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22 Biotechnology Law Report 376 Number 4 (August 2003) ©Mary Ann Liebert, Inc.

Social and Ethical Issues in : Lessons from Biotechnology and Other High

JOEL ROTHSTEIN WOLFSON*

INTRODUCTION human goals. In the early decades of the twenty-first century, concentrated effort can IOTECHNOLOGYCANBEBROADLYDEFINED as the bring together nanotechnology, biotechnol- Buse of specially bred living to solve ogy, information , and new tech- problems and produce new products or, more nar- nologies based in cognitive science. With rowly, as the intentional alteration of living organ- proper attention to ethical issues and societal isms by manipulation of their DNA. In either case, needs, the result can be a tremendous im- nanotechnology—that is, the creation of - provement in human abilities, societal out- size machines and other devices and the manipula- comes, and quality of life. 1 tion of substances molecule by molecule—will play an increasingly important role. The ability to cus- In an article entitled “Nanotechnology 1 Bio- tom build portions of DNA and other chemicals bit technology 5 Sustainability,” 2 Professor Street ex- by bit and the potential to create machines that can plores “ the potential for biotechnology and nan- interact with, or even penetrate cells of a living or- otechnology to become partners for the innovative ganism, will have a profound affect on biotechnol- solution of technological problems that have been ogy. with us for some time.” Among the areas high- Numerous articles have recently been written lighted in the article are advances that might be about the convergence of biotechnology, nanotech- made in , biomolecular motors, and nology, and other high technologies. For example, the use of biotechnology/ nanotechnology to clean in 2002, The National Science Foundation published up the environment, increase food production, and a lengthy set of papers on “Converging Technolo- create materials such as new plastics and chemicals. gies For Improved Human Performance,” which ex- Articles on the convergence of biotechnology and plored numerous aspects of the convergence of nanotechnology have ranged from the popular 3 to biotechnology, nanotechnology, information tech- the more scholarly. 4 nology, and cognitive sciences. In explaining the background for the project, the report begins: 1 Converging Technologies for Improved Human Performance , We stand at the threshold of a new renais- National Science Foundation (2002), p 1 (emphasis added). 2 sance in science and technology, based on a “Nanotechnology 1 Biotechnology 5 Sustainability,” G. Street, In: Michel J (ed): Proceedings of the Many Facets of International comprehensive understanding of the structure Education of . A.A. Balkema Publishers, 2000. and behavior of matter from the nanoscale up 3 See, e.g., “Nanotechnology, Biotechnology Come Together,” to the most complex system yet discovered, K. Burns, North County Times , August 19, 2001; “Scientists of Very Small Draw Disciplines Together,” Times C4 the human brain. Unification of science based (Feb. 10, 2003); “Fantastic Voyage: Tiny Pharmacies Propelled on unity in nature and its holistic investigation Through the Body Could Result from Cornell Breakthrough in will lead to technological convergence and a Molecular Motors,” Cornell News (Sept. 7, 1999). 4 See, e.g., Merkel RC. Biotechnology as a route to nanotech- more efficient societal structure for reaching nology, Trends Biotechnol 1999;17:271; “New Motifs in DNA Nanotechnology,” Fifth Foresight Conference on (1997); West JL, Halas NJ. Applications of *Joel Rothstein Wolfson practices with the firm of Blank Rome nanotechnology to biotechnology, Curr Opin Biotechnol Comisky & McCauley LLP in Washington, D.C. 2000;11:215.

376 Biotechnology Law Report • Volume 22, Number 4 377 In any event, biotechnologists and public policy tial benefits to society, a helpful discussion can be makers need to understand the social and ethical is- found at www.foresight.org/NanoRev/FIFAQ1.html sues raised by nanotechnology as they impact and (last visited June 2, 2003). merge with those of biotechnology. This article out- lines some of those issues. FIVE VEXING ISSUES

SOCIAL AND ETHICAL ISSUES IN Haves and have-nots of nanotechnology NANOTECHNOLOGY As we have seen with other technologies, the de- velopment and deployment of nanotechnology will Nanotechnology has an enormous potential to do likely occur first within certain classes of wealthy good in society. However, like many technologies, societies and then in wealthier nations in general. its introduction and implementation raise serious so- The effect and challenge of bridging the gaps be- cietal and ethical issues, both for the scientists who tween classes of haves and have-nots, and then are developing this technology and for the members countries that have and have-not, needs to be con- of the public who may benefit from or be exposed sidered. to it. The purpose of this paper is to explore some If the nanotechnology gap will be anything like of these societal and ethical issues. The purpose is the gap that exists in ownership of computers and not to take policy positions or to suggest solutions usage of the Internet, the nanotechnology gap be- but merely to raise some of the important social is- tween haves and have-nots will pose real societal sues. In this way, it is hoped that this paper can form issues. In 1995, the U.S. Department of Commerce the basis of a discussion on the public policy rami- published its Falling Through the Net: A Survey of fications of nanotechnology, from which positions the ‘Have Nots’ in Rural and Urban America .5 The and solutions can begin to emerge. report noted that the gap in the percentages of house- Many of the social and ethical issues are the same holds with computers between the rich, white, and as those that affect a wide range of other high tech- educated and poor minorities with less education nologies. That is, while the technology is new, the was enormous. A summary of some statistics from issues it raises have been faced before by researchers that survey illustrates the point (Table 1). and society. We need to remind ourselves about the This table illustrates the starkness of the divide. lessons we have already learned about social and In the mid 1990s, those with annual incomes over ethical issues that were raised by biotechnology $75,000 were seven times more likely to own com- (such as from regulatory failures in gene therapy), from the development of nuclear technologies, and from computer technologies. For those needing a 5 Falling Through the Net: A Survey of the ‘Have Nots’ in Rural brief introduction to nanotechnology and its poten- and Urban America , U.S. Department of Commerce, July 1995.

TABLE 1. 1995 DEPARTMENTOF COMMERCE REPORT

Percentage of households Characteristic (Urban households) with computers

Income $75,000 or more 64.4 $10,000–14,999 9.1 $10,000 or less 8.1 Race White 30.3 Black 11.8 Hispanic 13.2 Education College (4 years or more) 50.7 High school 6.1 Elementary school 2.8 378 Biotechnology Law Report • Volume 22, Number 4

TABLE 2. 2000 DEPARTMENTOF COMMERCE REPORT

Percentage of households Characteristic (Urban households) with computers

Income $75,000 or more 86.2 $10,000–14,999 22.4 $10,000 or less 15.1 ($5,000–$9,999) 23.6 (below $5,000) Race White 57.3 Black 33.3 Hispanic 34.2 Education College (4 years or more) 75.3 High school 38.3 Elementary school 13.7

puters than those with incomes under $15,000. Ur- centage of computer ownership than households ban whites had nearly three times the percentage with incomes between $10,000 and $15,000. Whites ownership of computers than urban blacks had. Peo- now had less than twice the percentage computer ple with college degrees had more than eight times ownership of blacks. Post-college-educated persons the percentage of computers compared with high had less than twice the percentage computer own- school-educated people and more than 17 times that ership of high school-educated persons. 6 of people who had only an elementary-school edu- Nonetheless, the digital divide in the United cation. States remains. For example, in this same October While the Department of Commerce has reported 2000 report, 7 the DEC reported that 77% of house- a dramatic narrowing of the digital divide since holds with incomes exceeding $75,000 per year 1995, the gap remains large. Comparing the statis- had Internet access (60.9% of households with in- tics from 1995 reveals the effect (Table 2). comes between $50,000– $75000 had access), Thus, according to the 2000 Report, high-income whereas only 12.7% of households with incomes households now had less than four times the per- of $15,000 or less had access (21.3% of households

6 The DEC 2000 Report noted the achievements: tion level, particularly for those with some high school or col- The rapid uptake of new technologies is occurring among lege education. Households headed by someone with “some most groups of Americans, regardless of income, education, college experience” showed the greatest expansion in Inter- race or ethnicity, location, age, or gender, suggesting that dig- net penetration of all education levels, rising from 30.2% in ital inclusion is a realizable goal. Groups that have tradition- December 1998 to 49.0% in August 2000. ally been digital “have nots” are now making dramatic gains: •Blacks and Hispanics still lag behind other groups but have shown impressive gains in Internet access. Black households •The gap between households in rural areas and households are now more than twice as likely to have home access than nationwide that access the Internet has narrowed from 4.0 they were 20 months ago, rising from 11.2% to 23.5%. His- percentage points in 1998 to 2.6 percentage points in 2000. panic households have also experienced a tremendous growth Rural households moved closer to the nationwide Internet rate during this period, rising from 12.6% to 23.6%. penetration rate of 41.5%. In rural areas this year, 38.9% of •The disparity in Internet usage between men and women has the households had Internet access, a 75% increase from largely disappeared. In December 1998, 34.2% of men and 22.2% in December 1998. 31.4% of women were using the Internet. By August 2000, •Americans at every income level are connecting at far higher 44.6% of men and 44.2% of women were Internet users. rates from their homes, particularly at the middle income lev- •Individuals 50 years of age and older—while still less likely els. Internet access among households earning $35,000 to than younger Americans to use the Internet—experienced the $49,000 rose from 29.0% in December 1998 to 46.1% in Au- highest rates of growth in Internet usage of all age groups: gust 2000. Today, more than two-thirds of all households 53% from December 1998 to August 2000, compared to a earning more than $50,000 have Internet connections (60.9% 35% growth rate for individual Internet usage nationwide. for households earning $50,000 to $74,999 and 77.7% for 7 Falling Through the Net : Toward Digital Inclusion : A Report households earning above $75,000). on Americans’ Access to Technology Tools , U.S. Department •Access to the Internet is also expanding across every educa- of Commerce, October 2000. Biotechnology Law Report • Volume 22, Number 4 379 with incomes between $15,000 and $25,000 had clean up toxic or household pollutants or to manu- access).8 facture superior goods with very low expenditures The gap in Internet usage between United States of energy and even without access to expensive raw and Europe on one hand, and the rest of the world materials, it will offer these benefits only to those on the other, remains stark. The BBC recently re- who have access to the technology. If the lessons of ported that, “Black and Hispanic households are ap- the past with computers and the Internet are any proximately one-third as likely to have home Inter- gauge, the gap between rich and poor nations and net access as households of Asian/Pacific Islander classes, and between developed and developing na- descent, and roughly two-fifths as likely as white tions, will be dramatic. households.” Internationally, it noted “ more than Similarly, as we have learned from the progress half of Internet users are from the USA despite mak- made in life expectancy from the right combination ing up just 4.7% of the total world population.” The of AIDS , technological advances can quickly BBC report further noted that North America has have important positive effects on the quality and 57% of Internet Users, Europe 21.7%, Asia 17%, length of life but only to those to whom the tech- South America 3%, the Middle East 0.5%, and nology is available. The high cost of AIDS drugs Africa 0.8%. 9 has meant that longer life is not available to the If nanotechnology will really offer the promise of have-nots either within American society or in de- dramatic increases in length of life or the ability to veloping countries. 10 The situation was summed up

