Contents

• Overview
• The National Nanotechnology Initiative
• Structure
• Funding
• Funding by Agency
• Funding by Program Component Area
• Selected Issues
• U.S. Competitiveness
• Global Funding
• Scientific Papers
• Patents
• Environmental, Health, and Safety Implications
• Nanomanufacturing
• Public Attitudes and Understanding
• Concluding Observations

Summary

Nanoscale science, engineering, and technology—commonly referred to collectively as nanotechnology—is believed by many to offer extraordinary economic and societal benefits. Congress has demonstrated continuing support for nanotechnology and has directed its attention particularly to three topics that may affect the realization of this hoped for potential: federal research and development (R&D) in nanotechnology; U.S. competitiveness in the field; and environmental, health, and safety (EHS) concerns. This report provides an overview of these topics and two others: nanomanufacturing and public understanding of and attitudes toward nanotechnology.

The development of this emerging field has been fostered by significant and sustained public investments in nanotechnology R&D. Nanotechnology R&D is directed toward the understanding and control of matter at dimensions of roughly 1 to 100 nanometers. At this size, the properties of matter can differ in fundamental and potentially useful ways from the properties both of individual atoms and molecules, on the one hand, and of bulk matter, on the other. Since the launch of the National Nanotechnology Initiative (NNI) in 2000, Congress appropriated approximately $20.421.8 billion for nanotechnology R&D through FY2015FY2016. President Obama has requested $1.54 billion in NNI funding for FY2016.

While more than 60 nations established similar programs after the launch of the NNI, it appears that several have eliminated centralizedmoved away from centralized, coordinated nanotechnology-focused programs (e.g., the United Kingdom, Japan, Russia), some in favor of market- or application-oriented topic areas (e.g., health care technologies). By one estimate, in 2012, total annual global public R&D investment was $7.5 billion, down from $8.3 billion in 2010; corporate nanotechnology R&D spending in 2012 was an estimated $10 billion. Data on economic outputs used to assess competitiveness in mature technologies and industries, such as revenues and market share, are not broadly available for assessing nanotechnology. As an alternative, data on inputs (e.g., R&D expenditures) and non-financial outputs (e.g., scientific papers or patents) may provide insight into the current U.S. position and serve as bellwethers of future competitiveness. By these criteria, the United States appears to be the overall global leader in nanotechnology, though some believe the U.S. lead may not be as large as it was for previous emerging technologies.

Some research has raised concerns about the safety of nanoscale materials. There is general agreement that more information on EHS implications is needed to protect the public and the environment; to assess and manage risks; and to create a regulatory environment that fosters prudent investment in nanotechnology-related innovation. Nanomanufacturing—the bridge between nanoscience and nanotechnology products—may require the development of new technologies, tools, instruments, measurement science, and standards to enable safe, effective, and affordable commercial-scale production of nanotechnology products. Public understanding and attitudes may also affect the environment for R&D, regulation, and market acceptance of products incorporating nanotechnology.

In 2003, Congress enacted the 21^st Century Nanotechnology Research and Development Act (P.L. 108-153), providing a legislative foundation for some of the activities of the NNI, addressing concerns, establishing programs, assigning agency responsibilities, and setting authorization levels. In the 114^th Congress, Subtitle B of H.R. 1898 (America Competes Reauthorization Act of 2015) would reauthorize the NNI. Previous efforts to enact comprehensive NNI reauthorization legislation in the 110^th Congress, 111^th Congress, and 113^th Congress were unsuccessful.

