An application that proposes modification in the label of a registered product that is not substantially similar to a currently registered product and that requires risk analysis by the Agency (i.e. by the Health Effects Division (HED), the Environmental Fate and Effects Division (EFED), the Biological and Economic Analysis Division (BEAD), Alternate Risk Integration Assessment Team(ARIA) etc.) to support the change. Examples of actions in this category include: label changes to Directions for Use (including REI, PPE, PHI, application rate, application frequency, application timing, addition of aerial or chemigation application methods consistent with PR Notice 87-1 and 93-2, ground water or surface water advisory statements, etc. that require risk analysis by EPA. In some cases, the applicant might not submit new data to support the label amendment, but the Agency would need a determination of whether the existing database would support a change or modification to the amended label. EPA-initiated amendment shall not be charged fees.

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.

The Agency will provide the applicant with a pre‐decisional determination 2 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 amendment 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.