regulating innovation via analogy: the case of

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"Regulating Innovation Via Analogy: The Case of Nanotechnology" Authors: Roger Eardley-Pryor and W. Patrick McCray Center for Nanotechnology in Society, University of California Santa Barbara Draft Working Paper for “Pressing Issues: The History of Technology Meets Public Policy” Workshop October 2013 Do Not Cite, Circulate, or Quote Outside of the Workshop Without Authors’ Permission Acknowledgements: This material is based, in part, upon work supported by the National Science Foundation under Cooperative Agreement No. 0938099. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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Page 1: Regulating Innovation Via Analogy: The Case of

"Regulating Innovation Via Analogy: The Case of Nanotechnology"

Authors: Roger Eardley-Pryor and W. Patrick McCray

Center for Nanotechnology in Society, University of California Santa Barbara

Draft Working Paper for “Pressing Issues: The History of Technology Meets Public Policy” Workshop

October 2013

Do Not Cite, Circulate, or Quote Outside of the Workshop Without Authors’ Permission

Acknowledgements: This material is based, in part, upon work supported by the National Science Foundation under Cooperative Agreement No. 0938099. Any opinions, findings, and conclusions or recommendations expressed in this material are those of the author(s) and do not necessarily reflect the views of the National Science Foundation.

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In April 2003, Vicki L. Colvin, a chemist at Rice University and director of that

school’s Center for Biological and Environmental Nanotechnology (CBEN) testified

before Congress. The topic was the societal implications of nanotechnology – the

manufacture of materials and devices with dimensions 100 nanometers or less. This

“emerging technology,” Colvin said, had a considerable “wow index.”1 Nanotech offered

“potential benefits to the economy, human health, and quality of life.” However, Colvin

warned, every new such emerging technology came with its own particular set of

concerns. If improperly handled, these concerns “can turn wow into yuck and ultimately

into bankrupt.” To drive her point home, Colvin shrewdly drew an analogy between this

potentially bankrupt story of nano to a historical example that would resonate with policy

makers – the “genetically modified foods industry.” (GMOs) Colvin’s analogy was

eminently quotable and made for an effective sound bite. It suggested that policy makers

needed to attend to the public perception and environmental consequences of new

technologies, especially as they weighed possible future regulations. It was, however, a

specious comparison that conflated two very different histories of specific emerging

technologies.2

But, for the moment, let’s put this analogy aside and return to it later. The focus

of our paper today is not to critique an individual scientist’s use of history as a tool to

speak to politicians and the public. Instead, our intent is to analyze a range of historical

1 Colvin; 2003 testimony, p. 49. A quick web search on “Vicki Colvin + wow to yuck” yields some 360,000 hits including several presentations and papers she and her Rice colleagues gave that use the phrase. 2 Ronald Sandler, “The GMO-Nanotech (Dis)Analogy?,” Bulletin of Science, Technology, and Society, 2006, 26, 1: 57-62; Arie Rip, “Folk Theories of Nanotechnologists,” Science as Culture, 2006, 15, 4: 349-65.

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examples and analogies that scientists, journalists, and policy makers have used in their

attempt to get a handle on nanotechnology and develop regulations for it. This paper

looks at the ways in which a range of actors – scientists, policy makers, and activists –

drew historical analogies to nanotechnology as a means to offer “lessons” for that

emerging technology’s future regulation. In doing so, this paper not only considers the

methodological use of historical analogy, it also considers the manner and context in

which those analogies were deployed in lieu of nanotechnology’s perils and potentials.

Thinking About Analogies

In 1965, after NASA requested comparisons between the American Railroad and

the U.S. Space Program, historian Bruce Mazlish wrote a classic article analyzing the

utility and limitations of historical analogies.3 Mazlish noted how analogy exists as a

suitable form of logic, a primitive yet essential form of reasoning. Historical analogies,

he explained, function as both model and myth. Mythically, analogies give meaning and

offer emotional security through an original archetype of familiar knowledge. Analogies

also furnish models for understanding by construing either a structural or a functional

relationship – appearing similar in the former, and behaving similarly in the latter. Amid

conditions of uncertainty, when all the data is either unavailable or unknowable, those

relational resemblances provide probable inferences and help us form hypotheses for

testing. As such, Mazlish described analogies as “a device of anticipation” to guide

scientific understanding, not dissimilar to the contemporary framework of “anticipatory

3 Bruce Mazlish, “Historical Analogy: The Railroad and the Space Program and Their Impact on Society,” in The Railroad and the Space Program: An Exploration in Historical Analogy, edited by Bruce Mazlish (Cambridge, MA: M.I.T. Press, 1965), pp. 1-52.

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governance” currently applied to nanotechnologies.4 Nanotechnology researcher and

computational biochemist, Judith Klein-Seetharaman, concurred. She encouraged

analogies between nanotech, other technologies, and other academic disciplines to

provide “a link to the general public since analogies allow people to grasp concepts

immediately when they can relate them to something they know.”5

Analogies tend to assume that the past both validates and predicts the future,

thereby providing a model for action. Mazlish cautioned, however, that assumptions

equating a recovered past with a predictive future confuses notions of probability with

possibility. Ultimately, an analogy proves nothing; it merely suggests a possibility.

“When used carelessly,” Mazlish warned, “historical analogy can be a misleading guide.

Worse, by establishing a facile resemblance, it may serve to prevent a more critical and

analytical approach.”6 Furthermore, an analogy that applies only to one instance clearly

lacks the strength of an analogy to many instances. In order to truly understand

something, Mazlish insisted that we study “the system, both dynamic and static, in which

it rests.”7 In other words, context matters, and differences of comparison could be as

illuminating as similarities.

