between infants and children and adults, and effects of

                in utero exposure to pesticide chemicals; and

                    (III) available information concerning the

                cumulative effects on infants and children of such

                residues and other substances that have a common

                mechanism of toxicity; and

                (ii) shall--

                    (I) ensure that there is a reasonable certainty that

                no harm will result to infants and children from

                aggregate exposure to the pesticide chemical residue;

                and

                    (II) publish a specific determination regarding the

                safety of the pesticide chemical residue for infants and

                children.

        The Secretary of Health and Human Services and the Secretary of

        Agriculture, in consultation with the Administrator, shall

        conduct surveys to document dietary exposure to pesticides among

        infants and children. In the case of threshold effects, for

        purposes of clause (ii)(I) an additional tenfold margin of

        safety for the pesticide chemical residue and other sources of

        exposure shall be applied for infants and children to take into

        account potential pre- and post-natal toxicity and completeness

        of the data with respect to exposure and toxicity to infants and

        children. Notwithstanding such requirement for an additional

        margin of safety, the Administrator may use a different margin

        of safety for the pesticide chemical residue only if, on the

        basis of reliable data, such margin will be safe for infants and

        children.

        (D) Factors

            In establishing, modifying, leaving in effect, or revoking a

        tolerance or exemption for a pesticide chemical residue, the

        Administrator shall consider, among other relevant factors--

                (i) the validity, completeness, and reliability of the

            available data from studies of the pesticide chemical and

            pesticide chemical residue;

                (ii) the nature of any toxic effect shown to be caused

            by the pesticide chemical or pesticide chemical residue in

            such studies;

                (iii) available information concerning the relationship

            of the results of such studies to human risk;

                (iv) available information concerning the dietary

            consumption patterns of consumers (and major identifiable

            subgroups of consumers);

                (v) available information concerning the cumulative

            effects of such residues and other substances that have a

            common mechanism of toxicity;

                (vi) available information concerning the aggregate

            exposure levels of consumers (and major identifiable

            subgroups of consumers) to the pesticide chemical residue

            and to other related substances, including dietary exposure

            under the tolerance and all other tolerances in effect for

            the pesticide chemical residue, and exposure from other non-

            occupational sources;

                (vii) available information concerning the variability

            of the sensitivities of major identifiable subgroups of

            consumers;

                (viii) such information as the Administrator may require

            on whether the pesticide chemical may have an effect in

            humans that is similar to an effect produced by a naturally

            occurring estrogen or other endocrine effects; and

                (ix) safety factors which in the opinion of experts

            qualified by scientific training and experience to evaluate

            the safety of food additives are generally recognized as

            appropriate for the use of animal experimentation data.

        (E) Data and information regarding anticipated and actual

                residue levels

            (i) Authority

                In establishing, modifying, leaving in effect, or

            revoking a tolerance for a pesticide chemical residue, the

            Administrator may consider available data and information on

            the anticipated residue levels of the pesticide chemical in

            or on food and the actual residue levels of the pesticide

            chemical that have been measured in food, including residue

            data collected by the Food and Drug Administration.

            (ii) Requirement

                If the Administrator relies on anticipated or actual

            residue levels in establishing, modifying, or leaving in

            effect a tolerance, the Administrator shall pursuant to

            subsection (f)(1) of this section require that data be

            provided five years after the date on which the tolerance is

            established, modified, or left in effect, and thereafter as

            the Administrator deems appropriate, demonstrating that such

            residue levels are not above the levels so relied on. If

            such data are not so provided, or if the data do not

            demonstrate that the residue levels are not above the levels

            so relied on, the Administrator shall, not later than 180

            days after the date on which the data were required to be

            provided, issue a regulation under subsection (e)(1) of this

            section, or an order under subsection (f)(2) of this

            section, as appropriate, to modify or revoke the tolerance.

        (F) Percent of food actually treated

            In establishing, modifying, leaving in effect, or revoking a

        tolerance for a pesticide chemical residue, the Administrator

        may, when assessing chronic dietary risk, consider available

        data and information on the percent of food actually treated

        with the pesticide chemical (including aggregate pesticide use

        data collected by the Department of Agriculture) only if the

        Administrator--

                (i) finds that the data are reliable and provide a valid

            basis to show what percentage of the food derived from such

            crop is likely to contain such pesticide chemical residue;

                (ii) finds that the exposure estimate does not

            understate exposure for any significant subpopulation group;

                (iii) finds that, if data are available on pesticide use

            and consumption of food in a particular area, the population

            in such area is not dietarily exposed to residues above

            those estimated by the Administrator; and

                (iv) provides for the periodic reevaluation of the

            estimate of anticipated dietary exposure.

                        (3) Detection methods

        (A) General rule

            A tolerance for a pesticide chemical residue in or on a food

        shall not be established or modified by the Administrator unless

        the Administrator determines, after consultation with the

        Secretary, that there is a practical method for detecting and

        measuring the levels of the pesticide chemical residue in or on

        the food.

        (B) Detection limit

            A tolerance for a pesticide chemical residue in or on a food

        shall not be established at or modified to a level lower than

        the limit of detection of the method for detecting and measuring

        the pesticide chemical residue specified by the Administrator

        under subparagraph (A).

                     (4) International standards

        In establishing a tolerance for a pesticide chemical residue in

    or on a food, the Administrator shall determine whether a maximum

    residue level for the pesticide chemical has been established by the

    Codex Alimentarius Commission. If a Codex maximum residue level has

    been established for the pesticide chemical and the Administrator

    does not propose to adopt the Codex level, the Administrator shall

    publish for public comment a notice explaining the reasons for

    departing from the Codex level.

(c) Authority and standard for exemptions

                            (1) Authority

        The Administrator may issue a regulation establishing,

    modifying, or revoking an exemption from the requirement for a

    tolerance for a pesticide chemical residue in or on food--

            (A) in response to a petition filed under subsection (d) of

        this section; or

            (B) on the Administrator's initiative under subsection (e)

        of this section.

                            (2) Standard

        (A) General rule

            (i) Standard

                The Administrator may establish or leave in effect an

            exemption from the requirement for a tolerance for a

            pesticide chemical residue in or on food only if the

            Administrator determines that the exemption is safe. The

            Administrator shall modify or revoke an exemption if the

            Administrator determines it is not safe.

            (ii) Determination of safety

                The term ``safe'', with respect to an exemption for a

            pesticide chemical residue, means that the Administrator has

            determined that there is a reasonable certainty that no harm

            will result from aggregate exposure to the pesticide

            chemical residue, including all anticipated dietary

            exposures and all other exposures for which there is

            reliable information.

        (B) Factors

            In making a determination under this paragraph, the

        Administrator shall take into account, among other relevant

        considerations, the considerations set forth in subparagraphs

        (C) and (D) of subsection (b)(2) of this section.

                           (3) Limitation

        An exemption from the requirement for a tolerance for a

    pesticide chemical residue in or on food shall not be established or

    modified by the Administrator unless the Administrator determines,

    after consultation with the Secretary--

            (A) that there is a practical method for detecting and

        measuring the levels of such pesticide chemical residue in or on

        food; or

            (B) that there is no need for such a method, and states the

        reasons for such determination in issuing the regulation

        establishing or modifying the exemption.

(d) Petition for tolerance or exemption

                    (1) Petitions and petitioners

        Any person may file with the Administrator a petition proposing

    the issuance of a regulation--

            (A) establishing, modifying, or revoking a tolerance for a

        pesticide chemical residue in or on a food; or

            (B) establishing, modifying, or revoking an exemption from

        the requirement of a tolerance for such a residue.

