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August 14, 2015

EPA Announces Three Webinars Covering PMN Submission Systems And Inviting Discussion Of Biotechnolog


On August 12, 2015, the U.S. Environmental Protection Agency (EPA) announced three webinars to review the new features of the updated online Premanufacture Notifications (PMN) Submission System. The new web-based submission system for the Toxic Substances Control Act (TSCA) Section 5 submissions is replacing the ePMN reporting software that is currently in use. The first webinar is on August 26, 2015, from 1:00 p.m. – 4:00 p.m., and will cover the process of registering with the Central Data Exchange (CDX) and user roles. The second webinar is on September 16, 2015, from 1:00 p.m. – 4:00 p.m., and will review the PMN form, support form, and joint submissions. The final webinar will occur on September 30, 2015, from 1:00 p.m. – 4:00 p.m., and will include a discussion of Notice of Commencement (NOC), biotech, "bona fide," and Significant New Use Rules (SNUR) Alternate Control Measures electronic submissions.

The inclusion of biotechnology algae in the third and final webinars was previously mentioned in the announcement of the "US Environmental Protection Agency Biotechnology Algae Project." The biotechnology algae project will result in the development of a stand-alone document that will assist innovators who are developing new microbial technology applications under TSCA. EPA will develop the algae guidance in conjunction with the update of the Points to Consider in the Preparation of TSCA Biotechnology Submissions for Microorganisms (Points to Consider) document. The webinar will allow the public to submit questions on both technical issues relating to the development of a biotechnology algae considerations document, as well as on the societal implications of the development of biotechnology algae. This invitation for stakeholder input is a key opportunity to explain the steps that are being taken to ensure responsible development and use of biotechnology, and to provide comment on how EPA can improve and update the Points to Consider document. More information regarding the biotechnology algae project is available in Bergeson & Campbell, P.C.'s (B&C®) memorandum EPA Posts Information on Biotechnology Algae Project.