46 Pages Posted: 19 Mar 2014 Last revised: 17 Jun 2016
Date Written: October 20, 2014
The rapidly emerging technology of synthetic biology will place great strain upon the extant regulatory system due to three atypical characteristics of this nascent technology: (1) synthetic biology organisms can evolve; (2) traditional risk structures do not apply; and (3) the conventional regulatory focus on end-products may be a poor match for novel organisms that produce products. This Article presents one of the first assessments of the regulatory and oversight challenges produced by the beneficial application of synthetic biology, for energy, environmental, medical, and other purposes. Due to the uncertainty present at this early stage of synthetic biology development, and the practical political context, it is unlikely that the significant statutory and regulatory gaps identified herein could be cured directly. This Article recommends instead a selection of “soft law” alternatives that could more quickly provide flexible and adaptive measures to help fill regulatory gaps in a manner that allows this promising technology to develop as rapidly as possible, while still adequately guarding against risks to human health and the environment.
Keywords: synthetic biology, biotechnology, emerging technology, regulation, governance, soft law
Suggested Citation: Suggested Citation
Mandel, Gregory N. and Marchant, Gary E., The Living Regulatory Challenges of Synthetic Biology (October 20, 2014). 100 Iowa L. Rev. 155 (2014); Temple University Legal Studies Research Paper No. 2014-12. Available at SSRN: https://ssrn.com/abstract=2410179 or http://dx.doi.org/10.2139/ssrn.2410179