I010 PRIA Fee Category

PRIA 3 Fee Determination Decision Tree:

Petition to Amend a Tolerance Exemption Descriptor to Add CASRNs

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

Action Code	Description	FY16/17 Fee	Decision Time (months)
I010	Petition to amend a tolerance exemption descriptor to add one or more CASRNs; no new data (2)	$ 1,654	6

PRIA Decision Tree

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

Waiver	Pay	Amount
50% waiver	You pay ---->>>>>	$ 827
75% waiver	You pay ---->>>>>	$ 414

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 to amend a tolerance exemption descriptor by adding one or more CAS Registry Numbers (CASRNs) to an existing tolerance exemption expression in which the tolerance exemption descriptor is for grouping of closely related substances with associated CASRNs rather than a single chemical entity. (An example of such a descriptor is “Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid “). An application under this category must demonstrate that the additional CASRNs to be added to the tolerance exemption expression are part of the grouping and are supported by the safety finding that was made to establish the group tolerance exemption. The application submission must contain a petition to amend existing tolerances or exemptions from the requirement but does not include the submission of data. Prior to a submission under this category OPP highly recommends the applicant request a meeting with the Agency to ensure that no additional data are required. Additional information regarding applications for approval of new food use inert ingredients can be found at http://www.epa.gov/opprd001/inerts/inertpetition.pdf. 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 data 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.

Action Code Interpretation

An application that proposes to amend a tolerance exemption descriptor by adding one or more CAS Registry Numbers (CASRNs) to an existing tolerance exemption expression in which the tolerance exemption descriptor is for grouping of closely related substances with associated CASRNs rather than a single chemical entity. (An example of such a descriptor is “Dimethylaminopropylamine, isopropylamine, ethanolamine, and triethanolamine salts of alkyl (C8-C24) benzenesulfonic acid “). An application under this category must demonstrate that the additional CASRNs to be added to the tolerance exemption expression are part of the grouping and are supported by the safety finding that was made to establish the group tolerance exemption. The application submission must contain a petition to amend existing tolerances or exemptions from the requirement but does not include the submission of data. Prior to a submission under this category OPP highly recommends the applicant request a meeting with the Agency to ensure that no additional data are required. Additional information regarding applications for approval of new food use inert ingredients can be found at http://www.epa.gov/opprd001/inerts/inertpetition.pdf.

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 data 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.

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