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Emerging Technologies and the Environment Gary Marchant, Ph.D., J.D. Lincoln Professor of Emerging Technologies, Law & Ethics Center for the Study of Law,

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Presentation on theme: "Emerging Technologies and the Environment Gary Marchant, Ph.D., J.D. Lincoln Professor of Emerging Technologies, Law & Ethics Center for the Study of Law,"— Presentation transcript:

1 Emerging Technologies and the Environment Gary Marchant, Ph.D., J.D. Lincoln Professor of Emerging Technologies, Law & Ethics Center for the Study of Law, Science & Technology Sandra Day O’Connor College of Law Arizona State University Tempe, AZ, USA September 10, 2007

2 Technology: Jekyll and Hyde l Mr. Hyde: – Industrial pollution – Internal combustion engine – Dioxin – Asbestos – Nuclear contamination – Global warming – Thalidomide l Dr. Jekyll: – Pharmaceuticals (most) – Internet – Vaccines – Renewable energy – Biotechnology? – Carbon sequestration? – Nanotechnology?

3 Technology: A Two-Edged Sword l “Technology advance has clearly been something of a two-edged sword. The vast majority of people in preindustrial times may have lived short and impoverished lives, but industrialization has brought us face to face with global warming, ozone depletion, and acid rain. Given this trade-off, most green radicals would conclude that ecological salvation is more important than human comfort or longevity…[T]he antitechnology thesis ignores the fact that technological advance has the power to heal as well as destroy. In the modern world technological poverty often forces immiserated peoples to degrade their environments. Similarly, old industrial processes are virtually synonymous with dirty industrial processes. – Martin Lews, Green Delusions (1992)

4 GMOs – Demonstrated Benefits l Reduce pesticide use l Use of less environmentally harmful herbicides l Less tilling of soils l Water quality protection through reduced soil erosion and run-off l Reduced greenhouse gas emissions (less plowing and herbicide applications) l Increased yields (less destruction of natural habitat) l Biorenewable energy

5 Global Impacts of Biotech Crops: 1996-2005 l GM crops have resulted in: – 493 million pound reduction in pesticide sprayings worldwide (7 percent reduction) – Decreased adverse environmental impacts of pesticides by 15% – global warming emissions reductions equivalent to removing 4 million cars from road for one year Brookes & Barfoot, AgbioForum, 9:139-151 (2006)

6 Fumonisin Reduction: Advantages of Bt-Maize l Fumonisin contamination occurs pre-harvest due to insect infestation. l 20 to 30 fold fumonisin reduction with high levels of insect resistance in Bt-maize l In 1989, the U.S. had large scale outbreaks of lethal lung edemas in pigs and brain tumors in horses due to high levels of fumonisin l Laboratory experiments link fumonisin to a variety of cancers of brain, liver, and kidney Source: Drew Kershen

7 Insect Damage: Bt-Maize v. nonBt-Maize Source: Drew Kershen

8 Food-Feed Standards for Fumonisin l October 2003 – UK Food Safety Agency – Tested 30 maize-based food products – Ten products voluntarily withdrawn after exceeding the (then) proposed standard for fumonisin in foods – 500 ppb All six organic products tested withdrawn (7.6 to 32.96 times the proposed standard) Four of 24 conventional products (3.96 to 9.46 times the proposed standard) No transgenic food tested because none for sale in UK Source: Drew Kershen

9 Second Generation of GM Foods l Improved shelf life and quality of fruits and vegetables l Crops with improved nutritional qualities (e.g., more healthy oils, more nutritious proteins) l Reduction or elimination of allergens and toxins in foods l Functional foods containing vitamins or pharmaceuticals l Vaccines in foods l Drought and salt-tolerant crops


11 GM Foods: No Unique Risks (At least so far) l U.S. National Academy of Sciences (1992): – “Crops modified by molecular and cellular methods should pose risks no different from those modified by classic genetic methods for similar traits.” l European Union (2001): – "The use of more precise technology and the greater regulatory scrutiny probably make (biotech crops) even safer than conventional plants and foods." l Nina Federoff, scientist (NAS): – “This is probably the safest technology that human beings have ever invented.”

