1


Background

OVERVIEW

On January 21, 2000, President Clinton announced a new U.S. initiative to explore and exploit the science and technology of matter on the nanometer scale (often referred to as the nanoscale). In an address at the California Institute of Technology on science and technology, President Clinton asked his audience to imagine “materials with 10 times the strength of steel and only a fraction of the weight; shrinking all the information at the Library of Congress into a device the size of a sugar cube; detecting cancerous tumors that are only a few cells in size.” The speech laid the foundation for the National Nanotechnology Initiative (NNI) (The White House 2000). The NNI—“the government’s central locus for the coordination of federal agency investments in nanoscale research and development” (NRC 2009, p. 3)— has set the pace for national and international research and development in nanoscale science and engineering and has led the world in the development and use of knowledge at the nanoscale with the potential to improve quality of life, stimulate economic growth, and address many of society’s most pressing challenges.

With our understanding of the role that nanoscale science and engineering can play in the development of innovative materials, processes, and products has also come the knowledge that nanotechnology may lead to new mechanisms by which people and the environment may be harmed. In today’s complex, interconnected, and resource-constrained world, it is important that products resulting from novel and emerging technologies that have uncertain risks, such as nanotechnology, be developed responsibly; that all stakeholders have an active role in socially responsible development; and that potential risks are identified and avoided as early as possible during research, innovation, and commercialization. This report maps out a research strategy that is intended to promote the responsible development of nanotechnology-enabled materials, processes, and products; and it offers an approach for helping to ensure that researchers, manufacturers, regulators, and others have the necessary information on potential risks and how to prevent, avoid, or mitigate them.



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1 Background OVERVIEW On January 21, 2000, President Clinton announced a new U.S. initiative to explore and exploit the science and technology of matter on the nanometer scale (often referred to as the nanoscale). In an address at the California Institute of Technology on science and technology, President Clinton asked his audience to imagine “materials with 10 times the strength of steel and only a fraction of the weight; shrinking all the information at the Library of Congress into a device the size of a sugar cube; detecting cancerous tumors that are only a few cells in size.” The speech laid the foundation for the National Nanotechnology Initiative (NNI) (The White House 2000). The NNI—“the government’s central locus for the coordination of federal agency investments in nanoscale research and devel- opment” (NRC 2009, p. 3)—has set the pace for national and international re- search and development in nanoscale science and engineering and has led the world in the development and use of knowledge at the nanoscale with the poten- tial to improve quality of life, stimulate economic growth, and address many of society’s most pressing challenges. With our understanding of the role that nanoscale science and engineering can play in the development of innovative materials, processes, and products has also come the knowledge that nanotechnology may lead to new mechanisms by which people and the environment may be harmed. In today’s complex, inter- connected, and resource-constrained world, it is important that products result- ing from novel and emerging technologies that have uncertain risks, such as nanotechnology, be developed responsibly; that all stakeholders have an active role in socially responsible development; and that potential risks are identified and avoided as early as possible during research, innovation, and commerciali- zation. This report maps out a research strategy that is intended to promote the responsible development of nanotechnology-enabled materials, processes, and products; and it offers an approach for helping to ensure that researchers, manu- facturers, regulators, and others have the necessary information on potential risks and how to prevent, avoid, or mitigate them. 18

