Transnational Models for Regulation of Nanotechnology

Roco M. C. and Bainbridge W. S. , Societal Implications of Nanoscience and Nanotechnology (Boston: Kluwer Press, 2001): 3–4. Lux Research has also predicted that nanotechnology values may rise to $2.6 trillion by 2014. Lux Research, Report, Sizing Nanotechnology's Value Chain, as cited in Nanotechnology: Enabling Technologies for Australian Innovative Industries (March 11, 2005): 10, available at <http://www.dest.gov.au/NR/rdonlyres/1E1B501A-727A-4153-85EF-134B2DAF0925/4112/nanotechnology_pmseic110305.pdf> (last visited August 7, 2006).

Salamanca-Buentello F. , “Nanotechnology and the Developing World,” Policy Forum 2 (2005): 300–303.

Baum R. , “Nanotechnology: Drexler and Smalley Make the Case For and Against ‘Molecular Assemblers’,” Chemical & Engineering News (December 1, 2003): at 37–42.

In the United States, the Food and Drug Administration regulates nanoparticles used in medicines and medical instruments. “FDA Regulation of Nanotechnology Products,” at <http://www.fda.gov/nanotechnology/regulation.html> (last visited August 7, 2006). The Environmental Protection Agency may have authority to regulate nanoparticles under the Toxic Substances Control Act. 15 U.S.C. §§ 2601 et seq. (1976), available at <http://www.access.gpo.gov/uscode/title15/chapter53_html> (last visited August 7, 2006). Finally, the Occupational Safety and Health Administration regulates the use of materials in the workplace through, in part, requirements for Material Safety Data Sheets for use of new materials in the workplace. 29 C.F.R. § 1910.1200 (2005).

There have been some attempts. See Reynolds G. H. , “Nanotechnology and Regulatory Policy: Three Futures,” Harvard Journal of Law and Technology 17 (2003): 179–209; Fiedler F. A. and Reynolds G. H. , “Legal Problems of Nanotechnology: An Overview,” Southern California Interdisciplinary Law Journal 3 (1994): 593–629.

Joy B. , “Why the Future Doesn't Need Us,” Wired (April 2000); Roco M. C. and Bainbridge W. S. , NSET Workshop Report: “Societal Implications of Nanoscience and Nanotechnology,” available at <http://www.wtec.org/loyola/nano/NSET.Societal.Implications/nanosi.pdf> (last visited August 7, 2006).

See Bailey R. , “Rebels Against the Future,” Reason Online, available at <http://reason.com/rb/rb022801.shtml> (last visited August 7, 2006).

Bennett I. and Sarewitz D. , “Too Little, Too Late? Research Policies on the Societal Implications of Nanotechnology in the United States,” available at <http://cspo.org/ourlibrary/documents/SciasCultSubmit.pdf> (last visited August 7, 2006); Center for Responsible Nanotechnology, Results of Our Ongoing Research, at <http://crnano.org/overview/htm> (last visited August 8, 2006).

One of the most vocal of these groups, the Canadian-based environment advocacy group ETC (Action Group on Erosion, Technology, and Concentration), has issued numerous statements and papers calling for a moratorium on nanotechnology research. See ETC, “Size Matters! The Case for a Global Moratorium,” at <http://www.etcgroup.org/article.asp?newsid=392> (last visited August 8, 2006). ETC has, on occasion, been able to convince politicians to support a total ban on some forms of nanotechnology research. Brumfiel G. , “Nanotechnology: A little knowledge…” Nature 424 (July 17, 2003): 246–8.

The National Nanotechnology Initiative's website is located at <www.nano.gov/> (last visited August 8, 2006).

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Bayh-Dole 35 U.S.C.A. §§ 200 to 211 (1980).

E.g., National Research Council, Genetically Modified Pest-Protected Plants: Science and Regulation (Washington, D.C.: National Academy Press, 2000): at 178.

