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3
Evaluation of the Federal Strategy
In Chapter 2, the committee identified the key elements of a nano-risk research strategy: an evaluation of the existing state of science, an overarching vision or statement of purpose, goals to ensure safe development of nanotechnologies, a road map for ensuring achievement of stated goals, evaluation for assessing progress in achieving the goals, a process of review to ensure the strategy remains responsive to the overarching vision and goals, identification of resources, mechanisms to achieve goals, and accountability. The committee evaluated Strategy for Nanotechnology-Related Environmental, Health, and Safety Research (NEHI 2008) by considering whether it contained those elements. In its evaluation, the committee considered input from public sessions held at the National Academies (March 31 and May 5, 2008) at which representatives of the Nanotechnology Environmental and Health Implications Working Group (NEHI) and of the stakeholder community—including industry, nongovernment organizations, and the insurance sector—provided comments on the federal strategy. Many of the stakeholders’ comments echoed sentiments of the committee and are provided here as support for the committee’s views on NNI (NEHI 2008). (See Appendix C for an agenda of the public sessions.)
The committee concluded that the development of the NNI (NEHI 2008) has provided a unique opportunity for coordination, planning, and consensus-building among 18 agencies within NEHI. However, the committee determined that the NNI document does not have the essential elements of a nano-risk research strategy, inasmuch as it does not evaluate the state of science, does not contain a clear set of goals, and does not have a plan of action for achieving the goals or mechanisms to review and evaluate funded research and assess whether progress has been achieved. There is no attempt to show how existing research will lead to answers to critical questions that the federal government, the research community, and other stakeholders are grappling with.
IS THERE AN EVALUATION OF THE EXISTING STATE OF SCIENCE?
The research categories and needs presented in the strategy are based on
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priorities reviewed and evaluated in the previous NNI reports, Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials (NEHI 2006) and Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document for Public Comment (NEHI 2007), both of which received public comment. The first of those reports developed five research categories with a total of 75 research priorities. The priorities were reduced to 25 in the second report. The new strategy (NEHI 2008) attempts to develop timelines and sequence the research needs and uses an accounting of research projects of FY 2006 to determine the strengths, limitations, and data gaps of the research portfolio.
There is no evaluation of the existing state of science or of federally funded research in each of the five categories identified in the strategy—instrumentation, metrology, and analytic methods; nanomaterials and human health; nanomaterials and the environment; human and environmental exposure assessment; and risk-management methods. Rather, the research categories and identified research needs (see Box 3-1) are analyzed solely in the context of FY 2006 research projects. The committee questions the NNI’s use of FY 2006 data to assess the extent to which federally funded environmental, health, and safety (EHS) research for nanomaterials is supporting the selected research needs. The majority of the research projects listed for FY 2006 focused on fundamentals of nanoscience that are not explicitly associated with risk, or on developing nanotechnology applications.1 There also is no clear connection between the research projects and how they will inform an understanding of risk. Without a clear articulation of how the research projects will inform that understanding, the report’s assessment is highly misleading and inappropriately used to identify whether research needs are being addressed.
NNI (NEHI 2008) contains conflicting statements about the use of FY 2006 research projects to evaluate research needs. The document states that “this analysis of strengths, weaknesses, and gaps will inform agency decisions about the magnitude and balance of future EHS research investments” (NEHI 2008, p. 9). But the document continues, “data gathered for FY 2006 represent a one-time-only ‘snapshot’ of the NNI agencies’ EHS research portfolios in one year. However, these are likely to be indicative of the overall trends in agency investments in more recent years” (NEHI 2008, p. 9). The strategy goes on to acknowledge limits of the gap analysis, including statements that the data represent only projects funded in FY 2006; that the data represent planned research, not research results; and that only federally funded research is accounted for—there is no mention of research funded by industry, nonprofit organizations, or other countries. Those statements in the strategy were echoed by Altaf Carim,
1
The 246 FY 2006 research projects listed include research on instrumentation and metrology and on medical applications that is not captured in the list of 130 environmental, health, and safety research projects included in the annual supplement to the president’s budget (Teague, unpublished material, 2008).