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 19 OPPORTUNITIES AND CHALLENGES Increasing our understanding of how matter on the nanoscale behaves and interacts with humans and ecologic systems is socially and economically impor- tant. In a world where the needs of a growing population threaten to outstrip increasingly limited resources and many global challenges remain unresolved— from disease to hunger to renewable energy—nanotechnology, along with other fields of technologic innovation, can contribute to a sustainable future (Maynard 2010). Nanoscale science and technology are leading to new ideas and tools that can enhance existing technologies and create new ones, help to support new jobs, revitalize economies, and contribute to solutions to some of society’s most pressing problems. But investing in research and development is just one step toward ensuring socially responsible, relevant, and successful technologic inno- vation. Realizing the economic and societal benefits of nanotechnology also requires educating the workforce, lowering barriers to technology transfer, and engaging with diverse stakeholders. And success with nanotechnology will also depend on developing and implementing new approaches to risk prevention and risk management that avoid past mistakes, that address issues in the innovation process, and that develop materials responsibly without impeding innovation unduly. As nanotechnology research and development have led to new materials— nanomaterials—questions about the safety of these materials have prompted concerns that they are likely to be attended by new risks. Specifically, concerns have been raised that materials behaving in unconventional ways might lead to unanticipated risks to human health and the environment. Those concerns were underpinned and to an extent driven by research in the 1990s that showed that inhaled fine particles have the potential to cause more serious health effects than those estimated in studies of larger particles (for example, Oberdörster et al. 2007). The research signaled the beginning of a paradigm shift away from an understanding that risk stems from chemical composition alone to a recognition that physical form and chemical properties are both important for understanding, predicting, and preventing harm. The concerns were exacerbated by the increase in production of materials that behaved in unique ways because of their physical form on the nanoscale and by growing awareness that methods for detecting, characterizing, monitor- ing, or controlling these materials in the environment were not available and that the materials were in products or in environments in which human exposures could occur (for example, see Maynard et al. 2006). Consequently, there is un- certainty about the potential human health and environmental effects of products emerging from nanotechnology and recognition that the safe and successful de- velopment of nanotechnology depends on early, strategic action to address po- tential risks. In response to the concerns, there has been an increase in funding for re- search and in peer-reviewed publications addressing the environmental, health, and safety (EHS) effects of engineered nanomaterials (ENMs) (PCAST 2010).

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20 Background In FY 2005, the combined investment by U.S. federal agencies in research on and development of EHS implications of nanotechnology was $34.8 million (NSET 2006). In FY 2012, the President’s budget request proposes $123.5 mil- lion—more than a threefold increase (NSET 2010). Worldwide publications addressing the EHS effects of ENMs have increased similarly, with 791 papers published in 2009 compared with 179 publications in 2005 (PCAST 2010). In 2006, the NNI published the first U.S. interagency assessment of EHS research needs associated with ENMs, identifying 75 research needs in five broad categories (NEHI 2006). The needs were assigned priorities by the Nanotechnology Environmental Health Implications Working Group (NEHI 2007) and were incorporated into an interagency research strategy by NEHI in 2008 (NEHI 2008). Recently, NEHI published a draft update (NEHI 2010) of the interagency research strategy that responds to input from the President’s Council of Advisors on Science and Technology, a National Research Council review of the 2008 NEHI report (NRC 2009), and various stakeholder groups, including members of the public.1 Those documents and many similar and com- plementary assessments by government agencies, academic institutions, indus- try, and other stakeholders (see Table 1-1) have helped to direct where EHS re- search should be focused if ENMs are to be developed and used safely. Yet despite progress in the development of research needs and in the amount of re- search that is funded and conducted, developers, regulators, and consumers of nanotechnology-enabled products remain uncertain about the types and quantity of nanomaterials in commerce or in development, their possible applications, and the potential risks associated with them. It is the disconnect between risk research and its relevance to and use in informed decision-making that prompts the question, How can research best be guided and conducted to ensure that the products of nanotechnology are devel- oped as safely, responsibly, and beneficially as possible? That question is central to the charge to this committee. COMMERCIALIZATION OF ENGINEERED NANOMATERIALS The development and use of new materials cannot be separated from ques- tions of potential risk. Understanding and addressing the EHS implications of ENMs is intricately entwined with their development. Over the last few years, industries—ranging from electronics to energy, materials to medicine, and chemicals to clean technologies—have been using nanotechnology to develop breakthrough innovations for products. To respond to the many opportunities, a global network of large corporations, academic 1 A final version of the strategy was published in October 2011 (NEHI 2011). Because the committee’s report had already gone to peer review, NEHI 2011 was not reviewed by this committee.

