Regulating nanoscience: A proposal and a response to J. Clarence Davies

Nanotechnology Law and Business

Volumn 3, Issue 4, 2006, Pages 485-506

  Berube, David M ^a  

^a UNIVERSITY OF SOUTH CAROLINA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ENVIRONMENTAL PROTECTION; INSURANCE; PILOT PLANTS; PROBLEM SOLVING; PRODUCT LIABILITY; RISK MANAGEMENT;

GOVERNMENT RESPONSES; INSURANCE REGIME; LEGISLATIVE EFFORTS; REGULATORY REGIMES;

NANOSCIENCE;

EID: 34748860055     PISSN: 15462080     EISSN: 15462080     Source Type: Journal    
DOI: None     Document Type: Article

References (118)

1. J. CLARENCE DAVIES, WOODROW WILSON CENTEB'S PROJECT ON EMERGING N ANOTECHNOLOGIES, MANAGING THE EFFECTS OF NANOTECHNOLOGY, (2006) [hereinafter "DAVIES, MANAGING THE EFFECTS"], available at http://www. nanotechproject.org/index.php?id=39 (last visited Nov. 1, 2006).
2. Cass R. Sunstein, Paradoxes of the Regulatory State, 57 UNIV. OF CHI. L. REV. 407 (1990).
3. Mark E. Miller & Reed D. Rubinstein, Insuring Nanotech's Future, R&D (Feb. 2006), http://www.rdmag.com/ShowPR.aspx?PUBCODE= 014&ACCT=1400000100&ISSUE=0512&RELTYPE=pr&Cat=0&SubCat= 0&ProdCode=00000000&PRODLETT=BA&SearchText=Greenberg%20Traurig, (last visited Nov. 1, 2006).
4. MUNICH RE GROUP, CHANCE: RISIKO-FOR A RISK-TAKING CULTURE, 2005, at 6.
5. Paul Davies, Regulatory Challenges with Emerging Technologies, in SWISS RE CTR. FOR GLOBAL DIALOGUE, NANOTECHNOLOGY: SMALL SIZE-LARGE IMPACT? RISK DIALOGUE SERIES 6-7, 57 (Dec. 2004), available at http://www.ruschlikon.net/INTERNET/rschwebp.nsf/(ID)/ 1283EEF86F4A1DA1C125702300426B21/SFILE/nanotechnology_report.pdf (last visited Nov. 1, 2006).
6. Clay Risen, Why We Need New Regulations of Nanotechnology, NEW REPUBLIC, Jan. 16, 2006, http://www.tnr.com/docprint. mhtml?i=w060116&s=risen011606, (last visited Nov. 1, 2006).
7. J. Clarence Davies, Developments in Nanotechnology, Hearing Before the S. Comm. on Commerce, Sei. & Tech., 109th Cong. 2 (Feb. 15, 2006)
8. (statement of J. Clarence Davies, Sr. Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson Int'l Ctr. for Scholars, and Sr. Fellow, Resources for the Future) [hereinafter "Davies, Testimony on Developments in Nanotechnology"], available at http://commerce.senate.gov/pdf/davies-021506.pdf, (last visited Nov. 1, 2006).
9. While the author may not have had access to all of the data, he has read all the sources cited therein. See Michael D. Cobb & Jane Macoubrie, Public Perceptions about Nanotechnology: Risks, Benefits and Trust (2004) (unpublished manuscript), available at http://www2.chass.ncsu.edu/cobb/me/ past%20articles%20and%20working%20papers/ Public%20Perceptions%20about%20Nanotechnology%20-%20Risks, %20Benefits%20and%20Trust.pdf, (last visited Nov. 1, 2006);
10. JANE MACOUBRIE, WOODROW WILSON INT'L CTR., INFORMED PUBLIC PERCEPTION OF NANOTECHNOLOGY AND TRUST IN GOVERNMENT (2005), available at http://www.wilsoncenter.org/news/docs/ macoubriereport.pdf (last visited Nov. 1, 2006).,
11. BMRB SOCIAL RESEARCH, NANOTECHNOLOGY: VIEWS OF THE GENERAL PUBLIC (Rep. No. BMRB/45/1001-666, Jan. 2004), available at http://www.nanotec.org.uk/ Market%20Research.pdf (last visited Nov. 1, 2006);
