Governance of Nanotechnology and Nanomaterials: Principles,Regulation,and Renegotiating the Social Contract

National Science Foundation Grant # 0608791: Nanoscale Interdisciplinary Research Team (NIRT), University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, Evaluating Oversight Models for Active Nanostructures and Nanosystems: Learning from Past Technologies in a Societal Context; Paradise J. Wolf S. M. Ramachandran G. Kokkoli E. Hall R. Kuzma J. , “Developing Oversight Frameworks for Nanobiotechnology,” Minnesota Journal of Law Science and Technology 9, no. 1 (2008): 399–416.

Nanoaction: A Project of the International Center on Technology Assessment (ICTA), Principles for the Oversight of Nanotechnologies and Nanomaterials (2007), available at <http://nanoaction.org/nanoaction/doc/nano-02-18-08.pdf> (last visited June 1, 2009).

These summaries are drawn directly from the Principles but are summarized in the author's words and are not necessarily endorsed by the signatories of the Principles.

See Nanoaction , supra note 2, at 4.

Id., at 5.

Id., at 6.

Id., at 7.

Id., at 8.

Id., at 9.

Id., at 10.

Id., at 11.

Initial endorsing organizations include: American Federation of Labor and Congress of Industrial Organizations (AFL-CIO) Center for Biological Acción, Ecológica (Ecuador), African Centre for Biosafety, American Federation of Labor and Congress of Industrial Organizations (U.S.), Bakery, Confectionery, Tobacco Workers and Grain Millers International Union, Beyond Pesticides (U.S.), Biological Farmers of Australia, Center for Biological Diversity (U.S.), Center for Community Action and, Environmental Justice (U.S.), Center for Food Safety (U.S.), Center for Environmental Health (U.S.), Center for Genetics and Society (U.S.), Center for the Study of Responsive Law (U.S.), Clean Production Action (Canada), Ecological Club Eremurus (Russia), EcoNexus (United Kingdom), Edmonds Institute (U.S.), Environmental Research Foundation (U.S.), Essential Action (U.S.), ETC Group (Canada), Forum for Biotechnology and Food Security (India), Friends of the Earth Australia, Friends of the Earth Europe, Friends of the Earth United States, GeneEthics (Australia), Greenpeace (U.S.), Health and Environment Alliance (Belgium), India Institute for Critical Action-Centre in Movement, Institute for Agriculture and Trade Policy (U.S.), Institute for Sustainable Development (Ethiopia), ICTA (U.S.), International Society of Doctors for the Environment (Austria), International Trade Union Confederation, International Union of Food, Agricultural, Hotel, Restaurant, Catering, Tobacco and Allied Workers' Associations, Loka Institute (U.S.), National Toxics Network (Australia), Public Employees for Environmental Responsibility (U.S.), Science and Environmental Health Network (U.S.), Silicon Valley Toxics Coalition (U.S.), Tebtebba Foundation-Indigenous Peoples' International Centre for Policy Research and Education (Philippines), The Soils Association (United Kingdom), Third World Network (China), United Steelworkers (U.S.), and Vivagora (France).

Tierney J. , “Trying for Balance at Interior Dept.,” New York Times, June 9, 2003, at A26 (discussing Bush's “new environmentalism,” which “emphasizes “cooperation at the local level rather than federal edicts”); Environmental Protection Agency (EPA), Everyday Choices: Opportunities for Environmental Stewardship, November 2005, at 7, available at <http://www.epa.gov/epainnov/pdf/rpt2admin.pdf> (last visited June 1, 2009) (assessing 133 volunteer programs at EPA).

Kerret D. Tal A. , “Greenwash or Green Gain? Predicting the Success and Evaluating the Effectiveness of Environmental Voluntary Agreements,” Penn State Environmental Law Review 14, no. 1 (2005): 37–84 (concluding that there is “irrefutable evidence suggesting that voluntary programs may produce less actual reductions of emissions and improvement in general environmental practices, and less awareness than a command and control alternative”).

Revkin A. , “Bush Offers Plan for Voluntary Measures to Limit Gas Emissions,” New York Times, February 15, 2002, at A6.

See generally Natural Resources Defense Council (NRDC), “Voluntary Efforts Won't Work: Why We Need Mandatory Limits on Carbon Dioxide,” available at <http://www.nrdc.org/globalWarming/fmandatory.asp> (last visited June 1, 2009).

549 U.S. 497, 127 S. Ct. 1438 (2007).

See, e.g., Barringer F. , “Ruling Undermines Lawsuits Opposing Emissions Controls,” New York Times , April 3, 2007, at A14; Barnes R. Eilpern J. , “High Court Faults EPA Inaction on Emissions,” Washington Post , April 3, 2007, at A1; Greenhouse L. , “Justices Say EPA Has Power to Act on Harmful Gases,” New York Times, April 3, 2007, at A1; Broder J. , “EPA Expected to Regulate Carbon Monoxide and Other Heat-Trapping Gases,” New York Times, February 18, 2009, at A15; Administrator Lisa Jackson, Memo to EPA Employees, January 23, 2009, available at <http://www.epa.gov/administrator/memotoemployees.html> (last visited May 13, 2009) (“As Congress does its work, we will move ahead to comply with the Supreme Court's decision recognizing EPA's obligation to address climate change under the Clean Air Act.”). Id.

