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Elements of an Effective Nanotechnology Risk-Research Strategy

OVERVIEW

The term strategy is often used to emphasize the importance and relevance of a process, leading to (for example) strategic reports, strategic plans, and strategic research programs. Yet the true meaning of the word has perhaps been lost or diluted through overuse. A possible shift in meaning may be relatively unimportant in many cases. But if there is a need for a well-constructed strategy to address a particular challenge, working from the wrong definition is likely to lead to confusion at best and a poorly conceived plan of action at worst. Therefore, in setting the scene for reviewing the National Nanotechnology Initiative’s Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (NEHI 2008), it is helpful to think through how the term strategy might apply to scientific research in general and to risk-focused research in particular.

Our aim in this chapter is to develop a sense of what the elements of an effective risk-focused research strategy might look like. We start by considering how strategic thinking or planning is related to research in general and what some of the key factors are in developing effective research strategies. We then focus on research aimed specifically at risks to people and the environment—whether real or perceived—and consider aspects of research strategies that are effective in avoiding or reducing the risks. Finally, we propose nine “elements” (see Box 2-1) that we believe are important in developing and implementing an effective research strategy aimed at identifying, assessing, and managing risks associated with nanotechnology. These elements are explained in further detail at the end of the chapter. It is against those elements that Strategy for Nanotechnology-Related Environmental, Health, and Safety Research is assessed later.

DEVELOPING EFFECTIVE RESEARCH STRATEGIES

Strategies generally define a set of goals, often in the context of an over-



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2 Elements of an Effective Nanotechnology Risk-Research Strategy OVERVIEW The term strategy is often used to emphasize the importance and relevance of a process, leading to (for example) strategic reports, strategic plans, and stra- tegic research programs. Yet the true meaning of the word has perhaps been lost or diluted through overuse. A possible shift in meaning may be relatively unim- portant in many cases. But if there is a need for a well-constructed strategy to address a particular challenge, working from the wrong definition is likely to lead to confusion at best and a poorly conceived plan of action at worst. There- fore, in setting the scene for reviewing the National Nanotechnology Initiative’s Strategy for Nanotechnology-Related Environmental, Health, and Safety Re- search (NEHI 2008), it is helpful to think through how the term strategy might apply to scientific research in general and to risk-focused research in particular. Our aim in this chapter is to develop a sense of what the elements of an ef- fective risk-focused research strategy might look like. We start by considering how strategic thinking or planning is related to research in general and what some of the key factors are in developing effective research strategies. We then focus on research aimed specifically at risks to people and the environment— whether real or perceived—and consider aspects of research strategies that are effective in avoiding or reducing the risks. Finally, we propose nine “elements” (see Box 2-1) that we believe are important in developing and implementing an effective research strategy aimed at identifying, assessing, and managing risks associated with nanotechnology. These elements are explained in further detail at the end of the chapter. It is against those elements that Strategy for Nanotech- nology-Related Environmental, Health, and Safety Research is assessed later. DEVELOPING EFFECTIVE RESEARCH STRATEGIES Strategies generally define a set of goals, often in the context of an over- 26

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27 Elements of an Effective Nanotechnology Risk-Research Strategy arching aim or vision; a plan of action for achieving the goals; and measures for indicating when the goals have been achieved. When that concept is applied to a complex subject, such as scientific research, developing suitable goals, imple- mentable action plans, and measures of success becomes similarly complex. Research is often open-ended and serendipitous, and it can be difficult to formu- late goals that will not stifle innovation. Even when the goals are clear—for in- stance, “to cure cancer” or “to develop renewable energy sources”—the road map for achieving them can be less than obvious. Promising research avenues can lead to dead ends, and seemingly trivial research directions sometimes turn out to be vitally important. Identifying measures of success ahead of time can sometimes seem like staring into a crystal ball. But, as difficult as the process is, strategies are required for science; in which resources are limited and there is a need to justify what is spent on the basis of what is achieved. Ensuring efficient progress, or “performance,” is a key aspect of any re- search strategy, and selecting useful measures requires a degree of sophistica- tion. In 2002, the Office of Management and Budget designed the Program As- sessment Rating Tool (PART) (OMB 2008) in an attempt to evaluate the performance of publicly funded programs, including research and development (R&D) programs. PART does not explicitly address the need for strategies, but it requires agencies to take strategically relevant steps that include defining out- come-based metrics, measuring the efficiency of research programs, and achiev- ing annual efficiency improvements. Applying those steps to scientific research is not easy. The 2008 National Research Council report Evaluating Research Efficiency in the U.S. Environmental Protection Agency concluded that “no agency had found a method of evaluating the efficiency of research based on the ultimate outcomes1 of that research” (p. 10), and indeed the report stated that BOX 2-1 Elements of a Research Strategy • Vision, or statement of purpose. • Goals. • Evaluation of the existing state of science. • Roadmap. • Evaluation. • Review. • Resources. • Mechanisms. • Accountability. 1 Ultimate outcomes include such results as lives saved or clean air and cannot be pre- dicted or known in advance, may occur long after research is completed, and usually depend on action taken by others (NRC 2008).