                        (2) Petition contents

        (A) Establishment

            A petition under paragraph (1) to establish a tolerance or

        exemption for a pesticide chemical residue shall be supported by

        such data and information as are specified in regulations issued

        by the Administrator, including--

                (i)(I) an informative summary of the petition and of the

            data, information, and arguments submitted or cited in

            support of the petition; and

                (II) a statement that the petitioner agrees that such

            summary or any information it contains may be published as a

            part of the notice of filing of the petition to be published

            under this subsection and as part of a proposed or final

            regulation issued under this section;

                (ii) the name, chemical identity, and composition of the

            pesticide chemical residue and of the pesticide chemical

            that produces the residue;

                (iii) data showing the recommended amount, frequency,

            method, and time of application of that pesticide chemical;

                (iv) full reports of tests and investigations made with

            respect to the safety of the pesticide chemical, including

            full information as to the methods and controls used in

            conducting those tests and investigations;

                (v) full reports of tests and investigations made with

            respect to the nature and amount of the pesticide chemical

            residue that is likely to remain in or on the food,

            including a description of the analytical methods used;

                (vi) a practical method for detecting and measuring the

            levels of the pesticide chemical residue in or on the food,

            or for exemptions, a statement why such a method is not

            needed;

                (vii) a proposed tolerance for the pesticide chemical

            residue, if a tolerance is proposed;

                (viii) if the petition relates to a tolerance for a

            processed food, reports of investigations conducted using

            the processing method(s) used to produce that food;

                (ix) such information as the Administrator may require

            to make the determination under subsection (b)(2)(C) of this

            section;

                (x) such information as the Administrator may require on

            whether the pesticide chemical may have an effect in humans

            that is similar to an effect produced by a naturally

            occurring estrogen or other endocrine effects;

                (xi) information regarding exposure to the pesticide

            chemical residue due to any tolerance or exemption already

            granted for such residue;

                (xii) practical methods for removing any amount of the

            residue that would exceed any proposed tolerance; and

                (xiii) such other data and information as the

            Administrator requires by regulation to support the

            petition.

        If information or data required by this subparagraph is

        available to the Administrator, the person submitting the

        petition may cite the availability of the information or data in

        lieu of submitting it. The Administrator may require a petition

        to be accompanied by samples of the pesticide chemical with

        respect to which the petition is filed.

        (B) Modification or revocation

            The Administrator may by regulation establish the

        requirements for information and data to support a petition to

        modify or revoke a tolerance or to modify or revoke an exemption

        from the requirement for a tolerance.

                             (3) Notice

        A notice of the filing of a petition that the Administrator

    determines has met the requirements of paragraph (2) shall be

    published by the Administrator within 30 days after such

    determination. The notice shall announce the availability of a

    description of the analytical methods available to the Administrator

    for the detection and measurement of the pesticide chemical residue

    with respect to which the petition is filed or shall set forth the

    petitioner's statement of why such a method is not needed. The

    notice shall include the summary required by paragraph (2)(A)(i)(I).

                  (4) Actions by the Administrator

        (A) In general

            The Administrator shall, after giving due consideration to a

        petition filed under paragraph (1) and any other information

        available to the Administrator--

                (i) issue a final regulation (which may vary from that

            sought by the petition) establishing, modifying, or revoking

            a tolerance for the pesticide chemical residue or an

            exemption of the pesticide chemical residue from the

            requirement of a tolerance (which final regulation shall be

            issued without further notice and without further period for

            public comment);

                (ii) issue a proposed regulation under subsection (e) of

            this section, and thereafter issue a final regulation under

            such subsection; or

                (iii) issue an order denying the petition.

        (B) Priorities

            The Administrator shall give priority to petitions for the

        establishment or modification of a tolerance or exemption for a

        pesticide chemical residue that appears to pose a significantly

        lower risk to human health from dietary exposure than pesticide

        chemical residues that have tolerances in effect for the same or

        similar uses.

        (C) Expedited review of certain petitions

            (i) Date certain for review

                If a person files a complete petition with the

            Administrator proposing the issuance of a regulation

            establishing a tolerance or exemption for a pesticide

            chemical residue that presents a lower risk to human health

            than a pesticide chemical residue for which a tolerance has

            been left in effect or modified under subsection (b)(2)(B)

            of this section, the Administrator shall complete action on

            such petition under this paragraph within 1 year.

            (ii) Required determinations

                If the Administrator issues a final regulation

            establishing a tolerance or exemption for a safer pesticide

            chemical residue under clause (i), the Administrator shall,

            not later than 180 days after the date on which the

            regulation is issued, determine whether a condition

            described in subclause (I) or (II) of subsection

            (b)(2)(B)(iii) of this section continues to exist with

            respect to a tolerance that has been left in effect or

            modified under subsection (b)(2)(B) of this section. If such

            condition does not continue to exist, the Administrator

            shall, not later than 180 days after the date on which the

            determination under the preceding sentence is made, issue a

            regulation under subsection (e)(1) of this section to modify

            or revoke the tolerance.

(e) Action on Administrator's own initiative

                          (1) General rule

        The Administrator may issue a regulation--

            (A) establishing, modifying, suspending under subsection

        (l)(3) of this section, or revoking a tolerance for a pesticide

        chemical or a pesticide chemical residue;

            (B) establishing, modifying, suspending under subsection

        (l)(3) of this section, or revoking an exemption of a pesticide

        chemical residue from the requirement of a tolerance; or

            (C) establishing general procedures and requirements to

        implement this section.

                             (2) Notice

        Before issuing a final regulation under paragraph (1), the

    Administrator shall issue a notice of proposed rulemaking and

    provide a period of not less than 60 days for public comment on the

    proposed regulation, except that a shorter period for comment may be

    provided if the Administrator for good cause finds that it would be

    in the public interest to do so and states the reasons for the

    finding in the notice of proposed rulemaking.

(f) Special data requirements

             (1) Requiring submission of additional data

        If the Administrator determines that additional data or

    information are reasonably required to support the continuation of a

    tolerance or exemption that is in effect under this section for a

    pesticide chemical residue on a food, the Administrator shall--

            (A) issue a notice requiring the person holding the

        pesticide registrations associated with such tolerance or

        exemption to submit the data or information under section

        3(c)(2)(B) of the Federal Insecticide, Fungicide, and

        Rodenticide Act [7 U.S.C. 136a(c)(2)(B)];

            (B) issue a rule requiring that testing be conducted on a

        substance or mixture under section 4 of the Toxic Substances

        Control Act [15 U.S.C. 2603]; or

            (C) publish in the Federal Register, after first providing

        notice and an opportunity for comment of not less than 60 days'

        duration, an order--

                (i) requiring the submission to the Administrator by one

            or more interested persons of a notice identifying the

            person or persons who will submit the required data and

            information;

                (ii) describing the type of data and information

            required to be submitted to the Administrator and stating

            why the data and information could not be obtained under the

            authority of section 3(c)(2)(B) of the Federal Insecticide,

            Fungicide, and Rodenticide Act [7 U.S.C. 136a(c)(2)(B)] or

            section 4 of the Toxic Substances Control Act [15 U.S.C.

            2603];

                (iii) describing the reports of the Administrator

            required to be prepared during and after the collection of

            the data and information;

                (iv) requiring the submission to the Administrator of

            the data, information, and reports referred to in clauses

            (ii) and (iii); and

                (v) establishing dates by which the submissions

            described in clauses (i) and (iv) must be made.

        The Administrator may under subparagraph (C) revise any such

        order to correct an error. The Administrator may under this

        paragraph require data or information pertaining to whether the

        pesticide chemical may have an effect in humans that is similar

        to an effect produced by a naturally occurring estrogen or other

        endocrine effects.

                          (2) Noncompliance

        If a submission required by a notice issued in accordance with

    paragraph (1)(A), a rule issued under paragraph (1)(B), or an order

    issued under paragraph (1)(C) is not made by the time specified in

    such notice, rule, or order, the Administrator may by order

    published in the Federal Register modify or revoke the tolerance or

    exemption in question. In any review of such an order under

    subsection (g)(2) of this section, the only material issue shall be

    whether a submission required under paragraph (1) was not made by

    the time specified.

(g) Effective date, objections, hearings, and administrative review

                         (1) Effective date

        A regulation or order issued under subsection (d)(4), (e)(1), or

    (f)(2) of this section shall take effect upon publication unless the

    regulation or order specifies otherwise. The Administrator may stay

    the effectiveness of the regulation or order if, after issuance of

    such regulation or order, objections are filed with respect to such

    regulation or order pursuant to paragraph (2).

                       (2) Further proceedings

        (A) Objections

            Within 60 days after a regulation or order is issued under

        subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or

        (n)(5)(C) of this section, any person may file objections

        thereto with the Administrator, specifying with particularity

        the provisions of the regulation or order deemed objectionable

        and stating reasonable grounds therefor. If the regulation or

        order was issued in response to a petition under subsection

        (d)(1) of this section, a copy of each objection filed by a

        person other than the petitioner shall be served by the

        Administrator on the petitioner.

        (B) Hearing

            An objection may include a request for a public evidentiary

        hearing upon the objection. The Administrator shall, upon the

        initiative of the Administrator or upon the request of an

        interested person and after due notice, hold a public

        evidentiary hearing if and to the extent the Administrator

        determines that such a public hearing is necessary to receive

        factual evidence relevant to material issues of fact raised by

        the objections. The presiding officer in such a hearing may

        authorize a party to obtain discovery from other persons and may

        upon a showing of good cause made by a party issue a subpoena to

        compel testimony or production of documents from any person. The

        presiding officer shall be governed by the Federal Rules of

        Civil Procedure in making any order for the protection of the

        witness or the content of documents produced and shall order the

        payment of reasonable fees and expenses as a condition to

        requiring testimony of the witness. On contest, such a subpoena

        may be enforced by a Federal district court.

