Developing U.S. Oversight Strategies for Nanobiotechnology: Learning from Past Oversight Experiences

Author:

Paradise Jordan,Wolf Susan M.,Kuzma Jennifer,Kuzhabekova Aliya,Tisdale Alison W.,Kokkoli Efrosini,Ramachandran Gurumurthy

Abstract

Devising appropriate oversight for nanotechnology is a challenge. The field spans many scientific disciplines and product areas, capitalizing on the unusual properties and capabilities of material at the atomic scale. The critical feature of nanotechnology is not only the size at which manufacture occurs (˜1-100 nanometers), but also the ability to control and manipulate the novel chemical, physical, and mechanical properties that emerge at this scale, including increased conductivity, optical properties, and reactivity. As nano-products enter the research and development (R&D) phase, hit the market, and enter consumer households, debate has emerged on oversight approaches. Regulators, manufacturers, and commentators are considering whether existing oversight systems are sufficient, those oversight systems need adjustment, or new oversight systems are needed.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

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2. Semiconductor Nanocrystals as Fluorescent Biological Labels

3. 5. For purposes of analysis, oversight of drugs and medical devices was analyzed in a single article due to commonalities between the two oversight systems at the U.S. Food and Drug Administration. Throughout this comparative article, we will refer to that single article as containing two case studies. Thus, there are a total of five case studies (oversight of GEOs, drugs, devices, workplace chemicals, and gene therapy).

4. 38. Occupational Safety and Health Act, 29 U.S.C. §§ 651–678 (2008).

5. “Science and Democracy,”;Wilsdon;Nature Nanotechnology,2009

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