Social and ethical issues in nanotechnology: Lessons from biotechnology and other high technologies

Biotechnology Law Report

Volumn 22, Issue 4, 2003, Pages 376-396

  Wolfson, Joel Rothstein ^a  

^a McCauley LLP   (United States)

Author keywords

[No Author keywords available]

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EID: 28844438493     PISSN: 0730031X     EISSN: None     Source Type: Journal    
DOI: 10.1089/073003103769015906     Document Type: Article

References (87)

1. Converging Technologies for Improved Human Performance, National Science Foundation (2002), p 1 (emphasis added).
2. "Nanotechnology + Biotechnology = Sustainability,"G. Street, In: Michel J (ed): Proceedings of the Many Facets of International Education of Engineers. A.A. Balkema Publishers, 2000.
3. See, e.g., "Nanotechnology,Biotechnology Come Together," K. Burns, North County Times, August 19, 2001;
4. "Scientists of Very Small Draw Disciplines Together," New York Times C4 (Feb. 10, 2003);
5. "Fantastic Voyage: Tiny Pharmacies Propelled Through the Body Could Result from Cornell Breakthrough in Molecular Motors," Cornell News (Sept. 7, 1999).
6. See, e.g., Merkel RC. Biotechnology as a route to nanotechnology, Trends Biotechnol 1999;17:271;
7. "New Motifs in DNA Nanotechnology," Fifth Foresight Conference on Molecular Nanotechnology (1997);
8. West JL, Halas NJ. Applications of nanotechnology to biotechnology, Curr Opin Biotechnol 2000; 11:215.
9. Falling Through the Net: A Survey of the 'Have Nots' in Rural and Urban America, U.S. Department of Commerce, July 1995.
10. The DEC 2000 Report noted the achievements: The rapid uptake of new technologies is occurring among most groups of Americans, regardless of income, education, race or ethnicity, location, age, or gender, suggesting that digital inclusion is a realizable goal. Groups that have traditionally been digital "have nots" are now making dramatic gains: • The gap between households in rural areas and households nationwide that access the Internet has narrowed from 4.0 percentage points in 1998 to 2.6 percentage points in 2000. Rural households moved closer to the nationwide Internet penetration rate of 41.5%. In rural areas this year, 38.9% of the households had Internet access, a 75% increase from 22.2% in December 1998. • Americans at every income level are connecting at far higher rates from their homes, particularly at the middle income levels. Internet access among households earning S35,000 to $49,000 rose from 29.0% in December 1998 to 46.1% in August 2000. Today, more than two-thirds of all households earning more than $50,000 have Internet connections (60.9% for households earning $50,000 to $74,999 and 77.7% for households earning above $75,000). • Access to the Internet is also expanding across every educa- tion level, particularly for those with some high school or college education. Households headed by someone with "some college experience" showed the greatest expansion in Internet penetration of all education levels, rising from 30.2% in December 1998 to 49.0% in August 2000. • Blacks and Hispanics still lag behind other groups but have shown impressive gains in Internet access. Black households are now more than twice as likely to have home access than they were 20 months ago, rising from 11.2% to 23.5%. Hispanic households have also experienced a tremendous growth rate during this period, rising from 12.6% to 23.6%. • The disparity in Internet usage between men and women has largely disappeared. In December 1998, 34.2% of men and 31.4% of women were using the Internet. By August 2000, 44.6% of men and 44.2% of women were Internet users. • Individuals 50 years of age and older - while still less likely than younger Americans to use the Internet - experienced the highest rates of growth in Internet usage of all age groups: 53% from December 1998 to August 2000, compared to a 35% growth rate for individual Internet usage nationwide.
11. Falling Through the Net: Toward Digital Inclusion: A Report on Americans' Access to Technology Tools, U.S. Department of Commerce, October 2000.