Nanoscale Materials; Notice of a Public Meeting, 70 Federal Register 24574 (May 10, 2005).

ICTA et al., Comments to the Environmental Protection Agency EPA Re: EPA Proposal to Regulate Nanomaterials through a Voluntary Pilot Program, Docket ID: OPPT-2004-0122, July 5, 2005, at 11.

Friends of the Earth (FoE) and ICTA, Joint ICTA-FoE Comments on EPA's “Concept Paper for Nanoscale Materials Stewardship Program (NMSP) under TSCA” and “TSCA Inventory Status of Nanoscale Substances – General Approach” – Federal Register notice July 12, 2007, Docket # EPA-HQ- OPPT-2004-0122, September 10, 2007, available at <http://www.nanoaction.org/doc/Joint%20Comments%20on%20EPA%20TSCA%20voluntary%20program_9_10_07_FINAL.pdf> (last visited June 1, 2009).

EPA, Nanoscale Materials Stewardship Program (NMSP), Interim Report, January 2009, available at <http://www.epa.gov/oppt/nano/nmsp-interim-report-final.pdf> (last visited June 1, 2009), at 3; id., at 27 (concluding that “approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program”); id. (“The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials.”).

Id., at 27 (noting “uncertainty regarding whether each NMSP participant reported all of the nanoscale materials it manufactures” and that “there may be gaps in the data reported by each participant. Review of NMSP submissions reveal a number of instances where the details of the manufacturing, processing, and use of nanoscale materials were not reported.”); id. (“A number of the NMSP submissions did not contain exposure or hazard-related data. Exposure and hazard data are two of the major categories of information EPA identified in its concept paper for the NMSP that are needed to inform risk assessment and risk management of nanoscale materials.”).

Weiss R. , “The Big Business of Nano Litigation,” Science Progress, February 23, 2009, available at <http://www.scienceprogress.org/2009/02/the-big-business-of-nano-litigation/> (last visited June 1, 2009).

Department for Environment, Food and Rural Affairs (DEFRA), The UK Voluntary Reporting Scheme for Engineered Nanoscale Materials (2008), available at <http://www.defra.gov.uk/ENVIRONMENT/nanotech/policy/pdf/vrs-nanoscale.pdf> (last visited June 1, 2009).

DEFRA, The UK Voluntary Reporting Scheme for Engineered Nanoscale Materials: Seventh Quarterly Report (2008), available at <http://www.defra.gov.uk/environment/nanotech/pdf/vrs-seventh-progress-report.pdf> (last visited June 1, 2009).

Hansen S. F. Ticker J. A. , “The Challenges of Adopting Voluntary Health, Safety and Environment Measures for Manufactured Nanomaterials: Lessons from the Past for More Effective Adoption in the Future,” Nanotechnology Law & Business 4, no. 3 (2007): 341–359.

15 U.S.C. § 2603(a) (A-B) (Toxic Substances Control Act (TSCA) Section 4) (explaining that EPA may only require testing if it first determines that a chemical substance presents an unreasonable risk to human health and the environment or that the chemical is produced in substantial quantities, and that there may be substantial human or environmental exposure, and that there is insufficient data available to provide the data, and testing is necessary to do so); 15 U.S.C. § 2605(a-b) (TSCA Section 6) (authorizing EPA to regulate existing chemicals or order more information from a manufacturer but only when it has a reasonable basis to conclude that the substance “presents or will present an unreasonable risk to health or the environment”).

SafeNano, Mandatory Nanomaterial Declaration proposed by French Government, January 23, 2009, available at <http://www.safenano.org/SingleNews.aspx?NewsID=590> (last visited June 1, 2009).

California Department of Toxic Substances Control, Formal AB289 Call In Letter, DTSC Chemical Call-in: Carbon Nanotubes , January 22, 2009, available at <http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/upload/Formal_AB289_Call_In_Letter_CNTs.pdf> (last visited June 1, 2009); see also Chemical Information Call-In website notice, available at <http://www.dtsc.ca.gov/TechnologyDevelopment/Nanotechnology/index.cfm#Chemical_Information_Call-in:_Carbon_Nanotubes> (last visited June 1, 2009) (notice of intent updating call-in to include reactive nanometal oxides).

Smith D. , “NSW Pushes for Nano Risk Labels,” Sydney Morning Herald, May 5, 2009, available at <http://www.smh.com.au/national/nsw-pushes-for-nano-risk-labels-20090504-asmk.html?page=-1> (last visited June 1, 2009).

