B642 PRIA Fee Category

An application for a microbial or biochemical pesticide that proposes the first indoor, food/food handling use. First 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 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 exemptions from tolerance for all food/feed commodities covered by the pending registration application(s).

Indoor means that the proposed use is for use inside of manmade structures. All indoor food uses included in any original application or petition for the first food use are covered by the base fee for the application in this category if submitted within the original application.

Some examples of indoor food uses include: use in a food handling and/or processing establishment and use on food crops in a greenhouse. 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.

A maximum of five new products are covered by the base fee. After the first five new products, each application for an additional new product or new inert ingredient approval that is submitted within this first food use application package is subject to the registration service fee for a new product or a new inert ingredient approval. All such associated applications that are submitted together will be subject to first food use decision review time.

Until the first food use is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be charged a first food use service fee and decision review timeframe. 

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 first food use  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 food use 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 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.