        (C) Final decision

            As soon as practicable after receiving the arguments of the

        parties, the Administrator shall issue an order stating the

        action taken upon each such objection and setting forth any

        revision to the regulation or prior order that the Administrator

        has found to be warranted. If a hearing was held under

        subparagraph (B), such order and any revision to the regulation

        or prior order shall, with respect to questions of fact at issue

        in the hearing, be based only on substantial evidence of record

        at such hearing, and shall set forth in detail the findings of

        facts and the conclusions of law or policy upon which the order

        or regulation is based.

(h) Judicial review

                            (1) Petition

        In a case of actual controversy as to the validity of any

    regulation issued under subsection (e)(1)(C) of this section, or any

    order issued under subsection (f)(1)(C) or (g)(2)(C) of this

    section, or any regulation that is the subject of such an order, any

    person who will be adversely affected by such order or regulation

    may obtain judicial review by filing in the United States Court of

    Appeals for the circuit wherein that person resides or has its

    principal place of business, or in the United States Court of

    Appeals for the District of Columbia Circuit, within 60 days after

    publication of such order or regulation, a petition praying that the

    order or regulation be set aside in whole or in part.

                     (2) Record and jurisdiction

        A copy of the petition under paragraph (1) shall be forthwith

    transmitted by the clerk of the court to the Administrator, or any

    officer designated by the Administrator for that purpose, and

    thereupon the Administrator shall file in the court the record of

    the proceedings on which the Administrator based the order or

    regulation, as provided in section 2112 of title 28. Upon the filing

    of such a petition, the court shall have exclusive jurisdiction to

    affirm or set aside the order or regulation complained of in whole

    or in part. As to orders issued following a public evidentiary

    hearing, the findings of the Administrator with respect to questions

    of fact shall be sustained only if supported by substantial evidence

    when considered on the record as a whole.

                       (3) Additional evidence

        If a party applies to the court for leave to adduce additional

    evidence and shows to the satisfaction of the court that the

    additional evidence is material and that there were reasonable

    grounds for the failure to adduce the evidence in the proceeding

    before the Administrator, the court may order that the additional

    evidence (and evidence in rebuttal thereof) shall be taken before

    the Administrator in the manner and upon the terms and conditions

    the court deems proper. The Administrator may modify prior findings

    as to the facts by reason of the additional evidence so taken and

    may modify the order or regulation accordingly. The Administrator

    shall file with the court any such modified finding, order, or

    regulation.

              (4) Final judgment; Supreme Court review

        The judgment of the court affirming or setting aside, in whole

    or in part, any regulation or any order and any regulation which is

    the subject of such an order shall be final, subject to review by

    the Supreme Court of the United States as provided in section 1254

    of title 28. The commencement of proceedings under this subsection

    shall not, unless specifically ordered by the court to the contrary,

    operate as a stay of a regulation or order.

                           (5) Application

        Any issue as to which review is or was obtainable under this

    subsection shall not be the subject of judicial review under any

    other provision of law.

(i) Confidentiality and use of data

                          (1) General rule

        Data and information that are or have been submitted to the

    Administrator under this section or section 348 of this title in

    support of a tolerance or an exemption from a tolerance shall be

    entitled to confidential treatment for reasons of business

    confidentiality and to exclusive use and data compensation to the

    same extent provided by sections 3 and 10 of the Federal

    Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136a, 136h].

                           (2) Exceptions

        (A) In general

            Data and information that are entitled to confidential

        treatment under paragraph (1) may be disclosed, under such

        security requirements as the Administrator may provide by

        regulation, to--

                (i) employees of the United States authorized by the

            Administrator to examine such data and information in the

            carrying out of their official duties under this chapter or

            other Federal statutes intended to protect the public

            health; or

                (ii) contractors with the United States authorized by

            the Administrator to examine such data and information in

            the carrying out of contracts under this chapter or such

            statutes.

        (B) Congress

            This subsection does not authorize the withholding of data

        or information from either House of Congress or from, to the

        extent of matter within its jurisdiction, any committee or

        subcommittee of such committee or any joint committee of

        Congress or any subcommittee of such joint committee.

                            (3) Summaries

        Notwithstanding any provision of this subsection or other law,

    the Administrator may publish the informative summary required by

    subsection (d)(2)(A)(i) of this section and may, in issuing a

    proposed or final regulation or order under this section, publish an

    informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

                  (1) Regulations under section 346

        Regulations affecting pesticide chemical residues in or on raw

    agricultural commodities promulgated, in accordance with section

    371(e) of this title, under the authority of section 346(a) \1\ of

    this title upon the basis of public hearings instituted before

    January 1, 1953, shall be deemed to be regulations issued under this

    section and shall be subject to modification or revocation under

    subsections (d) and (e) of this section, and shall be subject to

    review under subsection (q) of this section.

------------------------------------------------------------------------ ---

    \1\ See References in Text note below.

------------------------------------------------------------------------ ---

                  (2) Regulations under section 348

        Regulations that established tolerances for substances that are

    pesticide chemical residues in or on processed food, or that

    otherwise stated the conditions under which such pesticide chemicals

    could be safely used, and that were issued under section 348 of this

    title on or before August 3, 1996, shall be deemed to be regulations

    issued under this section and shall be subject to modification or

    revocation under subsection (d) or (e) of this section, and shall be

    subject to review under subsection (q) of this section.

                 (3) Regulations under section 346a

        Regulations that established tolerances or exemptions under this

    section that were issued on or before August 3, 1996, shall remain

    in effect unless modified or revoked under subsection (d) or (e) of

    this section, and shall be subject to review under subsection (q) of

    this section.

                       (4) Certain substances

        With respect to a substance that is not included in the

    definition of the term ``pesticide chemical'' under section

    321(q)(1) of this title but was so included on the day before

    October 30, 1998, the following applies as of October 30, 1998:

            (A) Notwithstanding paragraph (2), any regulation applying

        to the use of the substance that was in effect on the day before

        October 30, 1998, and was on such day deemed in such paragraph

        to have been issued under this section, shall be considered to

        have been issued under section 348 of this title.

            (B) Notwithstanding paragraph (3), any regulation applying

        to the use of the substance that was in effect on such day and

        was issued under this section (including any such regulation

        issued before August 3, 1996) is deemed to have been issued

        under section 348 of this title.

(k) Transitional provision

    If, on the day before August 3, 1996, a substance that is a

pesticide chemical was, with respect to a particular pesticidal use of

the substance and any resulting pesticide chemical residue in or on a

particular food--

        (1) regarded by the Administrator or the Secretary as generally

    recognized as safe for use within the meaning of the provisions of

    subsection (a) of this section or section 321(s) of this title as

    then in effect; or

        (2) regarded by the Secretary as a substance described by

    section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the

requirement for a tolerance, as of August 3, 1996. The Administrator

shall by regulation indicate which substances are described by this

subsection. Any exemption under this subsection may be modified or

revoked as if it had been issued under subsection (c) of this section.

(l) Harmonization with action under other laws

                     (1) Coordination with FIFRA

        To the extent practicable and consistent with the review

    deadlines in subsection (q) of this section, in issuing a final rule

    under this subsection that suspends or revokes a tolerance or

    exemption for a pesticide chemical residue in or on food, the

    Administrator shall coordinate such action with any related

    necessary action under the Federal Insecticide, Fungicide, and

    Rodenticide Act [7 U.S.C. 136 et seq.].

         (2) Revocation of tolerance or exemption following

                  cancellation of associated registrations

        If the Administrator, acting under the Federal Insecticide,

    Fungicide, and Rodenticide Act, cancels the registration of each

    pesticide that contains a particular pesticide chemical and that is

    labeled for use on a particular food, or requires that the

    registration of each such pesticide be modified to prohibit its use

    in connection with the production, storage, or transportation of

    such food, due in whole or in part to dietary risks to humans posed

    by residues of that pesticide chemical on that food, the

    Administrator shall revoke any tolerance or exemption that allows

    the presence of the pesticide chemical, or any pesticide chemical

    residue that results from its use, in or on that food. Subsection

    (e) of this section shall apply to actions taken under this

    paragraph. A revocation under this paragraph shall become effective

    not later than 180 days after--

            (A) the date by which each such cancellation of a

        registration has become effective; or

            (B) the date on which the use of the canceled pesticide

        becomes unlawful under the terms of the cancellation, whichever

        is later.