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28 Review of the Federal Strategy for Nanotechnology “ultimate-outcome-based metrics cannot be used to evaluate the efficiency of research” (NRC 2008, p. 5). Rather, the report reflected the need for sophisti- cated and nuanced approaches to setting and evaluating research agendas in concluding that “the primary goal of research is knowledge, and the develop- ment of new knowledge depends on so many conditions that its efficiency must be evaluated in the context of quality, relevance, and effectiveness in addressing current priorities and anticipating future R&D questions” (p. 10). Specifically, the report distinguished between investment efficiency—including the need to identify the most promising lines of research for achieving desired outcomes— and process efficiency, which relates input into research (for example, number of labor hours and dollars spent on laboratory equipment) to what is ultimately achieved. Development of effective research strategies that generate high-quality, relevant, and effective new knowledge will depend on the nature and context of the work to be done and the decisions to be made. There is a loose hierarchy in how science is organized, from laboratory-level studies through interdisciplinary research programs to governmentwide science initiatives; and different strate- gies to ensure success are used at each level. Overlying the hierarchy are ideas of how to divide and categorize different “types” of science. In 1945, Vannevar Bush, director of the Office of Scientific Research and Development, wrote in the report Science: The Endless Frontier that “basic re- search is performed without thought of practical ends. It results in general knowledge and an understanding of nature and its laws. This general knowledge provides the means of answering a large number of important practical prob- lems, though it may not give a complete specific answer to any one of them. The function of applied research is to provide such complete answers” (Bush 1945). The dichotomous perception of basic and applied research has dominated sci- ence policy in the United States for much of the last 50 years. Yet as Stokes and others have highlighted, a more nuanced and integrated approach to different “types” of science is perhaps more realistic (Stokes 1997). Rather than use the established but conceptually limited terminology, the panel found it helpful to describe research as “exploratory” or “targeted,”2 with the understanding that in many cases research will demonstrate attributes associated with both descrip- tions. In that context, the overarching aim of exploratory research is the expan- sion of scientific knowledge, whereas targeted research is focused on achieving specific goals, which are usually practical. The success of exploratory research might be measured with such indicators as an increase in knowledge, and the 2 Similarly, the Environmental Protection Agency uses a nomenclature to describe its research that includes core research and problem-driven research: problem-driven re- search is aimed at understanding and solving particular identified environmental prob- lems and reducing associated uncertainties, and core research is aimed at providing broader, more generic information to improve understanding relevant to environmental problems (NRC 1997).

