A530 PRIA Fee Category

An application for registration of an end-use or a manufacturing use pesticide product that is substantially similar, identical in its uses and formulation or that differ only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment to products that are currently registered. The applicant must identify the similar products for all active ingredients in the proposed product. All applications require the following:

• A data matrix is required with the application if it is not a 100% re-packaged product. •
• Product chemistry data (Group A and B) unless the product is identical (e.g. 100% repackaged product).
• The active ingredient listed on the CSF must be an EPA registered product. •
• In all cases, the registrant must identify the registered similar product for this category. •
• Acute toxicity requirements must be addressed by using:
  1. the cite-all method
  2. selective data citation where the applicant owns all required data, or
  3. applicant submits specific authorization letter from the data owner. 
• If a product is using the selective cite or a cite all, the product that is being cited as substantially similar or identical must be clearly identified on the 8570-1 application form. If multiple products are cited, they must be clearly delineated in the cover letter.

The application is not in this category if efficacy, acute toxicity, companion animal safety, and/or child resistant packaging data are submitted and must be reviewed to support the application. The application does not fall into this category if it contains a request to waive 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. If the use pattern on the TGAI differs from the proposed products, then additional data are required and the application does not fall within this category.

A different pattern of use that significantly changes or increases exposure such as a dosage rate increase or different method of application will result in the application being treated as a new use, and thus outside of this PRIA category. The company is required to provide a cited label to support the proposed uses by showing that the use pattern and rates do not exceed currently registered products.

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 product. In addition, substantially similar means that the product bears the same use patterns or fewer. Adding to or changing existing use patterns excludes the product from treatment as a substantially similar product. Substantially similar use patterns for public health products are limited to identical organisms on both products. For non-public health products substantially similar use patterns are limited to identical organisms on both products. Deleting use patterns is acceptable.

Identical products: Same composition and use patterns as an already registered end-use product.

Manufacturing Use Product: A 100% re-package of a manufacturing use product that requires no data submission nor data matrix is covered by this category.

Unregistered: The Agency has not issued an EPA Registration Number (license) for the source material.

An application for a new end-use product using a source of active ingredient that is not yet registered but has an application pending with the Agency for review, will be considered an application for a new product with an unregistered source of active ingredient.

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, 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.