Overview

Congress continues to demonstrate interest in and support for nanotechnology due to what many believe is its extraordinary potential for delivering economic growth, high-wage jobs, and other societal benefits to the nation. To date, Congress has directed its attention particularly to three topics that may affect the United States' realization of this hoped for potential: federal research and development (R&D) investments under the National Nanotechnology Initiative (NNI); U.S. international competitiveness in nanotechnology; and environmental, health, and safety (EHS) concerns. This report provides a brief overview of these topics and two other subjects of interest to Congress: nanomanufacturing and public attitudes toward, and understanding of, nanotechnology.¹

Nanotechnology R&D is directed toward the understanding and control of matter at dimensions of roughly 1 to 100 nanometers. At this size, the physical, chemical, and biological properties of materials can differ in fundamental and potentially useful ways from both the properties of individual atoms and molecules, on the one hand, and bulk matter, on the other hand.

In 2000, President Clinton launched the NNI to coordinate federal R&D efforts and promote U.S. competitiveness in nanotechnology. Congress first funded the NNI in FY2001 and provided increased regular appropriations for nanotechnology R&D for each year through FY2010.² From FY2010 to FY2015FY2016, however, overall NNI funding has declined by $425478 million (22.2%)25.0%); during the same period, overall federal R&D funding fell by less than 1%. President Obama's proposed funding of $1.495443 billion for nanotechnology R&D for FY2016 is essentially the same as the FY2015 level.

In 2003, Congress enacted the 21^st Century Nanotechnology Research and Development Act (P.L. 108-153). The act provided a statutory foundation for the NNI, established programs, assigned agency responsibilities, and authorized agency funding levels for FY2005 through FY2008. Though no funding has been explicitly authorized for the NNI beyond FY2008, Congress has continued to appropriate funds to agencies for nanotechnology research, and the executive branch continues to operate and report on the NNI, as coordinated by the Nanoscale Science, Engineering, and Technology (NSET) subcommittee of the National Science and Technology Council (NSTC).

Federal R&D investments are focused on advancing understanding of fundamental nanoscale phenomena and on developing nanomaterials, nanoscale devices and systems, instrumentation, standards, measurement science, and the tools and processes needed for nanomanufacturing. NNI appropriations also fund the construction and operation of major research facilities and the acquisition of instrumentation. The NNI also supports research directed at identifying and managing potential environmental, health, and safety impacts of nanotechnology, as well as its ethical, legal, and societal implications.

Most current applications of nanotechnology are evolutionary in nature, offering incremental improvements to existing products and generally modest economic and societal benefits. For example, nanotechnology is being used in microchips to improve speed and energy use while reducing size and weight; in display screens to improve picture quality, provide wider viewing angles, and longer product lives; in automobile bumpers, cargo beds, and step-assists to reduce weight, increase resistance to dents and scratches, and eliminate rust; in clothes to increase resistance to staining, wrinkling, and bacterial growth and to provide lighter-weight body armor; and in sporting goods, such as baseball bats and golf clubs, to improve performance.³

In the longer term, proponents of nanotechnology believe it may deliver revolutionary advances with profound economic and societal implications. The applications they discuss involve various degrees of speculation and varying time-frames. The examples below suggest a few of the areas where revolutionary advances may emerge, and for which early R&D efforts may provide insights into how such advances may be achieved. As yet, however, most of these examples are at an early stage of development.

