B672 PRIA Fee Category

An application for registration of an end-use or a manufacturing-use microbial or biochemical pesticide product which contains an unregistered source of active ingredient (i.e., the active ingredient in the proposed product is not derived from an EPA-registered product) or a registered source of active ingredient with new generic (active ingredient) data. This category only includes applications that require both product-specific (e.g., product chemistry, acute toxicity, and efficacy) and generic (e.g., mammalian and nontarget organism) data/waiver review. For proposed new products containing an unregistered source of active ingredient and for which all data cited to fulfill generic data requirements have been previously reviewed and accepted by the Agency, see category B673.

Generic and product-specific data requirements can be addressed with a combination of 1) submission of data; 2) citation of previously reviewed and accepted data; 3) submission or citation of data generated at government expense; 4) submission or citation of scientifically-sound rationale based on publicly available literature or other relevant information that addresses the data requirement; or 5) submission of a request for a data requirement to be waived supported by a scientifically-sound rationale explaining why the data requirement does not apply.

When uses against public health pests are proposed, efficacy (product performance) data for the product must be submitted.

This category does not include products containing an active ingredient(s) that requires a change in, or establishment of, a tolerance or tolerance exemption or require the Agency to conduct a dietary risk assessment.

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.

An application for a new end-use product using a source of active ingredient that (a) is not yet registered but (b) has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

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.