A550 PRIA Fee Category

An application for registration of a pesticide product that is not substantially similar or identical in its uses or formulation to products that are currently registered. These applications require product chemistry data (Group A and Group B), acute toxicity data (addressing all 6 endpoints), and possibly leaching data. This category covers an application for a product where a claim of pesticidal activity other than or in addition to contamination, fouling or deterioration caused by bacteria, viruses, fungi, protozoa, algae or slime is made. Refer to FIFRA Section 2(mm) for additional information.

Examples would include:

• Wood preservatives (e.g., termite claim)
• Antifoulants
• Ballast water
• Any of the above use patterns that would result in a significant increase in the level of exposure (increase in dosage rate, or a change in the route of exposure (fog vs. spray), to the active ingredient of man or other organisms.

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.

All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.

The applicant must identify the substantially similar product if option to use cite-all or the selective method to support actue toxicity data requirements.

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. 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. 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.

For generic data only: Either Formulator’s Exemption or the cite-all method must be used to satisfy the generic data requirements, or a selective citation where the applicant owns all data.

Applicants are encouraged to discuss any requirements for leaching data with the Agency prior to submission of an application.

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.