An application to amend a registration is in this category when it contains data to support a change in the label (such as use patterns, use site changes) or to add an alternate formulation or change the basic formulation of a currently registered product. These data include but are not limited to: toxicity data, non-target toxicity data, efficacy/product performance, child-resistant packaging data, additional (unregistered) sources of the active ingredient with supporting chemistry data, manufacturing process, efficacy (if public health pests are claimed), and data to support a pattern of use (e.g., increased application rate, different application methods) that changes the potential for human and/or environmental risks or exposure.

All of the inerts used in the product must be either approved or pending with the Agency for the applicable uses.

(a) EPA-initiated amendments shall not be charged registration service fees. (b) Registrant-initiated fast-track amendments are to be completed within the timelines specified in FIFRA Section 3(c)(3)(B) and are not subject to registration service fees. (c) Registrant-initiated fast-track amendments handled by the Antimicrobials Division are to be completed within the timelines specified in FIFRA Section 3(h) and are not subject to registration service fees. (d) Registrant initiated amendments submitted by notification under PR Notices, such as PR Notice 98–10, continue under PR Notice timelines and are not subject to registration service fees. (e) Submissions with data and requiring data review are subject to registration service fees.