4 Mazlish, “Historical Analogy,” 9; Daniel Barben, Erik Fisher, Cynthia Selin, and David H. Guston, “Anticipatory Governance of Nanotechnology,” in The Handbook of Science and Technology Studies, Third Edition, edited by Edward J. Hackett, Olga Amsterdamska, Michael Lynch, and Judy Wajcman (Cambridge, MA: MIT Press, 2008), 979-1000; David H. Guston and Daniel Sarewitz, “Real-Time Technology Assessment,” Technology in Society 24:1-2 (2002): 93-109. 5 Judith Klein-Seetharaman, “The Use of Analogies for Interdisciplinary Research in the Convergence of Nano-, Bio-, and Information Technology,” in Nanotechnology: Social Implications II – Individual Perspectives, edited by Mihail C. Roco and William Sims Bainsbridge (Dordrecht, The Netherlands: Springer, 2007), pp. 153. 6 Mazlish, “Historical Analogy,” 8. 7 Mazlish, “Historical Analogy,” 11.

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In ways that apply directly to an analysis of nanotechnology, Mazlish argued that

the most significant historical analogies treat their objects of comparison as a “complex

social invention,” or an invention simultaneously technological, economic, political,

sociological, and intellectual.8 By studying the contexts of that social invention, one

could best determine and possibly anticipate an object’s social impact, i.e., its secondary

consequences. The more that historical analogies help one generalize and better

understand such consequences – initially, unintended consequences – “the more we shall

be able to control them.” Mazlish concluded that, “Historical analogy as a scientific

device, emerging from the vague intuition of myth and model, is, potentially, a most

valuable tool. The caution is that we must accept only detailed, informed studies of the

complex phenomenon itself, and not accept simple or fuzzy generalities about vague

resemblances.”9

Given the history of nanotechnology as a tool used by policy-makers, scientists,

and corporate actors to unify diverse social relations of science and justify federal

funding for the linear “endless frontier” model of scientific development, any analysis of

nanotechnology must see it as a broad social invention, co-produced by the interactions

of technoscience and human society.10 When cultivating discourse on nanotechnologies,

Science & Technology Studies scholars have indicated that the framework of anticipatory

governance “implies an awareness of the co-production of sociotechnical knowledge and

8 Mazlish, “Historical Analogy,” 11. (Italics in the original.) 9 Mazlish, “Historical Analogy,” 14, 16. 10 W. Patrick McCray, “Will Small Be Beautiful? Making Policies for our Nanotech Future,” History and Technology 21:2 (2005): 177-203; K. Eric Drexler, “Nanotechnology: From Feynman to Funding,” Bulletin of Science, Technology & Society 24:1 (2004): 21-27; M. E. Gorman, J. F. Groves, and R. K. Catalano, “Societal Dimensions of Nanotechnology,” IEEE Technology and Society Magazine 29:4 (2004): 55-64.

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the importance of richly imagining sociotechnical alternatives that might inspire its

use.”11 We must therefore view critically the historical analogies applied to the complex

phenomenon of nanotechnology, discard any fuzzy generalities, and contemplate how a

deeper and more true understanding of nanotechnology might help us better control its

social impacts and unintended consequences.

Getting Safety on the Radar

Before turning to the ways in which historical analogies have been deployed when

it comes to thinking about regulating nanotech, we need to understand how the perceived

need for doing this emerged in the first place. At first the intersection of nanotechnology

and its potential implications might appear odd. When the U.S. government launched the

National Nanotechnology Initiative in 2000, environmental concerns were largely

invisible. When the National Academies of Science reviewed the NNI in 2002, its report

shows that, out of $464 million allocated for nano in FY2001, less than 1% went to the

Environmental Protection Agency.12 Nonetheless, despite this near-trivial amount of

budgetary heft, implications of nanotech and calls for its regulations were dominating

news about this emerging technology.13

In fact, given a series of events and publicity that few policy makers or regulators

could have anticipated, when Colvin testified in 2003, it would have been near

impossible for the people charged with managing nano to have ignored its environmental,

health, and safety (EHS) issues. In fact, this was an issue that had been on their minds for

11 Barben, et al, “Anticipatory Governance of Nanotechnology,” 992. 12 NAS, Small Wonders, Endless Frontiers report, 2002. 13 A cite here would be nice; something from the various media studies that talk about framing of nano.

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at least three years. Given the low profile that the EPA had in the national nano portfolio,

how did EHS issues get on the radar?

There are several causal factors but their common feature is that they all

originated not in the laboratory but in the realms of popular culture, celebrity, and social

activism.

The first shot across the bows of nano-advocates like Roco and Smalley appeared

even before Congress had approved Clinton’s nano-initiative. The source was

unexpected. Bill Joy himself was a Berkeley-trained computer researcher who Fortune

once dubbed the “Edison of the internet.”14 But, in the spring of 2000, Joy wrote an

incendiary article titled “Why the Future Doesn’t Need Us.” Joy’s venue for publication –

Wired magazine – was especially poignant given in trumpeting of the Internet revolution

and its cyber-libertarian ideology that deified markets and disparaged regulation.15

Joy highlighted perils he saw in emerging fields like nanotechnology and genetic

engineering. Joy himself had learned about nanotech through the futuristic writings of

nano-popularizer Eric Drexler. Motivated partly by controversies over corporate

development of genetically-modified crops and the difficulty of containing them. Joy

identified self-replication of newly emerging nano and genetic technologies as a clear and

future danger. Even more threatening was the possibility that a terrorist or deranged

scientist might deliberately modify organisms and unleash a “White Plague.” The

solution? Joy proposed “relinquishment” and limiting development of “the technologies

14 Brent Schlender. “The Edison of the Internet.” Fortune, February 1999; available at http://money.cnn.com/magazines/fortune/fortune_archive/1999/02/15/254898/index.htm (accessed April 2011). 15 See chapter 7 of Fred Turner, From Counterculture to Cyberculture: Stewart Brand, the Whole Earth Network, and the Rise of Digital Utopianism (Chicago: The University of Chicago Press, 2006).

