Andrew D. Maynard Ph.D. Chief Science Advisor Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars

Transcription

1 Developing Science Policies for Sustainable Nanotechnologies A presentation to the President s Council of Advisors on Science and Technology, Public Meeting on Nanotechnology, June Andrew D. Maynard Ph.D. Chief Science Advisor Project on Emerging Nanotechnologies, Woodrow Wilson International Center for Scholars Science policies for sustainable nanotechnologies So far today we have heard about the tremendous potential that nanotechnology has to revolutionize the way we do things; curing social ills, providing new jobs and creating wealth. We have also heard something about the new questions nanotechnology is raising concerning possible health and environmental impacts. There is no doubt that nanotechnology has the potential to make the world a better place. But if consumers and other stakeholders are not convinced that the benefits outweigh the risks, many applications will not see the light of day. Likewise, if the benefits are unclear and the risks uncertain, the products of nanotechnology will be a hard sell. The reality is that we will only realize the benefits of nanotechnology if we provide the right environment for the science and technology to grow into sustainable applications. And that means taking an integrated approach to identifying and addressing potential risks. In this context, I would like to talk about how we might develop science policies that respond to the new challenges nanotechnology is presenting us with. But first, let me say something about myself and the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies. The Wilson Center Project on Emerging Nanotechnologies Although much of my research career has been in occupational health, I am a physicist by training. I cut my teeth on nanotechnology research before the term nanotechnology had any credence using cutting-edge transmission electron microscopy to study atmospheric nanoparticles at the University of Cambridge in the UK. I am widely published in the fields of nanomaterial characterization, behavior, toxicology and potential impact, and spend more time than my family is happy with speaking about nanotechnology around the world. Between 2000 and 2005, I worked for the National Institute for Occupational Safety and Health (NIOSH), where I helped to develop the agency s nanotechnology research program. During this time, I represented NIOSH in the National Nanotechnology Initiative (NNI) and on the Nanotechnology Environmental and Health Implications working group (NEHI) of the NNI which I co-chaired with Dr. Norris Alderson from FDA. 1

2 In 2005, I joined the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies, as Chief Science Advisor. The Wilson Center was established by Congress as a national memorial to president Woodrow Wilson in It is a non-partisan and non-advocacy institution, supported by both public and private funds. The Project on Emerging Nanotechnologies is a joint initiative between the Wilson Center and the Pew Charitable Trusts. It is dedicated to collaborating with the full spectrum of nanotechnology stakeholders to ensure that as nanotechnologies advance, possible risks are minimized, public engagement remains strong and potential benefits are realized. Nanotechnology as a disruptive technology Nanotechnology is turning our world upside down. The increasing dexterity at the nanoscale that it provides gives us the opportunity to greatly enhance existing technologies, and to develop innovative new technologies. When you couple this capability with the unusual and sometimes unique behavior of materials that are engineered at near-atomic scales, you have the basis for a transformative technology that has the potential to impact virtually every aspect of our lives. But nanotechnology is also shaking up our understanding of what makes something harmful; and how we deal with that. You have already heard examples of the unusual biological behavior of nanomaterials from Dr. Oberdörster. But I would like to underline those examples with a very simple illustration from the world of consumer products. Nano-specific impact questions: an example from sunscreens Many sunscreens use particles of zinc oxide and titanium dioxide as the active ingredients in preventing skin damage from the sun. These physical agents provide an effective barrier against long and short wavelength UV radiation, but leave an unattractive white residue on the skin think white-nosed lifeguards. However, in the past few years, manufacturers have been using nanoscale forms of these ingredients, which have the rather attractive property of blocking UV radiation while being transparent to visible light so they go on clear while still providing effective protection. Using nanoparticles rather than chemical agents in sunscreens is attractive in other ways.while other UV-absorbing chemicals can sometimes react badly with the skin, titanium dioxide and zinc oxide particles are widely recognized as being relatively benign. These particles are also more photostable than many of their non-particulate counterparts, leading to products that protect the skin for longer in the sun. But placing these clear benefits to one side for the moment, think about the questions about possible risks that using these nanoparticles raise, which would not ordinarily be brought up if conventional chemicals or large particles were being used. For example, when the nanoparticles are being manufactured, how is exposure prevented? How do we 2

