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1
The National Nanotechnology Initiative and the Genesis of the Environmental, Health, and Safety Strategy
Nanotechnology consists of several enabling technologies that take advantage of unique properties of extremely tiny structures in applications ranging from medicine to electronics to material science. Research in nanotechnology is based on understanding the physical and chemical properties of materials at the level of molecules or complexes of molecules, or atomic clusters with the goal to be able to manipulate those properties. Nanotechnology is not simply about small particles, materials, or products and is defined by the federal government as including the following three factors (NSET 2008a):
Research and technology development at the atomic, molecular, or macromolecular levels on a length scale of about 1-100 nm (a nanometer is one-billionth of a meter—too small to be seen with a conventional optical microscope).
Creation and use of structures, devices, and systems that have novel properties and functions because they are small or of intermediate size, specifically, at the level of atoms and molecules.
Ability to control or manipulate materials on an atomic scale.
In the middle 1990s, as better methods for the characterization, processing, and manipulation of matter on the nanoscale were being developed in research programs supported by federal science and technology agencies, the agencies began holding informal discussions on a common vision for nanotechnology. The interagency dialogue culminated in the establishment in 2000 of the National Nanotechnology Initiative (NNI)—Box 1-1 details some of the history of the establishment of the initiative. The NNI serves strictly as a coordination mechanism for government agencies that support nanoscale research, such as the Department of Energy and the National Science Foundation, or that have a stake
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BOX 1-1
A Brief History of the National Nanotechnology Initiative
In September 1998, an interagency dialogue on nanotechnology was formalized as the Interagency Working Group on Nanotechnology (IWGN). Established under the National Science and Technology Council (NSTC) of the Office of Science and Technology Policy, the IWGN developed a number of reports on a long-term vision for nanoscale research and development (R&D), on international benchmarking of nanotechnology, and on U.S. government investment in nanotechnology R&D (Siegel et al. 1999; Roco et al. 2001). In March 1999, IWGN representatives proposed a nanotechnology initiative with a budget of a half-billion dollars for FY 2001 (Roco 2004). In November 2000, the National Nanotechnology Initiative (NNI) was formally established, and preparations were begun for a coordinated federal investment in nanoscale R&D.
In August 2000, as the NNI proposal matured, the NSTC established the Nanoscale Science, Engineering and Technology (NSET) Subcommittee to replace the IWGN. The NSET Subcommittee was tasked with implementing the NNI by coordinating with federal agencies and R&D programs. Beginning with eight agencies in 2001, the subcommittee now comprises representatives of over 25 federal departments and agencies and officials of the White House Office of Science and Technology Policy and the White House Office of Management and Budget.
In January 2001, the National Nanotechnology Coordination Office (NNCO) was established to provide daily technical and administrative support to the NSET Subcommittee and to assist in multiagency planning and the preparation of budgets and program-assessment documents. The NNCO was also tasked with assisting the NSET Subcommittee with the collection and dissemination of information on industry, state, and international nanoscale science and technology research, development, and commercialization activities (NRC 2002). The NNCO provides technical guidance and administrative support, organizes monthly NSET Subcommittee meetings, conducts workshops, and prepares information and reports, serving as a point of contact and helping to facilitate communication.
in the outcomes of nanoscale research, such as the Food and Drug Administration (FDA) and the Department of Justice. Under the broad umbrella of the initiative, each participating agency invests in projects and programs in support of its own mission. The NNI consists of individual and cooperative nanotechnology-related activities of 25 federal agencies with a wide array of research and regulatory responsibilities. The NNI itself does not fund research, and its budget is equal to the sum of the amounts at which member agencies fund their individual or joint nanotechnology-related programs and projects. Therefore, the NNI has no authority to make budgetary or funding decisions; it relies on the budgets of its member agencies. The goals of the NNI are as follows (NSET 2008a):
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Advance a world-class nanotechnology research and development program.
Foster the transfer of new technologies into products for commercial and public benefit.
Develop and sustain educational resources, a skilled workforce, and the supporting infrastructure and tools to advance nanotechnology.
Support responsible development of nanotechnology.
The NNI’s primary coordination mechanism is the National Science and Technology Council (NSTC) Nanoscale Science, Engineering, and Technology (NSET) Subcommittee (NSET 2008a). Through the operation of the NSET Subcommittee and subordinate structures of the NNI, the initiative addresses the general goals of supporting the missions of the participating agencies; ensuring continuing leadership by the United States in nanoscale science, engineering, and technology; and contributing to the nation’s economic competitiveness.