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that are too dangerous, by limiting our pursuit of certain kinds of knowledge.” This tocsin

might have gone unheard, known only to high-tech cognoscenti who read Wired, but for

the flurry of publicity that accompanied it.

Joy’s article came at an inconvenient time for nano-boosters as Congress was

preparing to vote on Clinton’s proposed new nano initiative. Sensing that the question

about nanotech’s implications was “becoming the determining one,” NSF science

manager Mike Roco recruited Rice chemist Richard Smalley to defuse the threat that

Joy’s article posed to future research and funding.16 Throughout 2000, Smalley addressed

select groups about the non-issue of nano-initiated dangers. Smalley must have believed

his efforts had some effect. “I hope,” he wrote Roco, “that Bill Joy has already hit his

high water mark.”17 For researchers and science managers like Smalley and Roco,

perhaps Joy’s article brought back unpleasant memories of the late 1960s when many

Americans expressed ambivalence and pessimism about technology.

But anxieties among scientists and policy makers that people might have the

wrong ideas about nanotechnology were fanned anew in late 2002. On the Monday

before Thanksgiving, HarperCollins published Prey by blockbuster novelist Michael

Crichton. Central to its plot was the deliberate release of autonomous, self-replicating

nanobots. Created by an amoral corporation working under contract to the Pentagon, the

predatory swarm of millions of nanobots attacked people until it was destroyed.

Crichton’s book hit every button that might stoke public alarm about nanotechnology: a

greedy, high-tech firm; lack of government regulation; new technologies turned into

military applications.

16 July 11, 2000 email from Roco to Smalley; Folder 3, Box 35, RS/CHF. 17 July 11, 2000 email from Smalley to Roco; Folder 3, Box 35, RS/CHF.

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Non-governmental organizations helped keep controversies over what a future

with nanotechnology might be like in front of American and European citizens. In

January 2003, the Action Group on Erosion, Technology, and Concentration (ETC), an

unwieldy name for a small Canadian organization, released a report called The Big Down.

ETC had previously led campaigns against genetically modified foods. Not surprisingly,

their report savaged the idea of nanotechnology. Sensationalistic and sometimes

scientifically shaky, ETC’s broadside echoed Joy’s call for a moratorium on technologies

that sought to “manipulate atoms, molecules, and sub-atomic particles to create new

particles.” It warned that, unless regulated, the controllers of what ETC called

“Atomtech” would become “the ruling force in the world economy.”18 ETC’s report

reflected their larger concerns, which were less about nanotechnology per se and more

about restricting corporate power and maintaining cultural diversity and human rights.

ETC’s views got a huge boost when The Big Down found its way to Prince

Charles. The very fact that he was even interested in nanotechnology created headlines

around the world (“Charles: ‘Grey Goo’ Threat to the World”) and seemed to put the

Prince of Wales in opposition to Prime Minister Tony Blair and his plans for revitalizing

the British economy.19

These are just a few examples that suggest how the regulation of nanotechnology

came to be seen as a necessity. What is striking about these examples is that none of them

were about a specific existing technology. Instead, these spurs to regulation referred to

hypothetical technologies and the creation of planet-threatening dangers, something that 18 The ETC Group, The Big Down: From Genomes to Atoms (Winnipeg, Canada: The ETC Group, 2003). 19 An example of a headline from spring 2003; this was from an Edinburgh weekly; http://scotlandonsunday.scotsman.com/uk/Charles-fears-science-could-kill.2422335.jp (accessed April 2011).

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translated into one set of analogies for nano-regulation. However, as Joy’s piece makes

clear, alarms about GMOs circa 2000 suggested that concerns about nano’s regulation

and EHS issues transcended existential threats to also light upon specific and potentially

troubling techniques and materials. In the next section of our paper, we’ll turn to these

varying aspects of nanotech, the threats it imaginably posed, and the resultant regulations

those threats suggested.

Drawing Comparisons

In 2003, participants at an NSF-sponsored workshop on nanotechnology’s societal

implications concluded that “One of the more disturbing possibilities is that policy

makers and leaders of social movements may respond to nanotechnology not as it

actually is, but in terms of false analogies.”20 To avoid this fate, policy-makers and other

stakeholders in the nano-enterprise face the daunting challenge of agreeing on what

nanotechnology actually is. Given the complex realm of research, policy, and application

that nanotechnology signifies, an agreed upon definition is no easy task. The particular

definitions that various stakeholders have applied to nanotechnology have shaped the

specific comparisons and analogies they have mobilized to understand, promote, and

control it. In short, one’s definition of nanotechnology determines the analogy one draws

to prior technologies, which in turn shapes one’s understanding for how to best regulate

nanotechnology.

So, for these diverse actors, what was nanotechnology? Was it something with

the capacity to spread across wide swaths of land, across borders, and reap tremendous

20 “Workshop Breakout Session Reports,” in Nanotechnology: Societal Implications I, Maximizing Benefits for Humanity, edited by Mihail C. Roco and William Sims Bainbridge (Dordrecht, The Netherlands: Springer, 2007), 73.

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environmental damage with the fear amplified in part because its minute size renders it

invisible? [DDT and fallout] Or was nanotechnology less an existential threat and

actually suite of scientific techniques and tools that require regulation? [biotech, rDNA,

and genetic engineering of the 1970s] Instead of a particular technique, was

nanotechnology a particular product, a specific category of material, a hazardous form of

matter that should be controlled for the health and safety of workers and consumers?

