[House Report 104-669]
[From the U.S. Government Publishing Office]



104th Congress                                            Rept. 104-669
                        HOUSE OF REPRESENTATIVES

 2d Session                                                      Part 2
_______________________________________________________________________


 
                  FOOD QUALITY PROTECTION ACT OF 1996

                                _______
                                

 July 23, 1996.--Committed to the Committee of the Whole House on the 
              State of the Union and ordered to be printed

                                _______
                                

  Mr. Bliley, from the Committee on Commerce, submitted the following

                              R E P O R T

                        [To accompany H.R. 1627]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Commerce, to whom was referred the bill 
(H.R. 1627) to amend the Federal Insecticide, Fungicide, and 
Rodenticide Act and the Federal Food, Drug, and Cosmetic Act, 
and for other purposes, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
The Amendment....................................................     1
Purpose and Summary..............................................    29
Background and Need for Legislation..............................    29
Hearings.........................................................    32
Committee Consideration..........................................    33
Rollcall Votes...................................................    33
Committee Oversight Findings.....................................    34
Committee on Government Reform and Oversight.....................    34
New Budget Authority and Tax Expenditures........................    34
Committee Cost Estimate..........................................    34
Congressional Budget Office Estimate.............................    35
Inflationary Impact Statement....................................    37
Advisory Committee Statement.....................................    37
Section-by-Section Analysis of the Legislation...................    37
Changes in Existing Law Made by the Bill, as Reported............    56

                               Amendment

  The amendment is as follows:
  Page 50, strike line 5 and all that follows through page 91, 
line 16, and insert the following:

    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 subsections (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), (c)(2), (d), and (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)''.

                          Purpose and Summary

    The purpose of H.R. 1627, Title IV, is to amend the Federal 
Food, Drug, and Cosmetic Act to modernize the regulation of 
pesticides. This measure replaces the outdated Delaney Clause 
with a unified safety standard, institutes workable protections 
for infants and children, establishes parameters for 
comprehensive risk assessment, ensures uniformity of safety 
standards, and improves consumer access to dietary information, 
among other provisions.

                  Background and Need for Legislation

    Pesticides are chemicals used to control pests (such as 
weeds, rodents, and insects) that hinder the production of an 
abundant, affordable, and varied food supply. Pesticide 
residues are small amounts of pesticide that remain in or on 
food after the crop has been harvested and processed. Over the 
years, a complex regulatory scheme has emerged to balance the 
agricultural and consumer benefits that pesticides can provide 
against potential risks to human health and the environment.
    This regulatory scheme is administered by three agencies: 
the Environmental Protection Agency (EPA), the Food and Drug 
Administration (FDA), and the U.S. Department of Agriculture 
(USDA). It is also based on two statutes: the Federal Food, 
Drug, and Cosmetic Act (FFDCA) and the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA). In the House of 
Representatives, the regulation of pesticides for agricultural 
use under FIFRA historically has been within the jurisdiction 
of the Committee on Agriculture, with the Committee on Commerce 
exercising jurisdiction over FFDCA provisions relating to 
health effects of pesticide residues in or on food, as well as 
certain monitoring and enforcement activities.

        The Regulatory Framework for Pesticide Residues in Food

    Pesticide residues in food are regulated under the FFDCA. 
Current law contains two standards: one for raw products and 
the other for processed food. This standard, known as the 
Delaney Clause, bars the establishment of tolerances for 
pesticide residues in processed foods if the pesticide is a 
carcinogen.
    EPA is responsible, under FIFRA, for regulating pesticide 
use and, under FFDCA, for setting residue tolerances for 
pesticides used on food crops. A tolerance establishes the 
maximum level of residue that can remain on the food products. 
Any food containing excess residues is considered adulterated 
and can be withheld from the market by the FDA, which is 
responsible for enforcing the tolerances.

      Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

    FIFRA governs pesticide registration and licensing, 
including labeling that prescribes conditions under which 
pesticides may be used legally. Manufacturers must register 
pesticides and be granted a license before a pesticide can be 
sold. FIFRA requires the registration or pre-market approval 
(in essence, a license) of any pesticide distributed in the 
United States for each intended use. The sale or use of a 
pesticide in a manner inconsistent with the terms of its 
registration is unlawful.
    The legal requirements for registration recognize that 
pesticides are both necessary and potentially harmful. EPA must 
register a pesticide if it will perform its intended function 
without posing ``any unreasonable risk to man or the 
environment taking into account the economic, social, 
environmental costs and benefits'' of the pesticide use. In 
sum, to register a pesticide, EPA must conclude that the 
benefits of such a product exceed its risks. EPA bases its 
decision on risk assessment which measures the probability and 
severity of adverse effects or harm to human and/or animal 
health. Assessments of dietary risks from pesticide residues 
depend on data from many sources: field studies that show what 
pesticides are used and the levels of residues that can be 
expected to occur; the estimates of food people eat; and 
toxicological data which assess the potential for adverse 
health effects from specific pesticides.
    The burden of showing that a pesticide meets FIFRA 
standards rests with the registrant. Developing this health and 
environmental data is costly and time-consuming. Currently, 
this process typically takes $8 million and 5 years to 
complete, excluding the time and expense of the basic research 
that leads to the discovery of a new pesticide or the cost of 
building new manufacturing facilities.
    As a result of amendments to FIFRA, EPA is in the process 
of reregistering pesticides originally registered many years 
ago when tests for the safety of residues were less 
sophisticated. New data required for reregistration may lead to 
the conclusion that some existing uses should be canceled or 
changed because of risks to public health.

              Federal Food, Drug, and Cosmetic Act (FFDCA)

    FFDCA governs ``tolerances'' for the maximum residue level 
legally allowed for a specific pesticide on a specific food. 
FFDCA prohibits the distribution of raw agricultural 
commodities and processed foods that contain levels of 
pesticide residues that are greater than permitted under 
Federally-approved ``tolerances.'' FFDCA currently contains two 
different legal standards for tolerances, one for raw 
agricultural commodities and one for certain processed foods, 
which are described below.
    In general, tolerances are calculated by measuring the 
amount of a pesticide that remains in or on a crop after it is 
treated with a pesticide at its proposed maximum allowable 
rate. Actual residues can vary as a result of weather and other 
factors. A tolerance is set at a level calculated to give 95 
percent certainty that the remaining residue will not exceed 
the tolerance when the pesticide is applied at the maximum 
level and frequency.
    Once EPA establishes the tolerances, FDA enforces these 
them by inspecting foods at various stages from the farm gate 
to the port of entry to retail stores. FDA and USDA also do 
studies that simulate the typical dietary intake of American 
consumers.
    Products with residues exceeding tolerances are considered 
to be ``adulterated'' and subject to seizure. It is important 
to note that EPA will not register the use of a pesticide on a 
food crop under FIFRA until the Agency has established all 
necessary tolerances under FFDCA.

                      Raw Agricultural Commodities

    Under Section 408 of FFDCA, EPA sets tolerances that are 
``safe for use, to the extent necessary to protect the public 
health'' for pesticide residues on raw agricultural 
commodities. In doing this, EPA must give appropriate 
consideration to ``the necessity for the production of an 
adequate, wholesome, and economical food supply.'' Thus, 
Section 408 is similar to registration under FIFRA in that it 
allows both the risks and benefits of a pesticide to be 
considered in setting tolerances for residues on raw 
agricultural commodities.

                            Processed Foods

    Section 409 of FFDCA controls the regulation of pesticide 
residues that concentrate in processed foods. In this instance, 
consideration of benefits is not permitted. Under Section 409, 
pesticide residues are subject to the zero-risk standard of the 
Delaney Clause which states that ``no additive shall be deemed 
safe (and therefore no tolerance may be set), if it is found * 
* * to induce cancer in man or animal. * * * '' The Delaney 
Clause sets a zero-risk standard for pesticides that induce 
cancer in test animals, even if the risk to humans is 
inconsequential.
    A major problem with the existing statutory framework 
derives from the current law's emphasis on whether a pesticide 
residue concentrates in processed food. If a raw agricultural 
product has a processed form but its pesticide residues do not 
concentrate (i.e., the residue on the processed food is less 
than the residue on the raw product), the residue in the 
processed food is covered by the raw food tolerance under 
Section 402 (a), which is known as the ``pass-through'' 
provision of the statute. The pass-through provision allows 
pesticides that do not concentrate in processed foods to by-
pass the zero-risk standard of the Delaney Clause. However, if 
the pesticide residue concentrates in the processed food (i.e., 
the processed food residue is greater than the raw product 
tolerance), it will be denied a 409 tolerance because it falls 
under the standard of the Delaney Clause. This policy has been 
the subject of litigation, and EPA is required under a consent 
agreement to meet deadlines for making decisions on a number of 
pending residue matters.

                           Current EPA Policy

    At the request of the EPA, the National Academy of Sciences 
(NAS) studied existing Delaney policy and issued a report 
entitled ``Regulating Pesticides in Food: The Delaney 
Paradox.'' The NAS report recommends that pesticide residues in 
both raw and processed food be regulated on the basis of a 
unified safety standard. In response to the NAS study, EPA 
issued a new policy interpretation of the Delaney Clause in 
October 1988. Instead of applying the zero-risk standard of the 
Delaney Clause, EPA tried to set one standard of de minimis or 
negligible risk, which was defined as a hypothetical cancer 
risk of less than one in a million over a 70-year lifetime for 
food tolerances under Section 409 of FFDCA. However, EPA's de 
minimis interpretation of the Delaney Clause was subsequently 
challenged in court and ruled invalid.
    Under the current court-imposed consent degree, EPA has 
agreed to a schedule for making tolerance revocation decisions 
on a number of section 408 and 409 tolerances, many of which 
EPA has acknowledged only pose a negligible risk. If the 
tolerances under which use of these pesticides is permitted are 
revoked, an estimated 100 crops--including numerous fruits and 
vegetables--will be affected. Disruption in the production of 
these crops could have serious dietary and cost consequences 
for consumers and serious adverse impacts on the economies of 
the nation's major agricultural States.

                                Hearings

    The Subcommittee on Health and Environment held two days of 
hearings on H.R. 1627, the Food Quality Protection Act, on June 
7, 1995, and June 29, 1995. (The June 29, 1995 hearing also 
considered H.R. 1771.)
    Testifying before the Subcommittee on June 7, 1995 were: 
Dr. Lynn R. Goldman, Assistant Administrator, Office of 
Prevention, Pesticides, and Toxic Substances, Environmental 
Protection Agency; Mr. William B. Schultz, Deputy Commissioner 
for Policy, Food and Drug Administration; Mr. Lawrence Elworth, 
Special Assistant for Pesticide Policy, Department of 
Agriculture; Dr. Carl K. Winter, Director, FoodSafe Program, 
University of California; Mr. Leonard P. Gianessi, Senior 
Research Associate, National Center for Food and Agricultural 
Policy; Dr. George M. Gray, Deputy Director, Harvard Center for 
Risk Analysis, Harvard School of Public Health; Ms. Juanita 
Duggan, Executive Vice President, Government Affairs and Public 
Communications, National Food Processors Association; Mr. 
Dennis Stolte, American Farm Bureau Federation; Dr. Steven 
Ziller, Vice President for Science and Technical Affairs, 
Grocery Manufacturers Association of America; Mr. Jay J. Vroom, 
President, American Crop Protection Association; Mr. Erik 
Olson, Natural Resources Defense Council; Mr. Jay Feldman, 
Executive Director, National Coalition Against the Misuse of 
Pesticides; and Ms. Carolyn Brickey, Executive Director, 
National Campaign for Pesticide Policy Reform.
    Testifying before the Subcommittee on June 29, 1995 were: 
Ms. Nancy Gould Chuda, Chair, The Colette Chuda Environmental 
Fund and Children's Health Environmental Coalition, accompanied 
by Mr. James Chuda, Vice-Chair; Mr. Robert Eichler; Dr. Philip 
J. Landrigan, Professor and Chair, Department of Community 
Medicine, Mount Sinai Medical Center; Dr. J. Routt Reigart, 
representing the American Academy of Pediatrics; Dr. Mary S. 
Wolff, Professor of Community Medicine, Environmental and 
Occupational Medicine, Mt. Sinai School of Medicine; Mr. Edward 
Hopkins, Environmental Policy Director, Citizen Action; and Ms. 
Caroline Smith-DeWaal, Director, Food Safety Program, Center 
for Science in the Public Interest.

                        Committee Consideration

    On July 17, 1996, the Subcommittee on Health and 
Environment met in open markup session and approved H.R. 1627, 
the Food Quality Protection Act of 1996, for Full Committee 
consideration, as amended, by a voice vote. On July 17, 1996, 
the Full Committee met in open markup session and ordered H.R. 
1627 reported to the House, as amended, by a roll call vote of 
45 yeas to 0 nays, a quorum being present.

                             Rollcall Votes

    Clause 2(l)(2)(B) of rule XI of the Rules of the House 
requires the Committee to list the recorded votes on the motion 
to report legislation and amendments thereto. The following is 
the recorded vote on the motion to report H.R. 1627, as amended 
by the Subcommittee on Health and Environment, including the 
names of those Members voting for and against.

