Kuzma, J., Najmaie, P. and Larson, J., “Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 546–586; Paradise, J., Tisdale, A. W., Hall, R. and Kokkoli, E., “Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 598-624; Choi, J. Y. and Ramachandran, G., “Review of the OSHA Framework for Oversight of Occupational Environments,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 633-650; Wolf, S. M., Gupta, R. and Kohlhepp, P., “Gene Therapy Oversight: Lessons for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 659684. See also Paradise, J., Wolf, S. M., Ramachandran, G., Kokkoli, E., Hall, R. and Kuzma, J., “Developing Oversight Frameworks for Nanobiotechnology,” Minnesota Journal of Law, Science & Technology 9, no. 1 (2008): 399-416.CrossRefGoogle Scholar

Privacy (can sensing/tracking tools also be used for unwarranted surveillance of individuals?), and enhancement (do nanoenabled muscle fibers provide an unfair advantage to the elite?) are two items at the top of the nano worry list for many ethicists, but these properties characterize many old and new technologies, not just nanotechnologies. In an era of electronic financial transactions and data transfers, national security regimes that trump rights of private citizens, radio frequency identification (RFID) tracking devices on cell phones and ID cards, and electronic medical records, the meaning of privacy has changed. In American culture, authorities must be seen as protecting the privacy of individuals, so there is a theater of legislative activity, but privacy, in the sense of having control and choice over information dissemination as some philosophers seem to imagine it, no longer exists in law or social life. There is also a plethora of literature on enhancement technologies that has arisen in the past decade, attempting to distinguish enhancements from therapies and “normal” from post-human capabilities. I would argue that the reason for attention to these areas lies in underlying cultural concerns about control and fairness. Some commentators question whether there is anything ethically unique to nanotechnology at all. See, e.g., Grunwald, A., “Nanotechnology: A New Field of Ethical Inquiry?” Science and Engineering Ethics 11, no. 2 (2005): 197–201; Godman, M., “But Is It Unique to Nanotechnology?” Science and Engineering Ethics 14, no. 3 (2008): 391-403.CrossRefGoogle Scholar

A few examples of the abundant literature on nanoethics now available include Evans, D., “Ethics, Nanotechnology and Health,” in ten Have, H., ed., Nanotechnologies: Ethics and Politics (Paris: UNESCO Publishing, 2007); Kjølberg, K. and Wickson, F., “Social and Ethical Interactions with Nano: Mapping the Early Literature,” Nanoethics 1, no. 1 (2007): 89-104; and Roco, M. C. and Bainbridge, W. S., eds., Societal Implications of Nanoscience and Nanotechnology (Boston: Kluwer Academic Publishers, 2001). Works that focus on autonomy, human dignity, and informed consent (i.e., primarily effects on individuals) include Brownsword, R., “Regulating Nanomedicine: The Smallest of Our Concerns,” Nanoethics 2, no. 1 (2008): 73-86; and Shrader-Frechette, K. S., “Nanotoxicology and Ethical Conditions for Informed Consent,” Nanoethics 1, no. 1 (2007): 47-56. Some aspects or applications of nanotechnologies may indeed recall long-standing concerns, but nanotechnologies are just not the same in terms of context or content as in vitro fertilization (IVF), genetic testing, or cognitive enhancement drugs, as some writers seem to suggest.Google Scholar

In contrast to existing drugs that target the influenza virus after it has already replicated inside human cells, nanoviricides target viruses in the bloodstream, before they infect cells. Hence, there is no need for the production of antibodies that vaccines would provide, and viral mutations are no longer significant. See Porter, N. and Hogle, L. F., “Nanotechnology and Public Health: Redefining Risk and Containment,” manuscript in preparation.Google Scholar

