R319 PRIA Fee Category

1. product chemistry and/or
2. acute toxicity and/or
3. child resistant packaging and/or
4. pest(s) requiring efficacy ⁽⁴⁾ - for 4 to 7 target pests. ^{(2) (3)}

An application for registration of a new end-use product that contains up to three registered conventional active ingredients. The active ingredients have never been registered as this combination before as a formulated product. The proposed label has the same uses as those found on the registered product labels for the single active ingredients (only one registered label per active ingredient). If the new combination product in this category requires efficacy data, 4 to 7 target pests can be proposed on the label. This category excludes on-animal products submitting or citing animal safety data for support. Each source of active ingredient in the formulation must use a registered source of active ingredient. Any science review must be within RD only. The application package should include a complimentary use table listing the currently registered identical or substantially similar products from which the most restrictive directions for use/parameters such as use rates, PHI, REI, etc. were used to generate the proposed label.

To fit this category, all applications require the following but are not limited to:

• Certification with Respect to Citation of Data and a data matrix.
• Companies/registrants cannot claim formulator’s exemption for a product they own, 40 CFR 152.85(b) and FIFRA 3 (c)(2)(D), and therefore, the formulation must be listed on the CSF.
• Product chemistry data (Group A and B) and CSF. In some cases, product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98- 1. If submitting self-certification for Group B data, an MRID must be assigned.
• 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).
• Acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation which includes submitting required data. A rationale for a waiver or bridging of these data can be submitted. If a bridging rationale or waiver request is submitted for any guideline, it must be assigned an MRID and listed on the data matrix. Any other MRIDs referenced within this MRID should also be listed on the data matrix.

This category does not include applications that require a determination on whether data can be bridged or translated to other formulation types (for the individual active ingredients).

If the application contains up to three active ingredients never registered before in combination that span regulatory divisions (antimicrobial, biopesticide, conventional) and require coordination among those divisions, the application does not belong in this category (see category M005).

The application does not fall into this category if it contains a request to waive generic data or a request to review any generic data.

Applications for new end use products that are submitted using an unregistered source of an existing active ingredient will be recoded to either category R333 or R334. All active ingredients derived from a manufacturing source which does not hold an active EPA registration number are considered unregistered. Even if the Agency may have reviewed the product chemistry data previously for that source of the active ingredient for another end use product, the active ingredient is considered unregistered.

If 3 or less target pests are submitted, then the action belongs in R314. For more than 7 target pests, the action belongs in R361.

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 R310 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 new end-use product 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.