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program manager in the Office of Science, Department of Energy, who acknowledged in his written testimony to the committee “that data was one of the inputs to the planning process—a snapshot of Federal activity that in fact was analyzed in order to determine where there were gaps and to identify the priority areas for future investment” (Carim 2008, p.1).
BOX 3-1
Priority Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, as Identified in the 2008 National Nanotechnology Initiative Research Strategy
Instrumentation, Metrology, and Analytical Methods
Develop methods to detect nanomaterials in biological matrices, environment, and workplace.
Understand how chemical and physical modifications affect the properties of nanomaterials.
Develop methods for standardizing assessment of particle size, size distribution, shape, structure, and surface area.
Develop certified reference materials for chemical and physical characterization of nanomaterials.
Develop methods to characterize a nanomaterial’s spatio-chemical composition, purity, and heterogeneity.
Nanomaterials and Human Health
Overarching Research Priority: Understand generalizable characteristics of nanomaterials in relation to toxicity in biological systems.
Broad Research Needs:
Understand the absorption and transport of nanomaterials throughout the human body.
Develop methods to quantify and characterize exposure to nanomaterials and characterize nanomaterials in biological matrices.
Identify or develop appropriate in vitro and in vivo assays/models to predict in vivo human responses to nanomaterials exposure.
Understand the relationship between the properties of nanomaterials and uptake via the respiratory or digestive tracts or through the eyes or skin, and assess body burden.
Determine the mechanisms of interaction between nanomaterials and the body at the molecular, cellular, and tissular levels.
Nanomaterials and the Environment
Understand the effects of engineered nanomaterials in individuals of a species and the applicability of testing schemes to measure effects.
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Understand environmental exposures through identification of principle sources of exposure and exposure routes.
Evaluate abiotic and ecosystem-wide effects.
Determine factors affecting the environmental transport of nanomaterials.
Understand the transformation of nanomaterials under different environmental conditions.
Human and Environmental Exposure Assessment
Characterize exposures among workers.
Identify population groups and environments exposed to engineered nanoscale materials.
Characterize exposure to the general population from industrial processes and industrial and consumer products containing nanomaterials.
Characterize health of exposed populations and environments.
Understand workplace processes and factors that determine exposure to nanomaterials.
Risk Management Methods
Overarching Research Priority: Evaluate risk management approaches for identifying and addressing risks from nanomaterials.
Understand and develop best workplace practices, processes, and environmental exposure controls.
Examine product or material life cycle to inform risk reduction decisions.
Develop risk characterization information to determine and classify nanomaterials based on physical or chemical properties.
Develop nanomaterial-use and safety-incident trend information to help focus risk management efforts.
Develop specific two-way risk communication approaches and materials.
Source: NEHI 2008.
The committee’s concerns about the limitations of the assessment of the state of science were reflected by Carolyn Cairns, program leader of product safety for Consumer’s Union, at the May 5, 2008 workshop: “The document resembles a laundry list of ad hoc projects that some agencies have shoe-horned into relevance for environmental health and safety. It is not a strategy that will accelerate the research needed to prevent our toxic past from repeating itself in
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nano-form. The document fails to articulate how the disparate projects outlined will be pulled together to glean meaningful conclusions that participating agencies can use to protect the public from dangers inherent in commercializing nanomaterials” (Cairns 2008, p.1).
DOES THE STRATEGY HAVE A VISION OR STATED PURPOSE?
The strategy document has various statements of purpose, but none provides a clear vision of where understanding of the environmental, health, and safety implications of nanotechnology should be in 5 or 10 years, including ensuring that the results of research are useful and applicable to decision-making for reducing potential environmental, health, and safety effects of nanomaterials. Relevant research is also needed for policy decisions on government oversight, in industry, and in a broader societal context.
The statement that stands out most as the purpose of the strategy document is that “the NEHI Working Group developed this nanotechnology-related EHS research strategy to accelerate 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 is adequate for an open-ended research program with no definite objectives, but it stops short of ensuring that the results of strategic research are useful and applicable to decision-making that will reduce the potential environmental and health effects of nanotechnologies.
