A440 PRIA Fee Category

An application that proposes a new indirect food use. Up to five (5) uses included in any original application or petition for a first food use and to establish tolerance exemptions are covered by the base fee for that application in this category if submitted within the original application.

Any use which either (1) requires the establishment or exemption from a tolerances, (2) is of a different use pattern (i.e. aquatic, terrestrial, outdoor, etc.) from what is currently registered, or (3) could result in the increase of exposure or a change in the route of exposure (ex. changes to application rate or changes to the application method) from that previously assessed by the agency, would be considered a new use (40CFR 152.3).

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.

Amendment applications to add new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product submitted in this package and/or new inert approval, however, is subject to its own registration service fee. The only exception would be if the new use(s) were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for the new uses.

Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time.

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.

Finally, if the new use(s) application includes nonfood and food/indirect food uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the 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 additional food use 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.