Introduction: The challenge of developing oversight approaches to nanobiotechnology.

543 N anotechnology is being hailed by many as the " next industrial revolution. " 1 A convergence of scientific fields including chemistry, biology , physics, optics, and mechanics, nanoscale science and technology operates at the scale of 1-100 nanome-ters where structures, devices, and systems have novel functions and properties because of their size. 2 One area with tremendous promise for health and medical applications — " nanobiotechnology " — specifically refers to nanotechnology designed for use in biological systems, in which nanomaterials are derived from biological molecules, or in which nanomaterials mimic biological systems. This convergence of nanotechnol-ogy and biology has been envisioned from the inception of the National Nanotechnology Initiative (NNI) at the beginning of this decade. As Dr. Mihail C. Roco, the Senior Nanotechnology Advisor at the National Science Foundation (NSF), notes, " Nanotechnology provides the tools and technology platforms for the investigation and transformation of biological systems , and biology offers inspiration models and bio-assembled components to nanotechnology. " 3 Federal and state funding for research and development of nanotechnology is rising, with over 1,000 manufacturer-identified nanoproducts on the market already. 4 Despite substantial financial funding and rapid advances, public awareness of the science and applications is strikingly low. A 2008 Hart Research Poll of 1000 U.S. adults reports that 75% have heard " little or nothing at all " about nanotechnology. 5 When the public does hear about nanotechnology, it is often to emphasize peril rather than promise. While concern over nanotechnology has calmed from the original hype and threat of self-replicating nanobots and grey goo, there remains an active controversy about the safety of nanotechnology in consumer products, environmental effects, and the potential for uses that would threaten national security and public health. The interaction of biology and nanotechnology challenges existing systems of oversight for laboratory research, human subjects research, manufacturing, marketed products, and disposal. Any new technology faces hurdles in its development, implementation, and public acceptance, including balancing public health and safety with scientific progress and innovation. Nanobiotechnology is no exception. Issues loom large. Among the most important is design of appropriate governance systems. Federal agencies are already grappling with the question of whether they should use existing oversight frameworks or create new ones. Developing an oversight system or method of gover-nance becomes complicated when the scope of the technology is broad and when the range of products and processes is expansive. 544 …