R070 PRIA Fee Category

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 use means any use that is not indoor as described in the indoor category. All non-food uses included in the application are covered by the base fee for the application in this category if submitted simultaneously. Non- food outdoor uses could include, for example, treatment of ornamentals in a shade house or turf uses.

A “reduced risk” (Conventional Reduced Risk Pesticide Program) submission must accompany the application for registration. The Agency’s Reduced Risk Committee will evaluate the submission and make the determination, based on criteria and guidance listed in PR Notice 97-3 and in FIFRA §3(c)(10) (B) (i-iv), whether the requested use(s) qualify as “reduced risk” when compared to currently registered pesticides for the same use(s). The reduced risk status of any use of a chemical is an initial assessment. Should information warrant, or should the Agency determine at any time that the data base for the chemical is unacceptable or upon a more thorough review found to be insufficient to demonstrate that the use/application is reduced risk, the Agency may reject reduced risk status. In the event that the uses do not qualify as “reduced risk” by decision of the Reduced Risk Committee, the application will not receive the reduced risk decision timeframe or fees. The fee category will be changed to the category R060, and the action will receive R060 decision review timeframe or fees. The decision review time of the R060 action shall be based on the submission date of the application originally submitted under R070 category.

A maximum of five new products (e.g., any combination of technical product, manufacturing-use product, and end use product) are covered by the base fee. After the first five new products, each application for an additional new product approval that is submitted within this new active ingredient package is subject to the registration service fee for a new product approval. Any inert ingredient petition submitted concurrently with a new active ingredient package will receive its own PRIA category and will not be counted among the five products covered under the base fee for the new active ingredient category. 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.

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 new active ingredient application.

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert petition submitted within the package for the applicable uses (food or nonfood).

Footnote 4 does not apply to this category as consideration of ESA has already been included in the review timeline.

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 must 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.