4–2 Indentation of the following sentences of this subparagraph is so in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably should be indented the same as flush matter of this subparagraph.

Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

(3) CANCELLATION.—

(A) If the registrant of a pesticide fails to submit the information required by paragraph (1) within the time prescribed by paragraph (2), the Administrator, by order and without hearing, shall cancel the registration of such specific minor use of the pesticide. If the registrant does not commit to support a pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this subparagraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996], for the submission of data under this section for the supported uses identified pursuant to this subparagraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1). If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3(c)(2)(B)(iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

(B)(i) If the registrant of a pesticide submits the information required by paragraph (1) within the time prescribed by paragraph (2) and such information does not conform to the guidelines for submissions established by the Administrator, the Administrator shall determine whether the registrant made a good faith attempt to conform its submission to such guidelines.

(ii) If the Administrator determines that the registrant made a good faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make any necessary changes or corrections.

(iii)(I) If the Administrator determines that the registrant did not make a good faith attempt to conform its submission to such guidelines, the Administrator may issue a notice of intent to cancel the registration. Such a notice shall be sent to the registrant by certified mail.

(II) The registration shall be canceled without a hearing or further notice at the end of 30 days after receipt by the registrant of the notice unless during that time a request for a hearing is made by the registrant.

(III) If a hearing is requested, a hearing shall be conducted under section 6(d), except that the only matter for resolution at the hearing shall be whether the registrant made a good faith attempt to conform its submission to such guidelines. The hearing shall be held and a determination made within 75 days after receipt of a request for hearing.

(4) GUIDELINES.—

(A) Not later than 1 year after the effective date of this section [December 24, 1988], the Administrator, by order, shall issue guidelines to be followed by registrants in—

(i) summarizing studies;

(ii) reformatting studies;

(iii) identifying adverse information; and

(iv) identifying studies that have been submitted previously that may not meet the requirements of section 3 or regulations issued under such section,

under paragraph (1).

(B) Guidelines issued under subparagraph (A) shall not be subject to judicial

review.

(5) MONITORING.—The Administrator shall monitor the progress of registrants in acquiring and submitting the data required under paragraph (1).

(f) PHASE FOUR.—

(1) INDEPENDENT REVIEW AND IDENTIFICATION OF OUTSTANDING DATA REQUIREMENTS.—

(A) The Administrator shall review the submissions of all registrants of pesticides containing a particular active ingredient under subsections (d)(3) and (e)(1) to determine if such submissions identified all the data that are missing or inadequate for such active ingredient. To assist the review of the Administrator under this subparagraph, the Administrator may require a registrant seeking reregistration to submit complete copies of studies summarized under subsection (e)(1).

(B) The Administrator shall independently identify and publish in the Federal Register the outstanding data requirements for each active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is contained in a pesticide to be reregistered under this section. The Administrator, at the same time, shall issue a notice under section 3(c)(2)(B) for the submission of the additional data that are required to meet such requirements.

(2) TIME PERIODS.—

(A) The Administrator shall take the action required by paragraph (1)—

(i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 18 months after the date of the listing of such active ingredient;

(ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 24 months after the date of the listing of such active ingredient; and

(iii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(D), not later than 33 months after the date of the listing of such active ingredient.

(B) If the Administrator issues a notice to a registrant under paragraph (1)(B) for the submission of additional data, the registrant shall submit such data within a reasonable period of time, as determined by the Administrator, but not to exceed 48 months after the issuance of such notice. The Administrator, on application of a registrant, may extend the period prescribed by the preceding sentence by no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, in the case of a minor use, extend the deadline for the production of residue chemistry data under this subparagraph for data required solely to support that minor use until the final deadline for submission of data under this section for the other uses of the pesticide established as of the date of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996] if—

(i) the data to support other uses of the pesticide on a food are being

provided;

(ii) the registrant, in submitting a request for such an extension provides a schedule, including interim dates to measure progress, to assure that the data production will be completed before the expiration of the extension period;

(iii) the Administrator has determined that such extension will not significantly delay the Administrator’s schedule for issuing a reregistration eligibility determination required under this section; and

(iv) the Administrator has determined that based on existing data, such extension would not significantly increase the risk of any unreasonable adverse effect on the environment.4–3 If the Administrator grants an extension under this subparagraph, the Administrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule for the production of the data. If the Administrator determines that the registrant is not meeting or has not met the

4–3 Indentation of the following sentences of this subparagraph is so in original (as added by sec. 201(c)(2) of P.L. 104-170). Probably should be indented the same as flush matter of this subparagraph.

schedule for the production of such data, the Administrator may proceed in accordance with clause (iv) of section 3(c)(2)(B) or other provisions of this section, as appropriate, regarding the continued registration of the affected products with the minor use and shall inform the public of such action. Notwithstanding the provisions of this subparagraph, the Administrator may take action to modify or revoke the extension under this subparagraph if the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on the environment. In such circumstance, the Administrator shall provide written notice to the registrant revoking the extension of time for submission of data. Such data shall instead be due in accordance with the date then established by the Administrator for submission of the data.

(3) SUSPENSIONS AND PENALTIES.—The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed by section 3(c)(2)(B)(iv) if the Administrator determines that (A) tests necessary to fill an outstanding data requirement for such pesticide have not been initiated within 1 year after the issuance of a notice under paragraph (1)(B), or (B) progress is insufficient to ensure submission of the data referred to in clause (A) within the time period prescribed by paragraph (2)(B) or the required data have not been submitted to the Administrator within such time period. If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing data in a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood uses and the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing data in a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written request of the registrant, shall not take any action pursuant to this paragraph in regard to such unsupported minor use until the final deadline established as of the date of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996], for the submission of data under this section for the supported uses identified pursuant to this paragraph unless the Administrator determines that the absence of the data is significant enough to cause human health or environmental concerns. On such a determination the Administrator may refuse the request for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish in the Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supported will be voluntarily deleted from the registration pursuant to section 6(f)(1). If the Administrator grants an extension under this paragraph, the Administrator shall monitor the development of the data for the uses being supported and shall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines that the registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceed in accordance with section 3(c)(2)(B)(iv) regarding the continued registration of the affected products with the minor and other uses and shall inform the public of such action in accordance with section 6(f)(2). Notwithstanding this subparagraph, the Administrator may deny, modify, or revoke the temporary extension under this paragraph if the Administrator determines that the continuation of the minor use may cause an unreasonable adverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing, to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shall be deleted from the registration.

(g) PHASE FIVE.—

(1) DATA REVIEW.—The Administrator shall conduct a thorough examination of all data submitted under this section concerning an active ingredient listed under subsection (c)(2) and of all other available data found by the Administrator to be relevant.

(2) REREGISTRATION AND OTHER ACTIONS.—

(A) IN GENERAL.—The Administrator shall make a determination as to eligibility for reregistration—

(i) for all active ingredients subject to reregistration under this section for which tolerances or exemptions from tolerances are required under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), not later than the last date for tolerance reassessment established under section 408(q)(1)(C) of that Act (21 U.S.C. 346a(q)(1)(C)); and

(ii) for all other active ingredients subject to reregistration under this section, not later than October 3, 2008.

(B) PRODUCT-SPECIFIC DATA.—

(i) IN GENERAL.—Before reregistering a pesticide, the Administrator shall obtain any needed product-specific data regarding the pesticide by use of section 3(c)(2)(B) and shall review such data within 90 days after its submission.

(ii) TIMING.—

(I) IN GENERAL.—Subject to subclause (II), the Administrator shall require that data under this subparagraph be submitted to the Administrator not later than 8 months after a determination of eligibility under subparagraph (A) has been made for each active ingredient of the pesticide, unless the Administrator determines that a longer period is required for the generation of the data.

(II) EXTRAORDINARY CIRCUMSTANCES.—In the case of extraordinary circumstances, the  Administrator may provide such a longer period, of not more than 2 additional years, for submission of data to the Administrator under this subparagraph.

(C) After conducting the review required by paragraph (1) for each active ingredient of a pesticide and the review required by subparagraph (B) of this paragraph, the Administrator shall determine whether to reregister a pesticide by determining whether such pesticide meets the requirements of section 3(c)(5). If the Administrator determines that a pesticide is eligible to be reregistered, the Administrator shall reregister such pesticide within 6 months after the submission of the data concerning such pesticide under subparagraph (B).

(D) DETERMINATION TO NOT REREGISTER.—

(i) IN GENERAL.—If after conducting a review under paragraph (1) or subparagraph (B) of this paragraph the Administrator determines that a pesticide should not be reregistered, the Administrator shall take appropriate regulatory action.

(ii) TIMING FOR REGULATORY ACTION.—Regulatory action under clause (i) shall be completed as expeditiously as possible.

(E) As soon as the Administrator has sufficient information with respect to the dietary risk of a particular active ingredient, but in any event no later than the time the Administrator makes a determination under subparagraph (C) or (D) with respect to pesticides containing a particular active ingredient, the Administrator shall—

(i) reassess each associated tolerance and exemption from the requirement for a tolerance issued under section 408 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 346a);

(ii) determine whether such tolerance or exemption meets the requirements of that Act;

(iii) determine whether additional tolerances or exemptions should be

issued;

(iv) publish in the Federal Register a notice setting forth the determinations made under this subparagraph; and

(v) commence promptly such proceedings under this Act and section 408 of the Federal Food, Drug, and Cosmetic Act as are warranted by such determinations.

(h) COMPENSATION OF DATA SUBMITTER.—If data that are submitted by a registrant under subsection (d), (e), (f), or (g) are used to support the application of another person under section 3, the registrant who submitted such data shall be entitled to compensation for the use of such data as prescribed by section 3(c)(1)(D). In determining the amount of such compensation, the fees paid by the registrant under this section shall be taken into account.

(i) FEES.—

(1) INITIAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.—The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $50,000 on submission of information under paragraphs (2) and (3) of subsection (d) for such ingredient.

(2) FINAL FEE FOR FOOD OR FEED USE PESTICIDE ACTIVE INGREDIENTS.—

(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $100,000—

(i) on submission of information for such ingredient under subsection (e)(1) if data are reformatted under subsection (e)(1)(C); or

(ii) on submission of data for such ingredient under subsection (e)(2)(B) if data are not reformatted under subsection (e)(1)(C).

(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is an active ingredient of any pesticide registered for a major food or feed use shall collectively pay a fee of $150,000 at such time as the Administrator shall prescribe.

(3) FEES FOR OTHER PESTICIDE ACTIVE INGREDIENTS.—

(A) The registrants of pesticides that contain an active ingredient that is listed under subparagraph (B), (C), or (D) of subsection (c)(2) and that is not an active ingredient of any pesticide registered for a major food or feed use shall collectively pay fees in amounts determined by the Administrator. Such fees may not be less than one-half of, nor greater than, the fees required by paragraphs (1) and (2). A registrant shall pay such fees at the times corresponding to the times fees prescribed by paragraphs (1) and (2) are to be paid.

(B) The registrants of pesticides that contain an active ingredient that is listed under subsection (c)(2)(A) and that is not an active ingredient of any pesticide that is registered for a major food or feed use shall collectively pay a fee of not more than $100,000 and not less than $50,000 at such time as the Administrator shall prescribe.

(4) REDUCTION OR WAIVER OF FEES FOR MINOR USE AND OTHER PESTICIDES.—

(A) An active ingredient that is contained only in pesticides that are registered solely for agricultural or nonagricultural minor uses, or a pesticide the value or volume of use of which is small, shall be exempt from the fees prescribed by paragraph (3).