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TABLE 1-1 Key Reports That Assess or Provide Information on Research Needs and Strategies for Addressing the Environmental, Health, and Safety Implications of Engineered Nanomaterialsa Year Report Source Relevance 2004 Nanoscience and Nanotechnologies: Opportunities and Uncertainties RS/RAE 2004 Identifies strategic-research gaps 2004 Technological Analysis: Industrial Application of Nanomaterials - Chances and Risks Luther 2004 Identifies strategic-research gaps 2004 Nanotechnology: Small Matter, Many Unknowns SwissRe 2004 Identifies strategic-research gaps 2005 Characterizing the Potential Risks Posed by Engineered Nanoparticles: A First UK DEFRA 2005 Identifies strategic-research gaps Government Research Report 2005 Communication from the Commission to the Council, the European Parliament and the EC 2005 Identifies strategic-research gaps Economic and Social Committee. Nanoscience and Nanotechnologies: An Action Plan for Europe 2005 - 2009. 2005 A Proposal to Increase Federal Funding of Nanotechnology Risk Research to at least Denison 2005 Identifies strategic-research gaps $100 Million Annually 2005 Joint NNI-ChI CBAN and SRC CWG5 Nanotechnology Research Needs Recommendations Vision 2020/SRC 2005 Identifies strategic-research gaps 2005 Small Sizes that Matter: Opportunities and Risks of Nanotechnologies Allianz/OECD 2005 Provides contextual information on strategic risk research 2006 Opinion on the Appropriateness of Existing Methodologies to Assess the Potential Risks SCENIHR 2006 Provides contextual information Associated with Engineered and Adventitious Products of Nanotechnologies on strategic risk research 2006 Nanotechnology: A Research Strategy for Addressing Risk Maynard 2006 Outlines a research strategy 2006 Safe handling of nanotechnology Maynard et al. 2006 Identifies strategic-research gaps 2006 Characterizing the Environmental, Health and Safety Implications of Nanotechnology: ICFI 2006 Provides contextual information Where Should the Federal Government Go From Here? on strategic risk research 2006 White paper on Nanotechnology Risk Governance Renn and Roco 2006 Provides contextual information on strategic risk research 2006 Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials NEHI 2006 Identifies strategic-research gaps 2007 Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance SCENIHR 2007 Identifies strategic-research gaps with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials (Continued) 21

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22 TABLE 1-1 Continued Year Report Source Relevance 2007 Opinion on Safety of Nanomaterials in Cosmetic Products SCCP 2007 Provides contextual information on strategic risk research 2007 Nano Risk Framework EDF/DuPont 2007 Provides contextual information on strategic risk research 2007 Nanotechnology White Paper EPA 2007 Identifies strategic-research gaps 2007 Nanotechnology: A Report of the U.S. Food and Drug Administration Nanotechnology FDA 2007 Provides contextual information Task Force on strategic risk research 2007 Nanotechnology Recent Development, Risks and Opportunities Lloyds 2007 Provides contextual information on strategic risk research 2007 Prioritization of Environmental, Safety and Health Research Needs for Engineered NEHI 2007 Identifies strategic-research gaps Nanoscale Materials: An Interim Document for Public Comment 2007 Characterizing the Potential Risks Posed by Engineered Nanoparticles: A Second UK DEFRA 2007 Identifies strategic-research gaps Government Research Report. 2007 Meeting Report: Hazard Assessment for Nanoparticles—Report from an Interdisciplinary Balbus et al. 2007 Identifies strategic-research gaps Workshop 2008 Proceedings of the Workshop on Research Projects on the Safety of Nanomaterials: Höck 2008 Identifies strategic-research gaps Reviewing the Knowledge Gaps 2008 Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale Council of Canadian Identifies strategic-research gaps Academies 2008 2008 Engineered Nanoscale Materials and Derivative Products: Regulatory Challenges Schierow 2008 Provides contextual information on strategic risk research 2008 Nanotechnology: Better Guidance is Needed to Ensure Accurate Reporting of Federal GAO 2008 Provides contextual information Research Focused on Environmental, Health and Safety Risks on strategic risk research 2008 Responsible Production and Use of Nanomaterials VCI 2008 Identifies strategic-research gaps 2008 Towards Predicting Nano-Biointeractions: An International Assessment of Nanotechnology ICON 2008 Identifies strategic-research gaps Environment, Health, and Safety Research Needs 2008 Strategic Plan for NIOSH Nanotechnology Research and Guidance: Filling the Knowledge NIOSH 2008 Outlines a research strategy Gaps. Draft Report

