Safe, secure and ethical? : assessing and regulating risks associated with synthetic biology

Abstract

Synthetic biology is an emerging field, with a rapidly developing academic-industrial base and the promise of extensive product launches over the next few years. An intense debate over the risks and benefits of synthetic biology has developed even before commercialization. Nongovernmental organizations and official commissions have published over a dozen reports on the potential pitfalls and promise of synthetic biology, with widely varying analytic assumptions, assessment methods, definitions of values, and policy recommendations. How should governments go about developing regulatory policies to govern synthetic biology? This thesis begins by outlining the synthetic biology academic-industrial base, and then describes and critiques official and unofficial assessments of synthetic biology risks and the regulatory policies now in place to regulate risks. It differentiates among risks to security, safety and environment, and ethics, and finds that regulations in each of these areas suffer from significant deficits. Regulations are not well grounded on technical understanding of synthetic biology, lack methodologies for risk assessment of organisms without close natural counterparts, frame risk assessment as a technocratic process without substantial input from stakeholders, and emphasize physical risks to safety and security over non-physical threats to ethics and values. The thesis suggests that the US government and European Union modify existing regulations governing risks associated with synthetic biology and, more fundamentally, processes for developing such regulations to mitigate some of the deficits identified above.