(B) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph (3) if, in consultation with the Secretary of Health and Human Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.

(C) An antimicrobial active ingredient, the production level of which does not exceed 1,000,000 pounds per year, shall be exempt from the fees prescribed by paragraph (3). For purposes of this subparagraph, the term “antimicrobial active ingredient” means any active ingredient that is contained only in pesticides that are not registered for any food or feed use and that are —

(i) sanitizers intended to reduce the number of living bacteria or viable virus particles on inanimate surface or in water or air;

(ii) bacteriostats intended to inhibit the growth of bacteria in the presence of moisture;

(iii) disinfectants intended to destroy or irreversibly inactivate bacteria, fungi, or viruses on surfaces or inanimate objects;

(iv) sterilizers intended to destroy viruses and all living bacteria, fungi, and their spores on inanimate surfaces; or

(v) fungicides or fungistats.

(D)(i) Notwithstanding any other provision of this subsection, in the case of a small business registrant of a pesticide, the registrant shall pay a fee for the reregistration of each active ingredient of the pesticide that does not exceed an amount determined in accordance with this subparagraph.

(ii) If during the 3-year period prior to reregistration the average annual gross revenue of the registrant from pesticides containing such active ingredient is—

(I) less than $5,000,000, the registrant shall pay 0.5 percent of such

revenue;

(II) $5,000,000 or more but less than $10,000,000, the registrant shall pay 1 percent of such revenue; or

(III) $10,000,000 or more, the registrant shall pay 1.5 percent of such revenue, but not more than $150,000.

(iii) For the purpose of this subparagraph, a small business registrant is a corporation, partnership, or unincorporated business that—

(I) has 150 or fewer employees; and

(II) during the 3-year period prior reregistration, had an average annual gross revenue from to chemicals that did not exceed $40,000,000.

(5) MAINTENANCE FEE.—

(A) IN GENERAL.—Subject to other provisions of this paragraph, each registrant of a pesticide shall pay an annual fee by January 15 of each year for each registration, except that no fee shall be charged for more than 200 registrations held by any registrant.

(B) In the case of a pesticide that is registered for a minor agricultural use, the Administrator may reduce or waive the payment of the fee imposed under this paragraph if the Administrator determines that the fee would significantly reduce the availability of the pesticide for the use.

(C) TOTAL AMOUNT OF FEES.—The amount of each fee prescribed under subparagraph (A) shall be adjusted by the Administrator to a level that will result in the collection under this paragraph of, to the extent practicable, an aggregate amount of—

(i) for fiscal year 2004, $26,000,000;

(ii) for fiscal year 2005, $27,000,000;

(iii) for fiscal year 2006, $27,000,000;

(iv) for fiscal year 2007, $21,000,000; and

(v) for fiscal year 2008, $15,000,000.

(D) MAXIMUM AMOUNT OF FEES FOR REGISTRANTS.—The maximum annual fee payable under this paragraph by—

(i) 4–4 a registrant holding not more than 50 pesticide registrations shall be—

(I) for fiscal year 2004, $84,000;

(II) for each of fiscal years 2005 and 2006, $87,000;

(III) for fiscal year 2007, $68,000; and

(IV) for fiscal year 2008, $55,000; and

(ii) 4–5 a registrant holding over 50 registrations shall be—

(I) for fiscal year 2004, $145,000;

(II) for each of fiscal years 2005 and 2006, $151,000;

(III) for fiscal year 2007, $117,000; and

(IV) for fiscal year 2008, $95,000.

4–4 Subclause margins are so in original (as added by sec. 501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

4–5 Subclause margins are so in original (as added by sec. 501(c)(1)(B)(ii) of P.L. 108-199). Probably should be further indented.

(E) MAXIMUM AMOUNT OF FEES FOR SMALL BUSINESSES.—

(i) IN GENERAL.—For a small business, the maximum annual fee payable under this paragraph by—

(I) a registrant holding not more than 50 pesticide registrations shall

be—

(aa) for fiscal year 2004, $59,000;

(bb) for each of fiscal years 2005 and 2006, $61,000;

(cc) for fiscal year 2007, $48,000; and

(dd) for fiscal year 2008, $38,500; and

(II) a registrant holding over 50 pesticide registrations shall be—

(aa) for fiscal year 2004, $102,000;

(bb) for each of fiscal years 2005 and 2006, $106,000;

(cc) for fiscal year 2007, $82,000; and

(dd) for fiscal year 2008, $66,500.

(ii) DEFINITION OF SMALL BUSINESS.—

(I) IN GENERAL.—In clause (i), the term “small business” means a corporation, partnership, or unincorporated business that—

(aa) has 500 or fewer employees; and

(bb) during the 3-year period prior to the most recent maintenance fee billing cycle, had an average annual global gross revenue from pesticides that did not exceed $60,000,000.

(II) AFFILIATES.—

(aa) IN GENERAL.—In the case of a business entity with 1 or more affiliates, the gross revenue limit under subclause (I)(bb) shall apply to the gross revenue for the entity and all of the affiliates of the entity, including parents and subsidiaries, if applicable.

(bb) AFFILIATED PERSONS.—For the purpose of item (aa), persons are affiliates of each other if, directly or indirectly, either person controls or has the power to control the other person, or a third person controls or has the power to control both persons.

(cc) INDICIA OF CONTROL.—For the purpose of item (aa), indicia of control include interlocking management or ownership, identity of interests among family members, shared facilities and equipment, and common use of employees.

(F) The Administrator shall exempt any public health pesticide from the payment of the fee prescribed under paragraph (3) if, in consultation with the Secretary of Health and Humans4–6 Services, the Administrator determines, based on information supplied by the registrant, that the economic return to the registrant from sales of the pesticide does not support the registration or reregistration of the pesticide.

(G) If any fee prescribed by this paragraph with respect to the registration of a pesticide is not paid by a registrant by the time prescribed, the Administrator, by order and without hearing, may cancel the registration.

4–6 So in original (as added by sec. 232(2) of P.L. 104-170). Probably should be “Human”.

(H) The authority provided under this paragraph shall terminate on September 30,

2008.

(6) OTHER FEES.—Except as provided in section 33, during the period beginning on the date of enactment of this section [October 25, 1988] and ending on September 30, 2010, the Administrator may not levy any other fees for the registration of a pesticide under this Act except as provided in paragraphs (1) through (5).

(7) APPORTIONMENT.—

(A) If two or more registrants are required to pay any fee prescribed by paragraph (1), (2), or (3) with respect to a particular active ingredient, the fees for such active ingredient shall be apportioned among such registrants on the basis of the market share in United States sales of the active ingredient for the 3 calendar years preceding the date of payment of such fee, except that—

(i) small business registrants that produce the active ingredient shall pay fees in accordance with paragraph (4)(C); and

(ii) registrants who have no market share but who choose to reregister a pesticide containing such active ingredient shall pay the lesser of—

(I) 15 percent of the reregistration fee; or

(II) a proportionate amount of such fee based on the lowest percentage market share held by any registrant active in the marketplace.

In no event shall registrants who have no market share but who choose to reregister a pesticide containing such active ingredient collectively pay more than 25 percent of the total active ingredient reregistration fee.

(B) The Administrator, by order, may require any registrant to submit such reports as the Administrator determines to be necessary to allow the Administrator to determine and apportion fees under this subsection, to determine the registrant’s eligibility for a reduction or waiver of a fee, or to determine the volume usage for public health pesticides.

(C) If any such report is not submitted by a registrant after receiving notice of such report requirement, or if any fee prescribed by this subsection (other than paragraph (5)) for an active ingredient is not paid by a registrant to the Administrator by the time prescribed under this subsection, the Administrator, by order and without hearing, may cancel each registration held by such registrant of a pesticide containing the active ingredient with respect to reapportion the fee among the remaining registrants and notify which the fee is imposed. The Administrator shall the registrants that the registrants are required to pay to the Administrator any unpaid balance of the fee within 30 days after receipt of such notice.

(j) EXEMPTION OF CERTAIN REGISTRANTS.—The requirements of subsections (d), (e), (f), and (i) (other than subsection (i)(5)) regarding data concerning an active ingredient and fees for review of such data shall not apply to any person who is the registrant of a pesticide to the extent that, under section 3(c)(2)(D), the person would not be required to submit or cite such data to obtain an initial registration of such pesticide.

(k) REREGISTRATION AND EXPEDITED PROCESSING FUND.—

(1) ESTABLISHMENT.—There shall be established in the Treasury of the United States a reregistration and expedited processing fund which shall be known as the Reregistration and Expedited Processing Fund.4–7

(2) 4–8 SOURCE AND USE.—

(A) All moneys derived from fees collected by the Administrator under subsection (i) shall be deposited in the fund and shall be available to the Administrator, without fiscal year limitation, specifically to offset the costs of reregistration and expedited processing of the applications specified in paragraph (3). Such moneys derived from fees may not be expended in any fiscal year to the extent such moneys derived from fees would exceed money appropriated for use by the Administrator and expended in such year for such costs of reregistration and expedited processing of such applications. The Administrator shall, prior to expending any such moneys derived from fees—

(i) effective October 1, 1997, adopt specific and cost accounting rules and procedures as approved by the General Accounting Office and the Inspector General of the Environmental Protection Agency to ensure that moneys derived from fees are allocated solely to the costs of reregistration and expedited processing applications specified in paragraph (3) in the same of the portion as appropriated funds;

(ii) prohibit the use of such moneys derived from fees to pay for any costs other than those necessary to achieve reregistration and expedited processing of the applications specified in paragraph (3); and

(iii) ensure that personnel and facility costs associated with the functions to be carried out under this paragraph do not exceed agency averages for comparable personnel and facility costs.

(B) The Administrator shall also—

(i) complete the review of unreviewed reregistration studies required to support the reregistration eligibility decisions scheduled for completion in accordance with subsection (l)(2); and

(ii) contract for such outside assistance as may be necessary for review of required studies, using a generally accepted competitive process for the selection of vendors of such assistance.

(3) REVIEW OF INERT INGREDIENTS; EXPEDITED PROCESSING OF SIMILAR APPLICATIONS.—

4–7  ADVANCE \d1 Sec. 501(b) of P.L. 104-170 amended sec. 4(k)(1) (7 U.S.C. 136a–1(k)(1)) by inserting “which shall be known as the Reregistration and Expedited Processing Fund”, without specifying the Act that was being amended. The amendment was executed to this Act to effectuate the probable intent of Congress.

 ADVANCE \d1 	4–8 Sec. 501(c) of P.L. 104-170 amended sec. 4(k)(2) (7 U.S.C. 136a–1(k)(2)) to read as provided above, without specifying the Act that was being amended. The amendment was executed to this Act to effectuate the probable intent of Congress.

(A) The Administrator shall use for each of the fiscal years 2004 through 2006, approximately $3,300,000, and for each of fiscal years 2007 and 2008, between 1/8 and 1/7, of the maintenance fees collected in such fiscal year4–9 to obtain sufficient personnel and resources—

(i) to review and evaluate new inert ingredients; and

(ii) to ensure the expedited processing and review of any application

  4–10 that ——

(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identical or substantially similar in composition and labeling to a currently-registered pesticide identified in the application, or that would differ in composition and labeling from any such currently-registered pesticide only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment;

(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data;

(III) proposes the initial or amended or registration of an end use pesticide that, if registered as proposed, would be used for a public health pesticide.