      COMMITTEE ON COMMERCE--104TH CONGRESS, ROLLCALL VOTE NO. 150

    Bill: H.R. 1627, Food Quality Protection Act of 1996.
    Motion: Motion by Mr. Bliley to order H.R. 1627 reported to 
the House, as amended.
    Disposition: Agreed to, by a rollcall vote of 45 yeas to 0 
nays.

----------------------------------------------------------------------------------------------------------------
          Representative              Aye      Nay     Present     Representative       Aye      Nay     Present
----------------------------------------------------------------------------------------------------------------
Mr. Bliley.......................        X   .......  ........  Mr. Dingell........        X   .......  ........
Mr. Moorhead.....................        X   .......  ........  Mr. Waxman.........        X   .......  ........
Mr. Tauzin.......................        X   .......  ........  Mr. Markey.........        X   .......  ........
Mr. Fields.......................        X   .......  ........  Mr. Collins........  ........  .......  ........
Mr. Oxley........................        X   .......  ........  Mr. Hall...........        X   .......  ........
Mr. Bilirakis....................        X   .......  ........  Mr. Richardson.....        X   .......  ........
Mr. Schaefer.....................        X   .......  ........  Mr. Bryant.........        X   .......  ........
Mr. Barton.......................        X   .......  ........  Mr. Boucher........        X   .......  ........
Mr. Hastert......................        X   .......  ........  Mr. Manton.........        X   .......  ........
Mr. Upton........................        X   .......  ........  Mr. Towns..........        X   .......  ........
Mr. Stearns......................        X   .......  ........  Mr. Studds.........  ........  .......  ........
Mr. Paxon........................        X   .......  ........  Mr. Pallone........        X   .......  ........
Mr. Gillmor......................        X   .......  ........  Mr. Brown..........        X   .......  ........
Mr. Klug.........................        X   .......  ........  Mrs. Lincoln.......  ........  .......  ........
Mr. Franks.......................        X   .......  ........  Mr. Gordon.........        X   .......  ........
Mr. Greenwood....................        X   .......  ........  Ms. Furse..........        X   .......  ........
Mr. Crapo........................        X   .......  ........  Mr. Deutsch........        X   .......  ........
Mr. Cox..........................        X   .......  ........  Mr. Rush...........  ........  .......  ........
Mr. Deal.........................        X   .......  ........  Ms. Eshoo..........        X   .......  ........
Mr. Burr.........................        X   .......  ........  Mr. Klink..........        X   .......  ........
Mr. Bilbray......................        X   .......  ........  Mr. Stupak.........        X   .......  ........
Mr. Whitfield....................        X   .......  ........  Mr. Engel..........        X   .......  ........
Mr. Ganske.......................        X   .......  ........                                                  
Mr. Frisa........................        X   .......  ........                                                  
Mr. Norwood......................        X   .......  ........                                                  
Mr. White........................        X   .......  ........                                                  
Mr. Coburn.......................        X   .......  ........                                                  
----------------------------------------------------------------------------------------------------------------

                      Committee Oversight Findings

    Pursuant to clause 2(l)(3)(A) of rule XI of the Rules of 
the House of Representatives, the Committee held legislative 
hearings and made findings that are reflected in this report.

              Committee on Government Reform and Oversight

    Pursuant to clause 2(l)(3)(D) of rule XI of the Rules of 
the House of Representatives, no oversight findings have been 
submitted to the Committee by the Committee on Government 
Reform and Oversight.

               New Budget Authority and Tax Expenditures

    In compliance with clause 2(l)(3)(B) of rule XI of the 
Rules of the House of Representatives, the Committee states 
that H.R. 1627 would result in no new or increased budget 
authority or tax expenditures or revenues.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 403 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 2(l)(3)(C) of rule XI of the Rules of 
the House of Representatives, the following is the cost 
estimate provided by the Congressional Budget Office pursuant 
to section 403 of the Congressional Budget Act of 1974:

                                     U.S. Congress,
                               Congressional Budget Office,
                                     Washington, DC, July 23, 1996.
Hon. Thomas J. Bliley, Jr.,
Chairman, Committee on Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for Title IV of H.R. 1627, 
the Food Quality Protection Act of 1996.
    Enactment of Title IV of H.R. 1627 would affect direct 
spending. Therefore, pay-as-you-go procedures would apply to 
the bill.
    If you wish further details on this estimate, we will be 
pleased to provide them.
            Sincerely,
                                         June E. O'Neill, Director.
    Enclosure.

               Congressional Budget Office Cost Estimate

    1. Bill number: Title IV of H.R. 1627.
    2. Bill title: Food Quality Protection Act of 1996.
    3. Bill status: Title IV, as ordered reported by the House 
Committee on Commerce on July 17, 1996.
    4. Bill purpose: Title IV of the bill would amend the 
Federal Food, Drug, and Cosmetic Act, and would authorize the 
appropriation of $12 million over the 1997-1999 period to the 
Department of Health and Human Services (HHS) to increase 
monitoring of pesticide residues in imported and domestic food. 
Title IV would change the standards EPA is directed to use when 
setting tolerances for pesticide residues in raw and processed 
food.
    5. Estimated cost to the Federal Government: Assuming 
appropriation of estimated amounts authorized for discretionary 
programs conducted by EPA and HHS, enacting Title IV of H.R. 
1627 would lead to fiscal year 1997 funding for food tolerance 
programs of about $26 million. CBO estimates that the bill 
would authorize appropriations totaling about $154 million over 
the 1997-2002 period.
    In 1996, about $2 million in fees was collected and spent 
by EPA for establishing pesticide tolerances in food. Under 
Title IV of H.R. 1627, we assume sufficient fees would continue 
to be collected for food tolerance work, and that the agency 
would spend all of the fees collected. Hence, the income from 
the fees and the spending of that income would offset each 
other, and there would be no net impact on direct spending for 
each fiscal year.

                                        SPENDING SUBJECT TO APPROPRIATION                                       
                                    [By fiscal year, in millions of dollars]                                    
----------------------------------------------------------------------------------------------------------------
                                                                  1996   1997   1998   1999   2000   2001   2002
----------------------------------------------------------------------------------------------------------------
Spending under current law:                                                                                     
    Budget authority...........................................     22  .....  .....  .....  .....  .....  .....
    Estimated outlays..........................................     22      7  .....  .....  .....  .....  .....
Proposed changes:                                                                                               
    Estimated authorization level..............................  .....     26     27     27     24     25     26
    Estimated outlays..........................................  .....     18     27     27     25     25     25
Spending under H.R. 1627, title IV.............................     22     26     27     27     24     25     26
Estimated outlays..............................................     22     25     27     27     25     25     25
----------------------------------------------------------------------------------------------------------------
Note.--The 1996 level is the amount appropriated for that year.                                                 

    The costs of this bill fall within budget functions 300 and 
550.
    6. Basis of estimate: For the purpose of this estimate, CBO 
assumes that the bill will be enacted before 1997 
appropriations for EPA and HHS are provided and that all funds 
authorized by Title IV of H.R. 1627 will be appropriated.
    The bill would specify an authorization of $12 million over 
the 1997-1999 period to HHS for increased monitoring of 
pesticide residues on imported and domestic food. For this 
estimate, we split the $12 million authorization into equal 
components of $4 million a year for fiscal years 1997 through 
1999. In addition, CBO estimates the bill would authorize the 
appropriation of $45 million to continue food safety programs 
conducted by EPA and about $97 million to continue pesticide 
residue monitoring conducted by HHS over the next six years.
    7. Pay-as-you-go considerations: Section 252 of the 
Balanced Budget and Emergency Deficit Control Act of 1985 sets 
up pay-as-you-go procedures for legislation affecting direct 
spending or receipts through 1998. CBO estimates that enacting 
Title IV of H.R. 1627 could affect direct spending. Therefore, 
pay-as-you-go procedures would apply to the bill. We estimate 
the pesticide tolerance fee collected under current law could 
increase if EPA's resource needs grow as a result of enactment 
of this title. If the fees are increased, we estimate that 
direct spending would increase by the same amount, thus 
resulting in no net impact.

------------------------------------------------------------------------
                                                 1996     1997     1998 
------------------------------------------------------------------------
Change in outlays............................        0        0        0
Change in receipts...........................    (\1\)    (\1\)    (\1\)
------------------------------------------------------------------------
\1\ Not applicable.                                                     

    8. Estimated impact on State, local, and tribal 
governments: Title IV of H.R. 1627 contains an 
intergovernmental mandate as defined in the Unfunded Mandates 
Reform Act of 1995 (Public Law 104-4) but this mandate would 
impose no significant costs on state, local, or tribal 
governments.
    This title would prohibit state and local governments from 
establishing or enforcing regulatory limits on pesticide 
residues that differ from limits established by the federal 
government. The bill would establish a process under which 
states could petition EPA for an exception to this prohibition. 
We estimate that state and local governments would incur no 
significant costs as a result of this provision.
    9. Estimated impact on the private sector: CBO has 
identified several private-sector mandates in the bill. Among 
these are provisions that would require large retail grocers to 
display information provided by EPA about pesticides, and that 
would require businesses that register, manufacture, or import 
certain products to screen for substances that may have an 
effect on humans that is similar to an effect produced by 
naturally occurring estrogen, or other endocrine effects as 
directed by EPA.
    Although the mandates become effective at different dates, 
CBO, estimates that the aggregate direct costs of mandates in 
this bill would not likely exceed the $100 million threshold 
established in Public Law 104-4 in the first five years that 
the mandates become effective. Costs for estrogenic testing 
could exceed the threshold in subsequent years, if more 
expensive tests become required. The direct costs of the new 
mandates on the private sector could be at least partially 
offset by savings from changes the bill would make to the 
standards EPA is directed to use when setting tolerances for 
pesticide residues in raw and processed food.
    10. Previous CBO estimate: On July 10, 1996, CBO prepared a 
cost estimate for H.R. 1627 (Titles I-V) as ordered reported by 
the House Committee on Agriculture, on June 19, 1996. The 
Commerce Committee version of Title IV is different from the 
Agriculture Committee version, and has a different budgetary 
impact.
    11. Estimate prepared by: Federal Cost Estimate: Kim Cawley 
and Anne Hunt. Impact on State, Local, and Tribal Governments: 
Marjorie Miller. Impact on the Private Sector: Patrice Gordon.
    12. Estimate approved by: Robert A. Sunshine, for Paul N. 
Van de Water, Assistant Director for Budget Analysis.

                     Inflationary Impact Statement

    Pursuant to clause 2(l)(4) of rule XI of the Rules of the 
House of Representatives, the Committee finds that the bill 
would have no inflationary impact.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

             Section-by-Section Analysis of the Legislation

                  SEC. 401. SHORT TITLE AND REFERENCE

     Section 401(a) authorizes citations to refer to this title 
as the Food Quality Protection Act of 1996; all amendments 
refer to the Federal Food, Drug, and Cosmetic Act (FFDCA; 21 
USC 321 et seq.), according to Section 401(b).

                         SEC. 402. DEFINITIONS

    Section 402(a) amends Section 201(q)(1) of the FFDCA (21 
USC 321(q)(1)) to change the existing definition of ``pesticide 
chemical'' to include: any pesticide as defined in the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA); any active 
ingredient of a pesticide; and any inert ingredient of a 
pesticide. (FIFRA definitions of these terms are at Section 
2(a) (7 USC 136(a)), Section 2(u) (7 USC 136(u)), and Section 
2(m) (7 USC 136(m)), respectively.) Section 402(a) also adds a 
new paragraph (2) at the end of Section 201(q) to define 
``pesticide chemical residue'' as a residue, in or on either 
raw or processed food, of a pesticide chemical (as defined at 
(1)) or of any other added substance that is present primarily 
due to metabolism or degradation of a pesticide chemical. It 
allows the Administrator of the U.S. Environmental Protection 
Agency (EPA) to exempt a substance from these definitions if 
the occurrence of the residue in a food is due to natural 
causes or human activities unrelated to ``a pesticidal 
purpose,'' and if the Administrator, after consulting with the 
Secretary of Health and Human Services (DHHS), determined that 
the substance should be regulated under a section of FFDCA 
other than Sections 402(a)(2)(B) and 408.
    Section 402(b) amends the current definition of a ``food 
additive'' in FFDCA Section 201(s) to exclude (1) a pesticide 
chemical residue on raw or processed food, and (2) a pesticide 
chemical. Section 402(c) amends FFDCA Section 201 by adding 
definitions for ``processed food'' and ``Administrator.'' New 
subsection (gg) defines ``processed food'' as any food other 
than a raw agricultural commodity, including any such commodity 
that has been subject to canning, freezing, cooking, 
dehydration, milling, or other processing. New subsection (hh) 
defines ``Administrator'' as the Administrator of the EPA.

