Pesticide Registration Improvement Extenstion Act (PRIA 3)
Fee Determination Decision Tree

An application that proposes a non-food use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. A non-food use includes a proposed use that is not a “food use” as described in the food use categories. Outdoor means any use that is not indoor as described in the “indoor category”. Other uses are those uses not covered by the definition of an antimicrobial found in FIFRA section 2(mm). This type of application would be for a product where a claim of pesticidal activity other than or in addition to contamination, fouling or deterioration caused by bacteria, viruses, fungi, protozoa, algae or slime is made. Refer to FIFRA Section 2(mm) for additional information. Examples would include:

• Wood preservatives (e.g. termite treatment)
• Antifoulants
• Ballast water

All non-food, section 2(mm) uses included in the original application or petition are covered by the base fee for that application in this category if submitted within the original application.

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. Any additional information that was neither requested nor required by the Agency, submitted at the applicant’s initiative after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, shall be assessed an additional 25% of the full service fee.

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 new active ingredient 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 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.