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5 Conclusions and Recommendations The National Nanotechnology Initiative document Strategy for Nanotechnology-Related Environmental, Health, and Safety Research could be an effective tool for communicating the breadth of federally supported research associated with developing a more comprehensive understanding of the environmental, health, and safety implications of nanotechnology. It is the result of considerable collaboration and co- ordination among 18 federal agencies and is likely to eliminate unnec- essary duplication of their research efforts. The Strategy for Nanotechnology-Related Environmental, Health, and Safety Research does not describe a strategy for nano-risk research. It lacks input from a diverse stakeholder group, and it lacks essential elements, such as a vision and a clear set of objectives, a comprehen- sive assessment of the state of the science, a plan or road map that de- scribes how research progress will be measured, and the estimated re- sources 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 described in the 2008 NNI document—by developing a national strategic plan for nanotechnol- ogy-related environmental, health, and safety research. Having reviewed the National Nanotechnology Initiative (NNI) strategy document, the committee has concluded that it does an excellent job of identify- ing numerous specific topics on which more research is needed to adequately address the environmental, health, and safety (EHS) concerns associated with engineered nanoscale materials. The committee found that, with some excep- tions, the specific research needs in each research category were appropriate for nanotechnology-related EHS research. However, although the inventories of the research needs are sufficient for some research categories, they are poorly de- 93

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94 Review of the Federal Strategy for Nanotechnology fined and incomplete in others, specifically risk management and exposure as- sessment. The committee also believes that some research needs that fall be- tween categories could be overlooked. The research needs in the NNI strategy document are not presented as concrete, measurable objectives, and the implementation plan fails to provide any sense of how success toward specific goals will be measured or what re- sources might be needed to achieve them. The committee carefully considered the “gap analysis” in the NNI docu- ment, which was based on identifying FY 2006 funded projects as relevant to one or more of the five broad research categories. The committee concluded that the gap analysis is flawed and is neither accurate nor complete in laying a foun- dation for a research strategy. The approach used does not provide an accurate picture of current resource allocations even among the five broad categories. The committee concluded that the use of the FY 2006 data to conduct the gap analysis is perhaps the greatest flaw identified in the document. It is particularly problematic in the discussions of human health and metrology, in which it re- sulted in the inclusion of research projects that are not directly relevant to under- standing the EHS needs related to nanomaterials. The issues arising from the gap analysis led to important deficiencies in all the research categories described in Section II of the 2008 NNI document. Because of the flaws in the gap analy- sis, it is difficult to understand the priorities of selected research needs and the logic for the priorities. The NNI document states (p. 46) that “the EHS research strategy funda- mentally depends on sustaining the broad spectrum of basic research. . . . The current balance of research funding addresses such basic investigations and sup- ports regulatory decision making.” However, although the committee has no reason to doubt the value of the compelling nanotechnology research described, it notes that probably less than half the grants and resources counted in the in- ventory will provide any useful data to support regulatory decision-making. The analysis suffers universally from a lack of coherent and consistent criteria for determining the value of information provided by various research activities. Such criteria would ideally be founded on an understanding of the uncertainties in each of the various research fields and the interrelationships among them. The federal funding specifically addressing nanotechnology-related EHS issues is far less than portrayed in the NNI document and may be inadequate. The committee concludes that if no new resources are provided and the current agency funding continues, the implementation plan described in the NNI docu- ment will not ensure that engineered nanomaterials are adequately evaluated for potential health and environmental effects. Such an evaluation is critical to en- sure that the future of nanotechnology is not burdened by uncertainties and in- nuendo about potential adverse health and environmental effects of engineered nanoscale materials. Those concerns have been voiced recently by both the nanotechnology industry and a variety of environmental and public-health inter- est groups.