12. Andrew Laing, A Report on Canadian and American News Media Coverage of Nanotechnology Issues, in FIRST IMPRESSIONS: UNDERSTANDING PUBLIC VIEWS ON EMERGING TECHNOLOGIES (2005), available at https://bioportal.gc.ca/ CMFiles/CBS_Report_FINAL_ENGLISH249SFD-9222005-5696.pdf (last visited Nov. 1, 2006).
13. In addition, the author has attended one of the focus groups associated with the studies in question, and there is no evidence that the conclusion reaches by J. Clarence Davies regarding a "higher standard" is justified. Davies made this comment a the conclusion of his testimony, supra note 7.
14. Davies, Testimony on Developments in Nanotechnology, supra note 9.
15. Kevin Bullis, Can EPA Regulate Nano?, TECHN. REV. (Dec. 20, 2005), http://www.technologyreview.com/.nanoTech/wtr_16068,318.p2.html, (last visited Nov. 1, 2006).
16. Rick Weiss, Stricter Nanotechnology Laws Are Urged, WASH. POST, Jan. 11, 2006, at A2, also available at http://www.washingtonpost.com/wp- dyn/content/article/2006/01/10/AR2006011001520.html (last visited Nov. 1, 2006).
17. L. Morello, Field Should Avoid Biotech-Style Backlash, Media Analysts Say, GREENWIRE (Jan. 9, 2006), http://www.eenews.net/Greenwire/ include/print.php7single-01090619, (login required).
18. Davies, Testimony on Developments in Nanotechnology, supra note 7.
19. Ronald Sandler & W. D. Kay, The GNO-Nanotech (Dis)analogy?, 26 BULLETIN OF SCI., TECH. & SOC'TY 57 (Feb. 2006).
20. Paul Thompson of Michigan State University, in a presentation at a conference held on his campus in late 2005, summarized the differences nicely. Paul Thompson, Presentation at the Michigan State University, First International IFAS Conference on Nanotechnology, What Can Nano Learn from Bio? (Oct. 26-27, 2005). The author has also added to the list of differences on many separate occasions although his book favors the positive association. Some of the differences between nanotechnology and biotechnology include the following: (1) the role Monsanto played with its terminator seed technology; (2) the association of bioengineered foods with an aggressive, government-directed foreign assistance program; (3) the strong green movement in Europe lacks a parallel in the U.S.; (4) the record of failed boycotts against products in the U.S.; (5) the strong positive attitudes favoring scientists and technologists in the U.S. versus the attitudes abroad. There are, of course, many others.
21. See Morello, supra note 12.
22. Davies, Testimony on Developments in Nanotechnology, supra note 7.
23. The Shock of the New, THE ECONOMIST, Mar. 26, 2005, at 13.
24. Morello, supra note 12 (quoting the author from a phone interview)
25. Id.
26. Gretchen Chapman and Eric Johnson, "Incorporating the Irrelevant: Anchors in Judgments of Belief and Value, Heuristics and Biases: The Psychology of Intuitive Judgment, Cambridge University Press, 2002, pg. 121.
27. P. Phibbs, Nanotechnology Could Require Changes to Controls on Toxics, White House Says, 28 CHEM. REG. RPTR. 381 (Apr. 5, 2004) (last visited Feb. 28, 2005).
28. ENVT'L. PROTECTION AGENCY ("EPA"), NANOTECHNOLOGY WHITE PAPER (External Review Draft, Dec. 2, 2005), http://www.epa.gov/osa/pdfs/ EPA_nanotechnology_white_paper_external_review_draft_12-02-2005.pdf, (last visited Nov. 1, 2006).
29. Rick Weiss, Nanotechnology Regulation Needed, Critics Say, WASHINGTON POST, Dec. 5, 2005, at A8, available at http://www.washingtonpost.com/wp-dyn/content/article/2005/12/04/AR2005120400729. html, (last visited Nov. 1, 2006).