Through various rules, the BIS has required such items as encryption software, to be registered as munitions and approved prior to export. Rules governing exports and reexports of encryption items are found in the Export Administration Regulations (EAR), 15 C.F.R. Parts 730–774. Sections 740.13, 740.17 and 742.15 of the EAR are the principal references for the export and reexport of encryption items. Bureau of Industry and Security, Encryption Export and Reexport Controls Revisions, Federal Register 69 (2004): 71356–71364.

The FDA maintains a website specifically covering its regulation and approval of medical devices and drugs that contain nanoparticles. FDA, “Nanotechnology” at <http://www.fad.gov/nanotechnology/> (last visited August 8, 2006). The FDA has a more comprehensive site for discussing its drug approval process at <http://www.fda.gov/cder/regulatory/applications/default.htm> (last visited August 8, 2006).

Moratoria, though, present additional risks in themselves: Although they may prevent the foreseeable development of dangerous or unethical technologies, they may also prevent the unforeseeable development of extremely useful and beneficial innovations.

The National Institutes of Health has a website discussing the allowable uses of federal funding for stem-cell research. NIH, “NIH's Role in Federal Policy” at <http://stemcells.nih.gov/policy/NIHFedPolicy.asp> (last visited August 8, 2006).

The National Conference of State Legislatures (NCSL) maintains a website detailing the various state laws and regulations prohibiting or controlling research into human cloning. NCSL, “State Human Cloning Laws,” at <http://www.ncsl.org/programs/health/genetics/rt-shcl.htm> (last visited August 8, 2006).

The UN Biosafety Protocol allows European Countries to ban importation of food containing genetically modified organisms. UN Biosafety Protocol, at <http://www.biodiv.org/biosafety/default.aspx> (last visited August 8, 2006).

The United States has also severely restricted private-sector research and development into atomic energy. Atomic Energy Act, 42 U.S.C. §§ 2011–2281 (2005).

For a general description of concerns surrounding the health, social and economic impacts of nanotechnology see: Luther W. , “Industrial Application of Nanomaterials: Chances and Risks—Technological Analyses,” (2004) available at <http://www.nano.uts.edu.au/nanohouse/nanomaterials%20risks.pdf> (last visited August 8, 2006); Mark D. , Report of Presentations from First International Symposium on Occupational Health Implications of Nanomaterials, Nanomaterials a Risk to Health at Work? (2004) available at <http://www.hsl.gov.uk/capabilities/nanosymrep_final.pdf> (last visited August 8, 2006); Heath and Consumer Protection Directorate General of the European Commission, “Nanotechnologies: A Preliminary Risk Analysis,” (2004) available at <http://europa.eu.int/comm/health/ph_risk/documents/ev_20040301_en.pdf> (last visited August 8, 2006); SwissRE, “Nanotechnology: Small Matter, Many Unknowns,” available for download at <http://www.swissre.com/INTERNET/pwsw-pspr.nsf/fmBookMarkFrameSet?ReadForm&BM=./vwAllby-IDKeyLu/ulur-5yaffs?OpenDocument> (last visited August 8, 2006).

Proffitt K. , “Yellow Light for Nanotech,” Science 305, no. 5685 (2004): 762–5 (quoting Julia Moore).

Several groups have called for moratoria on areas of nanotechnology research and distribution of products containing nanoparticles. The group GeneEthics Network has called for a ban of nanoparticles in sunscreens. Dearne K. , “Call for Ban on Nano-particles,” The Australian (October 4, 2005) available at <http://www.moleculartorch.com/2005/10/call-for-ban-on-nano-particles-article.html> (last visited August 16, 2006). ETC, as noted earlier, has made numerous calls for moratoria on the commercial production of nanoparticles. ETC, “No Small Matter,” Communique 76, available at <http://www.etcgroup.org/documents/Comm_NanoMat_July02.pdf> (last visited August 8, 2006).

The precautionary principle, widely adopted in European countries, requires that any technology with the capability of causing irreversible damage or negative consequences should be “proven safe” before development of the technology can proceed. See discussion in infra section IV(5).

See Proffitt, supra note 22, at 764.

