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[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[S. 2084 Introduced in Senate (IS)]

103d CONGRESS
  2d Session
                                S. 2084

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

_______________________________________________________________________

                   IN THE SENATE OF THE UNITED STATES

                  May 5 (legislative day, May 2), 1994

  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, and for other 
                               purposes.

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

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

    (a) Short Title.--This Act may be cited as the ``Pesticide Reform 
Act of 1994''.
    (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. 408. Tolerances and exemptions for pesticide chemical 
                            residues.
          ``(a) Requirement for tolerance or exemption.
          ``(b) Tolerances.
          ``(c) Exemptions.
          ``(d) Petitions and action on the initiative of the 
                            Administrator.
          ``(e) Temporary tolerance or exemption.
          ``(f) Confidentiality of data.
          ``(g) Existing pesticide chemical residues.
          ``(h) Food and Drug Administration monitoring of pesticide 
                            chemical residues.
          ``(i) Fees.
          ``(j) Judicial review''.
Sec. 4. Embargo authority.
Sec. 5. Civil Money Penalties.
Sec. 6. Recall.
Sec. 7. Evaluation of existing pesticide chemical residue tolerances 
                            and exemptions.
Sec. 8. Fees.
Sec. 9. 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 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)), including each active 
ingredient and inert ingredient, as defined in paragraphs (a) and (m) 
of section 2 of such Act, of the pesticide.
    ``(2) The term `pesticide chemical residue' means a residue in or 
on food of--
            ``(A) any pesticide chemical or a component of such 
        chemical; or
            ``(B) any other substance that is present in or on the 
        commodity or food as a result of the metabolism or other 
        degradation of a pesticide chemical.''.
            (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.
            (3) Raw agricultural commodity.--Paragraph (r) of section 
        201 (21 U.S.C. 321) is repealed.
    (b) Conforming Amendments.--
            (1) Section 201 (21 U.S.C. 321) is amended by adding at the 
        end the following:
    ``(gg) 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 
                bears or contains a pesticide chemical residue that is 
                unsafe within the meaning of section 408(a);''; and
                    (C) in clause (C), by striking ``: Provided, That 
                where a pesticide chemical'' through ``section 512''.
            (3) Section 403(l) (21 U.S.C. 343(l)) is amended by 
        striking ``raw agricultural commodity'' and ``commodity'' each 
        time it occurs and inserting ``food''.

