Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (2009)

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Summary The field of nanotechnology relies on the ability to engineer, manipulate, and manufacture materials at the nanoscale.1 Nanotechnology is already ena- bling the development of an industry that produces and uses engineered nano- materials in a wide variety of industrial and consumer products, such as targeted drugs, video displays, remediation of groundwater contaminants, high perform- ance batteries, dirt-repelling coatings on building surfaces and clothing, high- end sporting goods, and skin-care products. Over the next five to ten years, in- creasingly widespread use of complex engineered nanomaterials is anticipated in such products as medical treatments, super-strong lightweight materials, food additives, and advanced electronics. The increasing use of engineered nanoscale materials in industrial and consumer products will result in greater exposure of workers and the general public to these materials. Responsible development of nanotechnology implies a commitment to develop and to use these materials to meet human and societal needs while making every reasonable effort to antici- pate and mitigate adverse effects and unintended consequences. The U.S. National Nanotechnology Initiative (NNI) is the government’s central locus for the coordination of federal agency investments in nanoscale research and development. NNI is responsible for supporting the missions of its member research and regulatory agencies; ensuring U.S. leadership in nanoscale science, engineering, and technology; and contributing to the nation’s economic competitiveness. Within NNI, the Nanotechnology Environmental Health Impli- cations (NEHI) Working Group provides a forum for the NNI agencies to coor- dinate their activities related to understanding the potential risks posed by nanotechnology to protect public health and the environment.2 The NEHI’s co- 1 Nanoscale refers to materials on the order of one billionth of a meter. 2 Current members of NEHI consists of officials from the Consumer Product Safety Commission, Cooperative State Research, Education, and Extension Service, Department 3 

4 Review of the Federal Strategy for Nanotechnology ordination efforts have produced a series of documents that identify environ- mental, health, and safety (EHS) research needs related to nanomaterials (NEHI 2006, 2007, 2008).3 In 2007, the National Nanotechnology Coordination Office, which over- sees the day-to-day operations of the NNI, asked the National Research Council to review independently its Strategy for Nanotechnology-Related Environ- mental, Health, and Safety Research (NEHI 2008). In response, the National Research Council’s Board on Environmental Studies and Toxicology and Na- tional Materials Advisory Board oversaw the appointment of the Committee for Review of the Federal Strategy to Address Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, which produced this re- port. The committee was charged to conduct a scientific and technical review of the federal strategy and to comment in general terms on how the strategy devel- ops information needed to support EHS risk-assessment and risk-management needs with respect to nanomaterials. Assisted by information-gathering sessions that included representatives from NNI agencies, policy experts from the European Commission, and such stakeholders as manufacturing industry, nongovernment organizations, and the insurance sector, the committee evaluated the federal strategy, asking such ques- tions as the following: • What are the elements of an effective nanotechnology risk-research strategy? • Does the federal strategy have those elements? • With respect to the federal strategy, have the appropriate research needs been identified, are the gap analysis and the selection of priorities among research needs complete, and does the research identified support risk- assessment and risk-management needs? of Defense, Department of Energy, Department of State, Department of Transportation, Environmental Protection Agency, Food and Drug Administration, International Trade Commission, National Aeronautics and Space Administration, National Institute for Oc- cupational Safety and Health, National Institutes of Health, National Institute of Stan- dards and Technology, National Science Foundation, Occupational Safety and Health Administration, Office of Science and Technology Policy, Office of Management and Budget, and U.S. Geological Survey. 3 NEHI (Nanotechnology Environmental Health Implications Working Group). 2006. Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials. Arlington, VA: National Nanotechnology Coordination Office; NEHI (Nanotechnology Environmental Health Implications Working Group). 2007. Prioritization of Environ- mental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An In- terim Document for Public Comment. Arlington, VA: National Nanotechnology Coordi- nation Office; NEHI (Nanotechnology Environmental Health Implications Working Group). 2008. Strategy for Nanotechnology-Related Environmental, Health, and Safety Research. Arlington, VA: National Nanotechnology Coordination Office. 

