWS OF TOLERANCES.

    Section 408 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 101, is further amended by adding at the end the following:
    ``(u) Interim Procedures for Reviews of Tolerances.--
            ``(1) Application of requirements to certain actions.--This 
        subsection applies to--
                    ``(A) any review (including a reassessment) by the 
                Administrator of a tolerance, whether initiated by the 
                Administrator or by petition by another person; and
                    ``(B) any review (including a reassessment) by the 
                Administrator of any registration of a pesticide 
                chemical under the Federal Insecticide, Fungicide, and 
                Rodenticide Act (7 U.S.C. 136 et seq.) that is 
                associated with or results from such a tolerance 
                review;
        that the Administrator issues during the period described in 
        paragraph (2).
            ``(2) Period of applicability.--The period referred to in 
        paragraph (1) is the period beginning on January 1, 1999, and 
        ending on the date of completion of the process of reviewing 
        tolerances under subsection (q).
            ``(3) Limitation.--Notwithstanding any other provision of 
        law--
                    ``(A) in any tolerance review (including a 
                reassessment) to which this subsection applies, the 
                Administrator may not base the revocation or denial of, 
                or other adverse action regarding, a tolerance on any 
                information, calculation, or assumption described in 
                subsection (t)(3)(C); and
                    ``(B) in any review (including a reassessment) to 
                which this subsection applies of the registration of a 
                pesticide chemical under the Federal Insecticide, 
                Fungicide, and Rodenticide Act (7 U.S.C. 136 et seq.), 
                the Administrator may not base any adverse action 
                regarding a registration on any such information, 
                calculation, or assumption.''.

SEC. 103. IMPLEMENTATION RULES AND GUIDANCE.

    Section 408(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 346a(e)) is amended by adding at the end the following:
            ``(3) Implementation rules and guidance.--
                    ``(A) In general.--In establishing general 
                procedures and requirements to implement this section 
                in accordance with paragraph (1)(C), the Administrator 
                shall issue rules and guidance, including guidance 
                regarding the provisions of this Act regarding 
                aggregate exposure to pesticide chemicals and 
                cumulative effects of exposure to 2 or more pesticide 
                chemicals having a common mechanism of toxicity. The 
                Administrator shall include in such rules and guidance 
                general procedures and requirements to implement the 
                provisions of this Act that were added by amendments 
                made by the Regulatory Openness and Fairness Act of 
                1999.
                    ``(B) Issuance.--The Administrator shall issue--
                            ``(i) proposed rules and guidance described 
                        in subparagraph (A) not later than 180 days 
                        after the date of enactment of the Regulatory 
                        Openness and Fairness Act of 1999;
                            ``(ii) final rules and guidance described 
                        in subparagraph (A) not later than 1 year after 
the date of enactment of the Regulatory Openness and Fairness Act of 
1999; and
                            ``(iii) such revisions to the rules and 
                        guidance as the Administrator determines to be 
                        necessary and appropriate.''.

SEC. 104. DATA IN SUPPORT OF TOLERANCES AND REGISTRATIONS.

    (a) Federal Food, Drug, and Cosmetic Act.--Section 408(f) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(f)) is amended by 
adding at the end the following:
            ``(3) Issuance of guidelines.--
                    ``(A) In general.--The Administrator shall issue 
                guidelines specifying the kinds of information that 
                will be required to support the issuance or 
                continuation of a tolerance for a pesticide chemical 
                residue or the exemption from the requirement of such a 
                tolerance, established under this section. The 
                Administrator shall revise the guidelines from time to 
                time. The guidelines shall specify the conditions under 
                which data requirements will apply to particular types 
                of pesticide chemical residues.
                    ``(B) Procedures.--In issuing the guidelines 
                described in subparagraph (A), the Administrator shall 
                provide notice and an opportunity for comment, except 
                for those guidelines that already have been issued 
                after notice and an opportunity for comment under 
                section 3(c)(2)(A) of the Federal Insecticide, 
                Fungicide, and Rodenticide Act (7 U.S.C. 
                136a(c)(2)(A)).''.
    (b) Federal Insecticide, Fungicide, and Rodenticide Act.--The first 
sentence of section 3(c)(2)(A) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (7 U.S.C. 136a(c)(2)(A)) is amended by striking the 
period and inserting ``, after providing notice and an opportunity for 
comment on the guidelines or revisions by interested parties.''.

