Hostname: page-component-848d4c4894-ttngx Total loading time: 0 Render date: 2024-06-02T17:25:38.130Z Has data issue: false hasContentIssue false
  • English
  • Français

Nanotechnology: The Challenge of Regulating Known Unknowns

Published online by Cambridge University Press:  01 January 2021

Robin Fretwell Wilson
Get access Rights & Permissions [Opens in a new window]

Extract

Nanotechnology is a subject about which we know less than we should, but probably more than we think we do at first glance. Like Defense Secretary Donald Rumsfeld's “known unknowns,” we have learned enough to know what we should be concerned with. Glimmers of risk cropped up recently when German authorities recalled a bathroom cleansing product, “MagicNano,” that purported to contain nanosized particles (NSPs) and was on the market for only three days. More than one hundred people suffered severe respiratory problems – six of whom were hospitalized with pulmonary edema. Although a subsequent analysis of MagicNano found that the nanoliquid ingredient morphed in the production into “supersized” (not nanosized) particles, the recall nonetheless turned a white hot spotlight on the risk of NSPs. Latching onto the risks posed to workers producing materials using nanotechnology, the Washington Post has labeled nanotechnology a “seat-of-thepants occupational health experiment.”

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 34 , Issue 4 , Winter 2006 , pp. 704 - 713
Copyright
Copyright © American Society of Law, Medicine and Ethics 2006