Summary 5 WHAT ARE THE ELEMENTS OF AN EFFECTIVE NANOTECHNOLOGY RISK-RESEARCH STRATEGY? Strategies for conducting scientific research are particularly important when resources are limited and there is a need to ensure that relevant informa- tion is being generated as efficiently and cost-effectively as possible. A strategy generally defines a set of goals, often in the context of an overarching vision; a plan of action for achieving the goals; and milestones to indicate when the goals are expected to be achieved. Because scientific research is often open-ended and serendipitous, formulating goals can be difficult. One specific type of research strategy—a strategy for risk research— addresses challenges of broad societal significance: the reduction or prevention of harm to humans and the environment. Because of their potential influence on public-health and environmental policy and actions, it is critical that risk- research strategies be developed and implemented effectively and in a timely manner. And like any other risk-research strategy, one focused on nanotechnol- ogy-related risk research needs to be proactive—identifying possible risks and ways to mitigate risks before the technology has widespread commercial pres- ence. It has to address nanotechnology-based products that are beginning to en- ter commerce as well as those under development. But it also needs to lay the scientific groundwork for addressing materials and products that potentially will arise out of new research, new tools, and cross-fertilization between distinct fields of science and technology. Therefore, a nanotechnology-related risk- research strategy must rely on both targeted research, which addresses questions that are critical for ensuring the safety of nanomaterials and products that con- tain them, and exploratory research, which generates new knowledge that will inform future goals and research directions. In conducting this study, the committee identified nine elements that are integral to any effective risk-research strategy and that informed its evaluation of the 2008 NNI document: • 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? • Road map. What is the plan of action to achieve the stated research goals? • 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? 

6 Review of the Federal Strategy for Nanotechnology • 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? • 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? DOES THE FEDERAL STRATEGY HAVE THOSE ELEMENTS? On the basis of the information gathered at its public meetings and the professional expertise and experience of its members, the committee determined that the process of composing the government’s 2008 NNI document provided a unique and useful opportunity for coordination, planning, and consensus- building among NEHI-member federal agencies. The strategy demonstrates how the NNI and the agencies have effectively worked together to coordinate their funding and their assessment of EHS aspects of nanotechnology. However, NNI (NEHI 2008) does not have the essential elements of a re- search strategy—it does not present a vision, contain a clear set of goals, have a plan of action for how the goals are to be achieved, or describe mechanisms to review and evaluate funded research and assess whether progress has been achieved in the context of what we know about the potential EHS risks posed by nanotechnology. The NNI document contains various statements of purpose, but it does not provide a clear vision as to where our understanding of the EHS implications of nanotechnology should be in 5 or 10 years. It states that “the NEHI Working Group developed this nanotechnology-related EHS research strategy to acceler- ate progress in research to protect public health and the environment, and to fill gaps in, and—with the growing level of effort worldwide—to avoid unnecessary duplication of, such research” (NEHI 2008, p. 1). That statement of purpose is adequate for an open-ended research program with no definite objectives, but it falls short of ensuring that the results of strategic research are useful and appli- cable to decision-making that will reduce the potential environmental and health effects of nanotechnology. The strategy document does not present goals for research to help ensure that the development and implementation of nanotechnology is as safe as practi- cable or a road map to ensure that these research goals are achieved. Although the document identifies five “research needs” for each of five research catego- ries—“Instrumentation, Metrology, and Analytical Methods,” “Nanomaterials and Human Health,” “Nanomaterials and the Environment,” “Human and Envi- ronmental Exposure Assessment,” and “Risk Management Methods”—the needs 

