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Introduction and Background
 "Nanotechnology" touches upon a broad array of disciplines, including chemistry, biology, physics, computational science and engineering. Like information technology, nanotechnology has the potential to impact virtually every industry, from aerospace and energy to healthcare and agriculture. Based on the ability to see, measure, and manipulate matter at the scale of atoms and molecules, nanotechnology was born, in many ways, with the advent of atomic force microscopy in the mid-1980s. Today many industries such as semiconductors and chemicals already are creating products with enhanced performance based on components and materials with nanosized features.
 
 The breathtaking possibilities for useful and powerful nanotechnology applications led to the formal establishment of a National Nanotechnology Initiative (NNI) in Fiscal Year (FY) 2001. Due to its potential to promote innovation and economic benefits, as well as to strengthen the position of the United States as a leader in science and technology, the Administration has identified nanotechnology as a top research and development (R&D) priority for the past several years. Since its inception in FY 2001, the NNI budget has more than doubled and the number of participating agencies has grown from 6 to over 20.
 
 Such a broadly distributed program demands strong interagency coordination, which is provided by a subgroup of the National Science and Technology Council (NSTC), the Cabinet-level body by which the President coordinates science and technology policies across the Federal Government. Within the NSTC Committee on Technology, the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee is responsible for coordinating, planning, implementing, and reviewing the NNI.
 
 The history of the President's Council of Advisors on Science and Technology (PCAST) involvement with the NNI extends back to 1999 when the analogous body under the previous Administration supported the proposal for establishing such an initiative. In a letter to the President, that body included a recommendation that "the progress toward NNI goals be monitored annually by an appropriate external body of experts, such as the National Research Council." In part based on this recommendation, the National Research Council was commissioned to do a study of the NNI, which was released in 2002 (NRC 2002). The first of that study's ten recommendations was that the Office of Science and Technology Policy establish an independent standing nanoscience and nanotechnology advisory board to provide advice to the NSET Subcommittee on policy, strategy, goals, and management.
 
 The President's FY 2004 Budget, released in February 2003, acknowledged the National Research Council's recommendation for external review, and directed PCAST to conduct an assessment and provide advice regarding the strategic direction of the NNI program. PCAST began this task shortly thereafter. The requirement for an ongoing outside advisory panel was ratified by Congress in the 21st Century Nanotechnology Research and Development Act of 2003, Public Law 108-153 (the Act), which called for the President to establish or designate a National Nanotechnology Advisory Panel (NNAP). PCAST's role was reaffirmed when, in July 2004 by Executive Order, the President formally designated PCAST to fulfill the duties of the NNAP (Bush 2004). The order amended the original Executive Order (Bush 2001) that commissioned PCAST, thus establishing that nanotechnology should be included in the formal PCAST charter.
 
The Act calls upon the NNAP to assess the NNI in the following areas:
 
・Trends and developments in nanotechnology
・Progress in implementing the program
・The need to revise the program
・Balance among the component areas of the program, including funding levels
・Whether program component areas, priorities, and technical goals developed by the NSET Subcommittee are helping to maintain U.S. leadership
・Management, coordination, implementation, and activities of the program
・Whether social, ethical, legal, environmental, and workforce concerns are adequately addressed by the program
 The Act requires the NNAP to report on its assessments and to make recommendations for ways to improve the program at least every two years. This is the first such report provided by PCAST in its role as the NNAP. (Hereafter, "NNAP" is used to refer to PCAST in its capacity as the panel called for by the Act.)
 
 To augment its own expertise in managing large R&D programs, the NNAP identified a Technical Advisory Group (TAG) comprising approximately 45 nanotechnology experts who represent diverse disciplines and sectors across academia and industry. The TAG is a knowledgeable resource, providing input and feedback with a more nanotechnology-specific technical perspective.
 
 In the course of performing its assessment, the NNAP convened panels of experts to discuss advancements and opportunities in science and technology as well as the potential environmental, health, and safety implications of nanotechnology. The NNAP also met with members of the NSET Subcommittee throughout the review process to discuss the NNI R&D programs and thereby understand how the initiative is organized and managed. In addition to these sources, the NNAP called upon its TAG on several occasions for broader expert opinions on various topics. Members of the NNAP attended a number of the workshops organized by the NNI over the past two years, including the Research Directions II Workshop held in September 2004, to gain a better understanding of the broad research and application opportunities. These activities, along with numerous informal interactions by NNAP members with a range of nanotechnology stakeholders around the country and worldwide, have provided the basis for this report.
 