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2008 Strategy for Nanotechnology-Related Environmental, Health and Safety Research. NEHI 2008 Outlines a research strategy 2008 Novel Materials in the Environment: The Case of Nanotechnology RCEP 2008 Identifies strategic-research gaps 2009 Risk Assessment of Products of Nanotechnologies SCENIHR 2009 Identifies strategic-research gaps 2009 Scientific Opinion: The Potential Risks Arising from Nanoscience and Nanotechnologies EFSA 2009 Provides contextual information on Food and Feed Safety. on strategic risk research 2009 Workplace Exposure to Nanoparticles Kaluza et al. 2009 Provides contextual information on strategic risk research 2009 Nanomaterial Research Strategy EPA 2009 Outlines a research strategy 2009 Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation Breggin et al. 2009 Provides contextual information on strategic risk research 2009 Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and NRC 2009 Identifies strategic-research gaps Safety Research 2009 EMERGNANO: A Review of Completed and Near Completed Environment, Health and Aitken et al. 2009 Identifies strategic-research gaps Safety Research on Nanomaterials and Nanotechnology 2009 FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and FAO/WHO 2009 Provides contextual information Agriculture Sectors: Potential Food Safety Implications on strategic risk research 2010 ENRHES Engineered Nanoparticles: Review of Health and Environmental Safety Stone et al. 2010 Identifies strategic-research gaps 2010 Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges GAO 2010 Provides contextual information in Regulating Risk on strategic risk research 2010 Nanotechnologies and Food UKHL 2010 Identifies strategic-research gaps 2010 UK Nanotechnologies Strategy: Small Technologies, Great Opportunities HM Government 2010 Outlines a research strategy 2010 Report to the President and Congress on the Third Assessment of the National PCAST 2010 Provides contextual information Nanotechnology Initiative on strategic risk research 2010 Nanotechnology Research Directions for Societal Needs in 2020: Retrospective and Nel et al. 2010 Outlines a research strategy Outlook, Chapter 4 2010 National Nanotechnology Initiative NEHI 2010 Outlines a research strategy 2011 Environmental, Health, and Safety Strategyb a Reports are classified as either providing contextual information on strategic-risk research, identifying strategic-research gaps, or outlining a research strategy. With few exceptions (included for historical significance), these reports represent the assessments, opinions, and recommendations of panels of experts. b A final version of the strategy was published in October 2011 (NEHI 2011). 23