The committee notes that in some cases the strategy document reads as though it has two stated objectives: continuing to support nanotechnology and understanding risks. As the strategy states, “this effort has entailed identifying and prioritizing EHS research for nanomaterials; analyzing the current research portfolio in detail; performing a gap analysis to determine areas requiring emphasis; and developing a strategy to address these areas and to sustain the diverse program aimed at advancing knowledge and supporting risk decision making” (NEHI 2008, p.1; emphasis added). Those two objectives are emphasized again: “the NNI aims to maximize the benefits of this new technology at the same time it is developing an understanding of any potential risks and means to manage such risks” (NEHI 2008, p. 1). Stakeholders at the committee’s May 5, 2008 public session expressed concerns, similar to those of the committee, that the strategy document seemed to be divided between protecting public health from potential risks of nanomaterials and developing nanotechnology products.
A clear and distinct vision may be difficult for the coordinating agencies to articulate and agree to inasmuch as they reflect different backgrounds, goals, and legislative mandates (see discussion on limitations of the NNI and the NEHI at the end of this chapter).
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DOES THE STRATEGY HAVE GOALS TO ENSURE THE SAFE DEVELOPMENT OF NANOTECHNOLOGIES, AND IS THERE A ROAD MAP FOR ACHIEVING STATED GOALS?
NNI (NEHI 2008) does not present goals or a plan of action for achieving them. Although it identifies five “research needs” for each of the five general categories (see Box 3-1), the needs are not articulated as clear goals. There also are no measures of progress to evaluate how and to what extent the goals are being attained. As William Kojola, AFL-CIO industrial hygienist, commented, “a comprehensive set of goals and objectives should first be identified and then a strategy needs to be developed to accomplish these goals and objectives…. The current NNI strategy appears to essentially consist of a listing of agency projects cobbled together to look like a strategy” (Kojola 2008, p. 2).
The committee recognizes that the “emphasis diagrams” (NEHI 2008, Figures 3, 5, 7, 9, and 11) for the research needs in the five categories provide some element of timeframe and sequencing. As the strategy states, “priority… was considered both in terms of the kind of information developed (some information is of greater relevance than others to supporting risk management) and the appropriate sequencing of research (some research should be timed to occur following other research in order to gain the greatest benefit to decision making with respect to product use, regulations, and conduct of research)” (NEHI 2008, p. 10). Some research needs (for example, in the category of instrumentation, metrology, and analytic methods) could be translated into measureable objectives, but for many others there are insufficient details to determine the measurable objectives.
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 activities, whether in the organization—the government in this case—or outside it (such as research supported by industry, nonprofits, or other countries). Such an approach enables development of an action plan to leverage other efforts and to address and measure research deficiencies in a way that is transparent.
Because NNI (NEHI 2008) does not establish goals and a plan of action, there is no roadmap; the document never raises such questions as, What other research activities should be leveraged? and What additional research activities are needed? Rather, it asserts that current activities are addressing research needs. Terry Medley, global director of corporate regulatory affairs at DuPont, highlighted in his May 5, 2008 presentation to the committee the need for metrics for evaluation as a critical component of successful implementation of the NNI strategy (Medley 2008).
The committee notes that the role of goals and milestones in a complex and emerging research field is not to predict and hold research organizations to the predictions but to map out a systematic plan with chartable actions, which
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will of necessity change. The committee recognizes that useful goals and a plan of action in this context are not easy to formulate, but they are urgently needed.
DOES THE STRATEGY PROVIDE FOR EVALUATION OF RESEARCH PRIORITIES AND AN ASSESSMENT OF RESEARCH PROGRESS?
NNI (NEHI 2008) states that “the task forces analyzed the portfolio of projects in each category to determine the balance of effort…. In addition to tabulating the number of projects and total funding … the task forces considered the breadth of research, such as variety of nanomaterials or routes of exposure” (NEHI 2008, p. 7). Although there is some justification in the document for the research priorities selected, it is marginal. The research priorities were developed in NNI (NEHI 2006) and NNI (NEHI 2007), but it is not clear from those documents how they were ultimately selected.2 It is also not possible to discern relative priorities among the various research needs shown in each of the five categories or even among the five categories. Although the strategy clearly states that no effort was made to set priorities among the categories, because the category of instrumentation, metrology, and analytic methods is cross-cutting—supporting research in every other category—it has high priority itself (NEHI 2008, p. 9).