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29 Elements of an Effective Nanotechnology Risk-Research Strategy plan of action for a research strategy might include steps to empower the bright- est minds to engage in innovative research with as much freedom as possible. In contrast, targeted research has built-in goals, and an implementation plan might consider the best use of multiple mechanisms—contract research, investigator- driven research, or otherwise—to achieve the goals within specific budget and time constraints. In between there is a fruitful crossover regime wherein the ideas underpinning exploratory and targeted research combine, leading to ex- ploratory research that meets real challenges and targeted research that generates knowledge that is not necessarily applied knowledge. DEVELOPING EFFECTIVE RISK-RESEARCH STRATEGIES Strategies for risk research—loosely defined as research in support of identifying, assessing, and addressing actual and potential causes of harm to people and the environment—are not typically limited by disciplinary, agency, or philosophic boundaries. They should address challenges of broad societal significance, for example, the reduction or prevention of harm to humans and the environment. It is the social significance of risk research that perhaps sets it apart from other kinds of research when a research strategy is being developed and imple- mented. For example, although a poor research strategy for developing new ap- plications might impede progress in a particular field, a poor risk-research strat- egy has the potential to reverse progress if it results in unanticipated or poorly managed harm to people and the environment. Such a reversal may arise from failure to identify potential risks in a timely manner, failure to understand how to manage new risks effectively, inability to respond to existing risks, or even inability to communicate information on risks effectively. Poor risk-research strategies may also affect perceptions of risk and lead to decision-making in government, business, and society in general that is not necessarily science- based. Ultimately, failure to develop and implement an effective risk-research strategy can potentially lead to economic loss, environmental damage, loss of quality of life, and loss of life itself. Like any other research strategy, a risk-research strategy will have clearly defined goals, a plan of action for achieving the goals, and measures of success that can inform future modifications of the strategy—all in the context of the existing state of the science. The plan of action for implementing an effective risk-research strategy will rely heavily on targeted research—research that is focused on addressing questions that are critical for ensuring the safety of new materials and products. A long-term risk-research strategy will also encompass exploratory research to generate knowledge that will inform future goals and research directions. With both targeted and exploratory research, useful research will not be limited by conventional disciplines, just as the mechanisms through which materials and products might cause harm do not respect disciplinary boundaries.

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30 Review of the Federal Strategy for Nanotechnology Ultimately, the measure of success of a risk-research strategy is the degree to which harm to people and the environment is mitigated or avoided. If the re- search is in response to an existing problem, success is measured relatively eas- ily as a reduction in the problem (for example, a reduction in lives lost or in the incidence of disease). It is generally acknowledged that risk research ideally is pre-emptive—preventing problems rather than addressing them after the fact— so measures of success are harder to identify. However, it is possible to identify measures that do not rely on prior harm. For instance, in 2006, four research goals to underpin the safety of nanotechnology were identified in a commentary in Maynard et al. (2006)—to develop samplers to detect nanoparticles in air and water, to develop toxicity screening tests, to develop predictive models, and to develop systems for assessing the effects of nanomaterials over their complete life cycle. In each case, it is clear how achieving the goal will help to avoid harmful effects of engineered nanomaterials, and success in achieving the goal is highly measurable.3 Other approaches to identifying where progress has been made in avoiding harm are possible. And such concepts as “value of informa- tion” (which is explored further in Chapter 4) can help to guide limited re- sources in maximizing the degree to which measurable progress is made (for example, Clemen and Reilly 2004; Yokota and Thompson 2004). The critical point here is that, hard as it might be to formulate such metrics of success in a risk-research strategy, failure to do so will result in funding of irrelevant research and failure to fund relevant research. DEVELOPING NANOTECHNOLOGY-SPECIFIC RISK-RESEARCH STRATEGIES An effective nanotechnology risk-research strategy will be predominantly forward-looking—preparing for potential risks before the technology has a widespread commercial presence. It will address nanotechnology-based products that are beginning to enter commerce and nanotechnologies currently under de- velopment. But it will also need to lay the scientific groundwork for addressing future materials and products arising out of new research, new tools, and new cross-fertilization between previously distinct fields of science and technology. The need to be active and forward-looking makes it particularly hard to develop, implement, and evaluate an effective risk-research strategy. In this context, it is helpful to consider briefly how other organizations have approached the chal- lenges of developing such strategies. We aim to highlight some of the ap- proaches taken by others in response to the challenge of developing nanotech- nologies safely. 3 For example, the development, commercialization, and adoption by 2010 of instru- ments that simultaneously measure personal exposure to airborne nanometer-scale parti- cle number, surface area, and mass concentration, as proposed by Maynard et al. (2006), constitute clear goals whose achievement can be quantified against clear time and per- formance criteria.