“Nano-Regulation Creeps Closer,” Chemistry World , February 25, 2009, available at <http://www.rsc.org/chemistryworld/News/2009/February/25020901.asp#> (last visited June 1, 2009).

Pearl L. , “Canada, California Seek Information On Nanomaterials,” Pesticide & Toxic Chemical News 37, no. 13 (2009): 1.

EPA, NMSP Interim Report, supra note 22, at 28 (“Due to the limited participation in the In-Depth Program, EPA will also consider how best to apply rulemaking under TSCA section 4 to develop needed environmental, health, and safety data.”); Pearl , supra note 33.

Davies J. C. , Testimony at Committee on Energy and Commerce, U.S. House of Representatives, February 26, 2009, available at <http://www.rff.org/Documents/davies2–26Testimony.pdf> (last visited June 1, 2009).

Id.; Davies J. C. , Managing the Effects of Nanotechnology (Washington, DC: Project on Emerging Technologies, 2006) at 10, 12, available at <http://www.wilsoncenter.org/events/docs/Effectsnanotechfinal.pdf> (last visited June 1, 2009).

Royal Society, Nanoscience and Nanotechnologies, July 2005, at 72, available at <http://www.nanotec.org.uk/report/Nano%20report%202004%20fin.pdf> (last visited June 1, 2009).

See, e.g., Davies J. C. , Oversight of the Next Generation of Nanotechnology (Washington, DC: Project on Emerging Technologies, 2009), available at <http://207.58.186.238/process/assets/files/7316/pen-18.pdf> (last visited June 1, 2009); Schultz W. Barclay L. , A Hard Pill to Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements (Washington, D.C.: Project on Emerging Technologies, 2009), available at <http://www.nanotechproject.org/process/assets/files/7056/pen17_final.pdf> (last visited June 1, 2009); Felcher E. M. , The Consumer Products Safety Commission and Nanotechnology (Washington, D.C.: Project on Emerging Technologies, 2008), available at <http://www.nanotechproject.org/process/assets/files/7033/pen14.pdf> (last visited June 1, 2009); Davies J. C. , Nanotechnology Oversight: An Agenda for the New Administration (Washington, D.C.: Project on Emerging Technologies, 2008), available at <http://www.nanotechproject.org/process/assets/files/6709/pen13.pdf> (last visited June 1, 2009); Breggin L. K. Pendergrass J. , Where Does the Nano Go? End-of-Life Regulation of Nanotechnologies (Washington, D.C.: Project on Emerging Technologies, 2007), available at <http://www.nanotechproject.org/process/assets/files/2699/208_nanoend_of_life_pen10.pdf> (last visited June 1, 2009); Davies J. C. , EPA and Nanotechnology: Oversight for the 21st Century (Washington, D.C.: Project on Emerging Technologies, 2007), available at <http://www.nanotechproject.org/process/assets/files/2698/197_nanoepa_pen9.pdf> (last visited June 1, 2009); Taylor M. , Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs? (Washington, DC: Project on Emerging Technologies, 2006), available at <http://www.nanotechproject.org/file_download/files/PEN5_FDA.pdf> (last visited June 1, 2009); Breggin L. Carothers L. , “Governing Uncertainty: The Nanotechnology Environmental, Health, and Safety Challenge,” Columbia Journal of Environmental Law 31, no. 2 (2006): 285–329, at 310–13; American Bar Association, Section of Environment, Energy, and Resources (ABA SEER), “Regulation of Nanoscale Materials under the Toxic Substances Control Act,” June 2006, available at <http://www.abanet.org/environ/nanotech/pdf/TSCA.pdf> (last visited June 1, 2009); Lin A. C. , “Size Matters: Regulating Nanotechnology,” Harvard Environmental Law Review 31, no. 2 (2007): 349–408; Davies , supra note 36.

See, e.g., European Commission (EC), Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks Associated with Engineered and Adventitious Products of Nanotechnologies (Adopted September 28–29, 2005), at 6, 32, available at <http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_003.pdf> (last visited June 1, 2009).

See, e.g., Maynard A. , “Nanotechnology: The Next Big Thing, or Much Ado about Nothing?” Annals of Occupational Hygiene 51, no. 1 (2006): 1–12, at 7; Oberdorster G. , “Principles for Characterizing the Potential Human Health Effects from Exposure to Nanomaterials: Elements of a Screening Strategy,” Particle and Fibre Toxicology 2, no. 8 (2005), available at <http://www.particleandfibretoxicology.com/content/pdf/1743-8977-2-8.pdf> (last visited June 1, 2009).

See, e.g., Nel A. , “Toxic Potential of Materials at the Nanolevel,” Science 311, no. 5761 (2006): 622–627; Oberdorster G. , supra note 40; Maynard A. , “Safe Handling of Nanotechnology” Nature 444, no. 7117 (2006): 267–269.