         (3) Suspension of tolerance or exemption following

                   suspension of associated registrations

        (A) Suspension

            If the Administrator, acting under the Federal Insecticide,

        Fungicide, and Rodenticide Act, suspends the use of each

        registered pesticide that contains a particular pesticide

        chemical and that is labeled for use on a particular food, due

        in whole or in part to dietary risks to humans posed by residues

        of that pesticide chemical on that food, the Administrator shall

        suspend any tolerance or exemption that allows the presence of

        the pesticide chemical, or any pesticide chemical residue that

        results from its use, in or on that food. Subsection (e) of this

        section shall apply to actions taken under this paragraph. A

        suspension under this paragraph shall become effective not later

        than 60 days after the date by which each such suspension of use

        has become effective.

        (B) Effect of suspension

            The suspension of a tolerance or exemption under

        subparagraph (A) shall be effective as long as the use of each

        associated registration of a pesticide is suspended under the

        Federal Insecticide, Fungicide, and Rodenticide Act. While a

        suspension of a tolerance or exemption is effective the

        tolerance or exemption shall not be considered to be in effect.

        If the suspension of use of the pesticide under that Act is

        terminated, leaving the registration of the pesticide for such

        use in effect under that Act, the Administrator shall rescind

        any associated suspension of tolerance or exemption.

               (4) Tolerances for unavoidable residues

        In connection with action taken under paragraph (2) or (3), or

    with respect to pesticides whose registrations were suspended or

    canceled prior to August 3, 1996, under the Federal Insecticide,

    Fungicide, and Rodenticide Act, if the Administrator determines that

    a residue of the canceled or suspended pesticide chemical will

    unavoidably persist in the environment and thereby be present in or

    on a food, the Administrator may establish a tolerance for the

    pesticide chemical residue. In establishing such a tolerance, the

    Administrator shall take into account both the factors set forth in

    subsection (b)(2) of this section and the unavoidability of the

    residue. Subsection (e) of this section shall apply to the

    establishment of such tolerance. The Administrator shall review any

    such tolerance periodically and modify it as necessary so that it

    allows no greater level of the pesticide chemical residue than is

    unavoidable.

    (5) Pesticide residues resulting from lawful application of

                                  pesticide

        Notwithstanding any other provision of this chapter, if a

    tolerance or exemption for a pesticide chemical residue in or on a

    food has been revoked, suspended, or modified under this section, an

    article of that food shall not be deemed unsafe solely because of

    the presence of such pesticide chemical residue in or on such food

    if it is shown to the satisfaction of the Secretary that--

            (A) the residue is present as the result of an application

        or use of a pesticide at a time and in a manner that was lawful

        under the Federal Insecticide, Fungicide, and Rodenticide Act;

        and

            (B) the residue does not exceed a level that was authorized

        at the time of that application or use to be present on the food

        under a tolerance, exemption, food additive regulation, or other

        sanction then in effect under this chapter;

    unless, in the case of any tolerance or exemption revoked,

    suspended, or modified under this subsection or subsection (d) or

    (e) of this section, the Administrator has issued a determination

    that consumption of the legally treated food during the period of

    its likely availability in commerce will pose an unreasonable

    dietary risk.

       (6) Tolerance for use of pesticides under an emergency

                                  exemption

        If the Administrator grants an exemption under section 18 of the

    Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136p)

    for a pesticide chemical, the Administrator shall establish a

    tolerance or exemption from the requirement for a tolerance for the

    pesticide chemical residue. Such a tolerance or exemption from a

    tolerance shall have an expiration date. The Administrator may

    establish such a tolerance or exemption without providing notice or

    a period for comment on the tolerance or exemption. The

    Administrator shall promulgate regulations within 365 days after

    August 3, 1996, governing the establishment of tolerances and

    exemptions under this paragraph. Such regulations shall be

    consistent with the safety standard under subsections (b)(2) and

    (c)(2) of this section and with section 18 of the Federal

    Insecticide, Fungicide, and Rodenticide Act.

(m) Fees

                             (1) Amount

        The Administrator shall by regulation require the payment of

    such fees as will in the aggregate, in the judgment of the

    Administrator, be sufficient over a reasonable term to provide,

    equip, and maintain an adequate service for the performance of the

    Administrator's functions under this section. Under the regulations,

    the performance of the Administrator's services or other functions

    under this section, including--

            (A) the acceptance for filing of a petition submitted under

        subsection (d) of this section;

            (B) establishing, modifying, leaving in effect, or revoking

        a tolerance or establishing, modifying, leaving in effect, or

        revoking an exemption from the requirement for a tolerance under

        this section;

            (C) the acceptance for filing of objections under subsection

        (g) of this section; or

            (D) the certification and filing in court of a transcript of

        the proceedings and the record under subsection (h) of this

        section;

    may be conditioned upon the payment of such fees. The regulations

    may further provide for waiver or refund of fees in whole or in part

    when in the judgment of the Administrator such a waiver or refund is

    equitable and not contrary to the purposes of this subsection.

                             (2) Deposit

        All fees collected under paragraph (1) shall be deposited in the

    Reregistration and Expedited Processing Fund created by section 4(k)

    of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

    136a-1(k)]. Such fees shall be available to the Administrator,

    without fiscal year limitation, for the performance of the

    Administrator's services or functions as specified in paragraph (1).

(n) National uniformity of tolerances

        (1) ``Qualifying pesticide chemical residue'' defined

        For purposes of this subsection, the term ``qualifying pesticide

    chemical residue'' means a pesticide chemical residue resulting from

    the use, in production, processing, or storage of a food, of a

    pesticide chemical that is an active ingredient and that--

            (A) was first approved for such use in a registration of a

        pesticide issued under section 3(c)(5) of the Federal

        Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.

        136a(c)(5)] on or after April 25, 1985, on the basis of data

        determined by the Administrator to meet all applicable

        requirements for data prescribed by regulations in effect under

        that Act [7 U.S.C. 136 et seq.] on April 25, 1985; or

            (B) was approved for such use in a reregistration

        eligibility determination issued under section 4(g) of that Act

        [7 U.S.C. 136a-1(g)] on or after August 3, 1996.

          (2) ``Qualifying Federal determination'' defined

        For purposes of this subsection, the term ``qualifying Federal

    determination'' means a tolerance or exemption from the requirement

    for a tolerance for a qualifying pesticide chemical residue that--

            (A) is issued under this section after August 3, 1996, and

        determined by the Administrator to meet the standard under

        subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in

        the case of an exemption) of this section; or

            (B)(i) pursuant to subsection (j) of this section is

        remaining in effect or is deemed to have been issued under this

        section, or is regarded under subsection (k) of this section as

        exempt from the requirement for a tolerance; and

            (ii) is determined by the Administrator to meet the standard

        under subsection (b)(2)(A) (in the case of a tolerance) or

        (c)(2) (in the case of an exemption) of this section.

                           (3) Limitation

        The Administrator may make the determination described in

    paragraph (2)(B)(ii) only by issuing a rule in accordance with the

    procedure set forth in subsection (d) or (e) of this section and

    only if the Administrator issues a proposed rule and allows a period

    of not less than 30 days for comment on the proposed rule. Any such

    rule shall be reviewable in accordance with subsections (g) and (h)

    of this section.

                         (4) State authority

        Except as provided in paragraphs (5), (6), and (8) no State or

    political subdivision may establish or enforce any regulatory limit

    on a qualifying pesticide chemical residue in or on any food if a

    qualifying Federal determination applies to the presence of such

    pesticide chemical residue in or on such food, unless such State

    regulatory limit is identical to such qualifying Federal

    determination. A State or political subdivision shall be deemed to

    establish or enforce a regulatory limit on a pesticide chemical

    residue in or on a food if it purports to prohibit or penalize the

    production, processing, shipping, or other handling of a food

    because it contains a pesticide residue (in excess of a prescribed

    limit).

                       (5) Petition procedure

        (A) In general

            Any State may petition the Administrator for authorization

        to establish in such State a regulatory limit on a qualifying

        pesticide chemical residue in or on any food that is not

        identical to the qualifying Federal determination applicable to

        such qualifying pesticide chemical residue.

        (B) Petition requirements

            Any petition under subparagraph (A) shall--

                (i) satisfy any requirements prescribed, by rule, by the

            Administrator; and

                (ii) be supported by scientific data about the pesticide

            chemical residue that is the subject of the petition or

            about chemically related pesticide chemical residues, data

            on the consumption within such State of food bearing the

            pesticide chemical residue, and data on exposure of humans

            within such State to the pesticide chemical residue.