• Detection and treatment technologies for cancer and other diseases. Current nanotechnology disease detection efforts include the development of sensors that can identify biomarkers—such as altered genes,⁴ receptor proteins that are indicative of newly-developing blood vessels associated with early tumor development,⁵ and prostate specific antigen (PSA)⁶—that may provide an early indicator of cancer.⁷ One approach uses carbon nanotubes and nanowires to identify the unique molecular signals of cancer biomarkers. Another approach uses nanoscale cantilevers—resembling a row of diving boards—treated with molecules that bind only with cancer biomarkers. When these molecules bind, the additional weight bends the cantilevers indicating the presence and concentration of these biomarkers. Nanotechnology holds promise for showing the presence, location, and/or contours of cancer, cardiovascular disease, or neurological disease. Current R&D efforts employ metallic, magnetic, and polymeric nanoparticles with strong imaging characteristics attached to an antibody or other agent that binds selectively with targeted cells. The imaging results can be used to guide surgical procedures and to monitor the effectiveness of non-surgical therapies in killing the disease or slowing its growth. Nanotechnology may also offer new cancer treatment approaches. For example, nanoshells with a core of silica and an outer metallic shell can be engineered to concentrate at cancer lesion sites. Once at the sites, a harmless energy source (such as near-infrared light) can be used to cause the nanoshells to heat, killing the cancer cells they are attached to.⁸ Another treatment approach targets delivery of tiny amounts of a chemotherapy drug to cancer cells. In this approach the drug is encapsulated within a nanoshell that is engineered to bind with an antigen on the cancer cell. Once bound, the nanoshell dissolves, releasing the chemotherapy drug, killing the cancer cell. Such a targeted delivery approach could reduce the amount of chemotherapy drug needed to kill the cancer cells, reducing the side effects of chemotherapy.⁹ A more recent advance may enable a nanoparticle to carry three or more different drugs and release them "in response to three distinct triggering mechanisms."¹⁰
• Renewable power. Nanoscale semiconductor catalysts and additives show promise for improving the production of hydrogen from water using sunlight. The optical properties of these nanoscale catalysts allow the process to use a wider spectrum of sunlight. Similarly, nanostructured photovoltaic devices (e.g., solar panels) may improve the efficiency of converting sunlight into electricity by using a wider spectrum of sunlight. Improved hydrogen storage, a key challenge in fuel cell applications, may be achieved by tapping the chemical properties and large surface area of certain nanostructured materials. In addition, carbon nanotube fibers have the potential for reducing energy transmission losses from approximately 7% (using copper wires) to 6% (using carbon nanotube fibers), an equivalent annual energy savings in the United States of 24 million barrels of oil.¹¹
• Water treatment. Nanotechnology approaches—such as nanosorbents, nanocatalysts, bioactive nanoparticles, nanostructured catalytic membranes, and nanoparticle enhanced filtration—may enable improved water quality in both large-scale water treatment plants and point-of-use systems.¹² Nanotechnology water desalination and filtration systems may offer affordable, scalable, and portable water filtration systems. Filters employing nanoscale pores work by allowing water molecules to pass through, but prevent larger molecules, such as salt ions and other impurities (e.g., bacteria, viruses, heavy metals, and organic material), from doing so. Some nanoscale filtration systems also employ a matrix of polymers and nanoparticles that serve to attract water molecules to the filter and to repel contaminants.¹³
• High-density memory devices, faster data access. A variety of nanotechnology applications may hold the potential for improving the density of memory storage and accelerate access speed to stored data.¹⁴
• Higher crop yields and improved nutrition. Higher crop yield might be achieved using nanoscale sensors that detect the presence of a virus or disease-infecting particle. Early, location-specific detection may allow for rapid and targeted treatment of affected areas, increasing yield by preventing losses.¹⁵ Nanotechnology also offers the potential for improved nutrition. Some companies are exploring the development of nanocapsules that release nutrients targeted at specific parts of the body at specific times.¹⁶
• Self-healing materials. Nanotechnology may offer approaches that enable materials to "self-heal" by incorporating, for example, nanocontainers of a repair substance (e.g., an epoxy) throughout the material. When a crack or corrosion reaches a nanocontainer, the nanocontainer could be designed to open and release its repair material to fill the gap and seal the crack.¹⁷
• Toxin and pathogen sensors. Microfluidic and nanocantilever sensors (discussed earlier) may be engineered to detect specific pathogens (e.g., bacteria, virus) or toxins (e.g., sarin gas, hydrogen cyanide) by detecting their unique molecular signals or through selective binding with an engineered nanoparticle.¹⁸
• Environmental remediation. The high surface-to-volume ratio, high reactivity, and small size of some nanoscale particles (e.g., nanoscale iron) may offer more effective and less costly solutions to environmental contamination. By injecting engineered nanoparticles into the ground, these characteristics can be employed to enable the particles to move more easily through a contaminated site and bond more readily with targeted contaminants.¹⁹

Nanotechnology is also expected by some to make substantial contributions to federal missions such as national defense, homeland security, and space exploration and commercialization.

