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

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