See Abraham, J., “Regulatory Science as Culture: Contested Two-Dimensional Values at the US FDA,” Science as Culture 11, no. 3 (2002): 309–335.CrossRefGoogle Scholar

Wiener, J. B., “The Regulation of Technology, and the Technology of Regulation,” Technology in Society 26, nos. 2–3 (2004): 483–500, at 489.CrossRefGoogle Scholar

See generally id. (tracing the development and effects of various types of regulatory instruments).Google Scholar

Roco, M. C., “Nanotechnology: Convergence with Modern Biology and Medicine,” Current Opinion in Biotechnology 14, no. 3 (2003): 337–346, at 337.CrossRefGoogle Scholar

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).Google Scholar

See 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. et al., “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; Young Choi, J. and Ramachandran, G., “Review of the OSHA Framework for Oversight of Occupational Environments,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 633-650; and Wolf, S. M., Gupta, R. and Kohlhepp, P., “Gene Therapy Oversight: Lessons for Nanobiotechnology,” Journal of Law, Medicine & Ethics 37, no. 4 (2009): 659-684.CrossRefGoogle Scholar

Woodrow Wilson International Center, Project on Emerging Technologies, “Nanotechnology Consumer Products Inventory,” available at <http://www.nanotechproject.org/inventories/consumer/> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

Drexler, K. E., “Molecular Engineering: An Approach to the Development of General Capabilities for Molecular Manipulation,” Proceedings of the National Academy of Sciences 78, no. 9 (1981): 5275–5278.CrossRefGoogle Scholar

Binnig, G. and Rohrer, H., “Scanning Tunneling Microscopy,” IBM Journal of Research and Development 30, no. 4 (1986): 355–369.Google Scholar

Kroto, H. W. et al., “C60: Buckminsterfullerene,” Nature 318, no. 6042 (1985): 162–163.CrossRefGoogle Scholar

Scott, R. W. J., Wilson, O. M. and Crooks, R. M., “Synthesis, Characterization, and Applications of Dendrimer-Encapsulated Nanoparticles,” Journal of Physical Chemistry B 109, no. 2 (2005): 692–704.CrossRefGoogle Scholar

Bruchez, M. Jr. et al., “Semiconductor Nanocrystals as Fluorescent Biological Labels,” Science 281, no. 5385 (1998): 2013–2016.CrossRefGoogle Scholar

Balzani, V. et al., “Designing Dendrimers Based on Transition-Metal Complexes: Light Harvesting Properties and Predetermined Redox Patterns,” Accounts of Chemical Research 31, no.1 (1998): 26–34.CrossRefGoogle Scholar

Baughman, R. H., Zakhidov, A. A. and de Heer, W. A., “Carbon Nanotubes: The Route Toward Applications,” Science 297, no. 5582 (2002): 787–792; Xia, Y. et al., “One Dimensional Nanostructures: Synthesis, Characterization, and Applications,” Advanced Materials 15, no. 5 (2003): 353-389.CrossRefGoogle Scholar

Pangburn, T. O. et al., “Peptide and Aptamer Functionalized Nanovectors for Targeted Delivery of Therapeutics,” Journal of Biomechanical Engineering 131, no. 7 (2009): 074005-1-074005-20; Garg, A. et al., “Targeting Colon Cancer Cells Using PEGylated Liposomes Modified with a Fibronectin-Mimetic Peptide,” International Journal of Pharmaceutics 366, no. 1-2 (2009): 201–210; Demirgöz, D., Garg, A. and Kokkoli, E., “PR_b-targeted PEGylated Liposomes for Prostate Cancer Therapy,” Langmuir 24, no. 23 (2008): 13518-13524.CrossRefGoogle Scholar

See Pangburn, et al., supra note 16.Google Scholar

Environmental Protection Agency, Nanoscale Materials Stewardship Program Interim Report, available at <http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

Environmental Protection Agency, “Toxic Substances Control Act Inventory Status of Carbon Nanotubes,” Federal Register 73 (October 31, 2008): 64946.Google Scholar

H.R. 554, 111th Congress (2009).Google Scholar

California Department of Toxic Substances Control, “Chemical Information Call-in: Carbon Nanotubes,” available at <http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/index.cfm> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

Berkeley Municipal Code, §15.12.040–15.12.050 (2006).CrossRefGoogle Scholar

United Kingdom, Department for Environmental Food and Rural Affairs, Voluntary Reporting Scheme for Engineering Nanoscale Materials (London: Crown, 2008), available at <http://www.defra.gov.uk/environment/nanotech/policy/pdf/vrs-nanoscale.pdf> (last visited February 24, 2009).+(last+visited+February+24,+2009).>Google Scholar

United Kingdom Royal Society, Nanoscience and Nanotechnologies: Opportunities and Uncertainties, London, 2004, at 85, available at <http://www.nanotec.org.uk/finalReport.htm> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