(B) Any amounts made available under subparagraph (A) shall be used to obtain sufficient personnel and resources to carry out the activities described in such subparagraph that are in addition to the personnel and resources available to carry out such activities on the date of enactment of this section [October 25, 1988].

(C) 4–11 So long as the Administrator has not met the time frames specified in clause (ii) of section 3(c)(3)(B) with respect to any application subject to section 3(c)(3)(B) that was received prior to the date of enactment of the Food Quality Protection Act of 1996 [Aug. 3, 1996], the Administrator shall use the full amount of the fees specified in subparagraph (A) for the purposes specified therein. Once all applications subject to section 3(c)(3)(B) that were received prior to such date of enactment have been acted upon, no limitation shall be imposed by the preceding sentence of this subparagraph so long as the Administrator meets the time frames

4–9 P.L. 107-73 (115 Stat. 686) amended sec. 4(k)(3)(A) by striking “2001” and inserting “2002”; and by striking “1/7” and inserting “1/10”. In an earlier enactment, sec. 501(d)(1) of P.L. 104-170 amended sec. 4(k)(3) (7 U.S.C. 136a–1(k)(3)) by striking “for each of the fiscal years 1992, 1993, and 1994, 1/7th of the maintenance fees collected, up to 2 million each year” and inserting “for each of the fiscal years 1997 through 2001, not more than 1/7 of the maintenance fees collected in such fiscal year”, without specifying the Act that was being amended and without including a $ before “2 million”. The earlier amendment was executed to this Act, and to strike “$2 million”, to effectuate the probable intent of Congress.

4–10 So in original (as added by sec. 501(e)(2)(C) of P.L. 108-199). Probably should be no indent before “that”.

4–11 Sec. 501(d)(2) of P.L. 104-170 added subpara. (C) to sec. 4(k)(3) (7 U.S.C. 136a–1(k)(3)), without specifying the Act that was being amended. The amendment was executed to this Act to effectuate the probable intent of Congress.

specified in clause (ii) of section 3(c)(3)(B) on 90 percent of affected applications in a fiscal year. Should the Administrator not meet such time frames in a fiscal year, the limitations imposed by the first sentence of this subparagraph shall apply until all overdue applications subject to section 3(c)(3)(B) have been acted upon.

(4) UNUSED FUNDS.—Money in the fund not currently needed to carry out this section shall be—

(A) maintained on hand or on deposit;

(B) invested in obligations of the United States or guaranteed thereby; or

(C) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds.

(5) 4–12 ACCOUNTING AND PERFORMANCE.—The Administrator shall take all steps necessary to ensure that expenditures from fees authorized by subsection (i)(5)(C)(ii) are used only to carry out the goals established under subsection (l). The Reregistration and Expedited Processing Fund shall be designated as an Environmental Protection Agency component for purposes of section 3515(c) of title 31, United States Code. The annual audit required under section 3521 of such title of the financial statements of activities under this Act under section 3515(b) of such title shall include an audit of the fees collected under subsection (i)(5)(C) and disbursed, of the amount appropriated to match such fees, and of the Administrator’s attainment of performance measures and goals established under subsection (l). Such an audit shall also include a review of the reasonableness of the overhead allocation and adequacy of disclosures of direct and indirect costs associated with carrying out the reregistration and expedited processing of the applications specified in paragraph (3), and the basis for and accuracy of all costs paid with moneys derived from such fees. The Inspector General shall conduct the annual audit and report the findings and recommendations of such audit to the Administrator and to the Committees on Agriculture of the House of Representatives and the Senate. The cost of such audit shall be paid for out of the fees collected under subsection (i)(5)(C).

(l) 4–13 PERFORMANCE MEASURES AND GOAL.—The Administrator shall establish and publish annually in the Federal Register performance measures and goals. Such measures and goals shall include—

(1) the number of products reregistered, canceled, or amended, the status of reregistration, the number and type of data requests under section 3(c)(2)(B) issued to support product reregistration by active ingredient, the progress in reducing the number of unreviewed, required reregistration studies, the aggregate status of tolerances reassessed, and the number of applications for registration submitted under subsection (k)(3) that were approved or disapproved;

4–12 Sec. 501(e) of P.L. 104-170 amended sec. 4(k)(5) (7 U.S.C. 136a–1(k)(5)) to read as provided above, without specifying the Act that was being amended. The amendment was executed to this Act to effectuate the probable intent of Congress.

4–13 Sec. 501(f) of P.L. 104-170 amended sec. 4 (7 U.S.C. 136a–1) by redesignating subsecs. (l) and (m) as subsecs. (m) and (n), respectively, and inserting a new subsec. (l), without specifying the Act that was being amended. The amendments were executed to this Act to effectuate the probable intent of Congress.

(2) the future schedule for reregistrations, including the projection for such schedules that will be issued under subsection (g)(2)(A) and (B) in the current fiscal year and the succeeding fiscal year; and

(3) the projected year of completion of the reregistrations under this section.

(m) JUDICIAL REVIEW.—Any failure of the Administrator to take any action required by this section shall be subject to judicial review under the procedures prescribed by section 16(b).

(n) AUTHORIZATION OF FUNDS TO DEVELOP PUBLIC HEALTH DATA.—

(1) DEFINITION.—For the purposes of this section, “Secretary” means the Secretary of Health and Human Services, acting through the Public Health Service.

(2) CONSULTATION.—In the case of a pesticide registered for use in public health programs for vector control or for other uses the Administrator determines to be human health protection uses, the Administrator shall, upon timely request by the registrant or any other interested person, or on the Administrator’s own initiative may, consult with the Secretary prior to taking final action to suspend registration under section 3(c)(2)(B)(iv), or cancel a registration under section 4, 6(e), or 6(f). In consultation with the Secretary, the Administrator shall prescribe the form and content of requests under this section.

(3) BENEFITS TO SUPPORT FAMILY.—The Administrator, after consulting with the Secretary, shall make a determination whether the potential benefits of continued use of the pesticide for public health or health protection purposes are of such significance as to warrant a commitment by the Secretary to conduct or to arrange for the conduct of the studies required by the Administrator to support continued registration under section 3 or reregistration under section 4.

(4) ADDITIONAL TIME.—If the Administrator determines that such a commitment is warranted and in the public interest, the Administrator shall notify the Secretary and shall, to the extent necessary, amend a notice issued under section 3(c)(2)(B) to specify additional reasonable time periods for submission of the data.

(5) ARRANGEMENTS.—The Secretary shall make such arrangements for the conduct of required studies as the Secretary finds necessary and appropriate to permit submission of data in accordance with the time periods prescribed by the Administrator. Such arrangements may include Public Health Service intramural research activities, grants, contracts, or cooperative agreements with academic, public health, or other organizations qualified by experience and training to conduct such studies.

(6) SUPPORT.—The Secretary may provide for support of the required studies using funds authorized to be appropriated under this section, the Public Health Service Act, or other appropriate authorities. After a determination is made under subsection (d), the Secretary shall notify the Committees on Appropriations of the House of Representatives and the Senate of the sums required to conduct the necessary studies.

(7) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out the purposes of this section $12,000,000 for fiscal year 1997, and such sums as may be necessary for succeeding fiscal years.

Attachment B

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) - Sec. 136a.

Registration of pesticides (includes section 3(g) and Registration Review;

and section 3(c) (2)(B) for Data Call-Ins)

From the U.S. Code Online via GPO Access

[wais.access.gpo.gov]

[Laws in effect as of January 3, 2005]

[Document not affected by Public Laws enacted between

  January 3, 2005 and April 21, 2006]

[CITE: 7USC136a]

                          TITLE 7--AGRICULTURE

       CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL

             SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL

Sec. 136a. Registration of pesticides

(a) Requirement of registration

    Except as provided by this subchapter, no person in any State may

distribute or sell to any person any pesticide that is not registered

under this subchapter. To the extent necessary to prevent unreasonable

adverse effects on the environment, the Administrator may by regulation

limit the distribution, sale, or use in any State of any pesticide that

is not registered under this subchapter and that is not the subject of

an experimental use permit under section 136c of this title or an

emergency exemption under section 136p of this title.

(b) Exemptions

    A pesticide which is not registered with the Administrator may be

transferred if--

        (1) the transfer is from one registered establishment to another

    registered establishment operated by the same producer solely for

    packaging at the second establishment or for use as a constituent

    part of another pesticide produced at the second establishment; or

        (2) the transfer is pursuant to and in accordance with the

    requirements of an experimental use permit.

(c) Procedure for registration

                       (1) Statement required

        Each applicant for registration of a pesticide shall file with

    the Administrator a statement which includes--

            (A) the name and address of the applicant and of any other

        person whose name will appear on the labeling;

            (B) the name of the pesticide;

            (C) a complete copy of the labeling of the pesticide, a

        statement of all claims to be made for it, and any directions

        for its use;

            (D) the complete formula of the pesticide;

            (E) a request that the pesticide be classified for general

        use or for restricted use, or for both; and

            (F) except as otherwise provided in paragraph (2)(D), if

        requested by the Administrator, a full description of the tests

        made and the results thereof upon which the claims are based, or

        alternatively a citation to data that appear in the public

        literature or that previously had been submitted to the

        Administrator and that the Administrator may consider in

        accordance with the following provisions:

                (i) With respect to pesticides containing active

            ingredients that are initially registered under this

            subchapter after September 30, 1978, data submitted to

            support the application for the original registration of the

            pesticide, or an application for an amendment adding any new

            use to the registration and that pertains solely to such new

            use, shall not, without the written permission of the

            original data submitter, be considered by the Administrator

            to support an application by another person during a period

            of ten years following the date the Administrator first

            registers the pesticide, except that such permission shall

            not be required in the case of defensive data.

                (ii) The period of exclusive data use provided under

            clause (i) shall be extended 1 additional year for each 3

            minor uses registered after August 3, 1996, and within 7

            years of the commencement of the exclusive use period, up to

            a total of 3 additional years for all minor uses registered

            by the Administrator if the Administrator, in consultation

            with the Secretary of Agriculture, determines that, based on

            information provided by an applicant for registration or a

            registrant, that--

                    (I) there are insufficient efficacious alternative

                registered pesticides available for the use;

                    (II) the alternatives to the minor use pesticide

                pose greater risks to the environment or human health;

                    (III) the minor use pesticide plays or will play a

                significant part in managing pest resistance; or

                    (IV) the minor use pesticide plays or will play a

                significant part in an integrated pest management

                program.

          The registration of a pesticide for a minor use on a crop

            grouping established by the Administrator shall be

            considered for purposes of this clause 1 minor use for each

            representative crop for which data are provided in the crop

            grouping. Any additional exclusive use period under this

            clause shall be modified as appropriate or terminated if the

            registrant voluntarily cancels the product or deletes from

            the registration the minor uses which formed the basis for

            the extension of the additional exclusive use period or if

            the Administrator determines that the registrant is not

            actually marketing the product for such minor uses.

