I003 PRIA Fee Category

An application that proposes a change in food use for an inert ingredient. The use requires an amendment to a tolerance (or the exemption from the requirement of a tolerance) under section 408 of the FFDCA. The application submission must contain a petition to amend existing tolerances or exemptions from the requirement for all food/feed commodities for which food use approval is sought, but does not include the submission of data. This category does not include submissions for which an EPA risk assessment has not been conducted since 2006.  Such submissions fall into category I002 even when no new data are submitted.  This category fits for changes in food use that require a change to the existing tolerance or tolerance exemption that do not require the submission of data such as a change in the limitation of the percentage of the inert ingredient under an existing tolerance exemption or change in use limitations under an existing tolerance. Examples of food uses include: use on foods; for example, corn or apples; aquatic uses involving potable water, irrigation, or requiring tolerances for fish, or shellfish; uses on areas where food may be grown or raised such as pasture, rangeland, home garden, beehive; uses involving livestock, such as livestock housing, livestock dips, and livestock ear tags and food handling storage establishment premises and equipment (e.g. eating establishments, meat processing equipment, food handling equipment). This category does not include safeners [see category I013].  Prior to a submission under this category OPP highly recommends the applicant request a meeting with the Agency to discuss data needs. Additional information regarding applications for approval of new food use inert ingredients can be found at Guidance Documents for Inert Ingredients.

If another covered application intends to associate with and depend upon an already pending application for an inert ingredient approval in this category, the dependent application must identify the pending inert ingredient action with its inert approval tracking number assigned by the Agency, name of the inert ingredient(s) that is pending and the inert ingredient’s applicant’s name. Due to CBI concerns, the Agency will not provide information to the applicant of the dependent covered application regarding the status of the pending inert ingredient approval action beyond information that must be shared to adjust decision review times for the dependent application as discussed below. All other information on the inert ingredient’s approval action MUST come from the inert ingredient applicant. The decision review time due date for the dependent covered application will be extended to match the decision review time due date of the pending inert ingredient approval action, unless the decision review time due date for the dependent covered application is further out, in which case the dependent covered application will initially be subject to its own decision review time.

If the application covers multiple ingredients grouped by EPA into one chemical class, a single registration service fee will be assessed for approval of those ingredients.