[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 331 Introduced in Senate (IS)]

103d CONGRESS
  1st Session
                                 S. 331

    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
  authority under that Act to regulate pesticide chemical residues in 
                                 food.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

             February 4 (legislative day, January 5), 1993

  Mr. Kennedy introduced the following bill; which was read twice and 
         referred to the Committee on Labor and Human Resources

_______________________________________________________________________

                                 A BILL


 
    To amend the Federal Food, Drug, and Cosmetic Act to revise the 
  authority under that Act to regulate pesticide chemical residues in 
                                 food.

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

SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Pesticide Food 
Safety Act of 1993''.
    (b) Reference.--Whenever in this Act 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 (21 U.S.C. 
301 et seq.).
    (c) Table of Contents.--The table of contents of this Act is as 
follows:
Sec. 1. Short title; reference; table of contents.
Sec. 2. Definitions.
Sec. 3. Tolerances and exemptions for pesticide chemical residues.
Sec. 4. Evaluation of existing pesticide chemical residue tolerances 
                            and exemptions.
Sec. 5. Review of existing methods of analysis.
Sec. 6. Fees.
Sec. 7. General definitions.

SEC. 2. DEFINITIONS.

    (a) Pesticide.--
            (1) Pesticide chemical.--Section 201(q) (21 U.S.C. 321(q)) 
        is amended to read as follows:
    ``(q)(1) The term `pesticide chemical' means--
            ``(A) any substance that is a pesticide, as defined in 
        section 2(u) of the Federal Insecticide, Fungicide, and 
        Rodenticide Act (7 U.S.C. 136(u)); and
            ``(B) each active ingredient and inert ingredient, as 
        defined in subsections (a) and (m), respectively, of section 2 
        of the Federal Insecticide, Fungicide, and Rodenticide Act, of 
        the pesticide.
    ``(2) The term `pesticide chemical residue' means a residue in or 
on food of--
            ``(A) any pesticide chemical; or
            ``(B) any other substance that is present in the commodity 
        or food as a result of the metabolism or other degradation of a 
        pesticide chemical,
regardless of whether the residue may be detected.''.
            (2) Person.--Section 201(s) (21 U.S.C. 321(s)) is amended--
                    (A) by striking paragraphs (1) and (2) and 
                inserting the following:
            ``(1) pesticide chemical residue; or''; and
                    (B) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (2), (3), and (4), respectively.
    (b) Conforming Amendments.--
            (1) Section 201 (21 U.S.C. 321) is amended by adding at the 
        end the following:
            ``(gg) The term `processed food' means any food that has 
        been subject to processing from a raw agricultural commodity.
            ``(hh) The term `Administrator' means the Administrator of 
        the Environmental Protection Agency.''.
            (2) Section 402(a)(2) (21 U.S.C. 342(a)(2)) is amended--
                    (A) in clause (A)(i), to read as follows: ``(i) a 
                pesticide chemical residue'';
                    (B) in clause (B), to read as follows: ``(B) if it 
                is, or it bears or contains, a pesticide chemical 
                residue unsafe within the meaning of section 408(a);''; 
                and
                    (C) in clause (C)--
                            (i) by striking ``: Provided, That where a 
                        pesticide chemical'' and inserting ``, except 
                        that if a pesticide chemical''; and
                            (ii) by striking ``sections 406 and 409'' 
                        and inserting ``section 406''.

SEC. 3. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

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

``SEC. 408. TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES.

