R140 PRIA Fee Category

An application that proposes an additional indoor food use. This category includes a proposed indoor food use of any U. S. registered active ingredient for which there currently is a registered food use. The use requires the establishment of the exemption from the requirement of a tolerance under section 408 of the FFDCA. If residues are reasonably foreseeable or likely to occur in food or feed or around food, the application submission must contain a petition to establish tolerances or exemption(s) from tolerance for all food/feed commodities covered by the pending registration application(s). Increases in exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use. Indoor means that the proposed use is for use inside of manmade structures. Some examples of indoor food uses include: use in a food handling and/or processing establishment and use on food crops in a greenhouse. The fee applies to each additional food use requested (e.g., the fee for this category is multiplied by 4 if 4 uses are proposed). If a crop group or subgroup is requested, the fee is based on the number of representative crops in that group or subgroup that are not currently registered. If all of the representative crops have been registered, then requesting the crop group will count as one additional use.

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).

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 and/or new inert approval submitted in this package, 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.

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 use application.

If the new use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) 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 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.

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.