An application that proposes a food use for an active ingredient that is not currently contained as an active ingredient in any U.S. registered pesticide product. The use requires the establishment of an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), or an increase in an existing tolerance exemption or a food additive regulation or other clearance under section 409 of the FFDCA. The application may need to include a petition to establish an exemption from tolerance for all food commodities covered by the pending registration application(s) or, if residues would not be subject to FFDCA section 408, documentation of an applicable food additive regulation or other clearance under section 409 of the FFDCA. Refer to the definition of a “food use” for the uses subject to this category. All uses (food and non-food) included in any original application or petition for a new active ingredient or a first food use are covered by the base fee for that application in this category if submitted within the original application.

Examples include:

• Pre- and post-harvest use on crops (other than agricultural fungicides and aquatic herbicides, which are handled as conventional pesticides)
• Animal drinking water treatment (meat, meat by-products and/or milk tolerance exemption)
• Process water treatment for post harvest use (field washing of raw agricultural commodities)
• Treatment of permanent or semi-permanent food contact surfaces (sanitizers and disinfectants)
• Use of the product in food contact articles, other than food packaging with an intended ongoing effect in the finished article, including the articles surface or in food that may contact the article (e.g., conveyor belt-claims to kill bacteria on articles that come in contact with belt; or a lubricant with claims that the lubricant kills bacteria
• Treatment of raw agricultural commodities in a food processing facility (FDA food additive regulation)
• Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation - EPA dietary risk assessment)
• Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
• Production of food packaging (FDA food additive regulation)(e.g., adhesives, coatings)
• Production of food contact articles other than food packaging (FDA food additive regulation) (cutting board that contains an antimicrobial as a preservative)
• Food handling storage establishment premises and equipment (e.g. eating establishments, meat processing equipment, food handling equipment)
• Aseptic packaging (FDA food additive regulation)
• Ethanol production (treatment of empty fermentation tank) (check with the Agency prior to submission of an application)
• Aquatic area application (e.g., lakes, ponds, reservoirs, irrigation systems)(other than aquatic herbicides which are handled as conventional pesticides)
• Home produce washes (dietary risk assessment required)
• Human drinking water systems (e.g., water purifier units, emergency water systems, municipal water treatment)

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.

If EPA data rules are amended to newly require clearance under section 408 of the FFDCA for an ingredient of an antimicrobial product where such ingredient was not previously subject to such a clearance, then review of the data for such clearance of such product is not subject to a registration service fee for the tolerance action for two years from the effective date of the rule.

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 (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.