R299 PRIA Fee Category

A petition request to amend six or more existing tolerances on domestic or imported crops accompanied by submission of an associated label amendment. This may be a request to increase or decrease existing tolerances currently established under section 408 of the FFDCA. This category applies to requests to change the labeled use pattern in a way which results in the need for existing tolerances to be amended; often residue data supporting the tolerance amendments is included in the request. Examples of label changes that can require changes in tolerances include, but are not limited to, changes in application rates, application frequency, application timing, application method or PHIs). Examples of food uses include use on foods, for example, corn or apples; aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish; uses on areas where food may be grown or raised such as pasture, rangeland, home garden, beehive, and uses involving livestock, such as livestock housing, livestock dips, and livestock ear tags. 

Additional PRIA amendment requests not related to the proposed tolerance amendments would not be covered under this category.

If a tolerance amendment petition also requests the establishment of a new tolerance in association with the raw agricultural commodity (RAC) (e.g., a processed form of the RAC for which a tolerance was not previously established), this tolerance establishment activity falls under R170.

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 the revised use pattern(s) to registered product labels are covered by the base fee for this category. All items in the covered application must be submitted together in one package. Each application for a new product registration and/or new inert approval(s) that is submitted in this application package is subject to its own registration service fee. The only exception would be if the revised use pattern 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 this category.  All such associated applications that are submitted together will be subject to the category decision review time.

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 tolerance amendment 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.