R274 PRIA Fee Category

An application that proposes additional seed treatment uses only for any U.S. registered active ingredient for food use or non-food use and is not expected to result in residues above existing tolerance levels in raw agricultural commodities. The application must propose at least (6) specific seed treatment uses or 6 or more representative seeds for crop subgroups or crop groups. Guidance is available at Series 860 - Residue Chemistry Test Guidelines.

If residues occur in raw agricultural commodities that require the establishment of a new tolerance or modification of an existing tolerance, or if there are no data or rationale provided to make this determination, the seed treatments fall into a different category (see R277). Examples of food uses are corn, soybean, and wheat. If a seed treatment use is proposed on ornamental seed or other non-food use seed treatment uses, then the application would be in this category because it is known, without consideration of any data, that a tolerance is not required. If a crop group or subgroup is requested, the fee is based on the number of representative crops in that group or subgroup that are not currently registered. If all of the representative crops have been registered, then requesting the crop group will count as one additional use. If a tolerance needs to be established, the application does not belong in this category (see R277).

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood).

Amendment applications to add new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product submitted in this package and/or new inert approval, however, is subject to its own registration service fee. The only exception would be if the new use(s) were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for the new uses.

Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time.

If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency, after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the new use application.

If the new use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the application.

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 additional use registrations. 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.

If the Agency determines that endangered species analysis is required according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended to conduct the endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. This extension is contingent on Agency issuing the ESA guidance applicable to this PRIA category.