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

    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 such residue conforms with such 
                tolerance; or
                    ``(B) an exemption for such residue is in effect 
                under this section and such residue conforms 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 by reason of 
        bearing or containing any amount of such residue be considered 
        to be adulterated within the meaning of section 402(a)(1).
            ``(3) Derived food.--A tolerance or exemption for a 
        pesticide chemical residue established for a food shall apply 
        to all foods derived from such food unless a tolerance 
        specifies otherwise.
    ``(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 shall contain an expiration date for a 
                tolerance for a pesticide chemical established by the 
                regulation. Such date shall be not later than--
                            ``(i) the expiration date (if any) for such 
                        pesticide chemical established by the 
                        Administrator under section 3 of the Federal 
                        Insecticide, Fungicide, and Rodenticide Act, or
                            ``(ii) 18 years after the date such 
                        tolerance is established, whichever occurs 
                        first.
                    ``(C) Separate tolerances.--Under subparagraph (A), 
                the Administrator may establish a separate tolerance, 
                which more closely reflects actual exposure or which is 
                necessary for more efficient enforcement, and which is 
                based on reliable data and information relating to the 
                appropriate sampling, for a pesticide chemical residue 
                with respect to food at any point in the chain of 
                production or marketing, including--
                            ``(i) at the time the food is harvested,
                            ``(ii) at the time the food is purchased at 
                        retail, and
                            ``(iii) after the food is processed.
            ``(2) Standard.--
                    ``(A) Assurance of safety.--
                            ``(i) General rule.--A tolerance for a 
                        pesticide chemical residue in or on food shall 
                        not be established or left in effect unless the 
                        residue permitted under the tolerance is safe.
                            ``(ii) Cancer.--For pesticides found to 
                        induce cancer when ingested by humans or 
                        animals or determined on the basis of reliable 
                        scientific evidence to pose a potential dietary 
                        risk of cancer in humans, a tolerance shall not 
                        be established or left in effect unless the 
                        Administrator finds on the basis of 
                        conservative methods of risk assessment that 
                        the risk is negligible for all anticipated 
                        consumer exposures to such residue, including 
                        all other anticipated consumer exposures for 
                        which there is reliable information, and taking 
                        into account information concerning the special 
                        vulnerabilities of children and sensitive 
                        subpopulations.
                            ``(iii) Risk other than cancer.--For 
                        pesticide chemical residues that may pose a 
                        potential dietary risk of adverse health 
                        effects other than cancer in humans, a 
                        tolerance shall provide an ample margin of 
                        safety.
                            ``(iv) Definitions.--As used in this 
                        section:
                                    ``(I) Safe.--The term `safe' means 
                                with respect to a tolerance for a 
                                pesticide chemical residue that there 
                                is a reasonable certainty that no harm 
                                will result from all anticipated 
                                consumer exposures to such residue, 
                                including all anticipated dietary 
                                exposures and all other anticipated 
                                exposures for which there is reliable 
                                information, and taking into account 
                                information concerning the special 
                                vulnerabilities of children and 
                                sensitive subpopulations.
                                    ``(II) Margin of safety.--A margin 
                                of safety is considered ample if the 
                                Administrator determines there is a 
                                reasonable certainty of no harm to 
                                significant subpopulations from 
                                exposure to the pesticide chemical 
                                residue in the diet and from exposure 
                                to the pesticide chemical by other 
                                pathways. In making this determination, 
                                the Administrator shall give due 
                                consideration to the exposure level 
                                which is determined not to cause 
                                adverse effects in animal studies or in 
                                observations of exposed humans and to 
                                the application of appropriate factors. 
                                These factors may include factors to 
                                account for differences in sensitivity 
                                between and within species, adequacy of 
                                the study or studies, and completeness 
                                of the available data to assess 
                                potential for adverse effects.
                                    ``(III) Risk assessment 
                                procedures.--The Administrator shall 
                                periodically review the risk assessment 
                                procedures used to make safety 
                                determinations under this paragraph, 
                                including methodologies with respect to 
                                estimating exposure to pesticide 
                                chemicals and evaluating risks to 
                                significant subpopulations. The 
                                Administrator periodically shall revise 
                                the risk assessment procedures 
                                accordingly to incorporate advances in 
                                science and risk assessment. The 
                                Administrator may determine that a 
                                method of risk assessment different 
                                from the method required by subclause 
                                (II) is appropriate if the 
                                Administrator finds that the 
                                alternative risk assessment method will 
                                fully protect the public health.
                    ``(B) Factors.--In determining whether to 
                establish, modify, or revoke a tolerance under 
                subparagraph (A) for a pesticide chemical residue on a 
                food, the Administrator--
                            ``(i) except as provided in clause (ii), 
                        shall in estimating the anticipated dietary 
                        exposure to such residue assume that all food 
                        for which the pesticide chemical residue has or 
                        will have a tolerance bears or contains 
                        residues of the pesticide chemical equal to the 
                        levels established by their respective 
                        tolerances and where separate tolerances for a 
                        pesticide chemical residue in the same food are 
                        established for different points in the chain 
                        of production or marketing pursuant to 
                        subsection (b)(1)(C), the Administrator shall 
                        assume that the food bears or contains residues 
                        of the pesticide chemical equal to the level 
                        established by the tolerance set at the point 
                        closest to the time the food is purchased at 
                        retail;
                            ``(ii) may use data regarding the percent 
                        of a crop treated by a pesticide chemical to 
                        estimate dietary exposure to such residue 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) if data are available on 
                                pesticide use and consumption of food 
                                in a particular area, finds that 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;
                            ``(iii) shall fully account for available 
                        information on the probable consumption of 
                        foods for which there is or will be a tolerance 
                        for residues of the pesticide chemical, 
                        including, to the extent possible, consumption 
                        by significant subpopulations with differing 
                        food consumption patterns, including infants, 
                        children, and other subpopulations with 
                        disproportionately high consumption of 
                        particular foods;
                            ``(iv) shall fully account for available 
                        information on the cumulative effect of such 
                        residue and any chemically or pharmacologically 
                        related substances in the human diet, and other 
                        ways in which the consumer may be exposed to 
                        such residue and substances, including, to the 
                        extent representative data permit, through 
                        drinking water;
                            ``(v) shall fully account for valid 
                        scientific information regarding any estrogenic 
