R310 PRIA Fee Category

New end-use or manufacturing-use product with registered source(s) of active ingredient(s); includes products containing two or more registered active ingredients previously combined in other registered products; excludes products requiring or citing an animal safety study; requires review of data package within RD only; includes data and/or waivers of data for only:

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

An application for registration of an end-use or manufacturing use pesticide product that is not substantially similar or identical in its uses and/or formulation to a single product that is currently registered, and for which efficacy data for up to 3 target pests or pest groups are submitted or cited selectively. This category also includes new product applications containing a single registered active ingredient. Applicants should identify in the cover letter and/or EPA application form (8570-1, in the comment field) the registered product(s) that is being referenced for formulation and uses, which contains the same uses and formulation type as the proposed product 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, or 2) selective data citation which includes submitting required data. If using selective data citation for acute toxicity data, list only one set of data (i.e., 6-pack, single MRID per guideline) to support the proposed product on the data matrix. A rationale for a waiver or bridging of these data falls within this category. 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.

New uses for the active ingredient are not covered under this category (See Table 2).

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).

An application proposed as a 100% re-packaged product does not fall within this category (see category R300).

An end use on-animal product which requires animal safety data for support does not fit in this category (see R315).

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 4 to 7 target pests are submitted, then the action belongs in R316. For more than 7 target pests, the action belongs in R317.

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.

Total Number of PRE Example: A prospective registrant wishes to register a new end- use product with registered sources of active ingredients. The application will not require any animal safety data. The application will include product chemistry data, acute toxicology data and submitted or cited product performance data to support claims against pests of public health significance.

The proposed label example may include a general cockroach claim, a claim to control Oriental cockroaches, a general tick claim, and a claim against chiggers. In this example, the data necessary to support the desired claims are not on file at the Agency, so the registrant must submit or cite data with their application. To support the general cockroach claim, the Agency requires testing on both American and German cockroaches, so the prospective registrant must develop and submit or cite data supporting the desired claim on both species. Cockroaches are the general pest group and American and German cockroaches are the representative test species for the group; therefore, the studies supporting “cockroaches” count as 1 PRE for purposes of determining the PRIA category. Oriental cockroaches are not part of the general cockroaches pest group, they are a specific pest species. However, all studies supporting cockroach claims, including oriental cockroaches, count as 1 PRE, because there is already a general pest claim for cockroaches. If a prospective registrant wishes to support a claim against “ticks”, another general pest group, they must submit studies for each lone star ticks, deer (blacklegged) ticks, and American or brown dog ticks to support the general tick claim. The data to support the three required species of ticks count as 1 PRE for purposes of determining the PRIA category. Finally, the prospective registrant submits or cites data to support claims against chiggers. Chiggers count as a single PRE. Thus, data were submitted or cited to support claims against 3 pests requiring efficacy (i.e., cockroach (pest group), including Oriental cockroach specific claim; tick (pest group); and chiggers).

If the prospective registrant wishes to add a claim against the “gulf coast tick, which may transmit Rickettsia parkeri” an additional study will be required. Gulf coast ticks are not part of the general tick pest group, and not only is additional data required for this pest, but they also count as an additional PRE. This pest is one of the exceptions that is not covered by a general pest group or sub-group claim. The application would then contain product performance data supporting 4 pests requiring efficacy (i.e., cockroach (pest group), including Oriental cockroach specific claim; tick (pest group); chiggers; and gulf coast tick, which may transmit Rickettsia parkeri).

If the prospective registrant decides to include 4 additional claims to control pests requiring efficacy, then the application would contain product performance data supporting in total 8 pests requiring efficacy.

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.