                (iii) Except as otherwise provided in clause (i), with

            respect to data submitted after December 31, 1969, by an

            applicant or registrant to support an application for

            registration, experimental use permit, or amendment adding a

            new use to an existing registration, to support or maintain

            in effect an existing registration, or for reregistration,

            the Administrator may, without the permission of the

            original data submitter, consider any such item of data in

            support of an application by any other person (hereinafter

            in this subparagraph referred to as the ``applicant'')

            within the fifteen-year period following the date the data

            were originally submitted only if the applicant has made an

            offer to compensate the original data submitter and

            submitted such offer to the Administrator accompanied by

            evidence of delivery to the original data submitter of the

            offer. The terms and amount of compensation may be fixed by

            agreement between the original data submitter and the

            applicant, or, failing such agreement, binding arbitration

            under this subparagraph. If, at the end of ninety days after

            the date of delivery to the original data submitter of the

            offer to compensate, the original data submitter and the

            applicant have neither agreed on the amount and terms of

            compensation nor on a procedure for reaching an agreement on

            the amount and terms of compensation, either person may

            initiate binding arbitration proceedings by requesting the

            Federal Mediation and Conciliation Service to appoint an

            arbitrator from the roster of arbitrators maintained by such

            Service. The procedure and rules of the Service shall be

            applicable to the selection of such arbitrator and to such

            arbitration proceedings, and the findings and determination

            of the arbitrator shall be final and conclusive, and no

            official or court of the United States shall have power or

            jurisdiction to review any such findings and determination,

            except for fraud, misrepresentation, or other misconduct by

            one of the parties to the arbitration or the arbitrator

            where there is a verified complaint with supporting

            affidavits attesting to specific instances of such fraud,

            misrepresentation, or other misconduct. The parties to the

            arbitration shall share equally in the payment of the fee

            and expenses of the arbitrator. If the Administrator

            determines that an original data submitter has failed to

            participate in a procedure for reaching an agreement or in

            an arbitration proceeding as required by this subparagraph,

            or failed to comply with the terms of an agreement or

            arbitration decision concerning compensation under this

            subparagraph, the original data submitter shall forfeit the

            right to compensation for the use of the data in support of

            the application. Notwithstanding any other provision of this

            subchapter, if the Administrator determines that an

            applicant has failed to participate in a procedure for

            reaching an agreement or in an arbitration proceeding as

            required by this subparagraph, or failed to comply with the

            terms of an agreement or arbitration decision concerning

            compensation under this subparagraph, the Administrator

            shall deny the application or cancel the registration of the

            pesticide in support of which the data were used without

            further hearing. Before the Administrator takes action under

            either of the preceding two sentences, the Administrator

            shall furnish to the affected person, by certified mail,

            notice of intent to take action and allow fifteen days from

            the date of delivery of the notice for the affected person

            to respond. If a registration is denied or canceled under

            this subparagraph, the Administrator may make such order as

            the Administrator deems appropriate concerning the continued

            sale and use of existing stocks of such pesticide.

            Registration action by the Administrator shall not be

            delayed pending the fixing of compensation.

                (iv) After expiration of any period of exclusive use and

            any period for which compensation is required for the use of

            an item of data under clauses (i), (ii), and (iii), the

            Administrator may consider such item of data in support of

            an application by any other applicant without the permission

            of the original data submitter and without an offer having

            been received to compensate the original data submitter for

            the use of such item of data.

                (v) The period of exclusive use provided under clause

            (ii) shall not take effect until 1 year after August 3,

            1996, except where an applicant or registrant is applying

            for the registration of a pesticide containing an active

            ingredient not previously registered.

                (vi) With respect to data submitted after August 3,

            1996, by an applicant or registrant to support an amendment

            adding a new use to an existing registration that does not

            retain any period of exclusive use, if such data relates

            solely to a minor use of a pesticide, such data shall not,

            without the written permission of the original data

            submitter, be considered by the Administrator to support an

            application for a minor use by another person during the

            period of 10 years following the date of submission of such

            data. The applicant or registrant at the time the new minor

            use is requested shall notify the Administrator that to the

            best of their knowledge the exclusive use period for the

            pesticide has expired and that the data pertaining solely to

            the minor use of a pesticide is eligible for the provisions

            of this paragraph. If the minor use registration which is

            supported by data submitted pursuant to this subsection is

            voluntarily canceled or if such data are subsequently used

            to support a nonminor use, the data shall no longer be

            subject to the exclusive use provisions of this clause but

            shall instead be considered by the Administrator in

            accordance with the provisions of clause (i), as

            appropriate.

            (G) If the applicant is requesting that the registration or

        amendment to the registration of a pesticide be expedited, an

        explanation of the basis for the request must be submitted, in

        accordance with paragraph (10) of this subsection.

                 (2) Data in support of registration

        (A) In general

            The Administrator shall publish guidelines specifying the

        kinds of information which will be required to support the

        registration of a pesticide and shall revise such guidelines

        from time to time. If thereafter the Administrator requires any

        additional kind of information under subparagraph (B) of this

        paragraph, the Administrator shall permit sufficient time for

        applicants to obtain such additional information. The

        Administrator, in establishing standards for data requirements

        for the registration of pesticides with respect to minor uses,

        shall make such standards commensurate with the anticipated

        extent of use, pattern of use, the public health and

        agricultural need for such minor use, and the level and degree

        of potential beneficial or adverse effects on man and the

        environment. The Administrator shall not require a person to

        submit, in relation to a registration or reregistration of a

        pesticide for minor agricultural use under this subchapter, any

        field residue data from a geographic area where the pesticide

        will not be registered for such use. In the development of these

        standards, the Administrator shall consider the economic factors

        of potential national volume of use, extent of distribution, and

        the impact of the cost of meeting the requirements on the

        incentives for any potential registrant to undertake the

        development of the required data. Except as provided by section

        136h of this title, within 30 days after the Administrator

        registers a pesticide under this subchapter the Administrator

        shall make available to the public the data called for in the

        registration statement together with such other scientific

        information as the Administrator deems relevant to the

        Administrator's decision.

        (B) Additional data

            (i) If the Administrator determines that additional data are

        required to maintain in effect an existing registration of a

        pesticide, the Administrator shall notify all existing

        registrants of the pesticide to which the determination relates

        and provide a list of such registrants to any interested person.

            (ii) Each registrant of such pesticide shall provide

        evidence within ninety days after receipt of notification that

        it is taking appropriate steps to secure the additional data

        that are required. Two or more registrants may agree to develop

        jointly, or to share in the cost of developing, such data if

        they agree and advise the Administrator of their intent within

        ninety days after notification. Any registrant who agrees to

        share in the cost of producing the data shall be entitled to

        examine and rely upon such data in support of maintenance of

        such registration. The Administrator shall issue a notice of

        intent to suspend the registration of a pesticide in accordance

        with the procedures prescribed by clause (iv) if a registrant

        fails to comply with this clause.

            (iii) If, at the end of sixty days after advising the

        Administrator of their agreement to develop jointly, or share in

        the cost of developing, data, the registrants have not further

        agreed on the terms of the data development arrangement or on a

        procedure for reaching such agreement, any of such registrants

        may initiate binding arbitration proceedings by requesting the

        Federal Mediation and Conciliation Service to appoint an

        arbitrator from the roster of arbitrators maintained by such

        Service. The procedure and rules of the Service shall be

        applicable to the selection of such arbitrator and to such

        arbitration proceedings, and the findings and determination of

        the arbitrator shall be final and conclusive, and no official or

        court of the United States shall have power or jurisdiction to

        review any such findings and determination, except for fraud,

        misrepresentation, or other misconduct by one of the parties to

        the arbitration or the arbitrator where there is a verified

        complaint with supporting affidavits attesting to specific

        instances of such fraud, misrepresentation, or other misconduct.

        All parties to the arbitration shall share equally in the

        payment of the fee and expenses of the arbitrator. The

        Administrator shall issue a notice of intent to suspend the

        registration of a pesticide in accordance with the procedures

        prescribed by clause (iv) if a registrant fails to comply with

        this clause.

            (iv) Notwithstanding any other provision of this subchapter,

        if the Administrator determines that a registrant, within the

        time required by the Administrator, has failed to take

        appropriate steps to secure the data required under this

        subparagraph, to participate in a procedure for reaching

        agreement concerning a joint data development arrangement under

        this subparagraph or in an arbitration proceeding as required by

        this subparagraph, or to comply with the terms of an agreement

        or arbitration decision concerning a joint data development

        arrangement under this subparagraph, the Administrator may issue

        a notice of intent to suspend such registrant's registration of

        the pesticide for which additional data is required. The

        Administrator may include in the notice of intent to suspend

        such provisions as the Administrator deems appropriate

        concerning the continued sale and use of existing stocks of such

        pesticide. Any suspension proposed under this subparagraph shall

        become final and effective at the end of thirty days from

        receipt by the registrant of the notice of intent to suspend,

        unless during that time a request for hearing is made by a

        person adversely affected by the notice or the registrant has

        satisfied the Administrator that the registrant has complied

        fully with the requirements that served as a basis for the

        notice of intent to suspend. If a hearing is requested, a

        hearing shall be conducted under section 136d(d) of this title.

        The only matters for resolution at that hearing shall be whether

        the registrant has failed to take the action that served as the

        basis for the notice of intent to suspend the registration of

        the pesticide for which additional data is required, and whether

        the Administrator's determination with respect to the

        disposition of existing stocks is consistent with this

        subchapter. If a hearing is held, a decision after completion of

        such hearing shall be final. Notwithstanding any other provision

        of this subchapter, a hearing shall be held and a determination

        made within seventy-five days after receipt of a request for

        such hearing. Any registration suspended under this subparagraph

        shall be reinstated by the Administrator if the Administrator

        determines that the registrant has complied fully with the

        requirements that served as a basis for the suspension of the

        registration.

            (v) Any data submitted under this subparagraph shall be

        subject to the provisions of paragraph (1)(D). Whenever such

        data are submitted jointly by two or more registrants, an agent

        shall be agreed on at the time of the joint submission to handle

        any subsequent data compensation matters for the joint

        submitters of such data.

            (vi) Upon the request of a registrant the Administrator

        shall, in the case of a minor use, extend the deadline for the

        production of residue chemistry data under this subparagraph for

        data required solely to support that minor use until the final

        deadline for submission of data under section 136a-1 of this

        title for the other uses of the pesticide established as of

        August 3, 1996, if--

                (I) the data to support other uses of the pesticide on a

            food are being provided;

                (II) the registrant, in submitting a request for such an

            extension, provides a schedule, including interim dates to

            measure progress, to assure that the data production will be

            completed before the expiration of the extension period;

                (III) the Administrator has determined that such

            extension will not significantly delay the Administrator's

            schedule for issuing a reregistration eligibility

            determination required under section 136a-1 of this title;

            and

                (IV) the Administrator has determined that based on

            existing data, such extension would not significantly

            increase the risk of any unreasonable adverse effect on the

            environment. If the Administrator grants an extension under

            this clause, the Administrator shall monitor the development

            of the data and shall ensure that the registrant is meeting

            the schedule for the production of the data. If the

            Administrator determines that the registrant is not meeting

            or has not met the schedule for the production of such data,

            the Administrator may proceed in accordance with clause (iv)

            regarding the continued registration of the affected

            products with the minor use and shall inform the public of

            such action. Notwithstanding the provisions of this clause,

            the Administrator may take action to modify or revoke the

            extension under this clause if the Administrator determines

            that the extension for the minor use may cause an

            unreasonable adverse effect on the environment. In such

            circumstance, the Administrator shall provide, in writing to

            the registrant, a notice revoking the extension of time for

            submission of data. Such data shall instead be due in

            accordance with the date established by the Administrator

            for the submission of the data.