                       SEC. 403. PROHIBITED ACTS

    Section 403 amends FFDCA Section 301(j) (21 USC 331(j)), 
which prohibits disclosure of information about confidential 
methods or processes, except to employees of the DHHS, U.S. 
Department of Agriculture (USDA), certain committees of 
Congress, or to the courts when relevant to a proceeding. It 
adds FFDCA Section 408(i)(2) to the list of sections under 
which, if confidential information is gained, the prohibition 
applies.

                       SEC. 404. ADULTERATED FOOD

    Section 404 amends FFDCA section 402(a)(2) (21 USC 
342(a)(2)) so that all pesticide residues in all foods are 
regulated under Sections 408 and 402(a)(2), but not Section 406 
or 409. Existing Section 402(a)(2) states that all food shall 
be deemed adulterated (A) if it ``contains any added poisonous 
or added deleterious substance (other than one which is (i) a 
pesticide chemical in or on a raw agricultural commodity; (ii) 
a food additive; (iii) a color additive; or (iv) a new animal 
drug) which is unsafe within the meaning of Section 406,'' (B) 
``if it is a raw agricultural commodity and it bears or 
contains a pesticide chemical which is unsafe within the 
meaning of section 408(a)'', or (C) ``if it is, or if it bears 
or contains, any food additive which is unsafe within the 
meaning of Section 409.'' Under current law, therefore, 
pesticide residues on raw food are governed by Section 408, but 
pesticide residues on processed food are regulated under 
Section 409 if they concentrate during processing. Section 406 
states that food containing added poisonous or deleterious 
substances is unsafe unless the substance cannot be avoided and 
does not exceed limits set by EPA to protect public health 
(i.e., tolerances). Section 404 of H.R. 1627 also removes the 
clause following ``Provided'' in FFDCA Section 402 (a)(2). The 
effect is to retain the principle that food is considered 
adulterated or ``unsafe'' if a raw agricultural commodity 
contains a pesticide residue that is ``unsafe'' within the 
meaning of the new section 408, if a food contains any food 
additive that is unsafe within Section 409, if a food contains 
a new animal drug that is unsafe within the meaning of Section 
512, or if a food contains any other added poisonous or 
deleterious substance that is unsafe within the meaning of 
Section 406. However, pesticide residues in processed food also 
would be excluded from coverage of Section 406 (and Section 
409) and would fall instead under Section 408.

  SEC. 405. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES

    Section 405 amends FFDCA Section 408 (21 USC 346a), 
currently pertaining to pesticide residue tolerances for raw 
food. The proposed amendments would establish a single 
regulatory framework for both raw and processed foods.1
---------------------------------------------------------------------------
    \1\ FFDCA Section 409 is not amended by H.R. 1627. Instead, H.R. 
1627, Section 402 redefines ``food additive'' and ``pesticide chemical 
residue'' so that pesticide residues always are covered by Section 408, 
as it would be amended. A key effect of this change is to make the 
Delaney Clause no longer applicable to pesticide residues concentrated 
in processed foods.
---------------------------------------------------------------------------

Sec. 408(a). Requirement for Tolerance or Exemption

    New Section 408(a)(1)--General Rule retains the current 
provisions of Section 408(a) which deem any pesticide residue 
on food unsafe (and therefore the food is adulterated under 
Section 402(a)(2)(B)), unless it has a tolerance and is within 
the limits of the tolerance, or has an exemption from a 
tolerance. For purposes of new Section 408, both raw 
agricultural commodities and processed food products are 
considered ``food.'' A provision of the current law is moved by 
the bill; new subsection (k) exempts from tolerance 
requirements pesticides ``generally recognized as safe'' before 
enactment of H.R. 1627 (see below).
    New Section 408(a)(2)--Processed Food writes into law the 
``pass-through'' provision used currently by EPA. Presently, if 
a tolerance or exemption is in effect for a pesticide chemical 
in a raw food, the residue of that pesticide in that food, 
after it is processed, is not unsafe as long as the residue is 
below the raw food tolerance or is exempt from the requirement 
for a raw food tolerance. The new subsection permits all foods 
to be considered safe, and not adulterated under Section 
402(a)(2)(B), if they contain pesticide residues that are 
within a tolerance, or are exempt from the requirement for a 
tolerance, and the residues have been removed to the extent 
possible.
    New subsection 408(a)(3)--Residues of Degradation Products 
discusses products of precursor or parent pesticides. It 
requires EPA to apply the tolerances and exemptions established 
for residues of the parent pesticide to residues of the 
pesticide's breakdown products, as long as the tolerance did 
not expressly exclude breakdown products and EPA had not 
determined that the dietary exposure to the breakdown product 
posed a different or significantly greater potential health 
risk than the parent pesticide. The Committee understands that 
in making such a determination today, EPA does not include, in 
calculating the combined levels, degradation products that pose 
no health risk (such as GRAS substances). It is the Committee's 
intention that such degradation products not be included in any 
determination as to whether the combined residues of a 
pesticide and its degradation products meet the tolerance 
levels.
    New Section 408(a)(4)--Effect of a Tolerance Or Exemption 
specifically prohibits considering a food adulterated within 
the meaning of Section 402(a)(1) because it contains a 
pesticide residue, if a tolerance or exemption were in effect 
for that pesticide on that food. This clarifies the principle 
that pesticide residues are regulated under Section 402(a)(2) 
only.

Sec. 408(b). Authority and Standard for Tolerance

    Existing FFDCA Section 408(b) requires the EPA 
Administrator to promulgate regulations establishing tolerances 
for pesticides used on food ``to the extent necessary to 
protect the public health.'' In setting tolerances, the 
Administrator is required to consider relevant factors 
including the necessity for production of an adequate, 
wholesome, and economical food supply; other ways in which the 
consumer may be affected by the same pesticide or by other 
related substances; and the opinion and certification of 
usefulness of the pesticide by the Secretary of Agriculture. 
The Administrator is authorized to establish a tolerance at 
zero level if the scientific data do not justify establishing a 
greater tolerance.
    New Section 408(b)(1)--Authority authorizes the 
Administrator to issue regulations establishing, modifying, or 
revoking tolerances for pesticide chemical residues in or on a 
food in response to a petition or on the Administrator's 
initiative.
    New Section 408(b)(2)--Standard lays out the criterion by 
which tolerances would be set. New subsection 408(b)(2)(A)--
General Rule would set the general rule for the standard. Under 
new subsection 408(b)(2)(A)(i)--Standard the Administrator may 
establish or leave in effect a tolerance for a pesticide 
residue in or on food only if the Administrator determines that 
the tolerance is safe. EPA must revoke or modify a tolerance if 
it is not safe.
    New Section 408(b)(2)(A)--Determination of Safety defines 
``safe'' as a determination that there is a reasonable 
certainty that no harm will result from aggregate exposure to 
the residue, including all dietary exposures and all other 
exposures for which there is reliable information.
    In new Section 408(b)(2)(A)(iii) a rule of construction 
clarifies that if a determination is made under subsection 
408(b)(2)(A) the provisions of subsection of 408(b)(2)(B) do 
not apply.
    Subsection (b)(2)(A) establishes the standard of ``safe'' 
for tolerances for pesticide chemical residues in or on food. 
For the purposes of this section, ``safe'' means there is a 
reasonable certainty that no harm will result from aggregate 
exposure to the pesticide chemical residue. The Committee 
understands ``aggregate exposure'' to the pesticide chemical 
residue to include dietary exposures under all tolerances for 
the pesticide chemical residue, and exposure from other non-
occupational sources as well.
    The Committee has adopted the standard of ``reasonable 
certainty of no harm'' based on EPA's current application of 
the standard. The Committee understands that the Administrator 
currently applies this standard differently to threshold and 
nonthreshold effects. A threshold effect is an effect for which 
the Administrator is able to identify a level at which the 
pesticide chemical residue will not cause or contribute to any 
known or anticipated harm to human health. A nonthreshold 
effect is an effect for which the Administrator is not able to 
identify such a level.
    In the case of a threshold effect for a pesticide chemical 
residue, the Committee expects that a tolerance will provide a 
``reasonably certainty of no harm'' if the Administrator 
determines that the aggregate exposure to the pesticide 
chemical residue will be lower by an ample margin of safety 
than the level at which the pesticide chemical residue will not 
cause or contribute to any known or anticipated harm to human 
health. The Committee further expects, based on discussions 
with the Environmental Protection Agency, that the 
Administrator will interpret an ample margin of safety to be a 
100-fold safety factor applied to the scientifically determined 
``no observable effect'' level when data are extrapolated from 
animal studies.
    In the case of a nonthreshold effect which can be assessed 
through quantitative risk assessment, such as a cancer effect, 
the Committee expects, based on its understanding of current 
EPA practice, that a tolerance will be considered to provide a 
``reasonable certainty of no harm'' if any increase in lifetime 
risk, based on quantitative risk assessment using conservative 
assumptions, will be no greater than ``negligible.'' It is the 
Committee's understanding that, under current EPA practice, 
utilizing quantitative risk assessment to calculate Potency 
Factors called ``Q star'', EPA interprets a negligible risk to 
be a one-in-a-million lifetime risk. The Committee expects the 
Administrator to continue to follow this interpretation.
    The statutory language does not preclude EPA from changing 
its risk assessment methodology as the science of risk 
assessment evolves. If the Administrator in the future chooses 
to adopt a different interpretation of ``reasonable certainty 
of no harm,'' however, the new interpretation should be adopted 
by regulation and should be at least equally protective of 
public health. Any new interpretation must be scientifically 
based and the Administrator should bear the burden to 
demonstrate that the revised interpretation is equally 
protective of the public.
    New Section 408(b)(2)(B)--Tolerances for Eligible Pesticide 
Chemical Residues allows EPA to maintain or modify a tolerance 
for an eligible pesticide residue which does not fall under 
subsection (A) if: (1) EPA is not able to identify a level of 
exposure that will not cause or contribute to known or 
anticipated harm to human health (that is, there is a 
nonthreshold effect); (2) the lifetime risk of the nonthreshold 
effect is assessed by means of quantitative risk assessment; 
and (3) aggregate exposure to the residue is safe with respect 
to other effects for which EPA can identify a safe level of 
exposure (that is, threshold effects). The EPA Administrator 
may leave a tolerance in effect or modify it if: (1) the use of 
the pesticide that produces the residue protects consumers from 
adverse effects to health that pose a greater risk than the 
dietary risk from the residue, or the pesticide use avoids 
significant disruption in domestic production of an adequate, 
wholesome, and economical food supply; and (2) the annual risk 
from the nonthreshold effect (from aggregate exposure to the 
residue) does not exceed 10 times the annual risk allowed under 
a safe tolerance level, and the lifetime risk of the 
nonthreshold effect is not greater than twice the safe lifetime 
risk for such effect. In addition, all such tolerances must be 
safe for children. New Section 408(b)(2)(B)(v) directs EPA to 
review the need for the pesticide use and the risks of such use 
within 5 years of determining to leave in effect or modify such 
a tolerance, and as necessary thereafter. If it has not been 
demonstrated that the tolerance continues to meet the 
requirements of this subparagraph, EPA must issue a regulation 
to modify or revoke the tolerance within 180 days, in 
accordance with procedures under subsection (e).
    Clause (b)(2)(B)(iii) establishes the conditions regarding 
use that must be present before a tolerance may be modified or 
left in effect under subsection (b)(2)(B). Subclause (iii)(I) 
provides that the authority of subsection (b)(2)(B) may be used 
when use of the pesticide that produces the residue protects 
consumers from adverse effects on health that pose a greater 
risk than the dietary risk from the pesticide chemical residue. 
In this situation, eating food treated with the pesticide 
chemical is safer for consumers than eating the same food that 
is not treated with the pesticide. The Committee intends to 
address a situation in which, for example, a pesticide is the 
only effective way to prevent or minimize a dietary risk from a 
fungus or other crop condition. The fungus aflatoxin, a 
dangerous fungus which can be present on peanuts and corn, is 
one such representative example. Although there is currently no 
pesticide chemical which can protect these crops from 
aflatoxin, if such a pesticide were to be developed, the 
Committee believes it would be a candidate for a tolerance 
under this subparagraph if its dietary risks were lower than 
the dietary risks of aflatoxin.
    Subclause (iii)(II) provides that the authority of 
subsection (b)(2)(B) may be used when use of the pesticide that 
produces the residue is necessary to avoid a significant 
disruption in domestic production of a safe, economical, and 
wholesome food supply. This standard is a more precise version 
of the current provision in section 408(b). By adding reference 
to a ``significant disruption,'' the Committee intends to 
clarify the general understanding of the type of effect on 
farmers and consumers that is covered by this language. In 
determining whether the loss of a pesticide would cause a 
significant disruption in the production of an adequate, 
wholesome, and economical food supply, EPA is expected at take 
into account the availability and effectiveness of alternative 
pest control methods, the impact of loss of the pesticide on 
crops, the impact on the national availability and cost of food 
combined with the dietary impact of such loss, and the impact 
on the ability of consumers to access a nutritious food supply.
    The Committee expects this type of analysis to apply in 
exceptional situations such as the one illustrated here: In the 
1980s, unusual weather conditions caused a substantial increase 
in aflatoxin on corn used for animal feed across the Southeast. 
The FDA determined that it was necessary to raise the action 
level for aflatoxin on corn to avoid widespread shortages of 
animal feed. Although FDA's action in this illustrative case 
occurred under other provisions of this Act, the potential 
significant disruption that triggered the action is of the type 
the Committee envisions as representative.
    New Section 408(b)(2)(C)--Exposure to Infants and Children 
mandates criteria relating to safety of infants and children to 
be considered when establishing, modifying, leaving in effect, 
or revoking tolerances or exemptions for pesticide residues. In 
making such decisions, the Administrator shall (i) assess the 
risk of the pesticide residue based on: (I) data on consumption 
patterns among infants and children, if these patterns are 
likely to result in a disproportionately high consumption of 
foods bearing the residue as compared with the consumption by 
the general population; (II) data on the special susceptibility 
of infants and children to pesticide residues, including data 
on the neurological differences between infants, children, and 
adults and effects of in-utero exposure to chemicals; and (III) 
data on the cumulative effects on infants and children of such 
residues that have common mechanisms of toxicity. In the 
decision, the Administrator shall also (ii): (I) ensure that 
there is a reasonable certainty of no harm to infants and 
children from aggregate exposure to the pesticide chemical 
residue; and (II) publish a determination regarding the safety 
of the residue for infants and children.
    When data relating to infants and children are incomplete, 
and also to account for potential pre- and post-natal toxicity, 
the Administrator is to apply, under new Section 408(b)(2)(C), 
an additional tenfold margin of safety for infants and 
children. However, EPA may apply a different margin of safety 
if reliable data indicate that it will be safe for infants and 
children. The Secretary of Health and Human Services (DHHS) and 
the Secretary of Agriculture (USDA), in consultation with EPA, 
will document, through surveys, dietary exposure to pesticides 
among infants and children.
    It is the intention of the Committee that EPA interpret the 
language of this section in furtherance of the following 
recommendation of the National Research Council's Study, 
``Pesticides in the Diets of Infants and Children'':

