SYNTHETIC BIOLOGY AND BIOSAFETY GOVERNANCE IN THE EUROPEAN UNION AND THE UNITED STATES

Abstract

This article examines how synthetic biology, which is the construction of novel biological parts, devices, and systems, as well as the modification of regular organisms, impacts biosafety regimes in the European Union (EU) and the United States (US). The article examines the nature and benefits of synthetic biology. It then reviews associated biosafety challenges, before analysing the suitability of governance frameworks in the EU and the US in dealing with these challenges. Based on this analysis, the article contends that, despite some similarities with older technologies, synthetic biology is essentially novel. Consequently, it undermines existing biosafety regimes in both jurisdictions. The article advocates for effective governance, combining formal regulation and self-governance, in addition to the global coordination of governance measures. This will help maintain an agile policy and curtail any regulatory loopholes. This article fosters awareness on the existence of many unresolved controversies over the synthetic biology technology.