Gill, V., “Nanotechnology Regulation Creeps Closer,” Chemistry World, February 25, 2009, available at <http://www.rsc.org/chemistryworld/News/2009/February/25020901.asp> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

Ludlow, K., Bowman, D. and Hodge, G., “A Review of Possible Impacts of Nanotechnology on Australia's Regulatory Framework,” September 2007, available at <http://nano.foe.org.au/filestore2/download/248/Review%20of%20Nanotechnology%20Regulation%20in%20Australia%20-%20Monash%20Report%20July%202008.pdf> (last visited November 6, 2009). (last visited November 6, 2009).' href=https://scholar.google.com/scholar?q=Ludlow,+K.,+Bowman,+D.+and+Hodge,+G.,+“A+Review+of+Possible+Impacts+of+Nanotechnology+on+Australia's+Regulatory+Framework,”+September+2007,+available+at++(last+visited+November+6,+2009).>Google Scholar

European Commission, Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee, Nanosciences and Nanotechnologies: An Action Plan for Europe 2005–2009, Luxemburg, 2005, available at <http://eescopinions.eesc.europa.eu/viewdoc.aspx?doc=%5C%5Cesppub1%5Cesp_public%5Cces%5Cint%5Cint277%5Cen%5Cces582–2006_ac_en.doc> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar

See, e.g., Schultz, W. B. and Barclay, L., A Hard Pill to Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, Project on Emerging Technologies, Washington, D.C., 2009; Luoma, S. N., Silver Nanotechnologies and the Environment, Project on Emerging Technologies, Washington, D.C., 2008; Felcher, E. M., The Consumer Product Safety Commission and Nanotechnology, Project on Emerging Technologies, Washington, D.C., 2008; Davies, J. C., Nanotechnology Oversight: An Agenda for the Next Administration, Project on Emerging Technologies, Washington, D.C., 2008; Paradise, J. et al., “Developing Oversight Frameworks for Nanobiotechnology,” Minnesota Journal of Law, Science & Technology 9, no.1 (2008): 187-203; Roco, M. C., “Possibilities for Global Governance of Converging Technologies,” Journal of Nanoparticle Research 10, no. 1 (2008): 11-29; Taylor, M. R., Assuring the Safety of Nanomaterials in Food Packaging: The Regulatory Process and Key Issues, Project on Emerging Technologies, Washington, D.C., 2008; Breggin, L. K. and Pendergrass, J., Where Does the Nano Go? End-of-Life Regulation of Nanotechnologies, Project on Emerging Technologies, Washington, D.C., 2007; Davies, J. C., EPA and Nanotechnology: Oversight for the 21st Century, Project on Emerging Technologies, Washington, D.C., 2008; Kuzma, J., “Moving Forward Responsibly: Oversight for the Nanotechnology-Biology Interface,” Journal of Nanoparticle Research 9, no. 1 (2007): 165-182; Greenwood, M., Thinking Big about Things Small: Creating an Effective Oversight System for Nanotechnology, Project on Emerging Technologies, Washington, D.C., 2007; Taylor, M. R., Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? Project on Emerging Technologies, Washington, D.C., 2006; Davies, J. C., Managing the Effects of Nanotechnology, Project on Emerging Technologies, Washington, D.C., 2006; Abbott, K. W., Marchant, G. E. and Sylvester, D. J., “A Framework Convention for Nanotechnology?” Environmental Law Reporter 36, no. 12 (2006): 10931-10942; Kuzma, J., ed., University of Minnesota Center for Science, Technology and Public Policy Workshop Report, The Nanotechnology-Biology Interface: Exploring Models for Oversight, September 15, 2005, available at <http://www.hhh.umn.edu/centers/stpp/pdf/nanotech_bio_interface.pdf> (last visited September 18, 2009); American Bar Association, “Section of Environment, Energy, and Resources: Nanotechnology Project,” available at <http://www.abanet.org/environ/nanotech/> (last visited September 18, 2009); International Center for Technology Assessment, Principles for the Oversight of Nanotechnologies and Nanomaterials, July 31, 2007, available at <http://www.icta.org/doc/Principles%20for%20the%20Oversight%20of%20Nanotech-nologies%20and%20Nanomaterials_final.pdf> (last visited September 18, 2009); U.S. Environmental Protection Agency, Science Policy Council, Nanotechnology White Paper, Washington, D.C., 2007, available at <http://es.epa.gov/ncer/nano/publications/whitepaper12022005.pdf> (last visited September 18, 2009); U.S. Food and Drug Administration, Nanotechnology Task Force, Nanotechnology: A Report of the U.S. Food and Drug Administration, July 25, 2007, available at <www.fda.gov/nanotechnology/taskforce/report2007.pdf> (last visited September 18, 2009); National Nanotechnology Initiative, National Science & Technology Council, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, National Nanotechnology Coordination Office, Washington, D.C., 2006, available at <http://www.nano.gov/NNI_EHS_research_needs.pdf> (last visited September 18, 2009); National Research Council, Review of Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (Washington, D.C.: National Academies Press, 2008), available at <http://www.nap.edu/catalog.php?record_id=12559> (last visited September 18, 2009).Google Scholar