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Rumsfeld, Donald, Secretary of Defense, Defense Department Briefing (October 17, 2002). Available at <http://www.globalsecurity.org/military/library/news/2002/10/mil-021017-usia01.htm> (last visited September 24, 2006).+(last+visited+September+24,+2006).>Google Scholar
Weiss, R, “Nanotech Product Recalled in Germany,” Washington Post, April 6, 2006, at A2; “Has all the Magic Gone?” The Economist, April 15, 2006, available at <http://www.economist.com/science/displayStory.cfm?story_id=6795430> (last visited September 24, 2006).+(last+visited+September+24,+2006).>Google Scholar
von Bubnoff, A., “Study Shows no Nano in Magic Nano, the German Product Recalled for Causing Breathing Problems,” May 26, 2006. Small Times website, at <http://www.smalltimes.com/document_display.cfm?document_id=11586> (last visited September 13, 2006).+(last+visited+September+13,+2006).>Google Scholar
Weiss, R., “Nanotech Raises Worker-Safety Questions,” Washington Post, April 8, 2006, at A1.Google Scholar
The Royal Society & The Royal Academy of Engineering, Report, Nanoscience and Nanotechnologies: Opportunities and Uncertainties – Summary and Recommendations (2004), available at <http://www.nanotec.org.uk/finalreport.htm> (last visited September 13, 2006).+(last+visited+September+13,+2006).>Google Scholar
Roco, M.C. and Bainbridge, W. S., eds., National Science Foundation, Report, Converging Technologies for Improving Human Performance: Nanotechnology, Biotechnology, Information Technology and Cognitive Science(2002), available at <http://www.wtec.org/ConvergingTechnologies/Report/NBIC_report.pdf.> (last visited September 24, 2006).+(last+visited+September+24,+2006).>Google Scholar
Wired Magazine online, “Why the Future Doesn't Need Us,” at <http://www.wired.com/archive/8.04/joy.html> (last visited September 25, 2006). (last visited September 25, 2006).' href=https://scholar.google.com/scholar?q=Wired+Magazine+online,+“Why+the+Future+Doesn't+Need+Us,”+at++(last+visited+September+25,+2006).>Google Scholar
Baum, R., “Nanotechnology: Drexler and Smalley Make the Case for and against ‘Molecular Assemblers’,” Chemical & Engineering News, December 1, 2003, at 37. Available at <http://pubs.acs.org/cen/coverstory/8148/8148counterpoint.html> (last visited September 13, 2006).+(last+visited+September+13,+2006).>Google Scholar
Roco, M. C. and Bainbridge, W. S., eds., Societal Implications of Nanoscience and Nanotechnology (Boston: Kluwer Academic Publishers, 2001): at 4.Google Scholar
Forbes/Wolfe Nanotech Report website, “What is Nanotechnology?” at <http://www.forbesinc.com/newsletters/nanotech/nanotech.jsp?page=what_is> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Supra note 9, at 3.Google Scholar
See Lux Research, Press Release, Nanotechnology in $32 Billion Worth of Products; Global Funding for Nanotech R&D Reaches $9.6 Billion (May 8, 2006). Available at <http://www.luxresearchinc.com/press/RELEASE_TNR4.pdf> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
See Maruman Internet Gateway, “‘Fullerene,’ a Product of Nanotechnology, Brings out New Outstanding Carry,” at <http://www.maruman.co.jp/english/products/golf.html> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
See “Golf Driver Made of Titanium Fullerenes,” at <http://www.nanovip.com/products/Detailed/7.php> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Id.Google Scholar
Maruman & Co. Ltd. homepage, at <http://www.maruman.co.jp/> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Medicine at Michigan website, “Super Small Science Holds Huge Potential,” Fall 2005, at <http://www.medicineatmichigan.org/magazine/2005/fall/huron/huron-01.asp> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Robichaud, C. O. et al., “Relative Risk Analysis of Several Manufactured Nanomaterials: An Insurance Industry Context,” Environmental Science & Technology 39 (2005): 8985–8993, at 8985.Google Scholar
Id.Google Scholar
Forbes online, “Top Nano Products of 2005,” available at <http://www.forbes.com/home/investmentnewsletters/2006/01/09/in_jw_0109soapboxslide_3.html?thisSpeed=6000> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Nanotechwire.com website, “Nanotechnologies for Textiles – Already an $11 Billion Market – Cientifica Report,” at <http://www.nanotechwire.com/news.asp?nid=3226&ntid=&pg=14> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Eddie Bauer Online Catalogue, at <http://www.eddiebauer.com/> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Head online, at <http://www.head.com/tennis/racquets.php?region=us> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
SAE International, Automotive Engineering online, “Material Innovations, Nanocomposite Debuts on GM Vehicles,” at <http://www.sae.org/automag/material/10-2001/index.htm> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Jo Twist, “Eco Glass Cleans itself with Sun,” BBC News online, June 8, 2004, at <http://news.bbc.co.uk/2/hi/technology/3770353.stm> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Zelens homepage, “Fullerene C60 – Nobel Prize Winning Ingredient,” at <http://www.zelens.com/> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Id.Google Scholar
Olay Products, at <http://www.olay.com/indexhb.jsp> (last visited September 25, 2006); Nanophase, Investor Relations, “Second Quarter 2003 Conference Call,” at <http://www.nanophase.com/investor_relations/conference/Q2-2003.asp> (last visited September 14, 2006).+(last+visited+September+25,+2006);+Nanophase,+Investor+Relations,+“Second+Quarter+2003+Conference+Call,”+at++(last+visited+September+14,+2006).>Google Scholar