8 The 2000 Report summarized the depth of the divide: to 41.5% for households nationally). That gap is 4 percentage points wider than the 14 percentage point gap that existed in Nonetheless, a digital divide remains or has expanded December 1998. slightly in some cases, even while Internet access and computer —With respect to individuals, while about a third of the U.S. ownership are rising rapidly for almost all groups . For exam- population uses the Internet at home, only 16.1% of Hispanics ple, our most recent data show that divides still exist between and 18.9% of Blacks use the Internet at home. those with different levels of income and education, different —Differences in income and education do not fully account racial and ethnic groups, old and young, single and dual-parent for this facet of the digital divide. Estimates of what Internet families, and those with and without disabilities. access rates for Black and Hispanic households would have been if they had incomes and education levels as high as the •People with a disability are only half as likely to have access nation as a whole show that these two factors account for about to the Internet as those without a disability: 21.6% compared one-half of the differences. to 42.1%. And while just under 25% of people without a dis- •With regard to computer ownership, the divide appears to ability have never used a , close to 60% of have stabilized, although it remains large. people with a disability fall into that category. —The August 2000 divide between Black households and •Among people with a disability, those who have impaired vi- the national average rate with regard to computer ownership sion and problems with manual dexterity have even lower was 18 percentage points (a 32.6% penetration rate for Black rates of Internet access and are less likely to use a computer households, compared to 51.0% for households nationally). regularly than people with hearing difficulties. This differ- That gap is statistically no different from the gap that existed ence holds in the , as well as across age groups. in December 1998. •Large gaps also remain regarding Internet penetration rates —Similarly, the 17 percentage point difference between the among households of different races and ethnic origins. Asian share of Hispanic households with a computer (33.7%) and the Americans and Pacific Islanders have maintained the highest national average (51.%) did not register a statistically signifi- level of home Internet access at 56.8%. Blacks and Hispan- cant change from the December 1998 computer divide. ics, at the other end of the spectrum, continue to experience —Individuals 50 years of age and older are among the least the lowest household Internet penetration rates at 23.5% and likely to be Internet users. The Internet use rate for this group 23.6%, respectively. was only 29.6% in 2000. However, individuals in this age group were almost three times as likely to be Internet users if they —Large gaps for Blacks and Hispanics remain when mea- were in the labor force than if they were not. sured against the national average Internet penetration rate.— 9 “Plugging into the revolution,” Jane Black, BBC Online, Oc- The divide between Internet access rates for Black households tober 14, 1999, http://news.bbc.co.uk/1/hi/special_report/1999/ and the national average rate was 18 percentage points in Au- 10/99/information_rich_information_poor/467899.stm.(Last gust 2000 (a 23.5% penetration rate for Black households, com- visited June 2, 2003). pared to 41.5% for households nationally). That gap is 3 per- 10 See, e.g., “ Death Watch: The Global Response to AIDS in centage points wider than the 15 percentage point gap that Africa World Shunned Signs of the Coming Plague,” Barton existed in December 1998. Gellman, Washington Post , July 5, 2000; Page A1; “The End —The Internet divide between Hispanic households and the of AIDS? The plague continues, especially for the uninsured, national average rate was 18 percentage points in August 2000 but new drugs offer hope for living with HIV,” John Leland, (a 23.6% penetration rate for Hispanic households, compared Newsweek December 2, 1996. 380 Biotechnology Law Report • Volume 22, Number 4 this way by the Journal of the American Medical $3,000 in Brazil and less than $1,000 in India. Association 11: And when Brazil decided to provide the ge- neric drugs free to all its AIDS victims, it dis- Of the more than 21 million adults estimated proved the argument that poor countries to be living with HIV, about 90% live in the de- couldn’t master the complex regime of AIDS veloping world, where economic conditions pills. The government set up effective clinics, make it extremely unlikely they will benefit and reports indicate that Brazilian patients take from the expensive new antiretrovirals that have their medicine as meticulously as American proven so effective in managing the disease. AIDS sufferers do ...... “Many, if not most, lack any access to even ba- For five years, unAIDS (the Joint United sic pain-relieving drugs or treatment for their op- Nations program on HIV/AIDS) jawboned the portunistic infections,” said Peter Piot, MD, execu- companies to set lower prices for developing tive director of the Joint United Nations Program on countries. Finally, just before the international HIV/AIDS. AIDS conference held last July in Durban, While combination therapies can run as high as South Africa, five major pharmaceuticals $18,000 a year, most African countries can afford joined an “Accelerated Access” program to ne- to spend less than $10 a day on one person’s health gotiate 60% to 80% reductions in AIDS- care, said James McIntyre, MD, an obstetrician-gy- prices for poor nations. 12 necologist at Baragwanath Hospital in Soweto, South Africa. Similarly, the initiative to wire every school in Speaking at the 11th International AIDS Confer- the United States with Internet access shows that so- ence in Vancouver, Jonathan M. Mann, MD, MPH, ciety can narrow the technology gap if it sees the professor of epidemiology and international health problem and confronts it directly: at Harvard School of , said the ad- vances in HIV care illustrate the widening chasm In response to the educational opportunities between rich and poor nations: made available by dramatic technological in- novations in the early and mid-1990s, U.S. “The injustice is stark: Drugs are avail- Secretary of Education released the nation’ s able—at best—to the less than 10% of the first educational technology plan in 1996, Get- world’s people with HIV/ AIDS in the indus- ting America’ s Students Ready for the 21st trialized world ... Century: Meeting the Technology Literacy “And even though medical care inequities Challenge. This plan presented a far-reaching always have been ‘ the tragic rule’ separating vision for the effective use of technology in el- the haves from the have-nots, the HIV/ AIDS ementary and secondary education to help the pandemic is ‘profoundly different’ in one way next generation of school children to be better . . . educated and better prepared for the evolving For in AIDS, we all started in the same demands of the new American economy. place—with the same lack of treatment and Given that many schools and classrooms with the same hopes—and the unfairness has have only recently gained access to technology arisen right before our eyes.” for teaching and learning, the positive out- comes of these studies suggest a for ed- But there is hope. An initiative has been launched ucation that could be quite bright if the nation to get AIDS drugs to poor countries at low cost. It maintains its commitment to harnessing tech- was summarized this way in a recent Time article: nology for education.

