On October 15, 2015, Bergeson & Campbell, P.C. (B&C®) and the Woodrow Wilson International Center for Scholars (Wilson Center) hosted “Leveraging Synthetic Biology’s Promise and Managing Potential Risk,” a panel discussion featuring Lynn L. Bergeson, Sheryl Lindros Dolan, and Richard E. Engler, Ph.D., of B&C, and Todd Kuiken, Ph.D., Senior Program Associate, Synthetic Biology Project, Wilson Center.
The event coincided 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 B&C and released through the Wilson Center’s Synthetic Biology Project. Panelists discussed 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. The webcast was recorded and is viewable online.
Panelists spoke of the many challenges facing synthetic biology innovations. More government resources are needed to regulate efficiently these innovative products in a timely fashion, and greater clarity is needed to inform innovators as to the government oversight that these products will be subject prior to commercialization. The public’s understanding of the products and the regulatory process to which they are subject as a predicate to commercialization also needs enhancement to ensure public confidence in the oversight system.
Bergeson stated that B&C welcomed this opportunity to educate the public about synthetic biology through this collaborative report. The report contains several “teachable moments” that will help those in positions of decision-making to identify gaps and disconnects in regulation and communication and to be better able to anticipate challenges. Synthetic biology innovations are coming into the market at a fast pace. It is difficult for government regulators to keep up with the pace of these innovations due to jurisdictional ambiguities and limited federal resources.
Another challenge is inter-agency communication. Federal families are often not on the same page in terms of how they manage and address products of synthetic biology. There needs to be a “conscious effort” to communicate and the public needs to become more educated as to the regulatory process. Bergeson reminded attendees of the current opportunity to do so with the White House Office of Science and Technology Policy (OSTP) October 6, 2015, Request for Information (RFI) to solicit relevant data and information, including case studies that may assist in the development of the proposed update to the Coordinated Framework for the Regulation of Biotechnology (responses due November 13, 2015). More information on the RFI is available in B&C’s memorandum: Biotechnology: OSTP Seeks Comment on Clarifying Current Roles and Responsibilities Described in the Coordinated Framework for the Regulation of Biotechnology.