According to one commentator, “the smart approach is to leave nanotech development alone and instead allow individual regulatory agencies to weigh in on specific products and applications before they are introduced to the market.” Wolfe J. , “Nanotech vs. The Green Gang,” Forbes.com (April 6, 2005) available at <http://www.forbes.com/finance/2005/04/06/cz_jw_0406soapbox_inl.html?partner=rss> (last visited August 8, 2006).

At least one commentator believes that “Americans begin with a basically positive view of nanotechnology…despite its weak factual basis.” Cobb M. D. , “Framing Effect on Public Opinion about Nanotechnology,” available at <http://www2.chass.ncsu.edu/cobb/me/past%20articles%20and%20working%20papers/nano%20framing%20for%20science%20communication.pdf> (last visited August 16, 2006).

See Cobb , supra note 27.

Bennett I. and Sarewitz D. , “Too Little, Too Late? Research Policies on the Societal Implications of Nanotechnology in the United States,” available at <http://cspo.org/ourlibrabry/documents/SciasCultSubmit.pdf> (last visited August 8, 2006). According to Bennett and Sarewitz, a failure to discuss the range of possible regulation for nanotechnology will result in the repeat of the “brittle, reactive, regulatory governance modes that have characterized responses to technologies from nuclear power to genetically modified foods.” Id.

The chief example is the Kyoto Protocol on Climate Change. Available at <http://www.unfccc.int/resource/docs/convkp/kpeng.html> (last visited August 8, 2006).

Stockholm Convention on Persistent Organic Pollutants, May 22, 2001, art. 3(2)(b)(i), U.N. Doc. UNEP/POPS/CONF/4, 40 I.L.M. 532, 535 (entered into force May 17, 2004).

Montreal Protocol on Substances that Deplete the Ozone Layer, Sept. 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st Sess. (1987), 1522 U.N.T.S. 29 (entered into force January 1, 1989).

Porta M. and Zumeta E. , “Implementing the Stockholm Treaty on Persistent Organic Pollutants,” Occupational & Environmental Medicine 59 (2002): 651–653, at 651.

Hagen P. E. and Walls M. P. , “The Stockholm Convention on persistent Organic Pollutants,” Natural Resources & Environment (Spring 2005): at 49–52.

Miura L. , “Mercury: Dems Attack U.S. Policy on International Treaty,” Greenwire 10 (March 3, 2003).

Protocol to the Convention on Long-Range Transboundary Air Pollution on Persistent Organic Pollutants (Aarhus, 1998), 37 ILM (1998) 505. The only controversial substance on the list is DDT, which has important benefits in fighting malaria, and thus was not prohibited outright like the other eleven substances.

Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal, annex 1, Mar. 22, 1989, 28 I.L.M. 649, 678.

Treaty on the NonProliferation of Nuclear Weapons, opened for signature July 1, 1968, 21 U.S.T. 483, 484, 729 U.N.T.S. 161,169.

Convention on the Prohibition of the Development, Production, and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, opened for signature April 10, 1972, 26 U.S.T. 583, 1015 U.N.T.S. 163.

Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, January 13, 1993, 1974 U.N.T.S. 45, 32 I.L.M. 800.

Barletta M. , “Cross-Cutting Challenges to the Nonproliferation Regimes,” in Barletta M. and Sands A. , eds., NonProliferation Regimes at Risk, Center for NonProliferation Studies, Monterey Institute of International Affairs, Occasional Paper No. 3 (1999): 39–45.

Altmann J. and Gubrud M. , “Anticipating Military Nanotechnology,” IEEE Technology and Society Magazine (Winter 2004): at 33–40; Altmann J. , “Military Uses of Nanotechnology: Perspectives and Concerns,” Security Dialogue 35 (2004): 61–79.

Pinson R. D. , “Is Nanotechnology Prohibited by the Biological and Chemical Weapons Convention?” Berkeley Journal of International Law 22 (2004): 279–309, at 281.

Quoted in Johnson J. , “An End to Nuclear Nonproliferation?” Chemical & Engineering News (July 26, 2004): at 34, 38.

