Synthetic biology is an emerging technology with the potential to offer significant scientific developments to various fields such as with pharmaceutical development. Despite such promise, it has uncertain potential risks that may yield lasting and consequential damage to humans, animals, and the environment. In order to address such risks, national governments may utilize regulatory instruments to capture the process of synthetic biology development. However, where synthetic biology remains an uncertain technology with limited experimental testing, the regulation and governance of synthetic biology may vary from one government to another. This dissertation seeks to explain why such variations in the regulation of synthetic biology arise across various governments. Focusing on the specific cases of the United States, Singapore, and the European Union, these variations are hypothesized to be caused by elements of risk culture, or the political and institutional factors that influence local regulatory decision making. This hypothesis is tested via a literature analysis and an assessment of subject expert interviews from each case via qualitative discourse analysis. More specifically, findings from this dissertation indicate that of these factors, historical path dependency of the regulation of genetically modified organisms and similar biotechnologies has the strongest effect with respect to influencing variations of regulation for synthetic biology.
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A Comparative Analysis of Variations in Synthetic Biology Regulation.
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