12 GMOs – Numerous False Alarms l “Ice Minus” l Pusztai Toxic Potato l Starlink l Monarch Butterfly l Bayer Rice l Disappearing bees

13 Biotechnology: Environmental Savior? l “These young genetic engineers did believe that their work would be good for the planet, possibly making it easier to grow food or reducing agriculture’s dependence on chemicals …. [They] often saw themselves as ‘green’ revolutionaries ….They had gone through university and graduate school during the 1970s, in the heyday of environmentalism. They’d seen DDT banned and Earth Day celebrated. Chemicals represented a dirty and regrettable past, and biology was the savior …. When the genetic engineers found themselves attacked by a new generation of environmentalists, they were incredulous and hostile.” -Daniel Charles, Lords of the Harvest

14 Yet GMOs Have Been at Most a Limited Success… l Complete rejection in EU l Unenthusiastic acceptance in US l Factors: – Failure to consult – No obvious direct benefits to consumers – Corporate control – U.S. dominance – “Unnatural” – Importance of food


16 Mobilization of Organized GMO Opposition l “Potentially, the biological pollution from GMOs is far more dangerous than even nuclear or chemical pollution.” – Greenpeace l GM foods threaten “a form of annihilation every bit as deadly as nuclear holocaust.” – Jeremy Rifkin

17 GMOs: Media Sensationalism

18 Source: Vincent Covello, Center for Risk Communication Factors important to the public in interpreting risk information

19 Asymmetry of Trust l “Trust if fragile. It is typically created rather slowly, but it can be destroyed in an instant – by a single mishap or mistake. Thus, once trust is lost, it may take a long time to rebuild it to its former state.” – Paul Slovic, Perceived Risk, Trust, and Democracy

20 The GM Foods Precedent? l “The campaign against GMOs was successful despite the lack of sound scientific data demonstrating a threat to society. In fact, I argue that the lack of sufficient public scientific data on GMOs, whether positive or negative, was a controlling factor in the industry's fall from favor. The failure of the industry to produce and share information with public stakeholders left it ill-equipped to respond to GMO detractors. This industry went, in essence, from "wow" to "yuck" to "bankrupt." There is a powerful lesson here for nanotechnology.” Congressional Testimony of Vicki Colvin

21 The GMOs/Nanotech Analogy l Prince Chuck opposes both, but.. l At least 2 important differences – strong likelihood of direct, visible benefits to consumers – strong likelihood of real risks

22 Nano & Environment: Opportunity and Challenge l “For EPA, the rapid development of nanotechnology and the increasing production of nanomaterials and nanoproducts present both opportunities and challenges. Using nanomaterials in applications that advance green chemistry and engineering environmental sensors and remediation technologies may provide us with new tools for preventing, identifying, and solving environmental problems. In addition, at this early juncture in nanotechnology’s development, we have the opportunity to develop approaches that will allow us to produce, use, recycle, and eventually dispose of nanomaterials in ways that protect human health and safeguard the natural environment.” – EPA, White Paper on Nanotechnology (Feb. 2007)

23 Environmental Benefits: Groundwater Remediation l Nanoscale iron particles have been injected into hazardous waste sites to dechlorinate chlorinated hydrocarbons such as TCE, PCBs, and other toxic wastes l Nanomaterials may also decrease sequestration of hydrophobic contaminants such as PAHs that bind to soils and sediments

24 Environmental Benefits: Environmental Sensors l Nanoscale sensors are being developed for detecting biological and chemical contaminants l May be able to detect contamination less expensively, over a wider area, and at lower concentrations than existing methods l Can monitor agents in real time; data can be collected and analyzed remotely

25 Environmental Benefits: Water Quality l Nanotechnology-based flow-through capacitors have been designed to desalinize water at a fraction of the energy and cost of existing methods l Nano filters being field tested to eliminate arsenic from drinking water l Fertilizers and pesticides that incorporate nanotechnology may result in less runoff – protecting water quality (e.g., Chesapeake Bay) – but concern about these dispersive uses

26 Environmental Benefits: Emissions Control l Cerium oxide nanoparticles are being used in UK as diesel fuel additive to reduce emissions and improve fuel economy – buy may increase emissions of other toxics (e.g., cerium oxide)? l Nanomaterials also being studied for their ability to remove metal contaminants from combustion source emissions – e.g., silica-titania nanocomposites l Nanomaterials also playing a key role in development of fuel-celled vehicles

27 Environmental Benefits: Pollution Prevention l Nanotechnology will increasingly provide for more efficient, less wasteful manufacturing l Ultimate goal – zero waste manufacturing – Reduce demands for natural resources – Reduce (eventually eliminate) production of wastes