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24 Background laboratories, government-funded research centers, technology incubators, and startup companies has emerged to facilitate collaboration in technologic devel- opment. Those developers play unique roles in the three-stage nanotechnology value chain: production of ENMs, raw materials that make up the first stage of the value chain; primary products (also termed intermediate or nanointermediate products) that either contain ENMs or have been constructed from other materi- als to possess nanoscale features and that comprise the second stage; and secon- dary products, finished goods that incorporate ENMs or intermediate products— the third stage. In 2009, developers generated $1 billion from the sale of nanomaterials, which constitute the initial stage of the nanotechnology value chain (Lux Re- search in Wray 2010). In that year, the top 11 classes of nanomaterials (based on production volume) were ceramic nanoparticles, carbon nanotubes, nanoporous materials, graphene, metal nanoparticles, nanoscale encapsulation, fullerenes, dendrimers, nanostructured metals, nanowires, and quantum dots (Bradley 2010). Of these classes of nanomaterials, ceramic nanoparticles (50%), carbon nanotubes (20%), and nanoporous materials (20%) accounted for 90% of the total production volume (about 3,500 tons) (Bradley 2010). The market for products that rely on nanomaterials is expected to grow to $3 trillion by 2015 (Lux Research 2008a,b).2 Although the relative percentages (based on produc- tion volume) are not expected to change drastically through 2015, the more ex- otic materials, such as nanowires and quantum dots, are likely to experience the biggest jump in production because they are starting from a much lower baseline than older classes of materials, such as ceramic nanoparticles (Bradley 2010). The nanomaterials that make up the first stage of the value chain are used in the development of primary products or nanointermediates. In 2009, develop- ers generated $29 billion for this stage of the value chain (Lux Research in Wray 2010). The top 10 nanointermediate classes developed were coatings, compos- ites, catalysts, drug-delivery systems, energy storage, sensors, displays, memory, solar cells, and filters (Bradley 2010). For example, a variety of ceramic nanoparticles can be added to coating formulations to enhance function, includ- ing antiscratch, antifriction, and antimicrobial properties. Coatings, composites, and catalysts are the most prevalent of the nanointermediates. Nanointermediates are expected to generate about $480 billion in 2015 (Lux Research 2009a; Sibley 2009). Although the coatings, composites, and catalysts will make up a large share of the nanointermediate market in 2015 and beyond, they will be joined increasingly by intermediates in the health-care and life-sciences sectors, especially drug-delivery devices, and by intermediates in the electronics sector, that is, in logic chips and in memory applications. Both nanomaterials and nanointermediates feed into nanoenabled prod- ucts, the last stage of the value chain. In 2009, producers generated $224 billion from the sale of nanoenabled products (Lux Research in Wray 2010). The top 10 product classes developed were automotive products, buildings and construc- 2 This figure includes nanomaterials, intermediate products, and nanoenabled products.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 25 tion, consumer electronics, personal care, marine, aerospace, sporting goods, food and agriculture, industrial equipment, and textiles (Bradley 2010). Of automotives, for example, ceramic nanoparticle-based coatings are added to engines to increase fuel economy, and carbon nanotubes are added to fuel lines to reduce the risk of fire. In the future, the overall value of nanoenabled products is projected to reach about $2 trillion by 2015 (Lux Research in Wray 2010; Hwang and Bradley 2010; Lux Research 2009b), with automotives, buildings and construction, and consumer electronics dominating this stage of the value chain. PRESENT STATE OF STRATEGIC NANOTECHNOLOGY ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH Despite extensive investment in nanotechnology and increasing commer- cialization over the last 10 years, uncertainties about the EHS effects of nanoma- terials and nanomaterial-based products remain. There continues to be a lack of clarity about the safety, regulatory, and governance challenges that need to be addressed if materials, processes, and products based on nanotechnology are to be developed responsibly. Research is slowly being translated and communi- cated between people who are generating new knowledge and those who hope to use it—regulators, businesses, and consumers. But in spite of the EHS research that is being conducted, there remains a lack of an overarching, priority-set, co- ordinated research strategy that encompasses stakeholders in the public and pri- vate sectors and that identifies critical questions, maps out a path to answers, and ensures accountability for providing decision-makers with timely informa- tion. Because nanotechnology is presenting new and unusual challenges, mov- ing from reactive to proactive research represents a substantial paradigm shift in how risk-related research is conducted. The specific EHS issues raised by ENMs remain difficult to address. Nevertheless, the NNI has succeeded in coordinating regulatory and research agencies in identifying cross-agency research needs and in beginning to address the needs. The NNI documents (NEHI 2006, 2007, 2008, and 2010) that set forth the federal government’s research strategy for addressing EHS implications of ENMs are a considerable achievement and help to identify further research that is needed. Those documents are complemented by agency-specific research strategies (described below). However, despite the progress that has been made toward developing an interagency research strategy, research on the potential EHS implications of ENMs still lacks context with respect to what is already known, what is occurring now, and what is likely to be important in the future. In the absence of a clear and implementable research strategy, research appears to be driven predominantly by assumptions of what is important and what is scientifically interesting rather than by a clear, rationale assessment of what is needed.

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26 Background The current need for an overarching research strategy has been responded to in part by National Nanotechnology Initiative 2011 Environmental, Health, and Safety Strategy (NEHI 2010). The closing chapter begins to develop a framework that will support coordination among federal agencies; including establishment of a set of principles to encourage agencies to work together pro- ductively and mechanisms that support the NEHI and the National Nanotech- nology Coordination Office (NNCO) in implementing the strategy. The principles in NEHI (2010) are designed to help to set priorities among nanomaterials; to establish systems for conducting reproducible, valid, and translatable research; to ensure that the resulting data are of high quality; to cou- ple research to different risk-assessment needs; and to support partnerships with stakeholders and engagement with the international community. The principles set the scene for ensuring that relevant and responsive research is conducted rather than dictating which agencies conduct what research. However, there re- mains the task of combining the emerging framework with a strategically re- sponsive research strategy that facilitates the generation and application of timely and relevant data and that extends beyond the borders of federal agencies to include engagement with stakeholders and the international community. HISTORY OF NANOTECHNOLOGY ENVIRONMENTAL, HEALTH, AND SAFETY RESEARCH ASSESSMENTS In the early 2000s, a number of reports from diverse sources began to question the safety of nanotechnology-enabled products and emerging ENMs. They ranged from the ETC Group’s call for a moratorium on nanotechnology research (ETC Group 2003) to Sun Microsystems founder Bill Joy’s influential article in Wired magazine questioning the dangers of emerging technologies (Joy 2000) to the reinsurance giant Swiss Re’s assessment of the uncertain im- pacts of nanotechnology (Swiss Re 2004). In 2004, those concerns were placed into context by the UK Royal Society and Royal Academy of Engineering (RS/RAE) (RS/RAE 2004). After an extensive consultation and assessment pe- riod led by a panel of experts, the RS/RAE published a highly influential report examining the opportunities and uncertainties of “nanoscience and nanotech- nologies.” Concluding that “the lack of evidence about the risks posed by manu- factured nanoparticles and nanotubes is resulting in considerable uncertainty” (RS/RAE 2004, p. 85), the report made recommendations for avoiding potential risks and developing a better understanding of them. Although the RS/RAE re- port’s recommendations were directed toward the UK government, they were used worldwide to ground discussions of the responsible development of nanotechnologies based on the state of knowledge about potential risks. A number of risk-research assessments followed. In the UK, a response to the RS/RAE report by the UK government began to map out strategic research needs and a plan of action to address them (DEFRA 2007), and the European Union (EU) incorporated nanotechnology EHS research and development into