            (vii) If the registrant does not commit to support a

        specific minor use of the pesticide, but is supporting and

        providing data in a timely and adequate fashion to support uses

        of the pesticide on a food, or if all uses of the pesticide are

        nonfood uses and the registrant does not commit to support a

        specific minor use of the pesticide but is supporting and

        providing data in a timely and adequate fashion to support other

        nonfood uses of the pesticide, the Administrator, at the written

        request of the registrant, shall not take any action pursuant to

        this clause in regard to such unsupported minor use until the

        final deadline established as of August 3, 1996, for the

        submission of data under section 136a-1 of this title for the

        supported uses identified pursuant to this clause unless the

        Administrator determines that the absence of the data is

        significant enough to cause human health or environmental

        concerns. On the basis of such determination, the Administrator

        may refuse the request for extension by the registrant. Upon

        receipt of the request from the registrant, the Administrator

        shall publish in the Federal Register a notice of the receipt of

        the request and the effective date upon which the uses not being

        supported will be voluntarily deleted from the registration

        pursuant to section 136d(f)(1) of this title. If the

        Administrator grants an extension under this clause, the

        Administrator shall monitor the development of the data for the

        uses being supported and shall ensure that the registrant is

        meeting the schedule for the production of such data. If the

        Administrator determines that the registrant is not meeting or

        has not met the schedule for the production of such data, the

        Administrator may proceed in accordance with clause (iv) of this

        subparagraph regarding the continued registration of the

        affected products with the minor and other uses and shall inform

        the public of such action in accordance with section 136d(f)(2)

        of this title. Notwithstanding the provisions of this clause,

        the Administrator may deny, modify, or revoke the temporary

        extension under this subparagraph if the Administrator

        determines that the continuation of the minor use may cause an

        unreasonable adverse effect on the environment. In the event of

        modification or revocation, the Administrator shall provide, in

        writing, to the registrant a notice revoking the temporary

        extension and establish a new effective date by which the minor

        use shall be deleted from the registration.

            (viii)(I) If data required to support registration of a

        pesticide under subparagraph (A) is requested by a Federal or

        State regulatory authority, the Administrator shall, to the

        extent practicable, coordinate data requirements, test

        protocols, timetables, and standards of review and reduce

        burdens and redundancy caused to the registrant by multiple

        requirements on the registrant.

            (II) The Administrator may enter into a cooperative

        agreement with a State to carry out subclause (I).

            (III) Not later than 1 year after August 3, 1996, the

        Administrator shall develop a process to identify and assist in

        alleviating future disparities between Federal and State data

        requirements.

        (C) Simplified procedures

            Within nine months after September 30, 1978, the

        Administrator shall, by regulation, prescribe simplified

        procedures for the registration of pesticides, which shall

        include the provisions of subparagraph (D) of this paragraph.

        (D) Exemption

            No applicant for registration of a pesticide who proposes to

        purchase a registered pesticide from another producer in order

        to formulate such purchased pesticide into the pesticide that is

        the subject of the application shall be required to--

                (i) submit or cite data pertaining to such purchased

            product; or

                (ii) offer to pay reasonable compensation otherwise

            required by paragraph (1)(D) of this subsection for the use

            of any such data.

        (E) Minor use waiver

            In handling the registration of a pesticide for a minor use,

        the Administrator may waive otherwise applicable data

        requirements if the Administrator determines that the absence of

        such data will not prevent the Administrator from determining--

                (i) the incremental risk presented by the minor use of

            the pesticide; and

                (ii) that such risk, if any, would not be an

            unreasonable adverse effect on the environment.

                           (3) Application

        (A) In general

            The Administrator shall review the data after receipt of the

        application and shall, as expeditiously as possible, either

        register the pesticide in accordance with paragraph (5), or

        notify the applicant of the Administrator's determination that

        it does not comply with the provisions of the subchapter in

        accordance with paragraph (6).

        (B) Identical or substantially similar

            (i) The Administrator shall, as expeditiously as possible,

        review and act on any application received by the Administrator

        that--

                (I) proposes the initial or amended registration of an

            end-use pesticide that, if registered as proposed, would be

            identical or substantially similar in composition and

            labeling to a currently-registered pesticide identified in

            the application, or that would differ in composition and

            labeling from such currently-registered pesticide only in

            ways that would not significantly increase the risk of

            unreasonable adverse effects on the environment; or

                (II) proposes an amendment to the registration of a

            registered pesticide that does not require scientific review

            of data.

            (ii) In expediting the review of an application for an

        action described in clause (i), the Administrator shall--

                (I) within 45 days after receiving the application,

            notify the registrant whether or not the application is

            complete and, if the application is found to be incomplete,

            reject the application;

                (II) within 90 days after receiving a complete

            application, notify the registrant if the application has

            been granted or denied; and

                (III) if the application is denied, notify the

            registrant in writing of the specific reasons for the denial

            of the application.

        (C) Minor use registration

            (i) The Administrator shall, as expeditiously as possible,

        review and act on any complete application--

                (I) that proposes the initial registration of a new

            pesticide active ingredient if the active ingredient is

            proposed to be registered solely for minor uses, or proposes

            a registration amendment solely for minor uses to an

            existing registration; or

                (II) for a registration or a registration amendment that

            proposes significant minor uses.

            (ii) For the purposes of clause (i)--

                (I) the term ``as expeditiously as possible'' means that

            the Administrator shall, to the greatest extent practicable,

            complete a review and evaluation of all data, submitted with

            a complete application, within 12 months after the

            submission of the complete application, and the failure of

            the Administrator to complete such a review and evaluation

            under clause (i) shall not be subject to judicial review;

            and

                (II) the term ``significant minor uses'' means 3 or more

            minor uses proposed for every nonminor use, a minor use that

            would, in the judgment of the Administrator, serve as a

            replacement for any use which has been canceled in the 5

            years preceding the receipt of the application, or a minor

            use that in the opinion of the Administrator would avoid the

            reissuance of an emergency exemption under section 136p of

            this title for that minor use.

        (D) Adequate time for submission of minor use data

            If a registrant makes a request for a minor use waiver,

        regarding data required by the Administrator, pursuant to

        paragraph (2)(E), and if the Administrator denies in whole or in

        part such data waiver request, the registrant shall have a full-

        time period for providing such data. For purposes of this

        subparagraph, the term ``full-time period'' means the time

        period originally established by the Administrator for

        submission of such data, beginning with the date of receipt by

        the registrant of the Administrator's notice of denial.

                      (4) Notice of application

        The Administrator shall publish in the Federal Register,

    promptly after receipt of the statement and other data required

    pursuant to paragraphs (1) and (2), a notice of each application for

    registration of any pesticide if it contains any new active

    ingredient or if it would entail a changed use pattern. The notice

    shall provide for a period of 30 days in which any Federal agency or

    any other interested person may comment.

                    (5) Approval of registration

        The Administrator shall register a pesticide if the

    Administrator determines that, when considered with any restrictions

    imposed under subsection (d) of this section--

            (A) its composition is such as to warrant the proposed

        claims for it;

            (B) its labeling and other material required to be submitted

        comply with the requirements of this subchapter;

            (C) it will perform its intended function without

        unreasonable adverse effects on the environment; and

            (D) when used in accordance with widespread and commonly

        recognized practice it will not generally cause unreasonable

        adverse effects on the environment.

    The Administrator shall not make any lack of essentiality a

    criterion for denying registration of any pesticide. Where two

    pesticides meet the requirements of this paragraph, one should not

    be registered in preference to the other. In considering an

    application for the registration of a pesticide, the Administrator

    may waive data requirements pertaining to efficacy, in which event

    the Administrator may register the pesticide without determining

    that the pesticide's composition is such as to warrant proposed

    claims of efficacy. If a pesticide is found to be efficacious by any

    State under section 136v(c) of this title, a presumption is

    established that the Administrator shall waive data requirements

    pertaining to efficacy for use of the pesticide in such State.

                     (6) Denial of registration

        If the Administrator determines that the requirements of

    paragraph (5) for registration are not satisfied, the Administrator

    shall notify the applicant for registration of the Administrator's

    determination and of the Administrator's reasons (including the

    factual basis) therefor, and that, unless the applicant corrects the

    conditions and notifies the Administrator thereof during the 30-day

    period beginning with the day after the date on which the applicant

    receives the notice, the Administrator may refuse to register the

    pesticide. Whenever the Administrator refuses to register a

    pesticide, the Administrator shall notify the applicant of the

    Administrator's decision and of the Administrator's reasons

    (including the factual basis) therefor. The Administrator shall

    promptly publish in the Federal Register notice of such denial of

    registration and the reasons therefor. Upon such notification, the

    applicant for registration or other interested person with the

    concurrence of the applicant shall have the same remedies as

    provided for in section 136d of this title.

            (7) Registration under special circumstances

        Notwithstanding the provisions of paragraph (5)--

            (A) The Administrator may conditionally register or amend

        the registration of a pesticide if the Administrator determines

        that (i) the pesticide and proposed use are identical or

        substantially similar to any currently registered pesticide and

        use thereof, or differ only in ways that would not significantly

        increase the risk of unreasonable adverse effects on the

        environment, and (ii) approving the registration or amendment in

        the manner proposed by the applicant would not significantly

        increase the risk of any unreasonable adverse effect on the

        environment. An applicant seeking conditional registration or

        amended registration under this subparagraph shall submit such

        data as would be required to obtain registration of a similar

        pesticide under paragraph (5). If the applicant is unable to

        submit an item of data because it has not yet been generated,

        the Administrator may register or amend the registration of the

        pesticide under such conditions as will require the submission

        of such data not later than the time such data are required to

        be submitted with respect to similar pesticides already

        registered under this subchapter.

            (B) The Administrator may conditionally amend the

        registration of a pesticide to permit additional uses of such

        pesticide notwithstanding that data concerning the pesticide may

        be insufficient to support an unconditional amendment, if the

        Administrator determines that (i) the applicant has submitted

        satisfactory data pertaining to the proposed additional use, and

        (ii) amending the registration in the manner proposed by the

        applicant would not significantly increase the risk of any

        unreasonable adverse effect on the environment. Notwithstanding

        the foregoing provisions of this subparagraph, no registration

        of a pesticide may be amended to permit an additional use of

        such pesticide if the Administrator has issued a notice stating

        that such pesticide, or any ingredient thereof, meets or exceeds

        risk criteria associated in whole or in part with human dietary

        exposure enumerated in regulations issued under this subchapter,

        and during the pendency of any risk-benefit evaluation initiated

        by such notice, if (I) the additional use of such pesticide

        involves a major food or feed crop, or (II) the additional use

        of such pesticide involves a minor food or feed crop and the

        Administrator determines, with the concurrence of the Secretary

        of Agriculture, there is available an effective alternative

        pesticide that does not meet or exceed such risk criteria. An

        applicant seeking amended registration under this subparagraph

        shall submit such data as would be required to obtain

        registration of a similar pesticide under paragraph (5). If the

        applicant is unable to submit an item of data (other than data

        pertaining to the proposed additional use) because it has not

        yet been generated, the Administrator may amend the registration

        under such conditions as will require the submission of such

        data not later than the time such data are required to be

        submitted with respect to similar pesticides already registered

        under this subchapter.

            (C) The Administrator may conditionally register a pesticide

        containing an active ingredient not contained in any currently

        registered pesticide for a period reasonably sufficient for the

        generation and submission of required data (which are lacking

        because a period reasonably sufficient for generation of the

        data has not elapsed since the Administrator first imposed the

        data requirement) on the condition that by the end of such

        period the Administrator receives such data and the data do not

        meet or exceed risk criteria enumerated in regulations issued

        under this subchapter, and on such other conditions as the

        Administrator may prescribe. A conditional registration under

        this subparagraph shall be granted only if the Administrator

        determines that use of the pesticide during such period will not

        cause any unreasonable adverse effect on the environment, and

        that use of the pesticide is in the public interest.