3 measure exposure especially as we still do not know what the most appropriate exposure metrics are? How do we know what exposure levels are safe, and what levels are harmful for these nanoparticles? Can inhaled particles enter the bloodstream or migrate to the brain something that larger particles cannot do, but nanoparticles might be able to? And what happens if inhaled particles do migrate around the body, depositing in organs other than the lungs? How is waste material disposed of does it enter the environment uncontrolled, and what does it do once it is there? When these sunscreens are used, can the nanoparticles penetrate through the skin and enter the body that way? How does washed-off sunscreen containing nanoparticles affect the environment, especially the aquatic environment does the unusual behavior of these nanoparticles lead to impacts that would not be predicted from larger particles? Even though the nanotechnology being used in sunscreens is very crude compared to what we will see emerging over the next few years, these are questions that currently are largely unanswered. In fact, they echo many of the questions raised in the NNI report published last year on environmental, health and safety research needs for engineered nanoscale materials. 1 Challenging the chemicals-based risk evaluation paradigm At issue is the reality that the behavior of nanoscale materials for good or for bad depends on the form of the material, as well as its chemistry. And as a consequence, we can no longer rely on hazard evaluations, risk assessments or regulations that are based on our understanding of chemicals alone. While there is uncertainty over the potential risks associated with nanoparticles in sunscreens, it is likely that, even in the worst case, these risks will be minimal compared to the benefits. But the questions about possible risks still need answers if we are to ensure these and other nanotechnology-enabled products are as safe as possible. As the number of products using nanotechnology continues to grow, the need for sciencebased information on risks and how to manage them becomes increasingly urgent. Already, we are aware of over five hundred manufacturer-identified nanotechnology consumer products, 2 and these represent just the tip of the iceberg of current and close-tomarket consumer and commercial applications. Government, industry, academics and others all agree that there is a long list of very specific questions that need answers, if we are to develop these nanotechnologies as safely as possible. The challenge we face is answering these questions quickly and efficiently, to ensure that human health and the environment are protected, to provide 1 NSET (2006). Environmental, health and safety research needs for engineered nanoscale materials, Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology, National Science and Technology Council, Washington DC. 2 A Nanotechnology Consumer Product Inventory. accessed 6/15/07 3

4 industry and regulators with the information necessary to make good decisions, and to enable consumers to make informed choices on nanotechnology in their lives. This is a challenge that we have known about for some years. Back in 1999, I was involved in an assessment of ultrafine aerosol research needs at the British Health and Safety Laboratory the research arm of the UK Health and Safety Executive. On the topic of nanotechnology, we concluded there is considerable commercial commitment to the field [of nanotechnology], and it is certain that as scale-up problems are overcome, the mass production of both nanoparticles and nanophase materials will increase rapidly world-wide. When this occurs, the unique health problems associated with a unique product that can neither be treated as bulk material or on a molecular level will have to be fully addressed. 3 Similar concerns were raised in a seminal 2004 assessment by the UK Royal Society and Royal Academy of Engineering, 4 and a number of other influential reviews have reiterated the same issues. 5 Yet the response to this challenge has been less than overwhelming. In recent years, the US federal government has published spending figures on nanotechnology environmental safety and health research. But no information has been forthcoming on what research is being done, and whether this research will answer the safety questions being raised by industry and others. 6 This is important, because without specific research information, it is impossible to be sure that the research is relevant or useful. Investment in nanotechnology risk research In 2005, the Woodrow Wilson Center Project on Emerging Nanotechnologies took a close look at government-funded nanotechnology environment, health and safety research, to assess whether it matched the questions that need answering. The results suggested that investment in highly relevant research was rather low only $11 million per year, compared to a nanotechnology R&D budget of well over $1 billion. 7 This is in 3 A scoping study into ultrafine aerosol research and HSL s ability to respond to current and future research needs. Kenny, L. et al Health and Safety Laboratory, UK. Report Number IR/A/99/03. 4 RS/RAE (2004). Nanoscience and nanotechnologies: Opportunities and uncertainties, The Royal Society and The Royal Academy of Engineering, London, UK, 113 pp. 5 For an overview of reports addressing concerns and research needs, see Maynard, A. D. (2006). Nanotechnology: A research strategy for addressing risk, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington DC. 6 NSET (2006). The National Nanotechnology Initiative. Research and Development Leading to a Revolution in Technology and Industry. Supplement to the President's FY 2007 Budget, Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology, National Science and Technology Council, Washington DC. 7 Maynard, A. D. (2006). Nanotechnology: A research strategy for addressing risk, Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington DC. 4

