R298 PRIA Fee Category

An application and/or a petition request to amend an existing tolerance on domestic or imported crops in which an associated label amendment is also submitted. This may be a request to increase or decrease an existing tolerance(s) currently established under section 408 of the FFDCA. The fee for this category applies to tolerance amendments for each food use requested up to 5 uses (i.e. the fee for this category is multiplied by 4 if tolerance amendments for 4 uses are proposed) to which the label amendments apply. If tolerance and label amendments are being requested for six or more uses, the fee category R299 applies.

This category (R298) applies to requests to a change in the labeled use pattern in a way which results in the need for the tolerance to be amended; often residue data supporting the tolerance amendment 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 a change in 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 amendment would not be covered under this category.

If a tolerance amendment petition also requests the establishment of a 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 this product must be either approved or pending with the Agency for the applicable uses.

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.