In 2003, the 21st Century Nanotechnology Research and Development Act (Public Law 108-153) was signed into law. The legislation established the NNI’s operating structures and required that the president establish or designate an advisory panel with a membership qualified to provide advice and information on nanotechnology research, development, demonstrations, education, technology transfer, commercial applications, and societal and ethical concerns.1 The President’s Council of Advisors on Science and Technology (PCAST) was assigned by the president to play such a role. Figure 1-1 shows the current organizational structure of the NNI.
Thirteen NNI-participating agencies currently report investments in nanotechnology: the Department of Agriculture (USDA) (including the Forest Service [FS] and the Cooperative State Research, Education, and Extension Service [CSREES]), Department of Defense (DOD), Department of Energy (DOE), Department of Homeland Security (DHS), Department of Justice (DOJ), Department of Transportation (DOT), Environmental Protection Agency (EPA), National Aeronautics and Space Administration (NASA), National Institute for Occupational Safety and Health (NIOSH), National Institute of Standards and Technology (NIST), National Institutes of Health (NIH), and National Science Foundation (NSF). In FY 2007, the total investment by those agencies in NNI-related research was about $1.425 billion; DOD, DOE, NIH, NIST, and NSF contributed over 80% of the total NNI budget. The president’s research and development (R&D) budget request for the NNI for FY 2009 was $1.527 billion.
Released in December 2007, the updated NNI strategic plan (NSET 2007a) looks 5-10 years ahead to outline a vision of the NNI as working for a “future in which the ability to understand and control matter at the nanoscale
1
Such a panel had been called for in Small Wonders, Endless Frontiers: A Review of the National Nanotechnology Initiative (NRC 2002).
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leads to a revolution in technology and industry that benefits society” (NSET 2007a, p. 3).
The strategic plan outlines program component areas (PCAs)2 that were developed as a means of categorizing and describing the many investments in nanotechnology R&D by the federal agencies that support research. Table 1-1 shows the FY 2008 estimated agency expenditures for the PCAs among the NNI agencies. The committee notes that there may be additional nanotechnology research being performed by some agencies that is not reported in the table. Figure 1-2 shows shares of NNI funding in FY 2006 among the PCAs.
FIGURE 1-1 Organization of NNI. Source: Adapted from Teague 2008.
2
The PCAs are fundamental nanoscale phenomena and processes; nanomaterials; nanoscale devices and systems; instrumentation research, metrology, and standards for nanotechnology; nanomanufacturing; major research facilities and instrumentation acquisition; environmental, health, and safety; and education and ethical, legal, and other societal dimensions (NSET 2007a).
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TABLE 1-1 Estimated FY 2008 Agency NNI-Related Investments by Program Component Area (in $ millions)
Fundamental Nanoscale Phenomena and Processes
Nanomaterials
Nanoscale Devices and Systems
Instrumentation Research, Metrology, and Standards for Nanotechnology
Nanomanufacturing
Major Research Facilities and Instrumentation Acquisition
Environment, Health and Safety
Societal Dimensions
NNI Totala
DOD
258.7
68.9
119.8
8.0
5.4
24.6
2.0
487.4
NSF
138.8
62.1
50.3
16.0
26.9
31.6
29.2
33.8
388.7
DOE
51.4
77.5
13.0
12.0
2.0
92.0
3.0
0.5
251.4
DHHS (NIH)
55.6
25.4
125.8
5.9
0.8
7.7
4.6
225.8
DOC (NIST)
22.5
7.4
21.7
16.1
14.4
5.8
0.8
88.7
NASA
1.5
9.7
6.2
0.4
0.2
18.0
EPA
0.2
0.2
0.2
9.6
10.2
DHHS (NIOSH)
6.0
6.0
USDA (FS)
1.3
1.9
1.2
0.4
0.2
5.0
USDA (CSREES)
0.7
1.6
3.1
0.5
0.1
0.1
6.1
DOJ
2.0
2.0
DHS
1.0
1.0
DOT (FHWA)
0.9
0.9
TOTAL
531.6
254.7
342.3
60.4
50.2
154.4
58.6
39.0
1,491.2
aTotals may appear to be incorrect because of rounding.
Source: NSET 2008b, Table 3.
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FIGURE 1-2 NNI Research Funding by Program Component Area in FY 2006. Source: GAO 2008.
The PCAs provide a framework that allows the NSET Subcommittee, Office of Science and Technology Policy (OSTP), Office of Management and Budget (OMB), and Congress to be informed of NNI-related activities and that facilitates the management of investments in each PCA and the coordination and direction of nanotechnology-related activities in the participating agencies. The NSET Subcommittee has also established four interagency working groups to address specific cross-agency issues in the context of NNI goals and the PCAs: the Nanotechnology Environment and Health Implications (NEHI) Working Group; the Nanomanufacturing, Industry Liaison, and Innovation Working Group; the Nanotechnology Public Engagement and Communications Working Group; and the Global Issues in Nanotechnology Working Group (see Figure 1-1).