30. Ted Agres, Nanotech Ethics Debated, THE SCIENTIST 10031208-4 (Dec. 8, 2003), available at http://www.biomedcentral.com/news/20031208/04 (last visited Nov. 1, 2006).
31. J. Gruenwald, Marburger Says Nano Regulators Ensure Health, Safety, SMALL TIMES (June 18, 2004), http://www. smalltimes.com/print_doc.cfm?doc+id=8075 (last visited Nov. 1, 2006).
32. Id.
33. Simon Pitman, Report Highlights the Regulation of Nanotechnology, COSMETICS DESIGN.COM (Jan. 13, 2006), http://www. cosmeticsdesign.com/news/printNewsBis.asp?id-65096, (last visited Nov. 1, 2006).
34. Nanotechnology Concerns Closely Studied, WALL ST. J., June 24, 2005, at A13 (letter from E. Floyd Kvamme, co-Chairman of President's Council of Advisors on Science and Technology, in response to Fred Krupp's and Chad Holliday's June 14, 2005 Manager's Journal Column, Let's Get Nanotech Right).
35. B. Goldfarb, New Task Force Focuses on Nanotechnology Health Effects, NANOBIOTECH NEWS, Aug. 13, 2003, at 3.
36. Gina Roos, Study: Nano-Specific Laws Needed, EE TIMES ONLINE (Jan. 16, 2006), http://www.eet.com/news/latest/showArticle. jhtml, (last visited Nov. 1, 2006).
37. Sonia Arrison, Nanotechnology Needs Nano-Scale Regulation, TECHNEWSWORLD (Jan. 13, 2006), http://www.technewsworld.com/story/ 48272.html, (last visit Nov. 1, 2006).
38. The author would like to note that he possesses the utmost respect for J. Clarence Davies. His contributions to environmental rule making have been substantial. This article is intended to critique some of Mr. Davies' proposals in the nanotechnology context. In the case of nanotechnology, Mr. Davies' argument misunderstands the will of the American people, at least with respect to their elected representatives, and opts for a regulatory model that has been relegated to history. In addition, his review fails to consider the role of liability as an option to protect health and safety. This article presents a series of constructive criticisms aimed at Mr. Davies' proposals and should not be construed whatsoever to be a personal attack on Mr. Davies.
39. The Shock of the New, supra note 18, at 13.
40. Davies, Testimony on Developments in Nanotechnology, supra note 7.
41. DAVIES, MANAGING THE EFFECTS, supra note 1, at 18.
42. DAVIES, MANAGING THE EFFECTS, supra note 1, at 23.
43. Id. at 21.
44. Bullis, supra note 10.
45. This series of events (1999-2004) was precipitated by the announcement and subsequent litigation that 25% of users experience some kind of side effect and 5% develop serious health consequences such as stomach bleeding, acute renal failure, or worse. Cox-2 drugs include Advil®, Motrin®, Aleve®, Ordus®, Aspirin, and over 20 others.
46. Richard H. Murray, Liability Regimes in a Changing Risk Landscape, in NANOTECHNOLOGY: SMALL SIZE - LARGE IMPACT? 33 (Risk Dialogue Series, Dec. 6-7, 2004), http://www. ruschlikon.net/INTERNET/rschwebp.nsf/(ID)/1283EEF86F4A1DA1C125702300426B21/ SFILE/nanotechnology_report.pdf (last visited Nov. 1, 2006).
47. S. Miller, Law in a New Frontier, Abstracts of the Workshop on Societal Implications of Nanoscience and Nanotechnology, Dec. 3-5, 2003, at 85.
48. Sunstein, supra note 2, at 407.
