B645 PRIA Fee Category

An Experimental Use Permit (EUP) application for a microbial or biochemical pesticide product containing an already registered active ingredient, where the proposed use meets the definition of a new food use. New food use includes a proposed use of any U. S. registered active ingredient for which there is no registered “food use”.  The use requires the establishment or amendment of the existing exemption from the requirement of a tolerance under section 408 of the FFDCA. The application submission must contain a petition to add or amend tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s).

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 registration.  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.