ENVIRONMENT, HEALTH, AND SAFETY
Responsible development of technology can be characterized as the balancing of efforts to maximize the technology’s contributions and minimize its adverse consequences. Thus, responsible development of nanotechnology in-
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volves an examination of both its applications and its potential implications. It implies a commitment to develop and use technology to meet the most pressing human and societal needs while making every reasonable effort to anticipate and mitigate adverse implications and unintended consequences (NRC 2006).
Nanomaterials have unusual and useful properties. But their unique attributes make them a double-edged sword: although they can be tailored to yield special benefits, they can also have unknown and possibly adverse effects, such as unexpected toxic and environmental effects. The environmental, health, and safety (EHS) implications of nanotechnology are subjects of serious discussion by government agencies and commissions, nongovernment organizations, the research community, industry, insurers, the mass media, and the public. R&D and manufacturing personnel are the ones initially exposed to nanomaterials, so an initial focus of EHS research related to nanomaterials is occupational health and safety risks.
The Growing Importance of Understanding Environmental, Health, and Safety Issues
The Woodrow Wilson Center Project on Emerging Nanotechnologies reported that 609 consumer products involving nanomaterials were on the market as of April 2008.3 Some 60% of the consumer products reportedly were in the health and fitness category, which includes skin care and other products designed for direct application to the body (PEN 2008). The consulting firm Lux Research predicts that by 2010 the market value of specific nanomaterials will range from $16 million for nanowires to $1.5 billion for ceramic nanoparticles and that there will be a large expansion in all nanomaterial markets from 2005 to 2010 (Holman 2007). As nanomaterials become incorporated into an increasing number and share of consumer products, opportunities for exposure of workers, the general public, and the environment will also increase, so understanding of the potential risks posed by such exposure takes on greater urgency.
In addition to the application of ceramic and other nanoparticles in cosmetics and skin-care products, expanding applications of nanomaterials with relatively high exposure potential include the use of nanosilver in a wide variety of coatings, clothing, and personal-care products for its antimicrobial properties; use of cerium oxide nanoparticles as catalysts in motor-vehicle fuels; and a variety of ceramic and metallic nanoparticles in coatings (Holman 2007). Applications of carbon nanotubes, ceramic nanoparticles, and metal nanoparticles in composite materials, electronic and optical equipment, and other instruments may offer less exposure potential during the use phase of their life cycle but still result in exposure of workers during manufacturing processes and of workers and the general public at the end of the product life cycle. The combination of the heterogeneity of and enormous variations among nanomaterials and their applications; the
3
These products are identified as nanomaterial-based by the manufacturers or others.
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potential for novel forms of toxicity created by their unique size and structural and physical characteristics; and the variations in the frequency, magnitude and duration of releases or exposures, introduces considerable complexity into the design of research programs necessary to understand their potential toxicity.
Researchers, nonprofit organizations, industry, and consumer groups have been calling for an emphasis on EHS research on nanotechnology (Biswas and Wu 2005; Denison 2005; Maynard 2006; Wiesner et al. 2006; Gulledge 2008). In 2004, memorandums from OMB and OSTP to federal-agency heads emphasized the need to give EHS aspects of nanotechnology high priority, noting that “agencies also should support research on the various societal implications of the nascent technology” by placing “a high priority on research on human health and environmental issues…[and] cross-agency approaches” (OMB/OSTP 2004, p.3). The most recent memorandum, for FY 2009, notes that “agencies should strengthen interagency coordination of and support research on potential risks to human health and the environment, consistent with the [NNI (2006)], EHS Research Needs for Engineered Nanoscale Materials” (OMB/OSTP 2007, p. 5).
In 2005, PCAST acknowledged that current knowledge and data for assessing the risks posed by nanotechnology products were incomplete. Furthermore, PCAST said that because exposure to nanomaterials is most likely to occur during manufacturing, research on potential hazards associated with workplace exposure must be given the highest priority (PCAST 2005).4 In 2005, the NSET Subcommittee formally established the NEHI in a charter that set forth its purpose and objectives (NEHI 2005).5
The National Environmental Health Implications Working Group
The NEHI was formed to promote the exchange of information among agencies that support nanotechnology research and those responsible for regulation and guidelines related to nanoproducts; to facilitate identification, priority-setting, and implementation of research needed for the development, use, and oversight of nanotechnology; and to promote communication of information related to research on environmental and health implications of nanotechnology to other government and nongovernment organizations. The NEHI comprises representatives of 18 research and regulatory agencies, OSTP, and OMB and is cochaired by representatives of FDA and the EPA Office of Research and Development.6
4
The committee recognizes that PCAST has published a second report, The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel (PCAST 2008a). PCAST assessed the NNI draft strategy in a report, PCAST (2008b), that was an addendum to PCAST (2008a).
