An application that proposes an additional food use. Additional food use includes a proposed food use of any U. S. registered active ingredient for which there currently is an approved food use. 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 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. 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.

The fee applies to each additional food use requested in the application.

Examples of the uses in this category 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 in the product of 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 (conveyor belt - claims to kill bacteria that are 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)
• 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 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 any 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)

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.

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 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.

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 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.