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31 Elements of an Effective Nanotechnology Risk-Research Strategy In 2004, the British Royal Society and the Royal Academy of Engineering published what has come to be seen as a seminal report on the development of safe and beneficial nanotechnologies. In Nanoscience and Nanotechnologies: Opportunities and Uncertainties (Royal Society 2004), the UK carried out a study to define what is meant by nanoscience and nanotechnology; to summa- rize and identify gaps in knowledge; to identify potential health and safety, envi- ronmental, ethical, and societal effects; and to look toward the future of the field. This study was executed by a working group of experts of diverse back- grounds assembled by the Royal Society and the Royal Academy of Engineer- ing. The report concluded with 21 recommendations to the UK government and other parties on the responsible development of new and emerging technologies. They addressed industrial applications; possible adverse health, safety, and envi- ronmental effects; regulatory issues; social and ethical issues; and stakeholder and public discussion. Although the report was not a strategy in itself, it laid the groundwork for developing strategies that would underpin the responsible de- velopment of nanotechnologies—including risk research. Three themes in par- ticular stand out among the recommendations: the need for research into what makes nanotechnologies potentially harmful and how to avoid harm throughout their life cycle, the need for research to inform oversight and regulatory deci- sion-making, and the need for independent review of progress in the responsible development of nanotechnologies. The UK government responded to the report in 2005 with the document Characterizing the Potential Risks Posed by Engineered Nanoparticles. A First U.K. Government Research Report (HM Government 2005). It set out a program of research objectives to address potential risks posed by nanoparticles and funding mechanisms to address these objectives with the aim of developing an appropriate framework and measures for controlling unacceptable risks— engineered nanoparticles being the subset of engineered nanomaterials consid- ered to be of most concern (Royal Society 2004). The result was a nanotechnol- ogy risk-research strategy that identified what was needed—19 research objec- tives were identified—and how the UK government proposed to meet the needs. In 2007, the UK Council for Science and Technology (CST)—the UK government’s top-level advisory body on science and technology policy is- sues—published a 2-year review of progress toward the government’s commit- ments to developing nanotechnology responsibly (CST 2007). The review praised some aspects of the government’s progress and criticized others; the details are not as important here as the process. As a result, later in 2007, the government published a second research report, on characterizing the potential risks posed by engineered nanoparticles (HM Government 2007). The second report described progress in addressing the 19 objectives established in 2005, considered where changes in direction and emphasis were needed, addressed issues raised in the CST review, and planned future steps. It is beyond our scope to evaluate the substance of the UK nanotechnology risk-research plan, but some aspects of the process align with previous discus- sions on research strategies. The UK government has identified clear aims and

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32 Review of the Federal Strategy for Nanotechnology objectives, established mechanisms for addressing the objectives, and set in place a process of review and revision. There has been a degree of independence in authoritative input into the research strategy, from the original Royal Society and Royal Academy of Engineering report to the inclusion of nongovernment experts and stakeholders in developing and implementing the strategy. Looking beyond the UK, the European Union (EU) has been active in identifying and supporting research aimed at addressing potential nanotechnol- ogy-related risks. In 2004, the European Commission (EC) released the commu- nication Towards a European Strategy for Nanotechnology (EC 2004). The document focused on realizing the societal benefits of nanotechnology, but it emphasized addressing potential risks in informed decision-making: “Nanotech- nology must be developed in a safe and responsible manner. Ethical principles must be adhered to and potential health, safety or environmental risks scientifi- cally studied, . . . in order to prepare for possible regulation” (p. 3). After the 2004 communication, the EC published Nanosciences and Nanotechnologies: An Action Plan for Europe 2005–2009 (EC 2005) as a com- munication to the Competitiveness Council, the European Parliament, and the Economic and Social Committee. In the action plan, the EC recommended EU and member-state actions to address eight elements of nanotechnology devel- opment, including public health, safety, and environmental and consumer pro- tection (action point 6). Key to that action point were commitments and recom- mendations to identify and address safety concerns, evaluate and minimize exposures, and ensure adequate oversight of nanotechnologies—in essence, to establish a framework for strategic research that led to informed decisions. Like the UK nanotechnology plan, the EC plan provided for regular review, and in 2007 the EC published its first implementation report on the action plan (EC 2007). Although the European action plan for nanotechnology did not explicitly include a risk-research strategy, it did provide a framework for developing such strategies. In testimony to the committee from representatives of the EU direc- torate general for science, research, and development and the directorate general for health and consumer affairs (Aguar 2008; Martin 2008), it was clear that the EU response to developing nanotechnologies responsibly involves a complex interplay between EU agencies, member states, and nongovernment stake- holders. There does not appear to be a single overarching strategy governing risk research in Europe, but rather multiple initiatives that together form a cohesive approach to supporting research that will inform policy decisions. Two initia- tives in particular highlight the current state of affairs: the European Union Sev- enth Framework Program for Research and Development and a review of risk- assessment methods for assessing the risks associated with nanomaterials con- ducted by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR). The SCENIHR is an independent scientific committee estab- lished to provide the EC with sound scientific advice for preparing policy and proposals related to public health and the environment. It is one of three such committees that address nonfood issues; it complements the Scientific Commit-