SEC. 105. EXPEDITED ACTION.

    (a) Expedited Action To Provide Effective, Economic Alternatives.--
Section 3(c)(3) of the Federal Insecticide, Fungicide, and Rodenticide 
Act (7 U.S.C. 136a(c)(3)) is amended by adding at the end the 
following:
                    ``(E) Expedited action to provide effective, 
                economic alternatives.--The Administrator shall 
                expedite the review of any complete application for 
                registration or amended registration of a pesticide 
                under this section, for an experimental use permit 
                under section 5, or for an emergency exemption under 
                section 18, if the application seeks approval for the 
                registration or use of a pesticide--
                            ``(i) that, in the opinion of the 
                        Administrator, is likely to provide an 
                        effective and economic alternative to the use 
                        of a pesticide that has been or is likely to be 
                        removed from the market as a result of a review 
                        conducted under section 408 of the Federal 
                        Food, Drug, and Cosmetic Act (21 U.S.C. 346a); 
                        and
                            ``(ii) for which--
                                    ``(I) there is no registered 
                                effective and economical alternative 
                                (as of the date of submission of the 
                                application); or
                                    ``(II) the number of the 
                                alternatives is insufficient to avoid 
                                problems such as pest resistance.''.
    (b) Coordination.--Section 408(d)(4)(B) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 346a(d)(4)(B)) is amended--
            (1) by striking ``tolerance or exemption for'' and 
        inserting ``tolerance or exemption--
                            ``(i) for'';
            (2) by striking the period at the end and inserting ``; 
        or''; and
            (3) by adding at the end the following:
                            ``(ii) that is needed in connection with an 
                        application under section 3(c)(3)(E) of the 
                        Federal Insecticide, Fungicide, and Rodenticide 
                        Act (7 U.S.C. 136a(c)(3)(E)) for approval of an 
                        effective and economic alternative.''.
    (c) Tolerances for Emergency Uses.--Section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(l)(6)) is 
amended--
            (1) by inserting before the first sentence the following:
                    ``(A) In general.--'';
            (2) by inserting before the third sentence the following:
                    ``(B) Procedure.--'';
            (3) by inserting before the fifth sentence the following:
                    ``(C) Safety standard.--'';
            (4) in the fifth sentence, by striking the period and 
        inserting ``, except as described in subparagraph (D).''; and
            (5) by adding at the end the following:
                    ``(D) Emergency exemptions.--The Administrator may 
                establish a tolerance for a pesticide chemical residue 
                associated with an emergency exemption without regard 
                to other tolerances for a pesticide chemical residue 
                and before reviewing those other tolerances, if the 
                Administrator determines that any incremental exposure 
                that may result from the tolerance associated with the 
                emergency exemption will not pose any significant risk 
                to food consumers.''.

                     TITLE II--STUDIES AND REPORTS

SEC. 201. DEFINITIONS.

    In this title:
            (1) Administrator.--The term ``Administrator'' means the 
        Administrator of the Environmental Protection Agency.
            (2) Pesticide chemical; pesticide chemical residue.--The 
        terms ``pesticide chemical'' and ``pesticide chemical residue'' 
        have the meanings given the terms in section 201 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321).
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Agriculture.
            (4) Tolerance.--The term ``tolerance'' means a tolerance 
        for a pesticide chemical residue or an exemption from the 
        requirement of such a tolerance, established under section 408 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a).

SEC. 202. PRIORITIES AND RESOURCES.