Nanophase, supra note 28; Coppertone online, “General Protection Products,” at <http://www.coppertone.com/detail_gp_50spectra.aspx> (last visited September 25, 2006).+(last+visited+September+25,+2006).>Google Scholar
Skin 1 ColoreScience Crystalescience Lip Serum, at <http://www.skin-one.com/lipserum.html> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Id.Google Scholar
Angstrom Medica—Technology—Synthetic Bone, at <http://www.angstrommedica.com/technology/syntheticbones/default.htm> (last visited September 25, 2006).+(last+visited+September+25,+2006).>Google Scholar
Angstrom Medica—Technology, at <http://www.angstrommedica.com/technology/default.htm> (last visited September 25, 2006).+(last+visited+September+25,+2006).>Google Scholar
Smith & Nephew website, “Acticoat* 7 Technology,” at <http://wound.smith-nephew.com/nz/node.asp?NodeId=2986> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
See 3M ESPE United States, Press Release, 3M ESPE's Best Just got Better (June 10, 2005) at <http://cms.3m.com/cms/US/en/2-21/FFruiFU/view.jhtml> (last visited September 14, 2006). (last visited September 14, 2006).' href=https://scholar.google.com/scholar?q=See+3M+ESPE+United+States,+Press+Release,+3M+ESPE's+Best+Just+got+Better+(June+10,+2005)+at++(last+visited+September+14,+2006).>Google Scholar
Kloeppel, J. E., “Selective Coatings Create Biological Sensors from Carbon Nanotubes,” University of Illinois at Urbana-Champlain website, available at <http://www.news.uiuc.edu/NEWS/04/1213strano.html> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Supra note 17, at 19.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Nel, A. et al., “Toxic Potential of Materials at the Nanolevel,” Science 311, no. 5761 (2006): 622–627, at 622.CrossRefGoogle Scholar
Hett, A., Nanotechnology: Prospects and Pitfalls (SwissRE, May 10, 2004) available at <http://www.swissre.com/internet/pwsfilpr.nsf/vwFilebyIDKEYLu/YHAN-5YUD48/$File/Nano_London_final.pdf> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Rejeski, D, “The Next Small Thing,” The Environmental Forum, March-April 2004, at 42, 45.Google Scholar
Davies, J. C., Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Report, Managing the Effects of Nanotechnology (2006).Google Scholar
Id., at 14.Google Scholar
Id., at 10.Google Scholar
Id., at 11.Google Scholar
Id., at 10.Google Scholar
Id., at 10.Google Scholar
Renn, O. and Roco, M., “Nanotechnology and the Need for Risk Governance,” Journal of Nanoparticle Research 8, no. 2 (2006): at 1, Table 3.Google Scholar
Supra note 45, at 13.Google Scholar
Supra note 45, at 13.Google Scholar
Supra note 45.Google Scholar
Citizen Petition to the United States Food and Drug Administration, available at <http://www.icta.org/doc/Nano%20FDA%20petition%20final.pdf> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Id.Google Scholar
Supra note 55.Google Scholar
Sadrieh, N., Power Point Presentation, “FDA Considerations for Regulation of Nanomaterial Containing Products,” at <http://www.fda.gov/nanotechnology/NIST_meeting_Houston_01-06.ppt#38> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Id.Google Scholar
Supra note 58.Google Scholar
Supra note 42.Google Scholar
Oberdörster, Gunter et al., “Nanotoxicology: An Emerging Discipline Evolving from Studies of Ultrafine Particles,” Environmental Health Perspectives 113 (2005): 823–839, at 823.CrossRefGoogle Scholar
Warheit, D. B. et al., “Comparative Pulmonary Toxicity Assessment of Single-Wall Carbon Nanotubes in Rats,” Toxicological Science 77 (2004): 117–125, at 117; Lam, C. W. et al., “Pulmonary Toxicity of Single-Wall Carbon Nanotubes in Mice 7 and 90 Days after Intratracheal Instillation,” Toxicological Science 77 (2004): 126–134, at 126; Shvedova, A. A. et al., “Exposure to Carbon Nanotube Material: Assessment of Nanotube Cytotoxicity Using Human Keratinocyte Cells,” Journal of Toxicology & Environmental Health 66 (2003): Part A, 1909–1926, at 1909.CrossRefGoogle Scholar
See Lam, et al., supra note 62.Google Scholar
Supra note 62, at 827.Google Scholar
Id., at 826.Google Scholar
See National Institute for Occupational Safety and Health website, “Nanotechnology at NIOSH” at <http://www.cdc.gov/niosh/topics/nanotech/> (last visited September 14, 2006).+(last+visited+September+14,+2006).>Google Scholar
Supra note 62, at 829.Google Scholar
Supra note 62.Google Scholar
Supra note 62.Google Scholar
Supra note 62.Google Scholar
Supra note 62, at 830–831.Google Scholar
Supra note 62, at 829.Google Scholar
Supra note 62, at 830.Google Scholar
See Kreyling, W. G. et al., “Translocation of Ultrafine Insoluble Iridium Particles from Lung Epithelium to Extrapulmonary Organs is Size Dependent but Very Low,” Journal of Toxicology and Environmental Health 65 (2002): 1513–1530; Oberdörster, G et al., “Volumetric Loading of Alveolar Macrophages (AM): A Possible Basis for Diminished AM-Mediated Particle Clearance,” Experimental Lung Research 18 (1992): 87–104; Semmler, M. et al., “Long-Term Clearance Kinetics of Inhaled Ultrafine Insoluble Iridium Particles from the Rat Lung, Including Transient Translocation into Secondary Organs,” Inhalation Toxicology 16 (2004): 453–459.CrossRefGoogle Scholar
Supra note 62, at 830.Google Scholar
Supra note 62.Google Scholar
Supra note 62.Google Scholar
Supra note 62.Google Scholar
Supra note 62, at 831.Google Scholar
Tinkle, S. S. et al., “Skin as a Route of Exposure and Sensitization in Chronic Beryllium Disease,” Environmental Health Perspectives 111, no. 9 (2003): 1202–1208.CrossRefGoogle Scholar