12. The 2000 Report summarized the depth of the divide: Nonetheless, a digital divide remains or has expanded slightly in some cases, even while Internet access and computer ownership are rising rapidly for almost all groups. For example, our most recent data show that divides still exist between those with different levels of income and education, different racial and ethnic groups, old and young, single and dual-parent families, and those with and without disabilities. • People with a disability are only half as likely to have access to the Internet as those without a disability: 21.6% compared to 42.1%. And while just under 25% of people without a disability have never used a personal computer, close to 60% of people with a disability fall into that category. • Among people with a disability, those who have impaired vision and problems with manual dexterity have even lower rates of Internet access and are less likely to use a computer regularly than people with hearing difficulties. This difference holds in the aggregate, as well as across age groups. • Large gaps also remain regarding Internet penetration rates among households of different races and ethnic origins. Asian Americans and Pacific Islanders have maintained the highest level of home Internet access at 56.8%. Blacks and Hispanics, at the other end of the spectrum, continue to experience the lowest household Internet penetration rates at 23.5% and 23.6%, respectively. - Large gaps for Blacks and Hispanics remain when measured against the national average Internet penetration rate. - The divide between Internet access rates for Black households and the national average rate was 18 percentage points in August 2000 (a 23.5% penetrationrate for Black households, compared to 41.5% for households nationally). That gap is 3 percentage points wider than the 15 percentage point gap that existed in December 1998. - The Internet divide between Hispanic households and the national average rate was 18 percentage points in August 2000 (a 23.6% penetration rate for Hispanic households, compared to 41.5% for households nationally). That gap is 4 percentage points wider than the 14 percentage point gap that existed in December 1998. - With respect to individuals, while about a third of the U.S. population uses the Internet at home, only 16.1% of Hispanics and 18.9% of Blacks use the Internet at home. - Differences in income and education do not fully account for this facet of the digital divide. Estimates of what Internet access rates for Black and Hispanic households would have been if they had incomes and education levels as high as the nation as a whole show that these two factors account for about one-half of the differences. • With regard to computer ownership, the divide appears to have stabilized, although it remains large. - The August 2000 divide between Black households and the national average rate with regard to computer ownership was 18 percentage points (a 32.6% penetration rate for Black households, compared to 51.0% for households nationally). That gap is statistically no different from the gap that existed in December 1998. - Similarly, the 17 percentage point difference between the share of Hispanic households with a computer (33.7%) and the national average (51.%) did not register a statistically significant change from the December 1998 computer divide. - Individuals 50 years of age and older are among the least likely to be Internet users. The Internet use rate for this group was only 29.6% in 2000. However, individuals in this age group were almost three times as likely to be Internet users if they were in the labor force than if they were not.
13. "Plugging into the revolution," Jane Black, BBC Online, October 14, 1999,http://news.bbc.co.uk/l/hi/special-report/1999/ 10/99/information- rich-information-poor/467899.stm.(Last visited June 2, 2003).
14. See, e.g., "Death Watch: The Global Response to AIDS in Africa World Shunned Signs of the Coming Plague," Barton Gellman, Washington Post, July 5, 2000; Page A1; "The End of AIDS? The plague continues, especially for the uninsured, but new drugs offer hope for living with HIV," John Leland, Newsweek December 2, 1996.
15. "Special Reports: New Drugs Have Limited Impact Globally," JAMA HIV-AIDS Information Center, 1999, www.amaassn.org/special/hiv/newsline/ special/amnews/amn0916a.htm.
16. "Paying for AIDS Cocktails: Who Should Pick up the Tab for the Third World?" Time, Feb. 12, 2001.
17. See, e.g., e-Learning: Putting a World Class Education at the Fingertips of our Children, U.S. Department of Education, December 2002.
18. See, e.g., "Mail-Order Molecules Brew a Terrorism Debate Virus Created in Lab Raises Questions of Scrutiny for DNA Suppliers," Rick Weiss Washington Post, Wednesday, July 17, 2002, A01
19. See, e.g., "Creating Living Things," Editorial, Washington Post, November 23, 2002, A22; "Nothing Wrong with a Little Frankenstein," Chris Mooney, Washington Post, December 1, 2002, B01.
20. See, e.g., "Blair: Iraq Can Deploy Quickly; Report Presents New Details on Banned Arms," Glenn Frankel Washington Post, September 25, 2002, A01;
21. "Observers: Evidence for War Lacking; Report against Iraq Holds Little That's New," Dana Priest and Joby Warrick, Washington Post, September 13,2002, A30.
22. See, e.g., "Gene-Altered Canola Can Spread to Nearby Fields, Risking Lawsuits," Jill Carroll, Wall Street Journal, June 28, 2002, B6.