        (C) Authorization

            The Administrator may, by order, grant the authorization

        described in subparagraph (A) if the Administrator determines

        that the proposed State regulatory limit--

                (i) is justified by compelling local conditions; and

                (ii) would not cause any food to be a violation of

            Federal law.

        (D) Treatment

            In lieu of any action authorized under subparagraph (C), the

        Administrator may treat a petition under this paragraph as a

        petition under subsection (d) of this section to modify or

        revoke a tolerance or an exemption. If the Administrator

        determines to treat a petition under this paragraph as a

        petition under subsection (d) of this section, the Administrator

        shall thereafter act on the petition pursuant to subsection (d)

        of this section.

        (E) Review

            Any order of the Administrator granting or denying the

        authorization described in subparagraph (A) shall be subject to

        review in the manner described in subsections (g) and (h) of

        this section.

                    (6) Urgent petition procedure

        Any State petition to the Administrator pursuant to paragraph

    (5) that demonstrates that consumption of a food containing such

    pesticide residue level during the period of the food's likely

    availability in the State will pose a significant public health

    threat from acute exposure shall be considered an urgent petition.

    If an order by the Administrator to grant or deny the requested

    authorization in an urgent petition is not made within 30 days of

    receipt of the petition, the petitioning State may establish and

    enforce a temporary regulatory limit on a qualifying pesticide

    chemical residue in or on the food. The temporary regulatory limit

    shall be validated or terminated by the Administrator's final order

    on the petition.

                (7) Residues from lawful application

        No State or political subdivision may enforce any regulatory

    limit on the level of a pesticide chemical residue that may appear

    in or on any food if, at the time of the application of the

    pesticide that resulted in such residue, the sale of such food with

    such residue level was lawful under this section and under the law

    of such State, unless the State demonstrates that consumption of the

    food containing such pesticide residue level during the period of

    the food's likely availability in the State will pose an

    unreasonable dietary risk to the health of persons within such

    State.

                             (8) Savings

        Nothing in this chapter preempts the authority of any State or

    political subdivision to require that a food containing a pesticide

    chemical residue bear or be the subject of a warning or other

    statement relating to the presence of the pesticide chemical residue

    in or on such food.

(o) Consumer right to know

    Not later than 2 years after August 3, 1996, and annually

thereafter, the Administrator shall, in consultation with the Secretary

of Agriculture and the Secretary of Health and Human Services, publish

in a format understandable to a lay person, and distribute to large

retail grocers for public display (in a manner determined by the

grocer), the following information, at a minimum:

        (1) A discussion of the risks and benefits of pesticide chemical

    residues in or on food purchased by consumers.

        (2) A listing of actions taken under subparagraph (B) of

    subsection (b)(2) of this section that may result in pesticide

    chemical residues in or on food that present a yearly or lifetime

    risk above the risk allowed under subparagraph (A) of such

    subsection, and the food on which the pesticide chemicals producing

    the residues are used.

        (3) Recommendations to consumers for reducing dietary exposure

    to pesticide chemical residues in a manner consistent with

    maintaining a healthy diet, including a list of food that may

    reasonably substitute for food listed under paragraph (2).

    Nothing in this subsection shall prevent retail grocers from

providing additional information.

(p) Estrogenic substances screening program

                           (1) Development

        Not later than 2 years after August 3, 1996, the Administrator

    shall in consultation with the Secretary of Health and Human

    Services develop a screening program, using appropriate validated

    test systems and other scientifically relevant information, to

    determine whether certain substances may have an effect in humans

    that is similar to an effect produced by a naturally occurring

    estrogen, or such other endocrine effect as the Administrator may

    designate.

                         (2) Implementation

        Not later than 3 years after August 3, 1996, after obtaining

    public comment and review of the screening program described in

    paragraph (1) by the scientific advisory panel established under

    section 25(d) of the Federal Insecticide, Fungicide, and Rodenticide

    Act [7 U.S.C. 136w(d)] or the science advisory board established by

    section 4365 \2\ of title 42, the Administrator shall implement the

    program.

------------------------------------------------------------------------ ---

    \2\ See References in Text note below.

------------------------------------------------------------------------ ---

                           (3) Substances

        In carrying out the screening program described in paragraph

    (1), the Administrator--

            (A) shall provide for the testing of all pesticide

        chemicals; and

            (B) may provide for the testing of any other substance that

        may have an effect that is cumulative to an effect of a

        pesticide chemical if the Administrator determines that a

        substantial population may be exposed to such substance.

                            (4) Exemption

        Notwithstanding paragraph (3), the Administrator may, by order,

    exempt from the requirements of this section a biologic substance or

    other substance if the Administrator determines that the substance

    is anticipated not to produce any effect in humans similar to an

    effect produced by a naturally occurring estrogen.

                    (5) Collection of information

        (A) In general

            The Administrator shall issue an order to a registrant of a

        substance for which testing is required under this subsection,

        or to a person who manufactures or imports a substance for which

        testing is required under this subsection, to conduct testing in

        accordance with the screening program described in paragraph

        (1), and submit information obtained from the testing to the

        Administrator, within a reasonable time period that the

        Administrator determines is sufficient for the generation of the

        information.

        (B) Procedures

            To the extent practicable the Administrator shall minimize

        duplicative testing of the same substance for the same endocrine

        effect, develop, as appropriate, procedures for fair and

        equitable sharing of test costs, and develop, as necessary,

        procedures for handling of confidential business information.

        (C) Failure of registrants to submit information

            (i) Suspension

                If a registrant of a substance referred to in paragraph

            (3)(A) fails to comply with an order under subparagraph (A)

            of this paragraph, the Administrator shall issue a notice of

            intent to suspend the sale or distribution of the substance

            by the registrant. Any suspension proposed under this

            paragraph shall become final at the end of the 30-day period

            beginning on the date that the registrant receives the

            notice of intent to suspend, unless during that period a

            person adversely affected by the notice requests a hearing

            or the Administrator determines that the registrant has

            complied fully with this paragraph.

            (ii) Hearing

                If a person requests a hearing under clause (i), the

            hearing shall be conducted in accordance with section 554 of

            title 5. The only matter for resolution at the hearing shall

            be whether the registrant has failed to comply with an order

            under subparagraph (A) of this paragraph. A decision by the

            Administrator after completion of a hearing shall be

            considered to be a final agency action.

            (iii) Termination of suspensions

                The Administrator shall terminate a suspension under

            this subparagraph issued with respect to a registrant if the

            Administrator determines that the registrant has complied

            fully with this paragraph.

        (D) Noncompliance by other persons

            Any person (other than a registrant) who fails to comply

        with an order under subparagraph (A) shall be liable for the

        same penalties and sanctions as are provided under section 16 of

        the Toxic Substances Control Act [15 U.S.C. 2615] in the case of

        a violation referred to in that section. Such penalties and

        sanctions shall be assessed and imposed in the same manner as

        provided in such section 16.

                          (6) Agency action

        In the case of any substance that is found, as a result of

    testing and evaluation under this section, to have an endocrine

    effect on humans, the Administrator shall, as appropriate, take

    action under such statutory authority as is available to the

    Administrator, including consideration under other sections of this

    chapter, as is necessary to ensure the protection of public health.

                       (7) Report to Congress

        Not later than 4 years after August 3, 1996, the Administrator

    shall prepare and submit to Congress a report containing--

            (A) the findings of the Administrator resulting from the

        screening program described in paragraph (1);

            (B) recommendations for further testing needed to evaluate

        the impact on human health of the substances tested under the

        screening program; and

            (C) recommendations for any further actions (including any

        action described in paragraph (6)) that the Administrator

        determines are appropriate based on the findings.

(q) Schedule for review

                           (1) In general

        The Administrator shall review tolerances and exemptions for

    pesticide chemical residues in effect on the day before August 3,

    1996, as expeditiously as practicable, assuring that--

            (A) 33 percent of such tolerances and exemptions are

        reviewed within 3 years of August 3, 1996;

            (B) 66 percent of such tolerances and exemptions are

        reviewed within 6 years of August 3, 1996; and

            (C) 100 percent of such tolerances and exemptions are

        reviewed within 10 years of August 3, 1996.

