An application that proposes an indoor non-food use for a low risk/low toxicity food grade active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. A non-food use includes a proposed use that is not a “food use” as described in the food use categories. The product is for use inside a manmade structure. Low risk/low toxicity food grade active ingredients are those described in PR Notice 2000-6 (www.epa.gov/PR_Notices/pr2000-6.pdf). Other active ingredients proposed as low risk/low toxicity will be considered on a case–by-case basis. A product making public health claims requires that efficacy data be submitted using a protocol that AD has approved or using a standardized AOAC, ASTM or OECD protocol. Additional guidance and other approved protocols can be found at http://www.epa.gov/oppad001/regpolicy.htm. All studies must satisfy the GLP regulations.

All of the inerts used in the product must be either approved, pending with the Agency, or a new inert is submitted within the package for the applicable uses.

A maximum of five new products are covered by the base fee. After the first five new products, each application for an additional new product or new inert ingredient approval that is submitted within this new active ingredient package is subject to the registration service fee for a new product or a new inert ingredient approval. All such associated applications that are submitted together will be subject to the new active ingredient decision review time.

Until the new active ingredient is approved, any subsequent application for another new product containing the same active ingredient or an amendment to the proposed labeling will be charged a new active ingredient service fee and decision review timeframe.

If the applicant on his own initiative submits any additional information that was neither requested nor required by the Agency after completion of the technical deficiency screening, and which does not itself constitute a covered registration application, the applicant will be charged an additional 25% of the full registration service fee for the new active ingredient 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 active ingredient 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.