Unpackaging synthetic biology: Identification of oversight policy problems and options

Abstract

The emerging field of synthetic biology (SB) is just entering policy debates. Reports from nongovernmental 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.

Societal Risk Evaluation Scheme (SRES): Scenario-Based Multi-Criteria Evaluation of Synthetic Biology Applications

“…Prior to the interviews and survey, the participants were asked to read four short case studies about synthetic biology applications (see Appendix A). These cases and the case-study approach built upon previous examination of SB’s pernicious governance profile outlined by Kuzma and Tanji (2010) who note that “different categories of SB application may warrant different oversight regimes, and there might not be an appropriate ‘one size fits all’ approach…and we argue that policy recommendations should be built from consultation with experts and stakeholder multiple disciplines, and developed in the presence of stakeholders and public citizens” [2]. This project takes up the call of a more robust policy analytical approach of various SB application fields through the use of case studies within the Policy Delphi rubric.…”

“…SB is expected to provide benefits to society in multiple sectors in a bioeconomy including agriculture and food production, bioenergy, biosensor development, chemical synthesis, environmental protection and remediation, and human health among others. However, it is also likely to pose risks and societal impacts that are undesirable depending on the project and systems in which its applications are deployed [2]. While most SB applications are being developed for their extrinsic benefits to society, these same technologies may create human and environmental hazards.…”

Translational governance research for synthetic biology

“…It resembles other 'big science' fields like nanotechnology and genome sequencing; in that it garners significant investment from the federal government and is drawing attention to not only its promise for addressing societal problems, but also to concerns about its potential impacts and its focus on 're-engineering life' (Breithaupt 2006;Calvert 2010;Endy 2005). Categories of SB include, but are not limited to, synthesized or artificial genes, systems of engineered biological parts, and synthetic organisms (Kuzma and Tanji 2010). Although there are not clearly recognizable products of SB in the market yet, microorganisms with highly engineered metabolic pathways to produce industrial or pharmaceutical compounds are now in use.…”

Explaining local variation in agri-food biotechnology policies: 'green' genomics regulation in comparative perspective

“…Especially important is attempting to understand any 'general model' of regulation that might exist as well as any 'local variations' in such regulations. Understanding the nature and origins of these 'local variations' in biotechnology policy and regulation in particular is of interest to both proponents and opponents of new biotechnology policies and regulations as well as to students of other sectors faced with similar regulatory challenges from scientific and technologically innovative activity; such as nanotechnology or synthetic biology Hodge et al, 2007;Furger et al, 2007;Kuzma and Tanji, 2010).…”