          At present, to provide added protection during early 
        development, a third uncertainty factor of 10 is 
        applied to the NOEL, to develop the RfD. This third 10-
        fold factor has been applied by the EPA and FDA 
        whenever toxicity studies and metabolic/disposition 
        studies have shown fetal developmental effects.
          Because there exist specific periods of vulnerability 
        during postnatal development, the committee recommends 
        that an uncertainty factor up to the 10-fold factor 
        traditionally used by EPA and FDA for fetal 
        developmental toxicity should also be considered when 
        there is evidence of postnatal developmental toxicity 
        and when data from toxicity testing relative to 
        children are incomplete. The committee wishes to 
        emphasize that this is not a new, additional 
        uncertainty factor but, rather, an extended application 
        of a uncertainty factor now routinely used by the 
        agencies for a narrower purpose. (page 9)

    New Section 408(b)(2)(D)--Factors lists nine factors that 
EPA should consider in establishing, modifying, leaving in 
effect, or revoking a pesticide chemical residue tolerance or 
exemption. These include: (i) the validity, completeness, and 
reliability of the data from studies of the pesticide and its 
residue; (ii) the nature of any toxic effect shown to be caused 
by the pesticide or its residue; (iii) available information 
concerning the relationships of such studies to human risk; 
(iv) available information on dietary consumption patterns of 
consumers and major subgroups; (v) available information 
concerning cumulative effects of residues and other substances 
with a common toxicity mechanism; (vi) available information 
about the aggregate exposure levels of consumers and major 
subgroups to the residues and related substances, including 
dietary exposure under the tolerance and all other tolerances 
in effect for that pesticide, and exposure from other non-
occupational sources; (vii) information about the variability 
of the sensitivities of major identifiable subgroups of 
consumers; (viii) information as EPA may require on whether the 
pesticide may have similar health effects as naturally 
occurring estrogen, or other endocrine effects; and (ix) safety 
factors which experts believe are generally recognized as 
appropriate for use of animal experimentation data.
    New Section 408(b)(2)(E)--Data and Information Regarding 
Anticipated and Actual Residue Levels authorizes EPA to 
consider data on the anticipated residue levels on or in food 
and the actual residue levels that have been measured in food, 
including residue data collected by FDA, when the agency 
establishes, modifies, leaves in effect, or revokes a 
tolerance. However, within 5 years of a tolerance decision and 
thereafter as needed, clause (ii) requires EPA to require the 
submission of residue data demonstrating that residue levels 
have not increased above levels relied upon for a decision to 
establish, modify, or retain a tolerance. If data are not 
submitted or do not demonstrate this, Section 408(b)(2)(E) 
directs EPA to issue an order or regulation to modify or revoke 
the tolerance.
    New Section 408(b)(2)(F)--Percent of Food Actually Treated 
authorizes considering information on the percent of food 
actually treated with the pesticide, including aggregate 
pesticide use data collected by USDA, when EPA assesses chronic 
dietary risk and establishes a tolerance. The section limits 
use of such information to situations in which EPA finds: (i) 
the data are reliable and valid indicators of the percentage of 
food likely to contain the residue derived from the crop; (ii) 
the exposure is not underestimated for any significant 
subpopulation; and (iii) available data for a particular area 
do not indicate higher levels of dietary exposure. In addition, 
clause (iv) requires that EPA provide for the periodic 
reevaluation of the estimate of anticipated dietary exposure.
    New Section 408(b)(3)--Detection Methods concerns methods 
for detecting and measuring residue levels at the level of the 
tolerance. As a general rule, the EPA is prohibited from 
setting a tolerance unless there is a practical method for 
detecting and measuring residues. Subparagraph (B)-Detection 
Limit prohibits setting tolerance levels below the limit of 
detection of the method for measuring residues identified by 
EPA.
    New Section 408(b)(4)--International Standards requires EPA 
to consider any maximum residue level (MRL) established for a 
chemical by the international Codex Alimentarius Commission 
(Codex), when the Agency determines tolerance levels. 2 If 
a Codex MRL exists, and the EPA decides not to adopt the same 
level, the bill requires EPA to publish for public comment a 
notice explaining the departure. This new subsection is 
intended to avoid unnecessary restraints on international food 
trade by requiring EPA explicitly to consider international 
standards when setting U.S. tolerances and encouraging EPA to 
support international harmonization efforts.
---------------------------------------------------------------------------
    \2\ The Codex is sponsored by the United Nations Food and 
Agriculture Organization and the World Health Organization. Its purpose 
is to negotiate international standards for food. The United States is 
represented on various standing committees of the Codex by officials 
from FDA, EPA, and USDA.
---------------------------------------------------------------------------

Sec. 408(c). Authority and standard for exemptions

    Section 408(c) of current law requires the Administrator to 
promulgate regulations exempting any pesticide from the 
necessity of a tolerance if such an exemption is safe.
    New subsection (c)(1)--Authority authorizes the 
Administrator, in response to a petition or on the 
Administrator's initiative, to issue a regulation establishing, 
modifying, or revoking an exemption from the requirement for a 
pesticide residue tolerance on food. The Committee expects EPA 
to continue to issue exemptions for GRAS substances under this 
authority.
    New subsection (c)(2)--Standard limits the Administrator's 
authority to issue exemptions. Subsection (c)(2)(A)--General 
Rule provides that an exemption only can be established if it 
is safe, and that EPA must modify or revoke an exemption that 
is not safe. Clause (ii) defines ``safe'' as a determination 
that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue,'' 
including all dietary and other exposures for which reliable 
data exist. Subsection (c)(2)(B)--Factors requires the 
Administrator, in deciding on an exemption, to consider 
relevant factors, including those related to infants and 
children that are specified in subparagraph (C) and the nine 
factors specified in subparagraph (D) 3 of the new 
subsection (b)(2). The Committee understands that EPA currently 
issues exemptions only for the pesticide chemical residues that 
do not pose a dietary risk under reasonably foreseeable 
circumstances. The Committee intends that EPA retain its 
current practice.
---------------------------------------------------------------------------
    \3\ These 9 factors include: (i) the validity, completeness, and 
reliability of the data from studies of the pesticide and its residue; 
(ii) the nature of any toxic effect shown to be caused by the pesticide 
or its residue; (iii) available information concerning the 
relationships of such studies to human risk; (iv) available information 
on dietary consumption patterns of consumers and major subgroups; (v) 
available information concerning cumulative effects of residues and 
other substances with a common toxicity mechanism; (vi) available 
information about the aggregate exposure levels of consumers and major 
subgroups to the residues and related substances, including dietary 
exposure under the tolerance and all other tolerances in effect for 
that pesticide, and exposure from other non-occupational sources; (vii) 
information about the variability of the sensitivities of major 
identifiable subgroups of consumers; (viii) information as EPA may 
require on whether the pesticide may have similar health effects as 
naturally occurring estrogen or other endocrine effects; and (ix) 
safety factors which experts believe are generally recognized as 
appropriate for use of animal experimentation data.
---------------------------------------------------------------------------
    New subsection (c)(3)--Limitation prohibits an exemption, 
unless there is (A) a practical method for detecting and 
measuring the levels of the residue, or (B) there is no need 
for such a method, and the reasons are stated in the regulation 
establishing or modifying the exemption.

Sec. 408(d). Petition for tolerance or exemption

    Existing FFDCA Section 408(d) authorizes any applicant for 
a pesticide registration under FIFRA to file a petition for the 
issuance of a tolerance or an exemption. It requires the 
petition to contain data showing the name, chemical identity, 
and composition of the pesticide; the amount, frequency, and 
time of application of the pesticide; full reports of safety 
studies conducted; results of tests on pesticide residues on 
crops and identification of analytical methods used; practical 
methods for removing residue that exceeds a proposed tolerance; 
proposed tolerances, if they are being proposed; and reasonable 
grounds in support of the petition. The law also requires 
petitioners to provide samples of the pesticide upon request. 
The EPA must publish a notice of the petition filing within 30 
days, which must include discussion of the analytical methods 
to determine the pesticide residue levels. Within 90 days after 
a certification of usefulness of the pesticide by the Secretary 
of Agriculture, the Administrator is required either to 
establish a tolerance or to exempt the pesticide from a 
tolerance, unless the petitioner requests or the Administrator 
decides to refer the petition to an advisory committee. In that 
case, the Administrator must submit the petition and data to an 
advisory committee which must report to the Administrator with 
their recommendation within 60 days. The Administrator is 
required within 30 days of the committee report to issue a 
regulation establishing a tolerance or exempting the pesticide; 
the regulation becomes effective on publication.
    New subsection (d) is similar, for the most part, to 
current law, but the amended subsection authorizes any person 
to file a tolerance petition rather than only an applicant for 
a pesticide registration. New subsection (d)(1)--Petitions and 
Petitioners also authorizes petitions for establishing, 
modifying, or revoking a tolerance or an exemption.
    New subsection (d)(2)--Petition Contents identifies the 
information required in the petition. Subparagraph (d)(2)(A)--
Establishment authorizes the Administrator to require through 
regulations certain data and information to support a petition 
for a tolerance or an exemption. A petitioner must provide: 
(i)(I) a summary of the petition, data, information, and 
arguments; (II) a statement that the petitioner agrees to have 
the summary contents published with the notice of petition 
filing and as part of any proposed or final regulation; (ii) 
the name, chemical identity, and composition of the parent 
pesticide and its residue; (iii) data showing the recommended 
amount, frequency, method, and time of application of that 
pesticide; (iv) full reports on the results and methods used in 
safety testing; (v) full reports on the results and analytical 
methods used to decide on the nature and amount of residue 
likely to remain in or on the food; (vi) a practical method for 
detecting and measuring levels of residue (or for exemptions a 
statement of why it is not needed); (vii) a proposed tolerance 
for the residue if one is proposed; (viii) if the petition 
relates to a tolerance for a processed food, studies of the 
processing methods used to produce the food; (ix) any 
information that the Administrator requires to assess risk to 
infants and children; (x) any information that the 
Administrator requires related to whether the pesticide 
chemical may have a similar effect in humans as a naturally 
occurring estrogen or other endocrine effects; (xi) exposure 
information due to any tolerance or exemption already granted; 
(xii) practical methods for removing any residue amount that 
could exceed a proposed tolerance; and (xiii) other information 
that EPA requires to support the petition. If the information 
is already available to the Administrator, the petition may 
reference it in lieu of submitting it. Samples of the pesticide 
may be required.
    New subsection (d)(2)(B)--Modification or Revocation gives 
the Administrator authority to establish by regulation 
information and data requirements to support a petition to 
modify or revoke a tolerance or an exemption from a tolerance.
    New subsection (d)(3)--Notice directs the Administrator to 
publish the notice of petition filing within 30 days after 
determining that the petition has met the requirements in 
paragraph (2). The notice will include an announcement of the 
availability of a description of the analytical methods for 
detecting and measuring residues or a statement that such 
methods are not needed, and the summary of the petition.
    New subsection (d)(4)--Actions by the Administrator 
describes how EPA shall respond to a petition. Subparagraph 
(A)--In General directs EPA to (i) issue a final regulation; 
(ii) issue a proposed regulation followed by a final 
regulation; or (iii) issue an order denying the petition. New 
subparagraph (B) requires EPA to give priority to petitions for 
establishing or modifying a tolerance or exemption for the 
residue of a pesticide that is expected to pose less dietary 
risk to human health than other pesticide residues for which 
tolerances are in effect for the same or similar purposes. 
Subparagraph (C) provides for expedited EPA review of complete 
petitions for a tolerance or exemption for a pesticide residue 
posing less risk than a tolerance left in effect or modified 
for ``an eligible pesticide chemical residue'' under subsection 
(b)(2)(B). EPA must act on such a petition within 1 year. 
Clause (ii) directs EPA to review the need for the tolerance 
for the eligible pesticide chemical residue within 180 days of 
the date EPA issues a regulation establishing a tolerance or 
exemption for the safer pesticide residues. If EPA finds the 
need for such higher risk pesticide use no longer exists, new 
Section 408 requires EPA to revoke or modify the tolerance 
within 180 days of such a finding under the procedures of 
subsection (e).