49. Andrew Bridges, Report Examined Safety of Nanotechnology, USA TODAY, Jan. 12, 2006, (http://www.usatoday.com/tech/news/nano/2006-01- 12-safety-report_x.htm?csp34. (last visited Nov. 10, 2006).
50. EUROPEAN COMM'N RESEARCH DG, TOWARD A EUROPEAN STRATEGY FOR NANOTECHNOLOGY (2004), http://europa.eu.int/comm/research/industrial_technologies/pdf/ nanotechnology_communication_en.pdf (last visited Nov. 1, 2006).
51. Bullis, supra note 10.
52. Clive Cookson, Big Fears about Science of the Tiny, FINANCIAL TIMES, Jan., 2006, at 13.
53. Bullis, supra note 10.
54. Cookson, supra note 47.
55. Developments in Nanotechnology, Hearing Before the S. Comm. on Commerce, Sci. & Tech., 109th Cong. 2 (Feb. 15, 2006) (statement of Alan Gotcher, Ph.D., President and Chief Executive Officer of Altair Nanotechnologies, Inc.), available at http://commerce.senate.gov/pdf/ gotcher-021506.pdf, (last visited Nov. 1, 2006).
56. Id.
57. Walter R. Stahel, The Insurability of Emerging Technologies, in NANOTECHNOLOGY: SMALL SIZE - LARGE IMPACT? 33 (Risk Dialogue Series, Dec. 6-7, 2004), http://www. ruschlikon.net/INTERNET/rschwebp.nsf/(ID)/1283EEF86F4A1DA1C125702300426B21/ SFJLE/nanotechnology_report.pdf (last visited Nov. 1, 2006).
58. M. Miller & R. Rubinstein, Insuring Nanotech's Future, R&D (Feb. 2006), http://www.rdmag.com/ShowPR.aspx?PUBCODE=014&ACCT= 1400000100&ISSUE=0512&RELTYPE=pr&Cat=0&SubCat-0&ProdCode= 00000000&PRODLETT-BA&SearchText=Greenberg%20Traurig (last visited Nov. 10, 2006).
59. Defense coverage obligates the insurance carrier to defend and pay the costs of defending lawsuits.
60. Indemnity coverage obligates the insurance carrier to pay for judgments and settlements reached in a covered lawsuit.
61. ALLIANZ AG & ORGANISATION FOR ECON. CO-OPERATION & DEVELOPMENT, SMALL SIZES THAT MATTER: OPPORTUNITIES AND RISKS OF NANOTECHNOLOGIES 43 (Christoph Lauterwasser, ed. 2004), available at http://www.allianz.com/Az_Cnt/az/_any/cma/contents/796000/ saObj_796424_allianz_study_Nanotechnology_engl.pdf (last visited Nov. 1, 2006)
62. Id.
63. John R. Coomber, A Welcome to Swiss Re's First Conference on Nanotechnology, in in NANOTECHNOLOGY: SMALL SIZE-LARGE IMPACT? 5 (Risk Dialogue Series, Dec. 6-7, 2004), http://www.ruschlikon.net/INTERNET/rschwebp.nsf/(ID)/ 1283EEF86F4A1DA1C125702300426B21/SFILE/nanotechnology_report.pdf (last visited Nov. 1, 2006).
64. Christoph Lauterwasser, Dealing with Risks and Opportunities of New Technologies, in in NANOTECHNOLOGY: SMALL SIZE-LARGE IMPACT? 37 (Risk Dialogue Series, Dec. 6-7, 2004), http://www.ruschlikon.net/INTERNET/rschwebp.nsf/(ID)/ 1283EEF86F4A1DA1C125702300426B21/SFILE/nanotechnology_report.pdf (last visited Nov. 1, 2006).
65. Coomber, supra note 58, at 5.
66. T. Epprecht, The Punch of Tiny Particles, GLOBAL REINSURANCE (Dec. 2005/Jan. 2006), at 36.
67. Id.
68. ALLIANZ AG & ORGANISATION FOR ECON. CO-OPERATION & DEVELOPMENT, supra note 56, at 5.
69. Id. at 40.
70. Stahel, supra note 52, at 33.
71. Lauterwasser, supra note 59, at 36.
72. Miller & Rubinstein, supra note 53.
73. Id.
74. Epprecht, supra note 61, at 37.
75. Coomber, supra note 58, at 5.
76. Swiss REINSURANCE CO., NANOTECHNOLOGY: SMALL MATTER, MANY UNKNOWNS 37 (2004).
77. E. Dismuke, Insurance's Knowledge of the Nanotech World, NANOINVESTORNEWS (Oct. 20, 2004), http://www.nanoinvestornews.com/ modules.php?name=News&file=print&sid=3602, (last visited Oct. 27, 2004).
