Source: https://kipdf.com/biotechnology-can-be-broadly-defined-as-the_5aed34917f8b9a932c8b45ba.html
Timestamp: 2019-04-22 14:24:19+00:00

Document:
22 Biotechnology Law Report 376 Number 4 (August 2003) © Mary Ann Liebert, Inc.
We stand at the threshold of a new renaissance in science and technology, based on a comprehensive understanding of the structure and behavior of matter from the nanoscale up to the most complex system yet discovered, the human brain. Unification of science based on unity in nature and its holistic investigation will lead to technological convergence and a more efficient societal structure for reaching *Joel Rothstein Wolfson practices with the firm of Blank Rome Comisky & McCauley LLP in Washington, D.C.
Converging Technologies for Improved Human Performance, National Science Foundation (2002), p 1 (emphasis added). 2 “Nanotechnology1 Biotechnology 5 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; “Scientists of Very Small Draw Disciplines Together,” New York Times C4 (Feb. 10, 2003); “Fantastic Voyage: Tiny Pharmacies Propelled Through the Body Could Result from Cornell Breakthrough in Molecular Motors,” Cornell News (Sept. 7, 1999). 4 See, e.g., Merkel RC. Biotechnology as a route to nanotechnology, Trends Biotechnol 1999;17:271; “New Motifs in DNA Nanotechnology,” Fifth Foresight Conference on Molecular Nanotechnology (1997); West JL, Halas NJ. Applications of nanotechnology to biotechnology, Curr Opin Biotechnol 2000;11:215.
In any event, biotechnologists and public policy makers need to understand the social and ethical issues raised by nanotechnology as they impact and merge with those of biotechnology. This article outlines some of those issues.
Falling Through the Net: A Survey of the ‘Have Nots’ in Rural and Urban America, U.S. Department of Commerce, July 1995.
Biotechnology Law Report TABLE 2.
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. 7 Falling Through the Net: Toward Digital Inclusion: A Report on Americans’ Access to Technology Tools, U.S. Department of Commerce, October 2000.
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. 9 “Plugging into the revolution,” Jane Black, BBC Online, October 14, 1999, http://news.bbc.co.uk/1/hi/special_report/1999/ 10/99/information_rich_information_poor/467899.stm.(Last visited June 2, 2003). 10 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.
Similarly, the initiative to wire every school in the United States with Internet access shows that society can narrow the technology gap if it sees the problem and confronts it directly: In response to the educational opportunities made available by dramatic technological innovations in the early and mid-1990s, U.S. Secretary of Education released the nation’s first educational technology plan in 1996, Getting America’s Students Ready for the 21st Century: Meeting the Technology Literacy Challenge. This plan presented a far-reaching vision for the effective use of technology in elementary and secondary education to help the next generation of school children to be better educated and better prepared for the evolving demands of the new American economy. Given that many schools and classrooms have only recently gained access to technology for teaching and learning, the positive outcomes of these studies suggest a future for education that could be quite bright if the nation maintains its commitment to harnessing technology for education.
“Special Reports: New Drugs Have Limited Impact Globally,” JAMA HIV-AIDS Information Center, 1999, www.amaassn.org/special/hiv/newsline/ special/amnews/amn0916a.htm. 12 “Paying for AIDS Cocktails: Who Should Pick up the Tab for the Third World?” Time, Feb. 12, 2001.
See, e.g., e-Learning: Putting a World Class Education at the Fingertips of our Children, U.S. Department of Education, December 2002. 14 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. 15 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. 16 See, e.g., “Blair: Iraq Can Deploy Quickly; Report Presents New Details on Banned Arms,” Glenn Frankel Washington Post, September 25, 2002, A01; “Observers: Evidence for War Lacking; Report against Iraq Holds Little That’s New,” Dana Priest and Joby Warrick, Washington Post, September 13, 2002, A30.
See, e.g., “Gene-Altered Canola Can Spread to Nearby Fields, Risking Lawsuits,” Jill Carroll, Wall Street Journal, June 28, 2002, B6. 18 See, e.g., “ProdiGene-Modified Corn Plant Nearly Gets into U.S. Food Supply,” Scott Kilman, Wall Street Journal November 13, 2002. 19 See, e.g., “In Europe, a Unity of Distrust,” Jim Hoagland, Washington Post, February 1, 2001, A21; “Japan to Test 1 Million Cattle for ‘Mad Cow’; Concerns Grow after First Case Botched,” Kathryn Tolbert, Washington Post, September 20, 2001, A30; “Beef’s Battles in the Midst of a Comeback; Red Meat Faces Another Image Crisis,” Douglas Hanks III, Washington Post, March 28, 2001, F1. 20 Foresight Guidelines on Molecular Nanotechnology, original version 1.0, February 21, 1999; revised draft 3.7, June 4, 2000, Foresight Institute and Institute for Molecular Manufacturing.
