An application that proposes a non-food use for an active ingredient with a current EPA registration. A non-food use includes a proposed use that is not a “food use” as described in the food use categories. Outdoor use means any use that is not indoor as described in the “indoor category” and that fits the definition of an antimicrobial found in FIFRA section 2(mm). The fee applies to each new non-food use requested. 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.

Examples include:

• Once through cooling tower
• Aquatic area application (other than aquatic herbicides which are handled as conventional pesticides)
• Oil fields (marine and terrestrial)
• Sewage/wastewater treatment plants (water is treated prior to discharge into the environment)
• Swimming pool, spa

  Industrial processes and water systems treatment (e.g., reverse osmosis water systems, recirculating cooling tower systems, evaporative condensers)

• Wood preservative (2mm use/claims only) Other claims, place the product in category A490)
• Antifoulants (2mm use/claims only) Other claims, place the product in category A490)
• Ballast water (2mm use/claims only) Other claims, place the product in category A490)
• 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 for man or other organisms

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 use 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.

Amendment applications to add new use(s) to registered product labels are covered by the base fee for this category as long as they are all submitted in the same package. Each application for a new product submitted in this package and/or new inert approval, however, is subject to its own registration service fee. The only exception would be if the new use(s) were to be added only to a new product (no amendments to registered product labels in the application package) in which case the review of the one new product application would be covered by the base fee for the new uses.

Any new product or amendment to the proposed labeling, which contains the same new use(s), that is submitted subsequent to the submission of the new use application but prior to its decision review time expiration date, will be deemed a separate new use application subject to a separate fee and new decision review time.

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 use(s) application.

Finally, if the new use(s) application include non-food (indoor and/or outdoor) and food (outdoor and/or indoor) uses, the appropriate fee is due for each type of new use, and the longest decision review time applies to all of the new uses requested in the application.