B646 PRIA Fee Category

An Experimental Use Permit (EUP) application for a microbial or biochemical pesticide containing an active ingredient in a currently EPA-registered pesticide product, where the proposed use is a non-food use and does not require the establishment or amendment of a tolerance or tolerance exemption under section 408 of the FFDCA. This category includes applications with an agreement to destroy, or use only for experimental purposes, any crops treated during the experimental program. This category also includes a change in use pattern such that the exposure to humans and the environment could be significantly increased (e.g., additional routes of exposure) and therefore must be evaluated for increased risks. A non-food use determination can be made in a pre-application conditional ruling under PRIA Category B616.

All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.

Where the action involves approval of a new or amended label, on or before the end date of the decision review time, the Agency shall provide to the applicant a draft accepted label, including any changes made by the Agency that differ from the applicant-submitted label and relevant supporting data reviewed by the Agency. The applicant will notify the Agency that the applicant either (a) agrees to all of the terms associated with the draft accepted label as amended by the Agency and requests that it be issued as the accepted final Agency-stamped label; or (b) does not agree to one or more of the terms of the draft accepted label as amended by the Agency and requests additional time to resolve the difference(s); or (c) withdraws the application without prejudice for subsequent resubmission, but forfeits the associated registration service fee. For cases described in (b), the applicant shall have up to 30 calendar days to reach agreement with the Agency on the final terms of the Agency-accepted label. If the applicant agrees to all of the terms of the accepted label as in (a), including upon resolution of differences in (b), the Agency shall provide an accepted final Agency-stamped label to the registrant within 2 business days following the registrant’s written or electronic confirmation of agreement to the Agency.

If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to [section 33(c)(3)(G)] for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.