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Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology

Journal of Nanoparticle Research, Vol. 13, pp. 1345-1371, 2011

47 Pages Posted: 23 Jan 2011 Last revised: 28 Jul 2013

Gurumurthy Ramachandran, PhD

University of Minnesota, Twin Cities

Susan M. Wolf

University of Minnesota Law School

Jordan Paradise

Loyola University Chicago School of Law

Jennifer Kuzma

University of Minnesota, Twin Cities - Hubert H. Humphrey Institute of Public Affairs

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law

Efrosini Kokkoli, PhD

University of Minnesota, Twin Cities

Leili Fatehi, JD

University of Minnesota - Twin Cities - Hubert H. Humphrey Institute of Public Affairs

Date Written: 2011

Abstract

Federal oversight of nanobiotechnology in the United States has been fragmented and incremental. The prevailing approach (at FDA, OSHA, and other key agencies) has been to use existing laws and other administrative mechanisms for oversight. However, this “stay-the-course” approach is inadequate for this complex and convergent technology and may indeed undermine its promise. This technology demands a new, more dynamic approach to oversight.

In proposing a new oversight approach to nanobiotechnology, this article breaks new ground. The authors go beyond passive to active nanomaterials; focus on the specific challenges of nanobiotechnology; anticipate scientific convergence (marrying nanotechnology, biotechnology, information technology, and cognitive sciences); address dynamic oversight and regulation, cognizant of “new governance” approaches; and develop U.S. oversight recommendations with an eye to transnational and international approaches. The article proposes a new oversight framework with three essential features: (a) oversight can move dynamically between “soft” and “hard” approaches over time as information and nano-products evolve; (b) oversight integrates inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) oversight features an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology.

This proposed framework derives from detailed case analysis of key oversight regimes relevant to nanobiotechnology using a methodology grounded in expert elicitation and multi-criteria assessment, as described here and elsewhere. The proposal is informed by inputs from experts in academia, industry, NGOs, and government.

Keywords: Science Oversight, Technology Oversight, Dynamic Oversight, New Governance, Science Regulation, Technology Regulation, Nanotechnology, Nanobiotechnology, NNI, FDA, EPA, OSHA, NIOSH, NIH, OSTP, Law and Science, Bioethics

Suggested Citation

Ramachandran, PhD, Gurumurthy and Wolf, Susan M. and Paradise, Jordan and Kuzma, Jennifer and Hall, JD, Ralph and Kokkoli, PhD, Efrosini and Fatehi, JD, Leili, Recommendations for Oversight of Nanobiotechnology: Dynamic Oversight for Complex and Convergent Technology (2011). Journal of Nanoparticle Research, Vol. 13, pp. 1345-1371, 2011. Available at SSRN: https://ssrn.com/abstract=1744366

Gurumurthy Ramachandran, PhD

University of Minnesota, Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Susan M. Wolf (Contact Author)

University of Minnesota Law School ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States
612-625-3406 (Phone)
612-624-9143 (Fax)

HOME PAGE: http://www.law.umn.edu/facultyprofiles/wolfs.html

Jordan K. Paradise

Loyola University Chicago School of Law ( email )

25 E. Pearson
Chicago, IL 60611
United States

Jennifer Kuzma

University of Minnesota, Twin Cities - Hubert H. Humphrey Institute of Public Affairs ( email )

301 19th Ave S
Minneapolis, MN 55455
United States

Ralph Hall, JD

University of Minnesota, Twin Cities - School of Law ( email )

229 19th Avenue South
Minneapolis, MN 55455
United States

Efrosini Kokkoli, PhD

University of Minnesota, Twin Cities ( email )

420 Delaware St. SE
Minneapolis, MN 55455
United States

Leili Fatehi, JD

University of Minnesota - Twin Cities - Hubert H. Humphrey Institute of Public Affairs ( email )

301 19th Ave S
Minneapolis, MN 55455
United States
612-626-3419 (Phone)

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