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. See, e.g., “How The Bells Stole America’s Digital Future: A NetAction White Paper,” Bruce Kushnick, 2001, reprinted at http://www.netaction.org/broadband/bells/ (last visited June 2, 2003).
do in a reliable fashion. Under the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992, the FDA was granted greater postmarket controls, such as user reporting of devicerelated deaths or serious injuries to provide an early warning system for device complications or failures. Nanotechnology robots that are introduced into a human body to repair it would seem to be medical devices under the FDCA. Foods and food additives are also regulated by the FDA under the FDCA, which bans the introduction or delivery into interstate commerce of “misbranded” or “adulterated” food.26 “Misbranding” is the use of misleading labeling and packaging, as well as false representations as to quality.27 Section 402 of the FDCA defines “adulteration” as the addition of poisonous or deleterious substances to food.28 There are General Standards for adulteration,29 and if necessary, the FDA can prescribe Special Standards for particular types of adulterations.30 Nanotechnology that either creates food or food additives, or the misbranding of nanotechnology that is used in the human food supply would appear to be governed by existing FDA law.
See discussion of federal regulation of human research activities elsewhere in this document. 23 This topic is discussed in more detail elsewhere in this article. 24 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 characterized as “establish[ing] 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. 25 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 . . . recognized in 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.” 26 21 USC §331. 27 21 USC §342. 28 21 USC §342. 29 21 USC §342(a). 30 21 USC §342(a)(2).
Section 505 of the Food, Drug, and Cosmetic Act, 21 USC 355(d); §351 of the PHSA, 42 USC §262. 32 21 USC §331–334. 33 7 USC §§135–136y. 34 7 USC §136a. 35 7 USC §136i, 136j-l. 36 7 USC §§7711–7758. 37 Part of the Farm Bill of 2002. 38 “Old Laws, New Fish: Environmental Regulation of GeneAltered Foods is a Gray Area,” Justin Gillis, Washington Post, January 15, 2003, E01. 39 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.
See, e.g., “Polynesian rats,” Mark E. Tobin, in Prevention and Control of Wildlife Damage, USDA, 1994. 49 See, e.g., http://www.cpsr.org/publications/newsletters/issues/ 2001/Spring/index.html (last visited June 2, 2003). 50 Engines of Creation, K. Eric Drexler, Doubleday, 1986.
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. 52 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. 53 See, e.g., Human Cloning Prohibition Act of 2001, H.R. 2505 (introduced 7/16/2001); Human Cloning Ban and Stem Cell Research Protection Act of 2002, S. 1893 (introduced 1/24/2002). 54 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. 55 Ibid., Executive Summary, page 4.
have been resolved (one way or the other) by the time nanotechnology perfects its own methods of cloning, social issues will arise. It is likely that nanotechnology’s efforts will lead to twists in the assumptions that lead to the resolution of cloning issues in terms of genetic bioengineering. Policy makers should anticipate, now, that in setting the boundaries for bioengineered cloning, the need to foresee issues that will arise from cloning by nanotechnology and be ready to reevaluate cloning regulation before nanotechnology perfects its own methods of cloning. If we do not anticipate the nanotechnology problems, the debate will emerge in an environment like the current one: one filled with a frenzy and uproar, rather than in an atmosphere of reflection and deliberateness. Social policy and law always lag behind science It has often been said that law breathlessly tries to keep up with scientific advances. This is likely to be the case in nanotechnology. In Chapter 13 of his book, Drexler makes a strong pitch for keeping policy makers out of the debate about nanotechnology and urges the institution of technical panels. He summarizes his argument this way: Unfortunately, leaving judgment to experts causes problems. In Advice and Dissent, Primack and von Hippel point out that “to the extent that the Administration can succeed in keeping unfavorable information quiet and the public confused, the public welfare can be sacrificed with impunity to bureaucratic convenience and private gain.” Regulators suffer more criticism when a new drug causes a single death than they do when the absence of a new drug causes a thousand deaths. They misregulate accordingly. Military bureaucrats have a vested interest in spending money, hiding mistakes, and continuing their projects. They mismanage accordingly. This sort of problem is so basic and natural that more examples are hardly needed. Everywhere, secrecy and fog make bureaucrats more comfortable; everywhere, personal convenience warps factual statements on matters of public concern. As technologies grow more complex and important, this pattern grows more dangerous.
Some authors consider rule by secretive technocrats to be virtually inevitable. In Creating Alternative Futures, Hazel Henderson argues that complex technologies “become inherently totalitarian” (her italics) because neither voters nor legislators can understand them. Dr. Drexler sees two flaws with the present public policy framework. First, regulators have vested interests in maintaining their present power and the status quo. Second, secrecy and the incentive to cover-up mistakes by “technocrats” harm the formation of proper public policy. Thus, Dr. Drexler proposes “fact forums” of scientific experts to replace the present public policy framework. He summarizes his approach as follows: We need better procedures for debating technical facts—procedures that are open, credible, and focused on finding the facts we need to formulate sound policies. We can begin by copying aspects of other due-process procedures; we then can modify and refine them in light of experience. Using modern communications and transportation, we can develop a focused, streamlined, journal-like process to speed public debate on crucial facts; this seems half the job. The other half requires distilling the results of the debate into a balanced picture of our state of knowledge (and by the same token, of our state of ignorance). Here, procedures somewhat like those of courts seem useful. Since the procedure (a fact forum) is intended to summarize facts, each side will begin by stating what it sees as the key facts and listing them in order of importance. Discussion will begin with the statements that head each side’s list. Through rounds of argument, cross examination, and negotiation the referee will seek agreed-upon statements. Where disagreements remain, a technical panel will then write opinions, outlining what seems to be known and what still seems uncertain. The output of the fact forum will include background arguments, statements of agreement, and the panel’s opinions. It might resemble a set of journal articles capped by a concise review article—one limited to factual statements, free of recommendations for policy.
