M010 PRIA Fee Category

An application for conditional ruling by EPA on the substantial similarity between a cited, registered product and a not-yet submitted new product or product amendment.  The EPA response for this category is a letter indicating agreement/disagreement that the product cited by the applicant is substantially similar to the proposed new product or amendment, such that cited acute toxicity and/or product chemistry studies would adequately address product specific guideline requirements for the new product or amendment application when submitted.  This is a conditional ruling, and should the actual registration or amendment application, once submitted, differ from the pre-application in formulation, labeling, or cited studies, it may be that the Similarity Clinic determination for the actual application will not match the pre-application conditional ruling.

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 proposed product bears the same use patterns. Adding use patterns or changing existing use patterns (other than deleting them) would exclude the proposed product from treatment as a substantially similar product. Deleting use patterns is acceptable.

The submission of a pre-application conditional ruling application does not replace the Similarity Clinic screen conducted for the new product registration or amendment application.

This category does not contemplate multiple iterations of substantial similarity requests or rebuttal of the pre-conditional ruling on substantial similarity under the same application.  Any new proposal for citation to a different registered product must be submitted as a separate M010 application.  This category does not contemplate multiple products being submitted for consideration of substantial similarity as part of one application. This determination is not required by the Agency as a pre-condition of a registration application, and such a request is at the discretion of the applicant.