28 The Dark Side of Nanotechnology


30 Nano Toxicity: Conclusion of Recent Review l “Although it is possible that engineered NM may create toxic effects, there are currently no conclusive data or scenarios that indicate that these effects will become a major problem or that they cannot be addressed by a rational scientific approach. At the same time, we can no longer postpone safety evaluations of NM. A proactive approach is required, and the regulatory decisions should follow from there.” – Nel et al, Toxic Potential of Materials at the Nanolevel, Science 311:622-627 (Feb. 3, 2006)

31 “Magic Nano” l Protective glass and bathroom sealant marketed in Germany earlier this year. l Some customers alleged that they suffered “inhalation injuries” after using the product; several hospitalized l Triggered front-page news stories across world demanding stricter regulation of nanotechnology l When Germany government announced a few days later that product actually contained no nano, interest and media coverage immediately ceased

32 Nanotech & the Public: Heuristics l “Cognitive Dissonance Avoidance” (Mandel 2005) – individuals cannot simultaneously perceive that a particular technology can have both benefits and risks l Reactive media attention and the concerted actions of public interest groups can directly affect how individuals initially perceive risks—often resulting in the cementing of an individual’s opinion on a given technology’s risks and benefits that, once made, is exceedingly difficult to change and commonly result in the taking of extreme positions l Once a technology has become stigmatized, negative opinions harden and spread through “cascade” effects

33 Study of Public Nanotechnology Perceptions l These results paint a picture …of at least one possible future for nanotechnology. It is one in which citizens rapidly take affect-driven positions, which harden as they conform what they learn thereafter to their more basic cultural attitudes toward technology and risk. The result is likely to be a state of political polarization over the desirability of nanotechnology that very much resembles the one that now exists other controversial environmental issues, including nuclear power and global warming.” (Kahan et al., 2007, pp. 3-4).

34 Social Amplification of Risk l Social dynamics influence how risk events are represented and communicated. l Risk events have a “signal value” that is propagated through a social network. Source: Kasperson, R.E., Ortwin, R., Slovic, P., Brown, H., Emel, J., Goble, R.L., Kasperson, J.X., & Ratick, S.J. (1988). The social amplification of risk: A conceptual framework. Risk Analysis, 8(2), 177-187.Kasperson, R.E., Ortwin, R., Slovic, P., Brown, H., Emel, J., Goble, R.L., Kasperson, J.X., & Ratick, S.J. (1988). The social amplification of risk: A conceptual framework. Risk Analysis, 8(2), 177-187. Special Reference: Stigma and the Social Amplification of Risk: Toward a Framework for Analysis. A chapter from Risk, Media, and Stigma. J. Flynn, P. Slovic, H. Kunreuther (Eds.), in publication. Stigma and the Social Amplification of Risk: Toward a Framework for Analysis. A chapter from Risk, Media, and Stigma. J. Flynn, P. Slovic, H. Kunreuther (Eds.), in publication. Chapter text

35 Growing Pressure for Nanotechnology Regulations l Many voices in U.S. calling for regulation of nanotechnology now: – Environmental & citizen groups – Media – Congressmen – Insurers – Investors/Venture Capitalists – Local and state governments – General public – Scientists/Public health representatives – Academics

36 Principles for the Oversight of Nanotechnologies and Nanomaterials l July 31, 2007 by 45 public interest groups takes hard line against nanotechnology l Calls for ban on commercialization of any “untested or unsafe uses of nanomaterials and requiring product manufacturers and distributors to bear the burden of proof.” l “Current legislation provides inadequate oversight of nanomaterials A modified or sui generis, nano-specific regulatory regime must be an integral aspect of the development of nanotechnologies.”

37 Lux Research Report (June 2006) l “The absence of regulation drives perceptual risk; the longer the field limps along without regulations, the more restless NGOs will grow and the harder it will be to gain consumer trust. …. Under-regulation will be a bigger threat than over-regulation.” l Some investors and venture capitalists avoiding nanotech because of regulatory uncertainty l Increasing number of companies avoiding use of “nano” on their products and promotional materials

38 Industry Calls for Nano Oversight “What we want to avoid is for the trajectory of nanotechnology to follow that of genetically- modified organisms (GMOs), the most recent ‘magic’ technology. In the case of GMOs, deployment of applications outpaced attention to the environmental, health, and safety implications of the technology. Public concerns that arose because of this have significantly retarded the realization of GMO’s great commercial potential.” - Testimony of Stephen Harper, Director of EHS Policy, Intel Corp Senate Testimony, May 11, 2005