5 the face of industry, congress and non-government organizations calling for more money for nanotechnology environment, health and safety research. In February 2007, nineteen businesses, trade organizations and NGO s signed a letter to the Senate Subcommittee on Interior, Environment and Related Agencies Committee on Appropriations, emphasizing the importance of providing adequate funding for the environmental, health and safety implications of nanotechnology. 8 Signatories included, among others, BASF, Bayer, DuPont, Dow Chemical Company and the NanoBusiness Alliance. And at a hearing of the House Science Committee in September 2006, chair Sherwood Boehlert and ranking member Bart Gordon called for a more strategic, better funded research program to study the environmental and safety risks associated with nanotechnology. 9 In addition to finding that only a small amount of money is being spent on essential research, we also found that there was an apparent lack of strategy behind the research portfolio; a very worrisome state of affairs. There were no indications that this small investment would in fact provide decision-makers with the information they needed to make nanotechnology a success. It is now 2007, and there are signs of movement towards realizing that an ad hoc research agenda is an inefficient way to answer specific risk research questions. In 2006, the NNI published a comprehensive list of research needs to be met if sustainable nanotechnologies are to be developed. 10 A prioritized list of research needs following on from this is anticipated in the near future. Yet progress could hardly be described as fast. For instance, in 2003, participants at an NNI workshop on nanotechnology in the environment made ten important recommendations on addressing nanotechnology implications to health and in the environment. Those recommendations were finally published this month four years after the workshop. 11 At this rate of progress, the nanotechnology revolution will be done and dusted before we see any real progress towards understanding and avoiding potential nanotechnology risks! Approaching 21 st century technologies with a 20 th century mindset Nanotechnology presents us with new opportunities and new challenges. Not surprisingly, this technology of the 21 st century does not fit comfortably within the science frameworks and policies of the previous century. Already we have heard that the technology is no respecter of boundaries between scientific disciplines, or the rather idealistic distinctions between pure and applied science. Indeed, much of the potential of 8 Letter to the chair and ranking member of Senate Subcommittee on Interior, Environment and Related Agencies Committee on Appropriations, February Boehlert, S. and Gordon, B. (2006). Boehlert calls for better coordination and greater funding to understand nanotechnology risks. House Committee on Science, September NSET (2006). Environmental, health and safety research needs for engineered nanoscale materials, Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology, National Science and Technology Council, Washington DC. 11 NSET (2007). Nanotechnology and the Environment. Report of the National Nanotechnology Initiative Workshop, May , NSET, Washington DC. 5