    ``(a) Requirement for Tolerance or Exemption.--
            ``(1) General rule.--Any pesticide chemical residue shall 
        be deemed unsafe for the purpose of section 402(a)(2)(B) 
        unless--
                    ``(A) a tolerance for such residue is in effect 
                under this section and the quantity of such residue is 
                within the limits of such tolerance; or
                    ``(B) an exemption for such residue is in effect 
                under this section and such residue complies with such 
                exemption.
            ``(2) Effect of a 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, such food shall not be reason of 
        bearing or containing any amount of such residue be considered 
        to be adulterated within the meaning of section 402(a)(1).
    ``(b) Tolerances.--
            ``(1) Authority.--
                    ``(A) In general.--The Administrator may promulgate 
                regulations establishing, modifying, or revoking a 
                tolerance for a pesticide chemical residue--
                            ``(i) in response to a petition filed under 
                        subsection (d)(1); or
                            ``(ii) on the initiative of the 
                        Administrator under subsection (d)(4).
                    ``(B) Expiration date.--A regulation under this 
                paragraph may provide for an expiration date for the 
                tolerance.
                    ``(C) Separate tolerances.--The Administrator may 
                establish a separate tolerance under subparagraph (A) 
                for a pesticide chemical residue with respect to food 
                at each of the following times:
                            ``(i) At the time the food is harvested.
                            ``(ii) At the time the food is purchased at 
                        retail.
                            ``(iii) After the food is processed.
            ``(2) Standard.--
                    ``(A) General rule.--Except as provided in 
                subparagraph (F)--
                            ``(i) a tolerance may be established for a 
                        pesticide chemical residue only if the risk to 
                        human health from dietary exposure to the 
                        pesticide chemical residue is negligible; and
                            ``(ii) the tolerance for a pesticide 
                        chemical residue shall be revoked or modified 
                        unless the risk to human health from dietary 
                        exposure to the pesticide chemical residue is 
                        negligible.
                    ``(B) Negligible risk.--
                            ``(i) General rule.--For purposes of this 
                        paragraph, a risk to human health from dietary 
                        exposure to a pesticide chemical residue is 
                        negligible only if dietary exposure to the 
                        residue is reasonably certain to cause no harm 
                        to human health and the tolerance for such 
                        residue meets the requirements of clause (ii) 
                        or (iii).
                            ``(ii) Threshold pesticides.--
                                    ``(I) In general.--If the 
                                Administrator is able to identify a 
                                level at which a pesticide chemical 
                                residue will not cause or contribute to 
                                any known or anticipated harm to human 
                                health, the Administrator may establish 
                                or leave in effect a level for a 
                                tolerance for such residue only if the 
                                Administrator finds that such tolerance 
                                will provide an ample margin of safety, 
                                for each population group set out in 
                                subparagraph (E).
                                    ``(II) Considerations.--The level 
                                described in subclause (I) shall be 
                                based on consideration of--
                                            ``(aa) the nature of the 
                                        toxic effects caused by such 
                                        residue and data regarding the 
                                        prevalence of the same effects 
                                        caused by other chemicals;
                                            ``(bb) the validity, 
                                        completeness, and the 
                                        reliability of the data about 
                                        the pesticide chemical residue;
                                            ``(cc) the variability of 
                                        individual sensitivities and 
                                        the sensitivities of population 
                                        subgroups to the adverse 
                                        effects from such residue; and
                                            ``(dd) the possibility that 
                                        human susceptibility to such 
                                        adverse effects is 
                                        significantly greater than that 
                                        of test animals.
                                    ``(III) Margin of safety.--For 
                                purposes of this clause, a margin of 
                                safety for a level of a pesticide 
                                chemical residue is not ample unless 
                                human exposure per unit of body 
                                measurement, to the pesticide chemical 
                                residue and other chemicals that cause 
                                the same effect, is at least 100 times 
                                less than the no observable effect 
                                level in animals on which the pesticide 
                                chemical residue was tested, and, if 
                                human data are available, at least 10 
                                times less than the no observable 
                                effect level in humans exposed to such 
                                residue. The no observable effect level 
                                is the level of exposure to a pesticide 
                                chemical that reliable data, derived 
                                from exposure of humans or animals to 
                                the pesticide chemical, demonstrate 
                                will cause no adverse effect.
                            ``(iii) Nonthreshold pesticides.--If the 
                        Administrator is not able to identify a level 
                        at which a pesticide chemical residue will not 
                        cause or contribute to any known or anticipated 
                        harm to human health or if the Administrator 
                        finds that a pesticide chemical residue causes 
                        cancer in animals or humans, the Administrator 
                        may establish a level for a tolerance for such 
                        residue or leave a level in effect for such 
                        residue only if the Administrator finds that 
                        such level--
                                    ``(I) will not cause or contribute 
                                to, in individuals exposed to such 
                                pesticide chemical residue, a lifetime 
                                risk of an adverse human health effect 
                                that occurs at a rate of one in a 
                                million or a risk of an adverse human 
                                health effect that occurs at a rate of 
                                one in a million, divided by 70, for 
                                any single year of exposure during the 
                                first 5 years of the life of an exposed 
                                person, using conservative risk 
                                assessment models;
                                    ``(II) is the lowest level 
                                reasonably required to allow the 
                                accomplishment of the physical or other 
                                technical effect for which the use of 
                                the pesticide chemical involved is 
                                intended; and
                                    ``(III) in the case of processed 
                                food, is the lowest level that occurs 
                                if such pesticide chemical residue is 
                                removed to the extent possible in 
                                accordance with good manufacturing 
                                practice.
                    ``(C) Exposure.--Except as provided in subparagraph 
                (D), in determining dietary exposure to a pesticide 
                chemical residue for purposes of this paragraph, the 
                Administrator shall--
                            ``(i)(I) use only reliable, statistically 
                        significant data regarding the dietary exposure 
                        to persons who have consumed the food for which 
                        the tolerance for the residue is proposed or is 
                        in effect;
                            ``(II) take into account all other 
                        tolerances in effect for the same pesticide 
                        chemical residue; and
                            ``(III) take into account all other sources 
                        (including drinking water if data demonstrating 
                        widespread or significant regional 
                        contamination in drinking water are available) 
                        of dietary exposure to the same pesticide 
                        chemical residue; and
                            ``(ii) consider the exposure to be the 
                        level of exposure that would occur if--
                                    ``(I) all of the food, for which 
                                the tolerance for the pesticide 
                                chemical residue is proposed or in 
                                effect, has amounts of the pesticide 
                                chemical residue equal to the tolerance 
                                proposed or in effect;
                                    ``(II) all other sources of dietary 
                                exposure to such residue described in 
                                clause (i)(III) occur; and
                                    ``(III) human exposure to the 
                                pesticide chemical residue at the 
                                tolerance level occurs for a period 
                                equal to a lifetime.
                    ``(D) Special exposure rule.--
                            ``(i) Date.--The Administrator may 
                        calculate dietary exposure to a food based on 
                        reliable data that provide the Administrator 
                        with a valid statistical basis to identify the 
