R301 PRIA Fee Category

An application for registration of an end-use or a manufacturing use pesticide product that is substantially similar or identical in its uses and formulation to a single product that is currently registered and differ only in ways that would not significantly increase the risk of unreasonable adverse effects. The applicant must identify the substantially similar product for the proposed product on EPA’s application form (8570-1, box 6). 

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. A data matrix using selective data citation for generic data is not applicable in this category.
• Product chemistry data (Group A and B) unless the product is identical and supporting 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 inert ingredients must already be approved for the applicable uses in the product.
• The active ingredient listed on the CSF must be an EPA registered product.
• In all cases, the applicant must identify the currently registered similar product for this category.
• 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 where the applicant does not own all required data and does not have a specific authorization letter from the data owner. If using selective data citation for acute toxicity data, list only one set of data (6-pack that belongs to a single substantially similar product) to support the proposed product on the data matrix. If review of new data is needed, this application does not fall within this category.

The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted or cited and must be reviewed to support the application. Data that are selectively cited to support the application must have already been reviewed by the Agency for the same uses, formulation type, active ingredient and claims. For selective citation of efficacy data, the R301 category applies only if studies cited are identical to those for the cited product, and efficacy claims made on the proposed label are identical in meaning to those of the cited product. The application does not fall into this category if it contains a request to waive or bridge any of these data. An application that requires review of cited or submitted data other than product chemistry does not belong in this fee category.

Companion animal end use products must be 100% identical in composition and use to a currently registered product to be considered in this category. Otherwise, the R315 category is applicable.

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

Substantially similar: Product must have the same active ingredient, in substantially the same proportion, same chemical composition (solid, liquid, granular), and substantially similar inert ingredients as the already registered cited me-too product. In addition, substantially similar means that the proposed product bears the same use patterns. Adding use patterns or changing existing use patterns (other than deleting them) would exclude the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.

Identical: Same composition and use patterns as a currently registered end-use product.

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.

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 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.