                        or other hormonal effects associated with the 
                        residue; and
                            ``(vi) shall apply safety factors which 
                        after consultation with experts qualified by 
                        scientific training and experience to evaluate 
                        the safety of pesticide chemical residues 
                        determine are appropriate for use in connection 
                        with animal experimentation or other relevant 
                        data.
                    ``(C) Exposure of infants and children.--In 
                determining whether to establish, modify, or revoke a 
                tolerance for a pesticide chemical residue, the 
                Administrator, in addition to the requirements of 
                subparagraph (B)--
                            ``(i) shall assess the risk of the 
                        pesticide chemical residue based on the 
                        following:
                                    ``(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.
                                    ``(III) Available information 
                                concerning the cumulative effects on 
                                infants and children of such residues 
                                and other substances that have a common 
                                mechanism of toxicity;
                            ``(ii) shall--
                                    ``(I) ensure that there is an ample 
                                margin of safety for infants and 
                                children and impose other requirements 
                                necessary to ensure that exposure to 
                                the pesticide chemical residue will be 
                                safe; 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. For the purpose of subclause (I), an 
                additional tenfold margin of safety for the pesticide 
                chemical residue and other sources of exposure shall be 
                applied for children and infants to take into account 
                potential pre- and post-natal toxicity and completeness 
                of the data with respect to exposure to infants and 
                children. Notwithstanding this requirement for an 
                additional factor, the Administrator may determine that 
                a margin of safety for a pesticide chemical residue is 
                considered ample for children and infants if, on the 
                basis of reliable data, such margin will fully protect 
                the public health.
                    ``(D) 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 be found in 
                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 and may be less than the lowest level 
                that permits only such unavoidable levels to remain in 
                food. The Administrator shall evaluate any such 
                tolerance at least every five years to determine 
                whether modification of such tolerance is necessary so 
                that the tolerance provides only for no greater than 
                the level of the pesticide chemical residue that is 
                unavoidable.
                    ``(E) Practical methods of analysis.--
                            ``(i) General rule.--Except as provided in 
                        clause (ii), a tolerance for a pesticide 
                        chemical residue shall not be established or 
                        left in effect unless the Administrator 
                        determines, after consultation with the 
                        Secretary, that--
                                    ``(I) there is a multiresidue 
                                method for detecting and measuring the 
                                levels of such pesticide chemical 
                                residue in or on a food that will 
                                measure the residue at the level 
                                established by the tolerance; and
                                    ``(II) such method 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.
                            ``(ii) Exception.--If the Administrator is 
                        not able to make the determination described in 
                        clause (i), the Administrator shall identify, 
                        after consultation with the Secretary, the 
                        method for detecting and measuring levels of 
                        such pesticide chemical residue in or on a food 
                        that will measure the residue at the level 
                        established by the tolerance. The Administrator 
                        shall, every two years after the date of the 
                        determination under this clause, reevaluate the 
                        determination.
                            ``(iii) Pesticide reference standard.--
                                    ``(I) Provision to the 
                                administrator.--A registrant of a 
                                pesticide chemical for which a 
                                tolerance has been established shall 
                                provide the Administrator, upon 
                                request, with an appropriate pesticide 
                                reference standard for such pesticide 
                                chemical, including standards for all 
                                residues of toxicological significance. 
                                Each pesticide reference standard 
                                provided to the Administrator shall be 
                                certified by a competent laboratory for 
                                both identity and purity.
                                    ``(II) Administrator actions.--The 
                                Administrator shall maintain a 
                                repository of pesticide reference 
                                standards, audit the certification of 
                                such standards, and make such standards 
                                available to any private, public, 
                                domestic, or foreign laboratory 
                                requesting the standard. The 
                                Administrator may also request 
                                pesticide reference standards for 
                                pesticide chemical manufactured or used 
                                in foreign countries. To the extent 
                                that the Administrator obtains 
                                standards for pesticide chemicals 
                                manufactured or used in foreign 
                                countries, the Administrator shall 
                                certify such standards for identity and 
                                purity and make them available to any 
                                private, public, domestic, or foreign 
                                laboratory requesting such standard.
                                    ``(III) Definition.--For purposes 
                                of this clause, the term `pesticide 
                                reference standard' means a pesticide 
                                chemical of known identity, purity, and 
                                composition that is required for 
                                comparison purposes in laboratory 
                                analysis to measure the amount and 
                                confirm the identity of a pesticide 
                                chemical residue in food.
            ``(3) Consistent application.--The Administrator shall 
        issue guidelines providing for the consistent application of 
        the requirements of paragraphs (1) and (2). The lack of 
        guidelines does not affect the authority of the Administrator 
        to implement such paragraphs.
            ``(4) Reevaluation period.--Each tolerance for a pesticide 
        chemical residue established under this subsection shall 
        prescribe the period (at least every five years) for 
        reevaluating the estimate of the amount of dietary exposure to 
        such residue made under paragraph (2)(B)(ii).
            ``(5) Tolerances in effect on date of enactment.--For 
        pesticide chemical residue tolerances in effect on the date of 
        enactment of the Pesticide Reform Act of 1994 this subsection 
        shall apply as prescribed by section 7 of such Act.
    ``(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 presents no risk to human health 
                        at any level that is reasonably likely to occur 
                        under extreme conditions of use, including the 
                        health of the subpopulations identified in 
                        subsection (b)(2)(B)(iii), from dietary 
                        exposure to such residue.
                            ``(ii) Revocation.--An exemption shall be 
                        revoked unless the residue is not a human or an 
                        animal carcinogen and otherwise presents no 
                        risk to human health at any level that is 
                        reasonably likely to occur under extreme 
                        conditions of use, including the health of 
                        subpopulations identified in subsection 
                        (b)(2)(B)(iii), from dietary exposure to such 
                        residue.
                    ``(B) Exposure.--For purposes of subparagraph (A), 
                in determining dietary exposure to a pesticide chemical 
                residue, the Administrator shall--
                            ``(i) use only reliable information 
                        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) fully account for all other 
                        exemptions in effect for such residue;
                            ``(iii) fully account for all other sources 
                        of dietary exposure to the pesticide chemical 
                        and to chemically or pharmacologically related 
                        chemicals if there is adequate information 
                        about such sources of exposure; and
                            ``(iv) consider the exposure to be the 
                        level of exposure that would occur if human 
                        exposure to the pesticide chemical residue at 
                        the level that is reasonably likely to occur 