                  (8) Interim administrative review

        Notwithstanding any other provision of this subchapter, the

    Administrator may not initiate a public interim administrative

    review process to develop a risk-benefit evaluation of the

    ingredients of a pesticide or any of its uses prior to initiating a

    formal action to cancel, suspend, or deny registration of such

    pesticide, required under this subchapter, unless such interim

    administrative process is based on a validated test or other

    significant evidence raising prudent concerns of unreasonable

    adverse risk to man or to the environment. Notice of the definition

    of the terms ``validated test'' and ``other significant evidence''

    as used herein shall be published by the Administrator in the

    Federal Register.

                            (9) Labeling

        (A) Additional statements

            Subject to subparagraphs (B) and (C), it shall not be a

        violation of this subchapter for a registrant to modify the

        labeling of an antimicrobial pesticide product to include

        relevant information on product efficacy, product composition,

        container composition or design, or other characteristics that

        do not relate to any pesticidal claim or pesticidal activity.

        (B) Requirements

            Proposed labeling information under subparagraph (A) shall

        not be false or misleading, shall not conflict with or detract

        from any statement required by law or the Administrator as a

        condition of registration, and shall be substantiated on the

        request of the Administrator.

        (C) Notification and disapproval

            (i) Notification

                A registration may be modified under subparagraph (A)

            if--

                    (I) the registrant notifies the Administrator in

                writing not later than 60 days prior to distribution or

                sale of a product bearing the modified labeling; and

                    (II) the Administrator does not disapprove of the

                modification under clause (ii).

            (ii) Disapproval

                Not later than 30 days after receipt of a notification

            under clause (i), the Administrator may disapprove the

            modification by sending the registrant notification in

            writing stating that the proposed language is not acceptable

            and stating the reasons why the Administrator finds the

            proposed modification unacceptable.

            (iii) Restriction on sale

                A registrant may not sell or distribute a product

            bearing a disapproved modification.

            (iv) Objection

                A registrant may file an objection in writing to a

            disapproval under clause (ii) not later than 30 days after

            receipt of notification of the disapproval.

            (v) Final action

                A decision by the Administrator following receipt and

            consideration of an objection filed under clause (iv) shall

            be considered a final agency action.

        (D) Use dilution

            The label or labeling required under this subchapter for an

        antimicrobial pesticide that is or may be diluted for use may

        have a different statement of caution or protective measures for

        use of the recommended diluted solution of the pesticide than

        for use of a concentrate of the pesticide if the Administrator

        determines that--

                (i) adequate data have been submitted to support the

            statement proposed for the diluted solution uses; and

                (ii) the label or labeling provides adequate protection

            for exposure to the diluted solution of the pesticide.

              (10) Expedited registration of pesticides

        (A) Not later than 1 year after August 3, 1996, the

    Administrator shall, utilizing public comment, develop procedures

    and guidelines, and expedite the review of an application for

    registration of a pesticide or an amendment to a registration that

    satisfies such guidelines.

        (B) Any application for registration or an amendment, including

    biological and conventional pesticides, will be considered for

    expedited review under this paragraph. An application for

    registration or an amendment shall qualify for expedited review if

    use of the pesticide proposed by the application may reasonably be

    expected to accomplish 1 or more of the following:

            (i) Reduce the risks of pesticides to human health.

            (ii) Reduce the risks of pesticides to nontarget organisms.

            (iii) Reduce the potential for contamination of groundwater,

        surface water, or other valued environmental resources.

            (iv) Broaden the adoption of integrated pest management

        strategies, or make such strategies more available or more

        effective.

        (C) The Administrator, not later than 30 days after receipt of

    an application for expedited review, shall notify the applicant

    whether the application is complete. If it is found to be

    incomplete, the Administrator may either reject the request for

    expedited review or ask the applicant for additional information to

    satisfy the guidelines developed under subparagraph (A).

(d) Classification of pesticides

     (1) Classification for general use, restricted use, or both

        (A) As a part of the registration of a pesticide the

    Administrator shall classify it as being for general use or for

    restricted use. If the Administrator determines that some of the

    uses for which the pesticide is registered should be for general use

    and that other uses for which it is registered should be for

    restricted use, the Administrator shall classify it for both general

    use and restricted use. Pesticide uses may be classified by

    regulation on the initial classification, and registered pesticides

    may be classified prior to reregistration. If some of the uses of

    the pesticide are classified for general use, and other uses are

    classified for restricted use, the directions relating to its

    general uses shall be clearly separated and distinguished from those

    directions relating to its restricted uses. The Administrator may

    require that its packaging and labeling for restricted uses shall be

    clearly distinguishable from its packaging and labeling for general

    uses.

        (B) If the Administrator determines that the pesticide, when

    applied in accordance with its directions for use, warnings and

    cautions and for the uses for which it is registered, or for one or

    more of such uses, or in accordance with a widespread and commonly

    recognized practice, will not generally cause unreasonable adverse

    effects on the environment, the Administrator will classify the

    pesticide, or the particular use or uses of the pesticide to which

    the determination applies, for general use.

        (C) If the Administrator determines that the pesticide, when

    applied in accordance with its directions for use, warnings and

    cautions and for the uses for which it is registered, or for one or

    more of such uses, or in accordance with a widespread and commonly

    recognized practice, may generally cause, without additional

    regulatory restrictions, unreasonable adverse effects on the

    environment, including injury to the applicator, the Administrator

    shall classify the pesticide, or the particular use or uses to which

    the determination applies, for restricted use:

            (i) If the Administrator classifies a pesticide, or one or

        more uses of such pesticide, for restricted use because of a

        determination that the acute dermal or inhalation toxicity of

        the pesticide presents a hazard to the applicator or other

        persons, the pesticide shall be applied for any use to which the

        restricted classification applies only by or under the direct

        supervision of a certified applicator.

            (ii) If the Administrator classifies a pesticide, or one or

        more uses of such pesticide, for restricted use because of a

        determination that its use without additional regulatory

        restriction may cause unreasonable adverse effects on the

        environment, the pesticide shall be applied for any use to which

        the determination applies only by or under the direct

        supervision of a certified applicator, or subject to such other

        restrictions as the Administrator may provide by regulation. Any

        such regulation shall be reviewable in the appropriate court of

        appeals upon petition of a person adversely affected filed

        within 60 days of the publication of the regulation in final

        form.

                    (2) Change in classification

        If the Administrator determines that a change in the

    classification of any use of a pesticide from general use to

    restricted use is necessary to prevent unreasonable adverse effects

    on the environment, the Administrator shall notify the registrant of

    such pesticide of such determination at least forty-five days before

    making the change and shall publish the proposed change in the

    Federal Register. The registrant, or other interested person with

    the concurrence of the registrant, may seek relief from such

    determination under section 136d(b) of this title.

    (3) Change in classification from restricted use to general

                                     use

        The registrant of any pesticide with one or more uses classified

    for restricted use may petition the Administrator to change any such

    classification from restricted to general use. Such petition shall

    set out the basis for the registrant's position that restricted use

    classification is unnecessary because classification of the

    pesticide for general use would not cause unreasonable adverse

    effects on the environment. The Administrator, within sixty days

    after receiving such petition, shall notify the registrant whether

    the petition has been granted or denied. Any denial shall contain an

    explanation therefor and any such denial shall be subject to

    judicial review under section 136n of this title.

(e) Products with same formulation and claims

    Products which have the same formulation, are manufactured by the

same person, the labeling of which contains the same claims, and the

labels of which bear a designation identifying the product as the same

pesticide may be registered as a single pesticide; and additional names

and labels shall be added to the registration by supplemental

statements.

(f) Miscellaneous

           (1) Effect of change of labeling or formulation

        If the labeling or formulation for a pesticide is changed, the

    registration shall be amended to reflect such change if the

    Administrator determines that the change will not violate any

    provision of this subchapter.

                   (2) Registration not a defense

        In no event shall registration of an article be construed as a

    defense for the commission of any offense under this subchapter. As

    long as no cancellation proceedings are in effect registration of a

    pesticide shall be prima facie evidence that the pesticide, its

    labeling and packaging comply with the registration provisions of

    the subchapter.

           (3) Authority to consult other Federal agencies

        In connection with consideration of any registration or

    application for registration under this section, the Administrator

    may consult with any other Federal agency.

    (4) Mixtures of nitrogen stabilizers and fertilizer products

        Any mixture or other combination of--

            (A) 1 or more nitrogen stabilizers registered under this

        subchapter; and

            (B) 1 or more fertilizer products,

    shall not be subject to the provisions of this section or sections

    136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title if the

    mixture or other combination is accompanied by the labeling required

    under this subchapter for the nitrogen stabilizer contained in the

    mixture or other combination, the mixture or combination is mixed or

    combined in accordance with such labeling, and the mixture or

    combination does not contain any active ingredient other than the

    nitrogen stabilizer.

(g) Registration review

                          (1) General rule

        (A) Periodic review

            The registrations of pesticides are to be periodically

        reviewed. The Administrator shall by regulation establish a

        procedure for accomplishing the periodic review of

        registrations. The goal of these regulations shall be a review

        of a pesticide's registration every 15 years. No registration

        shall be canceled as a result of the registration review process

        unless the Administrator follows the procedures and substantive

        requirements of section 136d of this title.

        (B) Limitation

            Nothing in this subsection shall prohibit the Administrator

        from undertaking any other review of a pesticide pursuant to

        this subchapter.

                              (2) Data

        (A) Submission required

            The Administrator shall use the authority in subsection

        (c)(2)(B) of this section to require the submission of data when

        such data are necessary for a registration review.

        (B) Data submission, compensation, and exemption

            For purposes of this subsection, the provisions of

        subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section

        shall be utilized for and be applicable to any data required for

        registration review.

(h) Registration requirements for antimicrobial pesticides

                      (1) Evaluation of process

        To the maximum extent practicable consistent with the degrees of

    risk presented by an antimicrobial pesticide and the type of review

    appropriate to evaluate the risks, the Administrator shall identify

    and evaluate reforms to the antimicrobial registration process that

    would reduce review periods existing as of August 3, 1996, for

    antimicrobial pesticide product registration applications and

    applications for amended registration of antimicrobial pesticide

    products, including--

            (A) new antimicrobial active ingredients;

            (B) new antimicrobial end-use products;

            (C) substantially similar or identical antimicrobial

        pesticides; and

            (D) amendments to antimicrobial pesticide registrations.

                (2) Review time period reduction goal

        Each reform identified under paragraph (1) shall be designed to

    achieve the goal of reducing the review period following submission

    of a complete application, consistent with the degree of risk, to a

    period of not more than--

            (A) 540 days for a new antimicrobial active ingredient

        pesticide registration;

            (B) 270 days for a new antimicrobial use of a registered

        active ingredient;

            (C) 120 days for any other new antimicrobial product;

            (D) 90 days for a substantially similar or identical

        antimicrobial product;

            (E) 90 days for an amendment to an antimicrobial

        registration that does not require scientific review of data;

        and

            (F) 120 days for an amendment to an antimicrobial

        registration that requires scientific review of data and that is

        not otherwise described in this paragraph.

                         (3) Implementation

        (A) Proposed rulemaking

            (i) Issuance

                Not later than 270 days after August 3, 1996, the

            Administrator shall publish in the Federal Register proposed

            regulations to accelerate and improve the review of

            antimicrobial pesticide products designed to implement, to

            the extent practicable, the goals set forth in paragraph

            (2).

