An application for registration of an end use product that is not substantially similar or identical in its uses or formulation to products that are currently registered and requires data review and/or risk evaluation in the science divisions. A change in the formulation type or timing of application for the registered physical form that would require residue chemistry data, environmental fate data – and/or ecotoxicity, exposure data, etc., to support the change. For example this includes a change in the formulation that would change the way a product is applied (i.e. spot-on treatments, controlled release formulation), a change in the toxicity and/or exposure profile of the product, a pre-mix product that is not currently registered that requires science review per current guidelines, a change in the application rates or PHI, animal products with rate depletion data, change in the formulation, e.g. going from a liquid to a solid, etc.

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 unregistered source of the active ingredient for another end use product, the active ingredient is considered unregistered.

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 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.