... increasingly, poor countries and AIDS advocates are finding ways to shift the balance. 11 “Special Reports: New Drugs Have Limited Impact Glob- ... So a virtually identical version of the an- ally,” JAMA HIV-AIDS Information Center, 1999, www.ama- assn.org/special/hiv/newsline/ special/amnews/amn0916a.htm. tiretroviral combination cocktail that sells for 12 “Paying for AIDS Cocktails: Who Should Pick up the Tab $10,000 to $15,000 a year in the U.S. costs for the Third World?” Time , Feb. 12, 2001. Biotechnology Law Report • Volume 22, Number 4 381 The adoption of new and emerging tech- any compound one desires. Thus, terrorists could nologies by schools and classrooms offers even use nano-machines to assemble pure mixtures of more reason to be hopeful. With sufficient ac- dangerous toxins, even if they have no access to the cess and support, teachers will be better able underlying living creature that normally creates that to help their students comprehend difficult-to- toxin or to the raw material needed to produce the understand concepts and engage in learning, toxin. That is, at least theoretically, a nano-machine provide their students with access to informa- could build the anthrax toxin, molecule by molecule tion and resources, and better meet their stu- or at least chain by chain, in great abundance, even dents’ individual needs. If we take advantage if the terrorist had no access to the spore-forming of the opportunities presented to us, technol- bacterium Bacillus anthracis . The recent success at ogy will enhance learning and improve student assembling the polio , without even the aid of achievement for all students. nanotechnology, well illustrates this threat, 14 as Working together to achieve these goals does the initiation of a project to remove the genes constitutes a major leadership imperative fac- from gentilatium and replace them ing those seeking widespread improvements in with a pared-down and artificially constructed string teaching and learning. As a nation, we should of DNA with just enough genetic material to get the pledge to meet these new goals. 13 going again. 15 Terrorists could take relatively innocuous forms of a toxin or chemical and, by mak- Nanotechnology as a terrorist weapon ing a small addition to or deletion from the natural structure, change it into one far more dangerous. Because of its microscopic size, easy dispersal, On the other hand, as has been highlighted in the self-replication, and potential to inflict massive recent debate about the nuclear capabilities of Iraq, harm on persons, machines, or the environment, there may be choke points in the development or nanotechnology makes a tempting terrorist weapon. deployment of weapons that prevent their use by Since September 11, 2001, concerns about the rogue groups. For example, the United States has conversion of useful machines into terrorist weapons alleged that Iraqi scientists may largely possess the has been heightened. If rogue states and groups can know-how to build a nuclear weapon but have been acquire biological and chemical weapons of mass unable to gain access to sufficient quantities of destruction, then surely they can learn to use nan- weapons-grade enriched uranium. 16 Although it is otechnology. not clear that these kinds of non-proliferation strate- The dangers of nanotechnology as a terrorist gies and choke points exist in the exploitation of weapon are easy to see. First, a nano- that can nanotechnology, the quick identification of these operate within a human body could easily be pro- choke points and the rapid development of a global grammed to destroy rather than heal. Because of consensus on implementing non-proliferation strate- their small size, and because they might be quickly gies would be crucial. If such strategies do not ex- redesigned to avoid the latest counter-measure, nano-machines pose a potent threat as a terrorist weapon of the future. Similarly, nano-machines 13 could be designed to attack machines, rather than See, e.g., e-Learning: Putting a World Class Education at the Fingertips of our Children , U.S. Department of Education, humans. They could be made to destroy defensive December 2002. weapons, bring electrical generators to a halt, or eat 14 See, e.g., “Mail-Order Brew a Terrorism Debate away at protective encasements or linings around Virus Created in Lab Raises Questions of Scrutiny for DNA Suppliers,” Rick Weiss Washington Post , Wednesday, July 17, dangerous environments. Moreover, because of 2002, A01. their small size, they might be easily dispersed in 15 See, e.g., “ Creating Living Things,” Editorial, Washington the air or through the . Their transport could Post, November 23, 2002, A22; “Nothing Wrong with a Little be hard to detect. Finally, if these nano-machines Frankenstein,” Chris Mooney, Washington Post , December 1, 2002, B01. are programmed to be self-replicating or self-repli- 16 See, e.g., “Blair: Iraq Can Deploy Quickly; Report Presents cating and mutating, the danger they pose could be New Details on Banned Arms,” Glenn Frankel Washington very hard to contain. Post, September 25, 2002, A01; “Observers: Evidence for War Lacking; Report against Iraq Holds Little That’s New,” Dana Nanotechnology might someday permit one to as- Priest and Joby Warrick, Washington Post , September 13, 2002, semble, molecule by molecule or chain by chain, A30. 382 Biotechnology Law Report • Volume 22, Number 4 ist, then policy makers need to begin to develop ro- concern in the near term because most nanotech- bust defense mechanisms to deal with the potential nology is in the early experimental or developmen- nanotechnology terrorist threat. tal stage. Just as scientists have been working with deadly pathogens in laboratories across the world Inadvertent release or inadvertent spread of for a long time and have established effective pro- nanotechnology tocols that protect researchers and the general pub- lic from the inadvertent escape of these pathogens As we have learned with other technologies, sci- from facilities that study or genetically alter them, entists had thought they had proven methods to pre- research protocols should be able to protect the pub- vent the inadvertent spread of biotechnology into lic from an inadvertent spread or release of nan- the wider environment. They were wrong. Nan- otechnology during the developmental stages. The otechnologists face these same risks. Foresight Guidelines on Molecular Nanotechnology Well-intentioned and expert bioengineering sci- is one attempt to establish principles to guard against entists were confident that genetically engineered the inadvertent release of nanotechnology. 20 plant seeds would not be able to migrate into non- Nonetheless, inadvertent release or spread of nan- engineered fields and would not enter the human otechnology during deployment remains a sserious food chain by accident. They were wrong. Geneti- risk. Scientists and policy makers need to keep the cally altered seeds and products have been discov- risk in mind and devise coordinated contingency ered in human foods (such as taco shells), and seeds plans to deal with the eventuality. intended for animal feed were planted by farmers and spread into fields of non-engineered crops. 17 Who, if anyone, should regulate nanotechnology? Similarly, kernels from an experimental corn plant altered to produce a pharmaceutical product may As with any new technology, the question of have contaminated a subsequent soybean crop in- whether there should be regulation of nanotechnol- tended for human consumption. 18 ogy is an important one that needs to be resolved Likewise, food experts were confident that they early in its lifecycle. First, one must ask whether could control or exclude the disease agent that nanotechnology should be subject to comprehensive causes “mad cow” disease from human food chains. or more limited subject matter regulation or be left They, too, were wrong. That failure has led to mass largely unregulated. Second, one must ask if the animal kills causing enormous social and economic level of regulation should be different depending on costs for farmers and society and has had wide-rang- whether the activity at issue is research and devel- ing effects, including an erosion of public confi- opment or commercial deployment. Third, because dence in government and in the current means to certain types of nanotechnology are likely already ensure safe food supplies. 19 subject to various decentralized regulatory regimes, Nanotechnologists argue that inadvertent spread a subsidiary question is whether regulation of nan- will not happen because nano-machines need a con- otechnology should be centralized in one agency or fined source of power, like a battery. They argue that any inadvertent release is not likely to have sig- 17 nificant detrimental effects, because the nano-ma- See, e.g., “ Gene-Altered Canola Can Spread to Nearby Fields, Risking Lawsuits,” Jill Carroll, Wall Street Journal , June chines will simply run out of energy quickly. This 28, 2002, B6. assumption may be naïve. Scientists have already 18 See, e.g., “ProdiGene-Modified Corn Plant Nearly Gets into postulated that nano-machines could be built to rely U.S. Food Supply,” Scott Kilman, Wall Street Journal No- vember 13, 2002. on energy sources from the environment around 19 See, e.g., “ In Europe, a Unity of Distrust,” Jim Hoagland, them. Moreover, as lovers of electronic gadgets Washington Post , February 1, 2001, A21; “Japan to Test 1 Mil- know, batteries are becoming better, and power re- lion Cattle for ‘ Mad Cow’ ; Concerns Grow after First Case quirements are lessening. As a result, while a nano- Botched,” Kathryn Tolbert, Washington Post , September 20, 2001, A30; “Beef’s Battles in the Midst of a Comeback; Red machine may eventually fail for lack of power, mil- Meat Faces Another Image Crisis,” Douglas Hanks III, Wash- lions of them, inadvertently released, could do great ington Post , March 28, 2001, F1. 20 damage before that eventuality came true. Foresight Guidelines on Molecular Nanotechnology , origi- nal version 1.0, February 21, 1999; revised draft 3.7, June 4, It is important to keep in mind that the risk of the 2000, and Institute for Molecular Manufac- inadvertent spread of nanotechnology is less of a turing. Biotechnology Law Report • Volume 22, Number 4 383 continue to be decentralized. Finally, there is the to the public from false claims about the product but question of whether self-regulation, governmental more from poor quality or poor risk management. regulation, or a mixture of the two is the best ap- Thus, nanotechnology is like, and yet not like, com- proach. prehensively regulated industries. Nanotechnology is also both like and not like What level of regulation? some focused-regulation industries. Like health care providers or used car sales, poor nanotechnology The question of what level of regulation to im- practices may not necessarily lead to an immediate pose on an emerging technology is complex. A threat to human life, but their potential for health or range of industries (technological and non-techno- economic loss to consumers is great enough to have logical) are subject to comprehensive state or fed- motivated legislatures to impose detailed regula- eral regulatory schemes in the United States. Ex- tions in certain areas (such as disclosure of interest amples are the utilities, nuclear power, foods, drugs rates on loans or protection of privacy of health in- and cosmetics, and securities. Many industries, such formation) or to prohibit certain kinds of undesir- as the sale of cars, are unregulated in large part, but able practices (such as outlawing kickbacks or en- certain activities or practices are the subject of tar- acting lemon laws). There are likely to be particular geted regulations or prohibitions. Other industries, concerns about nanotechnology or its uses that such as the Internet, software, and consumer appli- might prompt legislatures to enact focused legisla- ances, are largely unregulated. Analogies and dis- tion to curb or regulate particular parts of the in- tinctions can be drawn between nanotechnology and dustry. industries in each of these categories, as these three Finally, nanotechnology is also both like and un- categories cover the range of possible regulatory ac- like unregulated industries. Even where defective tivity, one category must be chosen. products can cause injury and death, such as with There are two basic motivations for comprehen- heavy equipment or consumer appliances, most sive regulatory schemes— natural monopoly and products are not regulated. Rather, the legislatures overriding public harm. Utilities, such as electric- leave to tort law (such as personal injury lawsuits ity, gas, and telephone service, as well as activities or antitrust actions) the job of “regulating” bad con- such as broadcasting, have been subject to compre- duct. Also, one can make the argument that the same hensive regulation because they are important ser- market forces that shape and restrain bad practices vices that form natural monopolies so that there are in unregulated industries and the same possibility of inadequate free market forces to control quality, ac- rapid innovation from a lack of regulation that has cess, prices, and terms of service. 21 Nanotechnol- helped fuel the rapid growth of the Internet and the ogy does not form a natural monopoly. software industries are needed to propel the devel- On the other hand, nuclear power, drugs, cos- opment of nanotechnology. metics, and foods have been subject to comprehen- sive regulation, not because of their monopoly na- Developmental-versus deployment-stage ture, but because of the danger they pose to humans regulation from poor quality, poor risk management, false claims, or inadequate testing. Even where physical Sometimes, a level of regulation for develop- injury is not present but harm can result from poor mental activities is either not imposed or is imposed quality, poor risk management, and false claims, comprehensive regulation has been imposed, such 21 Although even this view is subject to challenge and debate. as in the stock market and securities area. As high- The deregulation of many telecommunications services through lighted elsewhere in this paper, nanotechnology can FCC action before and since the Federal Telecommunications pose a significant risk to humans, like the risks Reform Act of 1996, Pub. LA. No. 104-104, 110 Stat. 56 (1996) posed by these regulated industries. Whether the risk highlights the fact that the conclusion that utilities from natural monopolies has been subject to rethinking. On the other hand, is similar enough to warrant such comprehensive local telephone services remain regulated, and commentators regulation is the open question. I note, however, that disagree about whether telecommunications deregulation was a the regulatory concern about nanotechnology differs good thing. See, e.g., “How The Bells Stole America’s Digital Future: A NetAction White Paper,” Bruce Kushnick, 2001, from that of some of the industries listed above in reprinted at http://www.netaction.org/broadband/bells/ (last vis- that it does not stem primarily from a fear of harm ited June 2, 2003). 384 Biotechnology Law Report • Volume 22, Number 4 at a different level than when the same activity is do in a reliable fashion. Under the Safe Medical De- used later commercially or more generally. Psycho- vices Act of 1990 and the Medical Device Amend- logical counseling techniques are an example. When ments of 1992, the FDA was granted greater post- a researcher into family dynamics or psychology market controls, such as user reporting of device- wishes to perform human experimentation (with related deaths or serious injuries to provide an early federal funding 22), relatively strict regulation is im- warning system for device complications or failures. posed.23 However, when the same techniques are Nanotechnology that are introduced into a actually put into practice by school counselors or human body to repair it would seem to be medical ministers, there is little or no regulation. On the devices under the FDCA. other hand, laboratory development of new foods Foods and food additives are also regulated by and cosmetics is relatively unregulated. However, the FDA under the FDCA, which bans the intro- their sale (deployment) to the public is subject to duction or delivery into interstate commerce of relatively comprehensive regulation, and for some “misbranded” or “ adulterated” food. 26 “Misbrand- activities, because of the dangers during experi- ing” is the use of misleading labeling and packag- mentation, deployment, and even disposal, such as ing, as well as false representations as to quality. 27 with nuclear materials, comprehensive regulation is Section 402 of the FDCA defines “adulteration” as imposed from cradle to grave. the addition of poisonous or deleterious substances Policy makers must decide which model applies to food.28 There are General Standards for adulter- to nanotechnology. The answer may depend on the ation,29 and if necessary, the FDA can prescribe use. Nanotechnology regulation is not being written Special Standards for particular types of adulter- on a blank slate: there are a host of existing regu- ations.30 Nanotechnology that either creates food or latory schemes that will affect its development and food additives, or the misbranding of nanotechnol- deployment. This fact leads us into the next topic, ogy that is used in the human food supply would “Is the existing decentralized approach to nan- appear to be governed by existing FDA law. otechnology regulation adequate?”

