R363 PRIA Fee Category

An application for registration of an end use pesticide product that is identical in its formulation and use sites to a manufacturing use product (MUP) that is currently registered. The registrant must identify in the Application Form (EPA Form 8570-1) the currently registered MUP to be repacked, as well as a single currently registered end use product (of the same formulation type as the MUP). This cited end use product must have identical uses (or a subset) as the MUP, that will be listed on the proposed end use product label.

To fit this category, all applications require the following:

• 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 MUP 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 submission of data matrix or data review. If the use sites for the proposed product differs from the currently registered repacked MUP, 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., R310); 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.

This category does not apply to proposed end use labels containing structural pest claims, public health pest claims, quarantine pest claims; companion animal products or products that have child-resistant packaging.

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 the 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.