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 27 its action plan (2005-2009) for developing nanoscience and nanotechnology. Those activities were complemented by the EU Scientific Committee on Emerg- ing and Newly Identified Health Risks (SCENIHR) publication of a comprehen- sive review of “engineered and adventitious products of nanotechnologies,” which is one of the most comprehensive reviews of the potential health risks associated with ENMs (SCENIHR 2006). In December 2004, the NNI published its first strategic plan, which in- cluded a specific commitment to address the potential EHS implications of nanotechnology (NSET 2004). Under the goal of supporting the responsible development of nanotechnology, the NNI committed to “as necessary, expand support for research into environmental and health implications of nanotechnol- ogy” (NSET 2004, p. 12). The strategic plan also stated (NSET 2004, p. 12) that NNI-funded research will (1) increase fundamental understanding of nanoscale material interactions at the molecular and cellular level through in vitro and in vivo experiments and models; (2) increase fundamental un- derstanding of nanoscale material interactions with the environment; (3) increase understanding of the fate, transport, and transformation of nano- scale materials in the environment and their life cycles; and (4) identify and characterize potential exposure, determine possible human health im- pact, and develop appropriate methods of controlling exposure when working with nanoscale materials. Federal activities were to be coordinated by NEHI, a group of representa- tives of research and oversight agencies that began meeting informally in 2003 and was formally established in 2004 (NSET 2004). In 2005, in a parallel development, the NNI established two Consultative Boards for Advancing Nanotechnology (CBAN), consisting of representatives of the chemical and semiconductor industries, to help to define research needs. Those boards assembled subgroups that drew on public- and private-sector ex- perts to address the potential EHS implications of nanotechnology and published joint research recommendations (Vision 2020/SRC 2005). Five key research needs were proposed by the joint groups: a testing strategy for assessing toxic- ity, best metrics for assessing particle toxicity, exposure-monitoring methods, risk-assessment methods, and communication and education concerning EHS and societal impacts (Ford 2005). In keeping with those key needs, specific research topics were developed. For example, more detailed recommendations for near-term research to address the toxicity of nanomaterials were offered in an associated document and re- flected discussions between government and industry representatives (NNI-ChI CBAN ESH Working Group 2007). In 2006, Maynard (a member of the present committee) wrote a report that evaluated nine sources of information on EHS research needs, including

