B610 PRIA Fee Category

An Experimental Use Permit (EUP) application where the proposed use meets the definition of 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 temporary tolerances or exemption from tolerances for all food/feed commodities covered by the pending registration application(s). Increases in exposure such as a dosage rate increase or different method of application that will result in a temporary tolerance increase belong to this category.  Some 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 (the “clock” or decision review timeframe starts 21 days after the Agency receives the application and the required fees or approves a fee waiver or fee exemption). A change to a crop destruct application would require the applicant to withdraw their application and start the application process anew.

All of the inerts used in the product must be either approved or pending with the Agency 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 new active ingredient EUP. 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.