**Attachment A**

**Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4** 

- **Reregistration of Registered Pesticides SEC. 4. [7 U.S.C. 136a** 

**– 1] REREGISTRATION OF REGISTERED PESTICIDES.** 

(a) GENERAL RULE.

— The Administrator shall reregist er, in accordance with this section, each registered pesticide containing an y active ingredient contained in an y pesticide first registered before November 1, 1984, except for an y pesticide as to which the Administrator has determined, after November 1, 19 84, and before the effective date of this section [December 24, 1988], that

— (1) there are no outstanding data requirements; and (2) the requirements of section 3(c)(5) have been satisfied. (b) REREGI STRATION PHASES.

—Reregistrations of pesticides under this section shall be carried out in the following phases: (1) The first phase shall include the listing under subsection (c) of the active ingredients of the pesticides that will be reregistered. (2) The second phase shall include the submission to the A dministrator under subsection (d) of notices by

registrants respecting their intention to seek reregistration, identification by registrants of missing and inadequate data for such pesticides, and commitments by registrants to replace such missing or inade quate data within the applicable time period. (3) The third phase shall include submission to the Administrator by registrants of the information required under subsection (e). (4) The fourth phase shall include an independent, initial review by the Admin istrator under subsection (f) of submissions under phases two and three, identification of outstanding data requirements, and the issuance, as necessary , of requests for additional data. (5) The fifth phase shall include the review b y the Administrator un der subsection (g) of data submitted for reregistration and appropriate regulatory action b y the Administrator. (c) PHASE ONE.

— (1) PRI ORITY FOR REREGI STRATION.

—For purposes of the reregistration of the pesticides described in subsection (a), the Adminis trator shall list the active ingredients of pesticides and shall give priorit y to, among others, active ingredients (other than active ingredients for which registration standards have been issued before the effective date of this section [December 24, 198 8]) that

— (A) are in use on or in food or feed and may result in postharvest residues; (B) may result in residues of potential toxicological concern in potable ground water, edible fish, or shellfish; (C) have been determined by the Administrator befor e the effective date of this section [December 24, 1988] to have significant outstanding data requirements; or (D) are used on crops, including in greenhouses and nurseries, where worker exposure is most likely to occur. (2) REREGI STRATION LISTS.

—For pur poses of reregistration under this section, the Administrator shall by

order

— (A) not later than 70 days after the effective date of ingredients for which registration standards have been issued this section [December 24, 1988], list pesticide active befo re such effective date; (B) not later than 4 months after such effective date, list the first 150 pesticide active ingredients, as determined under paragraph (1); (C) not later than 7 months after such effective date, list the second 150 pesticide activ e ingredients, as determined under paragraph (1); and (D) not later than 10 months after such effective date, list the remainder of the pesticide active ingredients, as determined under paragraph (1). Each list shall be published in the Federal Register. (3) JUDI CI ALREVIEW.

— The content of a list issued by the Administrator under paragraph (2)shall not be subject to judicial review.

(4) NOTICE TO REGI STRANTS.

— On the publication of a list of Administrator shall send b y certified mail to the registrants of the pesticide active ingredients under paragraph (2), the pesticides containing such active ingredients a notice of the time b y which the registrants are to notify the Administrator under subsection (d) whether the registrants intend to seek or not to s eek reregistration of such pesticides. (d) PHASE TWO.

— (1) IN GENERAL.

— The registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall submit to the Administrator, within the time peri od prescribed by paragraph (4), the notice described in paragraph (2) and any information, commitment, or offer described in paragraph (3). (2) NOTICE OF INTENT TO SEEK OR NOT TO SEEK REREGI STRATION.

— (A) The registrant of a pesticide containing an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) shall notify the Administrator by

certified mail whether the registrant intends to seek or does not intend to seek reregistration of the pesticide. (B) If a registrant submits a no tice under subparagraph (A) of an intention not to seek reregistration of a pesticide, the Administrator shall publish a notice in the Federal Register stating that such a notice has been submitted. (3) MI SSI

NG OR INADEQUATE DATA.