                        under extreme conditions of use occurs for a 
                        period equal to a lifetime.
            ``(3) Consistent application.--The Administrator shall 
        issue guidelines providing for the consistent application of 
        the requirements of paragraphs (1) and (2). The lack of 
        guidelines does not affect the authority of the Administrator 
        to implement such paragraphs.
            ``(4) Exemptions in effect on date of enactment.--For 
        pesticide chemical residue exemptions in effect on the date of 
        enactment of the Pesticide Reform Act of 1994 this subsection 
        shall apply as prescribed by section 7 of such Act.
    ``(d) Petitions and Action on the Initiative of the 
Administrator.--
            ``(1) General rule.--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. Sections 553 and 554 of title 
        5, United State Code, shall not apply with respect to 
        procedures concerning such petitions.
            ``(2) Requirements for petitions.--A petition under 
        paragraph (1) to establish a tolerance or exemption for a 
        pesticide chemical residue shall contain--
                    ``(A) 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 subparagraph (D); and
                            ``(ii) a characterization of--
                                    ``(I) the exposure to the pesticide 
                                chemical residue due to any tolerance 
                                or exemption already granted for such 
                                residue; and
                                    ``(II) the additional exposure to 
                                such residue that would result if the 
                                requested tolerance or exemption were 
                                granted;
                    ``(B) a proposed tolerance for such residue, if a 
                tolerance is proposed;
                    ``(C) the name, chemical identity, and composition 
                of the pesticide chemical that produces such residue;
                    ``(D) reports of tests and investigations made with 
                respect to the safety of such pesticide chemical 
                residue, including complete information as to the 
                methods and controls used in conducting such tests and 
                investigations;
                    ``(E) data showing the amount, frequency, method, 
                and time of application of such pesticide chemical;
                    ``(F) 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;
                    ``(G) a description of methods for detecting and 
                measuring the levels of such chemical residue in or on 
                the food, which methods meet the requirements of 
                subsection (b)(2)(E);
                    ``(H) reports of investigations conducted on the 
                effects of processing methods used to produce food on 
                the level and identity of such pesticide chemical 
                residue;
                    ``(I) if the petition is for a pesticide chemical 
                residue that is described in subsection (b)(2)(A)(ii), 
                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;
                    ``(J) the pesticide reference standard (as defined 
                in subsection (b)(2)(E)(iii)) for the pesticide 
                chemical residue;
                    ``(K) such other data and information as the 
                Administrator may require to support the petition; and
                    ``(L) the data referred to in subsection 
                (b)(2)(B)(ii)(III) if available.
            ``(3) Actions on petitions.--
                    ``(A) Filing determination.--
                            ``(i) In general.--Within 45 days of the 
                        filing of a petition under paragraph (1) for 
                        the establishment, modification, or revocation 
                        of a tolerance or an exemption, the 
                        Administrator shall determine if the petition 
                        complies with the requirements of paragraph (2) 
                        or applicable requirements for petitions to 
                        modify or revoke tolerances or exemptions from 
                        tolerances. 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 of notice of filing.--A 
                        notice under clause (i) shall--
                                    ``(I) if it is a notice of the 
                                filing of a petition to establish a 
                                tolerance or exemption, 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 and include the 
                                summary required by paragraph (2)(A); 
                                and
                                    ``(II) if it is a notice of the 
                                filing of a petition to modify or 
                                revoke a tolerance or exemption, 
                                contain the full petition or a summary 
                                of the petition.
                    ``(B) Action.--The Administrator shall, within one 
                year 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, 
                        modifying, or revoking a tolerance or exemption 
                        for the pesticide chemical residue;
                            ``(ii) issue a proposed regulation 
                        establishing, modifying, or revoking 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) Comments.--If the Administrator issues a 
                notice of the filing of a petition under subparagraph 
                (A)(i) or a proposed regulation under subparagraph 
                (B)(ii), the Administrator shall allow at least thirty 
                days for comments on such notice or proposed 
                regulation.
                    ``(D) Final regulation.--If the Administrator 
                issues a proposed regulation under subparagraph 
                (B)(ii), the Administrator shall issue a final 
                regulation within one hundred and eighty days of the 
                date of the publication of the proposed regulations.
                    ``(E) Priorities.--The Administrator shall give 
                priority to petitions for the establishment or 
                modification 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 administrator's initiative.--
                    ``(A) General rule.--The Administrtor 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 thirty days for public comment on the 
                proposed regulation unless the Administrator finds that 
                such notice and comment would be contrary to the public 
                interest and states the reasons for the finding in the 
                notice of the final regulation. If the Administrator 
                makes such a finding and issues such a regulation, the 
                Administrator shall provide at least thirty days for 
                comment on the regulation after it is issued.
            ``(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 or 
                        exemption to remain in effect at a level not to 
                        exceed the level in effect immediately before 
                        such regulation is issued only--
                                    ``(I) for foods that contain such 
                                pesticide chemical residue in an amount 
                                that is not more than the amount that 
                                would remain if the pesticide chemical 
                                had been legally 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) is 
                                safe 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 food.
            ``(6) Required submission of data.--
                    ``(A) General rule.--If the Administrator finds 
                that additional data are required to determine whether 
                an existing tolerance or exemption from a tolerance 
                meets the safety standard in subsection (b)(2) or 
                (c)(2), the Administrator shall publish an order--
                            ``(i) requiring one or more interested 
                        persons to notify the Administrator that such 
                        person will submit the required data;
                            ``(ii) describing the type of data required 
                        to be submitted;
                            ``(iii) describing the reports required to 
                        be made during and after the collection of the 
                        data; and
                            ``(iv) establishing deadlines for the 
                        actions described in clauses (i), (ii), and 
                        (iii).
                    ``(B) Deadlines.--If an order is issued under 
                subparagraph (A) with respect to a tolerance or an 
                exemption and the Administrator finds that a deadline 
                or other condition in the order is not met, the 
                Administrator may revoke, pursuant to the procedures in 
                paragraph (4), the tolerance or exemption for failure 
                to comply with such order.
                    ``(C) Extensions.--
                            ``(i) Extension request.--Any person may 
                        request the Administrator to issue an order to 
                        extend the schedule established under 
                        subparagraph (A) before the expiration of a 
                        deadline in the schedule.
                            ``(ii) Grant of request.--The Administrator 
                        may grant a request under clause (i) only if 
                        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 schedule, the 
                        Administrator may extend the deadline for a 
                        period no longer than such time as is necessary 
                        for such person to submit the data.
            ``(7) 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 a 
        tolerance for the residue of the pesticide chemical. 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 
        subsection (b)(2) and with section 18 of the Federal 
        Insecticide, Fungicide, and Rodenticide Act.
    ``(e) Experimental Permits.--To the extent consistent with the 
public health, the Administrator shall promulgate regulations for 
exempting from the operation of this section new pesticide chemicals 
intended solely for investigational use by experts qualified by 
