R125 PRIA Fee Category

An Experimental Use Permit (EUP) application for seed treatment only that proposes a use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product, that and is not expected to result in residues in raw agricultural commodities. All uses included in the original application for a new active ingredient are covered by the base fee for the application in this category. In order for a food crop seed treatment to be considered in this category, (i.e., considered a non-food use), data must be available showing all raw agricultural commodity residues of concern in a radiotracer study are <5 ppb, OR the calculated theoretical maximum residue of concern is ≤5 ppb, OR other non-food uses described in the guidance. Guidance is available at Series 860 - Residue Chemistry Test Guidelines.

If residues occur in raw agricultural commodities, or if there are no data available to make this determination, seed treatments are considered to be food uses requiring tolerances and fall into a different category. 45% of this category’s fee will be credited against the new active ingredient’s application fee whose submission follows that of this EUP application.

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

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.

The Agency will provide the applicant with a pre-decisional determination 4 weeks prior to the PRIA decision review time due date which specifies any label changes that have to must be made in order to grant the requested experimental use permit. 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.