Food and Drug Administration (FDA), “FDA and Nanotechnology Products,” available at <http://www.fda.gov/nanotechnology/faqs.html> (last visited May 20, 2009); National Nanotechnology Initiative (NNI), “Factsheet: What Is Nanotechnology?” available at <http://www.nano.gov/html/facts/whatIsNano.html> (last visited May 20, 2009).

FDA, Regulation of Nanotechnology Products, available at <http://www.fda.gov/nanotechnology/regulation.html> (last visited May 20, 2009).

See EC, supra note 39, at 6. See also EC, Nanosciences and Nanotechnologies: An Action Plan for Europe 2005–2009: First Implementation Report 2005–2007 (2007), at 9, available at <ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/com_2007_0505_f_en.pdf> (last visited June 1, 2009) (“Because of uncertainties, the current risk assessment procedures require modification for nanoparticles. Knowledge gaps have been confirmed in areas such as nanoparticle characterization, detection and measurement; their fate and persistence in humans and the environment; and all aspects of the associated toxicology and ecotoxicology. These should be addressed to allow satisfactory risk assessments for humans and ecosystems.”).

Royal Society, supra note 37, at 49.

Tran C. L. , “A Scoping Study to Identify Hazard Data Needs for Addressing the Risks Presented by Nanoparticles and Nanotubes,” Institute of Occupational Medicine, December 2005, at 34, available at <http://randd.defra.gov.uk/Document.aspx?Document=CB01072_3060_FRP.doc> (last visited June 1, 2009).

See generally ICTA et al., “Petition Requesting FDA Amend Its Regulations for Products Composed of Engineered Nanoparticles Generally and Sunscreen Drug Products Composed of Engineered Nanoparticles Specifically,” FDA Docket # 2006P-210, May 16, 2006, available at <http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf> (last visited June 1, 2009).

TSCA Regulations, Premanufacture Notice Exemptions, 40 C. F.R. § 723.5 (2009) (Chemical substances manufactured in quantities of 10,000 kilograms or less per year, and chemical substances with low environmental releases and human exposures).

See, e.g., Breggin L. Pendergrass J. , “Addressing Nanotechnology Waste and Product Disposal: Can the Superfund Safety Net Catch the Tiny Particles?” Journal of Environmental Law 19, no. 3 (2007): 323–345, at 344.

See 59 Federal Register 45526 (Sept. 1, 1994) (proposed rule including microorganisms produced by biotechnology under TSCA jurisdiction).

See Taylor , supra note 38, at 4.

EPA, “Nanoscale Materials Stewardship Program and Inventory Status of Nanoscale Substances under the Toxic Substances Control Act; Notice of Availability,” 72 Federal Register 38083 (July 12, 2007) (announcing the availability of “Concept Paper for the Nanoscale Materials Stewardship Program under TSCA”, which describes EPA's current thinking regarding whether a nanoscale material is a “new” or “existing” chemical substance under TSCA); EPA, “Concept Paper for the Nanoscale Materials Stewardship Program under TSCA,” available at <http://www.epa.gov/oppt/nano/nmspconceptpaper.pdf> (last visited June 4, 2009).

15 U.S.C. § 2602(9) (2009) (definition of new chemical substance); 15 U.S.C. § 2607(b)(1) (2009) (TSCA Inventory) (requiring EPA to “compile, keep current, and publish a list of each chemical substance which is manufactured or processed in the U.S.”).

15 U.S.C. § 2604 (2009).

EPA, “TSCA Inventory Status of Nanoscale Substances – General Approach,” January 23, 2008, available at <http://www.epa.gov/oppt/nano/nmsp-inventorypaper2008.pdf> (last visited June 1, 2009).

Public Comment Docket for NMSP Concept Paper, “Comments of J. Clarence Davies,” EPA-HQ-OPPT-2004-0122-0059.1; see also EPA, “TSCA Nanoscale Materials Inventory Paper: Public Comments with EPA Responses”, December 20, 2007.

See, e.g., FCC v. Fox Television Stations , 129 S. Ct. 1800 (2009) (holding that agency changes in policy must be reviewed under the same standard as new policies, and do not require a different or more substantive rationale); Davies (2008), supra note 38, at 12 (recommending reversal).

See EPA, supra note 55, at 1.

See 40 C.F.R. Part 172, Subpart C (2009) (experimental use permits); 40 C.F.R. §§ 158.690, 158.740 (2009) (data registration requirements).

40 C.F.R. Part 174 (2009).

7 U.S.C. § 136a(a) (2009).

No Spray Coalition, Inc. v. City of New York , 351 F.3d 602, 604–05 (2d. Cir. 2003) (citing 7 U.S.C. § 136a(C)(5)(D)).

