R340 PRIA Fee Category

An application that proposes modification in the label, formula, or packaging of a registered product which requires the submission of data or the citation of data by the registrant that 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 up to 2 target pests. This category excludes 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 (up to 2 target pests), or 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 more than 2 target pests are submitted, then the action belongs in R341.

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 registrant wishes to amend their label by adding pest claims for 2 target pests requiring efficacy for a currently registered product. The application will not require any animal safety data. The application will include submitted or cited product performance data to support claims against pests of public health significance.

The proposed amendment example may include a general cockroach claim, a claim to control Oriental cockroaches and a general tick claim. 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 the registrant wishes to support a claim against “ticks”, another 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. Thus, data were submitted or cited to support claims against 2 pests requiring efficacy (i.e., cockroach (pest group), including Oriental cockroach specific claim; and tick (pest group)).

If the 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 3 pests requiring efficacy (i.e., cockroach (pest group), including Oriental cockroach specific claim; tick (pest group); and gulf coast tick, which may transmit Rickettsia parkeri).

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.