scientific training and experience to investigate the safety of 
pesticide chemicals. Such regulations may, in the discretion of the 
Administrator, among other conditions relating to the protection of the 
public health, provide for--
            ``(1) conditioning such exemption upon the establishment 
        and maintenance of such records, and
            ``(2) the making of such reports to the Secretary, by the 
        manufacturer or the sponsor of the investigation of such 
        article, of data (including analytical reports by 
        investigators) obtained as a result of such investigational use 
        of such article, as well as enable the Administrator to 
        evaluate the safety of such article in the event of the filing 
        of an application pursuant to this section. Such regulations, 
        among other things, shall set forth the conditions (if any) 
        upon which food treated with such pesticide chemicals may be 
        marketed for food use.
    ``(f) Confidentiality of Data.--
            ``(1) Access to data and information.--
                    ``(A) General rule.--Except as provided in 
                paragraphs (2) and (3), the Administrator shall not 
                make public data or information submitted to the 
                Administrator or cited to the Administrator in a 
                petition under subsection (d)(1) and data and 
                information otherwise considered by the Administrator 
                in issuing a proposed or final regulation or order 
                under this section which contains or relates to trade 
                secrets or commercial or financial information obtained 
                from a person and is privileged or confidential. The 
                person submitting information which they believe is 
                privileged or confidential information shall notify the 
                Administrator of such information. If a notice is not 
                made to the Administrator, the Administrator may make 
                such information public.
                    ``(B) Notice.--Except as to data or information 
                disclosed under paragraph (2), thirty days before 
                disclosing data or information claimed as privileged or 
                confidential under subparagraph (A), the Administrator 
                shall notify the person who submitted or cited the data 
                or information of the intent to disclose the data or 
                information to the public.
            ``(2) Authorized disclosure for governmental purposes.--
        Data and information that are entitled to confidential 
        treatment under paragraph (1)--
                    ``(A) shall be disclosed to either House of 
                Congress, to the extent of matter within its 
                jurisdiction, to any committee or subcommittee of the 
                Congress, and to any joint committee of the Congress or 
                subcommittee of such a joint committee and to the 
                Comptroller General of the United States;
                    ``(B) shall be disclosed to any officer or employee 
                of the United States or of any State--
                            ``(i) in connection with the official 
                        duties of such officer or employee under any 
                        law for the protection of health or the 
                        environment, or
                            ``(ii) for specific law enforcement 
                        purposes;
                    ``(C) shall be disclosed, under such security 
                requirements as the Administrator may provide, to 
                contractors with the United States and employees of 
                such contractors, if such disclosure is necessary for 
                the satisfactory performance by the contractor of a 
                contract with the United States or for work in 
                connection with this section or other statutes 
                administered by the Administrator;
                    ``(D) shall be disclosed to the extent the 
                Administrator determines disclosure is necessary to 
                protect the public health; and
                    ``(E) may be disclosed when relevant in any 
                proceeding under this section, except that disclosure 
                in such a proceeding shall be made in such manner as to 
                preserve confidentiality to the extent practicable.
            ``(3) Disclosure of health effects data and residue data.--
                    ``(A) General rule.--All data and information 
                concerning any test of a pesticide chemical residue or 
                a pesticide chemical to determine the potential effects 
                of such residue or chemical on human health or 
                concerning the levels of such residue in or on food 
                shall be available for disclosure to the public except 
                to the extent such data or information include--
                            ``(i) manufacturing or quality control 
                        processes,
                            ``(ii) methods for detecting the quantity 
                        of any deliberately added inert ingredient of a 
                        pesticide chemical other than methods for 
                        detecting residues of the inert ingredient in 
                        or on food, or
                            ``(iii) the identity or quantity of any 
                        deliberately added inert ingredient of a 
                        pesticide chemical other than an inert 
                        ingredient which is the subject of a petition 
                        under subsection (d)(1) or an action of the 
                        Administrator under subsection (d)(4).
                    ``(B) Data and information also submitted under 
                fifra.--Data and information described in subparagraph 
                (A) which were also submitted to the Administrator 
                under the Federal Insecticide, Fungicide, and 
                Rodenticide Act shall be available for disclosure to 
                the public in accordance with section 10(g) of such Act 
                (7 U.S.C. 136h(g)).
    ``(g) 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).
            ``(2) Pesticide chemical residues under regulations.--
        Regulations establishing, modifying, or revoking 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).
            ``(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 Reform Act of 1994, do not have 
                tolerances or exemptions from tolerances under this 
                section because the residues are generally recognized 
                as safe under this section or section 201(s) shall, 
                until the expiration of the period prescribed by 
                subparagraph (C), not be considered unsafe under 
                section 402(a)(2)(B) solely because the residues do not 
                have such a tolerance or exemption.
                    ``(B) List.--The Administrator shall--
                            ``(i) not later than 180 days after the 
                        date of the enactment of such Act, 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 201(s); and
                            ``(ii) require that any person who, before 
                        the date of the enactment of such Act, 
                        distributed in commerce as a pesticide 
                        chemical, a pesticide chemical that produces a 
                        pesticide chemical residue that is not on the 
                        list described in clause (i), and that such 
                        person determined such pesticide chemical is 
                        generally recognized as safe under this section 
                        or section 201(s), shall within 6 months of the 
                        date of the publication of the list under 
                        clause (i), report to the Administrator the 
                        data that supports the claim that the pesticide 
                        chemical residue is generally recognized as 
                        safe.
                    ``(C) Determination of the Administrator.--Not 
                later than 2\1/2\ years after the date of the enactment 
                of the Pesticide Reform Act of 1994, 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 residue 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).
    ``(h) Monitoring of Pesticide Chemical Residues.--
            ``(1) Sampling.--The Secretary shall conduct a 
        comprehensive surveillance and compliance enforcement 
        monitoring program for domestic and imported 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--
                    ``(A) sampling foods for pesticide chemical 
                residues included in a notice under paragraph (2);
                    ``(B) sampling foods that are high consumption 
                items for infants and children;
                    ``(C) analyzing pesticides most likely to result in 
                violation of this section;
                    ``(D) conducting incidence and level monitoring; 
                and
                    ``(E) collecting data on dietary intake of 
                pesticide residues on food as it is consumed.
            ``(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.
    ``(i) 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. Such 
fees shall be deposited in the Treasury and shall be credited to the 
appropriation account of the Administrator for salaries and expenses 
and shall be available for costs incurred in carrying out this section 
in accordance with appropriation Acts until expended without fiscal 
year limitation.
    ``(j) Judicial Review.--A petition for review of any final order of 
the Administrator issued under subsection (d) or any regulation that is 
the subject of such an order may be filed by any adversely affected 
person only in the United States Court of Appeals for the District of 
Columbia Circuit. Any such petition for review must be filed within 
sixty days of the issuance of such order or regulation. Judicial review 
shall be in accordance with sections 701 through 706 of title 5 of the 
United States Code, and the challenged order or regulation shall be 
sustained unless it is found to be arbitrary, capricious, and abuse of 
discretion, or not in accordance with law. Orders and regulations of 
the Administrator with respect to which review could have been obtained 
under this subsection shall not be subject to judicial review in civil 
or criminal proceedings for enforcement or other judicial 
proceedings.''.

