PRN 2011-3: Standard Format for Data Submitted Under FIFRA and Certain Provisions of FFDCA
This PR Notice updates and replaces Pesticide Registration Notice 86-5 and discusses both the recommended and the required procedures for submitting FIFRA and FFDCA data. All required procedures contained within this document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation; this document creates no new legally binding requirements. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” this document provides recommendations or guidance.
The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:
- An application for registration or amended registration of a pesticide product under FIFRA section 3 or 24.
- A submission of data required in conjunction with reregistration of a currently registered product under FIFRA section 4 (or its registration review under FIFRA section 3).
- An application for an experimental use permit under FIFRA section 5.
- A submission of data in response to a notice issued by EPA under FIFRA section 3(c)(2)(B).
- A petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under FFDCA section 408.
- Studies submitted under FIFRA section 6(a)(2).