Summary 7 are not articulated as clear goals that should be attained. A key element of any strategy is to identify goals and measures of progress or success before assessing what is being done. That allows a clear assessment of the value of current activi- ties. Such an approach enables development of an action plan to leverage other efforts and address research deficiencies in a way that is transparent and meas- urable. Because the NNI document does not establish goals and a plan of action, there is no element of accountability, and questions are never raised as to what other research activities are needed. The NNI document does not provide an evaluation of the state of science in each of the five research categories; rather, the research needs are evaluated against research projects that were funded in FY 2006 (see Appendix A of NEHI [2008]) to provide a “snapshot” of research activities. The 2008 NNI document uses the FY 2006 data to assess the extent to which federally funded EHS re- search related to nanomaterials is supporting selected research priorities and to conduct its gap analysis of the NNI research portfolio. The committee concludes that how the FY 2006 data were used in the analysis is probably the greatest deficiency in the 2008 document, inasmuch as it is the foundation of the docu- ment’s evaluation of the strengths, weaknesses, and gaps in currently funded federal research. This is problematic because most of the listed FY 2006 re- search projects were focused on understanding fundamentals of nanoscience that are not explicitly associated with risk or the development of nanotechnology applications.4 In addition, there is no clear statement of how the FY 2006 re- search projects would address the identified research needs and inform an un- derstanding of potential human health and environmental risks posed by engi- neered nanoscale materials. The 2008 document does provide some information on time frame and se- quencing for achieving the research needs (see Figures 3, 5, 7, 9, and 11 of NNI [NEHI 2008]) but with little justification. The NNI strategy does not identify resources necessary to address ques- tions concerning EHS research needs for nanomaterials. Although the detailed analysis of nanotechnology-related EHS expenditures in FY 2006 provides in- formation about what was spent during that year, there is no assessment of whether the aggregate level of spending was adequate to address EHS research needs or whether the resource expenditures by the agencies were appropriate to address EHS research needs based on their missions. An appropriate research strategy would quantify the resources needed to address research priorities and describe where the resources would come from. 4 The 246 FY 2006 research projects listed in NNI (NEHI 2008) include additional re- search on instrumentation and metrology research and on medical-application-oriented research that is not captured in the list of 130 EHS research projects in the annual sup- plement to the president’s budget. The committee’s own assessment of the number of FY2006 research projects that are relevant to understanding risk of nanomaterials is dis- cussed in Chapter 4. 

8 Review of the Federal Strategy for Nanotechnology Although lead agencies (for example, NIH, NIST, EPA, FDA, and NIOSH) are given roles for overseeing federal nanotechnology research, there is no accountability, that is, there is no single organization or person that will be held accountable for whether the government’s overall strategy delivers results. Accountability requires specific quantifiable objectives so that one can deter- mine whether adequate progress is being made. The 2008 NNI document does not adequately incorporate input from other stakeholders, such as industries that produce nanomaterials and end users of nanomaterials; environmental and con- sumer advocacy groups; foreign interests, including substantial efforts of other countries; and local and state governments. The committee recognizes that the 2006 and 2007 NNI reports have undergone public comment, but public com- ment is not the same as engaging stakeholders in the process. Without adequate input from external stakeholders, it is not possible for government agencies to develop an effective research strategy to underpin the emergence of safe nanotechnologies. Federal agencies may have a vested inter- est in justifying the value of current efforts rather than critically assessing what is being done and how deficiencies might be addressed. For example, when de- veloping their own research strategies, agencies tend to ask, What research can we do within our existing capabilities?, rather than the more appropriate ques- tion, What research should we be doing? REVIEW OF PRIORITY RESEARCH TOPICS, RESEARCH NEEDS, AND GAP ANALYSIS The committee reviewed the specific research categories and their desig- nated research needs as described in the 2008 NNI document (Section II) and considered the following questions: Were the appropriate research needs identi- fied? Were the gap analysis and priority sequencing of research needs complete? Does the identified research support risk-assessment and risk-management needs? The NNI’s five topical categories each address research that is important for EHS risk assessment and risk management, and collectively they cover the necessary broad research topics. The listed research needs in the five categories are similarly valuable but incomplete, in some cases missing elements crucial for progress in understanding the EHS implications of nanomaterials. For exam- ple, the subject of environmental exposure received insufficient emphasis in the exposure-assessment discussion, and characterization of chemical and biologic reactivity of nanoparticles was not included as a research need. That appears to have resulted from an effort to place research needs into one of the five “silo” categories with little discussion of the interrelationships and interconnections among categories. The committee notes examples of other research needs that it judged to be insufficiently addressed in the document. For “Nanomaterials and Human Health,” a more comprehensive analysis and evaluation of absorption, distribu- 