[GMOs or asbestos] Or, does nanotechnology better represent a new industry in need of

care and control in order to reap its economic benefits? [the nuclear power industry of the

1960s] As we show here, nanotechnology was all of these things. However, the

analogies applicable to these opposing definitions of nanotechnology indicated very

different actions for its actual regulation.

The most common and classic analogy drawn between nanotechnology and an

existing technology remains its comparison to GMOs and agricultural biotechnology. As

mentioned earlier, Bill Joy, the ETC group, and chemist Vicki Colvin all invoked GMO’s

as analogous to nanotechnology, which captured the attention of policy-makers,

investors, and the media. Both then and even more recently, Colvin, ETC, and Joy were

hardly the only ones making this analogy.21 Historian of technology, Langdon Winner,

warned Congress about the “crisis” surrounding biotechnology and GM foods as his

21 Michael D. Metha, “From Biotechnology to Nanotechnology: What Can We Learn from Earlier Technologies?” Bulletin of Science, Technology, and Society 24:1 (2004): 34-39; Kenneth David and Paul B. Thompson (eds.), What Can Nanotechnology Learn From Biotechnology? Social and Ethical Lessons for Nanoscience from the Debate over Agrifood Biotechnology and GMOs (Burlington, MA: Academic Press, 2008); Jennifer Kuzma, Pouya Najmaie, and Joel Larson, “Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms,” Journal of Law Medicine and Ethics: Developing Oversight Approaches to Nanobiotechnology: The Lessons of History (2009): 546-586.

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primary example of “technological backfire…relevant to the rise of nanotechnology.”

Winner also noted that in Zambia and amid severe famine, public fears over the unknown

risks of GMOs led to its refusal of genetically altered corn, even as a charitable gift.

Congressman Rick Smith, the chairman of the House Subcommittee on Research,

considered such testimonies as lessons for nanotech could avoid biotech’s supposed

“slowdown” of research, and by implication, its limitations on profit.22 By these

accounts, the lessons from GMOs indicated that nano policy-maker and other

stakeholders must include the public early and often in their technological decision-

making; they must explore and make transparent the possible risks of nanotechnology

before they arise; they must elevate consumer or social benefits as a priority; and they

must create international standards for nano-embedded products to avoid their premature

prohibition from valuable European markets and other emerging markets.

While many of these lessons from GMOs are quite appropriate for controlling the

development nanotechnology, the analogy between GMOs and nanotech also contains

several holes. Unlike GMOs, nanotechnology does not always involve biological

material.23 And despite Vicki Colvin’s memorable threat that, like GMOs, nano might

22 House of Representatives Committee on Science, “The Societal Implications of Nanotechnology,” Hearing before the Committee on Science, House of Representatives (108th Congress, 1st Session), April 9, 2003: Kurzweil, pg 21; Winner, pg 58; Smith, pg 73. 23 However, some nanotechnologies include biological matter, as when therapeutic nanotechnologies deliver genetic material to plants, animals, and humans. See, Jennifer Kuzma, Pouya Najmaie, and Joel Larson, “Evaluating Oversight Systems for Emerging Technologies: A Case Study of Genetically Engineered Organisms,” Symposium, Developing Oversight Approaches to Nanobiotechnology: The Lessons of History, Journal of Law Medicine and Ethics 37 (Winter 2009): 574. Other overlaps between biological matter and nanotechnologies occur when engineered nanomaterials find use in food and agriculture. In the absence of federal regulations about food and packaging products containing nanomaterials, the non-profit organization As You Sow created a

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move from “‘wow’ to ‘yuck’ to ‘bankrupt.’” most GMOs, and genetic engineering in

general, never enjoyed an unalloyed “wow” period. Criticism accompanied GMOs from

the very start. Furthermore, giant agribusiness firms like Monsanto never faced

bankruptcy; they prospered handsomely even after the public’s widespread negative

reactions to their products. Lastly, living organisms – especially those associated with

food – that were designed for broad release into the environment and for human ingestion

were almost guaranteed to generate concerns.24 Today, if possible slowdowns to the

development of nanotechnology exist, they come not from negative public backlash but

from the American economy’s recent recession. Rhetorically, however, the GMO

analogy was powerful. The idea that the next big technology might follow a “wow to

yuck” path alarmed those investing billions of dollars, political capital, or their scientific

careers. Upon deeper analysis, defining the excessively diverse fields of nanotechnology

simply as a material analogous to GMOs clearly suggests more differences that

similarities.

With planetary fears about grey goo and self-replicating nanobots, figures like

Michael Crichton, Bill Joy, Prince Charles, and, at times, even K. Eric Drexler, seemed to

define nanotechnology as so broad, diverse, and nebulous that they rendered it as a

questionable, minute, and invisible unknown. This line of thinking made nanotechnology

voluntary framework for food companies to evaluate the safety of their products. Other non-profit organizations have pressured the Food and Drug Administration to evaluate guidance on nanotechnology in foods. As You Sow, “Sourcing Framework for Food and Food Packaging Products Containing Nanomaterials,” (6 December 2011) http://www.asyousow.org/health_safety/nanoframework.shtml (accessed 9 January 2012). 24 Ronald Sandler, “The GMO-Nanotech (Dis)Analogy?,” Bulletin of Science, Technology, and Society 26:1 (2006): 57-62; Arie Rip, “Folk Theories of Nanotechnologists,” Science as Culture, 2006, 15, 4: 349-65.

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analogous to other existential and invisible, yet life-threatening technologies like

radioactive fallout or synthetic pesticides like DDT. Though not intuitive, the invisible

threats from fallout bear some connection to the potential EHS risks of nanotechnology.

