R331 PRIA Fee Category

An application for registration of a manufacturing use pesticide product that is identical in its formulation and uses to an end use product that is currently registered. The registrant must identify in the Application Form (EPA Form 8570-1) the currently registered end use product to be repacked.

To fit this category, all applications require the following but are not limited to:

• A Formulator’s Exemption statement.
• Companies/registrants cannot claim formulator’s exemption for a product they own, 40 CFR 152.85(b) and FIFRA 3 (c)(2)(D).
• Only one CSF per registration (listing a single registered end use product to be repackaged).
• The active ingredient listed on the CSF must be an EPA registered product in order to satisfy the data requirements for the active ingredient.

This category does not include data review or submission of a data matrix. The proposed MUP label can only have use sites identical to (or a subset of) the single repacked end use product (of the same formulation type). If the use sites for the proposed product differs from the currently registered repacked end use product, then additional data are required, and the application does not qualify for a repack or fall within this category.

 If the formulator’s exemption statement is not available to the applicant, the application falls under another category (e.g., R300); in such cases the full formula of the end use product will need to be listed on the CSF, and generic and product-specific data citations will need to be provided on the data matrix.

The Agency will provide the applicant with a pre-decisional determination 2 weeks prior to the PRIA decision review time due date which specifies any label changes that have to be made in order to grant the requested new product registration. If the label issues cannot be resolved prior to the PRIA decision review time due date and if a PRIA due date time extension has not been agreed upon, then the Agency will issue to the applicant its regulatory decision with the specific label changes and supporting documentation on or just before the PRIA decision review time due date. At that time the applicant must either (a) agree to all of the label changes and submit a revised label that incorporates all of these label changes; or (b) does not agree with one or more of the label changes and request up to 30 days to reach agreement with the Agency and submit a revised label that incorporates all of the agreed upon label changes, which the Agency has 2 business days to review; or (c) withdraw the application without prejudice.