                        percentage of the food in which the pesticide 
                        chemical residue actually occurs.
                            ``(ii) Percentage.--Such percentage shall 
                        be not less than the percentage of the food 
                        consumed in an appropriate locality, identified 
                        by the Administrator, which percentage 
                        represents the highest level of exposure to 
                        such residue in the United States.
                            ``(iii) Reevaluation.--The Administrator 
                        shall reevaluate the determination under this 
                        subparagraph every 2 years after the date of 
                        the determination. If, under such a 
                        reevaluation, the Administrator finds that the 
                        determination is not justified, the 
                        Administrator shall promptly issue a regulation 
                        requiring that the tolerance involved be set on 
                        the basis of the new determination.
                    ``(E) Population covered.--In determining if the 
                dietary exposure to a pesticide chemical residue is 
                negligible, the Administrator shall evaluate the risk 
                to--
                            ``(i) infants of the age 0 to 1;
                            ``(ii) children of the age 1 to 2;
                            ``(iii) children of the age 2 to 3;
                            ``(iv) children of the age 3 to 4;
                            ``(v) children of the age 4 to 5;
                            ``(vi) children of the age 6 to 10;
                            ``(vii) adolescents of the age 11 to 18;
                            ``(viii) other population groups that have 
                        been identified by the Administrator to have 
                        special food consumption patterns or for which 
                        data are sufficient to demonstrate special food 
                        consumption patterns; and
                            ``(ix) the entire population, who consume 
                        food with such pesticide chemical residue.
                    ``(F) Unavoidable persistence.--If a tolerance or 
                an exemption from the requirement for a tolerance for a 
                pesticide chemical residue is revoked and the 
                Administrator finds the pesticide chemical residue will 
                unavoidably persist in the environment and contaminate 
                food, the Administrator shall establish a new tolerance 
                under subsection (d)(4) for the pesticide chemical 
                residue. The level permitted by the tolerance shall not 
                be greater than the lowest level that permits only such 
                unavoidable levels to remain in food. The Administrator 
                shall evaluate any such tolerance at least once a year 
                to determine whether modification of such tolerance is 
                necessary so that the tolerance provides only for the 
                level of the pesticide chemical residue that is 
                unavoidable.
                    ``(G) Practical methods of analysis.--
                            ``(i) General rule.--A tolerance for a 
                        pesticide chemical residue shall not be 
                        established or allowed to remain in effect 
                        unless the Administrator determines, after 
                        consultation with the Secretary, that--
                                    ``(I) there is a method for 
                                detecting and measuring the levels of 
                                such pesticide chemical residue in or 
                                on a food that will detect the residue 
                                at the level established by the 
                                tolerance; and
                                    ``(II) except as provided in clause 
                                (ii), such method is the best 
                                available, practical method.
                            ``(ii) Special rule.--If the Administrator 
                        determines that a practical method of analysis 
                        for a pesticide chemical residue is not 
                        available, the Administrator shall identify the 
                        best available method that is designed to 
                        identify the lowest detectable amount of the 
                        pesticide chemical residue. The Administrator 
                        shall, every 2 years after the date of the 
                        determination under this clause, reevaluate the 
                        determination.
                            ``(iii) Practical method.--A method shall 
                        be considered practical for purposes of this 
                        subparagraph only if it is a multiresidue 
                        method that can be performed by the Secretary 
                        on a routine basis as part of surveillance and 
                        compliance sampling of foods for pesticide 
                        chemical residues with the personnel, 
                        equipment, and other resources available to the 
                        Secretary, or, if no multiresidue method is 
                        available, only if it can be so performed by 
                        the Secretary.
                    ``(3) Consistent application.--The Administrator 
                shall issue guidelines providing for the consistent 
                application of the requirements of paragraphs (1) and 
                (2).
    ``(c) Exemptions.--
            ``(1) Authority.--
                    ``(A) In general.--The Administrator may promulgate 
                regulations establishing or revoking an exemption from 
                the requirement for a tolerance for a pesticide 
                chemical residue--
                            ``(i) in response to a petition filed under 
                        subsection (d)(1); or
                            ``(ii) on the initiative of the 
                        Administrator under subsection (d)(4).
                    ``(B) Expiration date.--Such a regulation may 
                provide for an expiration date for the exemption.
            ``(2) Standard.--
                    ``(A) Authority and risk standard.--
                            ``(i) Establishment.--An exemption may be 
                        established for a pesticide chemical residue if 
                        such residue is not a human or animal 
                        carcinogen and otherwise presents no risk to 
                        human health, including the health of 
                        individuals in the population groups set out in 
                        subsection (b)(2)(E), from dietary exposure to 
                        such residue.
                            ``(ii) Revocation.--An exemption shall be 
                        revoked unless the residue is not a human or 
                        animal carcinogen and the residue does not 
                        present any risk to human health, including the 
                        health of individuals in the population groups 
                        set out in subsection (b)(2)(E), from dietary 
                        exposure to such residue.
                            ``(iii) Tolerance.--No exemption may be 
                        established or allowed to remain in effect for 
                        a pesticide chemical residue for which there is 
                        in effect a tolerance.
                    ``(B) Exposure.--For purposes of subparagraph (A), 
                in determining dietary exposure to a pesticide chemical 
                residue, the Administrator shall--
                            ``(i) use only reliable, statistically 
                        significant data regarding the dietary exposure 
                        resulting from the consumption of the food for 
                        which the exemption for such residue is 
                        proposed or is in effect;
                            ``(ii) take into account all other 
                        exemptions in effect for such residue and all 
                        other sources (including drinking water if data 
                        demonstrating widespread or significant 
                        regional contamination in drinking water are 
                        available) of dietary exposure to such residue; 
                        and
                            ``(iii) consider the exposure to be the 
                        level of exposure that would occur if--
                                    ``(I) all the food, for which the 
                                tolerance for such residue is proposed 
                                or in effect, has amounts of such 
                                residue equal to the tolerance proposed 
                                or in effect, respectively;
                                    ``(II) all other sources of dietary 
                                exposure to such residue described in 
                                clause (ii) occur; and
                                    ``(III) human exposure to the 
                                pesticide chemical residue at the 
                                tolerance level occurs for a period 
                                equal to a lifetime.
                    ``(C) Practical methods of analysis.--An exemption 
                for a pesticide chemical residue shall not be 
                established or allowed to remain in effect unless the 
                Administrator determines, after consultation with the 
                Secretary, that there is a method for detecting and 
                measuring the levels of such pesticide chemical residue 
                on a food and that such method is the best available, 
                practical method, as defined in subsection (b)(2)(G).
            ``(3) Consistent application.--The Administrator shall 
        issue guidelines providing for the consistent application of 
        the requirements of paragraphs (1) and (2).
    ``(d) Petitions and Action on the Initiative of the 
Administrator.--
            ``(1) General rule for petitions.--Any person may file with 
        the Administrator a petition proposing the issuance of a 
        regulation establishing, modifying, or revoking a tolerance or 
        exemption for a pesticide chemical residue.
            ``(2) Requirements for petitions to establish a tolerance 
        or exemption.--
                    ``(A) Contents.--A petition under paragraph (1) to 
                establish a tolerance or exemption for a pesticide 
                chemical residue shall contain--
                            ``(i) an informative summary of the 
                        petition and of the data, information, and 
                        arguments submitted or cited in support of the 
                        petition, including--
                                    ``(I) a summary of the reports 
                                required under clause (iv) respecting 
                                the safety of the pesticide chemical 
                                residue; and
                                    ``(II) a characterization of--
                                            ``(aa) the exposure to the 