In the case of HPA1 (avian flu) outbreaks, U.S. public health authorities focused on preventing transmission in humans. In resource-poor countries such as Viet Nam, where poultry raising is a primary industry, public health authorities wanted to control the virus in animals instead. Conflict arose as different intervention strategies – including technologies and the systems through which to deploy them – seemed to address very distinct social, political, and economic needs in addition to health needs. Id., at 5. For more on vaccine policy dynamics, see Heller, J., The Vaccine Narrative (Nashville, TN: Vanderbilt University Press, 2008).CrossRefGoogle Scholar

The unique properties of materials at the nanoscale are detailed in other papers in this symposium and will not be repeated here. The central question has to do with the fact that materials act entirely differently at the nanoscale than at the macro-level, as nano-particles can move across the blood-brain barrier, into the respiratory tract, and across cell walls. This leads many to question the individual and cumulative effects of various nanotechnologies on plants, animals, and the environment. Description of nanomedicine applications can be found in Jain, K. K., The Handbook of Nanomedicine (Totowa, NJ: Humana Press, 2008).CrossRefGoogle Scholar

Hilts, P., Protecting America's Health: The FDA, Business and One Hundred Years of Regulation (New York: Alfred Knopf, 2003).Google Scholar

Does the product act like a device (providing, for example, structural support or mechanical action), or a drug (acting as a chemical agent, with targeted effects specific to a molecule), or a biologic (a serum, vaccine, or blood component)?.Google Scholar

Many such hybrids had ambiguous modes of action. In these cases, sponsors were allowed to designate which Center would review their product. Not surprisingly, they chose the Center that would provide the easiest regulatory pathway. For an illustration with tissue engineered products, see Hogle, L., “Pragmatic Objectivity and the Standardization of Human Tissues,” Social Studies of Science, forthcoming.Google Scholar

FDA, “Performance Report to Congress for Office of Combination Products,” 2006, available at <http://www.fda.gov/oc/combination/report2006/overview.html> (last visited August 15, 2008).+(last+visited+August+15,+2008).>Google Scholar

Nanotechnology Task Force, Department of Health and Human Services, “Nanotechnology: A Report of the U.S. Food and Drug Administration,” July 25, 2007, available at <http://www.fda.gov/nanotechnology/taskforce/report2007.html> (last visited December 21, 2008).+(last+visited+December+21,+2008).>Google Scholar

The question of regulatory adequacy was also analyzed in Taylor, M., “Regulating the Products of Nanotechnology: Does the FDA Have the Tools It Needs?” Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, October, 2006, available at <http://www.wilsoncenter.org/index.cfm?topic_id=166192&fuseaction=topics.item&news_id=202942> (last visited December 21, 2008).Google Scholar

See Nanotechnology Task Force, supra note 11.Google Scholar

Reports of political interference continue to emerge. See Whitman, C. T., Commentary “Your Inbox, Mr. President,” Nature 457, no. 7227 (2009): 258–261 (on politicization of the EPA).Google Scholar

Freitas, R. A., Nanomedicine, Vol. IIA: Biocompatibility (Austin, TX: Landes Bioscience, 2003): at 7.CrossRefGoogle Scholar

Williams, D., “Revisiting the Definition of Biocompatibility,” Medical Device Technology 14, no. 8 (2003): 10–14.Google Scholar

Id., at 125–143.Google Scholar

Anonymous, “Special Report: Life 2.0: Synthetic Biology,” The Economist 380, no. 8493 (2006): 76–80; Samuel, G., Selgelid, M. and Kerridge, I., “Managing the Unimaginable: Regulatory Responses to the Challenges Posed by Synthetic Biology and Synthetic Genomics,” EMBO Reports 19, no. 1 (2009): 7-11.Google Scholar

See Nanotechnology Task Force, supra note 11.Google Scholar

van Loon, J., Risk and Technological Culture (New York: Routledge, 2002): at 7.Google Scholar

Kuzma, J. and Besley, J., “Ethics of Risk Analysis and Regulatory Review: From Bio- to Nanotechnology,” Nanoethics 2, no. 1 (2008): 149–162.CrossRefGoogle Scholar

Moreno, J., Keynote presentation, Launch of the Center for Nanotechnology and Society, Arizona State University, 2006.Google Scholar