Tucker J. B. , “The BWC New Process: A Preliminary Assessment,” The Nonproliferation Review (Spring 2004): 1–13, at 2–3.

National Research Council, Biotechnology Research in an Age Of Terrorism: Confronting the Dual Use Dilemma (Washington, D.C.: National Academies Press, 2003).

See Tucker , supra note 45, at 3.

Roberts B. , “Biological Weapons: New Challenges, New Strategies?” in Barletta M. and Sands A. , eds., NonProliferation Regimes at Risk, Center for NonProliferation Studies, Monterey Institute of International Affairs, Occasional Paper No. 3 (1999): at 16–18.

Baer S. , “U.N. Mulls Ban on Human Cloning, Including for Research, but Proposals Differ on Cloning of Embryos to Create Stem Cells,” Baltimore Sun, November 19, 2004, at 13A.

United Nations, Report of the Ad Hoc Committee on an International Convention Against the Reproductive Cloning of Human Beings (General Assembly, 57th Sess., Supp. No. 51 (A/57/51): 2002): at 3.

Arieff I. , “UN Backs U.S. Plea for Total Ban on Human Cloning,” Reuters, March 8, 2005.

U.N. Framework Convention on Climate Change, May 9, 1992, in 31 I.L.M. 849 (1992).

WHO Framework Convention on Tobacco Control, WHA Res. 56.1, World Health Assembly, 56th Ass., 4th plen. mtg, Agenda Item 13, Annex, WHO Doc. A56.VR/4 (May 21, 2003), at <http://www.who.int/tobacco/fctc/text/en/fctc_en.pdf> (last visited August 8, 2006).

Conference of the Parties to the Framework Convention on Climate Change: Kyoto Protocol, December 10, 1997, U.N. Doc. No. FCCC/CP/1997/L.7/Add.1, in 37 I.L.M. 32 (1998).

SwissRE, Nanotechnology: Small Matter, Many Unknowns (Zurich: Swiss Reinsurance Company, 2004): at 47.

See supra note 24.

Cameron James , “The Precautionary Principle in International Law,” in Reinterpreting the Precautionary Principle, O'Riordan T. Cameron J. , and Jordan A. , eds. (Cameron May: London, 2000) 113–124, at 122.

Sandin P. , “Dimensions of the Precautionary Principle,” Human & Ecological Risk Assessment 5 (1999): 889–907.

Marchant G. E. and Mossman K. L. , Arbitrary & Capricious: The Precautionary Principle in the European Union Courts (Washington: AEI Press, 2004): at 16.

Holm S. and Harris J. , Letter, “Precautionary Principle Stifles Discovery,” Nature 400 (1999): 398.

Moodie M. , “Confronting the Biological and Chemical Weapons Challenge: The Need for an Intellectual Infrastructure,” Fletcher Forum of World Affairs 28 (2004): 43–55, at 49.

See Reynolds G. H. , “Nanotechnology and Regulatory Policy: Three Futures,” Harvard Journal of Law & Technology 17 (2003): 179–209.

Meridian Institute, Report on the International Dialogue on Responsible Research and Development of Nanotechnology (June 2004).

See Bioweapons Prevention Project, at <http://www.bwpp.org> (last visited August 8, 2006).

Foresight Nanotech Institute, “Foresight Guidelines for Responsible Nanotechnology Development” at <http://foresight.org/guidelines/current.html> (last visited August 8, 2006).

Schrope M. , “Consensus Science, or Consensus Politics?” Nature 412 (2001): 112–114.

The ASTM International has established a committee to develop international consensus standards for nanotechnology. ASTM website, at <http://www.astm.org> (last visited August 8, 2006).

The Australia Group website, at <http://www.australiagroup.net/> (last visited August 8, 2006).

Confidence building measures are interim steps not requiring formal bilateral or multilateral agreement that can help alleviate tensions and build trust. See Marchant G. E. , “Confidence-Building Measures for Genetically Modified Foods,” Jurimetrics 44 (2003): 1–4.