B660 PRIA Fee Category

An application for registration of an end-use or a 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 identical, or substantially similar, in its uses and formulation to products that are currently registered and for which the Agency must make a determination of similarity to a registered product.

If a review of data other than product chemistry is needed, the application does not fall in this category. For proposed new products for which product-specific data or waiver requests beyond product chemistry (e.g., efficacy, acute toxicity, companion animal safety, and/or child resistant packaging), must be submitted and reviewed to support the application, see category B670. For proposed new products containing an unregistered source of active ingredient or new generic (active ingredient) data, see category B672. For 100% repacks, see category B674.

All applications require the following:

• The active ingredient in the proposed product must be derived from an EPA-registered product.
• The applicant must identify the currently registered similar product, and this must be accurately reflected on the CSF.
• A data matrix (if data are cited or submitted)
• Product chemistry data (Group A and B). In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1.
• Acute toxicity requirements must be addressed by using only: (1) the cite-all method, (2) selective data citation where the applicant owns all required data, or (3) applicant submits specific authorization letter from the data owner.

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.

Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical form (solid, liquid, granular), and substantially similar composition (inert ingredients) as the already registered product. In addition, substantially similar means that the proposed product bears the same use pattern. Adding to or changing existing use patterns excludes the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.

Identical: Same composition and use patterns as a currently registered product.

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.