Federal oversight of nanobiotechnology in the U.S. has been fragmented and incremental. The prevailing approach has been to use existing laws and other administrative mechanisms for oversight. However, this "stay-the- course" approach will be inadequate for such a complex and convergent technology and may indeed undermine its promise. The technology demands a new, more dynamic approach to oversight. The authors are proposing a new oversight framework with three essential features: (a) the oversight trajectory needs to be able to move dynamically between "soft" and "hard" approaches as information and nano-products evolve; (b) it needs to integrate inputs from all stakeholders, with strong public engagement in decision-making to assure adequate analysis and transparency; and (c) it should include an overarching coordinating entity to assure strong inter-agency coordination and communication that can meet the challenge posed by the convergent nature of nanobiotechnology. The proposed framework arises from a detailed case analysis of several key oversight regimes relevant to nanobiotechnology and is informed by inputs from experts in academia, industry, NGOs, and government.
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Acknowledgments Preparation of this article was supported by the National Science Foundation (NSF) grant #0608791, ‘‘NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context’’ (Principal Investigator: S. M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). Thanks are also due to Research Assistants Katie Wolf for work on Fig. 1 and Dan Lynch for work on capturing project group input.
This minimal response to the oversight challenge has been widely criticized; a number of organizations and academics have called for a more robust oversight approach with varying recommendations. Table 1 presents a roster of the key reports and articles, briefly encapsulating their recommendations. However, most of these recommendations have had little discernable impact on federal actions to date. In part this may be due to a lack of agency resources and the need for greater expertise in nanotechnology (and nanobio in particular). It may also reflect real agency uncertainty about how to generate the information needed on nanomaterials to evaluate them. The complexity of many nanomaterials, including those that combine multiple technologies and thus are convergent, will only increase the uncertainty. As noted above, convergent technologies may implicate multiple oversight agencies, creating confusion. Importantly, there have been no major public health disasters that could prompt an outcry for ‘‘reform.’’ This article presents recommendations that grew out of a 4-year project on ‘‘Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context,’’ funded by the National Science Foundation (NSF). The authors are the project investigators plus two key researchers on the project team. The authors convened a multi-disciplinary group of experts, who served on the project’s Working Group and Advisory Group. These individuals are listed alphabetically in Table 2 (with their institutions listed for identification only). They made vital intellectual contributions to this project. Note that listing an individual as a project member below does not necessarily mean that he or she agrees with the recommendations offered in this article.
- Dynamic oversight
- Oversight framework
- Public engagement