                                        pesticide chemical residue due 
                                        to any tolerance or exemption 
                                        already granted for such 
                                        residue; and
                                            ``(bb) the additional 
                                        exposure to such residue that 
                                        would result if the requested 
                                        tolerance or exemption were 
                                        granted;
                            ``(ii) a proposed tolerance for such 
                        residue, if a tolerance is proposed;
                            ``(iii) the name, chemical identity, and 
                        composition of the pesticide chemical that 
                        produces such residue;
                            ``(iv) reports of tests and investigations 
                        made with respect to the safety of such 
                        pesticide chemical, including complete 
                        information as to the methods and controls used 
                        in conducting such tests and investigations;
                            ``(v) data showing the amount, frequency, 
                        method, and time of application of such 
                        pesticide chemical;
                            ``(vi) 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 food when ready for sale to 
                        consumers, including a description of the 
                        analytical methods used;
                            ``(vii) a description of methods for 
                        detecting and measuring the levels of such 
                        pesticide chemical residue in or on the food, 
                        which methods meet the requirements of 
                        subsection (b)(2)(G) or (c)(2)(C);
                            ``(viii) reports of investigations 
                        conducted on the effects of processing methods 
                        used to produce food on the level and identity 
                        of such pesticide chemical residue;
                            ``(ix) if the petition is for a pesticide 
                        chemical residue that is described in 
                        subsection (b)(2)(B)(iii), all relevant data 
                        bearing on the physical or other technical 
                        effect the pesticide chemical involved is 
                        intended to have and the quantity of the 
                        pesticide chemical residue required to 
                        accomplish such effect; and
                            ``(x) such other data and information 
                        (including a sample of the pesticide chemical 
                        from which the pesticide chemical residue is 
                        derived) as the Administrator may require to 
                        support the petition.
                    ``(B) Information available to administrator.--If 
                information or data required by this paragraph are 
                available to the Administrator, the person submitting 
                the petition may, in lieu of submitting the information 
                or data, cite the availability of the information or 
                data.
            ``(3) Actions on petitions.--
                    ``(A) Notice.--
                            ``(i) In general.--Within 45 days of the 
                        filing of a petition under paragraph (1) for 
                        the establishment of a tolerance or an 
                        exemption, the Administrator shall determine if 
                        the petition complies with the requirements of 
                        paragraph (2). If the Administrator determines 
                        that the petition complies with such 
                        requirements, the Administrator shall publish a 
                        notice of the filing of the petition. If the 
                        Administrator determines that the petition does 
                        not comply with such requirements, the 
                        Administrator shall notify the petitioner of 
                        such determination.
                            ``(ii) Contents.--A notice published under 
                        this subparagraph shall--
                                    ``(I) announce the availability of 
                                a complete 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;
                                    ``(II) include the summary required 
                                by paragraph (2)(A)(i); and
                                    ``(III) provide at least 30 days 
                                for comments on the petition.
                    ``(B) Action.--The Administrator shall, within 270 
                days of the publication of a notice under subparagraph 
                (A) with respect to a petition, and after giving due 
                consideration to the petition, any comments on the 
                petition, and any other information available to the 
                Administrator--
                            ``(i) issue a final regulation in 
                        accordance with the petition establishing a 
                        tolerance or exemption for the pesticide 
                        chemical residue;
                            ``(ii) issue a proposed regulation 
                        establishing a tolerance or exemption for the 
                        pesticide chemical residue, which tolerance or 
                        exemption is different from the tolerance or 
                        exemption requested in the petition; or
                            ``(iii) issue an order denying the 
                        petition.
                    ``(C) Modification or revocation.--
                            ``(i) Notice.--Within 45 days of the filing 
                        of a petition under paragraph (1) for the 
                        modification or revocation of a tolerance or 
                        exemption, the Administrator shall publish a 
                        notice of the filing of the petition. Such 
                        notice shall contain the full petition or a 
                        summary of the petition and shall provide at 
                        least 30 days for comments on the petition.
                            ``(ii) Action.--The Administrator shall, 
                        within 270 days of the publication of the 
                        notice under subparagraph (A) and after giving 
                        due consideration to the petition, any comments 
                        on the petition, and any other information 
                        available to the Administrator--
                                    ``(I) issue a final regulation in 
                                accordance with the petition modifying 
                                or revoking a tolerance or exemption 
                                for the pesticide chemical residue;
                                    ``(II) issue a proposed regulation 
                                modifying or revoking a tolerance or 
                                exemption for the pesticide chemical 
                                residue, which tolerance or exemption 
                                is different from the modification or 
                                revocation requested in the petition; 
                                or
                                    ``(III) issue an order denying the 
                                petition.
                    ``(D) Comments and final regulations.--If the 
                Administrator issues a proposed regulation under 
                subparagraph (B)(ii) or (C)(ii)(II), the Administrator 
                shall allow at least 30 days for comments on such 
                proposed regulations. The Administrator shall issue a 
                final decision within 180 days of the date of the 
                publication of the proposed regulations.
                    ``(E) Priorities.--The Administrator shall give 
                priority to petitions for the establishment of a 
                tolerance 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.
            ``(4) Action on the initiative by the administrator.--
                    ``(A) General rule.--The Administrator may, on the 
                initiative of the Administrator, issue a final 
                regulation establishing, modifying, or revoking a 
                tolerance or exemption for a pesticide chemical 
                residue.
                    ``(B) Notice.--Before issuing a final regulation 
                under subparagraph (A), the Administrator shall issue a 
                notice of proposed rulemaking and provide a period of 
                not less than 30 days for public comment on the 
                proposed regulation unless the Administrator finds that 
                it would be contrary to the public interest to issue 
                the notice and provide the period and states the 
                reasons for the finding in the notice of the final 
                regulation.
            ``(5) Effective date.--
                    ``(A) General rule.--Except as provided in 
                subparagraph (B), a final regulation issued under 
                paragraph (3) or (4) shall take effect upon 
                publication.
                    ``(B) Delay.--
                            ``(i) General rule.--If a regulation issued 
                        under paragraph (3) or (4) revokes or modifies 
                        a tolerance for a pesticide chemical residue or 
                        revokes an exemption for a pesticide chemical 
                        residue, the Administrator may, in accordance 
                        with clause (ii), delay the effective date of 
                        the regulation to permit the tolerance of 
                        exemption to remain in effect at the level in 
                        effect immediately before such regulation is 
                        issued only--
                                    ``(I) for foods that, on the date 
                                of the publication of the regulation, 
                                contain such pesticide chemical residue 
                                in an amount that is not more than the 
                                amount that could legally be applied on 
                                the date the Administrator acted under 
                                paragraph (3) or (4); and
                                    ``(II) if dietary exposure to the 
                                pesticide chemical residue in or on the 
                                foods described in subclause (I) meets 
                                the negligible risk standard prescribed 
                                by subsection (b)(2) during the period 
                                of delay of the effective date.
                            ``(ii) Period of delay.--If the 
                        Administrator finds that delay of the effective 
                        date of such a revocation or modification is 
                        consistent with the public health, the 
                        Administrator may delay such date under clause 
                        (i), for each type of food that contains such 
                        pesticide chemical residue, for the period that 
