significant minor uses

(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) review the application in accordance with section 136w–8(f)(4)(B) of this title and, if the application is found to be incomplete, reject the application; (II) not later than the applicable decision review time established pursuant to section 136w–8(f)(4)(B) of this title , or, if no review time is established, not later than 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.


7 USC § 136a(c)(3)

Scoping language

For purposes of this subparagraph
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