7 U.S.C. § 136(u)(1) (2009).

7 U.S.C. § 136a (2009).

Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, “Analysis of Inventory of Nanotechnology-Based Consumer Products,” August 2008, available at <http://www.nanotechproject.org/inventories/consumer/analysis_draft/> (last visited May 20, 2009).

Weiss R. , “Groups Petition EPA to Ban Nanosilver in Consumer Goods,” Washington Post, May 2, 2008, at A4.

See generally Luoma S. , Silver Nanotechnologies and the Environment: Old Problems or New Challenges? (Washington, D. C.: Project on Emerging Technologies, 2008), available at <http://www.nanotechproject.org/process/assets/files/7036/nano_pen_15_final.pdf> (last visited June 1, 2009); Baker C. , “Synthesis and Antibacterial Properties of Silver Nanoparticles,” Journal of Nanoscience and Nanotechnology 5, no. 2 (2005): 244–249.

ICTA et al., “Petition for Rulemaking Requesting EPA Regulate Nano-Silver Products As Pesticides,” EPA Docket # EPA- HQ-OPP-20080650, May 1, 2008, available at <http://www.icta.org/nanoaction/doc/CTA_nano-silver%20petition___final_5_1_08.pdf> (last visited June 1, 2009); EPA, “Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability,” 73 Federal Register 69644–69646 (November 19, 2008) (opening public docket); EPA, “Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Extension of Comment Period,” 74 Federal Register 2072 (January 14, 2009) (extending public docket).

See supra, note 38.

See Schultz Barclay , supra note 38.

FDA's regulation of cosmetics and cosmetic ingredients does not include premarket approval, besides the addition of color additives. FDA, Center for Food Safety and Applied Nutrition, “FDA Authority Over Cosmetics,” available at <http://www.cfsan.fda.gov/∼dms/cos-206.html> (last visited May 20, 2009). FDA protects the public's health and safety by prohibiting the adulteration or misbranding of cosmetics and has the authority to require warning labels. 21 C.F.R. §§ 740.1 (Misbranding); 740.10(a) (Labeling of cosmetic products for which adequate substantiation of safety has not been obtained) (2009). FDA can also pursue enforcement actions against cosmetics manufacturers in violation of the law and request product recalls. 21 C. F.R. §§ 7.40–7.59 (2009).

Government Accountability Office (GAO), “Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act,” February 26, 2009, available at <http://www.gao.gov/new.items/d09428t.pdf> (last visited June 1, 2009); see also Lin , supra note 38, at 362–66.

Id. See, e.g., Davies (2006), supra note 38, at 10–12.

Corrosion Proof Fittings v. EPA , 947 F.2d 1201 (5th Cir. 1991).

Id. at 1215 (concluding that EPA had failed to carry its burden because it did not consider all evidence and did not give enough weight to the statutory directive to promulgate the least burdensome regulation required to adequately protect the environment).

See Felcher , supra note 38, at 3–4, 17–19.

See, e.g., Lin , supra note 38, at 367–368.

See, e.g., Weiss R. , “Nanotech Raises Worker-Safety Questions”, Washington Post April 8, 2006, at A1 (“To tour the gleaming offices of Altair Nanotechnologies Inc. is to see why the U.S. Commerce Department calls nanotech “the next industrial revolution” – a revolution not of smelters and smokestacks but of precision-engineered carbon “buckyballs” one-ten-thousandth the size of the head of a pin and microscopic nanospheres that can pack the power of a car battery in a napkinthin wafer. What could be more 21st-century?”); Piller C. , “Science's Tiny, Big Unknown,” Los Angeles Times, June 1, 2006, at A1 (“Nanotechnology has the potential to create revolutionary change across multiple, key areas of human endeavor, according to trade group NanoBusiness Alliance. To maintain its global economic lead and to keep the U.S. homeland secure, we must win the nanotech race.”).

See, e.g., National Science and Technology Council, National Nanotechnology Initiative, “Nanotechnology, Shaping the World Atom by Atom,” December 1999, at 4, available at <http://www.wtec.org/loyola/nano/IWGN.Public.Brochure/IWGN.Nanotechnology.Brochure.pdf> (last visited June 1, 2009) (proclaiming nanotechnology as “a likely launch pad to a new technological era because it focuses on perhaps the final engineering scales people have yet to master.”); id., at 8 (“If present trends in nanoscience and nanotechnology continue, most aspects of everyday life are subject to change.”); id. at 1 (stating the nanotechnology revolution will result in “unprecedented control over the material world.”).

Bond P. J. , Undersecretary of Commerce for Technology, U.S. Department. of Commerce, Technology Administration Remarks as Prepared for Delivery, World Nano-Economic Congress, Washington, D.C., September 9, 2003, available at <http://web.archive.org/web/20040110043144/http://www.technology.gov/Speeches/p_PJB_030909.htm> (last visited June 1, 2009).

