B640 PRIA Fee Category

An application for registration of a new use for a microbial or biochemical pesticide where there is a reasonable expectation or certainty that residues of the active ingredient could occur in human food, animal feed, or in livestock from the proposed use. The first food use requires the applicant to submit a petition to establish a tolerance for the active ingredient for the proposed use, and to submit data to demonstrate that dietary exposures to residues of the active ingredient at the tolerance level meet the FFDCA standard of reasonable certainty of no harm.

All uses included in any original application or petition for a first food use that otherwise satisfy the conditions for the category are covered by the base fee for that application.

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 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 the 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 4 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 first 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.