—Each registrant of a pes ticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) and for which the registrant submitted a notice under paragraph (2) of an intention to seek reregistration of such pesticide shall submit to the Admin istrator

— (A) in accordance with regulations issued b y the Administrator under section 3, an identification of

— (i) all data that are required by regulation to support the registration of the pesticide with respect to such active ingredient; (ii) data th at were submitted by the registrant previously

in support of the registration of the pesticide that are inadequate to meet such regulations; and (iii) data identified under clause (i) that have not been submitted to the Administrator; and (B) either

— (i ) a commitment to replace the data identified under subparagraph (A)(ii) and submit the data identified under subparagraph (A)(iii) within the applicable time period prescribed b y paragraph (4)(B); or (ii) an offer to share in the cost to be incurred b y a person who has made a commitment under clause (i) to replace or submit the data and an offer to submit to arbitration as described b y section 3(c)(2)(B) with regard to such cost sharing. For purposes of a submission by a registrant under subparagraph (A) (ii), data are inadequate if the data are derived from a study with respect to which the registrant is unable to make the certification prescribed b y subsection (e)(1)(G) that the registrant possesses or has access to the raw data used in or generated by s uch stud y. For purposes of a submission by a registrant under such subparagraph, data shall be considered to be inadequate if the data are derived from a study submitted before January 1, 1970, unless it is demonstrated to the satisfaction of the Administrator that such data should be considered to support the registration of the pesticide that is to be reregistered. (4) TIME PERIODS.

— (A) A submission under paragraph (2) or (3) shall be made

— (i) in the case of a pesticide containing an active ingredi ent listed under subsection (c)(2)(B), not later than 3 months after the date of publication 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 3 months after the date of publication 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 3 months after the date of publication of the listing of such active ingredient. On application, the Administrator may extend a time period prescribed by this subparagraph if the Administrator determines that factors bey ond the control of the registrant prevent the registrant from compl yi ng with such period. (B) A r egistrant shall submit data in accordance with a commitment entered into under paragraph (3)(B) within a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment. The Administrator, on application of a registrant, may extend the period prescribed b y the preceding sentence b y no more than 2 years if extraordinary circumstances beyond the control of the registrant prevent the registrant from submitting data within such pr escribed 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 solel y to support that minor use until the fi nal 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 o n existing data, such extension would not significantl y increase the risk of an y unreasonable adverse effect on the environment. 4

– 1 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. **4**

**– 1**  If Administrator determines that the registrant is not meeting or the has not met the 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 prov isions 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 su ch 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. (5) CANCELLATION AND REMOVAL.

— (A) If the registrant of a pesticide does not submit a notice under paragraph (2) or (3) within the time prescribed b y paragraph (4)(A), the Administrator shall issue a notice of intent to cancel the registration of s uch registrant for such pesticide and shall publish the notice in the Federal Register and allow 60 days for the submission of comments on the notice. On expiration of such 60 day s, the Administrator, by order and without a hearing, may cancel the registration or take such other action, including extension of applicable time periods, as may be necessary

to enable reregistration of such pesticide by another person. (B)(i) If

— (I) no registrant of a pesticide containing an active ingredient listed under sub section (c)(2)notifies the Administrator under paragraph (2) that the registrant intends to seek reregistration of

any pesticide containing that active ingredient; (II) no such registrant complies with paragraph (3)(A); or (III) no such registrant makes a commitment under paragraph (3)(B) to replace or submit all data described in clauses (ii) and (iii) of paragraph (3)(A); the Administrator shall publish in the Federal Register a notice of intent to remove the active ingredient from the list establishe d under subsection (c)(2) and a notice of intent to cancel the registrations of all pesticides containing such active ingredient and shall provide 60 day s for comment on such notice.

**4**

**– 1**  In dentation of the following sentences of this subparagraph is so in original (as added b y sec. 201(c)(2) of P.L. 104

- 170). Probably should be indented the same as flush matter of this subparagraph.

(I) during the comment period a person acquires the rights of the registrant in that registration; (II) during the comme nt period that person furnishes a notice of intent to reregister the pesticide in accordance with paragraph (2); and (III) not later than 120 day s after the publication of the notice under this subparagraph, that person has complied with paragraph (3) and the fee prescribed b y subsection (i)(1) has been paid. (6) SUSPENSI ONS AND PENALTIES.

— The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed b y section 3(c)(2)(B)(iv) if th e Administrator determines that (A) progress is insufficient to ensure the submission of the data required for such pesticide under a commitment made under paragraph (3)(B) within the time period prescribed b y paragraph (4)(B) or (B) the registrant has not submitted such data 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 o n 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 pestic ide, the Administrator, at the written request of the registrant, shall not take an y 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 A ct 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 the from the registrant, the Administrator shall publish in 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 da ta, 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). Notwithst anding 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 unreasonableadverse 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 b y which the minor use shall be deleted from the registration. (e) PHASE THREE

. — (1) INFORMATION ABOUT STUDIES.