    In conducting a review of a tolerance or exemption, the

    Administrator shall determine whether the tolerance or exemption

    meets the requirements of subsections \3\ (b)(2) or (c)(2) of this

    section and shall, by the deadline for the review of the tolerance

    or exemption, issue a regulation under subsection (d)(4) or (e)(1)

    of this section to modify or revoke the tolerance or exemption if

    the tolerance or exemption does not meet such requirements.

------------------------------------------------------------------------ ---

    \3\ So in original. Probably should be ``subsection''.

------------------------------------------------------------------------ ---

                           (2) Priorities

        In determining priorities for reviewing tolerances and

    exemptions under paragraph (1), the Administrator shall give

    priority to the review of the tolerances or exemptions that appear

    to pose the greatest risk to public health.

                     (3) Publication of schedule

        Not later than 12 months after August 3, 1996, the Administrator

    shall publish a schedule for review of tolerances and exemptions

    established prior to August 3, 1996. The determination of priorities

    for the review of tolerances and exemptions pursuant to this

    subsection is not a rulemaking and shall not be subject to judicial

    review, except that failure to take final action pursuant to the

    schedule established by this paragraph shall be subject to judicial

    review.

(r) Temporary tolerance or exemption

    The Administrator may, upon the request of any person who has

obtained an experimental permit for a pesticide chemical under the

Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136 et

seq.] or upon the Administrator's own initiative, establish a temporary

tolerance or exemption for the pesticide chemical residue for the uses

covered by the permit. Subsections (b)(2), (c)(2), (d), and (e) of this

section shall apply to actions taken under this subsection.

(s) Savings clause

    Nothing in this section shall be construed to amend or modify the

provisions of the Toxic Substances Control Act [15 U.S.C. 2601 et seq.]

or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C. 136

et seq.].

(June 25, 1938, ch. 675, Sec. 408, as added July 22, 1954, ch. 559,

Sec. 3, 68 Stat. 511; amended Pub. L. 85-791, Sec. 20, Aug. 28, 1958, 72

Stat. 947; Pub. L. 91-515, title VI, Sec. 601(d)(1), Oct. 30, 1970, 84

Stat. 1311; Pub. L. 92-157, title III, Sec. 303(a), Nov. 18, 1971, 85

Stat. 464; Pub. L. 92-516, Sec. 3(3), Oct. 21, 1972, 86 Stat. 998; Pub.

L. 98-620, title IV, Sec. 402(25)(A), Nov. 8, 1984, 98 Stat. 3359; Pub.

L. 102-300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102-571,

title I, Sec. 107(7), Oct. 29, 1992, 106 Stat. 4499; Pub. L. 103-80,

Sec. 3(k), Aug. 13, 1993, 107 Stat. 776; Pub. L. 104-170, title IV,

Sec. 405, Aug. 3, 1996, 110 Stat. 1514; Pub. L. 105-324, Sec. 2(b), Oct.

30, 1998, 112 Stat. 3036.)

                       References in Text

    The Federal Rules of Civil Procedure, referred to in subsec.

(g)(2)(B), are set out in the Appendix to Title 28, Judiciary and

Judicial Procedure.

    Section 346 of this title, referred to in subsec. (j)(1), originally

consisted of subsecs. (a) and (b). Subsec. (a) was redesignated as the

entire section 346 and subsec. (b) was repealed by Pub. L. 86-618, title

I, Sec. 103(a)(1), 74 Stat. 398.

    The Federal Insecticide, Fungicide, and Rodenticide Act, referred to

in subsecs. (l), (n)(1)(A), (r), and (s), is act June 25, 1947, ch. 125,

as amended generally by Pub. L. 92-516, Oct. 21, 1972, 86 Stat. 973,

which is classified generally to subchapter II (Sec. 136 et seq.) of

chapter 6 of Title 7, Agriculture. For complete classification of this

Act to the Code, see Short Title note set out under section 136 of Title

7 and Tables.

    Section 4365 of title 42, referred to in subsec. (p)(2), was in the

original ``section 8 of the Environmental Research, Development, and

Demonstration Act of 1978'', and was translated as meaning section 8 of

the Environmental Research, Development, and Demonstration Authorization

Act of 1978, to reflect the probable intent of Congress.

    The Toxic Substances Control Act, referred to in subsec. (s), is

Pub. L. 94-469, Oct. 11, 1976, 90 Stat. 2003, as amended, which is

classified generally to chapter 53 (Sec. 2601 et seq.) of Title 15,

Commerce and Trade. For complete classification of this Act to the Code,

see Short Title note set out under section 2601 of Title 15 and Tables.

                          Codification

    August 3, 1996, referred to in subsecs. (k), (n)(1)(B), (2)(A), and

(p)(1), (2), (7), was in the original references to the date of

enactment of this subsection and the date of enactment of this section,

which was translated as meaning the date of enactment of Pub. L. 104-

170, which amended this section generally, to reflect the probable

intent of Congress.

                               Amendments

    1998--Subsec. (j)(4). Pub. L. 105-324 added par. (4).

    1996--Pub. L. 104-170 amended section generally, substituting, in

subsec. (a), provisions relating to requirement for tolerance or

exemption for provisions relating to conditions for safety; in subsec.

(b), provisions relating to authority and standard for tolerance for

provisions relating to establishment of tolerances; in subsec. (c),

provisions relating to authority and standard for exemptions for

provisions relating to exemptions; in subsec. (d), provisions relating

to petition for tolerance or exemption for provisions relating to

regulations pursuant to petition, publication of notice, time for

issuance, referral to advisory committees, effective date, and hearings;

in subsec. (e), provisions relating to action on Administrator's own

initiative for provisions relating to regulations pursuant to

Administrator's proposals; in subsec. (f), provisions relating to

special data requirements for provisions relating to data submitted as

confidential; in subsec. (g), provisions relating to effective date,

objections, hearings, and administrative review for provisions relating

to advisory committees and their appointment, composition, compensation,

and clerical assistance; in subsec. (h), provisions relating to judicial

review for provisions relating to right of consultation; in subsec. (i),

provisions relating to confidentiality and use of data for provisions

relating to judicial review; in subsec. (j), provisions relating to

status of previously issued regulations for provisions relating to

temporary tolerances; in subsec. (k), provisions relating to transitions

for provisions relating to regulations based on public hearings before

January 1, 1953; in subsec. (l), provisions relating to harmonization

with action under other laws for provisions relating to pesticides under

Federal Insecticide, Fungicide, and Rodenticide Act, functions of

Administrator of Environmental Protection Agency, certifications,

hearings, time limitations, opinions, and regulations; in subsec. (m),

provisions relating to fees for provisions relating to amendment of

regulations; in subsec. (n), provisions relating to national uniformity

of tolerances for provisions relating to guaranties; in subsec. (o),

provisions relating to consumer right to know for provisions relating to

payment of fees, services or functions conditioned on payment, and

waiver or refund of fees; and adding subsecs. (p) to (s).

    1993--Pub. L. 103-80, Sec. 3(k)(6), substituted ``Administrator''

for ``Secretary'' wherever appearing except when followed by ``of

Agriculture''.

    Subsec. (a)(1). Pub. L. 103-80, Sec. 3(k)(1), substituted

``Administrator of the Environmental Protection Agency (hereinafter in

this section referred to as the `Administrator')'' for ``Secretary of

Health and Human Services''.

    Subsec. (d)(5). Pub. L. 103-80, Sec. 3(k)(2), substituted ``section

556(c) of title 5'' for ``section 7(c) of the Administrative Procedure

Act (5 U.S.C., sec. 1006(c))''.

    Subsec. (l). Pub. L. 103-80, Sec. 3(k)(3), substituted ``In the

event'' for ``It the event'' before ``a hearing is requested''.

    Subsec. (n). Pub. L. 103-80, Sec. 3(k)(4), made technical amendment

to reference to section 333(c) of this title to reflect amendment of

corresponding provision of original act.

    Subsec. (o). Pub. L. 103-80, Sec. 3(k)(5), which directed the

substitution of ``Administrator'' for ``Secretary of Health and Human

Services'' wherever appearing in the original text, was executed by

making the substitution in the first sentence before ``shall by

regulation require'', the only place ``Secretary of Health and Human

Services'' appeared in the original text.

    1992--Subsecs. (a), (d), (h), (i), (l), (m), (o). Pub. L. 102-300

substituted ``Health and Human Services'' for ``Health, Education, and

Welfare'' wherever appearing in the original statutory text.

    Subsec. (g). Pub. L. 102-571 substituted ``379e'' for ``376''.

    1984--Subsec. (i)(5). Pub. L. 98-620 struck out provision that

required the court to advance on the docket and expedite the disposition

of all causes filed therein pursuant to this section.