Consider the example of nuclear fallout: Each of the 500 or so open-air, nuclear

tests exploded between 1945 and 1980 released minute, invisible, radioactive debris

called “fallout,” which circulated around the planet’s stratosphere before falling back to

earth, exposing humans and the environment to its harmful radioactivity.25 The global

spread of these materials throughout ecosystems and into human bodies occurred without

full public or private consideration of their risks by policy-makers, by scientists, or by

unknowingly exposed publics. In WWII and during the Cold War, the dictates of national

security instigated the development and open-air testing of nuclear weapons. However,

by the end of the Cold War, national security came to be defined increasingly in terms of

economic security. Along those lines, American scientists and policy-makers in the late

1990s and early 2000s framed the need for the federal development of nanotechnology in

the rhetoric of economic national security. In order for the United States to maintain its

hegemony as a global power, and as the world’s leader in science and technology, the

argument went that America must initiate and maintain a federal program for

nanotechnology.

The nanotechnology enterprise, while typically not radioactive like fallout, has

also yielded novel engineered particles that exist only at invisible scales; new particles

that have found wide commercial distribution around the world before full public or

25 Harold L. Beck and Burton G. Bennett, “Historical Overview of Atmospheric Nuclear Weapons Testing and Estimates of Fallout in the Continental United States,” Health Physics 82:5 (May 2002): 591-608.

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private consideration of their potential risks to human health, or full consideration of their

threats to our environmental security. Today, in our economically globalized world,

environmental and consumer rights groups demand clear international standards to limit

the impact of commercialized but unlabeled and under-examined nano-products, as well

as wastes from nano-production.26 Federal as well as non-governmental initiatives – like

the NNI’s participation in the Organization for Economic Cooperation & Development’s

(OECD) Working Party on Manufactured Nanomaterials (WPMN), or the International

Council on Nanotechnology (ICON) based at Rice University – all reflect further the

recognition that, as the types, use, and functionality of more novel, man-made nano-

products expand over time, the impact of nanotechnology on the environment and the

human world may require the leading nano-nations to institute a standardized form of

international regulation, similar to the leading nuclear nations’ eventual control of atomic

fallout.27 (Although discussed here for reasons of space, a similar set of analogies could

be crafted by looking at the history of DDT.28)

In 2003, Oregon Congressman David Wu hinted at the analogy between

nanotechnology and nuclear fallout by citing a historic example of regulating fallout’s

novel and invisible threat via the Partial Nuclear Test Ban Treaty. This treaty, signed in

1963 by the United States, the Soviet Union, and Great Britain after years of international

negotiation, banned nuclear test explosions in the air, above the atmosphere, or at sea.

26 See, for example, a June 2009 report on “nano-silver” prepared by Friends of the Earth; a copy of this is available at http://nano.foe.org.au/node/332 (accessed September 2013) 27 National Nanotechnology Initiative, “International Engagement,” http://www.nano.gov/initiatives/international (Accessed 6 Oct 2011). 28 David Kinkela, DDT and the American Century: Global Health, Environmental Politics, and the Pesticide That Changed the World (Chapel Hill: The University of North Carolina Press, 2011).

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Though Representative Wu celebrated the Test Ban Treaty for its international

cooperation and control of hazardous fallout, he noted that “In many respects, the

Nuclear Test Ban Treaty is nothing but a ban on experimentation.”29 At the time,

organizations like ETC, Greenpeace, and Friends of the Earth-Australia had called for a

ban on nanotechnology production until researchers clearly understood all of

nanotechnology’s EHS risks. As with other examples, one’s definition of

nanotechnology – here as an invisible, existential, and global threat – determined the

appropriate analogy to prior technologies. That definition, in turn, indicated to various

nano-stakeholders particular forms of precaution, regulation, and control. If

nanotechnology was analogous to existential yet invisible threats fallout (or DDT), the

analogous regulation appeared to be an outright ban all future risks could be contained.

Other definitions of nanotechnology consider it less as an invisible threat needing

a global ban, and more like an actual material substance – a unique form of matter

requiring special oversight, particularly in workplace and occupational safety arenas.

Such a material definition of nanotechnology inspires its analogy to asbestos. Asbestos

refers to a group of naturally occurring, fibrous minerals, which have a tendency to break

down into microscopic fibers that get lodged easily in human lungs. The narrow

diameter of microscopic asbestos permits easy inhalation, while its longer length prevents

clearance, and its low solubility leads to very long bio-persistence. With frequent

exposure to the asbestos particles, these factors typically lead to unique and deadly forms

of lung cancer. Workers in asbestos production and those employed in building and

29 House of Representatives Committee on Science, “The Societal Implications of Nanotechnology,” Hearing before the Committee on Science, House of Representatives (108th Congress, 1st Session), April 9, 2003: Wu, pg 91.

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construction trades face, by far, the greatest risks of exposure to asbestos inhalation and

to its resultant afflictions.

Given the history of enormous and expensive litigation concerning the dangerous

effects of asbestos on various workers, the analogies between asbestos and

nanotechnology have inspired substantial toxicological analysis on carbon nanotubes – a

unique and common form of nanotechnology with remarkable similarities to asbestos.30

Discovered in 1991, carbon nanotubes (CNTs) are a new form of carbon molecule in an

elongated, tubular structure. With a diameter of only one to two nanometers, their

incredible tensile strength, and their high surface area and conductivity have inspired

widespread interest in industrial and commercial use, including in polymer composite

materials and in micro-electronics.31 However, this long and thin structure of CNTs

mirrors that of asbestos. Numerous toxicological studies indicate that CNTs share a

similar toxicity to asbestos.