                        is required for such food to be sold to 
                        consumers in the course of the usual practice 
                        for persons engaged in the production, 
                        processing, transportation, storage, and 
                        distribution of the type of food.
    ``(e) Special Data Requirements.--
            ``(1) Determination of inadequate data.--The Administrator 
        shall take the action described in paragraph (2) if a tolerance 
        or exemption is in effect for a pesticide chemical residue and 
        the Administrator determines that data contained in the 
        petition, which had been submitted, under subsection (d)(1) for 
        establishment of the tolerance or exemption, or under this 
        section, before the date of the enactment of the Pesticide Food 
        Safety Act of 1993, are not adequate to support the 
        continuation of such tolerance or exemption because--
                    ``(A) based on the data contained in the petition 
                and other data available to the Administrator, the 
                Administrator determines that dietary exposure to such 
                pesticide chemical residue may present a risk to human 
                health that is greater than the standard prescribed by 
                subsection (b)(2) or (c)(2); or
                    ``(B) the data contained in the petition are 
                insufficient to determine if the tolerance or exemption 
                meets the requirements of subsection (b)(2) or (c)(2) 
                or the requirements of subsection (d)(2).
            ``(2) Action by administrator.--When the Administrator 
        makes the determination described in paragraph (1) with respect 
        to a tolerance or exemption for a pesticide chemical residue, 
        the Administrator shall--
                    ``(A) within 30 days of a determination under 
                paragraph (1)(A), initiate an action under subsection 
                (d)(4) to modify or revoke the tolerance or exemption 
                so that the tolerance or exemption meets the standard 
                prescribed by subsection (b)(2) or (c)(2), and within 1 
                year of such determination issue a final regulation to 
                complete such action; and
                    ``(B) within 30 days of the date of a determination 
                under paragraph (1)(B), require the submission of data 
                to support--
                            ``(i) the existing tolerance or exemption; 
                        or
                            ``(ii) a new tolerance or exemption for 
                        such residue,
                that meets the standard prescribed by subsection (b)(2) 
                or (c)(2).
            ``(3) Submission of required data.--When the Administrator 
        requires the submission of data under paragraph (2)(B), the 
        Administrator shall publish an order--
                    ``(A) requiring one or more interested persons to 
                notify the Administrator that such person will submit 
                the required data;
                    ``(B) describing the type of data required to be 
                submitted;
                    ``(C) describing the reports required to be made 
                during and after the collection of the data; and
                    ``(D) establishing deadlines for the actions 
                described in subparagraphs (A) and (C).
            ``(4) Deadlines.--
                    ``(A) General rule.--Except as provided in 
                subparagraphs (B) and (C), if an order is issued under 
                paragraph (3) with respect to a tolerance or exemption 
                and a deadline in the order is not met, the tolerance 
                or exemption is revoked, effective 45 days after the 
                date the deadline is not met. Immediately after such 
                deadline is not met, the Administrator shall publish a 
                notice of the revocation.
                    ``(B) Extension request.--
                            ``(i) Request.--Any person may request the 
                        Administrator to issue an order to extend the 
                        deadline established under paragraph (3)(D) 
                        before expiration of the deadline.
                            ``(ii) Grant of request.--The Administrator 
                        may grant such a request only if--
                                    ``(I) the person submitting the 
                                request notified the Administrator 
                                pursuant to paragraph (3)(A) in 
                                compliance with the deadline 
                                established under paragraph (3)(C); and
                                    ``(II) the Administrator finds that 
                                extraordinary circumstances beyond the 
                                control of such person prevented such 
                                person from submitting the required 
                                data.
                            ``(iii) Extension.--If the Administrator 
                        issues an order extending a deadline--
                                    ``(I) the Administrator may extend 
                                the deadline for a period no longer 
                                than such time as is necessary for such 
                                person to submit the data; and
                                    ``(II) the Administrator shall 
                                establish a new deadline in accordance 
                                with paragraph (3)(D).
                    ``(C) Delay.--If a tolerance or exemption is 
                revoked under subparagraph (A), the Administrator may 
                delay the effective date of the revocation in 
                accordance with subsection (d)(5)(B).
            ``(5) Evaluation of data.--Within 90 days of the date of 
        the receipt of data under paragraph (3), the Administrator 
        shall evaluate such data and determine whether action is 
        required under subsection (d)(4) with respect to the tolerance 
        or exemption for the pesticide chemical residue for which the 
        data were submitted so that such tolerance meets the negligible 
        risk standard prescribed under subsection (b)(2) or (c)(2). If 
        the Administrator determines that action under subsection 
        (d)(4) is required, the Administrator shall complete such 
        action within 1 year of the date of such determination.
    ``(f) Confidentiality of Data.--
            ``(1) General rule.--Data submitted to the Administrator in 
        support of a petition under subsection (d)(1), which data have 
        not previously been made available to the public without 
        restriction, shall, upon request of the petitioner, be 
        considered as entitled to confidential treatment by the 
        Administrator until publication of a regulation or order under 
        subsection (d)(3) in response to the petition unless disclosure 
        of such data is required by subsection (d)(3)(A)(ii)(II) or (g) 
        or is allowed by paragraph (2).
            ``(2) Disclosure.--Data that are entitled to confidential 
        treatment under paragraph (1) until publication of a regulation 
        or order under subsection (d)(3) may be revealed to--
                    ``(A) either House of Congress or any committee or 
                subcommittee of such House to the extent of matter 
                within the jurisdiction of the committee or 
                subcommittee;
                    ``(B) any officer or employee of the United States 
                in connection with the official duties of such officer 
                or employee under any law for the protection of health 
                or the environment or for specific law enforcement 
                purposes;
                    ``(C) any officer or employee of a State in 
                connection with the official duties of such officer or 
                employee under any law of the State for the protection 
                of health or the environment or for specific law 
                enforcement purposes; or
                    ``(D) contractors with the United States authorized 
                by the Administrator to examine such data in the 
                carrying out of contracts under such statutes under 
                such security requirements as the Administrator may 
                provide.
    ``(g) Access to Data in Support of Petition.--
            ``(1) General rule.--
                    ``(A) Public access.--If data in support of a 
                petition are submitted to the Administrator, the 
                Administrator, before acting on such petition, shall 
                provide, in accordance with this subsection, public 
                access to health and safety data that are submitted or 
                cited in support of such petition.
                    ``(B) Request.--To obtain access to such data, a 
                person shall, not later than 30 days after the 
                publication under subsection (d)(3)(A) of a notice of 
                the filing of a petition, send by certified mail to the 
                Administrator and to the petitioner a request for such 
                access and the affirmation required by paragraph (2).
                    ``(C) Grant of request.--The Administrator shall 
                grant such request unless, within 15 days after the 
                receipt by the Administrator of such request and 
                affirmation, the petitioner submits to the 
                Administrator an objection to the request asserting 
                that the affirmation is inaccurate and other reasons 
                for the objection.
                    ``(D) Objection.--If an objection to a request is 
                submitted to the Administrator within such 15-day 
                period, the Administrator shall determine whether to 
                grant the request within 5 days after the receipt of 
                the objection. If the Administrator determines to grant 
                the request, access shall not be permitted until 5 days 
                after the petitioner making the objection has been 
                notified that access has been granted.
                    ``(E) Denial of request.--If access to data is 
                denied, comments on the petition for which such data 
                were submitted or cited shall be filed within 30 days 
                after the decision of the Administrator denying access.
            ``(2) Restriction.--
                    ``(A) Affirmation.--Data referred to in paragraph 
                (1) may be made available only to a person who provides 
                an affirmation (and such supporting evidence as the 
                Administrator may require) that--
                            ``(i) states that the person is not engaged 
                        in, and is neither employed by, nor acting 
                        (directly or indirectly) on behalf of, any 
                        other person, or affiliate of a person, engaged 
                        in, the production, sale, or distribution of a 
                        pesticide chemical;
                            ``(ii) identifies any business, employer, 
                        or other person, if any, on whose behalf the 
                        person is requesting access to the data; and