U.S. private-sector nanotechnology R&D funding (corporate and venture capital) is now estimated to be more than twice the amount of U.S. public funding.²⁰ In general, the private sector's efforts focus on translating fundamental knowledge and prototypes into commercial products; developing new applications incorporating nanoscale materials; and developing technologies, methods, and systems for commercial-scale manufacturing. Many other nations and firms around the world are also making substantial investments in nanotechnology.

With so much potentially at stake, some Members of Congress have expressed concerns about the U.S. competitive position in nanotechnology R&D and U.S. success in translating R&D results to commercial products. These concerns have led to an increased focus on barriers to commercialization efforts, including the readiness of technologies, systems, and processes for large-scale nanotechnology manufacturing; potential environmental, health, and safety (EHS) effects of nanoscale materials; public understanding and attitudes toward nanotechnology; and other related issues.

This report provides an overview of the NNI, federal R&D investments in nanotechnology, U.S. competitiveness in nanotechnology, and EHS-related issues.

The National Nanotechnology Initiative

President Clinton launched the National Nanotechnology Initiative in 2000, establishing a multi-agency program²¹ to coordinate and expand federal efforts to advance the state of nanoscale science, engineering, and technology, and to position the United States to lead the world in nanotechnology research, development, and commercialization. In FY2015FY2016, the NNI includes 11 federal departments and independent agencies and commissions with budgets dedicated to nanotechnology R&D, as well as 9 other federal departments and independent agencies and commissions with responsibilities for health, safety, and environmental regulation; trade; education; training; intellectual property; international relations; and other areas that might affect nanotechnology.²² The Environmental Protection Agency and the Food and Drug Administration both conduct nanotechnology R&D and have regulatory responsibilities.

Congress has played a central role in the NNI, providing appropriations for the conduct of nanotechnology R&D, establishing programs, and creating a legislative foundation for some of the activities of the NNI through enactment of the 21^st Century Nanotechnology Research and Development Act of 2003. The act authorized appropriations for FY2005 through FY2008 for NNI activities at five agencies: the National Science Foundation (NSF), Department of Energy (DOE), National Aeronautics and Space Administration (NASA), Department of Commerce (DOC) National Institute of Standards and Technology (NIST), and Environmental Protection Agency (EPA).

Congress has continued its active engagement in the NNI through hearings, proposed authorizing legislation, and annual appropriations. While many provisions of the 21^st Century Nanotechnology Research and Development Act have no sunset provision, FY2008 was the last year for which it authorized appropriations.

Legislation to amend and reauthorize the act was introduced in the 114^th Congress, 113^th Congress, 111^th Congress, and 110^th Congress. No comprehensive reauthorization legislation was introduced in 112^th Congress. In the 114^th Congress, Subtitle B of H.R. 1898, the America COMPETES Reauthorization Act of 2015, would reauthorize the National Nanotechnology Initiative. In the 113^th Congress, bills were introduced in the House and Senate that sought to amend the 21^st Century Nanotechnology Research and Development Act. In the House bill, the National Nanotechnology Initiative Amendments Act of 2014 was incorporated as part of H.R. 4159, the America COMPETES Reauthorization Act of 2014, which was referred to two committees and multiple subcommittees. No further action was taken on the bill. In the Senate, the National Nanotechnology Initiative Amendments Act of 2014 was incorporated as part of S. 2757, the America COMPETES Reauthorization Act of 2014. S. 2757 was referred to the Senate Committee on Commerce, Science, and Transportation and no further action was taken. During markup of the Frontiers in Innovation, Research, Science, and Technology Act of 2014 (H.R. 4186) by the House Committee on Science, Space, and Technology, an amendment to add a title reauthorizing the NNI was defeated. Earlier efforts to reauthorize the 21^st Century Nanotechnology Research and Development Act are discussed in CRS Report RL34401, The National Nanotechnology Initiative: Overview, Reauthorization, and Appropriations Issues, by [author name scrubbed]