39 What to Do? Option 1 Apply Regulatory Status Quo to Nanotechnology

40 EPA White Paper on Nanotechnology (Feb. 2007) l 120-page overview of EPA’s approach to nano l “in fiscal years 2007 and 2008, EPA will focus on the following high priority areas: environmental fate, transport, transformation and exposure, monitoring and detection methods” l “Having laid a foundation for understanding possible material alterations under various conditions, EPA will direct a greater share of fiscal year 2009 and 2010 resources to exploring the effects, specifically toxicity of the altered materials as identified in the first two years” l Primary goal – by 2011-2012 to have sufficient knowledge to develop integrated approaches to assess, manage, and communicate risks associated with engineered nanomaterials in the environment

41 Nanoscale Materials Stewardship Program l EPA published Federal Register notice in May 2005 and held public meeting in June 2005 l Tasked its National Pollution Prevention and Toxics Advisory Committee (NPPTACT) to establish an Interim Ad Hoc Work Group on Nanoscale Materials to further explore a voluntary program l Work Group developed an “Overview Document” presented to EPA in late 2005 l EPA announced plans to proceed with voluntary program in Oct. 2006; asked for participation in development l July 2007 – released “Concept Paper” on voluntary program for public comment l August 2007 – another public meeting

42 Limitations of Voluntary Approach l All major environmental groups are now refusing to support the NMSP – need regulation as backstop l Participation issues – especially for small and medium-sized nano start-ups? l Polls show general public does not trust a voluntary program – Wilson Center study (Macoubrie) – only 11% of the U.S. public believe voluntary programs can be sufficient for regulating nano

43 FDA Task Force l FDA announced in summer 2006 that it was forming a new internal task force to reconsider agency’s approach to nanotechnology l Report issued in July 2007 – No new regulation needed, although FDA plans to issue some new non-binding guidance documents – No evidence that nano products are more risky than comparable non-nano products – No labeling of nanotechnology products

44 No New Statutes Likely in Near to Mid Term l U.S. Congress has shown little or no interest in enacting new statutory authorities specifically for nanotechnology – Biotechnology precedent l Individual agencies and coordinating National Nanotechnology Initiative have denied need for new regulatory authorities l Unless some tragedy or high-profile incident occurs, no new nano statutes forthcoming

45 Problem 1: Fit Within Existing Statutory Regimes l TSCA requires pre-manufacture notice (PMN) for new chemical substances – Is a nanotech version of an existing chemical substance a “new” substance? – Low volume (10K kg/yr) and low exposure/release exemptions l Traditional assumptions used to assess risks of existing materials may not apply to nanomaterials – e.g., nano toxicity more related to surface area than weight – traditional chemical regulations assumes exposure & risk proportional to volume/weight of material l Are ambient concentrations a relevant risk measure for air quality standards for nanoparticles? l “Mode of action” criteria for distinguishing drugs (chemical) from devices (mechanical) obsolete?

46 Problem 2: Defining “New” l Many U.S. regulatory requirements target “new” materials or products l Is a nano-version of an approved product “new” from a regulatory perspective? – e.g., FDA - is a nano-sized version of an approved drug a “new” drug? – e.g. TSCA – is a nano-version of an existing chemical a “new” substance? l Relationship between “new” in regulatory and patent contexts?

47 Problem 3: Definitional Issues l National Nanotechnology Initiative offers the following definition which U.S. agencies are following: – “Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications.” l What does this mean from a regulatory perspective: – All dimensions must be 1 to 100 nm, or 1 or 2 dimensions? – What if some particles 100nm? Does it matter if 50% 10% 1%

48 Problem 4: Categorization l Nanotechnology involves a broad range of technologies, processes and products l Threshold issue – does it make sense to treat nanotechnology as a single category? – Davies – any more sense than regulating things that are blue? – FDA – rejected single category approach in favor of a product-by-product approach – Andrew Maynard, Wilson Center – term nanotechnology needs to be “decoupled” l Analogy: Process vs. product debate in GMOs

49 Problem 5: Uncertain Risks l Very large number of nanotechnology processes, application, materials, products and facilities with different risk profiles – e.g., carbon nanotubes l Only very preliminary toxicology data available l Nanotoxicity appears to be affected by large number of variables – prevents using structure to extrapolate risks l Kristen Kulinowski, ICON: – “We are in this awkward middle territory where we have just enough information to think there is an issue, but not enough information to really inform policymakers about what to do about it.”