22 Centralized versus decentralized regulation See discussion of federal regulation of human research ac- tivities elsewhere in this document. 23 One aspect of the debate about which category— This topic is discussed in more detail elsewhere in this arti- cle. comprehensive regulation, focused regulation, or 24 This decentralized approach was reinforced in 1986, when unregulated—should be used with nanotechnology the federal government completed the “Coordinated Framework is whether existing decentralized regulatory schemes for Regulation of Biotechnology,” 51 F.R. 23,302–23,350 (1986), which has been characterized as “establish[ing] the pol- are already focused on the major risks so that no icy that a product of biotechnology should be regulated ac- further action should be taken at this time. It is likely cording to its composition and intended use, rather than by the that some nanotechnology will be used to create method used to produce it.” The Regulation of Biotechnology , medical devices subject to the control of the Food Randy Vines, Virginia Tech Publication Number 443-006, May 2002. and Drug Administration. It is likely that some nan- 25 Federal Food, Drug, and Cosmetic Act, §201(h) defines “de- otechnology will be used to deploy products regu- vice” as “an instrument, apparatus, implement, machine, con- lated by the Environmental Protection Agency. Nan- trivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is otechnology used in human medical research will ... recognized in the official National Formulatry, or the United be naturally subject to regulation by the Department States Pharmacopoeia, or any supplement to them, intended for of Health and Human Services and hospital review use in the diagnosis of disease or other conditions, or in the 24 cure, mitigation, treatment, or prevention of disease, in man or boards. The question presented is whether the ex- other animals, or intended to affect the structure or any func- isting decentralized approach is adequate. tion of the body of man or other animals, and which does not Under federal law, medical devices 25 are subject achieve its primary intended purposes through chemical action to FDA jurisdiction under the Food, Drug, and Cos- within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its metic Act (FDCA) to ensure that they are “safe and primary intended purposes.” effective.” “ Safe” means that the probable benefits 26 21 USC §331. 27 to health in its intended use outweigh any probable 21 USC §342. 28 21 USC §342. risks of harm or injury by the device. “ Effective” 29 21 USC §342(a). means that the device does what it is supposed to 30 21 USC §342(a)(2). Biotechnology Law Report • Volume 22, Number 4 385 Under Section 505 of the FDCA and 351 of the more alike across a range of applications, then it Public Health Service Act, 31 drugs must be subject may be better to concentrate oversight within a sin- to premarket approval for their labeled uses. The in- gle agency so that it is able to view the entire scope troduction of a misbranded drug is prohibited. 32 of use of nanotechnology and form “nano-centric” Again, nanotechnology-created drugs appear to be regulatory programs. A recent article in the Wash- covered under current FDA regulation. ington Post (commenting on a report by the Pew Pesticides are regulated under the Federal Insec- Initiative on Food and Biotechnology) notes, in re- ticide, Fungicide and Rodenticide Act (FIFRA) of lation to genetically altered fish, for example, that 1947.33 Pesticides cannot be sold unless they are while the FDA has jurisdiction to regulate the food registered and properly labeled under the Act. 34 Ap- hazards that might be created by such fish, it has no plicators who use a pesticide unlawfully are subject power to investigate the environmental hazards re- to written warning, citation, and fines from the lated to an accidental release of the fish; that is, no EPA.35 Although it is not clear, nano-machines and central federal agency has the power to view certainly nanotechnology-created pesticides may be biotechnology (or nanotechnology) as a whole. 38 under the current jurisdiction of the EPA. The point here is that unless a debate on the merits A significant role in the above regulatory scheme of decentralized regulation of nanotechnology be- is given to the United States Department of Agri- gins sooner rather than later, agencies will naturally culture’s Animal and Plant Health Inspection Ser- begin to regulate the nanotechnology within their vice (APHIS). Under the Plant Protection Act of existing reaches. Such agencies will then have a 2000,36 the Secretary of Agriculture has the power vested interest in a decentralized approach to nan- to prohibit or restrict imports, exports, or interstate otechnology regulation. Such ingrained interests movements of plants, plant pests, noxious weeds, may make a change to central regulation more dif- and biological control organisms. Similarly, the An- ficult to achieve (assuming the right answer is cen- imal Health Protection Act (AHPA) of 2002 37 con- tralized regulation). 39 solidates various powers of the USDA in the area of regulation of animals and technologies that affect Governmental or self regulation? animals and permits the Secretary to prohibit or re- Finally, one must ask whether regulation should strict entry of any animal or related material if - be governmental or self or a mixture thereof. Many essary to prevent spread of any livestock pest or dis- regulatory schemes rely primarily on a series of gov- ease. The Secretary may also prohibit or restrict ernmentally created regulations and government en- exports if necessary to prevent the spread of live- forcement programs. Examples are food and drug stock pests or diseases from or within the U.S. regulation and environmental regulation. Agencies Regulation of research on human subjects that is impose a series of operational, record keeping, and “conducted, supported or otherwise subject to reg- reporting duties on the industries or activities within ulation by any Federal Department or Agency” is overseen by the Office for Human Research Pro- tections. 45 CFR Part 46 details the kinds of con- trols that are imposed on human research studies, 31 Section 505 of the Food, Drug, and Cosmetic Act, 21 USC including Institutional Review Boards and informed 355(d); §351 of the PHSA, 42 USC §262. 32 21 USC §331–334. consent procedures. 33 7 USC §§135–136y. The above are just some examples of how the reg- 34 7 USC §136a. ulation of nanotechnology would likely evolve if no 35 7 USC §136i, 136j-l. 36 7 USC §§7711–7758. debate is initiated into the benefits and risks of a de- 37 Part of the Farm Bill of 2002. centralized versus a centralized regulatory regime. 38 “Old Laws, New Fish: Environmental Regulation of Gene- On one hand, if nanotechnology medical devices or Altered Foods is a Gray Area,” Justin Gillis, Washington Post , January 15, 2003, E01. nanotechnology-created pesticides are more like 39 Another issue that must be balanced is the extent to which current medical devices and current chemical pesti- particular regulatory agencies have expertise that must be cides than they are like other and brought to bear versus the amount to which they are influenced nano-machines, then decentralized regulation makes by the industry they are supposed to regulate. In a similar vein, some agencies are seen as weak regulators, given their statu- sense. On the other hand, if nanotechnology experts tory charters or present leadership, and others are seen as too are few and expensive, or nanotechnology risks are zealous or ideological. 386 Biotechnology Law Report • Volume 22, Number 4 their domain. While private industry may suggest critics and scandals. 46 On the other hand, regulation regulations or comment on the advisability of pro- by those with knowledge of and involvement in the posed regulations, the governmental agency ulti- day-to-day real workings of an industry can viewed mately has the final say. Moreover, violations of the as effective and popular. regulations are prosecuted primarily by govern- Which model better suits the nanotechnology area mental agencies or prosecutors. is one that policy makers and the public must eval- On the other hand, a self-regulatory scheme, as uate. in the securities area, leaves the creation of rules and their primary enforcement to the industry mem- bers themselves. In the securities industry, the Se- THE MYTH OF THE “SHIELD” curities and Exchange Act of 1934 (SECA) provides that no broker or dealer (with minor exceptions) may Proponents of nanotechnology argue that the best perform transactions in securities unless it is a mem- defense against an accidental or intentional release ber of a “Securities Association.”40 The SECA then of nanotechnology would be to build a nanotech- requires that Securities Associations be registered nology shield. That is, one could build defensive with the U.S. Securities and Exchange Commission nano-machines that would hunt out and destroy any (SEC).41 A Securities Association must fill out a miscreant nano-machines. The myth of a shield has very detailed application that meets a long series of been shown in at least two different contexts. Un- tests set out in the statute before it can be approved less nanotechnologists can convince us that these by the SEC. Among these are requirements that gov- flaws will not occur in a nanotechnology shield, the ernance of the association be representative of the idea of a shield may distract policy makers and sci- members, that the rules provide for a code of con- entists from other avenues that would lead to better duct that meets certain standards, and that the asso- public safety. ciation be permitted to discipline its members. 42 First, as we know from prior attempts to intro- Disciplinary actions must be based on hearings and duce natural predators to combat invading insects there must be an internal appeal processes within and plants that otherwise have no natural defenses the Securities Association. The SEC has oversight against the pest, even where such predators do erad- of the Securities Association rules, and a member icate or control these pests, they can become pests can appeal to the SEC from a disciplinary decision. in and of themselves. Often, this problem arises be- Appeal can be had to the federal courts from an SEC cause an environment that has no natural defenses decision on any Association’s rules changes or from against a particular pest probably also has no nat- a disciplinary decision. The National Association of ural defense against that pest’s predators. In New Securities Dealers (NASD) is largest self-regulatory Zealand, stoats and weasels were imported in an at- organization in the United States, with a member- tempt to control a rabbit population that was threat- ship that includes virtually every broker/ dealer in ening to render the Kiwi bird extinct by eating the the nation that does securities business with the pub- same food. Although they ate some rabbits, the lic. The NASD conduct rules are a massive set. stouts and weasels also attacked the Kiwi popula- Some are broad, such as, “A member, in the con- tion they were meant to protect. 47 Similarly, in duct of his business, shall observe high standards of Hawaii, mongooses were imported to try to control commercial honor and just and equitable principles of trade.”43 Other rules prohibit very specific con- duct, such as, “No member shall deal with any non- 40 15 USC §780(b)(8). 41 15 USC §780-3(a). member broker or dealer except at the same prices, 42 15 USC §780-3(b). for the same commissions or fees, and on the same 43 NASD Manual Section 2110. terms and conditions as are by such member ac- 44 NASD Manual Section 2420. 45 corded to the general public.” 44 The NASD typi- See generally the notices of such actions by month at http://www.nasdr.com/2700.asp (last visited June 2, 2003). cally disciplines tens of brokers or dealers per 46 See, e.g., “Securities Markets Regulation: Time to Move to month, with suspensions, disbarments, and fines— a Market-Based Approach,” Dale Oesterle, Cato Institute, June far more than the SEC or federal prosecutors. 45 This 21, 2000. 47 See, e.g., The Land of New Zealand: A Report . Sven system has been in effect for almost 70 years. The MacAller, http:/ /www.stormbefore.com/squatley/newzeal.html securities self-regulatory scheme is not without its (last visited on June 2, 2003). Biotechnology Law Report • Volume 22, Number 4 387 the rat population. However, because the mon- must face. Some of these are overarching concerns gooses are active during the day and the rats at night that affect every stage of nanotechnology develop- and they both live in the area and both eat native ment and deployment. Others primarily affect only birds or their eggs, the predator is as much a pest the funding, development, or deployment stage. We as the pest it was supposed to eradicate. 48 turn first to the overarching issues. Second, as Computer Professionals for Social Re- sponsibility (CPSR) 49 pointed out during the “ Star Issues that affect every stage of nanotechnology Wars” debates of the 1980s, if a complex and costly development and deployment shield stands a fair chance of failure, it may be worse Self-replication: Human -like for the security of a nation than building no shield at nanotechnologies all. This outcome has several causes. First, the en- emy is always making benefit and cost calculations. Because nanotechnology has the power to self No weapon system is ideal, so a shield is just another replicate, it poses dangers that are similar to those type of potential “cost” in the calculation for that posed by biotechnology and bioengineering re- weapons system. If the enemy believes that the shield search and development but with its own unique will fail even a small percentage of the time, the en- twists. emy may have an incentive to build so many offen- In his book ,50 Dr. K. Eric sive weapons that either at least some of them will Drexler discusses the concept that nano-machines penetrate the shield and do significant damage or the could be produced to build other nanotechnology. sheer numbers of weapons will exhaust the shield. In He calls these building machines “assemblers.” Nor- this instance, a shield may actually cause overprolif- mally, assemblers are nano-machines that build use- eration of arms. Second, a false sense of security be- ful chemical chains, assemble minute components cause of a costly shield technology may cause mili- into a working computer, or the like. However, as- tary and political planners (who face a limited budget) semblers could be programmed to build machines to abandon or underutilize lower technology defenses identical to themselves, creating more assemblers. even though collectively they may be far more ef- That is, nano-machines could become self-replicat- fective and robust. Third, confidence in the ability of ing. a defensive shield may actually cause the nation to Some have argued that the danger posed by self- become more aggressive, as it believes that it can in- replicating assemblers would be relatively small, as flict more damage on its enemy than will be done to their only function is to produce more producers. it. That is, the United States was more likely to in- This is not necessarily true. First, as we know from vade Serbia, say, to protect human and other inter- human cells, if producers are inside an im- ests there (because American defense systems were portant structure (such as a human body, a bridge, correctly thought to be good enough to prevent dam- or a computer that controls a hospital’ s functions) age or casualties to Americans by Serbian weapons) and they reproduce quickly and efficiently, they may than America would be to attack a more technologi- cause the surrounding “organ” or structure to cease cally developed and savvy nation. Finally, a massive to function properly. Such failure can lead to death shield suffers from time lag. Weapons and defenses or other harmful consequences. are an ever-changing game of cat-and-mouse. Unless Further, nano-machines could be programmed to one can quickly, inexpensively, and correctly mutate do two functions: replicate a certain number of times the nano-machine shield to face new and quickly and then move on to do “useful” work. If there were changing offensive nano-machines, the shield will be programming or design errors in the instructions for effective only against what are by then obsolete and the “ useful” work function, then the danger posed unused nano-weapons. by self-replicating nano-machines could be severe. In the computer field, the analogous problem is the