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28 Background RS/RAE (2004) and CBAN (NNI-ChI CBAN ESH Working Group 2007), and outlined a possible federal research strategy (Maynard 2006). The report identi- fied 11 subjects on which further research was needed: human-health hazards, health outcomes, environmental impact, exposure, material characterization, exposure control, risk reduction, standards, safety, informatics, and effective approaches to research. Priorities were set among specific research needs asso- ciated with those subjects for generating new knowledge and supporting over- sight of emerging materials. In November 2006, “Safe Handling of Nanotechnology” was published (Maynard et al. 2006). The coauthors were experts in government, industry, and the nongovernment sector. It established five overarching research challenges to developing nanotechnology-based products safely and proposed a timeline for the international research community to address them. The five challenges were to develop “instruments to assess exposure to ENMs in air and water, within the next 3-10 years”; “validated methods to evaluate the toxicity of ENMs, within the next 5–15 years”; “models for predicting the potential impact of ENMs on the environment and human health, within the next 10 years”; “robust systems for evaluating the health and environmental impact of ENMs over their entire life, within the next five years”; and “strategic programmes that enable relevant risk-focused research, within the next 12 months.” In that same year, the 2006 NEHI report was published. It categorized the 75 nanotechnology-related EHS research needs in five broad categories: instru- mentation, metrology, and analytic methods; nanomaterials and human health; nanomaterials and the environment; health and environmental surveillance; and risk-management methods. The report was alluded to by Clayton Teague, direc- tor of NNCO, in testimony to the House Committee on Science and Technology on November 17, 2005, in which he noted that “a carefully designed research plan, along with shared Government and industry responsibility and collabora- tion should guide our efforts” (Teague 2005, p. 27). Following publication of NEHI (2006), a consultative document that presented 25 research priorities (five in each of the five research categories identified in the NEHI report) was pro- duced (NEHI 2007). In February 2008, the NNI strategy for nanotechnology-related EHS re- search was published (NEHI 2008). Building on the previous two reports (NEHI 2006, 2007), it expanded on the 25 research priorities identified in 2007 and indicated the changing emphasis that they should receive in the near, middle, and long terms in a research strategy. The document also developed a broad framework to guide strategic risk research and identified lead agencies for ad- dressing research needs. The strategy was developed predominantly by govern- ment-agency representatives but drew on feedback from public consultations and responses to earlier documents. The 2008 federal research strategy for nanotechnology-related EHS re- search (NEHI 2008) was reviewed by the National Research Council (NRC 2009), whose committee concluded (p. 10) that

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 37 FIGURE 1-1 A general framework for integrating particulate-matter research. Source: NRC 1998, p. 35. plementary research topics. Several of the research topics were overarching, such as the development and testing of air-quality models, and analysis and measurement. The committee proposed a "portfolio" of research to be under- taken over a 13-year span and estimated costs on a year-by-year basis. In approaching its charge, the PM Committee elaborated on criteria for se- lecting its research topics, for characterizing progress on the agenda, and for evaluating the reduction of uncertainty. The committee selected three criteria for its initial list of research topics: scientific value, decision-making value, and feasibility and timing (NRC 1998). The first report (NRC 1998) provided defini- tions of the criteria and discussed their implementation. In its second and third reports (NRC 1999, 2001), the PM Committee added interaction, integration, and accessibility. With regard to the assessment of progress on the research agenda, the PM Committee screened existing approaches for useful models and took an evidence-based approach, involving surveying expenditures, research projects, and publications. For each topic, the final report covered the questions What has been learned? and What remains to be done? (NRC 2004). The PM Committee reports provided useful examples for the present committee as it addressed its charge with regard to ENMs. The adoption of a toxicologic framework and the designation of research topics around the frame- work provided a needed transparent structure. The PM Committee's listing of operational criteria ensured clarity in how the research agenda was developed and tracked. (The present committee uses those criteria for evaluating research progress in Chapter 6.) Finally, the evidence-based approach ensured objectivity in the assessment of progress. GOALS OF THIS STRATEGY Despite the progress made to date, it remains imperative that we generate timely and relevant knowledge that will underpin the responsible development of technologies based on manipulating matter at the nanoscale. Nanoscale sci- ence and engineering are leading to remarkable new discoveries that have the potential to address major societal challenges while providing for substantial

