A431 PRIA Fee Category

An application that proposes a non-food use for a low risk active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. Active ingredients proposed as low risk will be considered on a case-by-case basis. Products that have any toxicity may result in the product being delayed to significant internal review processes.

An application that proposes a non-food use for a low risk active ingredient. The product is not currently registered as an active ingredient in any U.S. registered pesticide product. All applications submitted under this code must provide a scientifically valid rationale as to why it should be considered a low risk active ingredient.

Prior to submission a pre application meeting is highly recommended to determine the product’s category as a low risk.

All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.

If the Agency determines that endangered species analysis is required according to section 33(c)(3)(B) for this specific type of action, the decision review time can be extended to conduct the endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. This extension is contingent on Agency issuing the ESA guidance applicable to this PRIA category.

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 new active ingredient 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 new active ingredient decision review time.

Until the new active ingredient 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 new active ingredient service fee and decision review timeframe.

Any information that (a) was neither requested nor required by the Agency, and (b) is submitted by the applicant at the applicant’s initiative to support the application after completion of the technical deficiency screening, and (c) is not itself a covered registration application, must be assessed 25% of the full registration service fee for the new active ingredient or 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 active ingredient registration. If the label issues cannot be resolved prior to the PRIA decision review time due date, 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.

The Antimicrobial Pesticide Use Site Index (USI) describes and provides examples of direct food, indirect food and nonfood uses for proposed applications.  The USI also provides guidance to determine if proposed or labeled uses require the establishment of a tolerance or exemption from the requirement of a tolerance.