A538 PRIA Fee Category

An Experimental Use Permit (EUP) application for a new indirect food use(s) of an active ingredient that is not currently registered. The Antimicrobial Pesticide Use Site Index (USI) describes indirect food uses and provides guidance to determine if labeled uses require the establishment of a tolerance or exemption from the requirement of a tolerance. The USI gives examples of the general types of use sites that are commonly listed on antimicrobial labels. All indirect food uses 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 simultaneously. A credit of 45% of the New Active Ingredient fee will be applied to the application that follows.

45% of this category’s fee will be credited against the new active ingredient’s application fee whose submission follows that of this EUP.

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.