July 2, 2015

Synthetic Biology Project Comments on White House Plan to Update Coordinated Framework

The Synthetic Biology Project supports the effort by the White House Office of Science and Technology Policy (OSTP) to update the Coordinated Framework for the Regulation of Biotechnology to address emerging technologies like synthetic biology. The memo to agencies can be found here and a blog post can be found on the OSTP blog.

“We see this as a positive development and one that is long overdue considering the rapid advancement of biotech-related fields like synthetic biology,” says Dr. Todd Kuiken of the Synthetic Biology Project at the Wilson Center.

“Many applications using synthetic biology techniques are already on the market or close to coming to market,” Kuiken says. “Companies need a clear sense of the regulatory pathway to market for these products and there must be increased research to support regulatory decisions. To do this, federal agencies need to understand what applications are on the horizon and better coordinate their oversight to anticipate regulatory bottlenecks.”

In addition, there needs to be better public engagement around synthetic biology, an area where no overarching federal strategy exists. “According to our polling, the majority of Americans have heard little to nothing about synthetic biology,” Kuiken adds. “A lack of transparency at the federal level could result in a lack of trust and pushback from consumers, which could ultimately affect market growth. We hope OSTP’s effort will begin to address these concerns.”

Much of the Synthetic Biology Project’s work has focused on understanding the public perception of these new technologies as well as the potential regulatory pathways for novel applications.   

The Synthetic Biology Project regularly conducts national telephone surveys on emerging technologies. The most recent poll, conducted in 2013 by Hart Research Associates, found three out of four respondents had heard little or nothing at all about synthetic biology. Respondents also expressed greater concern about the risks of synthetic biology as they learned more about the technology.

A forthcoming report from the project examines the regulatory pathways of new applications that are close to entering the market. That report finds confusion about the regulatory jurisdiction of different agencies in the framework and questions about which statutes apply to the applications. Earlier this year, the project released an interactive, crowdsourced inventory to track applications and products that utilize synthetic biology techniques.

The OSTP memo also comes as the United Nations is considering the adequacy of local, national and international instruments to regulate synthetic biology and whether they provide a comprehensive framework to address issues like biological diversity.