50 Problem 6: Unobtainable Regulatory Triggers l Regulatory agencies often constrained by statutory authority from taking action on uncertain risks – e.g., TSCA § 6 – requires EPA to demonstrate “unreasonable” risk before regulating a product – e.g., TSCA § 4 – requires EPA to demonstrate potential for “substantial risk” before requiring a company to test its products – e.g., OSHA – demonstrate “significant risk” using human epidemiology studies

51 Problem 7: Maintaining Regulatory Flexibility l U.S. regulatory system is: – Highly legalistic – Politically influenced and polarized – Decentralized via separation of powers l One consequence is that formalized legislative and regulatory requirements become very difficult to update and can become outdated – e.g., Delaney Clause – e.g., CWA– point vs. non-point sources l How can regulatory system be flexible and dynamic enough to adapt to rapidly changing nanotechnologies? l David Rajeski, Wilson Center: – “If you think that any existing regulatory framework can keep pace with this rate of change, think again.”

52 Maintaining Flexibility: Nanotechnology Timeline

53 Problem 8: Incorporating Social and Ethical Concerns l Many public concerns with emerging technologies are of a social, ethical and/or political nature l Traditional U.S. regulatory system excludes ethical and social concerns from agency’s legal jurisdiction – e.g., biotechnology, cloning, nanotechnology l One solution would be to provide legal requirements to consider ethical/social risks along with environmental/health/safety risks l NNI takes different approach of trying to integrate social/ethical concerns further upstream at pre- regulatory stage of planning/conducting nanoscience

54 Why Can’t Agencies Consider Ethical/Social Concerns? l Unlike human health and environmental harms, no consensus on which social and ethical impacts are “good” or “bad” l Social and ethical risks are more intangible, harder to define and quantify l Justification for governmental intervention in the market to address ethical/social issues controversial l Regulatory agencies have expertise in fields such as science and economics; not in ethics and social sciences

55 Problem 9: Engaging the Public l U.S. regulatory agencies have put great emphasis on public participation and consensus processes l Three main difficulties – Lack of meaningful, effective mechanisms for public engagement under existing statutes – Growing and perhaps irreconcilable differences between major interested groups (e.g., industry vs. environmentalists – Most of the general public relatively disinterested

56 Problem 10: Selection of Regulatory Tools? l If regulation warranted, what type of regulation should be imposed? – Testing requirements – Disclosure requirements – Product bans – Emission standards – Exposure standards – Ambient standards – Labeling requirements – Liability requirements

57 Current Situation Untenable l No prospects of any nano-specific legislation on horizon – absent some outrage or calamity l Inadequate regulatory oversight under existing regulatory authorities – risk of harm to human health or environment – public unease l Growing emphasis and stridency of NGOs in opposition to nanotechnology l Potential for irreversible stigmatization of nano a growing prospect

58 Neal Lane (Pres. Clinton’s former Science Advisor) l “In my view, given what’s at stake, this situation is unacceptable. I fear that nanotechnology may be heading for a fall. A major environmental, medical or safety problem – real or bogus – with a product or application that’s labeled ‘nanotechnology’ – whether it actually is nanotechnology or not – could dampen public confidence and financial investment in nanotechnology’s future, and could even lead to unwise regulation. We should not let this happen.”

59 What to Do? Option 2 The Precautionary Principle

60 Invoking the PP for Nanotechnology l A growing number of activist groups and some scholars are calling for a moratorium on all nanotechnology research/ commercialization based on the precautionary principle l e.g., ECT group – invoking the precautionary principle, called for a global moratorium on nanotechnology in 2002 l e.g., Bill Joy (Sun Microsystems) – called for “relinquishment” of G-N-R (genetic- nanotechnology-robotic) technologies l e.g., Swiss Re – one of the world’s largest reinsurance companies

61 Precautionary Principle: Key Elements l Underlying concepts: – Better safe than sorry – Prevent harm before it occurs – Absence of evidence is not evidence of absence l Allow precautionary regulatory decisions to be made even in the face of inherent uncertainty l Put burden of proof on proponent of technology/ product

62 Examples of Overlooked Risks (False Negatives) l Products once thought safe but turned out to be hazardous: – asbestos – chlorofluorocarbons (CFCs) – leaded gasoline – MTBE – DES – beef with mad cow disease l But also consider false positives: – saccharin – Bendectin – silicone breast implants – “ice minus” bacteria – MMR vaccine – coffee! – chocolate!!

