R334 PRIA Fee Category

An application for registration of a new product (MUP or end use product) where the active ingredient used in the formulation is derived from an unregistered source (i.e., does not have an EPA registration number) and is supported by selective data citation. New manufacturing use product is any product intended (labeled) for formulation or repackaging into an end use formulated pesticide product.

The active ingredient is not a new active ingredient, but either (1) one that claims to be substantially similar or identical to another active ingredient which is currently registered (as referenced by EPA registration number) and will use selective data citation, or (2) an end use product which claims to be substantially similar or identical in its formulation to another end use product that is currently registered for which the selective data citation was used. Applicants should identify in the cover letter and/or EPA application form (8570-1, in the comment field) the registered product that is being referenced for formulation and uses which contains the same use(s) and formulation type as the proposed product label. If the submission includes addition of multiple unregistered sources/production sites, Group A data for each unregistered source should be submitted in separate MRIDs. Also, an additional fee will be charged for each additional unregistered source of active ingredient that is included in the application.

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.
• If registering an MUP that is a technical product, one set of product specific product chemistry data and CSF is required (under #1 below).
• If registering an end-use product, two sets of product chemistry data and CSFs are required ((under #1 and #2 below).

1. Product chemistry (Group A and B) on the unregistered source of the active ingredient and CSF. The applicant must identify to the Agency the toxicity of the impurities associated with the active ingredient; particularly impurities of toxicological significance (at any level). The impurity profile of the unregistered source of the active ingredient will be compared to registered source. The impurity profile of the unregistered source of the active ingredient either results in new impurities; or impurities of toxicological significance, or if the toxicity of new impurities is unknown to the applicant, then the application is submitted to HED for review.
2. Product chemistry data (Group A and B) for the end use product 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, public health pest efficacy, companion animal safety data and/or child resistant packaging data requirements must be addressed by using: 1) selective data citation. When 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.
• Proposed label for the MUP and/or end use product

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.