Unpackaging synthetic biology: Identification of oversight policy problems and options

The emerging field of synthetic biology (SB) is just entering policy debates. Reports from non-governmental organizations, such as the ETC Group and the International Risk Governance Council, have recently been issued, but there have been few systematic analyses of the policy problems that we will likely face as this area develops. Biosecurity issues are the most defined; other societal oversight issues and implications have not been well explored. Although SB could assist in addressing pressing global challenges, such as sustainable and renewable energy, there are considerable societal concerns that accompany its development and applications. This article is designed to anticipate and prepare for these concerns by identifying policy problems associated with SB oversight, upstream of its development. Projected applications of SB are reviewed and a typology of them is developed. Key oversight policy problems are then identified based on historical experiences with other emerging technologies, such as nanotechnology and biotechnology. Problems associated with biosecurity, biosafety, intellectual property, and ethics are discussed in relation to the typology of SB applications to identify applications of the highest potential concern. Finally, policy options for SB oversight are considered, preventative to promotional. We propose that different categories of SB application may warrant different oversight regimes: there might not be an appropriate "one size fits all" approach. We stop short of making specific recommendations, but suggest that the typology, problems, and oversight options identified in this article be used as a starting point for deliberative, democratic decisionmaking processes that take into account a wide range of perspectives about risk, economic impact, scientific progress, and moral reasoning in the design of oversight systems.