6 nanotechnology comes from breaking down traditional boundaries. I don t think it is too much of an overstatement to suggest that economies that develop new science policies to foster the safe development of nanotechnology, rather than relying on old modes of thinking, will benefit the most in the long term. The NNI has been tremendously successful in encouraging innovative exploratory nanotechnology research. Yet as questions surrounding the possible impacts of nanotechnology have arisen, these same exploratory research models have been applied to risk research. But are these models appropriate for risk-focused research? There is an implicit assumption within the federal government that basic research, supported under the umbrella of the National Nanotechnology Initiative, will eventually lead to solutions for identifying, assessing and managing possible risks. This attitude is reflected both in the lack of project-specific information behind the NNI spending figures on environment, health and safety research (suggesting that it is quantity of research rather than quality that is important), and the lead role of the National Science Foundation in risk research an agency dedicated to basic or exploratory research, and not to the mission-driven agendas of oversight agencies. This is not good science policy. Exploratory research is needed to frame the risk-relevant questions of tomorrow. But as the NNI itself and other organizations point out, there is a very long list of specific risk research questions that need answers today. The only way I can see to obtain these answers is through strategic goal-oriented research. Developing effective nanotechnology risk research policy Strategic Research Framework What might a good nanotechnology risk research policy look like? The ultimate aim of risk-relevant research must be to provide decision-makers with the information they need to develop and use nanotechnologies as safely as possible. This includes regulators, industry and consumers. Achieving this aim will require realistic funding, appropriate research and coordination mechanisms, and above all, a strategic research plan. In pursuit of this aim, there are specific research goals that will challenge and stretch the scientific community. In 2006, I worked with thirteen colleagues all internationally respected scientists, including Drs. Tinkle and Oberdörster on identifying the key scientific challenges to developing safe nanotechnologies. Our recommendations were published in the journal Nature in November 2006, and provide a framework on which to build strategic environment, health and safety research programs. 12 They address the need for measurement techniques, toxicity screening tests, predictive risk evaluation capabilities and life cycle assessment. 12 Maynard, A. D., Aitken, R. J., Butz, T., Colvin, V., Donaldson, K., Oberdörster, G., Philbert, M. A., Ryan, J., Seaton, A., Stone, V., Tinkle, S. S., Tran, L., Walker, N. J. and Warheit, D. B. (2006). Safe handling of nanotechnology. Nature 444:

7 Already, we are beginning to see research funders in other countries develop integrated, goal-oriented research agendas around these recommendations. At the end of 2006, the European Union called for proposals to be supported as part of its Seventh Framework research program. Two of the five environment, health and safety goals set by the EU within a 3.6 billion nanotechnology research program match key recommendations made in the Nature paper. But the significance of the European program is that it is not constrained by disciplinary or pure/applied research barriers. Rather, it is goal-oriented towards generating specific information that will support successful European nanotechnologies. A top-down strategic research framework can enable coordinated, goal-driven research across multiple agencies, allowing each organization to work within its own mission and particular expertise. It can also ensure that limited funds are used wisely, and not squandered. A colleague in the UK was once asked how British researchers managed to do such good work on so little funding. He replied that, because funds were limited, they had to think first. It is easy to mask poorly thought-out research strategies behind impressive-looking funding levels. But when it comes to understanding the potential impacts of nanotechnology, we do not have the luxury of hiding behind the figures. Effective research mechanisms A strategic framework is not enough on its own, though. We also need mechanisms in place that will ensure the necessary cross-disciplinary and cross-agency collaboration to get the work done. Following publication of the 2004 Royal Society and Royal Academy of Engineering report on nanotechnology, the British government established the Nanotechnology Research Coordination Group (NRCG) to develop a comprehensive risk research program in the area of nanoparticles. The NRCG includes members from research, regulatory and administrative agencies. Setting aside the question of funding, which as been slow to emerge in the UK, the NRCG represents a new organizational structure in the UK that has the potential to execute a strategic research plan across agencies to achieve common goals. This is something that is currently not possible in the US, within the structure and policies under which the NNI operates. While agency representatives meet regularly under the auspices of the NNI and the Nanotechnology Environment and Health Implications working group (NEHI), mechanisms to ensure coordinated research programs address common goals are weak at best. At the end of the day, NEHI has neither the scope nor the authority to ensure that a strategic research plan is executed across relevant agencies. Mechanisms are also needed to coordinate activities between government and industry. One particular mechanism that has been proposed by myself and others is a joint government-industry funded research initiative, addressing issues of mutual relevance. This would not replace purely government or purely industry-led research programs, but would provide a valuable way to exploit the strengths of both government and industry in 7

