An application that proposes the addition of a new unregistered source of active ingredient to a registered product. An example of this category would be adding a new production facility for a registered technical product, or adding a source of a.i. to an end use product that is not an EPA-registered source product. To fit this category all applications require the following:

• A data matrix is required with the application.
• All of the inerts listed on the CSF must be either approved or pending with the Agency for the applicable uses
• If amending an MUP - one set of product specific product chemistry data and CSF is required (under #1 below).
• If amending an end-use product then 2 sets of product chemistry data are required.
  1. Product chemistry (Group A and B) on the unregistered source of the active ingredient and CSF. The applicant must identify to the Agency the toxicity of the impurities associated with the active ingredient; particularly impurities of toxicological significance (at any level). The impurity profile of the unregistered source of the active ingredient will be compared to registered source. The impurity profile of the unregistered source of the active ingredient either results in new impurities; or impurities of toxicological significance, or if the toxicity of new impurities are unknown to the applicant, then the application is submitted to HED for review.
  2. Product chemistry data (Group A and B) for the end use product and CSF. In some cases product chemistry data can be satisfied as outlined in Pesticide Registration Notice 98-1.
• Acute toxicity, public health pest efficacy and/or child resistant packaging data requirements must be addressed by using: 1) selective data citation. A rationale for a waiver or bridging of these data falls within this category.
• Proposed label for the MUP and/or end use product

(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.