—Each registrant of a pesticide that contains an active ingredient listed under subparagraph (B), (C), or (D) of subsection (c)(2) who has submitted a notice under subsection (d)(2) of an intent to seek the reregistration of such pesticide shall submit, in accordance with the guidelines issued under paragraph (4), to the Administrator

— (A) a summary

of each study

concerning the active ingredient previously submitted by

the registrant in support of the registration of a pe sticide containing such active ingredient and considered b y the registrant to be adequate to meet the requirements of section 3 and the regulations issued under such section; (B) a summary

of each study

concerning the active ingredient previously submitte d by

the registrant in support of the registration of a pesticide containing such active ingredient that may not comply

with the requirements of section 3 and the regulations issued under such section but which the registrant asserts should be deemed to co mply with such requirements and regulations; (C) a reformat of the data from each study summarized under subparagraph (A) or (B) b y the registrant concerning chronic dosing, oncogenicity, reproductive effects, mutagenicity

, neurotoxicity , teratogenicity

, or residue chemistry of the active ingredient that were submitted to the Administrator before January 1, 1982; (D) where data described in subparagraph (C) are not required for the active ingredient b y regulations issued under section 3, a reformat of acute and subchronic dosing data submitted by the registrant to the Administrator before January 1, 1982, that the registrant considers to be adequate to meet the requirements of section 3 and the regulations issued under such section; (E) an identification of data that are required to be submitted to the Administrator under section 6(a)(2) indicating an adverse effect of the pesticide; (F) an identification of any other information available that in the view of the registrant supports the registration; (G) a certification that the registrant or the Administrator possesses or has access to the raw data used in or generated b y the studies that the registrant summarized under subparagraph (A) or (B); (H) either

— (i) a commitment to submit data to fill each outstanding data requirement identified by the registrant; or (ii) an offer to share in the cost of developing such data to be incurred b y a person who has made a commitment under clause (i) to submit such data, and an offer to submit to arbitration as de scribed b y s ection 3(c)(2)(B) with regard to such cost sharing; and (I) evidence of compliance with section 3(c)(1)(D)(ii) and regulations issued thereunder with regard to previously

submitted data as if the registrant were now seeking the original registration of the pesticide. A registrant who submits a certification under subparagraph (G) that is false shall be considered to have violated this Act and shall be subject to the penalties prescribed b y section 14. (2) TIME PERIODS.

— (A) The information r equired by paragraph (1) shall be submitted to the Administrator

— (i) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(B), not later than 12 months after the date of publication of the listing of such active ingr edient; (ii) in the case of a pesticide containing an active ingredient listed under subsection (c)(2)(C), not later than 12 months after the date of publication 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 12 months after the date of publication of the listing of such active ingredient.

(B) A registrant shall submit data in accordance with a commitment entered into under paragraph (1)(H) wi thin a reasonable period of time, as determined by the Administrator, but not more than 48 months after the date the registrant submitted the commitment under such paragraph. The Administrator, on application of a registrant, may extend the period prescrib ed by the preceding sentence b y no more than 2 y ears if extraordinary circumstances bey ond the control of the registrant prevent the registrant from submitting data within such prescribed period. Upon application of a registrant, the Administrator shall, i n 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 significantl y increase the risk of any unreasonable adverse effect on the environment. **4**

**– 2**  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 product ion 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) 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.

**4**

**– 2**  In dentation of the following sentences of this subparagraph is so in original (as added by sec. 20 1(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 A dministrator 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 o f data. Such data shall instead be due in accordance with the date then established b y 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 time ly and adequate fashion to support other nonfood uses ofthe 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

es tablished 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 abse nce 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 Admini strator 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 continu ation 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 eff ective date b y which the minor use shall be deleted from the registration. (B)(i) If the registrant of a pesticide submits the information required b y paragraph (1) within the time prescribed b y 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 g ood faith attempt to conform its submission to such guidelines, the Administrator shall provide the registrant a reasonable period of time to make an y necessary changes or corrections. (iii)(I) If the Administrator determines that the registrant did not m ake 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 with out a hearing or further notice at the end of 30 day s 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 day s 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 stud ies; (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 subp aragraph (A) shall not be subject to judicialreview.

(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 IDENTIFICATI ON OF OUTSTANDING DATA REQUI REMENTS.