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Conclusions and Recommendations 95 In many endeavors, society looks to the scientific community for insights, data, and recommendations for establishing policies or regulations. In the broad swath of nanoscience and nanotechnology, the present committee considers that the emerging field of nanotechnology is one such endeavor. The scientific input needed for understanding the potential effects is not necessarily that produced by exploratory research (although it has its place) but rather often relies heavily on generating, identifying, and applying specific knowledge. In this respect, scientific input into developing policies for risk assessment and risk manage- ment of currently available and emerging nanotechnology bears a closer resem- blance to the approval process for new drugs and medical devices than to the general advancement of new knowledge through exploratory research. The current nanotechnology risk research portfolio is dominated by agen- cies traditionally focused on exploratory and investigator-driven research, such as the National Institutes of Health and the National Science Foundation. If these agencies are to continue to lead research efforts in this area, the scope of research requests and the review criteria used to assess the relative merits of submitted proposals may need to be modified if the agencies want to ensure that the research they support feeds into an effective EHS risk research strategy based on appropriate, targeted research. There are several possible ways to accomplish such a change in criteria, for example, through joint initiatives, including requests for proposals with ex- plicit statements of need, between federal agencies focused on fundamental or investigator-driven science and mission-driven agencies responsible for protect- ing human health and the environment (such as the Environmental Protection Agency, the National Institute for Occupational Safety and Health, the Food and Drug Administration, and the Consumer Product Safety Commission). Ulti- mately, any useful strategic plan for addressing EHS aspects of nanotechnology will have to focus on obtaining timely research results that can assist all stake- holders, including federal agencies, in planning, controlling, and optimizing the use of purposely engineered nanomaterials while minimizing and controlling the potential EHS effects of concern to society. What is needed, the committee concludes, is an effective national strate- gic plan for nanotechnology-related EHS research that involves more stake- holders than the federal government. Such a plan would have to identify re- search needs clearly and estimate the financial and technical resources needed to address identified research gaps. A national strategic plan would be focused on providing solutions to challenges that do not necessarily fit neatly into discipli- nary and institutional silos, and ensure important research does not fall between the gaps. Such a plan would also provide specific, measurable objectives and a timeline for meeting them. The committee finds that the 2008 NNI document represents excellent in- put into a national strategic plan. A national strategic plan would ensure the timely development of engineered nanoscale materials that will bring about great improvements in the nation’s health, its environmental quality, its econ- omy, its security, and the quality of life without the unintended consequences of

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96 Review of the Federal Strategy for Nanotechnology damage to the environment and to the health of the very workers and consumers who stand to benefit from the technology. 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 strategic plan is essential for the successful development of and public acceptance of nanotechnology-enabled products. A value-of-information approach should be used to determine the research that is needed to reduce the current uncertainties with respect to the potential health and environmental ef- fects of nanomaterials. A national strategic plan would need to address nanotechnology-based products that are entering commerce and nanotechnol- ogy-based products that are under development. It would provide a path for de- veloping the scientific knowledge to support nanotechnology-related EHS risk- based decision-making. It would 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 committee chose the term national strategic plan rather than federal strategic plan because it concluded that one of the weaknesses of the 2008 NNI document is that it focuses only on federal government agency activities. Fed- eral programs are essential and in the national interest, but the nongovernment research community should also contribute research and knowledge to the un- derstanding of the EHS implications of nanotechnology. 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. The NNI can produce only a strategy that is the sum of the individual agency priorities, many of which are not aligned with EHS research related to nanomaterials. The structure of the NNI makes the development of a visionary and authoritative research strategy extraordinarily difficult. Because the NNI is a coordination mechanism, not a research funding program, it has no central au- thority to make budgetary or funding decisions, and it relies on its member agencies to gather resources or influence to shape the overall federal nanotech- nology-related EHS research activity. The NNI is responsible for ensuring U.S. competitiveness through the development of a rapid and robust nanotechnology- related research and development program while ensuring the safe and responsi- ble development of nanotechnology itself, and these two missions may be per- ceived as being in conflict. But the conflict is a false dichotomy in that strategic research on potential risks posed by nanotechnology can be an integral and fun- damental part of its sustainable development. Nonetheless, a clear separation of accountability for development of applications and assessment of potential EHS implications would help to ensure that the public-health mission is given appro- priate priority. Having considered those conclusions with respect to the 2008 NNI docu- ment and what is needed for a path forward, the committee offers the following two recommendations.

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Conclusions and Recommendations 97 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. • 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.