An application that proposes the first food use. First food use includes a proposed use for any U.S. registered active ingredient for which there is no registered “food use”. The use requires an exemption from the requirement of a tolerance under section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) or a food additive regulation or other clearance under section 409 of the FFDCA. If residues are reasonably foreseeable or likely to occur in or around food, either directly or indirectly, and the risks from all foreseeable residues are minimal, the application submission may need to include a petition to establish an exemption from tolerance for all food commodities covered by the pending registration application 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 first food use and to establish tolerance exemptions 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 the 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 – EPA dietary risk assessment)
• Process water treatment in a food handling facility to control a pest in the water (FDA food additive regulation)
• 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) (conveyor belt, cutting board that contains an antimicrobial as a preservative)
• Slimicides (FDA food additive regulation) (e.g., pulp and paper board)
• Production of food packaging (FDA food additive regulation) (e.g. adhesives, coatings)
• Food handling storage establishments 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.

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 first food use 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 first food use decision review time.

Until the first food use is approved, any subsequent application for another new use(s) containing the same active ingredient will be charged a first food use 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 first food use application.

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.

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 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.