R251 PRIA Fee Category

An Experimental Use Permit (EUP) application for food use which requires no changes to the existing tolerance(s) and the crop is not destroyed. Any U.S. registered active ingredient that currently has approved tolerance(s) for the proposed use. Due to the extended registration process in certain states, this category provides the ability to conduct an EUP without the need for crop destruct or for establishing temporary tolerance(s) while the state registration is under review. This category would allow the conduct of research in States for a new application method on a crop for which tolerance(s) were already federally approved. For example, in order to get a California (CA) EUP, CA requires a Federal EUP to do testing. Testing may be required by CA for an aerial application when only the ground application method is approved in the state. Examples of food uses include use on foods, for example, corn or apples; aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish; uses on areas where food may be grown or raised such as pasture, rangeland, home garden, beehive, and uses involving livestock, such as livestock housing, livestock dips, and livestock ear tags.

All of the inerts used in the product must be approved for the applicable uses.

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 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.

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.