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 OR a modification to an existing registration that is not substantially similar or identical in its uses to a currently registered product; that requires risk analysis by the Science Branches (i.e. by the Risk Assessment and Science Support Branch (RASSB), Product Science Branch (PSB), etc.) to support the change.

Examples of actions in this category include: label changes to Directions for Use (including REI, PPE, PHI, application rate, application frequency, application timing, increase in rate, different method of application (fogging vs. spraying), exposure change, etc. that require risk analysis by EPA. In some cases, the applicant might not submit new data to support the label amendment, but the Agency would need a determination of whether the existing database would support a change or modification to the amended label. EPA-initiated amendment shall not be charged fees.

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 of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.

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/amendment 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.

(a) EPA‐initiated amendments shall not be charged registration service fees. (b) Registrant‐ initiated fast‐track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant‐initiated fast‐ track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.