78. For example, this occurred at the first public meeting the EPA hosted on its voluntary pilot program on June 23, 2005 when a group of NGOs presented their position paper.
79. Swiss REINSURANCE CO., supra note 71, at 47.
80. Id.
81. Sonia Miller, A Matter of Torts: Why Nanotechnology Must Develop Processes of Risk Analysis, 232 N. Y. L. J. 67 (2004).
82. A product is unreasonably dangerous and defective if it is more dangerous than would be expected by a reasonable consumer.
83. A product is defective if the magnitude of the danger outweighs the utility of the product.
84. Miller & Rubinstein, supra note 53.
85. Miller, supra note 76.
86. Id.
87. Miller & Rubinstein, supra note 53.
88. P. Phibbs, Toxic Substances: Regulation of Nanoparticles Urged by Nanotechnology Research Firm, BNA DAILY ENV'T REPORT, June 16, 2005, at 115.
89. Murray, supra note 41, at 41.
90. Id.
91. Id.
92. ALLIANZ AG & ORGANISATION FOR ECON. CO-OPERATION & DEVELOPMENT, supra note 56, at 5.
93. Id. at 43.
94. Id. at 33.
95. Id. at 40.
96. The author would like to thank Robin F. Wilson of the University of Maryland Law School for providing reference to this model.
97. K. Smetters, Insuring against Terrorism: The Policy Challenge, Paper Presented at the January 8-9, 2004 Conference of the Brookings-Wharton Papers on Financial Services, (Draft Feb. 2, 2004) (Unpublished manuscript on file with author).
98. This summary was drawn from a power point presentation given at a conference at the University of South Carolina on Nano Ethics. Robin Fretwell Wilson, Nanotechnology and Bioterrorism: Issues AIn Regulation, Address at the University of South Carolina Nano Ethics Conference, Columbia, South Carolina (Mar. 4, 2005).
99. Smetters, supra note 92.
100. Id.
101. Id.
102. Lori Widmer, Terrorism Insurance: Where's the Coverage?, RISK & INS. (July 2002), www.riskandinsurance.com/ 0702choice.asp, (last visited Nov. 1, 2006).
103. G. Schmid, Nanotechnology-What's in Store for Us?, TOPICS (2003/1), at 22.
104. This refers to the liability potential for multiple insurance policies issued over multiple years by a single insurance company to a single insured being held to apply to continuing injury or damage.
105. Id. This refers to insurance coverage limited to losses which occur during the coverage period regardless of when they were caused or triggered.
106. ALLIANZ AG & ORGANISATION FOR ECON. CO-OPERATION & DEVELOPMENT, supra note 56, at 41.
107. Lauterwasser, supra note 59, at 37.
108. Barry P. Brownstein, The Price-Anderson Act: Is It Consistent with a Sound Energy Policy? CATO POLICY ANALYSIS NO. 36 (Apr. 17, 1984), http://www.cato.org/pubs/pas/pa036.html, (last visited May 18, 2005).
109. Smetters, supra note 92.
110. David M. Rocchio, The Price-Anderson Act: Allocation of the Extraordinary Risk of Nuclear Generated Electricity - A Model Punitive Damage Provision, 14 B.C. ENV'TL AFF. L. REV. 521, 535 (1987).
111. Id. at 525-526.
112. Smetters, supra note 92.
113. Rocchio, supra note 105, at 530.
114. Brownstein, supra note 103.
115. Miller & Rubinstein, supra note 53.
116. Id.
117. Id.
118. ALLIANZ AG & ORGANISATION FOR ECON. CO-OPERATION & DEVELOPMENT, supra note 56, at 42.