Structure

The NNI is coordinated within the White House through the National Science and Technology Council's NSET subcommittee. The NSET subcommittee is comprised of representatives from 20 federal departments and agencies, the Office of Science and Technology Policy (OSTP), and the Office of Management and Budget. (A list of NSET subcommittee member agencies is provided in the Appendix.) The NSET subcommittee has two working groups: National Environmental and Health Implications (NEHI) Working Group; and Nanomanufacturing, Industry Liaison, and Innovation (NILI) Working Group. Two previous working groups—Global Issues in Nanotechnology (GIN) Working Group and Nanotechnology Public Engagement and Communications (NPEC) Working Group—were eliminated.²³ Based on a 2010 recommendation by the President's Council of Advisors on Science and Technology (PCAST), the NSET subcommittee has designated coordinators for four broad areas—global issues; standards development; environmental, health, and safety research; and education, engagement, and societal dimensions—to "track developments, lead in organizing activities, report periodically to the NSET subcommittee, and serve as central points of contact for NNI information in the corresponding areas."²⁴ The National Nanotechnology Coordination Office (NNCO) provides administrative and technical support to the NSET subcommittee.

Funding

This section provides information on funding for the NNINNI funding by agency and by program component area (PCA).

Funding by Agency

Funding for the NNI is provided through appropriations to each of the NNI-participating agencies. The NNI has no centralized funding. Overall NNI funding is calculated by aggregating the nanotechnology-related expenditures of each NNI agency. Funding remains concentrated in the original six NNI agencies (see footnote 21), which accounted for approximately 94account for 94.2% of NNI funding in FY2015FY2016.

For FY2015FY2016, Congress appropriated an estimated $1.488435 billion for nanotechnology R&D, down 22.2% in current dollars from peak NNI funding in FY2010 of $1.913 billion$61.6 million (4.1%) in current dollars from the FY2015 level of $1.913 billion. The FY2016 appropriation is also down $478.1 million (25.0%) from peak regular appropriation funding in FY2010 (see Figure 1). The decrease is 28.432.2% in inflation-adjusted dollars (see Figure 2).²⁵ In total, Congress has appropriated approximately $20.922.3 billion for the NNI from FY2001 to FY2015FY2016. President Obama has requested $1.495443 billion for nanotechnology R&D in FY2016, essentially the same as the estimated total appropriated for FY2015. NNI funding by agency is detailed in Table 1.

Figure 1. Total NNI Funding in Current Dollars, FY2001-FY2016FY2017 (Request)

Source: CRS analysis of NNI data. Note: ARRA = American Recovery and Reinvestment Act of 2009.

Figure 2. Total NNI Funding in Constant FY2015FY2016 Dollars, FY2001-FY2016FY2017 (Request)

Source: CRS analysis of NNI data. Notes: ARRA = American Recovery and Reinvestment Act of 2009. Dollars adjusted using GDP (Chained) Price Index data obtained from Office of Management and Budget, Budget of the United States Government, Fiscal Year 20167, Historical Tables, Table 10.1, adjusted to FY2016 dollars.

Funding by Program Component Area

The 21^st Century Nanotechnology R&D Act of 2003 called for the NSET Subcommittee to develop categories of investment called Program Component Areas (PCAPCAs) to provide a means by which Congress and the executive branch can be informed of and direct the relative investments in these areas. The PCAs cut across the needs and interests of individual agencies and contribute to the achievement of one or more of the NNI's goals.