    (a) Environmental Protection Agency Proposal.--The Administrator 
shall prepare a proposal for revising the priorities of and resources 
available to the Administrator that will allow the Administrator--
            (1) to process promptly all--
                    (A) applications for registration of pesticide 
                chemicals under the Federal Insecticide, Fungicide, and 
                Rodenticide Act (7 U.S.C. 136 et seq.);
                    (B) petitions for tolerances (including exemptions) 
                under section 408 of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 346a);
                    (C) requests for experimental use permits, for 
                approval of new inert ingredients, and for emergency 
                exemptions, relating to pesticide chemicals under an 
                Act described in subparagraph (A) or (B); and
                    (D) requests for decisions on the merits of the 
                applications, petitions, and requests described in 
                subparagraphs (A) through (C); and
            (2) to perform tolerance reviews (including reassessments) 
        and other duties relating to pesticide chemicals, as required 
        by the Federal Food, Drug, and Cosmetic Act or the Federal 
        Insecticide, Fungicide, and Rodenticide Act.
    (b) Department of Agriculture Proposal.--The Secretary shall 
prepare a proposal for revising the priorities of and resources 
available to the Secretary that will allow the Secretary--
            (1) to obtain and provide to the Administrator adequate and 
        timely information on food consumption, pesticide chemical 
        residues in or on food and drinking water, and pesticide 
        chemical use;
            (2) to review actions proposed by the Administrator under 
        section 408 of the Federal Food, Drug, and Cosmetic Act and the 
        Federal Insecticide, Fungicide, and Rodenticide Act; and
            (3) to perform other duties related to the regulation of 
        pesticide chemicals (including pesticide chemical residues).
    (c) Report.--The Administrator and the Secretary shall prepare and 
submit to Congress a report containing the proposals described in 
subsections (a) and (b) not later than 180 days after the date of 
enactment of this Act.

SEC. 203. INTERNATIONAL TRADE EFFECTS.

    (a) Assessment.--
            (1) Assessment program.--The Secretary shall establish and 
        administer a program to continuously assess the strength of 
        major United States agricultural commodities and products in 
        the international marketplace. The commodities and products 
        assessed shall include fruits and vegetables, corn, wheat, 
        cotton, rice, soybeans, and nursery and forest products.
            (2) Factors.--In carrying out paragraph (1), the Secretary 
        shall examine factors pertinent to assessing the sustainability 
        and competitive strength of each commodity and product in the 
        international marketplace and the relationship of the factors 
        to regulatory actions taken under the Federal Food, Drug, and 
        Cosmetic Act and the Federal Insecticide, Fungicide, and 
        Rodenticide Act. The factors examined for each commodity and 
        product shall include commodity changes, regional changes, 
        prices, quality, input costs and availability, and the ratio of 
        imports to exports.
    (b) Report.--The Secretary shall prepare periodic reports 
describing the results obtained from the assessment program conducted 
under subsection (a). The Secretary shall submit the reports to the 
Committee on Agriculture of the House of Representatives and the 
Committee on Agriculture, Nutrition, and Forestry of the Senate. The 
Secretary shall submit the reports not later than October 1, 2000, and 
October 1 of every second year thereafter through 2010.

SEC. 204. ADVISORY COMMITTEE.