— (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 dat a 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 subsecti on (e)(1). (B) The Administrator shall independentl y 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 Admini strator 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 subsectio n (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 b y 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 b y no more than 2 y ears if extraordinary circumstances bey ond 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 deadl ine 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 i nterim 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 significantl y increase the risk of an y unreasonable adverse effect on the envir onment. **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 deter mines that the registrant is not meeting or has not met the**4**

**– 3**  In dentation 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 sub paragraph. 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 f

or 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

ac cordance with the date then established by the Administrator for submission of the data. (3) SUSPENSI ONS AND PENALTIES.

— The Administrator shall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribe d 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 y ear 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 su

pport 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 an y action pursuant to thi s 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 registr ant. 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 registr ation 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 registr ation 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 notic e revoking the temporary extension and establish a new effective date b y 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 datasubmitted 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) REREGI STRATION AND OTHER ACTIONS.

— (A) IN GENERAL.

— The Administrator shall make a determination as to e ligibility 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 th an 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 b y use of section 3(c)(2)(B) and shall review such data within 90 day s after its submission. (ii) TIM ING.

— (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 CI RCUMSTANCES.

— In the case of extraordinary circumstances, the Administrator may

provide such a lo nger period, of not more than 2 additional y ears, for submission of data to the Administrator under this subparagraph. (C) After conducting the review required b y paragraph (1) for each active ingredient of a pesticide and the review required b y subparagra ph (B) of this paragraph, the Administrator shall determine whether to reregister a pesticide b y 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) TIMI NG FOR REGULATORY ACTION.

—Regulatory action under clause (i) shall be compl eted 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 subpar agraph (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 b y 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 presc ribed 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) INIT IA L FEE FOR FOOD OR FEED USE PESTI CI DE ACTIVE INGREDI ENTS.

— 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 an y pesticide registered for a major food or feed use shall collectively pay a fee of $50,000 on submis sion of information under paragraphs (2) and (3) of subsection (d) for such ingredient. (2) FINAL FEE FOR FOOD OR FEED USE PESTI CI DE ACTIVE INGREDIENTS.

— (A) The registrants of pesticides that contain an active ingredient that is listed under subparagrap h (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 dat a 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 an y 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 PESTI CI DE ACTIVE IN GREDIENTS.

— (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 an y pesticide registered for a major food or feed use shall co llectively pay fees in amounts determined b y the Administrator. Such fees may not be less than one

- half of, nor greater than, the fees required b y paragraphs (1) and (2). A registrant shall pay such fees at the times corresponding to the times fees prescri bed b y 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 u se 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 MI NOR USE AND OTHER PESTI CI DES.

— (A) An active ingredient that is contained only in pesticides that are registered solel y 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 hea lth 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 reg istrant 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 b y paragraph (3). For purposes of this subparagraph, the term “antimicrobial active ingredient” means any active ingredient that is contained onl y in pesticides that are not registered for an y 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

in activate 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 sub paragraph. (ii) If during the 3

- ye ar 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 employ ees; and (II) during the 3

- ye ar period prior reregistration, had an average annual gross revenue from to chemicals that did not ex ceed $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 y ear 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 pay

ment of the fee imposed under this paragraph if the Administrator determines that th e fee would significantl y 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 b y the Administrator to a level that will result in the collection under t his paragraph of, to the extent practicable, an aggregate amount of

— (i) for fiscal year 2004, $26,000,000; (ii) for fiscal y ear 2005, $27,000,000; (iii) for fiscal ye ar 2006, $27,000,000; (iv) for fiscal year 2007, $21,000,000; and (v) for fiscal ye ar 2008, $15,000,000. (D) MAXI MUM AMOUNT OF FEES FOR REGISTRANTS.

— The maximum annual fee
pay able under this paragraph by

— (i) **4**

**– 4**  a registrant holding not more than 50 pesticide registrations shall be

— (I) for fiscal ye ar 2004, $84,000; (II) for each of fi scal ye ars 2005 and 2006, $87,000; (III) for fiscal year 2007, $68,000; and (IV) for fiscal y ear 2008, $55,000; and (ii) **4**

**– 5**  a registrant holding over 50 registrations shall be

— (I) for fiscal ye ar 2004, $145,000; (II) for each of fiscal ye ars 2005 an d 2006, $151,000; (III) for fiscal year 2007, $117,000; and (IV) for fiscal y ear 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 pay able 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 ye ars 2005 and 2006, $61,000; (cc) for fiscal year 2007, $48,000; and (dd) for fiscal ye ar 2008, $38,500; and (II) a re gistrant holding over 50 pesticide registrations shall be