See generally Roco M. C. , National Science Foundation and National Nanotechnology Initiative, “Governance of Nanotechnology for Human Development,” Presentation, Science and Technology for Human Future, April 28, 2006; Roco M. C. , “Nanotechnology's Future,” Scientific American, August 2006, available at <http://www.scientificamerican.com/article.cfm?id=nanotechnologys-future> (last visited June 4, 2009).

See Roco , supra note 81.

Reynolds G. , “Nanotechnology and Regulatory Policy: Three Futures,” Harvard Journal of Law and Technology 17, no. 1 (2002): 179–210, at 185.

See Davies (2009), supra note 38.

See Torriano G. , Second Alphabet (London: 1662) (“To go about to fetch bloud out of stones, viz. to attempt what is impossible.”).

See e.g., Greenwood M. , “TSCA Reform Building a Program That Can Work,” Environmental Law Report News & Analysis 39, no. 1 (2009): 10034–10041.

U.S. House of Representatives, Committee on Energy & Commerce, Subcommittee on Commerce, Trade, and Consumer Protection, “Revisiting the Toxic Substances Control Act of 1976,” February 26, 2009, available at <http://energycommerce.house.gov/index.php?option=com_content&task=view&id=1505&Itemid=95> (last visited May 20, 2009). See, e.g., Committee Testimony of Davies C. , available at <http://energycommerce.house.gov/Press_111/20090226/testimony_davies.pdf> (last visited June 1, 2009); Committee Testimony of Wright M. , available at <http://energycommerce.house.gov/Press_111/20090226/testimony_wright.pdf> (last visited June 1, 2009).

See, e.g., GAO, “Testimony Before the Subcommittee on Commerce, Trade, and Consumer Protection, Committee on Energy and Commerce, House of Representatives Chemical Regulation: Options for Enhancing the Effectiveness of the Toxic Substances Control Act,” February 26, 2009, at 4, available at <http://www.gao.gov/new.items/d09428t.pdf> (last visited June 1, 2009).

EC, “Communication from the Commission to the European Parliament, the Council and the European Economic and Social Committee: Regulatory Aspects of Nanomaterials,” SEC (2008) 2036, June 17, 2008, at 4, available at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0366:FIN:EN:PDF> (last visited June 1, 2009).

See, e.g., Layton L. , “Chemical Law Has Global Impact,” Washington Post, June 12, 2008, at A1.

See EC, supra note 91, at 4.

European Parliament, Committee on the Environment, Public Health and Food Safety, “Draft Report on Regulatory Aspects of Nanomaterials,” January 19, 2009, at 5–6 available at <http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML+COMPARL+PE-418.270+01+DOC+PDF+V0//EN&language=EN> (last visited June 1, 2009); European Trade Union Institute, “‘No Data, No Market’ for Nanotechnologies, MEPs Say,” available at <http://hesa.etui-rehs.org/uk/newsevents/newsfiche.asp?pk=1225> (last visited June 1, 2009).

GAO, “Options for Enhancing the Effectiveness of the Toxic Substances Control Act,” at 1–2, 4–8, available at <http://www.gao.gov/new.items/d09428t.pdf> (last visited June 1, 2009).

Id., at 9. See also Government Accountability OfficeGAO, GAO No. 05–458, “Chemical Regulation: Options Exist to Improve EPA's Ability to Assess Health Risks and Manage Its Chemical Review Program,” (June 2005), available at <http://www.gao.gov/new.items/d05458.pdf> (last visited June 1, 2009).

Id., at 2.

GAO, “High-Risk Series: An Update,” Report to the Congress, January 2009, at 2, available at <http://www.gao.gov/new.items/d09271.pdf> (last visited June 1, 2009).

S. 3040, 110th Congress (2008) (“To amend the Toxic Substances Control Act to reduce the exposure of children, workers, and consumers to toxic chemical substances”). An earlier version was introduced in 2005. See Child, Worker, and Consumer-Safe Chemicals Act of 2005, S. 1391, 109th Congress (2005).

See, e.g., Senator Boxer Opening Statement, “Oversight on EPA Toxic Chemical Policies,” April 29, 2008, available at <http://epw.senate.gov/public/index.cfm?FuseAction=Majority.PressReleases&ContentRecord_id=9abd162f-802a-23ad-c49-b0f6d51c9c42&Region_id=&Issue_id=> (last visited May 20, 2009) (“The overall toxic chemicals law, the Toxic Substances Control Act, or ‘TSCA,’ was adopted in 1976 and was supposed to help assure that toxic chemicals would be restricted or banned if they were hazardous. But in essence, TSCA puts the burden on the government to prove a toxic chemical is a risk. That is unlike the European program, called REACH. REACH puts the burden on the chemical industry – where it should be – to show that their chemicals are safe.”).