63 The Proliferation of the Precautionary Principle l Incorporated into more than 60 international environmental treaties l Included in 1992 Maastricht amendments to European Treaty l Incorporated into national laws of many countries (e.g., most EU nations, Australia, Canada) l Being applied as binding law by some courts (e.g., Australia, New Zealand, India) l Adopted by City of San Francisco (2003) and Seattle (2006)

64 Problem 1: No Standard Version of the PP l There is no standard text of the precautionary principle l Treaties, regulators, and courts apply “the” precautionary principle without specifying which version they are using l Over 50 different formulations have been collected; subtle differences in wording have significant policy consequences

65 Two Versions of the Precautionary Principle Rio Declaration: “Where there are threats of serious and irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” Wingspread Statement: “When an activity raises threats of harms to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically.”

66 Dimensions of Precautionary Principle

67 Problem 2: Ambiguity of the PP l How substantial must the potential risk be? l What level of risk is acceptable? l What early indications of potential hazard needed to trigger precaution? l How much data must proponent produce to demonstrate “safe”? l How are costs and risk-risk tradeoffs factored in? l What type of action is required to satisfy the principle?

68 Arbitrariness of the PP Two levels of arbitrariness: To which problems does the precautionary principle apply? What does the precautionary principle require for those problems to which it does apply?

69 Recent Examples of Arbitrary Applications l EU banned North American hormone-fed beef l Netherlands prohibited Corn Flakes cereal fortified with vitamins l Denmark banned OceanSpray Cranberry drinks because of Vitamin C l France banned Red Bull energy drinks because of caffeine l Support for EU subsidization of coal-mining industry l Zambia refused U.S. food aid because corn contained genetically modified kernels

70 Why Is the PP Not Being Applied to…. l Herbal supplements? l Tourism? l Asteroids? l Toothpicks? l Bean sprouts? l Organic foods?

71 Problem 3: Risks of Excessive Precaution l Potential for precaution disproportionate to benefits – e.g., how safe an automobile do we really want? – e.g., speed limit of 10 mph l Sometimes foregoing or delaying new technologies would do more good than harm – unclear which way PP cuts – e.g., clinical drug testing – e.g., GMOs? – e.g., nanotechnology? l Evidence that application of PP increases public’s concerns/anxiety about a technology (Wiedemann & Schultz, 2005)


73 PP Will Stifle Discovery l “As a principle of rational choice, the PP will leave us paralyzed. In the case of genetically modified (GM) plants, for example, the greatest uncertainty about their possible harmfulness existed before anybody had yet produced one. The PP would have instructed us not to proceed any further, and the data to show whether there are real risks would never have been produced. The same is true for every subsequent step in the process of introducing GM plants. The PP will tell us not to proceed, because there is some threat of harm that cannot be conclusively ruled out, based on evidence from the preceding step. The PP will block the development of any technology if there is the slightest theoretical possibility of harm.” Holm & Harris, Nature 400:398 (2000)

74 What to Do? Option 3 A New Model of Oversight

75 Challenge and Opportunity l Nanotechnology presents an unprecedented challenge to regulatory oversight – Pervasive uncertainties – Diverse applications and products – Rapid pace of development/evolution – International l Opportunity – inadequacy of existing risk management models necessitates development of new approaches that may be useful for other emerging technologies

76 Incremental, Cooperative, Reflexive Oversight Short Term Medium Term

77 Short Term Actions l Transnational private regulation – Responsible Care – Standards bodies – ISO, etc. – Foresight Guidelines for MNT – Dupont/ED Model – Other firm and industry norms

78 Medium Term: Setting Pathways l Ultimate regulation needs: (1) broad participation, (2) legal obligations, (3) substantive content l Bilateral/plurilateral, then expand l Soft law, then “harden” l Framework convention, then add content – Technical uncertainty

79 Important Role for Trusted Intermediaries l In era of increased polarization and ideological conflict, there is a need for organizations that credibly address both risks and benefits of emerging technology (i.e, recognize the two edged sword problem) l Nanotechnology fortunate to have several such organizations that can play a key role: – Wilson Center Project on Emerging Technologies – Foresight Institute – Center for Responsible Nanotechnology

80 Concluding Thought

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