Sec. 408(e). Action on administrator's own initiative

    The current FFDCA, Section 408(e), authorizes the 
Administrator to propose a tolerance or an exemption at any 
time. Thirty days after the proposal is published, the 
Administrator may publish the final regulation, which becomes 
effective upon publication, unless a registrant or applicant 
for a registration of the pesticide chemical named in the 
proposal requests referral of the proposal to an advisory 
committee. If requested, the Administrator must submit the 
proposal, and the advisory committee must report back certified 
recommendations within 60 days. Within 30 days of such 
certification, the Administrator may publish a regulation 
establishing a tolerance for a pesticide or exempting it. A 
regulation is effective upon publication, but any person 
adversely affected by it may file an objection.
    New subsection 408(e)(1)--General Rule authorizes rule 
making by the EPA Administrator to establish a tolerance or an 
exemption. In addition, it authorizes the Administrator to 
modify or to revoke a tolerance or an exemption, as well as to 
establish general implementation procedures and requirements. 
New subsection (e)(2)--Notice requires EPA to issue a notice of 
proposed rule making and to provide a 60 day public comment 
period before issuing the final regulation, unless there is 
good cause and it is in the public interest to shorten this 
requirement. An opportunity for a public hearing is provided by 
Section 408(g) below.

Sec. 408(f). Special data requirements

    New subsection (f)(1)--Requiring Submission of Additional 
Data requires EPA to collect additional data when reasonably 
required to support an existing pesticide tolerance or 
exemption. The Administrator is allowed to collect data under 
FIFRA, Section 3(c)(2)(B), or the Toxic Substances Control Act 
(TSCA), Section 4, or by publishing an order in the Federal 
Register. In the last case, a 60-day notice-and-comment period 
is required before the order could be issued. The order (i) 
directs persons who are required to submit data to identify 
which of them will provide data to EPA, (ii) describes the type 
of data and information required and why it could not be 
obtained under FIFRA or TSCA, (iii) describes the reports that 
would be prepared from this data, (iv) requires submissions of 
data and reports, and (v) sets the dates that the information 
is due. The Administrator may revise the order to make 
corrections. Subsection (f)(2)--Noncompliance authorizes the 
Administrator to modify or revoke the tolerance or exemption in 
question if the required data or reports are not submitted by 
the due date. The only issue that could be decided if the order 
were reviewed under subsection (g)(2) is whether a required 
submission had been made by the time specified. This provision 
does not prevent the Administrator from acting to modify or 
revoke a tolerance or exemption which does not meet the safety 
standard in subsection (b)(2) or (c)(2).

Sec. 408(g). Effective date, objections, hearings, and administrative 
        review

    The current FFDCA, Section 408(d)(5), provides 30 days 
after a regulation is issued for any person adversely affected 
by the regulation to file an objection with the Administrator 
and to request a public hearing to receive evidence relevant 
and material to the issues raised by the objection. A member of 
the National Academy of Sciences is required to designate a 
member of the advisory committee to testify before the hearing. 
As soon as practicable after the hearing, the law directs the 
Administrator to regulate based only on substantial evidence of 
record at the hearing. The regulation may take effect no sooner 
than 90 days after the rule is published, unless an emergency 
condition exists.
    New subsection (g)(1)--Effective Date states that any 
regulation or order will take effect upon publication unless 
the regulation or order specifies otherwise. The Administrator 
may adjust this effective date if objections are filed with 
respect to such a regulation or order.
    New subsection (g)(2)--Further Proceedings lists criteria 
for raising objections. New subparagraph (A) authorizes any 
person, not just a person adversely affected, to file an 
objection to a regulation or order issued under subsections 
(d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C) and 
doubles the time allowed for filing from 30 days to 60 days. It 
also requires the Administrator to give the petitioner a copy 
of the objections, if the regulation or order was issued in 
response to a petition filed under subsection (d)(1).
    New subparagraph (g)(2)(B) allows an objector to request a 
public evidentiary hearing. The Administrator would decide 
whether a hearing were necessary to receive factual evidence 
relevant to material issues of fact raised by the objections. 
The Committee expects EPA to use this discretion fairly and to 
grant hearings to responsible parties on all sides. The bill 
provides the hearing officer with various authorities, for 
example, to issue a subpoena to compel testimony, but requires 
the presiding officer to follow the Federal Rules of Civil 
Procedure in ordering protection of witnesses or documents and 
payment of expenses for witnesses. A subpoena may be enforced 
by a Federal district court.
    New subparagraph (g)(2)(C) requires the Administrator to 
issue an order as soon as practicable after the hearing, 
stating action to be taken. But, as under current law, any 
action taken must be based on substantial evidence in the 
hearing record and, if a hearing is held, explained in detail.

Sec. 408(h). Judicial review

    New Section 408(h) retains most of the existing provisions 
of FFDCA, Section 408(i). New subsection 408(h)(1)--Petition 
allows any person adversely affected by a regulation under 
subsection (c)(1)(a) or an order, issued under subsection 
(e)(1)(C), (f)(1)(C), or (g)(2)(C) or any regulation that is 
the subject of such an order within 60 days of its publication, 
to petition to have the regulation or order set aside and to 
obtain judicial review in the U.S. Court of Appeals for the 
circuit wherein that person resides or has a business or with 
the U.S. Court of Appeals for the District of Columbia Circuit. 
New subsection (h)(2)--Record and Jurisdiction requires the 
Administrator to file with the court the administrative record. 
The court has exclusive jurisdiction to affirm or set aside the 
order or regulation in whole or in part. The findings of the 
Administrator are required to be sustained only if supported by 
substantial evidence when considered on the record as a whole. 
New subsection 408(h)(3)--Additional Evidence allows for 
additional evidence to be presented to EPA if it appears proper 
to do so. The EPA can then modify its order or regulation to 
take into account that evidence. New subsection 408(h)(4)--
Final Judgment; Supreme Court Review makes the judgment of the 
court final, subject to review by the U.S. Supreme Court (as 
provided in section 1254 of Title 28 U.S.C.). Any petition or 
this appeal may not operate as a stay of the order or 
regulation, unless specifically ordered by the court. New 
subsection 408(h)(5)--Application prohibits review under any 
other section of law of issues subject to review under this 
subsection.

Sec. 408(i). Confidentiality and use of data

    Existing FFDCA, Section 408(f), requires that all data 
submitted under Section 408 or Section 409 be considered 
confidential by EPA or an advisory committee until publication 
of a regulation. New subsection 408(i)(1)--General Rule 
requires EPA to treat all submitted data and information 
confidentially and to provide for exclusive use and data 
compensation to the same extent as provided under FIFRA, 
Sections 3 and 10. New subsection 408(i)(2)--Exceptions allows 
disclosure of the information at the Administrator's 
discretion, to authorized Federal employees and contractors in 
carrying out official duties under this Act or other Federal 
statutes intended to protect the public health. Subparagraph 
(B) notes that information may not be withheld from either 
House of Congress or from any Committee, Subcommittee, or Joint 
Committee or Subcommittee to the extent that the matter lies 
within its jurisdiction. New subsection 408(i)(3)--Summaries 
permits publication of an informative summary of the data. The 
Committee intends that this section apply to data submitted to 
EPA prior to enactment, under old section 408 or 409, including 
data submitted under EPA guidelines by manufacturers of inert 
ingredients of pesticides. This provision is not intended to 
bring political forces to bear on EPA decision-making. The 
Committee expects EPA to issue regulations adequate to ensure 
appropriate protection of trade secret or confidential business 
information.

Sec. 408(j). Status of previously issued regulations

    New subsection 408(j)(1)--Regulations Under Section 406 
retains the provisions of FFDCA, Section 408(k), which concern 
regulations promulgated based on hearings held before 1953, but 
subjects modifications and revocations of such regulations to 
new Section 408, subsections (d) and (e), as well as to review 
under subsection (q). New subsections 408(j)(2)--Regulations 
under Section 409 and new subsection 408(j)(3)--Regulations 
under Section 408 are technical amendments which continue in 
effect all current regulations affecting pesticide residues 
that have been promulgated under current FFDCA Sections 408 or 
409 and subjects modifications and revocations of such rules to 
new subsections (d) and (e) and to review under subsection (q).

Sec. 408(k). Transitional provision

    New section 408(k) exempts from tolerance regulations those 
pesticide residues that before enactment (1) the Administrator 
or Secretary of Health and Human Services regarded as 
generally-recognized-as-safe (GRAS) within the meaning of 
subsection 408(a) or section 201(s). The new subsection (k)(2) 
also exempts from regulation any particular pesticide chemical 
on a particular food that was regarded as described in FFDCA 
section 201(s)(4). EPA is required to publish regulations 
listing which substances are covered by this exemption. Any 
exemption could be modified or revoked as if it had been issued 
under new subsection (c).
    If a new pesticide chemical residue would be generally 
regarded as safe, the Committee expects the Administrator to 
use the authority of subsection (c) to exempt the residue from 
the requirement for a tolerance. Under subsection (c), the 
Administrator has the authority to grant the residue a broad 
exemption covering multiple types of food in a single 
proceeding. Any petition to establish such an exemption should 
generally be given priority by the Administrator under 
subparagraph (d)(4)(B).

Sec. 408(l). Harmonization with action under other laws

    New subsection (l)(1)--Limitation directs EPA, to the 
extent practicable and consistent with deadlines for review in 
subsection (q), to coordinate any final action to suspend or 
revoke a tolerance or exemption with related action that might 
be necessary under FIFRA. The Committee expects EPA to 
coordinate and harmonize its actions under FIFRA and the FFDCA 
in a careful, consistent manner which is fair to all interested 
parties.
    New subsection (l)(2)--Revocation of Tolerance or Exemption 
Following Cancellation of Associated Registrations states that 
if EPA cancels or modifies the FIFRA registration of a 
pesticide for a food use because of dietary risks to human 
health posed by the residues, EPA also must revoke any 
tolerance or exemption that would allow the presence of the 
pesticide chemical in or on that food, using procedures set 
forth in subsection (e). A revocation under this paragraph 
becomes effective not later than 180 days after the date on 
which the use of the canceled pesticide becomes unlawful.
    New subsection 408(l)(3)--Suspension of Tolerance or 
Exemption Following Suspension of Associated Registrations--(A) 
Suspension requires the suspension of tolerances for food use 
pesticides, if the pesticide registration is suspended under 
FIFRA. A tolerance suspension becomes effective not later than 
60 days after the registration is suspended. Subparagraph (B)--
Effect of Suspension restores tolerances or exemptions if the 
Administrator rescinds a suspension of the registration for use 
of the pesticide.
    New subsection 408(l)(4)--Tolerances For Unavoidable 
Residues authorizes the Administrator to establish tolerances 
for unavoidably persistent residues of canceled or suspended 
pesticides on food. The required tolerance level is set taking 
into account the potential risk from exposure to the pesticide 
residue. These tolerances will be revisited periodically and 
modified as necessary to allow only that level of residue that 
is unavoidable due to its environmental persistence.
    New subsection 408(l)(5)--Pesticide Residues Resulting From 
Lawful Application of Pesticide allows pesticide residues on 
foods that were the result of lawful application of a 
pesticide. In a case where a tolerance or exemption for a 
pesticide residue is revoked, suspended, or modified, a food 
that was treated legally with the pesticide cannot be deemed 
unsafe, if: (A) the residue is present because of a lawful use 
under FIFRA, and (B) the pesticide residue did not exceed the 
previously authorized tolerance, exemption, food additive 
regulation, or other sanction level. EPA retains the power to 
declare legally treated food unlawful, but only after 
determining that consumption of the legally treated food during 
the period of its likely availability in commerce poses an 
unreasonable dietary risk. This provision allows continued use 
of existing food stocks that were treated with a lawful 
pesticide, thus protecting against unnecessary destruction of 
legally treated food, disruption in the marketplace, and 
economic loss. It also ensures that food producers are not 
unfairly penalized for legal use of pesticides that were 
subject to regulatory action at a subsequent date.
    New subsection 408(l)(6)--Tolerance for Use of Pesticides 
under an Emergency Exemption requires EPA to establish a 
tolerance or exemption for a pesticide residue if the agency 
grants a local or State exemption in the case of an emergency 
under FIFRA Section 18. Such a tolerance or exemption must 
terminate on a given date. EPA is not required to provide 
notice or a comment period on such a tolerance or exemption. 
The bill requires EPA, within 365 days of enactment of H.R. 
1627, to promulgate regulations concerning tolerances and 
exemptions under this paragraph. These regulations must be 
consistent with the safety standard established in Section 408 
(b)(2) and (c)(2) and with FIFRA Section 18.
    The Committee intends this requirement for Section 18 
tolerances or exemptions to resolve a long-standing dilemma 
regarding legal pesticide residues that, because there were no 
tolerances or exemptions, could have been considered 
technically in violation of law. However, the Committee also 
intends for the extremely important Section 18 process to 
continue in place, and for EPA to issue emergency exemption 
tolerances or exemptions expeditiously.

