B612 PRIA Fee Category

An application that proposes a food use for a microbial or biochemical pesticide active ingredient that is not currently an active ingredient in any U.S. registered pesticide product. The use does not require the establishment/amendment of a tolerance exemption under section 408 of the FFDCA. The application contains uses for food/feed commodities that are  all currently covered by an existing tolerance or tolerance exemption. 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 within the original application.

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.

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert is submitted within the package for the applicable uses.

If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency, after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the new active ingredient application.

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.