Summary 9 tion, metabolism, elimination, and toxicity of engineered nanomaterials at realis- tic exposure levels is needed. For “Human and Environmental Exposure,” expo- sures throughout the life cycle of nanomaterials was not sufficiently introduced or adequately integrated into this section, although a discussion was contained within “Risk Management Methods.” The NNI’s gap analysis is not accurate in that the relevance of FY 2006 research projects to the research needs is generally overstated. The 2008 docu- ment consistently—in every research category—appears to assume that funded projects with only distant links to a research question were meeting that research need. In the “Nanomaterials and Human Health” category, more than 50% of the inventoried projects describe research directly relevant to developing thera- peutic strategies aimed at cancer and other ailments rather than any of the re- search needs listed as relevant to potential EHS risks posed by nanomaterials. The committee acknowledges the value of therapeutic research but believes that it is not directly relevant to understanding potential risks associated with nano- materials that are important in occupational, environmental, and ecologic expo- sure scenarios. In the category of risk-management methods, there is no cover- age of management of environmental and consumer risks, including specific potential exposure scenarios, such as accidents and spills, environmental dis- charges, and exposure through consumer products. Uniformly, the committee agreed that many of the 246 research projects listed in Appendix A are of high scientific value, but the vast majority are of little or no direct value in reducing the uncertainty faced by stakeholders making decisions about nanotechnology and its risk-management practices. The 2008 document substantially overesti- mates the general nanotechnology-related research activity in environmental, health, and safety research. In many cases, the committee concluded that the sequencing of research needs was generally appropriate but not adequately justified. In a number of cases the committee questioned the rationale for a sequence. For example, in the “Instrumentation, Metrology, and Analytical Methods” category, why put the development of materials to support exposure assessment before materials to support toxicology studies? Why delay research into alternative surface-area measurement methods for 10 years if it is identified as a critical research sub- ject? In the “Nanomaterials and the Environment” category, the committee ques- tioned whether resources could be used more efficiently through the characteri- zation of exposure and transformation processes prior to characterization of organisms as well as higher-level ecosystem effects. Although many of the NNI’s identified research needs support risk- assessment and risk-management needs, the committee concluded that failure to identify important research needs, the lack of rationale for and discussion of research priorities, and the flaws in the gap analysis undermine the ability to ensure that currently funded research adequately supports EHS risk-assessment and risk-management needs and provides critical data for the federal agencies. 

10 Review of the Federal Strategy for Nanotechnology CONCLUSIONS AND RECOMMENDATIONS The NNI’s 2008 Strategy for Nanotechnology-Related Environmental, Health, and Safety Research could be an effective tool for communicat- ing the breadth of federally supported research associated with devel- oping a more complete understanding of the environmental, health, and safety implications of nanotechnology. It is the result of consider- able collaboration and coordination among 18 federal agencies and is likely to eliminate unnecessary duplication of their research efforts. However, the document does not describe a strategy for nano-risk re- search. It lacks input from a diverse stakeholder group, and it lacks essential elements, such as a vision and a clear set of objectives, a comprehensive assessment of the state of the science, a plan or road map that describes how research progress will be measured, and the estimated resources required to conduct such research. There remains an urgent need for the nation to build on the current research base related to the EHS implications of nanotechnology— including the federally supported research as described in the 2008 NNI document—by developing a national strategic plan for nanotechnology-related environmental, health, and safety research. A national strategic plan for nanotechnology-related EHS research would identify research needs clearly and estimate the financial and technical resources required to address identified research gaps. It would also provide specific, measurable objectives and a timeline for meeting them. The national strategic plan, unlike the 2008 NNI document, would consider the untapped knowledge of and input from nongovernment researchers and academics, who can contrib- ute to understanding the potential EHS implications of nanotechnology. Reducing the burden of uncertainty through targeted, effective research that identifies and eliminates potential environmental and health hazards of en- gineered nanoscale materials should have high priority for the nation. An effec- tive national EHS strategic research plan is essential to the successful develop- ment of and public acceptance of nanotechnology-enabled products. This strategy should be informed by value-of-information thinking to determine the research that is needed to reduce the current uncertainties with respect to the potential health and environmental effects of nanomaterials. A national strategic plan would need to address nanotechnology-based products that are entering commerce as well as nanotechnologies that are under development. It would provide a path to developing the scientific knowledge to support nanotechnol- ogy-related EHS risk-based decision-making. The committee concludes that a truly national strategy cannot be devel- oped within the limitations of the scope of research under the umbrella of the NNI. Although the 2008 NNI document potentially represents excellent input into the national strategic plan, the NNI can produce only a strategy that is the 