Supra note 62, at 834.Google Scholar
Supra note 62. See also Oberdörster, G et al., “Size Dependent Lymphatic Short Term Clearance of Amosite Fibers in the Lung,” Annals of Occupational Hygiene 32 (1988): 149–156.Google Scholar
Robichaud, supra note 18, at 8985.Google Scholar
Robichaud, supra note 18, at 8985.Google Scholar
Robichaud, supra note 18, at 8988.Google Scholar
Robichaud, supra note 18, at 8990.Google Scholar
Robichaud, supra note 18, at 8990.Google Scholar
Robichaud, supra note 18, at 8990.Google Scholar
Robichaud, supra note 18, at 8990.Google Scholar
Robichaud, supra note 18, at 8991.Google Scholar
Marchant, G. E. and Sylvester, D. J., “Transnational Models for Regulation of Nanotechnology,” Journal of Law, Medicine & Ethics 34, no. 4 (2006): 714–725.CrossRefGoogle Scholar
Id.Google Scholar
Id.Google Scholar
Holm, S. and Harris, J., Letter, “Precautionary Principle Stifles Discovery,” Nature 400 (July, 1999) at 398.CrossRefGoogle Scholar
Supra note 51, at Table 13.Google Scholar
MacDonald, J. W., “Commentary, Terrorism, Insurance, and TRIA: Are We Asking the Right Questions?” John Liner Review 18, no. 2 (2004): at 87, 89. Available at <http://www.autoturista.com.mx/docs/JLR_Summer_2004.pdf> (last visited September 15, 2006).Google Scholar
Hett, A. et al., “Nanotechnology: Small Matter, Many Unknowns,” (SwissRE, 2004), available at <http://www.swissre.com/INTERNET/pwsfilpr.nsf/vwFilebyIDKEYLu/ULUR-5YNGET/$File/Publ04_Nanotech_en.pdf> (last visited September 15, 2006).+(last+visited+September+15,+2006).>Google Scholar
Id. A second reinsurer, Allianz, believes that it is not appropriate at this time to consider a general exclusion of nanotechnology from insurance coverage because Nanotechnologies cover a very broad field with far from uniform characteristics. The terminology used in nanotechnologies is very broad. No uniform language or set of definitions exist; the sheer variety of nanotechnologies and their applications across broad sections of industrial segments mean a positive diversification effect for insurance portfolios; and the exposure of the general population to nanotechnologies is still comparatively low. Allianz website, “Small Sizes that Matter: Opportunities and Risks of Nanotechnologies” (2005): at 5, available at <http://www.allianz.com/azcom/dp/cda/0,796786-44,00.html> (last visited September 15, 2006). [hereinafter Opportunities and Risks].+(last+visited+September+15,+2006).+[hereinafter+Opportunities+and+Risks].>Google Scholar
“Opportunities and Risks,” supra note 99, at 5.Google Scholar
Hett, supra note 98.Google Scholar
Abraham, Kenneth S., Insurance Law & Regulation: Cases and Materials, 4th ed. (Foundation Press, 2005): at 153.Google Scholar
Terrorism Risk and Insurance Act of 2002, Pub. L. No. 107-297. 116 Stat. 2322.Google Scholar
Nanosphere website, “About Us,” at <http://www.nanosphereinc.com/about/> (last visited September 15, 2006).+(last+visited+September+15,+2006).>Google Scholar
Konarkatech website, at <http://www.konarkatech.com/> (last visited September 15, 2006).+(last+visited+September+15,+2006).>Google Scholar
See National Science Foundation website, “SBIR Phase 1: Amplified Electron Generation in Photovoltaic Cells by Means of Quantum Dot/Dye Combinations,” at <http://www.nsf.gov/awardsearch/showAward.do?AwardNumber=0539032> (last visited September 15, 2006); see also, National Science Foundation, “SBIR Phase I: Nanostructured Hybrid Organic-Inorganic Solar Cell,” at <http://www.nsf.gov/awardsearch/showAward.do?AwardNumber=0340213> (last visited September 15, 2006).+(last+visited+September+15,+2006);+see+also,+National+Science+Foundation,+“SBIR+Phase+I:+Nanostructured+Hybrid+Organic-Inorganic+Solar+Cell,”+at++(last+visited+September+15,+2006).>Google Scholar
National Science Foundation, Grant Policy Manual (2005): at 117, available at <http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gpm> (last visited September 15, 2006). NSF's Grant General Conditions guide also advises grantees to protect themselves as “NSF cannot assume any liability for accidents, illnesses or claims arising out of any work supported by an award or for unauthorized use of patented or copyrighted materials.” National Science Foundation, Grant General Conditions (GC-1) (2006): at 37, available at <http://www.nsf.gov/publications/pub_summ.jsp?ods_key=gc131506> (last visited September 15, 2006). (last visited September 15, 2006).' href=https://scholar.google.com/scholar?q=National+Science+Foundation,+Grant+Policy+Manual+(2005):+at+117,+available+at++(last+visited+September+15,+2006).+NSF's+Grant+General+Conditions+guide+also+advises+grantees+to+protect+themselves+as+“NSF+cannot+assume+any+liability+for+accidents,+illnesses+or+claims+arising+out+of+any+work+supported+by+an+award+or+for+unauthorized+use+of+patented+or+copyrighted+materials.”+National+Science+Foundation,+Grant+General+Conditions+(GC-1)+(2006):+at+37,+available+at++(last+visited+September+15,+2006).>Google Scholar
Andrew Maynard, Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies, Report, Nanotechnology: A Research Strategy for Addressing Risk (July 2006).Google Scholar
The FDA set up an internal nanotech task force in June, 2006. United Press International, “FDA Sets up Nanotech Task Force”, available at <http://www.upi.com/HealthBusiness/view.php?StoryID=20060809-123753-6291r> (last visited September 15, 2006).+(last+visited+September+15,+2006).>Google Scholar