B646 PRIA Fee Category

An application for an Experimental Use Permit (EUP) for a microbial or biochemical pesticide for an already registered active ingredient, where the proposed use does not fall under the definition of a food use, or with an agreement to destroy or use only for experimental uses purposes any crops treated during the experimental program. This category also includes a change in use pattern such that the exposure to humans and the environment could be significantly increased (e.g., additional routes of exposure) and therefore must be evaluated for increased risks.

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.