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Regulation of Synthetic Biology

BioBricks, Biopunks and Bioentrepreneurs

Alison McLennan

This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
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Chapter 5: Environmental risk: uncertainty, precaution, prudent vigilance and adaptation

Alison McLennan


Chapter 5 considers the potential for applications of synthetic biology to be released into the environment and cause environmental harm. There is uncertainty about the harm that could be caused and disagreement about the degree of risk. The chapter explores strategies for managing these risks to the environment in light of legal and policy approaches to regulating where there is scientific uncertainty. It critiques the Presidential Commission’s approach to issues of risk and uncertainty, which is based on the principle of ‘responsible stewardship’ and the concept of ‘prudent vigilance’. It argues that in relation to environmental risk, the Presidential Commission should have adopted the precautionary principle in favour of prudent vigilance. The policy tool of ‘planned adaptation’ is useful for synthetic biology regulation as it will assist in managing uncertainty and maintaining regulatory connection.

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