National Academy of Sciences, Committee on the Introduction of Genetically Engineered Organisms into the Environment, Introduction of Recombinant-DNA Organisms into the Environment (Washington, D.C.: National Academies Press, 1987).Google Scholar

Office of Science and Technology Policy, Coordinated Framework for the Regulation of Biotechnology, 51 Federal Register § 23302 (1986).Google Scholar

Kuzma, J. and Verhage, P., Nanotechnology in Agriculture and Food Protection, Project on Emerging Technologies, Washington, D.C., 2006.Google Scholar

Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. §§ 351–360 (2008).Google Scholar

Paradise, J. et al., “Exploring Emerging Nanotechnology Drugs and Medical Devices,” Food and Drug Law Journal 36, no. 2 (2008): 407–420, at 411–414.Google Scholar

See FFDCA, , supra note 32.Google Scholar

See Paradise, et al., supra note 33, at 415–417.Google Scholar

Ziem, G. E. and Castleman, B. I., “Threshold Limit Values: Historical Perspective and Current Practice,” Journal of Occupational Medicine 31, no. 11 (1989): 910–918.CrossRefGoogle Scholar

Mine Safety and Health Act, 30 U.S.C. §§ 801–965 (2008).Google Scholar

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

Toxic Substances Control Act, Subchapter I: Control of Toxic Substances, 15 U.S.C. §§ 2601–2629 (2008).Google Scholar

See Wolf, , Gupta, and Kohlhepp, , supra note 6.Google Scholar

Food and Drug Administration, Center for Devices and Radiological Health Strategic Plan, Total Product Life Cycle Model, available at <http://www.fda.gov/cdrh/strategic/tplc.html> (last visited November 4, 2009).+(last+visited+November+4,+2009).>Google Scholar

See references to all case studies in this symposium, supra note 6.Google Scholar

The exact survey instrument and methodology employed for expert elicitation varied somewhat among the case studies, given the different subject matter. For specific information, refer to each case study in the symposium.Google Scholar

See Kuzma, J. et al., “An Integrated Approach to Oversight Assessment for Emerging Technologies,” Risk Analysis 28, no. 4 (2008): 1197–1219.CrossRefGoogle Scholar

See references to all case studies in this symposium, supra note 6.Google Scholar

Note that the case study on chemicals in the workplace used 26 criteria, not 28, as two of the oversight evaluation criteria were not germane.Google Scholar

For additional information and explanation, refer to the case studies in this symposium on drugs and medical devices, GEOs, and workplace chemicals, see supra note 6.Google Scholar

See, e.g., Morgan, G. and Henrion, M., Performing Probability Assessment in Uncertainty (Cambridge, U.K.: Cambridge University Press, 1990): at 141–171.Google Scholar

See references to all case studies in this symposium, supra note 6.Google Scholar

See Kuzma, et al., supra note 44.Google Scholar

See references to all case studies in this symposium, supra note 6.Google Scholar

National Research Council, Genetically Engineered Pest-Protected Plants: Science and Regulation (Washington, D.C.: National Academies Press, 2000).Google Scholar

See 21 C.F.R. 310.305; 21 C.F.R. 314.80 (2009).CrossRefGoogle Scholar

See, e.g., 21 U.S.C. § 505(o)(4) regarding “new safety information” relevant to labeling. For a discussion of the impact of this provision, see Danzis, S. D. and Pitlyk, S. E., “FDAAA's Safety Labeling Provisions,” Food and Drug Law Institute Update Magazine, January/February 2009, at 10–13.Google Scholar

Wardak, A. and Gorman, M., “Using Trading Zones and Life Cycle Analysis to Understand Nanotechnology Regulation,” Journal of Law, Medicine & Ethics 34, no. 4 (2006): 695–703; Breggin, , Pendergrass, , supra note 28.CrossRefGoogle Scholar

Wilsdon, J. and Willis, R., “See-Through Science,” available at <http://www.demos.co.uk> (last visited September 18, 2009); Toumey, C., “Science and Democracy,” Nature Nanotechnology 1, no. 1 (2006): 6–7.Google Scholar

See Wardak, and Gorman, , supra note 56.Google Scholar

See Choi, and Ramanchandran, , supra note 6.Google Scholar

See Davies, , Nanotechnology Oversight: An Agenda for the New Administration, supra note 28.Google Scholar

Food and Drug Administration Mission Statement, “What We Do,” available at <http://www.fda.gov/opacom/morechoices/mission.html> (last visited September 18, 2009).+(last+visited+September+18,+2009).>Google Scholar