Regulatory Developments

EPA Schedules Workshop on Considerations for Risk Assessment of Biotechnology Algae

August 25, 2015 PRINT

The U.S. Environmental Protection Agency (EPA) published a notice in the August 25, 2015, Federal Register announcing a public meeting on September 30, 2015, to receive public input and comments on EPA's data needs to support risk assessments of biotechnology products subject to oversight under the Toxic Substances Control Act (TSCA) that make use of genetically engineered algae and cyanobacteria. The notice states that the workshop will inform an update to an EPA guidance document entitled Points to Consider in The Preparation of TSCA Biotechnology Submissions for Microorganisms.

As reported in our August 3, 3015, memorandum, EPA Posts Information on Biotechnology Algae Project, EPA has posted a document concerning its development of a project intended to support public dialog concerning the development and use of biotechnology. EPA has oversight responsibility for the production and use of intergeneric cyanobacteria, eukaryotic microalgae, and their products by application of genetic engineering approaches. EPA's recently posted document, US Environmental Protection Agency Biotechnology Algae Project, states that it is focusing its project around these biotechnology algae applications.

EPA encourages all members of the public interested in participating in this workshop to register to attend, whether in-person or through the web-connect and teleconference that will also be available. Advance registration will close on September 25, 2015. EPA will hear oral comments at the September 30, 2015, workshop. Written comments are due October 31, 2015. The notice will be available on August 25, 2015, at www.regulations.gov in docket number EPA-HQ-OPPT-2015-0508.


 
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