SEC. 4. EMBARGO AUTHORITY.

    (a) Administrative Embargo Authority.--Section 304(g) (21 U.S.C. 
334(g)) is amended by redesignating paragraph (2) as paragraph (3) and 
adding after paragraph (1) the following new paragraph:
            ``(2) If an officer or employee of the Department has 
        reason to believe that any article of food is adulterated 
        within the meaning of section 402(a)(2)(B), the officer or 
        employee may order the food detained (in accordance with 
        regulations prescribed by the Secretary) for a reasonable 
        period which may not exceed twenty days (or ten days, in the 
        case of a perishable food) unless the Secretary determines that 
        a longer period of detention is required to institute an action 
        under subsection (a) or section 302, in which case the 
        Secretary may authorize a detention period of not more than 
        thirty days (or not more than fifteen days, in the case of a 
        perishable food). Regulations of the Secretary shall require 
        that before a food may be detained, the Secretary or an officer 
        or employee designated by the Secretary shall approve the 
        detention order. Such an order may require the labeling or 
        marking of a food during the period of its detention for the 
        purpose of identifying the food as detained.''.
    (b) Prohibition on Removal.--Paragraph (3) of section 304(g) (21 
U.S.C. 334(g)), as redesignated by subsection (a), is amended--
            (1) in subparagraph (A), by striking ``a device subject to 
        a detention order issued under paragraph (1)'' and inserting 
        ``an article subject to a detention order under paragraph (1) 
        or (2)'',
            (2) in the matter preceding clause (i) of sub-paragraph 
        (B), by striking ``a device subject to a detention order under 
        paragraph (1)'' and inserting ``an article subject to a 
        detention order under paragraph (1) or (2)'', and
            (3) in subparagraph (B)(ii), by striking ``if'' and 
        inserting ``in the case of a device''.
    (c) Prohibited Act.--Section 301(r) (21 U.S.C. 331(r)) is amended 
by inserting ``or a food'' after ``device'' each time it appears.