5
The committee recognizes that the informal work of NEHI began as early as 2003.
6
Current members of NEHI consists of officials from the Consumer Product Safety Commission, Cooperative State Research, Education, and Extension Service, Department of Defense, Department of Energy, Department of State, Department of Transportation,
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The NEHI, in its charter, was tasked with the following objectives:
To improve communication of information related to environmental and health aspects of nanotechnology by the National Nanotechnology Coordination Office (NNCO), the NSET Subcommittee, and individual agencies.
To assist in the development of information and strategies as a basis for the drafting of guidance in the safe handling and use of nanoproducts by researchers, workers, and consumers.
To support, with input from the NSET Subcommittee and other appropriate interagency groups, the development of tools and methods for identifying and setting priorities among specific research to enable risk analysis of and regulatory decision-making regarding nanoproducts.
To support development of nanotechnology standards, including nomenclature and terminology, by consensus-based standards organizations.
The structure of the NEHI mirrors that of the NNI, as it serves primarily as a coordinating body across federal research and regulatory agencies. The NEHI, like the NNI, has no authority over the individual agencies and no budget of its own, so it cannot ensure that agencies address or fund specific kinds of EHS research adequately.
The NEHI’s formal coordination efforts have resulted in various reports that have identified EHS research priorities for nanomaterials in a series of documents, starting with Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials (NEHI 2006), which developed five research categories with a total of 75 research needs. The five research categories were instrumentation, metrology, and analytic methods; nanomaterials and human health; nanomaterials and the environment; health and environmental surveillance; and risk-management methods. In 2007, NNI released Prioritization of Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials (NEHI 2007) that reduced the 75 to 25 research needs. In early 2008, A Strategy for Nanotechnology-Related Environmental, Health, and Safety Research was released (NEHI 2008).7 It notes that nanotechnology-related EHS
Environmental Protection Agency, Food and Drug Administration, International Trade Commission, National Aeronautics and Space Administration, National Institute for Occupational Safety and Health, National Institutes of Health, National Institute of Standards 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.
7
In addition to NEHI (2008), many individual agencies have established separate processes to develop their own EHS nanotechnology research strategies. These processes have varied in their structure, their degree of stakeholder involvement, and their complexity. For the most part, the agency personnel engaged in the development of the agency research strategies have been represented on the NEHI, thus allowing for coordination between the NNI research strategy and the individual agency research strategies. The
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research and the strategy itself aim to accelerate research to protect public health and the environment and to fill gaps in research, and—in light of the growing level of effort worldwide—to avoid unnecessary duplication of research. The approach, the document notes, is driven by the breadth of issues, from transport in the environment and effects on human health to managing risks and the overarching need to measure and characterize nanomaterials in various environments. Addressing such a variety of issues, the NNI asserts, requires participation by and coordination of the various NNI agencies with their diverse competences and expertise.
STRUCTURE OF THIS REPORT
This National Research Council (NRC) report is an independent assessment of the 2008 NNI document. The NNCO asked the NRC to evaluate the scientific and technical aspects of the draft strategy and to comment in general terms on how the strategy would develop information needed to support the EHS risk-assessment and risk-management needs with respect to nanomaterials.
The committee conducted the evaluation of the NNI draft strategy by asking several questions: What is a research strategy, and more specifically, a risk-research strategy? What are the necessary components of such a strategy (Chapter 2)? Does the strategy have the necessary components (Chapter 3)? For each of the research categories identified in the strategy—including instrumentation, metrology, and analytic methods; human health; environment; exposure assessment; and risk-management methods—are the appropriate research needs identified, is the gap analysis complete and accurate, are priorities among research needs set correctly, and would the research support EHS risk-assessment and risk-management needs (Chapter 4)? Chapter 5 offers the committee’s conclusions and recommendations and a look toward future steps in the development of an EHS research strategy for nanomaterials. Society is looking to the scientific community for guidance with respect to nanotechnology, and the committee, in its evaluation, considers nanotechnology to be a field that requires targeted research for understanding the scientific uncertainties surrounding potential EHS risks.
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