23. See, e.g., "ProdiGene-Modified Corn Plant Nearly Gets into U.S. Food Supply," Scott Kilman, Wall Street Journal November 13, 2002.
24. See, e.g., "In Europe, a Unity of Distrust," Jim Hoagland, Washington Post, February 1, 2001, A21;
25. "Japan to Test 1 Million Cattle for 'Mad Cow'; Concerns Grow after First Case Botched," Kathryn Tolbert, Washington Post, September 20, 2001, A30;
26. "Beef's Battles in the Midst of a Comeback; Red Meat Faces Another Image Crisis," Douglas Hanks III, Washington Post, March 28, 2001, Fl.
27. Foresight Guidelines on Molecular Nanotechnology, original version 1.0, February 21, 1999;
28. revised draft 3.7, June 4, 2000, Foresight Institute and Institute for Molecular Manufacturing.
29. Although even this view is subject to challenge and debate. The deregulation of many telecommunications services through FCC action before and since the Federal Telecommunications Reform Act of 1996, Pub. LA. No. 104-104,110 Stat. 56 (1996) highlights the fact that the conclusion that utilities from natural monopolies has been subject to rethinking. On the other hand, local telephone services remain regulated, and commentators disagree about whether telecommunications deregulation was a good thing.
30. See, e.g., "How The Bells Stole America's Digital Future: A NetAction White Paper," Bruce Kushnick, 2001, reprinted at http://www.netaction.org/oroadband/bells/ (last visited June 2, 2003).
31. See discussion of federal regulation of human research activities elsewhere in this document.
32. This topic is discussed in more detail elsewhere in this article.
33. This decentralized approach was reinforced in 1986, when the federal government completed the "Coordinated Framework for Regulation of Biotechnology," 51 F.R. 23,302-23,350 (1986), which has been characterizedas "establishing] the policy that a product of biotechnology should be regulated according to its composition and intended use, rather than by the method used to produce it." The Regulation of Biotechnology, Randy Vines, Virginia Tech Publication Number 443-006, May 2002.
34. Federal Food, Drug, and Cosmetic Act, §201 (h) defines "device" as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is . . . recognizedin the official National Formulatry, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes."
35. 21 USC §331.
36. 21 USC §342.
37. 21 USC §342.
38. 21 USC §342(a).
39. 21 USC §342(a)(2).
40. Section 505 of the Food, Drug, and Cosmetic Act, 21 USC 355(d);
41. §351 of the PHSA, 42 USC §262.
42. 21 USC §331-334.
43. 7 USC §§135-136y.
44. 7 USC §136a.
45. 7 USC §136i, 136J-1.
46. 7 USC §§7711-7758.
47. Part of the Farm Bill of 2002.
48. "Old Laws, New Fish: Environmental Regulation of Gene-Altered Foods is a Gray Area," Justin Gillis, Washington Post, January 15, 2003, E01.
49. Another issue that must be balanced is the extent to which particular regulatory agencies have expertise that must be brought to bear versus the amount to which they are influenced by the industry they are supposed to regulate. In a similar vein, some agencies are seen as weak regulators, given their statutory charters or present leadership, and others are seen as too zealous or ideological.
50. 15 USC §780(b)(8).
51. 15 USC §780-3(a).
52. 15 USC §780-3(b).
53. NASD Manual Section 2110.
54. NASD Manual Section 2420.
55. See generally the notices of such actions by month at http://www.nasdr.com/2700.asp (last visited June 2, 2003).
56. See, e.g., "Securities Markets Regulation: Time to Move to a Market-Based Approach," Dale Oesterle, Cato Institute, June 21, 2000.
57. See, e.g., The Land of New Zealand: A Report. Sven MacAller, http ://www.stormbefore.com/squatley/newzeal.html (last visited on June 2, 2003).
58. See, e.g., "Polynesian rats," Mark E. Tobin, in Prevention and Control of Wildlife Damage, USDA, 1994.
59. See, e.g., http://www.cpsr.org/publications/newsletters/issues/ 2001/Spring/index.html (last visited June 2, 2003).
60. Engines of Creation, K. Eric Drexler, Doubleday, 1986.
61. See, e.g., Eisenberg T, Gries D, Hartmanis J, Holdomb D, Lynn MS, Santoro T. The Cornell Commission: on Morris and the Worm. Commun ACM 1989;32:706-710. Several other articles in the same issue explore other aspects of the Morris worm.