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33 Elements of an Effective Nanotechnology Risk-Research Strategy tee on Consumer Products and the Scientific Committee on Health and Envi- ronmental Risks. Research at the EU level is funded through framework programs that es- tablish the aims and aspirations of pan-European R&D initiatives. The current program is Framework Program 7 (FP7) and will run from 2007 to 2013 (EC 2006). Over this period, over €3.5 billion will be invested in nanotechnology R&D, some of which will be invested in risk research. Calls for proposals within the framework program range from enabling exploratory research to targeting specific issues and typically require collaboration between disciplines, countries, and public and private organizations. In the 2007 call for proposals, four catego- ries focused specifically on environmental health and safety: portable devices for exposure measurement and analysis, risk assessment of engineered nanopar- ticles, review of the scientific literature on potential risks, and creation of a criti- cal database on the effects of nanoparticles on the environment, health, and safety. Those topic categories, although forming only a small part of the re- search needed to address potential adverse effects of nanotechnologies, targeted specific issues identified through consultation with a broad base of experts and stakeholders. This process of consultation is continuing to inform research calls under FP7. The second initiative of interest here is an “opinion” published by the SCENIHR in 2007 (SCENIHR 2007). The SCENIHR was asked, in light of current scientific knowledge and in relation to the general information on and practices of chemical risk assessment, to assess the appropriateness of risk- assessment methods described in the current chemical-related technical guidance documents for risk assessment of nanomaterials and to suggest improvements in the method. Although it did not result in a risk-research strategy, the assessment was important on three counts: it formed part of the tapestry of independent and expert science-based input into the EU planning and decision-making process, which includes strategic decision-making on research directions; it systemati- cally established the level of information needed on emerging nanomaterials to evaluate—and thus manage—potential risks and in doing so provided a frame- work for developing research strategies to fill gaps; and it explicitly identified research subjects that need further attention if informed decisions were to be made on responsible development and use of nanomaterials. Those two examples and others not included here are indicative of an ap- proach to risk research in Europe that engages a broad array of experts and stakeholders, identifies key policy goals, establishes mechanisms for supporting research to address the goals, and periodically reviews progress toward the goals. The Organisation for Economic Co-operation and Development (OECD) has also begun to address the coordination of nanotechnology risk-research strategies among member countries. In 2006, the Working Party on Manufac- tured Nanomaterials (WPMN) was established under the OECD Chemicals Committee with the aim of promoting international cooperation in aspects of manufactured nanomaterials related to human health and environmental safety

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34 Review of the Federal Strategy for Nanotechnology to assist in the development of rigorous safety evaluation of nanomaterials. The working party is supporting eight projects that collate, coordinate, and dissemi- nate information and activities linking scientific understanding to the effective oversight of engineered nanomaterials; the second project addresses research strategies regarding manufactured nanomaterials. Although the OECD WPMN is not developing a nanotechnology risk- research strategy, its aim is to exchange information and identify common re- search needs to address human-health and environmental-safety issues associ- ated with manufactured nanomaterials (or engineered nanomaterials) and to un- dertake to meet the needs. In many ways, that is a step toward establishing an international framework within which individual countries and economies can develop risk-research strategies that address the needs of decision-makers while being coordinated with other global initiatives. The OECD process predomi- nantly involves government representatives, but there are provisions in the or- ganization’s structure for industry and nongovernment environmental organiza- tions to participate in the working party. It is thus likely that when the results of the research-strategies project begin to emerge, they will to some extent repre- sent input from stakeholders beyond government departments and agencies. However, it should be recognized that non-government stakeholder involvement in this process is neither inclusive nor representative. Apart from national and international government initiatives to develop nanotechnology risk-research strategies, there have been a number of independ- ent initiatives to map out strategic research needs and approaches. Several pa- pers have been published in recent years highlighting specific research needs, including Principles for Characterizing the Potential Human Health Effects from Exposure to Nanomaterials: Elements of a Screening Strategy (Oberdörster et al. 2005), Safe Handling of Nanotechnology (Maynard et al. 2006), and Haz- ard Assessment for Nanoparticles—Report from an Interdisciplinary Workshop (Balbus et al. 2007). Recently, the International Council on Nanotechnology released Towards Predicting Nano-Bio Interactions: An International Assessment of Research Needs for Nanotechnology Environment, Health and Safety (ICON 2008). It reports on two international multistakeholder workshops that were tasked to identify and set priorities for the research needed to classify nanomaterials by physical and chemical properties and to develop predictive models for their in- teractions with living systems. The result was 36 recommendations on research needed to understand more fully how nanomaterials interact with biologic sys- tems and on how to use this knowledge to avoid undue harm on near-term, mid- dle-term and long-term time scales. A comprehensive overview of challenges to and solutions for developing a nanotechnology risk-research strategy was published by the Project on Emerg- ing Nanotechnologies (Maynard 2006). Nanotechnology: A Research Strategy