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38 Background economic growth. Those discoveries are enabling the emergence of new tech- nologies and the enhancement of existing technologies. Without strategic re- search on emergent risks associated with the new and enhanced technologies— and a clear understanding of how to prevent, manage, and avoid them—the fu- ture of safe and sustainable nanotechnology-based materials, products, and processes is uncertain. In today’s fast-paced and interconnected world, a worth- while economic and social return on government and industry investment in nanotechnology is unlikely to be fully realized without risk research, including research on translating knowledge into evidence-informed and socially respon- sible decision-making. Without the research, decision-makers will not have the tools and information that they need to develop safe and responsible technolo- gies, trust in business and government to ensure safety could erode, and there will continue to be an inability to identify materials that pose important risks and to confidently differentiate them from materials and products that pose little or no risk. There is a need to rethink and re-evaluate what is important from a human health and environmental perspective in addressing current and emerging ENMs and to establish a scientific foundation for risk-based decision-making. We need an EHS research strategy that is independent of any one stakeholder group, that reflects the interests of multiple types of stakeholders, that has as its primary aim protection of human and environmental health, that builds on past efforts and is flexible in anticipating and adjusting to emerging challenges, and that provides decision-makers and decision-influencers with timely, relevant, and accessible information. Ten years after the establishment of the NNI, the emphasis of nanotech- nology is shifting from research to commercialization. As it does, society cannot afford to remain entangled in confusion as the challenges and opportunities pre- sented by nanotechnology are addressed. Although they were invaluable in their own right, previous attempts to identify research needs and develop research strategies have not brought needed clarity to nanotechnology EHS research needs, nor provided a relevant and actionable research strategy. The strategy presented here marks the development of a forward-looking, multiple stake- holder perspective that protects human and environmental health while reaping the potential benefits of nanoscale science. In light of these needs, the goals of the research strategy are to generate scientific evidence that  Guides approaches to environmental and human health protection even as our knowledge of ENMs is expanding and the research strategy itself is evolving.  Makes it possible to identify and predict risks posed by nanomaterials with sufficient certainty to enable informed decisions on how the risks should be prevented, managed, or mitigated.

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Environmental, Health, and Safety Aspects of Engineered Nanomaterials 39  Makes it possible to identify and evaluate the relative merits of various risk-management options, including measures to reduce the inherent hazard or exposure potential of nanomaterials. Chapter 2 of this report presents a conceptual framework for considering the EHS risks associated with nanomaterials. Chapter 3 provides an overview of what is known about the EHS aspects of nanomaterials in the context of the con- ceptual framework and identifies knowledge gaps. Chapter 4 addresses cross- cutting tools needed to understand the relationship of ENM properties and their interactions with humans and the environment. Chapter 5 presents the commit- tee’s vision of the research agenda, including the recommended timing and costs of research activities. Chapter 6 describes implementation of the research strat- egy and how research progress will be evaluated. REFERENCES Aitken, R.J., S.M. Hankin, B. Ross, C.L. Tran, V. Stone, T.F. Fernandes, K. Donaldson, R. Duffin, Q. Chaudhry, T.A. Wilkins, S.A. Wilkins, L.S. Levy, S.A. Rocks, and A. Maynard. 2009. EMERGNANO: A Review of Completed and Near Completed Environment, Health and Safety Research on Nanomaterials and Nanotechnology. DEFRA (UK Department for Environment Food and Rural Affairs) Project CB0409. Report TM/09/01. Institute of Occupational Medicine, Edinburg, UK [online]. Available: http://www.safenano.org/Uploads/EMERGNANO_CB0409_ Full.pdf [accessed Nov. 10, 2010]. Allianz/OECD (Allianz Center for Technology and Organisation for Economic Co- operation and Development). 2005. Small Sizes That Matter: Opportunities and Risks of Nanotechnologies: Report in Co-operation with the OECD International Futures Programme, C. Lauterwasser, ed. Allianz AG, München, and OECD Inter- national Futures Programme, Paris [online]. Available: http://www.oecd.org/data oecd/32/1/44108334.pdf [accessed Sept. 7, 2011]. 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. Meeting report: Hazard assess- ment for nanoparticles-report from an interdisciplinary workshop. Environ. Health Perspect. 115(11):1654-1659. Bradley, J. 2010. Nanotech’s Evolving Environmental Health, and Safety Landscape. Presentation at Nanosafe 2010: International Conference on Safe Production and Use of Nanomaterials, Nov. 16-18, 2010, Minatec, France [online]. Available: http://www.nanosafe.org/home/liblocal/docs/Nanosafe%202010/2010_oral%20pre sentations/PL0a_Bradley.pdf [accessed Dec. 17, 2010]. Breggin, L., R. Falkner, N. Jaspers, J. Pendergrass, and R. Porter. 2009. Securing the Promise of Nanotechnologies: Towards Transatlantic Regulatory Cooperation. London: Chatham House [online]. Available: http://www.chathamhouse.org.uk/ files/14692_r0909_nanotechnologies.pdf [accessed Apr. 14, 2011].

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