A400 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Antimicrobial Active Ingredient Registration for Outdoor Non-Food Use

Below is the fee for your selected Fee Category for Fiscal Years 2016/2017

Action Code	Description	FY16/17 Fee	Decision Time (months)
A400	New Active Ingredient, Non-food use; outdoor; FIFRA §2(mm) uses (2) (3)	$ 95,724	18

Do you plan to request either of the following types of waivers?

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$ 47,862
75% waiver	You pay ---->>>>>	$ 23,931

To pay the fee shown above, go to Paying PRIA Application Fees web page and follow the instructions.

How to submit your application directly to EPA.

Action Code Interpretation
An application that proposes a non-food use for an 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. 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). All non-food, section 2(mm) uses included in the original application or petition are covered by the base fee for that application in this category if submitted within the original application. Examples include: Once through cooling tower treatments Aquatic area application (e.g. sewage/wastewater treatment) other than aquatic herbicides which are handled as conventional pesticides Industrial processes and water systems treatment (e.g. reverse osmosis water systems, recirculating cooling tower systems, evaporative condensers) Swimming pools, spas Oil fields (marine and terrestrial) Sewage treatment plants (water is treated prior to discharge into the environment) Wood preservative (2mm use/claims only) Other claims place the product in category A410 Antifoulant (2mm use/claims only) Other claims place the product in category A410 Ballast water (2mm use/claims only) Other claims place the product in category A410 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 4 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: agree to all of the label changes and submit a revised label that incorporates all of these label changes; or indicate a lack of agreement 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 two business days to review; or withdraw the application without prejudice.

Action Code Interpretation

An application that proposes a non-food use for an 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. 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). All non-food, section 2(mm) uses included in the original application or petition are covered by the base fee for that application in this category if submitted within the original application.

Examples include:

Once through cooling tower treatments
Aquatic area application (e.g. sewage/wastewater treatment) other than aquatic herbicides which are handled as conventional pesticides
Industrial processes and water systems treatment (e.g. reverse osmosis water systems, recirculating cooling tower systems, evaporative condensers)
Swimming pools, spas
Oil fields (marine and terrestrial)
Sewage treatment plants (water is treated prior to discharge into the environment)
Wood preservative (2mm use/claims only) Other claims place the product in category A410
Antifoulant (2mm use/claims only) Other claims place the product in category A410
Ballast water (2mm use/claims only) Other claims place the product in category A410

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 4 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:

agree to all of the label changes and submit a revised label that incorporates all of these label changes; or
indicate a lack of agreement 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 two business days to review; or
withdraw the application without prejudice.

Go to the start of the Decision Tree

A400 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Antimicrobial Active Ingredient Registration for Outdoor Non-Food Use

Below is the fee for your selected Fee Category for Fiscal Years 2016/2017

PRIA Decision Tree