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35 Elements of an Effective Nanotechnology Risk-Research Strategy for Addressing Risk draws on nine published reports,4 including the Royal Soci- ety and Royal Academy of Engineering report (Royal Society 2004) and the EC action plan for nanoscience and nanotechnologies published in 2005 (EC 2005), and develops recommendations on the aims, objectives, and implementation of a responsive risk-research strategy. The report differs from others cited here in that it is one person’s opinion rather than reflecting the views of multiple stake- holders and experts. However, it draws heavily on opinions and perspectives published elsewhere. Maynard (2006) identifies “the roll-out of ‘safe’ nanotechnologies” as the overarching aim of a risk-research strategy and identifies a number of research objectives, including addressing human and environmental health hazards, mate- rial characterization and exposure, exposure control, and risk reduction. It con- siders how the objectives might be best achieved in a timely manner by develop- ing and implementing an effective research strategy. In particular, four com- ponents of a government-led strategic research framework are identified and expanded on: linking research to oversight, balancing different approaches to research and research funding (specifically, balancing exploratory and targeted research and using the full spectrum of funding mechanisms appropriately), en- suring authority to direct research, and enabling coordination and partnerships. Much of the report stresses the importance of targeted research in an effec- tive strategy, which would lead to informed decision-making, but it also stresses the need for exploratory research that will underpin future targeted questions regarding emerging risks. In addition, the report distinguishes between research that addresses nanotechnology risks directly and what it refers to as “indirect research.” The latter is identified as research that has the potential to inform an understanding of the effects of nanotechnologies but is not necessarily directed primarily at risks. For example, research into general characterization methods or research into nanotechnology-based drug development might be considered indirect research in the context of risk but lead to risk-relevant information. The report attaches considerable importance to that category of research but warns that “unless this latent potential [is] realized through targeted research, the work will be worthless to understanding and addressing risk.” On the basis of those examples and others not included in this brief over- view, it is fair to say that an understanding of what an effective nanotechnology risk-research strategy might look like is still evolving. However, common themes emerge from the above examples and discussions, including the need to link research to decision-making processes, to identify overarching aims and key objectives, to ensure broad expert and multistakeholder input, to ensure access to adequate resources, and to initiate a program of independent review and revi- sion. 4 Royal Society (2004); Chemical Industry Vision 2020 Technology Partnership and SRC (2005); Dennison (2005); EC (2005); EPA (2005); HM Government (2005); May- nard and Kuempel (2005); NIOSH (2005); and Oberdörster et al. (2005).

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36 Review of the Federal Strategy for Nanotechnology ELEMENTS OF A RISK-RESEARCH STRATEGY On the basis of the preceding discussion of research strategies in general and nanotechnology risk-research strategies in particular, the present committee suggests nine elements as key components of an effective research strategy that addresses environmental, health, and safety effects of emerging nanotechnolo- gies. The importance of those elements will depend on the context of a given research strategy. However, it is hard to imagine a successful risk-research strat- egy that does not address each one of them to some extent. Consequently, the elements have informed our assessment of the National Nanotechnology Initia- tive Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (NEHI 2008). The nine elements are the following: • Vision, or statement of purpose. What is the ultimate purpose of con- ducting research on potential risks associated with nanotechnology? • Goals. What specific research goals need to be achieved to guide the development and implementation of nanotechnologies that are as safe as possi- ble? • Evaluation of the state of science. What is known about the potential for the products of nanotechnology to cause harm and about how possible risks might be managed? Could existing knowledge and expertise be mined to pro- vide insight into and solutions to potential nanotechnology-related risks? • Road map. What is the plan of action to achieve the stated research goals? What are the specific objectives, and when do they need to be achieved? How will available resources, institutions, and funding mechanisms be used? Are there needs for new mechanisms to ensure that the right research is carried out? How will other efforts and initiatives be leveraged, including industry and international initiatives? How will the road map be adjusted in light of new knowledge? What is the time required for the plan to become effective? • Evaluation. How will research progress be measured, and who will be responsible for measuring it? Are there measurable milestones that can be evaluated against a clear timeline? • Review. How will the strategy be revised in light of new findings, to ensure that it remains responsive to the overarching vision and goals? • Resources. Are there sufficient resources to achieve the stated goals? If not, what are the plans to obtain new resources or to leverage other initiatives to achieve the goals? • Mechanisms. What are the most effective approaches to achieving the stated goals? How will exploratory and targeted research be used? What will be the balance between principal-investigator–driven and goal-driven research and between intramural and extramural research programs? How will research ef- forts be coordinated to ensure a coherent approach to achieving stated goals?