— (aa) for fiscal year 2004, $102,000; (bb) for each of fiscal ye ars 2005 and 2006, $106,000; (cc) for fiscal year 2007, $82,000; and (dd) for fiscal ye ar 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 employ ees; and (bb) during the 3

- ye ar period prior to the most recent maintenance fee billing cy cle, 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, directl y or indirectly , either pe rson 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, identi ty of interests among famil y members, shared facilities and equipment, and common use of employ ees. (F) The Administrator shall exempt any public health pesticide from the pay ment of the fee prescribed under paragraph (3) if, in consultation with the Secr etary of Health and Humans **4**

**– 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 pestici de. (G) If an y 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 add ed by sec. 232(2) of P.L. 104

- 170). Probabl y 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 an y 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 he ld 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 collectivel y 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 an y such report is not submitted by a registrant after receiving notice of such report requirement, or if an y fee prescribed b y this subs ection (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, b y 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 day s after receipt of such notice. (j) EXEMPTION OF CERTAIN REGI STRANTS.

— The requirements of subsections (d), (e), (f), and (i) (other than subsection (i)(5)) regarding data concerning an active ingredient and fees f or review of such data shall not apply to an y 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) REREGI STRATION 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 money s 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 y ear limitation, specificall y to offset the costs of re registration and expedited processing of the applications specified in paragraph (3). Such money s derived from fees may not be expended in any

fiscal
ye ar to the extent such money s derived from fees would exceed money appropriated for use b ythe Administrator and expended in such ye ar for such costs of reregistration and expedited

processing of such applications. The Administrator shall, prior to expending an y such money s derived from fees

— (i) effective October 1, 1997, adopt specific and cost accounting rules and procedures as approved b y the General Accounting Office and the Inspector General of the Environmental Protection Agency

to ensure that money s derived from fees are allocated solely to the costs of reregistration and expedited processing applicat ions specified in paragraph (3) in the same of the portion as appropriated funds; (ii) prohibit the use of such money s 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 al so

— (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 PROCESSI NG OF SIMILAR APPLICATIONS.

—

**4**

**– 7**  Sec. 501(b) of P.L. 104

- 170 amended sec. 4(k)(1) (7 U.S.C. 136a

– 1(k)(1)) b y 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 i ntent of Congress.

**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 i ntent 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 ye ars 2007 and 2008, between 1/8 and 1/7, of the maintenance fees collected in such fiscal year**4**

**– 9**  to obtai n sufficient personnel and resources

— (i) to review and evaluate new inert ingredients; and (ii) to ensure the expedited processing and review of an y application
**4**

**– 10**  that

—— (I) proposes the initial or amended registration of an end

- use pesticide th at, 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 an y such currently

- registered pe sticide onl y in way s 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) propose s 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) An y 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 no t met the time frames specified in clause (ii) of section 3(c)(3)(B) with respect to an y 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 imp osed 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 ear lier 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 y ears 1992, 1993, and 1994, 1/7th of the maintenance fees collected, up to 2 million each y ear” and inserting “for each of the f

iscal ye ars 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 fisca l

ye ar. Should the Administrator not meet such time frames in a fiscal y ear, 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 currentl y 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 instrument s that are lawful investments for fiduciary , trust, or public funds. (5) **4**

**– 12**  ACCOUNTI

NG 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 fe es, 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 cost s 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 money s derived from such fees. The Inspector General shall conduct the annual a udit 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 a mended, the status of reregistration, the number and t ype 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 aggre gate 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 subs ecs. (m) and (n), respectivel y, 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, includ ing the projection for such schedules that

will be issued under subsection (g)(2)(A) and (B) in the current fiscal y ear and the succeeding fiscal ye ar; and (3) the projected ye ar of completion of the reregistrations under this section. (m) JUDI CI AL REVIE W.

— 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 PUBLI C HEALTH DATA.

— (1) DEFINIT ION.

—For the purpo ses of this section, “Secretary ” means the Secretary of Health and Human Services, acting through the Public Health Service. (2) CONSULTATION.

— Inthe 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 acti on 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 SU PPORT 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 commi tment by the Secretary

to conduct or to arrange for the conduct of the studies required b y the Administrator to support continued registration under section 3 or reregistration under section 4. (4) ADDITIONAL TIME.

— If the Administrator determines that suc h 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

arran gements 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 Secr etary 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 not ify

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 sectio n $12,000,000 for fiscal y ear 1997, and such sums as may

be necessary

for succeeding fiscal y ears.