    (a) Establishment.--There is established an advisory committee to 
be known as the Pesticide Advisory Committee (referred to in this 
section as the ``Advisory Committee'').
    (b) Membership.--
            (1) Composition.--The Advisory Committee shall be composed 
        of 20 members, appointed by the Administrator and the 
        Secretary. The members of the Advisory Committee shall 
        represent a wide variety of interests and viewpoints and shall 
        be appointed from among individuals who are representatives of 
        organizations who are interested in the regulation of pesticide 
        chemicals, including representatives of--
                    (A) organizations that represent--
                            (i) food consumers;
                            (ii) persons with a special interest in 
                        environmental protection;
                            (iii) farmworkers;
                            (iv) agricultural producers (including 
                        persons engaged in crop production, livestock 
                        and poultry production, or nursery and forestry 
                        production);
                            (v) nonagricultural pesticide chemical 
                        users;
                            (vi) food manufacturers and processors;
                            (vii) food distributors and marketers; and
                            (viii) manufacturers of agricultural and 
                        nonagricultural pesticide chemicals; and
                    (B) Federal and State agencies.
            (2) Publication.--The Administrator shall publish in the 
        Federal Register the name, address, and professional 
affiliation of each member of the Advisory Committee.
            (3) Terms of appointment.--Each member of the Advisory 
        Committee shall serve for a term of years determined by the 
        Administrator and the Secretary, except that--
                    (A) the terms of service of the members initially 
                appointed shall be (as specified by the Administrator 
                and the Secretary) for such fewer number of years as 
                will provide for the expiration of terms on a staggered 
                basis;
                    (B) a member appointed to fill a vacancy occurring 
                prior to the expiration of the term for which a 
                predecessor was appointed, shall be appointed for the 
                remainder of the term; and
                    (C) the Secretary and the Administrator may extend 
                the term of a member of the Advisory Committee until a 
                new member is appointed to fill the vacancy.
            (4) Vacancies.--Any vacancy occurring in the membership of 
        the Advisory Committee shall be filled in the same manner as 
        the original appointment. The vacancy shall not affect the 
        power of the remaining members to execute the duties of the 
        Advisory Committee.
    (c) Duties.--The Advisory Committee shall--
            (1) provide advice to the Administrator and the Secretary 
        on matters related to implementation of section 408 of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a) and the 
        Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
        136 et seq.), including proposed and final rules, policies, 
        procedures, and testing guidelines used to regulate tolerances 
        and pesticide chemical registrations;
            (2) foster communication between the Administrator, the 
        Secretary, and the various organizations who represent persons 
        having particular interest in the regulation of pesticide 
        chemicals under the Federal Food, Drug, and Cosmetic Act and 
        the Federal Insecticide, Fungicide, and Rodenticide Act; and
            (3) carry out the functions performed by the Tolerance 
        Reassessment Advisory Committee.
    (d) Meetings.--
            (1) Frequency.--The Advisory Committee shall meet at least 
        2 times per year, at times determined jointly by the 
        Administrator and the Secretary. Not later than 14 days before 
        the date of each meeting, the Administrator shall publish a 
        notice regarding the meeting in the Federal Register.
            (2) Open meetings.--The Advisory Committee shall conduct 
        its principal business--
                    (A) in meetings that are--
                            (i) open to the public; and
                            (ii) in facilities that can accommodate the 
                        reasonably foreseeable number of persons 
                        attending; or
                    (B) by teleconference, with open access.
            (3) Facilities.--The Secretary shall be responsible for 
        providing or making arrangements for the meeting facilities or 
        teleconferences.
    (e) Communications.--The Administrator or the Secretary shall 
ensure that written communications between the Administrator or 
Secretary, respectively, and the Advisory Committee, are recorded and 
made available to any person upon request.
    (f) Chairperson.--The Advisory Committee shall select a Chairperson 
from among its members.
    (g) Powers of the Advisory Committee.--
            (1) Hearings.--The Advisory Committee may hold such 
        hearings, sit and act at such times and places, take such 
        testimony, and receive such evidence as the Advisory Committee 
        considers advisable to carry out this section.
            (2) Information from federal agencies.--Except as otherwise 
        provided in Federal law, the Advisory Committee may secure 
        directly from any Federal department or agency such information 
        as the Advisory Committee considers necessary to carry out this 
        section. Upon request of the Chairperson of the Advisory 
        Committee, the head of the department or agency shall furnish 
        the information to the Advisory Committee.
            (3) Postal services.--The Advisory Committee may use the 
        United States mails in the same manner and under the same 
        conditions as other departments and agencies of the Federal 
        Government.
            (4) Gifts.--The Advisory Committee may accept, use, and 
        dispose of gifts or donations of services or property.
    (h) Advisory Committee Personnel Matters.--
            (1) Travel expenses.--
                    (A) In general.--The members of the Advisory 
                Committee shall not receive compensation for the 
                performance of services for the Advisory Committee, but 
                shall be allowed travel expenses, including per diem in 
                lieu of subsistence, at rates authorized for employees 
                of agencies under subchapter I of chapter 57 of title 
                5, United States Code, while away from their homes or 
                regular places of business in the performance of 
                services for the Advisory Committee.
                    (B) Funds.--Funds used to provide travel expenses 
                under subparagraph (A) shall be paid by the 
                Administrator from appropriations available for those 
                purposes.
            (2) Detail of government employees.--Any employee of the 
        Department of Agriculture (and no other Federal employee) may 
        be detailed to the Advisory Committee without reimbursement, 
        and the detail shall be without interruption or loss of civil 
        service status or privilege.
    (i) Permanent Committee.--Section 14 of the Federal Advisory 
Committee Act (5 U.S.C. App.) shall not apply to the Advisory 
Committee.
                                 <all>
```