Kid Safe Chemicals Act of 2008, S. 3040, 110th Congress (2008), available at <http://www.govtrack.us/congress/bill.xpd?bill=s110–3040> (last visited June 1, 2009). See also Congressional Research Service Summary of Kid Safe Chemicals Act, available at <http://www.govtrack.us/congress/bill.xpd?bill=s110–3040&tab=summary> (last visited June 1, 2009).

See, e.g., NRDC et al., “Transition to Green: Leading the Way to A Healthy Environment, A Green Economy and a Sustainable Future – Environmental Transition Recommendations For the Obama Administration,” November, 2008, at 14–12 to 14–14, available at <http://docs.nrdc.org/legislation/files/leg_08112401a.pdf> (last visited June 1, 2009) (recommending passage in the first 100 days). The Transition to Green report was prepared by a coalition of 29 prominent environmental organizations.

See generally Dennison R. , “Ten Essential Elements of TSCA Reform,” Environmental Law Reporter 39, no. 1 (2009): 10020–10028.

See generally Harremoes P. , The Precautionary Principle in the 20th Century: Late Lessons from Early Warnings (London: Earthscan Publications, 2002).

See, e.g., Bowman D. Val Calster G. , “Reflecting on REACH: Global Implications of the European Union's Chemicals Regulation,” Nanotechnology Law & Business 4, no. 3 (2007): 375–384, at 381.

See, e.g., NNI, supra note 42; EC, SCENIHR, “Risk Assessment of Products of Nanotechnologies” (adopted January 19, 2008), at 13, available at <http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_023.pdf> (last visited June 1, 2009) (“It must be noted that nanotechnology as introduced nanoparticulate forms of chemicals, of which properties, behavior and effects are largely unknown, and hence, of concern.”).

EPA, “U.S. Environmental Protection Agency Nanotechnology White Paper,” February 2007, at 54, available at <http://es.epa.gov/ncer/nano/publications/whitepaper12022005.pdf> (last visited June 1, 2009).

See, e.g., Maynard , supra note 41; Oberdorster G. , “Nanotoxicology: An Emerging Discipline Evolving from Studies of Ultrafine Particles,” Environmental Health Perspectives 113, no. 7 (2005): 823–839.

See, e.g., Maynard , supra note 40; Oberdorster , supra note 40.

Science and Environmental Health Network, “Wingspread Consensus Statement on the Precautionary Principle,” January 26, 1998, available at <http://www.sehn.org/wing.html> (last visited June 1, 2009) (“When an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”)

United Nations Economic, Scientific, and Cultural Organization (UNESCO), World Commission on the Ethics of Scientific Knowledge and Technology (COMEST), “The Precautionary Principle,” March 2005, available at <http://unesdoc.unesco.org/images/0013/001395/139578e.pdf> (last visited June 1, 2009).

Id., at 14, Box 2.

Id., at 50.

EC, “Communication from the Commission on the Precautionary Principle,” February 2000, at 2, available at <http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2000:0001:FIN:EN:PdF> (last visited June 1, 2009).

See, e.g., Lin , supra note 38, at 383–384 (“Application of the precautionary principle to nanotechnology is appropriate because there exist scientifically tenable grounds for believing that the release of nanomaterials may result in serious harm to human health and the environment.”).

Project on Emerging Nanotechnologies, “New Nanotech Products Hitting the Market at the Rate of 3–4 Week,” April 24, 2008, available at <http://www.nanotechproject.org/news/archive/6697> (last visited May 20, 2009).

The Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, “Nanotechnology Consumer Products Inventory,” available at <http://www.nanotechproject.org/consumerproducts> (last visited May 20, 2009).

Research Lux , “Overhyped Technology Starts to Reach Potential: Nanotech to Impact 3.1 Trillion in Manufactured Goods in 2015,” July 22, 2008, available at <http://www.luxresearchinc.com/press/RELEASE_Nano-SMR_7_22_08.pdf> (last visited June 1, 2009).

Weiss R. , “For Now, Nanotechnology Means Little More Than Better Golf Ball,” Washington Post, March 10, 2006, at A3 (“They promised robots the size of blood cells, able to crawl through the body in search of disease. Featherweight aircraft parts stronger than steel. Solar-charged batteries better and cheaper than oil. Those and other revolutionary products may yet emerge from nanotechnology, the nascent but quickly maturing field of molecular-scale engineering in which scientists are harnessing the power of the very small. But for now, it turns out, people will have to settle for odoreating shoe inserts, livelier golf balls, agedefying nano-nutritional supplements and – for those with a hankering for a really small treat – nanotech chocolate chewing gum. Such are the products emerging at the intersection of exotic science and prosaic consumerism, as outlined in the first comprehensive inventory of nanoproducts, out today.”).

See NNI, “About the NNI,” available at <http://www.nano.gov/html/about/home_about.html> (last visited June 1, 2009).

