R341 PRIA Fee Category

An application that proposes modification in the label, formula, or packaging of a registered product which is substantially similar or is not substantially similar to a currently registered product and which requires the submission of data or the citation of data by the registrant which requires an analysis by the Registration Division (RD) only. For the purposes of public health claims, this category includes adding/modifying pest(s) claims for greater than 2 target pests. This category excludes on-animal products submitting or citing animal safety data for support of the amendment application.

To fit this category the inert ingredients 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). Examples of actions in this category include alternate formulations with product chemistry data, label changes to precautionary statements based on product chemistry and/or acute product toxicity data, efficacy data (greater than 2 target pests), and child resistant packaging data.

An amendment requesting the addition of an unregistered source of active ingredient does not belong in this category, and instead falls under the R351 category. Registered source of active ingredient means that the active ingredient source product has been issued an EPA Registration Number (license).

EPA-initiated amendments shall not be charged registration service fees.

If 2 or less target pests are submitted, then the action belongs in R340.

For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” (hereafter referred to as PRE) are both invertebrate and vertebrate pests. Invertebrate public health pests (e.g., ticks, mosquitoes, cockroaches, flies, etc.), structural pests (e.g., termites, carpenter ants, and wood-boring beetles) and certain invasive invertebrate species (e.g., Asian Longhorned beetle, Emerald Ashborer) are listed in the product performance rule, 40 CFR (Code of Federal Regulations) part 158, subpart R (87 FR 22464, Subpart R). This list may be updated/refined as invasive pest needs arise. All other pests (e.g., vertebrates) are listed in PRN 2023-1 (Guidance: Pesticide Registrants on the Lists of Pests of Significant Public Health Importance).

To determine the number of PREs, which determines the appropriate PRIA category, pest groups, sub-groups and pest-specific claims as listed in 40 CFR Part 158, subpart R should be counted as follows. If seeking a label claim against a general pest group (e.g., cockroaches, mosquitoes, termites, flies, etc.), each group will count as 1 PRE. If seeking a claim against a pest sub-group (e.g., small biting flies, filth flies, large biting flies, subterranean termites, fire and harvester ants, fire ants, etc.), or specific species (e.g., smokybrown cockroach, house fly, etc.) without a general claim, then each sub-group or specific pest count as 1 PRE.

In addition, one individual PRE may encompass multiple claims. For example, if a registrant seeks both a general efficacy claim and a speed-of-kill claim against the singular PRE Group “Cockroaches”, then this will count as a singular PRE as long as the submitted or cited data adequately addresses each claim against the PRE.

Refer to the interpretation in R340 for examples on how to calculate the total number of PRE.

The Agency will provide the applicant with a pre-decisional determination 2 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 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.