                            ``(iii) states that the person will not 
                        intentionally or recklessly violate this 
                        subsection.
                    ``(B) Affiliate.--For purposes of this paragraph, 
                an affiliate of a person is a person who directly or 
                indirectly, through one or more intermediates, controls 
                or is controlled by or is under common control with the 
                other person.
                    ``(C) Fraud.--Section 1001 of title 18, United 
                States Code, shall apply to an affirmation made under 
                this paragraph.
            ``(3) Comments.--
                    ``(A) General rule.--Data supporting a petition may 
                be made available under paragraph (1) to a person only 
                for the purpose of permitting the person to comment to 
                the Administrator on such petition. Such comments may 
                reasonably quote data submitted to the Administrator. 
                No person, including the Administrator, may make such 
                comments public before the decision of the 
                Administrator on the petition for which such data were 
                submitted or after such decision if the petition is 
                denied.
                    ``(B) Restrictions.--A person who obtains data 
                (directly or indirectly) under paragraph (1) may not 
                publish, copy, or transfer the data to any other person 
                to obtain approval to sell, manufacture, or distribute 
                a pesticide chemical anywhere in the world.
            ``(4) Procedure.--
                    ``(A) In general.--Data made available under 
                paragraph (1) may be examined at an office of the 
                Environmental Protection Agency or an appropriate State 
                agency under the conditions prescribed by this 
                subsection and may not be removed from such office.
                    ``(B) Record.--The Administrator shall maintain a 
                record of the persons who inspect data. A copy of such 
                record shall be sent on request to the person who 
                submitted the data.
                    ``(C) Basis for comments.--Once access to data 
                supporting a petition is granted, the data may be 
                examined and notes may be taken for use in developing 
                comments on the petition. Such comments on the petition 
                shall be filed within 60 days after the decision of the 
                Administrator granting access, unless the comment 
                period is extended by the Administrator for an 
                additional 30 days for good cause.
    ``(h) Access to Data After Decision.--When the Administrator takes 
final action on a petition submitted under subsection (d)(1) or on the 
initiative of the Administrator under subsection (d)(4), the 
Administrator shall make available to the public the administrative 
record of the decision, including the data relied upon for the 
decision.
    ``(i) Existing Pesticide Chemical Residues.--
            ``(1) Pesticide chemical residues under regulations under 
        section 406.--Regulations affecting pesticide chemical residues 
        promulgated, in accordance with sections 701(e) and 406, upon 
        the basis of public hearings instituted before January 1, 1953, 
        shall be deemed to be tolerances issued under this section and 
        shall be subject to modification or revocation under subsection 
        (d) or (e).
            ``(2) Pesticide chemical residues under regulations.--
        Regulations establishing tolerances for pesticide chemical 
        residues under this section and section 409 or exemptions for 
        pesticide chemical residues under this section on or before the 
        date of the enactment of this section shall be deemed to be 
        tolerances or exemptions issued under this section and shall be 
        subject to modification or revocation under subsection (d) or 
        (e).
            ``(3) Generally recognized as safe pesticide chemical 
        residues.--
                    ``(A) General rule.--Pesticide chemical residues 
                that, on the day before the date of the enactment of 
                the Pesticide Food Safety Act of 1993, do not have 
                tolerances or exemptions from tolerances under this 
                section because the residues are generally recognized 
                as safe under this section or section 409 shall, until 
                the expiration of the period prescribed by subparagraph 
                (C), not be considered unsafe under section 
                402(a)(2)(B) solely because the chemicals do not have 
                such a tolerance or exemption.
                    ``(B) List.--Not later than 90 days after the date 
                of the enactment of such Act, the Administrator shall--
                            ``(i) publish a list of all pesticide 
                        chemical residues that the Administrator has 
                        determined are generally recognized, on the day 
                        before the date of the enactment of such Act, 
                        as safe under this section or section 409; and
                            ``(ii) require, by regulation, that any 
                        person who, before the date of the enactment of 
                        such Act, distributed in commerce as a 
                        pesticide chemical, a pesticide chemical that 
                        is not on the list described in clause (i), and 
                        that such person determined is generally 
                        recognized as safe under this section or 
                        section 409, shall--
                                    ``(I) report to the Administrator 
                                the identity of such pesticide 
                                chemical; and
                                    ``(II) report to the Administrator 
                                the data that supports the claim that 
                                the pesticide chemical is safe.
                    ``(C) Determination of the administrator.--Not 
                later than 270 days after such date, the Administrator 
                shall determine if each pesticide chemical reported to 
                the Administrator in accordance with subparagraph 
                (B)(ii) is generally recognized as safe. If the 
                Administrator determines, by order, that such pesticide 
                chemical is generally recognized as safe, the residue 
                of such pesticide chemical shall be considered a 
                pesticide chemical residue subject to an exemption 
                under this section, which exemption shall be subject to 
                modification or revocation under subsection (d) or (e).
    ``(j) Food and Drug Administration Monitoring of Pesticide Chemical 
Residues.--
            ``(1) Sampling.--The Secretary shall conduct surveillance 
        and compliance sampling of food for pesticide chemical residues 
        to determine if the pesticide chemical residues are in 
        compliance with this section. In carrying out this paragraph, 
        the Secretary shall give priority to foods that contain 
        pesticide chemical residues included in a notice under 
        paragraph (2).
            ``(2) Notification.--The Administrator shall notify the 
        Secretary of the pesticide chemical residues that the 
        Administrator determines, in the administration of this 
        section--
                    ``(A) are above the standard prescribed by 
                subsection (b)(2); or
                    ``(B) are not above such standard but that may 
                under certain circumstances reach or exceed such 
                standard.
    ``(k) Fees.--The Administrator shall by regulation require the 
payment of such fees as will in the aggregate, in the judgment of the 
Administrator, be sufficient over a reasonable term to provide, equip, 
and maintain an adequate service for the performance of the functions 
of the Administrator under this section. Under such regulations, the 
performance of the services or other functions of the Administrator 
under this section may be conditioned upon the payment of such fees. 
Such regulations may further provide that the continuation in effect of 
a tolerance or exemption shall be conditioned upon the payment of an 
annual fee and 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.
    ``(l) Judicial Review.--
            ``(1) Review.--Any person (including a person without an 
        economic interest) who may be adversely affected by a final 
        regulation or order issued under subsection (d)(3), (d)(4), 
        (e)(4), or (i)(3) may obtain judicial review of such regulation 
        or order by filing a petition requesting that the regulation or 
        order be set aside in whole or in part in the United States 
        Court of Appeals for the circuit in which such 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 the regulation or order under such 
        subsection.
            ``(2) Review of data.--
                    ``(A) In general.--Any person (including a person 
                without an economic interest) may obtain judicial 
                review, of the adequacy of the data made available by 
                the Administrator under subsection (h) to support the 
                issuance of a tolerance or exemption for a pesticide 
                chemical residue, by filing a petition for the review 
                of the data in the United States Court of Appeals for 
                the circuit in which such person resides or has its 
                principal place of business, or in the United States 
                Court of Appeals for the District of Columbia Circuit.
                    ``(B) Scope of review.--Review in a proceeding 
                initiated under this paragraph shall be limited to 
                whether the data under review are adequate to 
                demonstrate that the tolerance or exemption supported 
                by such data meets the standards required by subsection 
                (b)(2) or (c)(2) and interpreted by the guidelines 
                issued under subsection (b)(3) or (c)(3). Unless the 
                court determines that such data are adequate, the court 
                shall revoke the tolerance or exemption supported by 
                such data.
                    ``(C) Burden of proof.--In any such proceeding the 
                Administrator shall have the burden of proof on all 
                issues.
            ``(3) Court responsibility.--In any action seeking judicial 
        review of actions under this section, the court shall have the 
        principal responsibility for deciding issues of law.
            ``(4) Attorney fees.--Any petitioner who prevails in a 
        proceeding brought under this section shall be entitled to 
        recover reasonable attorney fees and expenses (including expert 
        witness fees.)
    ``(m) Definitions.--For purposes of this section, the terms 
`modify' and `modification' mean the lowering of a tolerance for a 
pesticide chemical residue.''.
    (b) Conforming Amendment.--Section 303 (21 U.S.C. 333) is amended 
by adding at the end the following:
    ``(g) A person who violates a tolerance established under section 
408(b)(2) for a food at the time the food is purchased at retail shall 
not be subject to any penalty under this section.''.

