R345 PRIA Fee Category

1. animal safety and
2. pest(s) requiring efficacy and/or
3. product chemistry and/or
4. acute toxicity and/or
5. child resistant packaging. ^{(2) (3) (4)}

This category applies to an application that proposes modifying an existing, registered label for an end use pesticide animal product by adding additional claims against pest(s) requiring efficacy for use on adults or juveniles or breeding animals of the same species. For example, spot-on products are generally labeled animal specific, in that a product is labeled for dogs or cats, but not generally both, while shampoos and sprays may be labeled for both animals (dogs and cats).

To fit this category, this amendment would require the following but are not limited to:

• A data matrix and data compensation forms are required with the application.
• 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). In those cases where the product relies upon a pending inert clearance, the new animal safety studies must be conducted with the pending inert in the tested product as it is intended to be marketed and sold as the end use product.
• If new efficacy claims are sought, then new pest efficacy data matching the claim(s) are required.
• If the packing type has changed (e.g., spot-on vs. stripe-on) so that the dose volume is altered (new or different), new child resistant packaging data is required.
• Which companion animal safety studies are required is based upon the specific label claims in the proposed label. For example, if the proposed end use product label claim is to use the product on 12-week-old kittens weighing =3 lbs and on breeding cats, then two companion animal studies are required: the first using kittens = 12 weeks of age and weighing at least 3 lbs. and a second study on pregnant and nursing adult cats. Each of these studies must demonstrate an adequate margin of safety.

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

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.

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.