NNI, National Science and Technology Council, “Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials,” September 2006, available at <http://www.nano.gov/NNI_EHS_research_needs.pdf> (last visited June 1, 2009); NNI, National Science and Technology Council, “Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment,” August 2007, available at <http://www.nano.gov/Prioritization_EHS_Research_Needs_Engineered_Nanoscale_Materials.pdf> (last visited June 1, 2009); NNI, National Science and Technology Council, “Strategy for Nanotechnology-Related Environmental, Health, and Safety Research,” February 2008, available at <http://www.nano.gov/NNI_EHS_Research_Strategy.pdf> (last visited June 1, 2009).

See, e.g., Service R. , “Report Faults U.S. Strategy for Nanotoxicology Research,” Science 322, no. 5909 (2008): 1779; Dean C. , “Panel Criticizes U.S. Effort on Nanomaterial Risks,” New York Times , December 11, 2009, at A41; Steenhuysen J. , “Nanotechnology Plans Seen Falling Short,” Reuters , December 10, 2008; Morello L. , “NANOTECH: Federal Safety Research Lacks Direction - Science Committee,” Environment & Energy Daily , September 22, 2006, available at <http://www.eenews.net/EEDaily/2006/09/22/archive/7?terms=morello> (last visited June 1, 2009); Weiss R. , “Nanotechnology Risks Unknown Insufficient Attention Paid to Potential Dangers, Report Says,” Washington Post, September 26, 2006, at A12 (“Committee Chairman Sherwood L. Boehlert (R-NY) accused the administration of ‘sauntering’ toward solutions ‘at a time when a sense of urgency is required.’ Ranking Democrat Bart Gordon (Tennessee) went further, calling the administration's latest summary of nanotech research needs, released at the hearing, ‘a very juvenile piece of work.’”).

National Research Council (NRC), Review of Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (Washington, D.C.: National Academies Press, 2008).

Id., at Executive Summary.

See generally Sargent J. , “CRS Report to Congress, The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues,” February 29, 2008, available at <http://ftp.fas.org/sgp/crs/misc/RL34401.pdf> (last visited June 1, 2009).

See generally Feder B. , “Teeny-Weeny Rules for Itty-Bitty Atom Clusters,” New York Times, January 16, 2007, at 45, available at <http://www.nytimes.com/2007/01/14/weekinreview/14feder.html> (last visited June 4, 2009) (“Federal and state regulators…have so far been happy to sponsor meetings and studies that call for regulation but notably reluctant to engage in any. A very small fraction of the billions of dollars being invested in nanotechnology research is being used to ferret out potential risks.”).

See EPA, supra note 107.

FDA, “Food and Drug Administration-Regulated Products Containing Nanotechnology Materials; Public Meeting,” 71 Fed. Reg. 46232–46233 (August 11, 2006).

FDA, “Nanotechnology, A Report of the U.S. Food and Drug Administration Nanotechnology Task Force,” July 25, 2007, available at <http://www.fda.gov/nanotechnology/> (last visited June 1, 2009).

See, e.g., FDA Task Force Report, supra note 131, at 14, 17–18.

Id., at 4, 11, 12, 13 (“There may be a fundamental difference in the kind of uncertainty associated with nanoscale materials compared to conventional chemicals, both with respect to knowledge about them and the way testing is performed.”); id., at 15 (“Also as discussed above, there may be general differences in properties relevant to evaluation of safety and effectiveness (as applicable) of products using nanoscale materials compared to products using other materials.”); id., at 17 (“[B]ecause many of these tests were developed for molecular forms of materials, and nanoscale materials may behave differently, the ability of these tests to support decisions about biological effects or further testing requirements need to be evaluated.”); id., at 18 (“Currently, ability to detect nanoscale materials in the body or in products regulated by FDA is limited and…may require substantial effort.”); id., at 18 (“[M]aterials in the nanoscale range may present particular challenges, for example relating to tests that assess product stability or development of potentially hazardous byproducts.”); id., at 18 (“Standard approaches for handling materials for testing will also need to be evaluated and may need to be modified.”); id., at 20 (“As discussed in the State of the Science section, the Task Force believes that nanoscale materials will present regulatory challenges that are similar to those posed by other new technologies that FDA has dealt with in the past, such as biotechnology products, but also some potentially new challenges.”); id., at 30 ('As discussed in the State of the Science section, although the science of nanotechnology is continuing to evolve, it is known that the size of a particle can affect its properties such that versions of the same substance with differing particle sizes can have different properties…. To appropriately assess the safety…it will be important in some cases for FDA or the manufacturer to take into account whether the product contains nanoscale materials.”); id., at 32 (Because nanoscale materials can behave differently than other versions of the same materials, it will be important for FDA to obtain relevant information about the characteristics of products containing nanoscale materials.”); id., at 32 (“[T]he presence of nanoscale materials may change the regulatory status/regulatory pathway of products.”)

FDA, “Consideration of FDA-Regulated Products That May Contain Nanoscale Materials; Public Meeting,” 73 Federal Register 46022–46024 (August 7, 2008).