SEC. 4. EVALUATION OF EXISTING PESTICIDE CHEMICAL RESIDUE TOLERANCES 
              AND EXEMPTIONS.

    (a) Evaluation.--Within 1 year of the date of the enactment of this 
Act, the Administrator of the Environmental Protection Agency shall, 
for each pesticide chemical residue that has a tolerance or exemption 
in effect under the Federal Food, Drug, and Cosmetic Act, evaluate all 
available data with respect to the safety of such pesticide chemical 
residue and the nature and amount of such residue remaining in or on 
foods and determine if--
            (1) the tolerance or exemption meets the requirements of 
        subsection (b)(2) or (c)(2) of section 408 of such Act;
            (2) the tolerance or exemption does not meet such 
        requirements; or
            (3) the data are insufficient to determine if the tolerance 
        or exemption meets such requirements.
    (b) Sufficient Data.--
            (1) Acceptable risk data.--If, with respect to any 
        pesticide chemical residue that is evaluated under subsection 
        (a), the Administrator finds that data for the pesticide 
        chemical residue are sufficient to determine that the tolerance 
        or exemption for the pesticide chemical residue meets the 
        standard under section 408(b)(2) or 408(c)(2) of such Act, the 
        Administrator shall publish such finding.
            (2) Unacceptable risk data.--If, with respect to any 
        pesticide chemical residue that is evaluated under subsection 
        (a), the Administrator finds that data for the pesticide 
        chemical residue are sufficient to determine that the tolerance 
        or exemption for the pesticide chemical residue does not meet 
        the standard under section 408(b)(2) or 408(c)(2) of such Act, 
        the Administrator shall, within 1 year of the date of such 
        finding, modify or revoke the tolerance.
            (3) Insufficient data.--
                    (A) General rule.--
                            (i) Submission of data.--If, with respect 
                        to any pesticide chemical residue that is 
                        evaluated under subsection (a), the 
                        Administrator determines that the data are 
                        insufficient to determine whether the tolerance 
                        or exemption meets the requirements of section 
                        408(b)(2) or 408(c)(2) of such Act, the 
                        Administrator shall establish a schedule for 
                        the submission of data in accordance with the 
                        requirements of sections 408(e)(2)(B) and 
                        408(e)(3) of such Act, which data shall be the 
                        basis for a determination by the Administrator 
                        as to whether the tolerance or exemption meets 
                        the standard prescribed by section 408(b)(2) or 
                        408(c)(2) of such Act.
                            (ii) Determinations.--The Administrator 
                        shall--
                                    (I) within 2 years of the date of 
                                the enactment of this Act, make such a 
                                determination respecting a tolerance or 
                                exemption meeting a standard under 
                                section 408 of such Act for at least 30 
                                percent of the tolerances or exemptions 
                                in effect for pesticide chemical 
                                residues in existence on such date;
                                    (II) within 4 years of the date of 
                                the enactment of this Act, make such a 
                                determination for at least 60 percent 
                                of the tolerances or exemptions in 
                                effect for pesticide chemical residues 
                                in existence on such date;
                                    (III) within 6 years of the date of 
                                the enactment of this Act, make such a 
                                determination for at least 90 percent 
                                of the tolerances or exemptions in 
                                effect for pesticide chemical residues 
                                in existence on such date; and
                                    (IV) within 7 years of the date of 
                                the enactment of this Act, make such a 
                                determination for 100 percent of the 
                                tolerances or exemptions in effect for 
                                pesticide chemical residues in 
                                existence on such date.
                            (iii) Deadlines.--Section 408(e)(4) of such 
                        Act shall apply to the deadlines established by 
                        such schedule.
                    (B) Priorities.--In establishing such schedule, the 
                Administrator shall give priority to the consideration 
                of any pesticide chemical residue for which there is 
                reason to believe that the tolerance or exemption in 
                effect for such residue may present a risk greater than 
                the negligible risk standard prescribed by section 
                408(b)(2) or 408(c)(2) of such Act.
                    (C) Action by the administrator.--If the 
                Administrator determines under subparagraph (A) that a 
                tolerance or exemption does not meet the standard under 
                section 408(b)(2) or 408(c)(2) of such Act after the 
                submission of data in accordance with the schedule 
                prescribed by such subparagraph, the Administrator 
                shall take the action described in section 408(e)(2)(A) 
                of such Act with respect to such tolerance or 
                exemption.