In general, the process behind the selection of the research priorities and the later priority weightings in the emphasis diagrams is not transparent. There also is little discussion of the itemized research needs in the emphasis diagrams. Many of the research needs make sense, but a few are questionable. For instance, why put the development of materials to support exposure assessment before the development of materials to support toxicology studies (NEHI 2008, p. 18)? Why delay research into alternative surface-area measurement methods for 10 years in light of its being identified as a critical research subject (NEHI 2008, p. 18)? Why delay the development of high-throughput screening methods by 5 years (NEHI 2008, p. 24)? There are many other examples. Further discussion of research priority-setting in each of the research categories is discussed in Chapter 4.
Without clear goals, as discussed above, effective priority-setting is nearly impossible. Without effective priority-setting among research needs, measurement of research progress makes little sense.
2
NNI (NEHI 2006) and NNI (NEHI 2007) identify principles for identifying and setting priorities for EHS research, including value of information, leveraging research by other governments and the private sector, and adaptive management of nanomaterial EHS research; but it is not clear how these principles were used in selecting the research priorities.
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DOES THE STRATEGY IDENTIFY THE RESOURCES NEEDED TO ACHIEVE STATED GOALS?
The strategy does not identify resources necessary to address questions concerning EHS research needs for understanding nanomaterials and does not identify the projected resources needed to execute the strategy, including funding, education, and training of personnel. This absence of a discussion of resources constitutes a major deficiency. Although the detailed analysis of nanotechnology EHS expenditures in FY 2006 provides information about what was spent during that particular year, there is no assessment of whether the spending was adequate to address EHS research needs voiced by individuals, organizations, and governments worldwide (Denison 2005; Maynard 2007; Ziegler 2007), whether the expenditures by the agencies were appropriate to address EHS research needs based on their missions, or how much additional resources would be required.
From the FY 2006 expenditures, it is difficult even to assess the balance of research among objectives, because in many cases the monetary value of a research project is a function of an agency’s budget rather than of scientific needs. However, with respect to the overall funding level, the strategy document suggests that sufficient funding is already being dedicated to EHS research by the NNI and that funds should not be redirected to this research from other kinds of nanotechnology research. The strategy states, surprisingly, that “the current balance of research funding addresses such basic investigations and supports regulatory decision making. Gaps identified in the research that supports regulatory decision making should not be addressed at the cost of broad-based fundamental research—to do so would ultimately undercut the U.S. nanotechnology initiative as a whole” (NEHI 2008, p. 46). An appropriate research strategy should quantify the resources needed to address research priorities, identify where the resources might come from, and ensure that there is adequate training of personnel.
DOES THE STRATEGY PROVIDE ACCOUNTABILITY FOR ACHIEVING STATED GOALS?
Although lead agencies are identified for each of the five research categories, there is no accountability—no organization or person will be held accountable for the success or failure of the strategy to deliver results. The strategy states that “the success of the strategy … depends on the collective efforts of the NNI agencies through their individual and joint activities coordinated by the NEHI Working Group and the NSET Subcommittee. Progress will also depend on the agency priorities and resources” (NEHI 2008, p. 7). That is, accountability is divided among agencies, a working group, and the NSET Subcommittee, and progress depends on individual agency priorities and resources.
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In comments to the committee, Terry Medley, of DuPont, stated (Medley 2008, p. 4):
The executive summary of the document raises two critical questions. 1) Who will implement the strategy? 2) How will the strategy be implemented? With regard to who will implement the strategy, it identifies agencies that will serve as coordinators for the five research areas, it does not explicitly address the coordinating agencies ability to make final decisions regarding the activities in their specific research areas. With regard to how the strategy will be implemented it states that as nanotechnology EHS research and knowledge continue to grow, needs and priorities will evolve. Accordingly, this plan will be reviewed and updated as research progresses. Again, the strategy calls for a coordinated approach as the research progresses, but does not specifically address who has the authority to make changes or revisions needed.