OTHER ISSUES FACING NANOTECHNOLOGY 48 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/ Beyond the largest vexing issues facing nan- 2001/Spring/index.html (last visited June 2, 2003). otechnology, there are other issues policy makers 50 Engines of Creation , K. Eric Drexler, Doubleday, 1986. 388 Biotechnology Law Report • Volume 22, Number 4 proliferation of computer worms. A worm is a self- into the DNA of another and thereby contained program that can travel from computer create a hazard? The second was whether the system to computer system, replicate itself there, do food and other products of animal biotechnol- damage, and then send itself to another intercon- ogy, whether genetically engineered, or from nected computer system. Perhaps the most famous clones, are substantially different from those Internet worm was created by Robert Tappan Mor- derived by more traditional, extant technolo- ris, Jr., on November 2, 1988. It has been reported gies. A third major concern was whether the that Morris did not expect the worm to replicate as technologies result in novel environmental fast as it did nor to take up so much processing hazards. The fourth concern was whether the power on the computers it infested. The problem technologies raise animal health and welfare was that he set some parameters within the program issues. Finally, there was concern as to to the wrong values, and his worm, which was never whether ethical and policy aspects of this intended to do harm, wreaked havoc— all because emerging technology have been adequately ad- his worm had bugs. 51 The problem with complex dressed. Are the statutory tools of the various technologies is that bugs within them can cause government departments and agencies in- them to behave in an unexpected and destructive volved sufficiently defined? Are the techno- manner. We need to keep this lesson in mind when logic expertise and capacity within agencies we evaluate the risks of nanotechnology. 52 sufficient to cope with the new technologies should they be deemed to pose a hazard? 55 Cloning and nanotechnology Even if we assume that the current battles over Nanotechnology can be used to clone machines genetic bioengineering as a cloning technique will as well as living creatures. Issues similar to those currently plaguing policy makers about biological cloning need to be raised early in the life of nan- 51 otechnology. See, e.g., Eisenberg T, Gries D, Hartmanis J, Holdomb D, Lynn MS, Santoro T. The Cornell Commission: on Morris and Proponents of nanotechnology postulate a world the Worm. Commun ACM 1989;32:706–710. Several other ar - where DNA strands can be custom built by repair- ticles in the same issue explore other aspects of the Morris ing or replacing sequences in existing strands of worm. 52 While more far fetched, it is not clear that assemblers could DNA or even by building the entire strand, from not interact with microscopic living organisms. One could imag- scratch, one sequence at a time. With enough nano- ine that a bacterium or other creature could find a way to incor- robots working quickly enough, one could build a porate or become symbiotic with the misdesigned assemblers, producing a totally unexpected and bad result. Examples of cap- DNA strand that will produce a perfect clone. Be- ture and symbiosis in nature are common. For example, it is fore Congress now are several bills that would limit thought that mitochondria, which are the energy powerhouses of or ban cloning of human beings. 53 The same issues cells, were originally bacteria that became permanently captured will arise, or re-arise, if nanotechnology is success- by eukaryotic cells millions of years ago. See, e.g., “All Family Trees Lead to ‘ Eve,’ An African; Scientists Conclude Genetic ful in promoting cloning of DNA segments, cells, Analysis Indicates Common Ancestor 200,000 Years Ago,” organs, or entire organisms. Boyce Rensberger, Washington Post , January 13, 1987, A3. As A prepublication report of the National Academy the article points out, this is lucky for some scientists, who have 54 used that fact to show that we all may have a common relative, of Sciences highlights the dangers and promise of called “Eve.” Lichens, sharks, and cleaner fish; tick birds on rhi- cloning. The issues highlighted in the Report echo nos; ox and pecker birds; and termites and their intestinal cellu- those that will affect the nanotechnology debate in lose-digesting flagellates are just a few of the overwhelming ex- amples of symbiosis in nature. The possibility that nano-machines this area: could become symbiotic with creatures, while remote, cannot be completely discounted. During the committee’ s deliberations, five 53 See, e.g., Human Cloning Prohibition Act of 2001, H.R. 2505 overarching concerns emerged. The first was (introduced 7/16/2001); Human Cloning Ban and Stem Cell Re- search Protection Act of 2002, S. 1893 (introduced 1/24/2002). whether anything could theoretically go wrong 54 Animal Biotechnology : Science Based Concerns , Committee with any of the technologies. For example, is on Defining Science-Based Concerns Associated with Products it theoretically possible that a DNA sequence of Animal Biotechnology, Committee on Agricultural Biotech- nology, Health, and the Environment, Board on Life Sciences, from a vector used for gene transfer could es- National Research Council, August, 2002. cape and unintentionally become integrated 55 Ibid., Executive Summary, page 4. Biotechnology Law Report • Volume 22, Number 4 389 have been resolved (one way or the other) by the Some authors consider rule by secretive time nanotechnology perfects its own methods of technocrats to be virtually inevitable. In Cre- cloning, social issues will arise. It is likely that nan- ating Alternative , Hazel Henderson otechnology’s efforts will lead to twists in the as- argues that complex technologies “become in- sumptions that lead to the resolution of cloning is- herently totalitarian” (her italics) because nei- sues in terms of genetic bioengineering. Policy ther voters nor legislators can understand them. makers should anticipate, now, that in setting the boundaries for bioengineered cloning, the need to Dr. Drexler sees two flaws with the present pub- foresee issues that will arise from cloning by nan- lic policy framework. First, regulators have vested otechnology and be ready to reevaluate cloning reg- interests in maintaining their present power and the ulation before nanotechnology perfects its own status quo. Second, secrecy and the incentive to methods of cloning. If we do not anticipate the nan- cover-up mistakes by “technocrats” harm the for- otechnology problems, the debate will emerge in an mation of proper public policy. Thus, Dr. Drexler environment like the current one: one filled with a proposes “ fact forums” of scientific experts to re- frenzy and uproar, rather than in an atmosphere of place the present public policy framework. He sum- reflection and deliberateness. marizes his approach as follows:

We need better procedures for debating Social policy and law always lag behind technical facts—procedures that are open, science credible, and focused on finding the facts we It has often been said that law breathlessly tries need to formulate sound policies. We can be- to keep up with scientific advances. This is likely gin by copying aspects of other due-process to be the case in nanotechnology. procedures; we then can modify and refine In Chapter 13 of his book, Drexler makes a strong them in light of experience. Using modern pitch for keeping policy makers out of the debate communications and transportation, we can about nanotechnology and urges the institution of develop a focused, streamlined, journal-like technical panels. He summarizes his argument this process to speed public debate on crucial facts; way: this seems half the job. The other half requires distilling the results of the debate into a bal- Unfortunately, leaving judgment to experts anced picture of our state of knowledge (and causes problems. In Advice and Dissent, Pri- by the same token, of our state of ignorance). mack and von Hippel point out that “to the ex- Here, procedures somewhat like those of tent that the Administration can succeed in courts seem useful. keeping unfavorable information quiet and the Since the procedure (a fact forum) is in- public confused, the public welfare can be sac- tended to summarize facts, each side will be- rificed with impunity to bureaucratic conve- gin by stating what it sees as the key facts nience and private gain.” Regulators suffer and listing them in order of importance. Dis- more criticism when a new drug causes a sin- cussion will begin with the statements that gle death than they do when the absence of a head each side’s list. Through rounds of ar- new drug causes a thousand deaths. They mis- gument, cross examination, and negotiation regulate accordingly. Military bureaucrats have the referee will seek agreed-upon statements. a vested interest in spending money, hiding mis- Where disagreemen ts remain, a technical takes, and continuing their projects. They mis- panel will then write opinions, outlining what manage accordingly. This sort of problem is so seems to be known and what still seems un- basic and natural that more examples are hardly certain. The output of the fact forum will in- needed. Everywhere, secrecy and fog make bu- clude backgrou nd arguments, statements of reaucrats more comfortable; everywhere, per- agreement, and the panel’s opinions. It might sonal convenience warps factual statements on resemble a set of journal articles capped by a matters of public concern. As technologies concise review article—one limited to factual grow more complex and important, this pattern statements, free of recommend ations for grows more dangerous. policy. 390 Biotechnology Law Report • Volume 22, Number 4 Unfortunately, despite the initial appeal of a sci- on the basis of new evidence, and the fact that one entist-driven public policy debate, society has needs to expect the unexpected at all times lead to learned that scientists are not always the best pol- the need to involve others in public policy debates. icy makers. A recent article in the Washington Post Moreover, public policy involves more than scien- (May 27, 2002), about flaws in the swine flu vac- tific truth: it involves a balancing of competing so- cine program of 1976 illustrates this problem. The cietal needs and goals. Broader goals, such as the swine influenza epidemic of 1918–1919 claimed the allocation of scarce resources among competing lives of between 20 and 100 million people, so when technologies and non-technology needs, the weigh- the virus reappeared in 1976, public health officials ing of costs and benefits in pursuing particular proj- took quick action. The consensus of the majority of ects, whether certain technologies should be regu- medical experts was that an epidemic was likely and lated or banned, whether certain bad activities the side effects of a vaccine small. The Post notes should be made criminal or should be regulated, and that, “According to various accounts, the idea that who should bear the legal liability for damages a swine flu epidemic was quite unlikely never re- caused by the failure of technology, are all issues ceived a full airing or a fair hearing, although nu- that are beyond the expertise of technical panels but merous experts apparently held that view. ... A few are vital to the conclusion of a rational public pol- experts suggested the vaccine be made and stock- icy debate. piled but used only if there was more evidence of On the other hand, it is important for the nan- an epidemic. This was considered but rejected early otechnology community to educate the public and on. The argument was that the influenza vaccine had policy makers early about important aspects and few, if any, serious side effects, and that it would characteristics of nanotechnology so that the debate be far easier (and more defensible) to get it into peo- on public policy is not tainted by those who slant ple’s bodies before people started dying.” That is, the scientific facts in the heat of the debate in order the Centers for Disease Control, on the basis of the to persuade. Similarly, schools, universities, and input and consensus from medical experts, con- governments must undertake programs early to ed- cluded that there was a “ strong possibility” of a ucate themselves and their students or employees on swine flu epidemic and that “the chances seem to the science of nanotechnology. be 1 in 2.” In fact, the epidemic never emerged, and the experts were very wrong—the vaccine had se- Long-term social effects of the success of vere side effects, the worst being a nerve disease nanotechnology known as Guillain-Barré syndrome. The article notes, “On Dec. 16, the swine flu vaccine campaign If its proponents are correct, nanotechnology was halted. About 45 million people had been im- could have vast and sudden impacts on our society. munized. The federal government eventually paid Policy makers and society need to consider re- out $90 million in damages to people who devel- sponses to such profound effects. This paper illus- oped Guillain-Barré. The total bill for the program trates only two examples. was more than $400 million.” The article ends with Nanotechnology might increase dramatically the lessons from Harvey Fineberg, a former dean of life expectancy of human beings through diagnos- Harvard’s School of Public Health, “Among them: tic or treatment nano-machines, improved drugs, or Don’t over-promise; think carefully about what DNA repair. This is often seen as a purely positive needs to be decided when; don’t expect the con- outcome. However, a sudden increase in the life ex- sensus of experts to hold in the face of changing pectancy of a large number of people will likely events. The biggest, he said recently, was perhaps mean that the carrying capacity of cities, countries, the most obvious: Expect the unexpected at all and perhaps even the entire world will be exhausted times.” in supporting currently living persons. This would The point here is that although scientific input and mean that new births would have to be controlled. expert panels, perhaps even the “fact forums” pro- Further, longer productive lifespans mean that key posed by Dr. Drexler, are vital to an informed pub- power positions in government, academia, and cor- lic policy debate, the politics within academia, the porations will not be turning over in their normal push for consensus in panels despite minority views, manner. As a result, we need to consider the effects the rapidly changing opinions about scientific issues on society of a slower turnover of power to the next Biotechnology Law Report • Volume 22, Number 4 391 generation. One of the great advantages of new chil- This is not a problem only in the United States. dren is that they introduce new ideas and challenge In an article entitled, “How Should UK Science Be existing norms. It is said that some of the greatest Funded?” it was noted that, “According to latest fig- scientists completed their greatest contributions be- ures from the OST, one-third of UK government fore the age of 30. Moreover, children grow up to funding for science, and technology accept as natural things that their parents found im- comes from the Ministry of Defence. This amounts possible to live with. For example, racial integra- to 2.1 billion a year. In comparison, the Dept of tion in jobs and the military, and even interracial Environment, Transport and the Regions is respon- marriage, seen a generation ago as an idea that might sible for less than 3% of government funding of sci- tear apart the United States, is now accepted as fact ence and technology.” Similarly, in India, “ Ac- by most children. 56 Similarly, the use and accep- cording to reports issued by the Indian government tance of new technologies, such as computers, is far and analyzed in SIPRI Yearbook 1998, the main re- more prevalent in children than in their more senior cipient of the government’s scientific largesse has counterparts. been the Defence Or- If the proponents of nanotechnology are correct, ganisation (DRDO), which performs roughly 85 nanotechnology will mean that computers will fi- percent of India’ s military research and develop- nally think like human beings. As they envision it, ment. The organization received 15 billion rupees nano-machines will either be small enough to be- in fiscal year 1996–97, the last for which compre- come fast enough to break the barrier into “ con- hensive statistics are available.” sciousness,” or nano-machines will build biological Military funding poses both personal ethical and computers that will mimic the way in which brains societal challenges. Personally, scientists involved think and grow. In either case, if they are correct, in nanotechnology need to be aware of, and come we need to come to grips with the effects of con- to grips with, the fact that their own research may scious computers on society. Will humans find pro- lead to the production of weapons of mass destruc- ductive things to do with their time and energies if tion. A number of scientists involved in the devel- computers can take over their jobs? Who will con- opment of the nuclear bomb, in retrospect, found trol whom? Will computers have the ability to rebel that knowledge hard to live with. 58 against humans? Will computers dominate and Military funding can also have distorting effects eliminate humans and other “living” things? These on the progress of science as a whole. Scientists science-fiction questions will have a greater impact need to gain funding for their research. They need if the most optimistic projections of nanotechnol- to prepare grant proposals that win funding ap- ogy come true. 57 proval. Thus, they naturally tailor their proposals and research to areas that will catch the attention of Issues that affect the development stage the granting organization. In the case of the mili- tary, they need to slant proposals to weapons de- Military funding and directed research can velopment. In some cases, the funding organization distort scientific research tells the researchers what types of proposals they are The military is an enormous funder of scientific looking for. In such cases, it is obvious how scien- research. However, the mission of this funding is tists must alter, or at least tailor, the focus of their not the basic advance of science but the develop- research to meet the goals of the request for pro- ment of science that can produce weapons, detect posals. In other cases, the proposals are more open, the enemy, or protect troops against an enemy at- tack. According to the National Science Foundation, in Fiscal Year 1990, the defense share of the federal 56 “Biracial Couples Report Tolerance; Survey Finds Most are R&D budget authority was 62.6% of the total gov- Accepted by Families,” Darryl Fears and Claudia Deane, Wash- ington Post , July 5, 2001, A1; “Racial Divide in Sports Doesn’t ernmental R&D budget. In year 2001, it was ex- Matter to Athletes; They Say that Playing Brings People To- pected to decrease to 50.1%. Even with this dra- gether,” Camille Powell, Washington Post , June 21, 2001, T10. matic decrease, funding by the government of 57 See, e.g., “Why the future doesn’t need us,” , Wired, 8.04, April 2000. scientific research is largely devoted to developing 58 See, e.g., misgivings of Werner Heisenberg and speeches of military applications. J. Robert Oppenheimer. 