SEC. 5. REVIEW OF EXISTING METHODS OF ANALYSIS.

    (a) Determination.--Within 180 days of the date of the enactment of 
this Act, the Administrator of the Environmental Protection Agency 
shall determine, for each method of detecting and measuring levels of 
pesticide chemical residues, whether the requirements of section 
408(b)(2)(G) of the Federal Food, Drug, and Cosmetic Act have been met.
    (b) Notice.--The Administrator shall issue a notice identifying 
each pesticide chemical for which there is such a method that does not 
meet such requirements. Any such method that does not meet such 
requirements shall be revised so that the method meets such 
requirements within 3 years of the date of the issuance of the notice.
    (c) Revocation.--If upon the expiration of such 3-year period, a 
method does not meet such requirements, then any tolerance or exemption 
in effect for the pesticide chemical residue subject to such method 
shall be considered revoked.

SEC. 6. FEES.

    The Administrator of the Environmental Protection Agency 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 functions of the Administrator under this section 
and sections 4 and 5 of this Act.

SEC. 7. GENERAL DEFINITIONS.

    As used in sections 4 and 5 of this Act:
            (1) In general.--The terms that are also used in section 
        408 of the Federal Food, Drug, and Cosmetic Act shall have the 
        meanings given the terms by sections 201 and 408 of such Act.
            (2) Dietary exposure.--The term ``dietary exposure'' means 
        dietary exposure as determined under section 408(b)(2)(C) of 
        the Federal Food, Drug, and Cosmetic Act.
            (3) Exemption.--The term ``exemption'' means an exemption 
        from the requirement for a tolerance under section 408 of the 
        Federal Food, Drug, and Cosmetic Act.

                                 <all>

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