Sec. 408(m). Fees

     New subsection 408(m)(1)--Amount requires EPA to assess 
fees to cover, for example, the Agency's costs for accepting 
petitions, writing regulations, accepting objections, and 
certifying and filing court transcripts. Waivers or refunds of 
fees may be given by the Administrator, if it is equitable and 
not contrary to the purposes of this subsection. New subsection 
408(m)(2)--Deposit requires all collected fees to be deposited 
in the FIFRA 4(k) Reregistration and Expedited Processing Fund, 
and made available without fiscal year constraints for EPA's 
tolerance-related activities which are specified in Section 
408(m)(1).

Sec. 408(n). National uniformity of tolerances.

    New section 408(n) preempts State and local regulation of 
food with pesticide residues under certain conditions. Under 
current law, States and local governments can set tolerances 
for pesticide residues in foods that are lower (more stringent) 
than those established by EPA. They also may require warnings 
for food products that contain legal pesticide residues (that 
is, below Federal tolerance levels). New subsection 408(n)(1)--
Qualifying Pesticide Chemical Residues defines ``qualifying 
pesticide chemical residue'' as (A) a residue from a pesticide 
use (A) first registered under section 3(c)(5) of FIFRA on or 
after April 25, 1985 (the pesticides not subject to 
reregistration requirements of FIFRA Section 4(g)) or (B) 
residues of ``older'' pesticides (subject to reregistration 
requirements) that EPA has evaluated and approved for 
reregistration for that use.
    New subsection 408(n)(2)--Qualifying Federal Determination 
defines ``qualifying Federal determination'' as a tolerance or 
exemption (A) issued after enactment of this Act, and 
determined by the Administrator to meet the safety standard of 
new Section 408(b)(2)(A) (tolerances) or (c)(2) (exemptions); 
or (B) left in effect or deemed to have been issued under 
Section 408 pursuant to subsection (j), or regarded as exempt 
under subsection (k), and determined by EPA to meet the 
relevant safety standard. A determination to modify or leave in 
effect a tolerance under subsection (b)(2)(B) is not a 
qualifying Federal determination.
    New subsection 408(n)(3)--Limitation requires the 
Administrator to establish the safety of a ``qualifying Federal 
determination'' that was deemed to have been issued under 
Section 408, rather than actually issued after enactment, by 
issuing a rule in accord with Section 408(d) or (e), after 
first proposing the rule and allowing at least 30 days for 
public comment. The rule is reviewable in accordance with 
subsections (g) and (h).
    New subsection 408(n)(4)--State Authority prohibits State 
and local regulation of any ``qualifying pesticide chemical 
residue'' to which any ``qualifying Federal determination'' 
applies except as provided in paragraphs (5), (6), and (8). 
State and local governments are not authorized to regulate 
qualifying pesticide chemical residues covered by a qualifying 
Federal determination unless the State or local regulation is 
identical to the qualifying Federal determination.
    New subsection (n)(5)--Petition Procedures establishes 
petition procedures for States to request exceptions to the 
prohibition on State regulations. Subsection (n)(5)(A)--In 
General allows States to petition for a regulatory limit on a 
qualifying residue different than the Federal limit, if the 
State's petition establishes adequate justification to EPA. 
Subsection (n)(5)(B)--Petition Requirement requires that this 
justification include supporting scientific data about the 
pesticide, consumption data, and exposure data of people 
residing in the State, and any other EPA requirements. 
Subsection (n)(5)(C)--Authorization authorizes State exemptions 
from uniform Federal limits if (i) they are justified by 
compelling local conditions and (ii) they would not cause any 
food to be in violation of Federal law. Subsection (n)(5)(D)--
Treatment of Petition allows the Administrator to treat a State 
petition as if it were a petition to modify or revoke a 
tolerance or exemption under Section 408(d). Subsection 
(n)(5)(E)--Review subjects to review under subsections (g) and 
(h) (pertaining to administrative and judicial review, 
respectively) any EPA order granting or denying State authority 
in response to a petition.
    New subsection (n)(6)--Urgent Petition Procedure provides 
for temporary State regulations if EPA does not act within 30 
days of receiving an urgent petition for State authorization. 
If a State petition demonstrates that a significant public 
health threat exists from acute exposure to a pesticide residue 
on food during the period that such food is available in that 
State, the petition will be considered urgent. If EPA does not 
issue an order to grant or deny State authority that is 
requested in an urgent petition within 30 days of its receipt, 
the State is authorized to establish and enforce a temporary 
regulatory limit on a qualifying pesticide chemical residue in 
or on the food. The final EPA order will validate or terminate 
the temporary regulatory limit.
    New subsection (n)(7)--Residues from Lawful Application 
assures that no State or political subdivision can declare a 
food unlawful because it contains a residue that resulted from 
the application of a pesticide at a time when such residue 
level complied with all Federal and State laws. An exception is 
allowed if the State can demonstrate that the residue level 
will pose an unreasonable dietary risk to the health of persons 
within that State due to consumption of that food during the 
period in which it is likely to be available.
    New subsection (n)(8)--Savings excludes from the preemption 
provisions of subsection (n) ``warning requirements'' and other 
statements relating to the presence of such residues in food.

Sec. 408(o). Consumer right to know

    This section requires EPA within 2 years of enactment and 
annually thereafter, in consultation with USDA and DHHS, to 
publish and distribute to large retail grocers for public 
display (in a manner determined by each grocer) certain 
information relevant to pesticide residues. The information, 
which must be conveyed in a format understandable to a lay 
person, includes: (1) a discussion of the risks and benefits of 
pesticide chemical residues in or on food; (2) a list of 
actions taken under subsection (b)(2)(B) relating to eligible 
pesticide residues that may result in risks greater than 
allowed for under subparagraph (A), and of the food on which 
the pesticides producing such residues are used; and (3) 
recommendations on how consumers might reduce dietary exposures 
to pesticide residues while maintaining a healthy diet. The 
Committee expects the EPA recommendations to be consistent with 
established nutritional guidelines. Retail grocers may provide 
additional information.

Sec. 408(p). Estrogenic substances screening program

    New Section 408(p)(1) directs EPA, in consultation with 
DHHS, to develop a screening program within 2 years to gather 
information scientifically to evaluate whether certain 
substances may have effects in humans that are similar to 
effects produced by naturally occurring estrogen or other 
endocrine effects. Paragraph (2) requires EPA to solicit public 
comments on and review of the screening program by the 
scientific advisory panel for pesticide policy or the EPA 
science advisory board, which evaluates a broader range of EPA 
programs. The program must be implemented within 3 years of 
enactment of H.R. 1627. Paragraph (3) mandates testing of all 
pesticide chemicals and authorizes EPA to test any other 
substance that may have an effect cumulative to that of a 
pesticide chemical residue, if a substantial population may be 
exposed to it. Paragraph (4) authorizes EPA to issue orders 
exempting substances from the testing requirements if they are 
not expected to produce an estrogenic effect in humans. EPA 
must issue an order to conduct testing of covered substances 
and to submit reports to pesticide registrants and to persons 
who manufacture or import covered substances. The bill requires 
such orders to establish a reasonable time period for 
generating the information and reporting to EPA. EPA 
implementing regulations and orders should minimize duplicative 
testing requirements, provide equitable arrangements for 
sharing testing costs, and develop procedures to handle 
confidential business information. The other substances that 
may be tested under this paragraph are intended by the 
Committee to be other environmental contaminants. Paragraph 
(5)(C) requires issuance of a notice of intent to suspend the 
sale or distribution of a substance if a registrant fails to 
comply with a test order. Such suspension will become final 
after 30 days unless a hearing is requested or the EPA decides 
that the registrant has complied fully with paragraph (5). 
However, EPA must terminate a suspension if the registrant has 
fully complied with paragraph (5). Any hearing held will be 
conducted in accordance with section 554 of title 4 U.S.C. 
(that is, the formal adjudicatory hearing process). The only 
matter to be resolved at the hearing is whether the registrant 
failed to comply with an EPA order. An EPA decision after the 
hearing is a final agency action and thus may be judicially 
reviewed under the Administrative Procedure Act (5 U.S.C. 701). 
If a manufacturer or an importer who is not a registrant fails 
to comply with a test order, that person is liable for the 
penalties and sanctions provided under TSCA Section 16, which 
may include up to $25,000 per day in fines and, if the person 
knowingly or willfully violates an order, imprisonment for up 
to one year. A person assessed a fine may request a hearing 
and, if ordered to pay the fine after the hearing, may file a 
petition for judicial review of EPA's order. The bill mandates 
EPA action ``as is necessary to ensure the protection of public 
health'' if the screening program finds a substance to have an 
endocrine effect on humans. Any action is to be taken under 
EPA's existing statutory authority. EPA must report to Congress 
within 4 years on its findings from the screening program and 
any recommendations for further testing and actions.

Sec. 408(q). Schedule for review

    New Section 408(q) directs EPA to review tolerances and 
exemptions for pesticide residues in effect before enactment of 
H.R. 1627. Review should take place as expeditiously as 
practicable and assure that (A) 33 percent of the tolerances 
and exemptions are reviewed within 3 years, (B) 66 percent are 
reviewed within 6 years, and (C) all tolerances and exemptions 
are reviewed within 10 years. In reviewing the tolerances and 
exemptions, EPA is required to determine whether they meet the 
requirements of subsections (b)(2) or (c)(2). Before the 
deadline for review, the bill directs EPA to issue regulations 
under subsection (d)(4) or (e)(1) to modify or revoke 
tolerances and exemptions that do not meet the requirements of 
subsections (b)(2) or (c)(2).
    Paragraph (2) orders the Administrator to give priority to 
the review of tolerances or exemptions that appear to pose the 
greatest risk to public health. New paragraph (3) requires that 
EPA publish within 12 months a schedule for review of 
tolerances and exemptions established prior to enactment of 
H.R. 1627. Priority setting for the review of tolerances and 
exemptions under this subsection is not to be considered a 
rulemaking and is not subject to judicial review. However, if 
EPA fails to take final action pursuant to the schedule, this 
failure shall be subject to judicial review.
    In establishing an orderly review of existing tolerances 
and providing EPA with discretion in setting priorities, the 
Committee intends for the Agency to align such priorities 
responsibly with other important business, such as reviewing 
and responding to petitions. The Committee does not intend the 
petition process to be used in a way that is disruptive of 
EPA's priorities, except in cases where an action is needed 
urgently to protect the public health.

Sec. 408(r). Temporary tolerance or exemption

    New Section 408(r) provides, as in current FFDCA, section 
408(j), that EPA may issue temporary tolerances or exemptions 
for the use of pesticides under a FIFRA experimental use 
permit.

Sec. 408(s). Savings clause

    New Section 408(s) clarifies that the section does not 
modify or amend TSCA or FIFRA.

            SEC. 406. AUTHORIZATION FOR INCREASED MONITORING

    Section 6 authorizes to be appropriated an additional $12 
million for increased monitoring by FDA of pesticide residues 
in imported and domestic food.