The 2004 NNI Strategic Plan identified seven PCAs. The 2007 NNI Strategic Plan split the seventh PCA, Societal Dimensions, into two PCAs: Environment, Health, and Safety; and Education and Societal Dimensions. In 2014, the NSET Subcommittee revised its taxonomy for PCAs "to accommodate the maturation of the Initiative, the enhanced emphasis on applications, and the greater participation by agencies and communities that are not focused primarily on R&D."²⁶ The revision reduces the number of PCAs from eight to five.²⁷

Table 2 provides a funding breakout using the new PCA structure for FY2013-FY2016FY2017 (request).

Selected Issues

The remainder of this report discusses four issues of congressional interest with respect to nanotechnology: U.S. competitiveness; environmental, health, and safety implications; nanomanufacturing; and public attitudes and understanding.

U.S. Competitiveness

Nanotechnology is largely still in its infancy. Accordingly, measures such as revenues, market share, and global trade statistics—which are often used to assess and track U.S. competitiveness in more mature technologies and industries—are generally not available for assessing the U.S. position internationally in nanotechnology. To date, the federal government does not collect data on nanotechnology-related revenues, trade, or employment, nor are comparable international government data available.

Nevertheless, many nanotechnology experts assert that the United States, broadly speaking, is the global leader in nanotechnology. Some experts believe, however, that in contrast to many previous emerging technologies—such as semiconductors, satellites, software, and biotechnology—the U.S. lead is narrower, and the investment level, scientific and industrial infrastructure, technical capabilities, and science and engineering workforces of other nations are more substantial.

Some organizations do occasionally produce estimates of global R&D and product revenues for nanotechnology. In the absence of formal data collection, these figures often depend on subjective estimates of nanotechnology's contribution to a particular industry or product. While some products are defined by their nanotechnology properties (for example, nanoscale silver used for antibacterial purposes), many products incorporate nanotechnology as only a part of their functionality (for example, nanoscale gates in semiconductors) thus rendering an assessment of the value of nanotechnology in a particular product subjective (i.e., what percentage of semiconductor revenues should be attributed to nanotechnology).

In 2014, Lux Research, Inc., an emerging technologies consulting firm, produced a report, Nanotechnology Update: Corporations Up Their Spending as Revenues for Nano-enabled Products Increases, that included an estimate of revenues from nanomaterials, nano-intermediates, and nano-enabled products.²⁸ The report, funded in part by the National Science Foundation and the National Nanotechnology Coordination Office, estimates that total global revenues from nano-enabled products reached $731 billion in 2012, up from $339 billion in 2010. Of the 2012 revenues, the United States accounted for $236 billion, or about one-third of total global sales, about the same as Europe ($235 billion) and about 10% higher than Asia ($214 billion). Other countries—aggregated by Lux Research as "Rest of the World"—accounted for an estimated $47 billion.

An alternative mechanism for gauging a nation's competitive position in emerging technologies—in the absence of periodic, comprehensive, and reliable economic output data (e.g., revenues, market share, trade)—is the use of inputs (e.g., public and private research investments) and non-financial outputs (e.g., scientific papers, patents). By these measures (discussed below), the United States appears to lead the world, generally, in nanotechnology. However, R&D investments, scientific papers, and patents may not provide reliable indicators of the United States' current or future competitive position. Scientific and technological leadership may not necessarily result in commercial leadership or national competitiveness for a variety of reasons:

• Basic research in nanotechnology may not translate into viable commercial applications.
• Basic research results are generally available to all competitors.
• U.S.-based companies may conduct production and other work outside of the United States.
• U.S.-educated foreign students may return home to conduct research and create new businesses.
• U.S. companies with leading-edge nanotechnology capabilities and/or intellectual property may be acquired by foreign competitors.
• U.S. policies or other factors may prohibit nanotechnology commercialization, make it unaffordable, or make it less attractive than foreign alternatives.
• Aggregate national data may be misleading as countries may establish global leadership in niche areas of nanotechnology.