392 Biotechnology Law Report • Volume 22, Number 4 but again, the scientist must write to his or her au- Jesse Gelsinger, the Tucson teenager who died Sept. dience and propose projects that will win approval. 17 after undergoing an experimental therapy for a In many cases, one can look at proposals that have rare metabolic disorder.” These incidents are not won in the past and follow that well-trodden path. limited to the University of Pennsylvania. The same In this way, even when there is an open call for pro- article continues, “ In addition to Penn’ s problems, posals, the proposals that are submitted are distorted the field—which tries to cure disease by giving peo- by the knowledge that they being submitted to a mil- ple healthy copies of “ disease” genes—has been itary organization. rocked by revelations that researchers elsewhere But this structural distortion is not unique to mil- weren’t properly reporting the deaths and illnesses itary funding: it happens in the growing area of di- of hundreds of volunteers to the National Institutes rected research. There has been an increase in cor- of Health as required by federal regulations. . .. porate and other directed research. This is not Most recently, the FDA shut down four gene ex- necessarily a bad thing: particularly with govern- periments by a prominent researcher at Tufts Uni- mental sources of R&D and basic scientific research versity and cited him for numerous safety lapses, in- being reduced, corporate funding of basic science is cluding the failure to tell his own institution about welcome. Moreover, a partnership between those the death of a volunteer and the inclusion of patients with important scientific expertise and those who who did not qualify and may have been harmed by are producing actual products and services can yield the experimental treatment.” Six months after this significant results. 59 On the other hand, certain di- article was published, the Washington Post reported rected research by tobacco companies has been cited that “A Harvard-affiliated hospital in Boston qui- as an example of corporate research money being etly suspended a gene therapy experiment last sum- used to try to advance bad scientific positions in or- mer after three of the first six patients died and a der to ward off or counter commonly held scientific seventh fell seriously ill, previously unreleased re- principles. 60 The tendency for directed money to search records show. Richard Junghans, the Harvard distort otherwise-objective views cannot be denied, Medical School researcher who led the study, just as it does when it comes from the military or blames the problems on a series of tragic coinci- other sources (including nonprofit advocacy groups) dences that were mostly not related to the treatment. that seek a particular outcome for the research. But the federal committee that oversees gene ther- Society must come to grips with the good and bad apy had no chance to question that conclusion—or effects of directed research. Although this is not a share it with other scientists working on similar ex- topic unique to nanotechnology, it is one that can periments—because Junghans did not report the have the effect of distorting or inappropriately redi- deaths or illness to the National Institutes of Health recting science onto paths that are not in society’s when they occurred, as required by federal regula- best interests. tions.”62 These incidents illustrate the point that re- Inherent conflicts of interest between searchers, commercial and academic alike, have in- research or commercial exploitation and disclosure or sharing of results 59 See, e.g., “At Kansas State, Seeking , with Hopes of Recently, there have been a number of scandals Profits Pending, Turns Donated Rights into Products, Compa- involving failure to timely report incidents in hu- nies and Jobs,” Robert E. Pierr, Washington Post , June 8, 2002, man clinical research. For example, Washington A3. 60 See, e.g., “The Smoke You Don’t See: Uncovering Tobacco Post reported that “The University of Pennsylvania Industry Scientific Strategies Aimed against Environmental To- announced yesterday that its gene therapy institute, bacco Smoke Policies,” Am J Public Health 2000;91: which has been an international leader in the cut- 1419–1423, September 2000; Dearlove JV, Bialous SA, Glantz ting-edge field of medical research, will no longer SA. Tobacco industry manipulation of the hospitality industry 61 to maintain smoking in public places. Tobacco Control 2002; experiment on people.” The Post noted, “The uni- 11:94–104. versity’s action came after the Food and Drug Ad- 61 “Penn Ends Gene Trials on Humans,” Deborah Nelson, Rick ministration found that Wilson had not properly re- Weiss, Washington Post May 25, 2000, A1. 62 “Earlier Gene Test Deaths Not Reported; NIH was Unaware ported the deaths of experimental animals or serious of ‘Adverse Events’,” Deborah Nelson, Rick Weiss, Washing- side effects suffered by volunteers who preceded ton Post January 31, 2000, A1. Biotechnology Law Report • Volume 22, Number 4 393 herent conflicts of interest that cause them to fail to Conflicts of interest are not new, but they do pose conduct research properly, to report failures, and to a societal risk. Policy makers and regulators need to admit mistakes. The proponents of nanotechnology be proactive in evaluating ways to ensure that these have argued that scientists can police themselves conflicts of interests do not keep societal risks hid- and can be trusted to adopt and use safe experi- den from them. mental methods and to report incidents. Society has learned from experience that even the best-inten- Issues that affect the deployment stage tioned researchers do not always follow safe proto- Workplace issues cols and report adverse events. 63 Related to this conflict is the conflict that arises As with other technologies, workers in assembly during commercial exploitation of a new technol- plants will be exposed to byproducts of the manu- ogy. Commercial exploitation of science inherently facturing process. These byproducts could include requires that the researcher keep confidential the toxic chemicals that are used to produce the nan- outcome of his or her research in order to provide otechnology, as well as unusable microscopic pieces the researcher (or his or her employer) a competi- such as nano-wires that escape the manufacturing tive advantage over competitors and to keep com- environment and float free in the air. petitors from “free-riding” on the results of this very As reported in Micro magazine, “ Although SIA expensive research. This is not inherently a bad has touted its annual U.S. government ranking in thing. Being able to keep important developments the top 5% of all U.S. industries in worker safety, secret until they are ready to be marketed and sold critics argue that exposure in the cleanroom to to the general public gives researchers an important chemicals such as arsine, benzene, and HCl heighten incentive to continue to do leading-edge research. the risk of cancer and miscarriages.” The article On the other hand, as seen in the medical field, this goes on to say: has sometimes meant that drug side effects or bad interactions are not timely disclosed to regulatory In general, electronic computer equipment agencies or the public. The same conflict could af- is a complicated assembly of more than 1,000 fect nanotechnology research. materials, many of which are highly toxic, Finally, there is a related conflict of interest such as chlorinated and brominated sub- problem where the scientist has a financial stake stances, toxic gases, toxic , photo-active in the outcome of the research. For example, as the and biologically active materials, acids, plas- Washington Post reported recently on its front page tics and plastic additives. The list of toxic ma- on June 30, 2002, “One of the nation’s largest can- terials in computer components also includes cer centers enrolled 195 people in tests of an ex- lead and cadmium in computer circuit boards, perimental drug without informing them that the lead oxide and barium in computer monitors’ institution’s president held a financial interest in cathode ray tubes, mercury in switches and flat the product that stood to earn him millions. The screens, and brominated flame retardants on tests at M.D. Anderson Cancer Center in Houston printed circuit boards, cables and plastic cas- involved Erbitux, the controversial cancer drug ing. Comprehensive health impacts of the mix- that is at the center of broad investigations in New tures and material combinations in the prod- York and Washington. Most of the patients, who ucts are often not known. 65 were quite ill by the time they enrolled in the tests, have died. The cancer center, a unit of The Uni- versity of Texas system, has since acknowledged that it should have informed the patients of the con- 63 See also “Science Breaks Down When Cheaters Think They flict of interest involving its president, John Won’t be Caught,” Sharon Begley, Wall Street Journal , Sep- Mendelsohn. It has recently adopted policies to en- tember 27, 2002, B1, on why, despite the fact that scientific fraud seems to be a counterproductive and irrational activity, it sure that patients are told ahead of time if Mendel- seems to occur with some regularity. sohn or the cancer center itself has a financial 64 “A Hospital’s Conflict of Interest: Patients Weren’t Told of stake. Ethicists say that such conflicts of interest Stake in Cancer Drug,” Justin Gillis, Washington Post , June 30, 2002, A1. pose risks to patients and to the integrity of scien- 65 “Study Results Prompt SIA to Examine Whether Fab Chem- tific studies.”64 icals Imperil Workers’ Health,” 2001 Micro, April 2002. 394 Biotechnology Law Report • Volume 22, Number 4 There is an additional risk in nanotechnology: mi- ficial working under a court search warrant, that is croscopic pieces of assemblies can break off and a positive development. Where it is a competitor of float in the air. The later risk of hazardous airborne a business or a hacker it is a social concern. microfibers is illustrated by the societal problems that arose from . “An estimated 1.3 million Software issues and nanotechnology employees in construction and general industry face Some of the plans for nanotechnology involve co- significant asbestos exposure on the job. Heaviest ordination of the activities of huge numbers of nano- exposures occur in the construction industry, par- machines. This coordination will be done by com- ticularly during the removal of asbestos during ren- puter programs. These complex programs may ovation or demolition. Employees are also likely to reside inside a single computer that directs the ac- be exposed during the manufacture of asbestos prod- tions of the dispersed nano-machines or may involve ucts (such as textiles, friction products, insulation, the coordination of the actions of millions of inde- and other building materials) and during automotive pendent micro-modules, each with its own copy of brake and clutch repair work.”66 Ashahi Weekly , in a portion of the software. In either case, software an article entitled “Asbestos Deaths Seen Likely to plays a crucial role in the operation and coordina- Soar,” made it clear this is a problem in Japan (and tion of these nano-components. We have learned other nations), not just the U.S. In Japan, the article that software is inherently buggy and susceptible to stated, “An estimated 100,000 people will die from massive catastrophic failure. cancerous lung tumors over the next four decades As David Parnas, a member of CPSR, and others due to past exposure to asbestos, researchers say.” pointed out during the Star Wars debates of the While nanotechnology is seen by its proponents 1980s, computer scientists have long known that as the ultimate “clean” technology, it will present systems of great length and complexity (the U.S. risks to workers in the near term and may always Navy’s AEGIS combat software contains 2 million present workplace safety issues. Society needs to lines of code; the Star Wars program was estimated understand that these risks exist and deal with them. to need between 7 million and 60 million lines of codes) are likely to be filled with bugs that create Nanotechnology as a police/big brother tool unexpected and often catastrophic failures. 