An application and/or a petition request to amend an existing tolerance or exemption from the requirement of a tolerance related to an approved safener ingredient.  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 (i.e. the fee for this category is multiplied by 4 if tolerance amendments for 4 uses are proposed).  If there is a related label amendment application submitted in conjunction with the tolerance amendment request for the safener, review of the label(s) is included under the base fee.

If the label amendment request related to the amendment of the safener ingredient also dictates that amendment to an established tolerance(s) for active ingredient(s) are needed, additional PRIA categories may apply (e.g. R292).

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.