The similarities between asbestos and CNTs, and the historical circumstances of

attempts to regulate asbestos in the Unite States, all offer unique suggestions for how to

proceed toward the regulation of some nanotechnologies, particularly CNTs. Worldwide,

30 Robert J. Aitkin, Sheona A.K. Peters, Alan D. Jones, and Vicki Stone, “Regulation of Carbon Nanotubes and Other High Aspect Ration Nanoparticles: Approaching This Challenge from the Perspective of Asbestos,” in International Handbook on Regulating Nanotechnologies, edited by Graeme A. Hodge, Diana M. Bowman, Andrew D. Maynard, (2010), 205-206; Gunter Oberdorster, Vicki Stone, and Ken Donaldson, “Toxicology of Nanoparticples: A Historical Perspective,” Nanotoxicology 1:1 (March 2007): 2-25; C.W. Lam, J.T. James, R. McCluskey, R.L. Hunter, “Pulmonary Toxicity of Single-wall Carbon Nanotubes in Mice 7 and 90 Days after Intratracheal Instillation,” Toxicological Science 77:126 (2004): 134; C.W. Lam, J.T. James, R. McCluskey, A. Sivaram, R. Hunter, “A Review of Carbon Nanotube Toxicity and Assessment of Potential Occupational and Environmental Health Risks,” Critical Review Toxicology 36:3 (2006):189-217. 31 Aitkin, et al., “Regulation of Carbon Nanotubes,” 205-206.

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upward of sixty nations, including many in the European Union, have partially or

completely banned asbestos. Given the known threats of asbestos, the U.S. EPA

attempted an all-out ban on its manufacture and use; however, in 1991, the U.S. Fifth

Court of Appeals overturned the ban. In the Corrosion Proof Fittings v. EPA ruling in

1991, the court ruled that EPA had not suggested likely substitutes for products

containing asbestos. As a result, the court claimed EPA did not meet the requirements to

impose the “least burdensome” controls. The court promptly lifted the ban for all but the

most dangerous existing asbestos products. The inability of EPA to ban asbestos, despite

decades of evidence confirming its hazards, indicates the need for serious reform of

TSCA, the existent United States’ law for chemical regulation.32 While this need for

reform applies for existing substances like asbestos, it applies even more so for novel and

analogous nanotechnologies like CNTs.

A final definition for nanotechnology moves beyond consideration of novel forms

of matter and instead identifies nanotechnology as a suite of technological practices for

manipulating nature – techniques that render the natural world as unnatural. This

identification of nanotechnology with particular material practices yields its analogy to

the processes used in the early 1970s, first in creating and later in regulating recombinant

DNA molecules (rDNA). Techniques for creating recombinant DNA involve isolating

and removing a section of DNA molecules from the DNA strand of one species, and then

splicing that section into the DNA of a completely different species. It produces an

entirely new, human-made, and hybridized DNA molecule that exists in a living host cell,

32 Marc Landry, “EPA and Nanotechnology: The Need for a Grand Bargain?,” in Governing Uncertainty: Environmental Regulation in the Age of Nanotechnology, edited by Christopher Bosso (Washington, DC: RFF Press, 2010), pp. 87.

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often an E. coli bacterium.33 The techniques for creating rDNA provided the starting

point for what became today’s biotechnology industry. As DNA strands measure about

two nanometers in diameter, we can also label rDNA techniques as a material process of

nanotechnology.

The strong similarities between nanotechnology’s practices of atomic-scale

manipulation and the technological practices of rDNA offer further lessons in the

eventual regulation of rDNA. Paul Berg, a biochemist at Stanford who was among the

first to produce a recombinant DNA molecule in 1972, expressed concern with other

scientists over the dangers inherent in their research, such as accidently creating and

releasing into the environment entirely new carcinogenic bacteria or viruses. In 1974,

Berg and other cellular biologists agreed to a moratorium on rDNA practices until they

better understood whether the technology was safe, and until the U.S. National Institutes

of Health (NIH) could establish a national “advisory committee to evaluate the hazards of

rDNA … and devise guidelines for work with [rDNA].”34

33 For further descriptions of rDNA techniques, see the transcripts of Stanley Cohen’s conference presentation, “The Science,” in “The Emergence of Biotechnology: DNA to Genentech: Reflections and Assessments” (Philadelphia: Chemical Heritage Foundation; Biomolecular Sciences Initiative, 1997), pp. 23-32. 34 National Human Genome Research Institute, “1972: First Recombinant DNA,” http://www.genome.gov/25520302 (Accessed 28 October 2011); Paul Berg, et al., “Letter: Potential Biohazards of Recombinant DNA Molecules,” Science 185 (1974): 303. Commentary and reproductions of key documents concerning the controversy and eventual commercialization of rDNA exist in James D. Watson and John Tooze, The DNA Story: A Documentary History of Gene Cloning (San Francisco: Freeman, 1981). Analysis on the complex politics surrounding the regulation of rDNA research can be found in Susan Wright, “Recombinant DNA Technology and Its Social Transformation, 1972-1982,” Osiris 2:2 (1986): 303-360; Wright, Molecular Politics: Developing American and British Regulatory Policy for Genetic Engineering, 1972-1982 (Chicago: Chicago University Press, 1994); Sheldon Krimsky, Genetic Alchemy: The Social History of the Recombinant DNA Controversy (Cambridge, MA: MIT Press, 1985); and Hebert

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In 1976, after a series of Asilomar Conferences where hundreds of cellular

biologists hotly debated and nearly lifted the moratorium on rDNA, the NIH’s

Recombinant DNA Advisory Committee (or, RAC) produced its research guidelines.

These guidelines clearly defined rDNA techniques and instituted multiple layers for its

control, including requirement of biological containments. Upon introduction of the

RAC’s NIH guidelines, the research moratorium from the prior years ended, allowing for

the slow but progressive growth of modern biotech research and, eventually, its

commercialization. That analogy is a favorable one, particularly for those promoting

nanotechnology as a pillar in future economic growth.