SEC. 5. CIVIL MONEY PENALTIES.

    Section 303(f) (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) 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, in addition to any other 
        penalties that may be prescribed by law, 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.'',
            (3) in paragraph (3), as so redesignated, by striking 
        ``paragraph (1)'' each place it occurs and inserting 
        ``paragraph (1) or (2)'', and
            (4) in paragraph (5), as so redesignated, by striking 
        ``(3)'' each place it occurs and inserting ``(4)''.

SEC. 6. RECALL.

    (a) Authority.--Chapter III is amended--
            (1) by redesignating sections 309 and 310 as section 310 
        and 311, respectively, and
            (2) by adding after section 308 the following:

                                ``recall

    ``Sec. 309. (a) General Rule.--If the Secretary has reason to 
believe that an article of food is adulterated within the meaning of 
section 402(a)(2)(B), the Secretary may require the manufacturer, 
processor, or distributor of such article to take immediately all 
action necessary to recall such article from all wholesale and retail 
establishments. A recall order of the Secretary under this subsection 
shall be a final agency action subject to review by the United States 
district court for the judicial district in which the manufacturer, 
processor, or distributor resides or transacts business or in which is 
located the article of food that is the subject of such order.
    ``(b) Report.--Manufacturers, processors, and distributors shall 
report promptly to the Secretary any recall of a food undertaken by the 
manufacturer, processor, or distributor, including any recall required 
under subsection (a) or section 302 and any recall conducted at the 
initiative of the manufacturer, processor, or distributor on the 
grounds that the food may be adulterated within the meaning of section 
403(a)(2)(B).
    ``(c) Scope of Order.--For purposes of this section, an order under 
subsection (a) with respect to an article of food shall include an 
order to retrieve or replace such article.''.
    (b) Prohibited Act.--Section 301 (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(w) The failure to comply with a recall order under section 
309(a) or a requirement to report a recall under section 309(b).''.

SEC. 7. EVALUATION OF EXISTING PESTICIDE CHEMICAL RESIDUE TOLERANCES 
              AND EXEMPTIONS.