 Including the more than $1 billion that the Federal Government estimates it will spend in FY 2005, over 4 billion taxpayer dollars have been spent since FY 2001 on nanotechnology R&D. In addition, the President's 2006 Budget includes over $1 billion for research across 11 Federal agencies (including both NIH and the National Institute for Occupational Safety and Health, or NIOSH, within the Department of Health and Human Services). With such a large and sustained investment, the NNAP members believe the President, the Congress and the American people are seeking answers to four basic questions relative to the Federal investment in nanotechnology R&D:
 
1. Where Do We Stand?
2. Is This Money Well Spent and the Program Well Managed?
3. Are We Addressing Societal Concerns and Potential Risks?
4. How Can We Do Better?
 
 These questions provide the underlying structure for this report, and the answers provide the assessments and recommendations called for by the Act.
 
 As the first of what will be periodic assessments, this report focuses especially on the question of U.S. competitiveness. The Nation cannot afford to cede leadership in this emerging area of science and technology. Remaining at the forefront in nanotechnology requires not only sustained investment and public-private cooperation, but also an understanding of where the opportunities lie, and of the level and direction of activity in other nations.
 
Definition of Nanotechnology
 Since its inception, the NNI has defined "nanotechnology" as encompassing the science, engineering, and technology related to the understanding and control of matter at the length scale of approximately 1 to 100 nanometers. However, nanotechnology is not merely working with matter at the nanoscale, but also research and development of materials, devices, and systems that have novel properties and functions due to their nanoscale dimensions or components.
 
 Wisely in our view, the NNI has distinguished nanotechnology R&D from other types of ongoing scientific research that have achieved a certain level of miniaturization or that operate at a nanometer-length scale. One area in which this distinction is especially challenging is at the intersection of nanotechnology and biology. Many biological structures and processes are on the nanoscale. The National Institutes of Health (NIH) have the following corollary:
 
 White much of biology is grounded in nanoscale phenomena, NIH has not re-classified most of its basic research portfolio as nanotechnology. Only those studies that use nanotechnology tools and concepts to study biology; that propose to engineer biological molecules toward functions very different from those they have in nature; or that manipulate biological systems by methods more precise than can be done by using molecular biological, synthetic chemical, or biochemical approaches that have been used for years in the biology research community are classified as nanotechnology projects.
 
 The NNAP endorses this definitional focus upon the novel properties that occur at the nanoscale and the distinction made between nanotechnology and biology, and the associated goal of understanding and gaining control over them.
 
CHAPTER 1: Where Do We Stand?
 Following the establishment of the NNI in FY 2001, worldwide interest and investment in nanotechnology R&D have grown steadily. Today, virtually every country that supports scientific and technology R&D has a nanotechnology initiative; by many estimates, the total investment by governments outside the United States surpasses $3 billion annually, with comparable investment by the private sector.
 
 While technical and business experts continue to debate the future advancements and economic impacts of nanotechnology, public interest and media coverage have grown dramatically. Scientific advances and technical progress continue, spurred on by vast investments by governments and the private sector, yet most agree that nanotechnology is, by and large, still in a nascent stage and that its ultimate impact on the world economy remains to be seen. What all agree upon is that significant potential clearly exists.
 
 The question, "Where Do We Stand?" refers to the basic competitive position of the United States relative to other countries in the nanotechnology arena. Because nanotechnology is still at an early stage and is dominated by both publicly and privately supported R&D activities, a determination of the Nation's competitive position depends on benchmarking research rather than on economic indicators such as market share. The measurement of research outputs is notoriously challenging (Committee on Science, Engineering, and Public Policy 2000); frequently used metrics include the numbers of and citations to scientific and technical publications and patents. Because some of the knowledge created through research is not captured by these measures of output, the amount going into the pipeline in the form of financial support often is used as an indicator of research activity level, and presumably correlates to some degree with the generation of new knowledge. The NNAP therefore has chosen to compare nanotechnology R&D investment, as well as publication and patent output, as a means of assessing the position of the United States in this emerging area.
 
Table 1.  Estimated Government Nanotechnology R&D Investments in 1997-2004 ($ Millions)
Region 1997 1998 1999 2000 2001 2002 2003 2004 2005
EU 126 151 179 200 〜225 〜400 〜650 〜950 〜1,050
Japan 120 135 157 245 〜465 〜720 〜800 〜900 〜950
U.S. 116 190 255 270 465 697 862 989 1,081
Others 70 83 96 110 〜380 〜550 〜800 〜900 〜1,000
Total
(% of 1997)
432
(100%)
559
(129%)
687
(159%)
825
(191%)
〜1,535
(355%)
〜2,350
(547%)
〜3,100
(720%)
〜3,700
(866%)
〜4,100
(945%)
Source: M. Roco, National Science Foundation
 
Figure 1.  Government Nanotechnology R&D Investments in 1997-2004
Source: M. Roco, National Science Foundation
 


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