                   SEC. 407. ALTERNATIVE ENFORCEMENT

    Section 407 amends FFDCA Section 303(g) (21 U.S.C. 333(f)) 
to insert a new paragraph (2). It subjects any person who 
introduces into interstate commerce or delivers for 
introduction into interstate commerce any food that is 
adulterated by a pesticide chemical residue to a civil money 
penalty of not more than $50,000 for an individual or $250,000 
for a corporation for such introduction or delivery. An 
aggregate limit of $500,000 is set for all individuals and 
corporations subject to adjudication in a single proceeding. 
This paragraph does not apply to growers. Persons assessed a 
civil penalty may not be sanctioned under the criminal 
authorities for the introduction or delivery for introduction 
into interstate commerce of the adulterated food. Nor may 
seizure authorities of Section 304 or the injunction 
authorities of Section 302 be used against a person who is 
assessed a civil penalty. Subparagraph (C) provides the 
presiding officer in a hearing to assess a civil penalty with 
the same authority to compel testimony or production of 
documents as a presiding officer has under Section 
408(g)(2)(B). The third sentence of paragraph (3)(A) (of 
Section 303(g), as amended by this section, which authorizes 
the Secretary to issue subpoenas) does not apply to any 
investigation under Section 303(g)(2).
    The Committee intends for FDA to use this new civil penalty 
authority judiciously and to impose penalties that are 
commensurate with the level of violation and with other factors 
such as the history of past violations and ability of the 
individual or company to pay a fine. The Committee intends that 
one important factor to be considered in determining whether to 
levy a civil monetary penalty, and the amount of such penalty, 
is whether the individual or company has acted promptly and 
responsibly to remove a violative product from the market and 
to correct the cause of the violation. Finally, the Committee 
intends that all civil penalties collected under this authority 
shall be deposited in the general fund.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3 of rule XIII of the Rules of the 
House of Representatives, changes in existing law made by title 
IV of the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

                  FEDERAL FOOD, DRUG, AND COSMETIC ACT

          * * * * * * *

                        CHAPTER II--DEFINITIONS

  Sec. 201. For the purposes of this Act--
  (a) * * *
          * * * * * * *
  [(q) The term ``pesticide chemical'' means any substance 
which, alone, in chemical combination or in formulation with 
one or more other substances, is a pesticide within the meaning 
of the Federal Insecticide, Fungicide, and Rodenticide Act (7 
U.S.C., secs. 135-135k) as now in force or as hereafter 
amended, and which is used in the production, storage, or 
transportation of raw agricultural commodities.]
  (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.
          * * * * * * *
  (s) The term ``food additive'' means any substance the 
intended use of which results or may reasonably be expected to 
result, directly or indirectly, in its becoming a component or 
otherwise affecting the characteristics of any food (including 
any substance intended for use in producing, manufacturing, 
packing, processing, preparing, treating, packaging, 
transporting, or holding food; and including any source of 
radiation intended for any such use), if such substance is not 
generally recognized, among experts qualified by scientific 
training and experience to evaluate its safety, as having been 
adequately shown through scientific procedures (or, in the case 
of a substance used in food prior to January 1, 1958, through 
either scientific procedures or experience based on common use 
in food) to be safe under the conditions of its intended use; 
except that such term does not include--
          [(1) a pesticide chemical in or on a raw agricultural 
        commodity; or
          [(2) a pesticide chemical to the extent that it is 
        intended for use or is used in the production, storage, 
        or transportation of any raw agricultural commodity; 
        or]
          * * * * * * *
          (1) a pesticide chemical residue in or on a raw 
        agricultural commodity or processed food; or
          (2) a pesticide chemical; or

               CHAPTER III--PROHIBITED ACTS AND PENALTIES

                            prohibited acts

  Sec. 301. The following acts and the causing thereof are 
hereby prohibited:
  (a) * * *
          * * * * * * *
  (j) The using by any person to his own advantage, or 
revealing, other than to the Secretary or officers or employees 
of the Department, or to the courts when relevant in any 
judicial proceeding under this Act, any information acquired 
under authority of section 404, 409, 412, 505, 506, 507, 510, 
512, 513, 514, 515, 516, 518, 519, 520, 704, 708, or 721 
concerning any method or process which as a trade secret is 
entitled to protection; or the violating of section 408(i)(2) 
or any regulation issued under that section. This paragraph 
does not authorize the withholding of 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.
          * * * * * * *
  (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.
          * * * * * * *

                               penalties

  Sec. 303. (a) * * *
          * * * * * * *
  (g)(1)(A) Except as provided in subparagraph (B), any person 
who violates a requirement of this Act which relates to devices 
shall be liable to the United States for a civil penalty in an 
amount not to exceed $15,000 for each such violation, and not 
to exceed $1,000,000 for all such violations adjudicated in a 
single proceeding.
          * * * * * * *
  (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.
  [(2)] (3)(A) A civil penalty under paragraph (1) or (2) shall 
be assessed by the Secretary by an order made on the record 
after opportunity for a hearing provided in accordance with 
this subparagraph and section 554 of title 5, United States 
Code. Before issuing such an order, the Secretary shall give 
written notice to the person to be assessed a civil penalty 
under such order of the Secretary's proposal to issue such 
order and provide such person an opportunity for a hearing on 
the order. In the course of any investigation, the Secretary 
may issue subpoenas requiring the attendance and testimony of 
witnesses and the production of evidence that relates to the 
matter under investigation.
  (B) In determining the amount of a civil penalty, the 
Secretary shall take into account the nature, circumstances, 
extent, and gravity of the violation or violations and, with 
respect to the violator, ability to pay, effect on ability to 
continue to do business, any history of prior such violations, 
the degree of culpability, and such other matters as justice 
may require.
  (C) The Secretary may compromise, modify, or remit, with or 
without conditions, any civil penalty which may be assessed 
under paragraph (1) or (2). The amount of such penalty, when 
finally determined, or the amount agreed upon in compromise, 
may be deducted from any sums owing by the United States to the 
person charged.
  [(3)] (4) Any person who requested, in accordance with 
paragraph [(2)(A)] (3)(A), a hearing respecting the assessment 
of a civil penalty and who is aggrieved by an order assessing a 
civil penalty may file a petition for judicial review of such 
order with the United States Court of Appeals for the District 
of Columbia Circuit or for any other circuit in which such 
person resides or transacts business. Such a petition may only 
be filed within the 60-day period beginning on the date the 
order making such assessment was issued.
  [(4)] (5) If any person fails to pay an assessment of a civil 
penalty--
          (A) after the order making the assessment becomes 
        final, and if such person does not file a petition for 
        judicial review of the order in accordance with 
        paragraph [(3)] (4), or
          (B) after a court in an action brought under 
        paragraph [(3)] (4) has entered a final judgment in 
        favor of the Secretary,
the Attorney General shall recover the amount assessed (plus 
interest at currently prevailing rates from the date of the 
expiration of the 60-day period referred to in paragraph [(3)] 
(4) or the date of such final judgment, as the case may be) in 
an action brought in any appropriate district court of the 
United States. In such an action, the validity, amount, and 
appropriateness of such penalty shall not be subject to review.
          * * * * * * *

                            CHAPTER IV--FOOD

          * * * * * * *

                            adulterated food

  Sec. 402. A food shall be deemed to be adulterated--
  (a)(1) If it bears or contains any poisonous or deleterious 
substance which may render it injurious to health; but in case 
the substance is not an added substance such food shall not be 
considered adulterated under this clause if the quantity of 
such substance in such food does not ordinarily render it 
injurious to health; or [(2)(A) if it bears or contains any 
added poisonous or added deleterious substance (other than one 
which is (i) a pesticide chemical in or on a raw agricultural 
commodity; (ii) a food additive; (iii) a color additive; or 
(iv) a new animal drug) which is unsafe within the meaning of 
section 406, or (B) if it is a raw agricultural commodity and 
it bears or contains a pesticide chemical which is unsafe 
within the meaning of section 408(a); or (C) if it is, or it 
bears or contains, any food additive which is unsafe within the 
meaning of section 409: Provided, That where a pesticide 
chemical has been used in or on a raw agricultural commodity in 
conformity with an exemption granted or a tolerance prescribed 
under section 408 and such raw agricultural commodity has been 
subjected to processing such as canning, cooking, freezing, 
dehydrating, or milling, the residue of such pesticide chemical 
remaining in or on such processed food shall, notwithstanding 
the provisions of sections 406 and 409, not be deemed unsafe if 
such residue in or on the raw agricultural commodity has been 
removed to the extent possible in good manufacturing practice 
and the concentration of such residue in the processed food 
when ready to eat is not greater than the tolerance prescribed 
for the raw agricultural commodity; or (D) if it is, or it 
bears or contains, a new animal drug (or conversion product 
thereof) which is unsafe within the meaning of section 512; (3) 
if it consists] (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 in whole or in part of any filthy, putrid, or 
decomposed substance, or if it is otherwise unfit for food; or 
(4) if it has been prepared, packed, or held under unsanitary 
conditions whereby it may have become contaminated with filth, 
or whereby it may have been rendered injurious to health; or 
(5) if it is, in whole or in part, the product of a diseased 
animal or of an animal which has died otherwise than by 
slaughter; or (6) if its container is composed, in whole or in 
part, of any poisonous or deleterious substance which may 
render the contents injurious to health; or (7) if it has been 
intentionally subjected to radiation, unless the use of the 
radiation was in conformity with a regulation or exemption in 
effect pursuant to section 409.
          * * * * * * *

     [tolerances for pesticide chemicals in or on raw agricultural 
                              commodities

