New end use product containing four or more registered active ingredients never before registered as this combination in a formulated product; new product label is identical or substantially similar to the labels of currently registered products which separately contain the respective component active ingredients;  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:

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

An application for registration of a new end-use product that contains four or more registered conventional active ingredients which have never been registered in combination as a formulated product.  The proposed label has the same uses as those found on the registered product labels for the single active ingredients.  Each source of active ingredient in the formulation must be an EPA-registered product.  Any science review must be within RD only.   If the new combination product in this category requires efficacy review, data for 4 to 7 target pests can be submitted or cited.  This category excludes on-animal products submitting or citing animal safety data for support.  All of the inerts used in the product must be approved or pending with the Agency for the applicable uses. 

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.
• Product chemistry data (Group A and B) and CSF. In some cases product chemistry data can be satisfied as outlined in PR Notice 98-1.
• If applicable, acute toxicity, efficacy, and or child resistant packaging data requirements must be addressed by using; (1) the cite-all method; (2) selective data citation. A rationale for a waiver or bridging of these data can be submitted

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 this is the case, see category R320).

If the application contains four or more active ingredients never registered before in combination that span regulatory divisions (antimicrobial, biopesticide, conventional) and require coordination between 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.For the purposes of classifying proposed registration actions into PRIA categories, “pest(s) requiring efficacy” (hereafter referred to as PRE) are: public health pests (e.g., disease transmitting, pathogen transferring, biting, stinging, allergen producing or pests otherwise injurious to humans or companion animals), livestock pests (e.g., horn flies, stable flies, cattle ticks, etc…), wood-destroying pests (i.e., termites, carpenter ants, and wood-boring beetles) and certain invasive species (e.g., Asian longhorned beetle and emerald ash borer). 

The number of PREs, which determines the appropriate PRIA category, is the sum of: 1) the number of pest Groups (general; e.g., cockroaches, filth flies, mosquitoes, etc…) for which submitted or cited data require efficacy review, and 2) the number of individual pest Species not already covered as part of a Group for which submitted or cited data require efficacy review. If a registrant submits or cites data seeking a claim against an individual PRE species not already covered by a Group, then each pest species will count as 1 PRE. If a registrant submits or cites data seeking a label claim against a pest Group, then each Group will count as 1 PRE, even if data are required for more than one Species to support claims against that Group. 

To determine whether a claim will count toward a Group or a Species, the Agency maintains a publicly available document, “Technical Support Document – Scientific Issues Associated with Product Performance Data Needs for Pesticide Products Claiming efficacy against Invertebrate Pests of Significant Public Health or Economic Importance”, which outlines Groups and Species. In this document, Appendix 1 (entitled “Pest Tables”) lists Groups of pests and the Species contained within each Group, and will serve as the guiding reference to determine Groups or Species as PREs. Use of this document in determining a PRIA category is limited to determining the number of PREs in a registrant’s application. 

NOTE: Appendix 5 of this document, entitled “Label Claims and Representative Test Species for Pesticide Products Claiming Efficacy against Invertebrate Pests of Significant Public Health or Economic Importance”, provides guidance on the tests a registrant must provide to obtain a Group claim.
 

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 formula contains four active ingredients never before registered in this combination in other registered products. 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 will 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 pest Group 8 and American and German cockroaches are the representative test species for the group; therefore, the studies supporting “cockroaches” count as one PRE for purposes of determining the PRIA category. Oriental cockroaches are part of pest Group 8. No additional data are required to support a claim against oriental cockroaches. The prospective registrant wishes to support a claim against “ticks”, pest Group 2. The prospective registrant 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 one 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, the PRIA category for this action is R318 since data were submitted or cited to support claims against 3 pests requiring efficacy (i.e., cockroach (pest group 8), including Oriental cockroach specific claim; tick (pest group 2); 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. The application would then contain product performance data supporting 4 pests requiring efficacy (i.e., cockroach (pest group 8), including Oriental cockroach specific claim; tick (pest group 2); chiggers; and gulf coast tick, which may transmit Rickettsia parkeri). The PRIA category would now be R321.

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.

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