With these caveats, the following section reviews input and non-economic output measures as indicators of the U.S. competitive position in nanotechnology.

Global Funding

The United States has led, and continues to lead, all nations in known public investments in nanotechnology R&D, though the estimated U.S. share of global public investments has fallen as other nations have established similar programs and increased funding. In its 2014 report, Lux Research estimated total (public and private) global nanotechnology funding for 2012 to be approximately $18.5 billion, of which the United States accounted for approximately $6.6 billion (36%). In 2010 corporate R&D accounted for a majority of global nanotechnology funding for the first time.²⁹30 Cientifica, a privately held nanotechnology business analysis and consulting firm, estimated global public investments in nanotechnology in 2010 to be approximately $10 billion per year, with cumulative global public investments through 2011 reaching approximately $67.5 billion. Cientifica also concluded that the United States had fallen behind both Russia and China in nanotechnology R&D funding on a purchasing power parity (PPP) basis (which takes into account the price of goods and services in each nation), but still led the world in real dollar terms (adjusted on a currency exchange rate basis).³⁰31

Private investments in nanotechnology R&D come from two primary sources, corporations and venture capital (VC) investors. According to Lux Research, between 2010 and 2012 corporate spending on nanotechnology R&D increased fastest in the United States (32%), followed by Asia (11%), and Europe (3%). All other nations, collectively, increased funding by 22%.³¹32 Total global corporate nanotechnology R&D spending in 2012 was an estimated $9.4 billion (in PPP dollars), led by the United States ($4.1 billion), Japan ($2.3 billion), Germany ($707 million), China (approximately $400 million), and Korea ($474 million).³²

According to Lux Research, venture capital funding for nanotechnology fell 27% in 2012, from an estimated $793 million in 2011 to $580 million in 2012. The United States accounted for more than $400 million of VC funding, nearly 70% of total global VC funding, followed by the United Kingdom with more than $100 million in 2012.³³34 Lux Research previously reported that the amount of venture capital funding in Europe was one-fifth that of the North American level.³⁴

Scientific Papers

The publication of peer-reviewed scientific papers is considered by some to be an indicator of a nation's scientific leadership. A study by the National Bureau of Economic Research in 2005 reported that the U.S. share of nanotechnology papers was a world-leading 24%, but that this represented a decline from approximately 40% in the early 1990s, concluding:

Taken as a whole these data confirm that the strength and depth of the American science base points to the United States being the dominant player in nanotechnology for some time to come, while the United States also faces significant and increasing international competition.³⁵

Reflecting the same trend, the number of papers in the Science Citation Index (SCI)³⁶37 related to nanotechnology discoveries rose from 18,085 in 2000 to approximately 65,000 in 2008, a compound annual growth rate (CAGR) of 17.3%. The U.S. share of these papers grew at a somewhat slower pace (13.8% CAGR) from 5,342 in 2000 to approximately 15,000 in 2008, reducing the U.S. share from 29.5% in 2000 to approximately 23.1% in 2008.³⁷

One measure of the importance of a scientific paper is the number of times it is cited in other papers. An analysis by Evaluametrics, Ltd. reports that nanotechnology papers attributed to the United States are much more frequently cited than those attributed to China, the nations of the European Union (EU27), and the rest of the world as a whole. This held true overall and separately in each of the four disciplines examined (biology, chemistry, engineering, and physics). The U.S. lead was particularly pronounced in biology. China fell below the world average number of citations in each discipline, as well as overall. The EU27European Union performed near the world average in engineering and physics, and somewhat higher in chemistry.