  [Sec. 408. (a) Any poisonous or deleterious pesticide 
chemical, or any pesticide chemical which is not generally 
recognized, among experts qualified by scientific training and 
experience to evaluate the safety of pesticide chemicals, as 
safe for use, added to a raw agricultural commodity, shall be 
deemed unsafe for the purposes of the application of clause (2) 
of section 402(a) unless--
          [(1) a tolerance for such pesticide chemical in or on 
        the raw agricultural commodity has been prescribed by 
        the Administrator of the Environmental Protection 
        Agency (hereinafter in this section referred to as the 
        ``Administrator'') under this section and the quantity 
        of such pesticide chemical in or on the raw 
        agricultural commodity is within the limits of the 
        tolerance so prescribed; or
          [(2) with respect to use in or on such raw 
        agricultural commodity, the pesticide chemical has been 
        exempted from the requirement of a tolerance by the 
        Administrator under this section.
While a tolerance or exemption from tolerance is in effect for 
a pesticide chemical with respect to any raw agricultural 
commodity, such raw agricultural commodity shall not, by reason 
of bearing or containing any added amount of such pesticide 
chemical, be considered to be adulterated within the meaning of 
clause (1) of section 402(a).
  [(b) The Administrator shall promulgate regulations 
establishing tolerances with respect to the use in or on raw 
agricultural commodities of poisonous or deleterious pesticide 
chemicals and of pesticide chemicals which are not generally 
recognized, among experts qualified by scientific training and 
experience to evaluate the safety of pesticide chemicals, as 
safe for use, to the extent necessary to protect the public 
health. In establishing any such regulation, the Administrator 
shall give appropriate consideration, among other relevant 
factors, (1) to the necessity for the production of an 
adequate, wholesome, and economical food supply; (2) to the 
other ways in which the consumer may be affected by the same 
pesticide chemical or by other related substances that are 
poisonous or deleterious; and (3) to the opinion of the 
Secretary of Agriculture as submitted with a certification of 
usefulness under subsection (l) of this section. Such 
regulations shall be promulgated in the manner prescribed in 
subsection (d) or (e) of this section. In carrying out the 
provisions of this section relating to the establishment of 
tolerances, the Administrator may establish the tolerance 
applicable with respect to the use of any pesticide chemical in 
or on any raw agricultural commodity at zero level if the 
scientific data before the Administrator does not justify the 
establishment of a greater tolerance.
  [(c) The Administrator shall promulgate regulations exempting 
any pesticide chemical from the necessity of a tolerance with 
respect to use in or on any or all raw agricultural commodities 
when such a tolerance is not necessary to protect the public 
health. Such regulations shall be promulgated in the manner 
prescribed in subsection (d) or (e) of this section.
  [(d)(1) Any person who has registered, or who has submitted 
an application for the registration of, a pesticide under the 
Federal Insecticide, Fungicide, and Rodenticide Act may file 
with the Administrator, a petition proposing the issuance of a 
regulation establishing a tolerance for a pesticide chemical 
which constitutes, or is an ingredient of such pesticide, or 
exempting the pesticide chemical from the requirement of a 
tolerance. The petition shall contain data showing--
          [(A) the name, chemical identity, and composition of 
        the pesticide chemical;
          [(B) the amount, frequency, and time of application 
        of the pesticide chemical;
          [(C) full reports of investigations made with respect 
        to the safety of the pesticide chemical;
          [(D) the results of tests on the amount of residue 
        remaining, including a description of the analytical 
        methods used;
          [(E) practicable methods for removing residue which 
        exceeds any proposed tolerance;
          [(F) proposed tolerances for the pesticide chemical 
        if tolerances are proposed; and
          [(G) reasonable grounds in support of the petition.
Samples of the pesticide chemical shall be furnished to the 
Administrator upon request. Notice of the filing of such 
petition shall be published in general terms by the 
Administrator within thirty days after filing. Such notice 
shall include the analytical methods available for the 
determination of the residue of the pesticide chemical for 
which a tolerance or exemption is proposed.
  [(2) Within ninety days after a certification of usefulness 
by the Secretary of Agriculture under subsection (l) with 
respect to the pesticide chemical named in the petition, the 
Administrator shall, after giving due consideration to the data 
submitted in the petition or otherwise before him, by order 
make public a regulation--
          [(A) establishing a tolerance for the pesticide 
        chemical named in the petition for the purposes for 
        which it is so certified as useful, or
          [(B) exempting the pesticide chemical from the 
        necessity of a tolerance for such purposes,
unless within such ninety-day period the person filing the 
petition requests that the petition be referred to an advisory 
committee or the Administrator within such period otherwise 
deems such referral necessary, in either of which events the 
provisions of paragraph (3) of this subsection shall apply in 
lieu hereof.
  [(3) In the event that the person filing the petition 
requests, within ninety days after a certification of 
usefulness by the Secretary of Agriculture under subsection 
(l), with respect to the pesticide chemical named in the 
petition, that the petition be referred to an advisory 
committee, or in the event the Administrator within such period 
otherwise deems such referral necessary, the Administrator 
shall forthwith submit the petition and other data before him 
to an advisory committee to be appointed in accordance with 
subsection (g) of this section. As soon as practicable after 
such referral, but not later than sixty days thereafter, unless 
extended as hereinafter provided, the committee shall, after 
independent study of the data submitted to it by the 
Administrator and other data before it, certify to the 
Administrator a report and recommendations on the proposal in 
the petition to the Administrator, together with all underlying 
data and a statement of the reasons or basis for the 
recommendations. The sixty-day period provided for herein may 
be extended by the advisory committee for an additional thirty 
days if the advisory committee deems this necessary. Within 
thirty days after such certification, the Administrator shall, 
after giving due consideration to all data then before him, 
including such report, recommendations, underlying data, and 
statement, by order make public a regulation--
          [(A) establishing a tolerance for the pesticide 
        chemical named in the petition for the purposes for 
        which it is so certified as useful; or
          [(B) exempting the pesticide chemical from the 
        necessity of a tolerance for such purposes.
  [(4) The regulations published under paragraph (2) or (3) of 
this subsection will be effective upon publication.
  [(5) Within thirty days after publication, any person 
adversely affected by a regulation published pursuant to 
paragraph (2) or (3) of this subsection \1\, or pursuant to 
subsection (e), may file objections thereto with the 
Administrator, specifying with particularity the provisions of 
the regulation deemed objectionable, stating reasonable grounds 
therefor, and requesting a public hearing upon such objections. 
A copy of the objections filed by a person other than the 
petitioner shall be served on the petitioner, if the regulation 
was issued pursuant to a petition. The petitioner shall have 
two weeks to make a written reply to the objections. The 
Administrator shall thereupon, after due notice, hold such 
public hearing for the purpose of receiving evidence relevant 
and material to the issues raised by such objections. Any 
report, recommendations, underlying data, and reasons certified 
to the Administrator by an advisory committee shall be made a 
part of the record of the hearing, if relevant and material, 
subject to the provisions of section 556(c) of title 5, United 
States Code. The National Academy of Sciences shall designate a 
member of the advisory committee to appear and testify at any 
such hearing with respect to the report and recommendations of 
such committee upon request of the Administrator, the 
petitioner, or the officer conducting the hearing: Provided, 
That this shall not preclude any other member of the advisory 
committee from appearing and testifying at such hearing. As 
soon as practicable after completion of the hearing, the 
Administrator shall act upon such objections and by order make 
public a regulation. Such regulation shall be based only on 
substantial evidence of record at such hearing, including any 
report, recommendations, underlying data, and reasons certified 
to the Administrator by an advisory committee, and shall set 
forth detailed findings of fact upon which the regulation is 
based. No such order shall take effect prior to the ninetieth 
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 his findings as to such conditions.
  [(e) The Administrator may at any time, upon his own 
initiative or upon the request of any interested person, 
propose the issuance of a regulation establishing a tolerance 
for a pesticide chemical or exempting it from the necessity of 
a tolerance. Thirty days after publication of such a proposal, 
the Administrator may by order publish a regulation based upon 
the proposal which shall become effective upon publication 
unless within such thirty-day period a person who has 
registered, or who has submitted an application for the 
registration of, a pesticide under the Federal Insecticide, 
Fungicide, and Rodenticide Act containing the pesticide 
chemical named in the proposal, requests that the proposal be 
referred to an advisory committee. In the event of such a 
request, the Administrator shall forthwith submit the proposal 
and other relevant data before him to an advisory committee to 
be appointed in accordance with subsection (g) of this section. 
As soon as practicable after such referral, but not later than 
sixty days thereafter, unless extended as hereinafter provided, 
the committee shall, after independent study of the data 
submitted to it by the Administrator and other data before it, 
certify to the Administrator a report and recommendations on 
the proposal together with all underlying data and a statement 
of the reasons or basis for the recommendations. The sixty-day 
period provided for herein may be extended by the advisory 
committee for an additional thirty days if the advisory 
committee deems this necessary. Within thirty days after such 
certification, the Administrator may, after giving due 
consideration to all data before him, including such report, 
recommendations, underlying data and statement, by order 
publish a regulation establishing a tolerance for the pesticide 
chemical named in the proposal or exempting it from the 
necessity of a tolerance which shall become effective upon 
publication. Regulations issued under this subsection shall 
upon publication be subject to paragraph (5) of subsection (d).
  [(f) All data submitted to the Administrator or to an 
advisory committee in support of a petition under this section 
shall be considered confidential by the Administrator and by 
such advisory committee until publication of a regulation under 
paragraph (2) or (3) of subsection (d) of this section. Until 
such publication, such data shall not be revealed to any person 
other than those authorized by the Administrator or by an 
advisory committee in the carrying out of their official duties 
under this section.
  [(g) Whenever the referral of a petition or proposal to an 
advisory committee is requested under this section, or the 
Administrator otherwise deems such referral necessary, the 
Administrator shall forthwith appoint a committee of competent 
experts to review the petition or proposal and to make a report 
and recommendations thereon. Each such advisory committee shall 
be composed of experts, qualified in the subject matter of the 
petition and of adequately diversified professional background 
selected by the National Academy of Sciences and shall include 
one or more representatives from land-grant colleges. The size 
of the committee shall be determined by the Administrator. 
Members of an advisory committee shall receive compensation and 
travel expenses in accordance with subsection (b)(5)(D) of 
section 721. The members shall not be subject to any other 
provisions of law regarding the appointment and compensation of 
employees of the United States. The Administrator shall furnish 
the committee with adequate clerical and other assistance, and 
shall by rules and regulations prescribe the procedures to be 
followed by the committee.
  [(h) A person who has filed a petition or who has requested 
the referral of a proposal to an advisory committee in 
accordance with the provision of this section, as well as 
representatives of the Department of Health and Human Services, 
shall have the right to consult with any advisory committee 
provided for in subsection (g) in connection with the petition 
or proposal.
  [(i)(1) In a case of actual controversy as to the validity of 
any order under subsection (d)(5), (e), or (l) any person who 
will be adversely affected by such order may obtain judicial 
review by filing in the United States Court of Appeals for the 
circuit wherein such person resides or has his principal place 
of business, or in the United States Court of Appeals for the 
District of Columbia Circuit, within 60 days after entry of 
such order, a petition praying that the order be set aside in 
whole or in part.
  [(2) In the case of a petition with respect to an order under 
subsection (d)(5) or (e), a copy of the petition shall be 
forthwith transmitted by the clerk of the court to the 
Administrator, or any officer designated by him for that 
purpose, and thereupon the Administrator shall file in the 
court the record of the proceedings on which he based his 
order, 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 the order 
complained of in whole or in part. The findings of the 
Administrator with respect to questions of fact shall be 
sustained if supported by substantial evidence when considered 
on the record as a whole, including any report and 
recommendation of an advisory committee.
  [(3) In the case of a petition with respect to an order under 
subsection (l), a copy of the petition shall be forthwith 
transmitted by the clerk of the court to the Secretary of 
Agriculture, or any officer designated by him for that purpose, 
and thereupon the Administrator shall file in the court the 
record of the proceedings on which he based his order, 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 the order complained of in 
whole or in part. The findings of the Administrator with 
respect to questions of fact shall be sustained if supported by 
substantial evidence when considered on the record as a whole.
  [(4) If application is made to the court for leave to adduce 
additional evidence, the court may order such additional 
evidence to be taken before the Administrator or the Secretary 
of Agriculture, as the case may be, and to be adduced upon the 
hearing in such manner and upon such terms and conditions as to 
the court may seem proper, if such evidence is material and 
there were reasonable grounds for failure to adduce such 
evidence in the proceedings below. The Administrator or the 
Secretary of Agriculture, as the case may be, may modify his 
findings as to the facts and order by reason of the additional 
evidence so taken, and shall file with the court such modified 
findings and order.
  [(5) The judgment of the court affirming or setting aside, in 
whole or in part, any order under this section shall be final, 
subject to review by the Supreme Court of the United States 
upon certiorari or certification as provided in section 1254 of 
title 28 of the United States Code. The commencement of 
proceedings under this section shall not, unless specifically 
ordered by the court to the contrary, operate as a stay of an 
order.
  [(j) 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 his own initiative, establish a 
temporary tolerance for the pesticide chemical for the uses 
covered by the permit whenever in his judgment such action is 
deemed necessary to protect the public health, or may 
temporarily exempt such pesticide chemical from a tolerance. In 
establishing such a tolerance, the Administrator shall give due 
regard to the necessity for experimental work in developing an 
adequate, wholesome, and economical food supply and to the 
limited hazard to the public health involved in such work when 
conducted in accordance with applicable regulations under the 
Federal Insecticide, Fungicide, and Rodenticide Act.
  [(k) Regulations affecting pesticide chemicals in or on raw 
agricultural commodities which are promulgated under the 
authority of section 406(a) upon the basis of public hearings 
instituted before January 1, 1953, in accordance with section 
701(e), shall be deemed to be regulations under this section 
and shall be subject to amendment or repeal as provided in 
subsection (m).
  [(l) The Secretary of Agriculture, upon request of any person 
who has registered, or who has submitted an application for the 
registration of, a pesticide under the Federal Insecticide, 
Fungicide, and Rodenticide Act, and whose request is 
accompanied by a copy of a petition filed by such person under 
subsection (d)(1) with respect to a pesticide chemical which 
constitutes, or is an ingredient of, such [a pesticide], shall, 
within thirty days or within sixty days if upon notice prior to 
the termination of such thirty days the Administrator deems it 
necessary to postpone action for such period, on the basis of 
data before him, either--
          [(1) certify to the Administrator  that such 
        pesticide chemical is useful for the purpose for which 
        a tolerance or exemption is sought; or
          [(2) notify the person requesting the certification 
        of his proposal to certify that the pesticide chemical 
        does not appear to be useful for the purpose for which 
        a tolerance or exemption is sought, or appears to be 
        useful for only some of the purposes for which a 
        tolerance or exemption is sought.
In the event that the Secretary of Agriculture takes the action 
described in clause (2) of the preceding sentence, the person 
requesting the certification, within one week after receiving 
the proposed certification, may either (A) request the 
Secretary of Agriculture to certify to the Administrator \1\ on 
the basis of the proposed certification; (B) request a hearing 
on the proposed certification or the parts thereof objected to; 
or (C) request both such certification and such hearing. If no 
such action is taken, the Administrator may by order make the 
certification as proposed. In the event that the action 
described in clause (A) or (C) taken, the Administrator shall 
by order make the certification as proposed with respect to 
such parts thereof as are requested. In the event a hearing is 
requested, the Secretary of Agriculture shall provide 
opportunity for a prompt hearing. The certification of the 
Secretary of Agriculture as the result of such hearing shall be 
made by order and shall be based only on substantial evidence 
of record at the hearing and shall set forth detailed findings 
of fact. In no event shall the time elapsing between the making 
of a request for a certification under this subsection and 
final certification by the Secretary of Agriculture exceed one 
hundred and sixty days. The Administrator shall submit to the 
Administrator with any certification of usefulness under this 
subsection an opinion, based on the data before him, whether 
the tolerance or exemption proposed by the petitioner 
reasonably reflects the amount of residue likely to result when 
the pesticide chemical is used in the manner proposed for the 
purpose for which the certification is made. The Secretary of 
Agriculture, after due notice and opportunity for public 
hearing, is authorized to promulgate rules and regulations for 
carrying out the provisions of this subsection.
  [(m) The Administrator shall prescribe by regulations the 
procedure by which regulations under this section may be 
amended or repealed, and such procedure shall conform to the 
procedure provided in this section for the promulgation of 
regulations establishing tolerances, including the appointment 
of advisory committees and the procedure for referring 
petitions to such committees.
  [(n) The provisions of section 303(c) with respect to the 
furnishing of guaranties shall be applicable to raw 
agricultural commodities covered by this section.
  [(o) 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 Secretary's functions under this section. 
Under such regulations, the performance of the Secretary's 
services or other functions pursuant to this section, including 
any one or more of the following, may be conditioned upon the 
payment of such fees: (1) the acceptance of filing of a 
petition submitted under subsection (d); (2) the promulgation 
of a regulation establishing a tolerance, or an exemption from 
the necessity of a tolerance, under this section, or the 
amendment or repeal of such a regulation; (3) the referral of a 
petition or proposal under this section to an advisory 
committee; (4) the acceptance for filing of objections under 
subsection (d)(5); or (5) the certification and filing in court 
of a transcript of the proceedings and the record under 
subsection (i)(2). Such regulations may further provide for 
waiver or refund of fees in whole or in part when in the 
judgment of the Administrator such waiver or refund is 
equitable and not contrary to the purposes of this subsection.]


       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 subsections (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), (c)(2), (d), and (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.
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