67 Test- Nanotechnology can penetrate places and devices ing and debugging software is more an art than a without detection. It can detect and recover infor- science, and even well-meaning expert computer professionals are unable to predict reliably what ac- mation that people otherwise have the ability to keep 68 secret. As such, nanotechnology has the potential to tions and results may occur from bugs in code. In be a massive engine of police repression or over- some cases, bugs lead to shutdown of systems, sight. which in the case of many nanotechnology applica- The of has opened up new dangers to privacy and human rights. Small cameras can be implanted in places once incon- 66 “Asbestos.” OSHA Website, http://www.osha-slc.gov/SLTC/ ceivable. Electronic bugs can listen in quiet or very asbestos/ (last visited June 2, 2003). 67 noisy places and transmit the data with very low These size estimates, as well as both sides of the arguments related to software reliability, were summarized and analyzed electronic emissions. Today, the normal means of in SDI: Technology Survivability and Software , Office of Tech- implanting such devices requires a human being to nology Assessment, Congress of the United States, May 1988. implant the device in the hostile location. In the fu- That report concluded “The nature of software and experience with large, complex software systems indicate that there will ture, with nano-machines being able to move on always be irresolvable questions about how dependable [ ] soft- their own, the implantation of ever-smaller devices ware would be and about the confidence the United States could may become possible. place in dependability estimates” ( See the Report at page 4). In another vein, proponents of nanotechnology For a recent summary of these arguments, see “National Mis- sile Defense: The Trustworthy Software Argument,” William note that with smaller integrated chips, the power Yurcik, CPSR Newsletter , Volume 19, Number 2, Spring 2001, of computers will greatly increase. As a result, en- and other articles in that issue. 68 crypted private messages will be more vulnerable to An extensive discussion of software failures and the reasons for them, as well as overlying ethical considerations, can be being decrypted by unauthorized persons. Obvi- found in Chapter 5 of Computer Ethics (second edition), Tom ously, where such a person is a law enforcement of- Forester and Perry Morrison, 1994. Biotechnology Law Report • Volume 22, Number 4 395 tions may be an acceptable outcome. On the other trade secret law. However, it is important to con- hand, sometimes, the unexpected shutdown of sys- sider the benefits and costs of a sui generis form of tems (such as in the case of a nanotechnology shield, protection for this new . a nanotechnology detection system, or a manufac- Traditionally, patents have been the major type of turing process) can lead to unacceptable outcomes. intellectual property protection for physical inven- Moreover, not all bugs lead to shutdown. Many per- tions. Patents protect innovative inventions, pro- mit the system to continue to operate, but the ac- cesses, and designs. Part of what makes pro- tions the system takes and the results or outputs are tection so powerful is: (1) patents protect a very wide flawed, even dangerous. range of subject matter; and (2) innocent infringe- Where nanotechnology is deployed to interact ment is not a defense. In other words, one can pro- with human bodies, plants, and animals in open en- tect, not only mechanical devices, but also formulas vironments and to control vital physical machines, for drugs, genetic sequences, software, business pro- software bugs present a societal risk that must be cesses, and even the means to manufacture devices, weighed in the implementation of any nanotechnol- under patents. Second, unlike copyright, for exam- ogy project. ple, the independent creation of the same or a simi- lar invention or process is still an infringement of the Nanotechnology incident reporting statutes patent and subjects the later inventor and all those who use the invention process to damage claims. For some specific diseases and for some kinds of Patents have been controversial in the software and incidents, current laws require prompt reporting to business process area. The controversy swelled in the a central authority. Today, no such laws exist with United States in the late 1990s, after the Supreme respect to nanotechnology. Court ruled, first, that software was patentable subject There are a host of statutes in various states that matter69 and later courts ruled that business methods require health workers to report incidents of certain were patentable. 70 In recent years, the controversy has diseases in humans and other animals, such as AIDS, quieted somewhat within the United States but is be- anthrax, botulism, cholera, gonorrhea, rabies (hu- ginning to engender passions in Europe, after the Eu- man), syphilis, and tuberculosis. There are a host of ropean Union released a proposal for patenting soft- statutes that similarly require reporting of certain in- ware.71 Among the reasons people cite for objecting cidents, such as child abuse. The OSHA regulations to patent protection for software are: (1) that patents require employers to keep records and report safety protect inventions from the date of filing, but the incidents in the workplace. Since 1975, the FDA has patent office does not make the application for a patent mandated reporting of major blood transfusion reac- publicly known for a period that may stretch to up to tions. Reporting of certain types of incidents at nu- 18 months; (2) that the cost of obtaining a patent and clear plants is mandatory. Incidents that occur during the cost of defending against even an invalid claim of human testing are required to be recorded promptly. infringement can run in the tens to hundreds of thou- The reasons for such reporting requirements are var- sands of dollars; (3) that software and the Internet do ied, but generally, they try to give a warning to offi- not need patents to spark innovation and thrive; and cials early enough in the process that they can see (4) that patents increase barriers to entry because they patterns emerging, take actions to prevent the spread create monopolies within the scope of the patent. 72 of the problem, quickly track down the origins of the incident, mobilize diverse resources at appropriate levels, and keep long-term statistics on each type of 69 v. Diehr , 450 U.S. 175 (1981). disease or incident. Laws or regulations that require 70 State Street Bank & Trust Co. v. Signature Fin. Group , reporting of certain types of nanotechnology inci- Inc., 149 F.3d 1368 (Fed. Cir. 1998), cert. denied , 119 S. Ct. 851 (1999). dents may need to be considered. 71 Directive on the Patentability of Computer-Implemented Inventions, 20.02.2002 COM(2002) 92 final 2002/ 0047 (COD). PATENT AND INTELLECTUAL PROPERTY 72 See, e.g., Should Patents be Granted for Computer Soft- PROTECTION OF NANOTECHNOLOGY ware or Ways of Doing Business : The Government’s Con- clusions, U.K. Patent Office, March 2001; James Gleick, “Patently absurd,” New York Times Magazine , March 13, Nanotechnology may seem to fall logically within 2002; Robert Lemos, “Patents, lawsuits plague the Net,” ZD- the existing protections of patent, copyright, and Net News, March 30, 2000. 396 Biotechnology Law Report • Volume 22, Number 4 Copyright protects a particular tangible expres- the quality of the burger. That identifying source can sion made (or designed) by a human being from be protected under trademark by McDonald’s even unauthorized copying, distribution, the making of if it later ventures into other fields such as hotels, “derivative works,” and public display and perfor- software, or airplanes. mance. Independent creation is a defense—that is, In sum, the difference between patent, copyright, to prove infringement, one must show that the in- and trademark is that a patent protects a particular fringer had access to the work and copied the work. invention (or device), process, or design; copyright Copying can be shown indirectly if placing the two protects a particular audiovisual expression (such as creations side by side convinces the judge or jury a novel, software, or design); and trademark pro- that copying was likely. There are a series of “fair tects the manufacturer’s (or other business’s) trade use” defenses to copyright infringement. Also, names. copyright cannot be claimed in the utilitarian ele- A series of sui generis or neighboring rights have ments of a work if that is the only way to do some- also been created in recent years. Among these is thing. That is, under the “ merger doctrine,” while the European Union’s database protection scheme. one can protect the design of a fanciful Coke bot- In brief, factual databases are protected for a short tle, one cannot copyright the shape of a shoe box, period (15 years) only against the unauthorized and because a shoe box is likely to be in the shape of a substantial extraction of the data. Moral rights are a rectangular cube in order to accommodate shoes that similar example. While moral rights differ greatly are much longer than wide, with a lid to open, and between countries, in essence, they protect an au- in that shape to permit stacking of the boxes. Thus, thor by requiring that the work produced by that au- a chemical compound designed by a human may thor be attributed to him or her and not be edited or well not be able to be copyrighted, as its utilitarian altered without the author’s permission, even if the function dictates its shape. Similarly, while one author is no longer (or never was) the owner of the might be able to copyright a nano-sculpture, one copyright in the work. may well not be able to copyright a nano-robot’s As nanotechnology progresses, the weaknesses shape that is dictated by its function. and strengths of the patent/ copyright/trademark Trademark protects any logo, shape, color, slo- regime have to weighed against the creation of a gan, or other graphic, words, sounds, etc. that iden- scheme that is tailored to the peculiarities of nan- tify the attached product or service as coming from otechnologies. The same debate that is now playing a single source. A trademark indicates that a trusted out in the patenting of business processes, software, source oversees the quality of the product or ser- or biotechnologies will play out with nanotechnol- vice. That is, McDonald’s does not trademark its ogy. We need to look at the resolutions of those de- hamburger per se; it trademarks the name “ Mc- bates in evaluating what protection should be Donald’s” as an indicator of the entity that ensures granted to nanotechnology.