R040 PRIA Fee Category

An Experimental Use Permit (EUP) application for food use(s) of an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. The application proposes a food use. The use requires the establishment of or the exemption from the requirement of a tolerance under section 408 of the FFDCA. The application submission must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). All uses (food and non-food) included in any original application or petition for a new active ingredient are covered by the base fee for the application in this category if submitted simultaneously. 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.

The Agency will not accept a certification for crop destruct once the review clock has started. A change to a crop destruct application would require the applicant to withdraw their application and start the process application again.

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 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 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.