B670 PRIA Fee Category

An application for registration of an end-use or manufacturing-use microbial or biochemical pesticide product which contains a registered source of active ingredient (i.e., the active ingredient in the proposed product is derived from an EPA-registered product), and the product is not substantially similar or identical in its uses and/or formulation to products that are currently registered. This category only includes applications that require product-specific data review (e.g., product chemistry, acute toxicity, and/or efficacy). For proposed new products containing an unregistered source of active ingredient or new generic (active ingredient) data, see category B672. For proposed new products containing new uses, see Table 12.

Product-specific data requirements can be addressed with a combination of

1. submission of product-specific 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.

A formulator’s exemption for generic data requirements can be claimed when the registered source of the active ingredient is owned by another pesticide registrant. If the registered source of the active ingredient is owned by the current applicant, a formulator’s exemption is not applicable, and the generic data used to support the active ingredient is instead referenced on the applicant’s data matrix.

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.