            (ii) Requirements

                Proposed regulations issued under clause (i) shall--

                    (I) define the various classes of antimicrobial use

                patterns, including household, industrial, and

                institutional disinfectants and sanitizing pesticides,

                preservatives, water treatment, and pulp and paper mill

                additives, and other such products intended to

                disinfect, sanitize, reduce, or mitigate growth or

                development of microbiological organisms, or protect

                inanimate objects, industrial processes or systems,

                surfaces, water, or other chemical substances from

                contamination, fouling, or deterioration caused by

                bacteria, viruses, fungi, protozoa, algae, or slime;

                    (II) differentiate the types of review undertaken

                for antimicrobial pesticides;

                    (III) conform the degree and type of review to the

                risks and benefits presented by antimicrobial pesticides

                and the function of review under this subchapter,

                considering the use patterns of the product, toxicity,

                expected exposure, and product type;

                    (IV) ensure that the registration process is

                sufficient to maintain antimicrobial pesticide efficacy

                and that antimicrobial pesticide products continue to

                meet product performance standards and effectiveness

                levels for each type of label claim made; and

                    (V) implement effective and reliable deadlines for

                process management.

            (iii) Comments

                In developing the proposed regulations, the

            Administrator shall solicit the views from registrants and

            other affected parties to maximize the effectiveness of the

            rule development process.

        (B) Final regulations

            (i) Issuance

                The Administrator shall issue final regulations not

            later than 240 days after the close of the comment period

            for the proposed regulations.

            (ii) Failure to meet goal

                If a goal described in paragraph (2) is not met by the

            final regulations, the Administrator shall identify the

            goal, explain why the goal was not attained, describe the

            element of the regulations included instead, and identify

            future steps to attain the goal.

            (iii) Requirements

                In issuing final regulations, the Administrator shall--

                    (I) consider the establishment of a certification

                process for regulatory actions involving risks that can

                be responsibly managed, consistent with the degree of

                risk, in the most cost-efficient manner;

                    (II) consider the establishment of a certification

                process by approved laboratories as an adjunct to the

                review process;

                    (III) use all appropriate and cost-effective review

                mechanisms, including--

                        (aa) expanded use of notification and non-

                    notification procedures;

                        (bb) revised procedures for application review;

                    and

                        (cc) allocation of appropriate resources to

                    ensure streamlined management of antimicrobial

                    pesticide registrations; and

                    (IV) clarify criteria for determination of the

                completeness of an application.

        (C) Expedited review

            This subsection does not affect the requirements or extend

        the deadlines or review periods contained in subsection (c)(3)

        of this section.

        (D) Alternative review periods

            If the final regulations to carry out this paragraph are not

        effective 630 days after August 3, 1996, until the final

        regulations become effective, the review period, beginning on

        the date of receipt by the Agency of a complete application,

        shall be--

                (i) 2 years for a new antimicrobial active ingredient

            pesticide registration;

                (ii) 1 year for a new antimicrobial use of a registered

            active ingredient;

                (iii) 180 days for any other new antimicrobial product;

                (iv) 90 days for a substantially similar or identical

            antimicrobial product;

                (v) 90 days for an amendment to an antimicrobial

            registration that does not require scientific review of

            data; and

                (vi) 120 days for an amendment to an antimicrobial

            registration that requires scientific review of data and

            that is not otherwise described in this subparagraph.

        (E) Wood preservatives

            An application for the registration, or for an amendment to

        the registration, of a wood preservative product for which a

        claim of pesticidal activity listed in section 136(mm) of this

        title is made (regardless of any other pesticidal claim that is

        made with respect to the product) shall be reviewed by the

        Administrator within the same period as that established under

        this paragraph for an antimicrobial pesticide product

        application, consistent with the degree of risk posed by the use

        of the wood preservative product, if the application requires

        the applicant to satisfy the same data requirements as are

        required to support an application for a wood preservative

        product that is an antimicrobial pesticide.

        (F) Notification

            (i) In general

                Subject to clause (iii), the Administrator shall notify

            an applicant whether an application has been granted or

            denied not later than the final day of the appropriate

            review period under this paragraph, unless the applicant and

            the Administrator agree to a later date.

            (ii) Final decision

                If the Administrator fails to notify an applicant within

            the period of time required under clause (i), the failure

            shall be considered an agency action unlawfully withheld or

            unreasonably delayed for purposes of judicial review under

            chapter 7 of title 5.

            (iii) Exemption

                This subparagraph does not apply to an application for

            an antimicrobial pesticide that is filed under subsection

            (c)(3)(B) of this section prior to 90 days after August 3,

            1996.

            (iv) Limitation

                Notwithstanding clause (ii), the failure of the

            Administrator to notify an applicant for an amendment to a

            registration for an antimicrobial pesticide shall not be

            judicially reviewable in a Federal or State court if the

            amendment requires scientific review of data within--

                    (I) the time period specified in subparagraph

                (D)(vi), in the absence of a final regulation under

                subparagraph (B); or

                    (II) the time period specified in paragraph (2)(F),

                if adopted in a final regulation under subparagraph (B).

                          (4) Annual report

        (A) Submission

            Beginning on August 3, 1996, and ending on the date that the

        goals under paragraph (2) are achieved, the Administrator shall,

        not later than March 1 of each year, prepare and submit an

        annual report to the Committee on Agriculture of the House of

        Representatives and the Committee on Agriculture, Nutrition, and

        Forestry of the Senate.

        (B) Requirements

            A report submitted under subparagraph (A) shall include a

        description of--

                (i) measures taken to reduce the backlog of pending

            registration applications;

                (ii) progress toward achieving reforms under this

            subsection; and

                (iii) recommendations to improve the activities of the

            Agency pertaining to antimicrobial registrations.

(June 25, 1947, ch. 125, Sec. 3, as added Pub. L. 92-516, Sec. 2, Oct.

21, 1972, 86 Stat. 979; amended Pub. L. 94-140, Sec. 12, Nov. 28, 1975,

89 Stat. 755; Pub. L. 95-396, Secs. 2(a), 3-8, Sept. 30, 1978, 92 Stat.

820, 824-827; Pub. L. 100-532, title I, Secs. 102(b), 103, title VI,

Sec. 601(b)(1), title VIII, Sec. 801(b), Oct. 25, 1988, 102 Stat. 2667,

2677, 2680; Pub. L. 101-624, title XIV, Sec. 1492, Nov. 28, 1990, 104

Stat. 3628; Pub. L. 102-237, title X, Sec. 1006(a)(3), (b)(1), (2), (c),

Dec. 13, 1991, 105 Stat. 1894-1896; Pub. L. 104-170, title I,

Secs. 105(b), 106(b), title II, Secs. 210(b), (c)(1), (d), (e), (f)(2),

222-224, 231, 250, Aug. 3, 1996, 110 Stat. 1491, 1494-1497, 1499, 1503,

1504, 1508, 1510; Pub. L. 108-199, div. G, title V, Sec. 501(b), Jan.

23, 2004, 118 Stat. 419.)

                            Prior Provisions

    A prior section 3 of act June 25, 1947, was classified to section

135a of this title prior to amendment of act June 25, 1947, by Pub. L.

92-516.

                               Amendments

    2004--Subsec. (h)(2)(F). Pub. L. 108-199, Sec. 501(b)(1),

substituted ``120 days'' for ``90 to 180 days''.

    Subsec. (h)(3)(D)(vi). Pub. L. 108-199, Sec. 501(b)(2)(A),

substituted ``120 days'' for ``240 days''.

    Subsec. (h)(3)(F)(iv). Pub. L. 108-199, Sec. 501(b)(2)(B), added cl.

(iv).

    1996--Subsec. (c)(1)(F)(ii) to (vi). Pub. L. 104-170, Sec. 210(b),

added cls. (ii), (v), and (vi), redesignated former cls. (ii) and (iii)

as (iii) and (iv), respectively, and in cl. (iv) substituted ``(i),

(ii), and (iii)'' for ``(i) and (ii)''.

    Subsec. (c)(1)(G). Pub. L. 104-170, Sec. 250(1), added subpar. (G).

    Subsec. (c)(2)(A). Pub. L. 104-170, Secs. 210(d)(1), 231, inserted

heading, inserted ``the public health and agricultural need for such

minor use,'' after ``pattern of use,'', and substituted ``potential

beneficial or adverse effects on man and the environment'' for

``potential exposure of man and the environment to the pesticide''.

    Subsec. (c)(2)(B). Pub. L. 104-170, Sec. 210(d)(2), inserted

heading.

    Subsec. (c)(2)(B)(vi). Pub. L. 104-170, Sec. 210(c)(1), added cl.

(vi).

    Subsec. (c)(2)(B)(vii). Pub. L. 104-170, Sec. 210(f)(2), added cl.

(vii).

    Subsec. (c)(2)(B)(viii). Pub. L. 104-170, Sec. 222, added cl.

(viii).

    Subsec. (c)(2)(C). Pub. L. 104-170, Sec. 210(d)(3), inserted

heading.

    Subsec. (c)(2)(E). Pub. L. 104-170, Sec. 210(d)(4), added subpar.

(E).

    Subsec. (c)(3)(A), (B). Pub. L. 104-170, Sec. 210(e)(1), (2),

inserted headings.

    Subsec. (c)(3)(C), (D). Pub. L. 104-170, Sec. 210(e)(3), added

subpars. (C) and (D).

    Subsec. (c)(9). Pub. L. 104-170, Sec. 223, added par. (9).

    Subsec. (c)(10). Pub. L. 104-170, Sec. 250(2), added par. (10).

    Subsec. (f)(4). Pub. L. 104-170, Sec. 105(b), added par. (4).

    Subsec. (g). Pub. L. 104-170, Sec. 106(b), added subsec. (g).

    Subsec. (h). Pub. L. 104-170, Sec. 224, added subsec. (h).

    1991--Subsec. (c)(1)(D). Pub. L. 102-237, Sec. 1006(a)(3)(B), (C),

added subpar. (D) and redesignated former subpar. (D) as (F).

    Subsec. (c)(1)(E). Pub. L. 102-237, Sec. 1006(a)(3)(A), (C), added

subpar. (E) and struck out former subpar. (E) which read as follows:

``the complete formula of the pesticide; and''.

    Subsec. (c)(1)(F). Pub. L. 102-237, Sec. 1006(a)(3)(A), (B), (D),

redesignated former subpar. (D) as (F), in cl. (i) substituted ``With''

for ``with'' and a period for semicolon at end, in cl. (ii) substituted

``Except'' for ``except'' and a period for semicolon at end, in cl.

(iii) substituted ``After'' for ``after'' and a period for semicolon at

end, and struck out former subpar. (F) which read as follows: ``a

request that the pesticide be classified for general use, for restricted

use, or for both.''

    Subsec. (c)(2)(A). Pub. L. 102-237, Sec. 1006(b)(1), (2),

substituted ``the Administrator'' for ``he'' before ``requires'',

``shall permit'', ``shall make'', and ``deems'', and substituted ``the

Administrator's'' for ``his''.

    Subsec. (c)(2)(D). Pub. L. 102-237, Sec. 1006(c), clarified

amendment made by Pub. L. 100-532, Sec. 102(b)(2)(A). See 1988 Amendment

note below.

    Subsec. (c)(3)(A). Pub. L. 102-237, Sec. 1006(b)(2), substituted

``the Administrator's'' for ``his''.

