Reproduction-Powered Industry: Coordinating Agency Regulations for Synthetic Biology

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Volume 15, Issue 2 (Jan 2014)

The products of synthetic biology may improve medicine, national security, environmental protection, and the economy, but under-regulated development could catastrophically compromise these endeavors. Considering the dangers exhibited by existing microorganisms and public access to tools of synthetic biology construction, the field’s untested novelty implicates human health and safety. Further, social justice concerns are raised by the resources required to sustain a shift from a fossil fuel-based economy to a biofuel-based economy. Current regulations are insufficient to address these risks. Accordingly, regulations must be modified through amendments coordinated between the National Institutes of Health, the Environmental Protection Agency, and the Food and Drug Administration. Interagency regulation provides the strongest prospect for supporting beneficial developments while protecting against hazards unique to the field. This Article provides a brief history of synthetic biology and examines its public and private development. This Article also examines its potential benefits and risks and current applicable regulations, both national and international. It concludes with propositions for regulatory modification, and attention is given to domestic interagency regulation.


Brendan Parent, Reproduction-Powered Industry: Coordinating Agency Regulations for Synthetic Biology, 15 N.C. J.L. & Tech. 307 (2014), available at

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