B641 PRIA Fee Category

A petition to amend an established tolerance or tolerance exemption for a microbial or biochemical pesticide to support a new or existing product registration, with supporting data/information to demonstrate that dietary exposures to residues of the active ingredient at the tolerance level meet the FFDCA standard of reasonable certainty of no harm. This category does not include New Uses (see Table 12).

All inert ingredients used in the product must be EPA approved for the proposed use(s), pending approval with the Agency for the applicable uses, or included in an inert petition submitted within the package for the applicable uses. Each application for a new inert approval submitted in this package is subject to its own registration service fee.

If the Administrator determines that endangered species analysis is required for this action, using guidance finalized according to [section 33(c)(3)(G)] for this specific type of action, the decision review time can be extended for endangered species assessment one time only for up to 50%, upon written notification to the applicant, prior to completion of the technical screening. To the extent practicable, any reason for renegotiation should be resolved during the same extension.