    Subsec. (c)(5). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``determines''.

    Subsec. (c)(6). Pub. L. 102-237, Sec. 1006(b)(1), (2), substituted

``the Administrator'' for ``he'' before ``shall notify'' in two places

and ``the Administrator's'' for ``his'' in four places.

    Subsec. (d)(1). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``shall classify it for both'' in

subpar. (A), before ``will classify'' in subpar. (B), and before ``shall

classify'' in subpar. (C).

    Subsec. (d)(2). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the

Administrator'' for ``he'' before ``shall notify''.

    1990--Subsec. (c)(2)(A). Pub. L. 101-624 inserted after third

sentence ``The Administrator shall not require a person to submit, in

relation to a registration or reregistration of a pesticide for minor

agricultural use under this subchapter, any field residue data from a

geographic area where the pesticide will not be registered for such

use.''

    1988--Subsec. (a). Pub. L. 100-532, Sec. 601(b)(1), substituted

``Requirement of registration'' for ``Requirement'' in heading and

amended text generally. Prior to amendment, text read as follows:

``Except as otherwise provided by this subchapter, no person in any

State may distribute, sell, offer for sale, hold for sale, ship, deliver

for shipment, or receive and (having so received) deliver or offer to

deliver, to any person any pesticide which is not registered with the

Administrator.''

    Subsec. (c)(1)(D). Pub. L. 100-532, Sec. 801(b)(1)-(4), in

introductory provisions, substituted ``paragraph (2)(D)'' for

``subsection (c)(2)(D) of this section'', in cl. (i), substituted ``(i)

with'' for ``(i) With'' and ``, except that'' for ``: Provided, That'',

in cl. (ii), substituted ``clause (i)'' for ``subparagraph (D)(i) of

this paragraph'', and in cl. (iii), substituted ``clauses (i) and (ii)''

for ``subparagraphs (D)(i) and (D)(ii) of this paragraph''.

    Subsec. (c)(2)(A). Pub. L. 100-532, Sec. 801(b)(5)(A), (B),

substituted ``(2) Data in support of registration.--

        ``(A) The''

for ``(2)(A) Data in support of registration.--The'', and directed that

subpar. (A) be aligned with left margin of subsec. (d)(1)(A) of this

section.

    Subsec. (c)(2)(B). Pub. L. 100-532, Secs. 102(b)(1), 801(b)(5)(C)-

(F), substituted ``(B)(i) If'' for ``(B) Additional data to support

existing registration.--(i) If'', directed that cls. (ii) to (v) be

aligned with left margin of subpar. (A), in cls. (ii) and (iii),

inserted ``The Administrator shall issue a notice of intent to suspend

the registration of a pesticide in accordance with the procedures

prescribed by clause (iv) if a registrant fails to comply with this

clause.'', in cl. (iv), substituted ``title. The only'' for ``title:

Provided, that the only'', and in cl. (v), substituted ``paragraph

(1)(D)'' for ``subsection (c)(1)(D) of this section''.

    Subsec. (c)(2)(C). Pub. L. 100-532, Sec. 801(b)(5)(G), (H), struck

out ``Simplified procedures'' after ``(C)'' and directed that text be

aligned with left margin of subpar. (A).

    Subsec. (c)(2)(D). Pub. L. 100-532, Sec. 102(b)(2)(A), and Pub. L.

102-237, Sec. 1006(c), substituted ``the pesticide that is the subject

of the application'' for ``an end-use product''.

    Subsec. (c)(2)(D)(i). Pub. L. 100-532, Sec. 102(b)(2)(B), struck out

``the safety of'' after ``data pertaining to''.

    Subsec. (c)(3). Pub. L. 100-532, Sec. 103, substituted ``(A) The

Administrator'' for ``The Administrator'' and added subpar. (B).

    Subsec. (c)(7). Pub. L. 100-532, Sec. 801(b)(6), in introductory

provisions, substituted ``paragraph (5)'' for ``subsection (c)(5) of

this section'', in subpars. (A) and (B), substituted ``paragraph (5).

If'' for ``subsection (c)(5) of this section: Provided, That, if'', and

in subpar. (C), substituted ``prescribe. A'' for ``prescribe: Provided,

that a''.

    Subsec. (d)(1)(A). Pub. L. 100-532, Sec. 801(b)(7), substituted

``restricted use. If'' for ``restricted use, provided that if'' and

``restricted uses. The Administrator'' for ``restricted uses: Provided,

however, That the Administrator''.

    Subsec. (f)(2). Pub. L. 100-532, Sec. 801(b)(8), substituted ``this

subchapter. As'' for ``this subchapter: Provided, That as''.

    Subsec. (g). Pub. L. 100-532, Sec. 801(b)(9), struck out subsec. (g)

which read as follows: ``The Administrator shall accomplish the

reregistration of all pesticides in the most expeditious manner

practicable: Provided, That, to the extent appropriate, any pesticide

that results in a postharvest residue in or on food or feed crops shall

be given priority in the reregistration process.''

    1978--Subsec. (c)(1)(D). Pub. L. 95-396, Sec. 2(a)(1), added subpar.

(D), and struck out provisions which required the applicant for

registration of a pesticide to file with the Administrator a statement

containing ``if requested by the Administrator, a full description of

the tests made and the results thereof upon which the claims are based,

except that data submitted on or after January 1, 1970, in support of an

application shall not, without permission of the applicant, be

considered by the Administrator in support of any other application for

registration unless such other applicant shall have first offered to pay

reasonable compensation for producing the test data to be relied upon

and such data is not protected from disclosure by section 136h(b) of

this title. This provision with regard to compensation for producing the

test data to be relied upon shall apply with respect to all applications

for registration or reregistration submitted on or after October 21,

1972. If the parties cannot agree on the amount and method of payment,

the Administrator shall make such determination and may fix such other

terms and conditions as may be reasonable under the circumstances. The

Administrator's determination shall be made on the record after notice

and opportunity for hearing. If either party does not agree with said

determination, he may, within thirty days, take an appeal to the Federal

district court for the district in which he resides with respect to

either the amount of the payment or the terms of payment, or both.

Registration shall not be delayed pending the determination of

reasonable compensation between the applicants, by the Administrator or

by the court.''.

    Subsec. (c)(2). Pub. L. 95-396, Secs. 2(a)(2)(A)-(D), 3, 4,

designated existing provisions as subpar. (A), inserted in second

sentence ``under subparagraph (B) of this paragraph'' after ``kind of

information'', struck out from introductory text of third sentence

``subsection (c)(1)(D) of this section and'' after ``Except as provided

by'', and inserted provisions relating to establishment of standards for

data requirements for registration of pesticides with respect to minor

uses and consideration of economic factors in development of standards

and cost of development, and added subpars. (B) to (D).

    Subsec. (c)(5). Pub. L. 95-396, Sec. 5, provided for waiver of data

requirements pertaining to efficacy.

    Subsec. (c)(7), (8). Pub. L. 95-396, Sec. 6, added pars. (7) and

(8).

    Subsec. (d)(1)(A). Pub. L. 95-396, Sec. 7(1), authorized

classification of pesticide uses by regulation on the initial

classification and registered pesticides prior to reregistration.

    Subsec. (d)(2). Pub. L. 95-396, Sec. 7(2), substituted ``forty-five

days'' for ``30 days''.

    Subsec. (d)(3). Pub. L. 95-396, Sec. 7(3), added par. (3).

    Subsec. (g). Pub. L. 95-396, Sec. 8, added subsec. (g).

    1975--Subsec. (c)(1)(D). Pub. L. 94-140 inserted exception relating

to test data submitted on or after January 1, 1970, in support of

application, inserted provision that compensation for producing test

data shall apply to all applications submitted on or after October 21,

1972, and provision relating to delay of registration pending

determination of reasonable compensation, struck out requirement that

payment determined by court not be less than amount determined by

Administrator, and substituted ``If either party'' for ``If the owner of

the test data''.

                    Effective Date of 2004 Amendment

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

Stat. 434, provided that: ``Except as otherwise provided in this section

[enacting section 136w-8 of this title, amending this section and

sections 136a-1, 136x, and 136y of this title, and enacting provisions

set out as notes under sections 136 of this title and section 346a of

Title 21, Food and Drugs] and the amendments made by this section, this

section and the amendments made by this section take effect on the date

that is 60 days after the date of enactment of this Act [Jan. 23,

2004].''

                    Effective Date of 1988 Amendment

    Amendment by Pub. L. 100-532 effective on expiration of 60 days

after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a

note under section 136 of this title.

                    Effective Date of 1978 Amendment

    Section 2(b) of Pub. L. 95-396 provided that: ``The amendment to

section 3(c)(1)(D) of the Federal Insecticide, Fungicide, and

Rodenticide Act [subsec. (c)(1)(D) of this section] made by [subsec.

(a)(1) of] this section shall apply with respect to all applications for

registration approved after the date of enactment of this Act [Sept. 30,

1978].''

                             Effective Date

    For effective date of section, see section 4 of Pub. L. 92-516, set

out as a note under section 136 of this title.

                   Biological Pesticide Handling Study

    Section 1498 of Pub. L. 101-624 provided that:

    ``(a) Study.--Not later than September 30, 1992, the National

Academy of Sciences shall conduct a study of the biological control

programs and registration procedures utilized by the Food and Drug

Administration, the Animal and Plant Health Inspection Service, and the

Environmental Protection Agency.

    ``(b) Development of Procedures.--Not later than 1 year after the

completion of the study under subsection (a), the agencies and offices

described in such subsection shall develop and implement a common

process for reviewing and approving biological control applications that

are submitted to such agencies and offices that shall be based on the

study conducted under such subsection and the recommendation of the

National Academy of Sciences, and other public comment.''

                      Education, Study, and Report

    Pub. L. 100-478, title I, Sec. 1010, Oct. 7, 1988, 102 Stat. 2313,

provided that:

    ``(a) Education.--The Administrator of the Environmental Protection

Agency in cooperation with the Secretary of Agriculture and the

Secretary of the Interior, promptly upon enactment of this Act [Oct. 7,

1988], shall conduct a program to inform and educate fully persons

engaged in agricultural food and fiber commodity production of any

proposed pesticide labeling program or requirements that may be imposed

by the Administrator in compliance with the Endangered Species Act (16

U.S.C. 1531 et seq.). The Administrator also shall provide the public

with notice of, and opportunity for comment on, the elements of any such

program and requirements based on compliance with the Endangered Species

Act, including (but not limited to) an identification of any pesticides

affected by the program; an explanation of the restriction or

prohibition on the user or applicator of any such pesticide; an

identification of those geographic areas affected by any pesticide

restriction or prohibition; an identification of the effects of any

restricted or prohibited pesticide on endangered or threatened species;

and an identification of the endangered or threatened species along with

a general description of the geographic areas in which such species are

located wherein the application of a pesticide will be restricted,

prohibited, or its use otherwise limited, unless the Secretary of the

Interior determines that the disclosure of such information may create a

substantial risk of harm to such species or its habitat.

    ``(b) Study.--The Administrator of the Environmental Protection

Agency, jointly with the Secretary of Agriculture and the Secretary of

the Interior, shall conduct a study to identify reasonable and prudent

means available to the Administrator to implement the endangered species

pesticides labeling program which would comply with the Endangered

Species Act of 1973, as amended, and which would allow persons to

continue production of agricultural food and fiber commodities. Such

study shall include investigation by the Administrator of the best

available methods to develop maps and the best available alternatives to