Abstract

http://ssrn.com/abstract=2410179
 


 



The Living Regulatory Challenges of Synthetic Biology


Gregory N. Mandel


Temple University - James E. Beasley School of Law

Gary E. Marchant, JD, PhD


Arizona State University - College of Law

March 17, 2014

Iowa Law Review, Vol. 100, 2014, Forthcoming
Temple University Legal Studies Research Paper No. 2014-12

Abstract:     
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: (i) synthetic biology organisms can evolve; (ii) traditional risk structures do not apply; and (iii) 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. The 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.

Number of Pages in PDF File: 53

Keywords: synthetic biology, biotechnology, emerging technology, regulation, governance, soft law

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Date posted: March 19, 2014 ; Last revised: April 18, 2014

Suggested Citation

Mandel, Gregory N. and Marchant, JD, PhD, Gary E., The Living Regulatory Challenges of Synthetic Biology (March 17, 2014). Iowa Law Review, Vol. 100, 2014, Forthcoming; Temple University Legal Studies Research Paper No. 2014-12. Available at SSRN: http://ssrn.com/abstract=2410179 or http://dx.doi.org/10.2139/ssrn.2410179

Contact Information

Gregory Mandel (Contact Author)
Temple University - James E. Beasley School of Law ( email )
1719 N. Broad Street
Philadelphia, PA 19122
United States
(215) 204-2381 (Phone)
Gary E. Marchant, JD, PhD
Arizona State University - College of Law ( email )
Box 877906
Tempe, AZ 85287-7906
United States
(480) 965-3246 (Phone)
(480) 965-2427 (Fax)
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