    1972--Subsecs. (d)(1), (e), (l). Pub. L. 92-516 substituted

references to pesticide for references to economic poison wherever

appearing therein.

    1971--Subsec. (g). Pub. L. 92-157 struck out ``, which the Secretary

shall by rules and regulations prescribe,'' after ``as compensation for

their services a reasonable per diem'' prior to amendment in 1970, by

Pub. L. 91-515, which overlooked such language when amending subsec. (g)

as provided in 1970 Amendment note.

    1970--Subsec. (g). Pub. L. 91-515 substituted provisions authorizing

members of an advisory committee to receive compensation and travel

expenses in accordance with section 376(b)(5)(D) of this title, for

provisions authorizing such members to receive as compensation a

reasonable per diem for time actually spent on committee work, and

necessary traveling and subsistence expenses while serving away from

their places of residence.

    1958--Subsec. (i)(2). Pub. L. 85-791, Sec. 20(a), in first sentence,

substituted ``transmitted by the clerk of the court to the Secretary,

or'' for ``served upon the Secretary, or upon'', substituted ``file in

the court the record of the proceedings'' for ``certify and file in the

court a transcript of the proceedings and the record'', and inserted

``as provided in section 2112 of title 28'', and which, in second

sentence, substituted ``the filing of such petition'' for ``such

filing''.

    Subsec. (i)(3). Pub. L. 85-791, Sec. 20(b), in first sentence,

substituted ``transmitted by the clerk of the court to the Secretary of

Agriculture, or'' for ``served upon the Secretary of Agriculture, or

upon'', substituted ``file in the court the record of the proceedings''

for ``certify and file in the court a transcript of the proceedings and

the record'', and inserted ``as provided in section 2112 of title 28'',

and, in second sentence, substituted ``the filing of such petition'' for

``such filing''.

                    Effective Date of 1984 Amendment

    Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.

8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date

note under section 1657 of Title 28, Judiciary and Judicial Procedure.

                    Effective Date of 1972 Amendment

    Amendment by Pub. L. 92-516 effective at close of Oct. 21, 1972,

except if regulations are necessary for implementation of any provision

that becomes effective on Oct. 21, 1972, and continuation in effect of

subchapter I of chapter 6 of Title 7, Agriculture, and regulations

thereunder, relating to control of economic poisons, as in existence

prior to Oct. 21, 1972, until superseded by provisions of Pub. L. 92-516

and regulations thereunder, see section 4 of Pub. L. 92-516, set out as

an Effective Date note under section 136 of Title 7.

                          Transfer of Functions

    Functions vested in Secretary of Health, Education, and Welfare [now

Health and Human Services] in establishing tolerances for pesticide

chemicals under this section together with authority to monitor

compliance with tolerances and effectiveness of surveillance and

enforcement and to provide technical assistance to States and conduct

research under this chapter and section 201 et seq. of Title 42, The

Public Health and Welfare, and functions of Department of Agriculture

and Secretary of Agriculture under subsec. (l) of this section

transferred to Administrator of Environmental Protection Agency by

Reorg. Plan No. 3 of 1970, Sec. 2(a)(4), eff. Dec. 2, 1970, 35 F.R.

15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government

Organization and Employees.

                             Tolerance Fees

    Pub. L. 108-199, div. G, title V, Sec. 501(d)(2), Jan. 23, 2004, 118

Stat. 422, provided that: ``Notwithstanding section 408(m)(1) of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a(m)(1)), during the

period beginning on October 1, 2003, and ending on September 30, 2008,

the Administrator of the Environmental Protection Agency shall not

collect any tolerance fees under that section.''

   Data Collection Activities To Assure Health of Infants and Children

    Section 301 of Pub. L. 104-170 provided that:

    ``(a) In General.--The Secretary of Agriculture, in consultation

with the Administrator of the Environmental Protection Agency and the

Secretary of Health and Human Services, shall coordinate the development

and implementation of survey procedures to ensure that adequate data on

food consumption patterns of infants and children are collected.

    ``(b) Procedures.--To the extent practicable, the procedures

referred to in subsection (a) shall include the collection of data on

food consumption patterns of a statistically valid sample of infants and

children.

    ``(c) Residue Data Collection.--The Secretary of Agriculture shall

ensure that the residue data collection activities conducted by the

Department of Agriculture in cooperation with the Environmental

Protection Agency and the Department of Health and Human Services,

provide for the improved data collection of pesticide residues,

including guidelines for the use of comparable analytical and

standardized reporting methods, and the increased sampling of foods most

likely consumed by infants and children.''

ATTACHMENT E:

Reserved for consultations

ATTACHMENT F:  Forms

		Forms that are commonly associated with Data Call-ins are listed below and are  available electronically as a PDF file on the Office of Pesticide Program, internet cite at   HYPERLINK "http://www.epa.gov/opprd001/forms/"  http://www.epa.gov/opprd001/forms/

			EPA Form No. 8570-4 - Confidential Statement of Formula.   This attachment is only electronically via the Internet.

			EPA Form 8570-27 - Formulator's Exemption Statement. This attachment is only electronically via the Internet.

 		EPA Form 8570-28 - Certification of Compliance with Data Gap 			 Procedures.  This attachment is only electronically via the Internet.

			EPA Form 8570-32 - Certification of Attempt to Enter into an Agreement 				with Registrants for Development of Data Form.  This attachment is only 				available electronically via the Internet.

			EPA Form 8570-34 - Certification with Respect to Citation of Data Form

			This attachment is only available electronically via the Internet.

			EPA Form 8570-35 - Data Matrix Form.  This attachment is only 				 available electronically via the Internet.

			EPA Form 8570-36 - Summary of the Physical/Chemical Properties 			 Form.   This attachment is only available electronically via the Internet.

			EPA Form 8570-37 - Self-Certification Statement for the Physical/Chemical Properties.   This attachment is only available electronically via the Internet.

			The forms below have been approved with the DCI related ICRs by OMB for several years, although no official EPA Form number had been assigned in the past.  These two forms are automatically generated by EPA’s computer databases and are pre-populated with information that is specific to each individual registrant that receives a Data Call-In notice for a given pesticide.  These forms are not widely accessible to general public.

			Data Call-In Response Form – This form is a part of Attachment F and is only available as an electronic attachment to the supporting statement.  This form can  be accessed at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  using the docket identifier EPA-HQ-OPP-2007-0923

			Requirements Status and Registrant’s Response - This form is a part of Attachment F and is only available as an electronic attachment to the supporting statement.  This form can only be accessed at   HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov  using the docket identifier EPA-HQ-OPP-2007-0923

ATTACHMENT G:

General Methodology Used to Estimate Paperwork Burden Hours and Costs

by the Office of Pesticide Programs for Submission of Required

Data/Information or Responding to a Data Call-In Notice.

	This attachment is part of the supporting statement and is only available as part of the electronic docket EPA-HQ-OPP-2007-0923.

ATTACHMENT H

Work Sheets to Calculate Industry and EPA Labor Costs

ATTACHMENT H

Work Sheets to Calculate Industry and EPA Labor Costs

INDUSTRY LABOR COSTS

Labor Category

Formula

Managerial

Technical

Clerical

Unloaded Hourly Rate1

= W	$48.31 	$31.26 	$15.78

Benefits Percentage2

Lb = B/W	43%	43%	43%

Benefits per hour

B = W*Lb	$20.77 	$13.44 	$6.79

Loaded Hourly Rate

Wb = W + B

       = W(1+Lb)	$69.08 	$44.70 	$22.57

Overhead Percentage3

Lo = OH/Wb	50%	50%	50%

Overhead per hour

OH = Wb*Lo	$34.54 	$22.35 	$11.28

Fully Loaded Hourly Rate

Wf = Wb + OH

=  W + B + OH 	$103.62 	$67.05 	$33.85

1.  Data Source:    HYPERLINK "http://www.bls.gov/oes/current/naics4_325300.htm"  http://www.bls.gov/oes/current/naics4_325300.htm

     Management:   11-0000, Management Occupations

     Technical:   19-0000, Life, Physical, and Social Science Occupations

     Clerical:    43-0000, Office and Administrative Support Occupations

     May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.