Summary 11 sum of the individual agency strategies and priorities. The structure of the NNI makes the development of a visionary and authoritative research strategy ex- traordinarily difficult. Because the NNI is not a research funding program but rather a coordination mechanism, comprising the activities of 25 federal agen- cies, it has no central authority to make budgetary or funding decisions, and it relies on the budgets of its member agencies to gather resources or influence the shape of the overall federal nanotechnology-related EHS research activity. Be- cause the NNI is responsible for ensuring U.S. competitiveness through the rapid development of a robust research and development program in nanotech- nology while ensuring the safe and responsible development of nanotechnology, it may be perceived as having a conflict of interest. But the conflict is a false dichotomy. Strategic research on potential risks posed by nanotechnology should be an integral and fundamental part of the sustainable development of nanotechnology. Nonetheless, a clear separation of accountability for develop- ment of applications and assessment of potential implications of nanotechnology would help to ensure that the public-health mission has appropriate priority. The committee is concerned that the actual amount of federal funding spe- cifically addressing the EHS risks posed by nanotechnology is far less than por- trayed in the NNI document and may be inadequate. The committee concludes that if no new resources are provided and the current levels of agency funding continue, the research that is generated cannot adequately evaluate the potential health and environmental risks and effects associated with engineered nanoma- terials to address the uncertainties in current understanding. Such an evaluation is critical for ensuring that the future of nanotechnology is not burdened by un- certainties and innuendo about potential adverse health and environmental ef- fects. Those concerns have been voiced recently by the nanotechnology industry and various environmental and public-health interest groups. Having reviewed the 2008 NNI strategy document and discussed what is needed for a path forward, the committee presents the following recommenda- tions: A robust national strategic plan is needed for nanotechnology-related environmental, health, and safety research that builds on the five categories of research needs identified in the 2008 NNI document. The development of the plan should include input from a broad set of stakeholders across the research community and other interested par- ties in government, nongovernment, and industrial groups. The strat- egy should focus on research to support risk assessment and man- agement, should include value-of-information considerations, and should identify • Specific research needs for the future in such topics as poten- tial exposures to engineered nanomaterials, toxicity, toxicoki- netics, environmental fate, and standardization of testing. • The current state of knowledge in each specific area. 

12 Review of the Federal Strategy for Nanotechnology • The gap between the knowledge at hand and the knowledge needed. • Research priorities for understanding life-cycle risks to hu- mans and the environment. • The estimated resources that would be needed to address the gap over a specified time frame. As part of a broader strategic plan, NNI should continue to foster the successful interagency coordination effort that led to its 2008 docu- ment with the aim of ensuring that the federal plan is an integral part of the broader national strategic plan for investments in nanotechnol- ogy-related environmental, health, and safety research. In doing so, it will need a more robust gap analysis. The federal plan should identify milestones and mechanisms to ascertain progress and identify invest- ment strategies for each agency. Such a federal plan could feed into a national strategic plan but would not itself be a broad, multistake- holder national strategic plan. Development of a national strategic plan should begin immediately and not await further refinement of the current federal strategy. CONCLUDING REMARKS A robust national strategic plan for addressing nanotechnology-related EHS risks will need to focus on promoting research that can assist all stake- holders, including federal agencies, in planning, controlling, and optimizing the use of engineered nanomaterials while minimizing EHS effects of concern to society. Such a plan will ensure the timely development of engineered nanoscale materials that will bring about great improvements in the nation’s health, its environmental quality, its economy, and its security.