Unpackaging Synthetic Biology: Identification of Policy Problems and Options

Abstract

The emerging field of synthetic biology (SB) is just entering policy debates. Reports from non-governmental organizations have recently been issued, however there have been few systematic analyses of the policy problems that we will likely face as this area develops. Biosecurity issues are the most well-defined, but other societal oversight issues and implications have not been well explored. Although SB could assist in addressing pressing global challenges like sustainable and renewable energy, there are considerable societal concerns that accompany its development and applications. This paper 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. Then, key oversight policy problems are 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 potentially the highest concern. Finally policy options for SB oversight are considered including preventative to promotional. We propose that different categories of SB applications may warrant different oversight regimes, and there might not be an appropriate “one size fits all” approach. We stop short of making specific recommendations however, and suggest that the typology, problems, and oversight options identified in this paper be used as a starting point for deliberative, democratic decision-making processes that take into account a wide-range of perspectives about risk, economic impacts, scientific progress, and moral reasoning in the design of oversight systems.

Keywords: synthetic biology, oversight, policy