EPA LABOR COSTS

Labor Category

Formula

Managerial

Technical

Clerical

Unloaded Hourly Rate1

= W	$47.16 	$31.18 	$18.29

Benefits Percentage2

Lb = B/W	43%	43%	43%

Benefits per hour

B = W*Lb	$20.28 	$13.41 	$7.86

Loaded Hourly Rate

Wb = W + B

       = W(1+Lb)	$67.44 	$44.59 	$26.15

Overhead Percentage3

Lo = OH/Wb	50%	50%	50%

Overhead per hour

OH = Wb*Lo	$33.72 	$22.29 	$13.08

Fully Loaded Hourly Rate

Wf = Wb + OH

=  W + B + OH 	$101.16 	$66.88 	$39.23

1.  Data Source:    HYPERLINK "http://www.bls.gov/oes/current/naics4_999100.htm"  http://www.bls.gov/oes/current/naics4_999100.htm

     Management:   11-0000, Management Occupations

     Technical:   19-0000, Life, Physical, and Social Science Occupations

     Clerical:    43-0000, Office and Administrative Support Occupations

     May 2006 data

2. Fringe benefits/wage per hour.

3. U. S. Environmental Protection Agency, EPA Air Pollution Control Cost Manual, Sixth Edition, EPA-452-02-001, January 2002, pg. 2-34.  The loading for indirect costs is within the range of 20-70% of the load labor rate (wage + benefits) suggested in EPA guidance.

1RRegistrants are required to submit a Confidential Statement of Formula (EPA Form 8570-4) to comply with registration-related requirements under FIFRA section 3, such as when a registrant seeks to add uses for a currently-registered pesticide, or when the registrant changes a registered pesticide’s formulation.  The requirement is mentioned here since registrants have not always submitted the required information immediately to EPA and the deficiency may remain at the time of the regulatory review.  The paperwork burden for the submission of Form 8570-4 is covered under OMB Control No. 2070-0060 (Application for New/Amended Pesticide Registration; EPA ICR. No. 0277)

 Registrants are required to submit a Confidential Statement of Formula (EPA Form 8570-4) to comply with registration-related requirements under FIFRA section 3, such as when a registrant seeks to add uses for a currently-registered pesticide, or when the registrant changes a registered pesticide’s formulation.  The requirement is mentioned here since registrants have not always submitted the required information immediately to EPA and the deficiency may remain at the time of the regulatory review.  The paperwork burden for the submission of Form 8570-4 is covered under OMB Control No. 2070-0060 (Application for New/Amended Pesticide Registration; EPA ICR. No. 0277)

 See 69 FR 26819, May 14, 2004; also   HYPERLINK "http://www.epa.gov/oppsrrd1/public.htm"  http://www.epa.gov/oppsrrd1/public.htm

 The FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. The FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation.  FIFRA, as amended by the FQPA of 1996, established a Science Review Board consisting of at least 60 scientists who are available to the FIFRA SAP on an ad hoc basis to assist in reviews conducted by the Panel.

  For example, in 2004 the Agency evaluated a sampling of  95 pesticide product reviews (PDCIs) related to 5 randomly selected pesticide chemicals to determine the number of new Acute Toxicity and Product Chemistry studies generated in response to a DCI.  Based on this evaluation, it was determined that approximately 18% of the Acute Toxicity data requirements and approximately 10% of the Product Chemistry data requirements were newly generated data.  Among the six Acute Toxicity requirements surveyed, (acute oral, acute dermal, acute inhalation, acute eye irritation, acute dermal irritation and dermal sensitization), the Acute eye irritation (870.2400), and Acute dermal irritation (870.2500) studies accounted for as much as 50% of the new data produced (in equal proportions).  The other 50% of the new data is equally distributed between the remaining four study requirements.   Among the ten Product Chemistry requirements surveyed, (Storage Stability (830.6317), Corrosion Characteristics (830.6320), Viscosity (830.7100) and the Analytical Methods (830.1800) guidelines accounted for approximately 90% of the new data produced (in equal proportions).  The remaining 10% of the new data was equally distributed between the Flammability (830.6315), pH (830.7000), Density (830.7300), and various requirements for technical/pure active ingredients including Preliminary analysis (830.1700), Water solubility (830.7840 or 830.7860), and Vapor pressure (830.7950).

Draft:912/0526/07

 PAGE

 PAGE   2

Draft: 912/26//13/07

 PAGE   55

  PAGE   171

 PAGE   172


[Federal Register: August 10, 2007 (Volume 72, Number 154)]
[Notices]
[Page 45036]
[DOCID:fr10au07-73]

-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-32-000]

Gulf South Pipeline Company, LP; Notice of Availability of the
Final Environmental Impact Statement for the Proposed Southeast
Expansion Project

August 3, 2007.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared this Final Environmental Impact Statement
(EIS) for the natural gas pipeline facilities proposed by Gulf South
Pipeline Company, LP (Gulf South) under the above-referenced docket.
Gulf South's Southeast Expansion Project (Project) would be located in
various counties and parishes in eastern Louisiana, Mississippi, and
western Alabama.
    The Final EIS was prepared to satisfy the requirements of the
National Environmental Policy Act. The FERC staff concludes that the
proposed Project, with the appropriate mitigation measures as
recommended, would have limited adverse environmental impact.
    The U.S. Fish and Wildlife Service (FWS), U.S. Environmental
Protection Agency (EPA), and the U.S. Army Corps of Engineers (COE) are
federal cooperating agencies for the development of this EIS. A federal
cooperating agency has jurisdiction by law or special expertise with
respect to any environmental impact involved with the proposal and is
involved in the NEPA analysis.
    Gulf South indicates that the general purpose of the proposed
Project is to provide producers in eastern Texas and northern Louisiana
an eastern market outlet for production from CenterPoint Energy Gas
Transmission Company in the Perryville, Louisiana, area.
    The Final EIS addresses the potential environmental impacts
resulting from the construction and operation of the following
facilities:
     Approximately 111 miles of 42-inch-diameter natural gas
transmission pipeline extending easterly from Simpson County,
Mississippi, to Choctaw County, Alabama;
     Three new compressor stations, the Delhi, Harrisville, and
Destin Compressor Stations, located in Richland County, Louisiana;
Simpson County, Mississippi; and Choctaw County, Alabama, respectively;
and
     Other ancillary facilities including five meter and
regulator (M/R) facilities, eight mainline valves, one side valve, and
two pig launcher and/or receiver facilities.
    Dependent upon Commission approval, Gulf South proposes to complete
construction and begin operating the proposed Project in January 2008.
    The Final EIS has been placed in the public files of the FERC and
is available for public inspection at:Federal Energy Regulatory
Commission, Public Reference Room, 888 First Street, NE., Room
2A,Washington, DC 20426,<PHONE_NUMBER>.
    A limited number of copies of the Final EIS are available from the
Public Reference Room identified above. In addition, CD copies of the
Final EIS have been mailed to affected landowners; various federal,
state, and local government agencies; elected officials; environmental
and public interest groups; Native American tribes; local libraries and
newspapers; intervenors; and other individuals that expressed an
interest in the proposed Project. Hard-copies of the Final EIS have
also been mailed to those who requested that format during the scoping
and comment periods for the proposed Project.
    In accordance with the Council on Environmental Quality's (CEQ)
regulations implementing NEPA, no agency decision on a proposed action
may be made until 30 days after the U.S. Environmental Protection
Agency (EPA) publishes a notice of availability of a Final EIS.
However, the CEQ regulations provide an exception to this rule when an
agency decision is subject to a formal internal process that allows
other agencies or the public to make their views known. In such cases,
the agency decision may be made at the same time the notice of the
Final EIS is published, allowing both periods to run concurrently.
Should the FERC issue Gulf South authorizations for the proposed
Project, it would be subject to a 30-day rehearing period. Therefore,
the Commission could issue its decision concurrently with the EPA's
notice of availability.
    Additional information about the proposed Project is available from
the Commission's Office of External Affairs, at 1-866-208-FERC or on
the FERC Internet Web site (http://www.ferc.gov). To access information

via the FERC Web site, click on the ``eLibrary'' link, then click on
``General Search'' and enter the docket number (CP07-032), excluding
the last three digits, in the Docket Number field. Be sure you have
selected an appropriate date range. The ``eLibrary'' link provides
access to the texts of formal documents issued by the Commission, such
as orders, notices, and rulemakings. For assistance with ``eLibrary,''
please contact FERC Online Support at<EMAIL_ADDRESS>or
toll-free at 1-866-208-3676, or for TTY, contact<PHONE_NUMBER>.
    In addition, the Commission now offers a free service called
eSubscription that allows you to keep track of all formal issuances and
submittals in specific dockets. This can reduce the amount of time you
spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
these documents. To learn more about eSubscription and to sign-up for
this service, please go to http://www.ferc.gov/esubscribenow.htm.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-15628 Filed 8-9-07; 8:45 am]

BILLING CODE 6717-01-P