62. While more far fetched, it is not clear that assemblers could not interact with microscopic living organisms. One could imagine that a bacterium or other creature could find a way to incorporate or become symbiotic with the misdesigned assemblers, producing a totally unexpected and bad result. Examples of capture and symbiosis in nature are common. For example, it is thought that mitochondria, which are the energy powerhouses of cells, were originally bacteria that became permanently captured by eukaryotic cells millions of years ago. See, e.g., "All Family Trees Lead to 'Eve,' An African; Scientists Conclude Genetic Analysis Indicates Common Ancestor 200,000 Years Ago," Boyce Rensberger, Washington Post, January 13, 1987, A3. As the article points out, this is lucky for some scientists, who have used that fact to show that we all may have a common relative, called "Eve." Lichens, sharks, and cleaner fish; tick birds on rhinos; ox and pecker birds; and termites and their intestinal cellulose-digesting flagellates are just a few of the overwhelming examples of symbiosis in nature. The possibility that nano-machines could become symbiotic with creatures, while remote, cannot be completely discounted.
63. See, e.g., Human Cloning Prohibition Act of 2001, H.R. 2505 (introduced 7/16/2001);
64. Human CloningBan and Stem Cell Research Protection Act of 2002, S. 1893 (introduced 1/24/2002).
65. Animal Biotechnology. Science Based Concerns, Committee on Defining Science-Based Concerns Associated with Products of Animal Biotechnology, Committee on Agricultural Biotechnology, Health, and the Environment, Board on Life Sciences, National Research Council, August, 2002.
66. Ibid., Executive Summary, page 4.
67. "Biracial Couples Report Tolerance; Survey Finds Most are Accepted by Families," Darryl Fears and Claudia Deane, Washington Post, July 5, 2001, A1;
68. "Racial Divide in Sports Doesn't Matter to Athletes; They Say that Playing Brings People Together," Camille Powell, Washington Post, June 21, 2001, T10.
69. See, e.g., "Why the future doesn't need us," Bill Joy, Wired, 8.04, April 2000.
70. See, e.g., misgivings of Werner Heisenberg and speeches of J. Robert Oppenheimer.
71. See, e.g., "At Kansas State, Seeking Patents, with Hopes of Profits Pending, Turns Donated Rights into Products, Companies and Jobs," Robert E. Pierr, Washington Post, June 8, 2002, A3.
72. See, e.g., "The Smoke You Don't See: Uncovering Tobacco Industry Scientific Strategies Aimed against Environmental Tobacco Smoke Policies," Am J Public Health 2000;91: 1419-1423, September 2000;
73. Dearlove JV, Bialous SA, Glantz SA. Tobacco industry manipulation of the hospitality industry to maintain smoking in public places. Tobacco Control 2002; 11:94-104.
74. "Penn Ends Gene Trials on Humans," Deborah Nelson, Rick Weiss, Washington Post May 25, 2000, Al.
75. "Earlier Gene Test Deaths Not Reported; NIH was Unaware of 'Adverse Events'," Deborah Nelson, Rick Weiss, Washington Post January 31, 2000, A1.
76. See also "Science Breaks Down When Cheaters Think They Won't be Caught," Sharon Begley, Wall Street Journal, September 27, 2002, B1, on why, despite the fact that scientific fraud seems to be a counterproductiveand irrational activity, it seems to occur with some regularity.
77. "A Hospital's Conflict of Interest: Patients Weren't Told of Stake in Cancer Drug," Justin Gillis, Washington Post, June 30, 2002, A1.
78. "Study Results Prompt SIA to Examine Whether Fab Chemicals Imperil Workers' Health," 2001 Micro, April 2002.
79. "Asbestos." OSHA Website, http://www.osha-slc.gov/SLTC/ asbestos/ (last visited June 2, 2003).
80. These size estimates, as well as both sides of the arguments related to software reliability, were summarized and analyzed in SDI: Technology Surviv ability and Software, Office of Technology Assessment, Congress of the United States, May 1988. That report concluded "The nature of software and experience with large, complex software systems indicate that there will always be irresolvable questions about how dependable [ ] software would be and about the confidencethe United States could place in dependability estimates" (See the Report at page 4).
81. For a recent summary of these arguments, see "National Missile Defense: The Trustworthy Software Argument," William Yurcik, CPSR Newsletter, Volume 19, Number 2, Spring 2001, and other articles in that issue.
82. An extensive discussion of software failures and the reasons for them, as well as overlying ethical considerations, can be found in Chapter 5 of Computer Ethics (second edition), Tom Forester and Perry Morrison, 1994.
83. Diamond v. Diehr, 450 U.S. 175 (1981).
84. State Street Bank & Trust Co. v. Signature Fin. Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998), cert, denied, 119 S. Ct. 851 (1999).
85. Directive on the Patentability of Computer-Implemented Inventions, 20.02.2002 COM(2002) 92 final 2002/0047 (COD).
86. See, e.g., Should Patents be Granted for Computer Software or Ways of Doing Business: The Government's Conclusions, U.K. Patent Office, March 2001; James Gleick, "Patently absurd," New York Times Magazine, March 13, 2002;
87. Robert Lemos, "Patents, lawsuits plague the Net," ZD-Net News, March 30, 2000.