Gordijn, B., “Nanoethics: From Utopian Dreams and Apocalyptic Nightmares towards a More Balanced View,” Science and Engineering Ethics 11, no. 4 (2005): 521–533; Nordman, A., “If and Then: A Critique of Speculative Nanoethics,” Nanoethics 1, no. 1 (2007): 36-46.CrossRefGoogle Scholar

Gaskell, G., Einsiedel, E., Hallman, W., Hornig Priest, S., Jackson, J. and Olsthoorn, J., “Social Values and the Governance of Science,” Science 310, no. 5756 (2005):1908–1909. This survey of Americans, Canadians, and Europeans suggested that while the majority of respondents felt that decisions about technology should be left to experts and based on scientific evidence, about one-third favored moral and ethical considerations over scientific evidence, and about one-quarter favored public opinion over expert opinion in decision-making. This raises questions about both public support for current science policy administration and the role of public participation in making decisions that may affect their lives and work. The authors note differences between countries as well as between types of technologies (stem cells, nanotechnology, biotechnology).CrossRefGoogle Scholar

Critical self-evaluations of bioethics appear in the edited volume, Eckenwiler, L. A. and Cohn, F. G., eds., The Ethics of Bioethics: Mapping the Moral Landscape (Baltimore, MD: Johns Hopkins University Press, 2007). See also Jasanoff, S., Designs on Nature: Science and Democracy in Europe and the United States (Princeton, NJ: Princeton University Press, 2005): at 200, 286.Google Scholar

Charo, A., “Passing on the Right: Conservative Bioethics Is Closer Than It Appears,” Journal of Law, Medicine & Ethics 32, no. 4 (2004): 307–314.CrossRefGoogle Scholar

Susan Wolf discusses the intertwined histories of bioethics and law in Wolf, S. M., “Law and Bioethics: From Values to Violence,” Journal of Law, Medicine & Ethics 32, no. 4 (2004): 293–306. While beyond the scope of the current paper, it is important to consider not only how law responds to technologies, but also how technologies affect law. An example of this is California's Proposition 71 and the resulting forms of state governance established to address stem cell research.CrossRefGoogle Scholar

See Gordijn, , supra note 23.Google Scholar

In fact, this is what many argue will happen with stem cell science. Drug discovery, tools for diagnostics, and knowledge of disease models may turn out to be the most important outcomes, rather than development of therapeutics.Google Scholar

The BioBricks Foundation links not-for-profit and commercial research using an open source-style access to biological parts and information. See <http://bbf.openwetware.org/> (last visited August 18, 2009).+(last+visited+August+18,+2009).>Google Scholar

Currently, viral vectors are used to ferry genes to a location for gene therapy and to create induced pluripotent stem cells, potentially inducing cancers. As much as 50% of time in surgery is spent controlling bleeding. Self-assembly gels can seal the wound and quickly stop bleeding (see Jain, , supra note 6, at 191). Nanoneedles can be used in combination with atomic force microscopy to do “surgery” on living cells, entering the membrane while causing minimal damage (id., at 60).Google Scholar

Professional associations, codes of ethics, and agreements on definitions and classifications that occur at consensus conferences and in other venues all serve regulatory purposes as much as federal regulatory agency action does. Recommendations for more formal governance and assessment methods can be found in Guston, D. and Sarewitz, D., “Real-Time Technology Assessment,” Technology in Society 24, no. 1–2 (2002): 93–109; Marchant, G. E., Sylvester, D. J. and Abbott, K. W., “Risk Management Principles for Nanotechnology,” Nanoethics 2, no. 1 (2008): 43-60; and Kuzma, J., “Moving Forward Responsibly: Oversight for the Nanotechnology-Biology Interface,” Journal of Nanoparticle Research 9, no. 1 (2007): 165-182.CrossRefGoogle Scholar

Rosenberg, C., Our Present Complaint: American Medicine, Then and Now (Baltimore, MD: Johns Hopkins University Press, 2007).Google Scholar