Because of the absence of clearly stated goals and measurable objectives, it is difficult to imagine how the strategy could be used objectively to measure the success of future research efforts. Accountability may require specific quantifiable objectives so that one can determine whether progress is being made.
The strategy does demonstrate how the NNI and other federal agencies have worked together effectively to coordinate their funding and assessment of EHS aspects of nanotechnology and thus avoided, to some extent, unnecessary duplication of research. That is indicative of the function of the NNI, which has been described as a “coordinating platform” (Murashov 2008). However, there is essentially no stakeholder input outside these federal agencies, and in essence the strategy has been constructed in a federal vacuum.
The strategy does not adequately incorporate input from other stakeholders, such as industries that produce nanomaterials and end users of nanomaterials; environmental and consumer advocacy groups; foreign interests, including substantial efforts of other countries; and local and state governments. The committee recognizes that the 2006 and 2007 NNI documents have undergone public comment, but public comment is not the same as actively engaging other stakeholders in the process. In light of the extensive contributions and interests of other nations, in particular the European Union and Japan, it is particularly surprising that the federal strategy appears largely to ignore what other nations are doing. International coordination would help to ensure that there is not unnecessary duplication of research efforts and that data quality is maintained.
To have effective stakeholder engagement requires that the strategy be developed through a process of stakeholder input and consultation. There are many models of this, including tripartite input from government, industry, and civil society representatives, which would ensure that the strategy developed served the needs of regulators, industry, and citizens without being unduly biased by any particular group. Another model is the National Institute for Occupational Safety and Health’s National Occupational Research Agenda, in which research
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needs and directions are developed through a well-established system of stakeholder input (NORA 2008).
Without input from and accountability to external stakeholders, it is not possible for government agencies to develop an effective research strategy to underpin the emergence of safe nanotechnologies. The reason is that federal agencies have a vested interest in justifying the applicability of current efforts rather than critically assessing what is not being done and how deficiencies might be addressed. For example, when agencies are developing their own research strategies, they tend to ask, what research can we do within our existing capabilities?, rather than the more appropriate, What research should we be doing? Other relevant questions need to be addressed, such as, Are resources adequate? Are adequate mechanisms and organizational structures in place to achieve the desired goals? As a result, the federal strategy becomes a justification for current activities based on a retrospective examination that demonstrates success rather than the development of a prospective strategy that questions current practices with an eye to future research needs. That is reflected in remarks by William Gulledge, senior director of the Chemical Products and Technology Division of the American Chemistry Council, an industry trade association, who emphasized the need for a more broadly defined strategy, noting that the NNI plan “’represents a bottom-up approach where agencies identify their priorities…We still need a top-down, broad, overall look’ at nanomaterials” (Risk Policy Report 2008, p.2).
CONCLUSIONS
The committee concludes that Strategy for Nanotechnology-Related Environmental, Health, and Safety Research should not be considered a nano-risk research strategy, because it is missing the necessary elements. Nevertheless, it is important to recognize what the document is and what it has achieved. The NNI strategy represents an impressive collaboration and coordination effort involving 18 federal agencies whose nanotechnology research interests span the gamut from exploratory research (for example, research funded by the National Science Foundation to characterize materials on the surface of nanostructures or nanoparticles) to targeted research (for example, research funded by the Environmental Protection Agency to examine the bioaccumulation of nanomaterials in the food chain). The increased collaboration will probably eliminate unnecessary duplication of research efforts. As the document states, “agencies whose missions support nanomaterial research may use this document to better understand where their activities fit into the overall strategy. Moreover, agencies can use it to identify opportunities for collaboration and cooperation, and manage their relationships with other agencies and their research” (NEHI 2008, p. 6).
The development of the strategy has led to extensive discussion and consensus-building among program managers in the various agencies that participate in the NEHI Working Group and in the NSET Subcommittee; in many
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cases, these are the same program managers who set priorities and make funding decisions on research proposals (Carim 2008). The strategy is also referenced in requests for research solicitations and has stimulated proposal submissions by individual researchers (Carim 2008). In addition, it has spawned the development of EHS strategies by federal agencies.