generation. One of the great advantages of new children is that they introduce new ideas and challenge existing norms. It is said that some of the greatest scientists completed their greatest contributions before the age of 30. Moreover, children grow up to accept as natural things that their parents found impossible to live with. For example, racial integration in jobs and the military, and even interracial marriage, seen a generation ago as an idea that might tear apart the United States, is now accepted as fact by most children.56 Similarly, the use and acceptance of new technologies, such as computers, is far more prevalent in children than in their more senior counterparts. If the proponents of nanotechnology are correct, nanotechnology will mean that computers will finally think like human beings. As they envision it, nano-machines will either be small enough to become fast enough to break the barrier into “consciousness,” or nano-machines will build biological computers that will mimic the way in which brains think and grow. In either case, if they are correct, we need to come to grips with the effects of conscious computers on society. Will humans find productive things to do with their time and energies if computers can take over their jobs? Who will control whom? Will computers have the ability to rebel against humans? Will computers dominate and eliminate humans and other “living” things? These science-fiction questions will have a greater impact if the most optimistic projections of nanotechnology come true.57 Issues that affect the development stage Military funding and directed research can distort scientific research The military is an enormous funder of scientific research. However, the mission of this funding is not the basic advance of science but the development of science that can produce weapons, detect the enemy, or protect troops against an enemy attack. According to the National Science Foundation, in Fiscal Year 1990, the defense share of the federal R&D budget authority was 62.6% of the total governmental R&D budget. In year 2001, it was expected to decrease to 50.1%. Even with this dramatic decrease, funding by the government of scientific research is largely devoted to developing military applications.
“Biracial Couples Report Tolerance; Survey Finds Most are Accepted by Families,” Darryl Fears and Claudia Deane, Washington Post, July 5, 2001, A1; “Racial Divide in Sports Doesn’t Matter to Athletes; They Say that Playing Brings People Together,” Camille Powell, Washington Post, June 21, 2001, T10. 57 See, e.g., “Why the future doesn’t need us,” Bill Joy, Wired, 8.04, April 2000. 58 See, e.g., misgivings of Werner Heisenberg and speeches of J. Robert Oppenheimer.
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. 60 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; 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. 61 “Penn Ends Gene Trials on Humans,” Deborah Nelson, Rick Weiss, Washington Post May 25, 2000, A1. 62 “Earlier Gene Test Deaths Not Reported; NIH was Unaware of ‘Adverse Events’,” Deborah Nelson, Rick Weiss, Washington Post January 31, 2000, A1.
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 counterproductive and irrational activity, it seems to occur with some regularity. 64 “A Hospital’s Conflict of Interest: Patients Weren’t Told of Stake in Cancer Drug,” Justin Gillis, Washington Post, June 30, 2002, A1. 65 “Study Results Prompt SIA to Examine Whether Fab Chemicals Imperil Workers’ Health,” 2001 Micro, April 2002.
“Asbestos.” OSHA Website, http://www.osha-slc.gov/SLTC/ asbestos/ (last visited June 2, 2003). 67 These size estimates, as well as both sides of the arguments related to software reliability, were summarized and analyzed in SDI: Technology Survivability 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 confidence the United States could place in dependability estimates” (See the Report at page 4). 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. 68 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.
the quality of the burger. That identifying source can be protected under trademark by McDonald’s even if it later ventures into other fields such as hotels, software, or airplanes. In sum, the difference between patent, copyright, and trademark is that a patent protects a particular invention (or device), process, or design; copyright protects a particular audiovisual expression (such as a novel, software, or design); and trademark protects the manufacturer’s (or other business’s) trade names. A series of sui generis or neighboring rights have also been created in recent years. Among these is the European Union’s database protection scheme. In brief, factual databases are protected for a short period (15 years) only against the unauthorized and substantial extraction of the data. Moral rights are a similar example. While moral rights differ greatly between countries, in essence, they protect an author by requiring that the work produced by that author be attributed to him or her and not be edited or altered without the author’s permission, even if the author is no longer (or never was) the owner of the copyright in the work. As nanotechnology progresses, the weaknesses and strengths of the patent/copyright/trademark regime have to weighed against the creation of a scheme that is tailored to the peculiarities of nanotechnologies. The same debate that is now playing out in the patenting of business processes, software, or biotechnologies will play out with nanotechnology. We need to look at the resolutions of those debates in evaluating what protection should be granted to nanotechnology.
Report "BIOTECHNOLOGY CAN BE BROADLY DEFINED as the"

References: §201
 §331
 §342
 §342
 §342
 §342
 §351
 §262
 §331
 §136
 §136
sui generis