The history of oversight for rDNA technology, with self-regulation first by

scientists and then by the government, offers examples for nanotechnology, both in

anticipating and then controlling its potential threats with broad participation from

various actors. Nanotechnology-stakeholders have identified a similar goal of early

anticipation and mutually agreeable control through their framework of anticipatory

governance. However, definitive action toward actual oversight of nano-scale

engineering remains mostly discursive, even after 10+ years of nanotechnology’s federal

funding and development. For some nanotech stakeholders – particularly entrepreneurs

affiliated with commercialized industry – the NIH’s decision to institute guidelines for

rDNA technology, rather than push for legally binding regulations, offers additional

insights for the eventual oversight of nanotechnology. Government guidelines consist of

procedures that people are expected to follow when receiving federal dollars, whereas

regulations are substantive rules for all actors that carry the authority of law. Donald

Gottweis, Governing Molecules: The Discursive Politics of Genetic Engineering in Europe and the United States (Cambridge, MA: MIT Press, 1998).

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Fredrickson, the former head of the NIH who charted the RAC’s oversight of rDNA

practices, believed that the overabundance of caution and the quick action for guidelines

(but not regulation) was necessary and appropriate. “Uncertainty of risk,” he warned, “is

a compelling reason for caution. It will occur again in some areas of scientific research,

and the initial response must be the same.”35 Christine Paterson, a co-founder and former

President of the Foresight Institute for advancing nanotechnology (also Drexler’s ex-

wife), took Fredrickson’s advice to heart. In her 2003 Congressional testimony on the

societal implications of nanotechnology, Paterson described the Foresight Institute’s set

of “draft rules” to prevent possible accidents in nanotech, which she, Drexler, and others

modeled explicitly on “the early days of biotech.” For Fredrickson and the Foresight

leaders, flexible and adaptive guidelines, rather than the hard law of regulation, would

help nanotechnology advance, just as it helped rDNA research progress – while still

ensuring reasonable oversight. One drawback to any nanotechnology guidelines similar

to those from the RAC, may be that the guidelines would only apply to federally funded

research and research conducted at universities. Privately funded research in start-up

nanotech companies would not be subject merely to guidelines, only to the hard law of

regulation.

Conclusions

Earlier this year, Britian’s Lord Robin Butler made a call for the various

departments of national governments to employ “historical advisers.” In considering a

series of major foreign policy decisions made by the UK since 1945, Butler noted that

35 Fredrickson, The Recombinant DNA Controversy, pp. 278, cited in Jeffery P. Kahn, “Commentary: Who’s Afraid of the RAC? Lessons from the Oversight of Controversial Science,” Journal of Law, Medicine, and Ethics, Developing Oversight Approaches to Nanobiotechnology: The Lessons of History (Winter 2009), 685-687.

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“Those who take major policy decisions in ignorance of relevant history are like a driver

who commits to some maneuver in the road without looking into the rear mirror.”36 In the

process, he implied the value of historical analogy as a useful tool for policy makers to

understand and utilize.

As we have shown in this paper, particular definitions of nanotechnology tend to

foster a particular analogy between it and previous technologies. This relation, we

believe, also suggest a particular form or regime of regulation for nanotechnology. The

particular definitions that various stakeholders have applied to nanotechnology have

shaped the specific comparisons and analogies they have mobilized to understand,

promote, and/or control it. In short, one’s definition of nanotechnology determines the

analogy one draws to prior technologies, which then shapes one’s understanding for how

to best regulate nanotechnology. We would be interested to see whether similar examples

can be found with other technologies, emerging or otherwise.

Seeking regulation of innovation via analogy is tricky when definitions or even a

common shared understanding for the technology are absent. As a commonly used term,

as we’ve shown, nanotechnology meant many things to different stakeholders and at

different points in time. As a form of technology, it was dynamic, not static. In its

current usage, nanotechnology incorporates a vast range of disciplines; it encompasses a

broad set of material practices and techniques; it refers to various types of matter –

sometimes new forms of matter that exist at minute scales; and, for some,

nanotechnology embodies a invisible, existential threat. As a result, the term

36 Lord Robin Butler, “Every department should have a historical adviser, argues Lord Butler of Brockwell,” http://www.civilserviceworld.com (Published March, 3 2013; accessed August 30, 2013).

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“nanotechnology” functions as a short-hand label for several different phenomena. Each

particular phenomenon indicates a particular analogy that implies a particular path toward

its safety and control. Taken all together, this means that nanotechnology exists as a

socially constructed collection of techno-scientific ideas, practices, and materials.

With such a vague and fuzzy set of definitions, how can scientists, policy-makers,

activists, businesses, and other nano-stakeholders possibly agree upon the proper form of

nanotechnology’s regulation? J. Clarence Davies, initial author of what eventually

became the Toxic Substances Control Act (TSCA), explained that “the way

nanotechnology is defined in a regulatory context can make a significant difference in

what is regulated, how it is regulated, and how well the regulations work.”37 But, without

a clear definition of nanotechnology, how can regulators know what to regulate? How

can they move forward?

Over the past few years, scholars like Andrew Maynard – a leading expert on risk

science and the potential regulation of nanotechnology – have argued that a precise

definition for nanotechnology would actually impede proper regulation.38 Instead of a

categorical definition, Maynard argues that objective science must dictate proper

regulation of engineered nanomaterials; that regulation must focus on “trigger points,” or

empirical points that transition a material from acting conventionally to performing

unconventional, risky, and potentially threatening behavior.

Yet, in late 2011, in apparent opposition to Maynard’s views on avoiding strict

definitions for nanotechnology and letting objective science dictate action, Health Canada

37 J. Clarence Davies, “From Novel Materials to Next Generation Nanotechnology: A New Approach to Regulating the Products of Nanotechnology,” in International Handbook on Regulating Nanotechnologies (2010), 546. 38 Andrew Maynard, “Don’t Define Nanomaterials,” Nature 475 (7 July 2011): 31.