    (a) Classification.--
            (1) Identification.--Within one hundred and eighty days of 
        the date of 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 on 
        such date, identify each tolerance or exemption which does not 
        appear to meet the requirements of section 408(b)(2) or 
        408(c)(2) of the Federal Food, Drug, and Cosmetic Act and 
        publish a notice summarizing the data and analysis upon which 
        such determination is made. The notice published pursuant to 
        this paragraph shall include all tolerances for a pesticide 
        chemical, if the cumulative risk from exposure for any 
        pesticide chemical residue, calculated by the methodology in 
        paragraph (2), appears not to meet the requirements of section 
        408(b)(2) of the Federal Food, Drug, and Cosmetic Act.
            (2) Factors.--In making the determination under paragraph 
        (1) with respect to tolerances for a pesticide chemical 
        residue, the Administrator shall--
                    (A) use the toxicological conclusions, including 
                appropriate factors where applicable, used in the most 
                current risk assessment for the pesticide chemical 
                residue performed by the Administrator on or before the 
                date of enactment;
                    (B) assume that all food for which the pesticide 
                chemical residue has a tolerance bears or contains 
                residues of the pesticide chemical equal to the levels 
                established by their respective tolerances.
            (3) Objections.--Any person adversely affected by the 
        Administrator's action under paragraph (1) may file objections 
        to the action with the Administrator. Such objections must be 
        filed within thirty days of publication of the notice required 
        in paragraph (1). The Administrator shall act on such 
        objections within sixty days of the receipt of the objections.
            (4) Subsequent identifications.--On a yearly basis in the 
        four-year period after the date of enactment of this Act, if 
        the Administrator concludes that any additional tolerances or 
        exemptions do not appear to meet the requirements of section 
        408(b)(2) and 408(c)(2) of the Federal Food, Drug, and Cosmetic 
        Act, the Administrator shall identify such tolerances and 
        exemptions and publish a notice summarizing the data and 
        analysis upon which such identification is made. Prior to 
        identifying any additional tolerances or exemptions under this 
        paragraph, the Administrator shall publish the identification 
        as a proposal and seek public comment.
    (b) Data Submission.--
            (1) Deadline for submission of data on apparently 
        unacceptable pesticide chemical residues.--For any pesticide 
        chemical residue for which the Administrator makes the 
        identification described in subsection (a)(1) or (a)(4), any 
        person wanting to maintain the tolerance or exemption for such 
        pesticide chemical shall have two years from the publication of 
        the notices in subsection (a) to submit data or information on 
        such chemical relative to the safety standard in section 
        408(b)(2) or 408(c)(2) of the Federal Food, Drug, and Cosmetic 
        Act.
            (2) Deadline for submission of data on all other pesticide 
        chemical residues.--For any other pesticide chemical residue 
        that had a tolerance or exemption from a tolerance on the date 
        of enactment of this Act, any person wanting to maintain the 
        tolerance or exemption for such pesticide chemical residue 
        shall have not more than five years from such date of 
        enactment, subject to any schedule imposed under paragraph (3), 
        to submit data or information relative to the safety standards 
        in such section 408(b)(2) or 408(c)(2) of the Federal Food, 
        Drug, and Cosmetic Act.
            (3) Schedule.--For any pesticide chemical residue for which 
        the Administrator does not make the identification described in 
        subsection (a), the Administrator may establish a schedule for 
        the submission of data for the tolerance or exemption for such 
        pesticide chemical residue which data shall be the basis for a 
        determination by the Administrator as to whether the tolerance 
        or exemption meets the requirements of such section 408(b)(2) 
        or 408(c)(2) of the Federal Food, Drug, and Cosmetic Act.
            (4) Extensions.--
                    (A) Request.--Any person may request the 
                Administrator to issue an order to extend a deadline 
                established under paragraph (1), (2), or (3) before 
                expiration of the deadline.
                    (B) Grant of request.--The Administrator may grant 
                such a request only if the Administrator finds that 
                extraordinary circumstances beyond the control of such 
                person prevented such person from submitting the 
                required data.
                    (C) 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 may extend the 
                        deadline in paragraph (1) for no more than one 
                        year and any deadline established under 
                        paragraph (2) or (3) so long as such extension 
                        does not extend the deadline beyond six years 
                        from the date of enactment of the Act.
    (c) Deadlines for Action.--
            (1) Three-year deadline.--Within three years of the date of 
        enactment of this Act, the Administrator shall issue a final 
        decision for 75 percent of the tolerances and exemptions of the 
        pesticide chemical residues identified in subsection (a)(1) by 
        classifying such tolerances and exemptions as meeting or not 
        meeting the requirements of section 408(b)(2) or 408(c)(2) of 
        the Federal Food, Drug, and Cosmetic Act. Such decisions shall 
        be based only on data received by the Administrator before the 
        deadline in subsection (b)(1) or before the expiration of an 
        extension granted under subsection (b)(4), whichever is later.
            (2) Four-year deadline.--Within four years of the date of 
        enactment of the Act, the Administrator shall issue a final 
        decision for 100 percent of the tolerances and exemptions of 
        the pesticide chemical residues identified in subsection (a)(1) 
        by classifying such tolerances and exemptions as meeting or not 
        meeting the requirements of section 408(b)(2) or 408(c)(2) of 
        the Federal Food, Drug, and Cosmetic Act. Such decision shall 
        be based only on data received by the Administrator before the 
        deadline in subsection (b)(1) or before the expiration of an 
        extension granted under subsection (b)(4), whichever is later.
            (3) Deadline for subsequently identified tolerances and 
        exemptions.--Within four years of the date of identification of 
        a tolerance or exemption under subsection (a)(4) or seven years 
        from the date of enactment, whichever is sooner, the 
        Administrator shall issue a final decision classifying such 
        tolerance or exemption as meeting or not meeting the 
        requirements of section 408(b)(2) or 408(c)(2) of the Federal 
        Food, Drug, and Cosmetic Act. Such decision shall be based only 
        on data received by the Administrator before the deadline in 
        subsection (b)(1) or before the expiration of an extension 
        granted under subsection (b)(4), whichever is later.
            (4) Seven-year deadline.--Within seven years of the date of 
        the enactment of this Act, the Administrator shall determine if 
        each tolerance or exemption in existence on the date of 
        enactment of this Act and not identified in subsection (a) 
        meets the requirements of section 408(b)(2) or 408(c)(2) of the 
        Federal Food, Drug, and Cosmetic Act. Such determination shall 
        be based only on data received by the Administrator before the 
        deadline in subsection (b)(2) or the deadline in a schedule 
        established by the Administrator for the pesticide chemical 
        residue under subsection (b)(3) or the expiration of an 
        extension granted under subsection (b)(4), whichever is later.
            (5) Revocation proceedings.--If the Administrator 
        determines under this subsection that any tolerance or 
        exemption does not meet the requirements of section 408(b)(2) 
        or 408(c)(2) of the Federal Food, Drug, and Cosmetic Act, the 
        Administrator shall promptly initiate revocation proceedings 
        for such tolerance or exemption under section 408(d) of such 
        Act.
    (d) Expiration of a Tolerance or Exemption.--
            (1) General rule.--No later than six and one-half years but 
        not before six years from the date of the enactment of this 
        Act, the Administrator shall publish a list of tolerances and 
        exemptions for pesticides chemical residues which shall expire 
        seven years after such date of enactment, unless the 
        Administrator--
                    (A) has issued a decision finding that such 
                pesticide chemical residue meets the requirements of 
                section 408(b)(2) or 408(c)(2) of the Federal Food, 
                Drug, and Cosmetic Act, or
                    (B) has granted an extension under paragraph (2).
            (2) Extension.--Upon petition of any person, the 
        Administrator may grant an extension beyond the seven-year 
        period in section (d)(1), of not more than one year for the 
        term of a tolerance or exemption for a pesticide chemical 
        residue if the Administrator finds that a person seeking to 
        support such tolerance or exemption has met all applicable 
        requirements for the submission of information or data required 
        by subsection (b), the Administrator has not completed review 
        of the data submitted pursuant to subsection (b), and the 
        extension would not adversely affect public health. Any 
        tolerance granted an extension under this paragraph shall 
        expire when the extension expires, unless prior to expiration 
        of the extension the Administrator makes the finding in 
        subparagraph (A).
            (3) List.--The Administrator shall include on the list 
        established under paragraph (1) each tolerance and exemption 
        which was identified under subsection (a)(1) or (a)(4) for 
        which the Administrator has not issued a decision classifying 
        it as meeting or not meeting the requirements of section 
        408(b)(2) or 408(c)(2) of the Federal Food, Drug, and Cosmetic 
        Act, and which the Administrator now determines do not appear 
        to meet such requirements. The Administrator shall develop such 
        list using the methodology specified in subsection (a)(2)(B) 
        and is only required to consider data submitted on or before 
        the expiration of the deadlines for data submission in 
        subsection (b).
            (4) Objections.--Any person adversely affected by the 
        Administrator's action under paragraph (1) may file objections 
        to the action with the Administrator. The person filing the 
        objection must file it within thirty days of the publication of 
        the list specified in paragraph (1), and must demonstrate, 
        using the methodology specified in subsection (a)(2)(B) and 
        considering only data submitted on or before the expiration of 
        the deadlines for data submission in subsection (b), that the 
        tolerance or exemption which was identified under subsection 
        (a)(1) or (a)(4) should not be included on the list under 
        paragraph (1). The Administrator shall act on such objections 
        within sixty days of the receipt of the objections.
    (e) Transitional Revocation Rule.--
            (1) General rule.--If the Administrator determines under 
        section 408 of the Federal Food, Drug, and Cosmetic Act that a 
        tolerance for a pesticide chemical residue should be revoked or 
        if a tolerance will expire within one year based on operation 
        of subsection (d), the Administrator may, upon a petition from 
        any person, extend the tolerance for a period not longer than 
        five years after such determination if the Administrator 
        finds--
                    (A) the risk to health presented by exposure to 
                such residue is equal to or less than ten times the 
                risk allowed under section 408(b)(2) of such Act, and
                    (B)(i) that the health benefits to the person 
                exposed to such residue are greater than the dietary 
                risks to health presented to such person by such 
                exposure, or
                    (ii) that such extension is necessary to avoid a 
                significant disruption in domestic food production.
        The Administrator may not extend a tolerance under this 
        paragraph for a period which extends beyond ten years after the 
        date of enactment of this Act.
            (2) Modification.--The Administrator may modify or revoke a 
        tolerance or exemption extended under paragraph (1), if the 
        Administrator determines that circumstances no longer justify 
        the continuation of such tolerance or exemption as extended.
            (3) Definitions.--For the purposes of this subsection, the 
        term ``health benefits'' means the benefits which occur when 
        the application of a pesticide chemical residue to a food 
        directly reduces the incidence of illness or disease but such 
        term does not include benefits from an adequate, wholesome, or 
        economical food supply.
    (f) Deadline Suits, Judicial Review.--
            (1) Deadline suits.--Any person may commence a civil action 
        on such person's own behalf against the Administrator in the 
        United States District Court for the District of Columbia where 
        there is alleged a failure of the Administrator to perform any 
        of the nondiscretionary acts required by subsections (c)(2), 
        (c)(3), or (c)(4). The court shall have jurisdiction in actions 
        brought under this paragraph to order the Administrator to 
        perform such act. For suits involving subsections (c)(2) or 
        (c)(3), if the court finds that the Administrator has failed to 
        perform a nondiscretionary act, the court shall have 
        jurisdiction to order the Administrator to perform such act 
        within a specified period of time, but that period may not 
        exceed eight years after the date of enactment of this Act. 
        Suits involving subsections (c)(2) or (c)(3) must be brought 
        within six years of the date of the enactment of this Act. No 
        action may be commenced prior to sixty days after the plaintiff 
        has given notice of such action to the Administrator.
            (2) Judicial review.--A petition for review of a final 
        action of the Administrator under subsection (a)(3), (a)(4), 
        (d)(2), (d)(3) or (e)(1) may be filed by any adversely affected 
        person only in the United States Court of Appeals for the 
        District of Columbia Circuit. Any such petition for review must 
        be filed within sixty days of the issuance of the final action. 
        Judicial review shall be in accordance with sections 701 
        through 706 of title 5 of the United States Code, and the 
        challenged action shall be sustained unless it is found to be 
        arbitrary, capricious, an abuse of discretion, or not in 
        accordance with law. Any determinations made by the 
        Administrator under subsections (b) or (c), shall be subject to 
        judicial review only in a petition for review of a final action 
        of the Administrator under section 408(d) of the Federal Food, 
        Drug, and Cosmetic Act pursuant to section 408(j) of such Act. 
        In reviewing a final action of the Administrator under 
        subsection (a)(3), the court may not extend the deadline for 
        data submission in subsection (b)(1). Actions of the 
        Administrator with respect to which review could have been 
        obtained under this subsection shall not be subject to judicial 
        review in civil or criminal proceedings for enforcement or 
        other judicial proceedings.
    (g) Report to Congress.--The Administrator shall annually submit a 
report to Congress that lists the tolerances which have been revoked 
pursuant to tolerance review. The report shall also provide an analysis 
of the impacts of tolerance revocation.
    (h) Construction.--Any reference under this section to any 
provision of section 408 of the Federal Food, Drug, and Cosmetic Act is 
a reference to such provision as amended by this Act.

SEC. 8. FEES.

    (a) General Rule.--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 Act. The fee requirement of this subsection 
shall not apply to any agency of the Federal Government.
    (b) Deposit, and so Forth.--Such fees shall be deposited in the 
Treasury and shall be credited to the appropriation account of the 
Administrator for salaries and expenses and shall be available for 
costs incurred in carrying out this section in accordance with 
appropriation Acts until expended without fiscal year limitation.

SEC. 9. 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.

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