Abstract
This article uses lessons from biotechnology to help inform the design of oversight for nanobiotechnology. Those lessons suggest the following: first, oversight needs to be broadly defined, encompassing not just regulatory findings around safety and efficacy, but also public understanding and acceptance of the technology and its products. Second, the intensity of scrutiny and review should reflect not just risks but also perceptions of risk. Finally, a global marketplace argues for uniform standards or commercially practical solutions to differences in standards. One way of designing oversight to achieve these purposes is to think about it in three phases—precaution, prudence, and promotion. Precaution comes early in the technology or product’s development and reflects real and perceived uncertainties. Prudence governs when risks and hazards have been identified, containment approaches established, and benefits broadly defined. Transparency and public participation rise to the fore. The promotional phase moves toward shaping public understanding and acceptance and involves marketing issues rather than safety ones. This flexible, three-phase approach to oversight would have avoided some of the early regulatory problems with agricultural biotechnology. It also would have led to a more risk-adjusted pathway to regulatory approval. Furthermore, it would avoid some of the arbitrary, disruptive marketing issues that have arisen.
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Acknowledgments
Preparation of this article was supported by National Science Foundation (NSF) grant #0608791, “NIRT: Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context” (Principle Investigator: S. M. Wolf; Co-PIs: E. Kokkoli, J. Kuzma, J. Paradise, and G. Ramachandran). The views expressed are those of the author and do not necessarily reflect the views of NSF.
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Johnson, R.S. Governing nanobiotechnology: lessons from agricultural biotechnology regulation. J Nanopart Res 13, 1467–1476 (2011). https://doi.org/10.1007/s11051-011-0252-z
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DOI: https://doi.org/10.1007/s11051-011-0252-z