8 addressing specific challenges. It is a model that has worked well in addressing vehicle pollution, through the Health Effects Institute, 13 and it is one that I believe has great potential for leveraging government and industry funds in a similar way for nanotechnology risk research. Appropriate funding levels and distribution This brings me to the third component necessary for an effective environment, health and safety research strategy, and one that I cannot emphasize enough: funding. At present, each agency within the NNI is responsible for funding its individual nanotechnology research programs. And this leads to some unusual disparities, especially in the area of environment, health and safety research. Remembering that we already have a long list of questions that require goal-oriented research to be answered, those agencies best equipped to answer many of the questions including the Environmental Protection Agency, the National Institute for Occupational Safety and Health, and the Food and Drug Administration are the least-well funded in this area. Instead, agencies with no mission to conduct health and safety research, and little understanding of how best to do this research, account for the bulk of risk-related research funding, according to the NNI. 14 This is not a good basis for a strategic research program. To be effective, the overall funding for goal-oriented nanotechnology risk research must increase. Estimates of the necessary funding have ranged from $50 million per year to $100 million per year, from industry, non-government organizations and others. 15 But to be effective, these funds must be used judiciously; with mission-driven research agencies like EPA and NIOSH playing a lead role, and regulatory agencies including the Food and Drug Administration, the Consumer Product Safety Commission and EPA having access to the resources necessary for developing and implementing effective regulatory oversight frameworks. Successful nanotechnology development through foresight We cannot afford to drive blind into the nanotechnology future. Not only will this prevent us seeing and navigating around the inevitable bends associated with possible risks, but it will also give those economies with the foresight to identify and negotiate the 13 The Health Effects Institute (HEI) is a non-profit corporation chartered in 1980 as an independent research organization to provide high-quality, impartial and relevant science on the health effects of air pollution. It is jointly funded by government and industry. HEI (2007). Heath Effects Institute 2006 Annual Report. Science for Decisions, Health Effects Institute, Boston MA. 14 NSET (2006). The National Nanotechnology Initiative. Research and Development Leading to a Revolution in Technology and Industry. Supplement to the President's FY 2007 Budget, Subcommittee on Nanoscale Science, Engineering and Technology, Committee on Technology, National Science and Technology Council, Washington DC. 15 In 2005, Environmental Defense estimated that $100 million per year is needed for nanotechnology risk research, while in 2006, Maynard estimated that a minimum of $50 million dollars a year is needed for targeted research, in the report Nanotechnology: A research strategy for addressing risk (Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, Washington DC., 2006). 8

9 bends a very real competitive edge. Despite a good start, the US is still caught up in developing new technologies within an old mindset. If emerging nanotechnologies are to be built on a sound understanding of the potential risks and how to avoid them new research strategies, new mechanisms of execution and new funding are all needed. These should be overseen by an interagency group with the authority to develop a strategic research framework and ensure its execution a NEHI group with teeth. As a final example of what is possible, Australia recently announced the formation of an AU$36.2 million initiative to develop nanotechnologies for niche markets the Niche Manufacturing Flagship. What sets this initiative apart is an integrated approach to environment health and safety research from the get-go, leading to products that have been researched and designed with safety in mind. In the long run, it is products arising from programs like this that are most likely to be embraced by consumers and industry alike. This is the type of competition the US faces as it considers the next steps in nanotechnology R&D and it is stiff competition. In March of this year, the UK Prime Minister s top advisory body on science and technology warned that the country s lead in nanotechnology is fading, because the government has not invested enough in research on the possible health and environmental effects. 16 Britain and other countries are now waking up to the need for future nanotechnologies to be based on a sound understanding of possible impact. The question is, does the US have the will to develop the innovative science policies needed to maintain leadership in an innovative technology like nanotech? 16 Donald McLeod, Lack of Funding Threatens Nanotechnology Research. The Education Guardian, March The article refers to the Council for Science and Technology report: Nanosciences and Nanotechnologies: A Review of Governments Progress on its Policy Commitments. March 2007, London, UK. 9