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EPA Pesticide Registration (PR) Notice 2011-3 (January 2012)

Effectively immediately, PR Notice 86-5 has been updated and is being replaced by PR Notice 2011-3. This notice contains recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Food, Drug, and Cosmetic Act (FFDCA) data to EPA’s Office of Pesticide Programs (OPP).

PR Notice 2011-3 applies to all data submitted to EPA to support any submission intended to persuade EPA to grant a registration or other approval required to sell or distribute a pesticide product. Submissions may include an application for registration or amended registration, data required in conjunction with a currently registered FIFRA product, an application for an experimental use permit, data in response to a notice issued by EPA under FIFRA, or a petition to establish a tolerance or tolerance exemption.

Since the publication of PR Notice 86-5 in July of 1986, the only acceptable submission of data was paper. However, with advances in information technology, statutory and regulatory changes, and new policy initiatives make this an appropriate time for EPA to update its guidance. PR 2011-3 allows registrants to submit electronic submissions and provides a flexible format for data submission.

The following list is a summary of the changes recommended by PR Notice 2011-3:

Electronic submission on CD or DVD is recommended. OPP is planning to make this option available to more types of submissions.
A major process change being planned by OPP is that Master Record Identifiers (MRIDs) will no longer be assigned after documents have been
     screened. In the case of electronic submissions, MRIDs are being pre-assigned.
Currently, three identical copies of applicable data are required. As OPP phases in its up-front imaging of paper submissions, EPA plans to
     reduce this requirement to a single copy.
Any prior language in PR Notice 85-6 that discourages double-sided printing and color printing has been eliminated.
Section G of PR Notice 86-5 has been eliminated.
Information on asserting claims of data confidentiality has been updated.
Information on flagging of studies for potential adverse effects has been updated.
OECD dossier format is an option that did not exist when PR Notice 86-5 was written.
References to the data requirements for antimicrobial pesticides have been inserted as appropriate.

To view the full Pesticide Registration Notice 2011-3, please visit:
http://www.epa.gov/PR_Notices/pr2011-3.pdf

For more information, please
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