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October 9, 2015

Bergeson & Campbell, P.C. and the Wilson Center Release Report on Synthetic Biology’s Challenge to U.S. Regulatory Systems

The ACTA Group

Panel Discussion to Be Held Wednesday, October 15, 2015, from 12:00 p.m. – 2:00 p.m. (EDT)

On October 15, 2015, the Woodrow Wilson International Center for Scholars (Wilson Center) will host “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Managing Partner of Bergeson & Campbell, P.C. (B&C®), and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center. The event coincides with the release of “The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic Biology?,” authored by the legal experts, scientists, and policy specialists of Bergeson & Campbell, P.C. (B&C®) and released through the Wilson Center’s Synthetic Biology Project.

Panelists will discuss how synthetic biology applications would be regulated by the U.S. Coordinated Framework for Regulation of Biotechnology, how this would affect the market pathway of these applications, and whether the existing framework will protect human health and the environment. A light lunch will be served. The event is open to the public. Register for “Leveraging Synthetic Biology’s Promise and Managing Potential Risk” via the Wilson Center website.

“The DNA of the U.S. Regulatory System: Are We Getting It Right For Synthetic Biology?,” to be released on October 15, 2015, includes a survey of the current commercial applications of synthetic biology, analysis of issues facing U.S. regulatory systems and agencies called into play by products of synthetic biology, case studies illustrative of how novel technologies challenge the regulatory infrastructure and can induce competing and sometimes conflicting jurisdictional oversight, and a review of recommendations for improvement including those contained in the July 2, 2015, memorandum issued by the White House Office of Science and Technology Policy directing the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) to update the 1986 Coordinated Framework for Regulation of Biotechnology.

B&C and affiliated consulting firm, The Acta Group (Acta®), have been at the forefront of addressing legal, regulatory, and policy implications of synthetic biology and other emerging transformative technologies worldwide. Additional resources include Lynn L. Bergeson, Charles M. Auer, Oscar Hernandez, “Creative Adaptation: Enhancing Oversight of Synthetic Biology Under the Toxic Substances Control Act,” Industrial Biotechnology, October 2014, Biotechnology and Synthetic Biology Memoranda from the B&C website, and Biotechnology and Synthetic Biology Articles from the B&C website.