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as well as the European Commission announced specific, “cross-cutting,” and politically

designed definitions for nanomaterials to use explicitly “for all regulatory purposes.” In

the United States, the NNI’s recent research strategy for environmental, health, and

safety, emphasized the need for all U.S. agencies to establish an agreed-upon

standardization – e.g., a definition – for nanomaterials. The actions of Health Canada and

the EU, and the NNI’s recent call for a defining standardization of nanotechnology all

indicate an acceptance of nanotechnology as a co-evolving process of socio-technical and

politically constructed scientific phenomena. In order for societies and their governments

to instill reasonable oversight over a diverse suite phenomena like nanotechnology, a

flexible, iterative, continually revisited, and socially constructed definition of

nanotechnology is necessary for its legal regulation. Otherwise, the real threats posed by

the trigger-points of various nanotechnologies might never solidify for its proper control

to protect workers, consumers, and nature.

As Bruce Mazlish indicated in 1965, when seeking to understand an object, either

on its own terms or by means of historical analogy, context matters. We must view that

object as a “complex social invention” – something shaped by its historically constructed

contexts. As such, that object requires complex, politically invented, and socially agreed-

upon definitions for its social control and regulation. In 2003, participants at an NSF-

sponsored workshop on nanotechnology’s societal implications concluded that “One of

the more disturbing possibilities is that policy makers and leaders of social movements

may respond to nanotechnology not as it actually is, but in terms of false analogies.”39

39 “Workshop Breakout Session Reports,” in Nanotechnology: Societal Implications I, Maximizing Benefits for Humanity, edited by Mihail C. Roco and William Sims Bainbridge (Dordrecht, The Netherlands: Springer, 2007), 73.

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To avoid this fate, policy-makers and other stakeholders in the nano-enterprise face the

daunting challenge of inventing an agreed-upon definition for what nanotechnology is

and what it means.

Mazlish’s point also means we must be aware that new applications of

technologies will invite new analogies or bring about the redeployment of older ones.

Developing research and new applications of nanotechnology to human food and food

packaging highlights how historical analogies evolve over time as new social applications

of technology develop. Increasingly, agribusinesses and the processed food industry are

exploring the use of nanomaterials to provide stronger flavors and colors, prolong

freshness, improve the content and delivery of nutritional additives, and for antibacterial

uses in food packaging.40 In February 2013, the environmental health organization As

You Sow released a report characterizing the current environment for nanomaterials in

food as one “where little safety data, or even agreed-upon study methods, exist and where

state and federal laws and regulations have not yet been developed to ensure product and

consumer safety.”41 The recent introduction of nanomaterials to food and food packaging

40 Anne Bruce, “Nanotechnology helps food manufacturers make healthier food” (July 30, 2012), www.foodmanufacture.co.uk; Rick Pendrous, “Nano-based technology to lengthen shelf-life” (November 6, 2012), www.foodmanufacture.co.uk; Rui M. S. Cruz, Javiera F. Rubilar, Igor Khemelinskii, and Margaret C. Vieira, “Nantechnology in Food Applications” in Advances in Food Science and Technology, edited by Visakh P.M., Sabu Thomas, Laura B. Iurriga, and Pablo Daniel Ribotta, (Beveryly, MA: Scrivener Publishing LLC, 2013), 103-122. Already, nanomaterials appear in food and food-related products, sometimes without knowledge by the food corporations or their consumers: David Biello, “Nano-Powder on Your Donuts: Should You Worry?” Scientific American (February 6, 2013). 41 As You Sow, Slipping Through the Cracks, (2013), pg 9.

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may have revitalized the initial analogy – harkening back to this paper’s opening vignette

– between nanotechnology and GMOs.42

As historians, we understand that technologies are not fixed things. Policy makers

need to appreciate this as well as they approach the regulatory process. If we believe that

technologies change over time, so to will analogies used to understand and help regulate

them. By same token, new historical analogies can come to the fore. This also leave a

space to reconsider the utility of old ones. We started this paper with the analogy between

GMOs and nano, largely trying to discredit it as ahistorical and somewhat of a

disanalogy, a bad guide and poor tool to guide policy making. We’re ending by

suggesting that, while not perfect, it’s an analogy that has some usefulness in certain

circumstances.

Technologies (and their accompanying analogies) evolve over time as new social

considerations arise and as scientific understanding and applications progress. The

evolving nature of techno-historical analogies’ appropriateness amid the unceasing

evolution of science further emphasizes this paper’s argument on the need for iterative

and adaptive regulation of nanotechnology. The eventual legal and political control of

nanotechnology must be flexible and amenable to match our evolving understanding

about and uses for nanotechnology itself.

42 Like GMOs before it, nanotechnologies are now being designed for explicit ingestion by humans. The analogy drawn in 2003 by political actors and scientists between nanotechnology and GMOs – despite the dismissal of such analogies as a form of “folk theory” – may once again appear salient and appropriate. Ronald Sandler, “The GMO-Nanotech (Dis)Analogy?,” Bulletin of Science, Technology, and Society, 2006, 26, 1: 57-62; Arie Rip, “Folk Theories of Nanotechnologists,” Science as Culture, 2006, 15, 4: 349-65.

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If historical analogies teach can teach us anything about the potential regulation of

nanotechnology, we need regulations that are iterative and adaptive. This demands that

our analogies also be flexible and more than one size fits all. Because if technologies

change over time – as they surely do – then the analogies we use to guide regulation must

also be robust and flexible enough to change too. This suggests new terrain and new

approaches for policy makers and regulating agencies. When it comes to crafting

definitions as well as regulations that mirror the complex realm of research, policy, and

application, what we probably have to do is take a little risk.