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37 Elements of an Effective Nanotechnology Risk-Research Strategy What provisions are there for enabling interdisciplinary research that crosses established funding and agency boundaries? • Accountability. How will stakeholders participate in the process of de- veloping and evaluating a research strategy? Who will be accountable for pro- gress toward stated goals? Who will be responsible for disseminating informa- tion generated within the research strategy and ensuring its use in raising awareness and making decisions? REFERENCES Aguar, P. 2008. The EU Framework for EHS Research on Nanotechnology. Presentation at the Second Meeting on Review of the Federal Strategy to Address Environ- mental, Health, and Safety Research Needs for Engineered Nanoscale Materials, May 5, 2008, Washington, DC. Balbus, J.M., A.D. Maynard, V.L. Colvin, V. Castranova, G.P. Daston, R.A. Denison, K.L. Dreher, P.L. Goering, A.M. Goldberg, K.M. Kulinowski, N.A. Monteiro- Riviere, G. Oberdörster, G.S. Omenn, K.E. Pinkerton, K.S. Ramos, K.M. Rest, J.B. Sass, E.K. Silbergeld, and B.A. Wong. 2007. Hazard assessment for nanopar- ticles: Report from an Interdisciplinary Workshop. Environ. Health Perspect. 115(11):1654-1659. Bush, V. 1945. Science - The Endless Frontier. Washington, DC: Office of Scientific Research and Development [online]. Available: http://www.nsf.gov/about/history/ vbush1945.htm [accessed July 3, 2008]. Chemical Industry Vision 2020 Technology Partnership and SRC (Semiconductor Re- search Corporation). 2005. Joint NNI-ChI CBAN and SRC CWG5 Nanotechnol- ogy Research Needs Recommendations [online]. Available: http://www.chemical vision2020.org/pdfs/chem-semi_ESH_recommendations.pdf [accessed Aug. 26, 2008]. Clemen, R.T., and T. Reilly. 2004. Making Hard Decisions with Decision Tools, 2nd Ed. Florence, KY: Brooks/Cole Publishers. CST (Council for Science and Technology). 2007. Nanosciences and Nanotechnologies: A Review of Government's Progress on its Policy Commitments. London, UK: Council for Science and Technology [online]. Available: http://www.oecd.org/ dataoecd/58/60/38390159.pdf [accessed Aug. 26, 2008]. Denison, R.A. 2005. A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at Least $100 Million Annually. Environmental Defense. April 2005 [online]. Available: http://www.edf.org/documents/4442_100milquestionl.pdf [ac- cessed July 29, 2008]. EC (European Commission). 2004. Communication from the Commission: Towards a European Strategy for Nanotechnology. COM(2004) 338 final. Brussels: Commis- sion of the European Communities [online]. Available: ftp://ftp.cordis.europa.eu/ pub/nanotechnology/docs/nano_com_en.pdf [accessed Aug. 26, 2008]. EC (European Commission). 2005. Communication from the Commission to the Council, the European Parliament and the Economic and Social Committee: Nanoscience and Nanotechnologies: An Action Plan for Europe 2005 - 2009. COM (2005) 243 final. Brussels: Commission of the European Communities [online]. Available: ftp://ftp.cordis.europa.eu/pub/nanotechnology/docs/nano_action_plan2005_en.pdf [accessed Aug. 26, 2008].

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