The limitations of the document may be due to the NNI-NEHI structure, in that perhaps only a bottoms-up approach could be developed. The NEHI is primarily a coordinating body rather than a visionary one (see Chapter 1). It sees its role as ensuring coordination of activities of otherwise independent agencies that have their own distinct missions. That limits the ability of the NEHI and the NNI to create a vision and an overall plan for federal research to understand potential EHS risks posed by nanomaterials most efficiently. Without an explicit vision or clearly stated purpose, the result of the effort is what is reflected in the document: a compilation of studies rather than a more difficult priority-setting and development of milestones and evaluation measures for determining progress toward a vision. As the strategy states, “development of specific EHS research programs—by NNI agencies singly or jointly—is informed largely, but not exclusively, by the research and information needs of agencies with regulatory and oversight responsibilities” (NEHI 2008, p. 3).
The structure of the NNI and the NEHI, comprising the activities of a large number of diverse agencies with differing missions, makes the development of a visionary and authoritative research strategy extraordinarily difficult. Because the NEHI has essentially no authority over the individual agencies—and so no one agency has authority to shape a research agenda within a second agency—this means that the product of the NEHI can be little more than a compilation of individual agency agendas. Because the NNI has no authority to make budgetary or funding decisions (see Chapter 1) and simply relies on the budgets of its member agencies, it has no resources or influence to shape the overall federal EHS research activity. The NEHI must devise a research strategy that is responsive to individual agency budgetary priorities rather than developing a much-needed vision and strategy that include assurances that adequate resources go to the appropriate agencies to realize the vision. Finally, the NNI has no central figure who is not affiliated with any of the member agencies but is charged with oversight of EHS research and has the budgetary authority to make the necessary research and resource decisions.
Because the NNI is responsible for ensuring U.S. competitiveness through the development of a robust research and development program and ensuring the safe development of nanotechnology, it may be perceived as having a conflict of interest. That may be implied in the previously cited statement in the NNI document that addressing EHS research gaps must not detract from fundamental research to develop the technology. The committee concludes that the conflict constitutes a false dichotomy and that strategic research on potential risks posed by nanotechnology can be an integral and fundamental part of the sustainable development of nanotechnology. Nevertheless, a clear separation of accountability for development of applications and assessment of potential implications of
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nanotechnology would help to ensure that the public-health mission receives appropriate priority. The nation has addressed concerns about separation of technology development and regulatory oversight authorities for a new and potentially hazardous technology in the past. When both supporters and critics of nuclear energy raised strong concerns about both development and regulatory oversight being housed in the Atomic Energy Commission (AEC), Congress responded in 1974 by creating the Nuclear Regulatory Commission (NRC) to house the oversight function and moved the technology development research into the Department of Energy (U.S. NRC 2008). Congress and the executive branch should consider this model in assuring the safe development of nanotechnology. As an interim step, the NNI Amendments Act of 2008 [H.R.5940.RFS] establishes a separate authority within the NNI with accountability for EHS research.
REFERENCES
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Carim, A.H. 2008. Presentation at the Second Meeting on Review of the Federal Strategy to Address Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials, May 5, 2008, Washington, DC.
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 [accessed July 29, 2008].
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Nanoscale Materials: An Interim Document for Public Comment. Arlington, VA: National Nanotechnology Coordination Office. August 2007 [online]. Available: http://www.nano.gov/Prioritization_EHS_Research_Needs_Engineered_Nanoscale_Materials.pdf [accessed Aug. 22, 2008].
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Risk Policy Report. 2008. Critics Slam Federal Nano Environmental, Health Research Strategy. Inside EPA’s Risk Policy Report 15(20):5-6. May 13, 2008.
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Ziegler, P.D. 2007. Current Status of Planning and Implementation under the National Nanotechnology Initiative. Statement of the American Chemistry Council at the Hearing on Research On Environmental and Safety Impacts of Nanotechnology, Before the House Committee on Science and Technology, October 31, 2007 [online]. Available: http://www.americanchemistry.com/s_acc/sec_article.asp?CID=655&DID=6334 [accessed Nov. 19, 2008].