R292 PRIA Fee Category

A petition to amend an existing tolerance on domestic or imported crops and for which there is not a related label amendment request necessitating the proposed tolerance amendment. This may be a request to increase or decrease an existing tolerance currently established under section 408 of the FFDCA. The fee for this category applies to each additional food use to which the requested tolerance amendments apply, up to 5 uses (e.g., the fee for this category is multiplied by 4 if 4 uses are proposed). If tolerance amendments are being requested for six or more uses, the fee category R297 applies.

For purposes of counting, all tolerance amendments within a commodity (e.g., tomato) are counted as one use. If amendment to a crop group or subgroup tolerance is requested, the fee is based on the number of representative crops in that group or subgroup. This category is applicable when a tolerance amendment is being requested but no related label amendment is necessary or being requested.

Additionally, this category includes an applicant’s request to amend established tolerances to harmonize with existing Codex Maximum Residue Limits (MRLs) for an active ingredient. The base fee for the category covers all proposed tolerance amendments related to harmonization with Codex MRLs, for the active ingredient, provided no related label amendments or residue data are provided in conjunction with the harmonization request. A Codex MRL-related tolerance amendment request (multiple harmonized tolerances) will count as one use for calculating the fee in the multiplier framework described in the previous paragraph. To explain further, if the Agency receives a petition to amend tolerances for fruiting vegetables crop group 8-10 (3 representative crops), and a request to align with Codex MRLs for three existing tolerances of carrots, celery and potato in the same petition, the fee for this category is multiplied by 4.

Examples of situations to which this category might apply include but are not limited to requests to decrease an existing tolerance, increase an existing tolerance to reflect residue data demonstrating higher observed residues than the existing tolerance, or move an existing tolerance from one paragraph to another within the citation in 40 CFR Part 180. 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.

If a tolerance amendment petition also requests the establishment of another 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.