Patents

Patent counts—assessments of how many patents are issued to individuals or institutions of a particular country—are frequently used to assess technological competitiveness. By this measure, the U.S. competitive position in nanotechnology appears to be strong. A 2007 U.S. Patent and Trademark Office analysis of patents in the United States and in other nations stated that U.S.-origin inventors and assignees/owners have

• the most nanotechnology-related U.S. patents by a wide margin;
• the most nanotechnology-related patent publications globally, but by a narrower margin (followed closely by Japan); and
• the most nanotechnology-related inventions that have patent publications in three or more countries (31.7%), followed by Japan (26.9%), Germany (11.3%), Korea (6.6%), and France (3.6%).³⁸

39Environmental, Health, and Safety Implications

Some of the unique properties of nanoscale materials—for example their small size and high ratio of surface area to volume—have given rise to concerns about their potential implications for health, safety, and the environment. While nanoscale particles occur naturally and as incidental by-products of other human activities (e.g., soot), EHS concerns have been focused primarily on nanoscale materials that are intentionally engineered and produced.³⁹

Environmental, health, and safety (EHS) concerns include both direct consequences of nanotechnology for health, safety, and the environment, and how uncertainty about EHS implications and potential regulatory responses might affect U.S. competitiveness. One such effect might be the discouragement of investment in nanotechnology due to the possibility of regulations that might bar products from the market, impose high regulatory compliance costs, or result in product liability claims and clean-up costs.

Much of the public dialogue about risks associated with nanotechnology has focused on carbon nanotubes (CNTs) and other fullerenes (molecules formed entirely of carbon atoms in the form of a hollow sphere, ellipsoid, or tube) since they are currently being manufactured and are among the most promising nanomaterials. These concerns have been amplified by some research on the effects of CNTs on animals, and on animal and human cells. For example, researchers have reported that carbon nanotubes inhaled by mice can cause lung tissue damage;⁴⁰41 that buckyballs (spherical fullerenes) caused brain damage in fish;⁴¹42 and that buckyballs can accumulate within cells and potentially cause DNA damage.⁴²43 On the other hand, work at Rice University's Center for Biological and Environmental Nanotechnology conducted in 2005 found cell toxicity of CNTs to be low and that toxicity can be reduced further through simple chemical changes to the CNT's surface.⁴³

Among the potential EHS benefits of nanotechnology are applications that may reduce energy consumption, pollution, and greenhouse gas emissions; remediate environmental damage; cure, manage, or prevent deadly diseases; and offer new materials that protect against impacts, self-repair to prevent catastrophic failure, or change in ways that provide protection and medical aid to soldiers on the battlefield.

Potential EHS risks of nanoscale particles in humans and animals depend in part on their potential to accumulate, especially in vital organs such as the lungs and brain, that might harm or kill, and to diffuse in the environment and potentially harm ecosystems. For example, several products on the market today contain nanoscale silver, an effective antibacterial agent. Some scientists have raised concerns that the dispersion of nanoscale silver in the environment could kill microbes that are vital to ecosystems.

Like nanoscale silver, other nanoscale particles might produce both positive and negative effects. For example, some nanoscale particles have the potential to penetrate the blood-brain barrier, a structure that protects the brain from harmful substances in the blood. Currently, the barrier hinders the delivery of therapeutic agents to the brain.⁴⁴45 The characteristics of some nanoscale materials may allow pharmaceuticals to be developed to purposefully and beneficially cross the blood-brain barrier and deliver medicine directly to the brain to treat, for example, a brain tumor. Alternatively, other nanoscale particles might unintentionally pass through this barrier and harm humans and animals.

There is widespread uncertainty about the potential EHS implications of nanotechnology. A survey of business leaders in the field of nanotechnology indicated that nearly two-thirds believe that "the risks to the public, the workforce, and the environment due to exposure to nano particles are 'not known,'" and 97% believe that it is very or somewhat important for the government to address potential health effects and environmental risks that may be associated with nanotechnology.⁴⁵

Many stakeholders believe that concerns about potential detrimental effects of nanoscale materials and products on health, safety, and the environment—both real and perceived—must be addressed for a variety of reasons, including the following:

• protecting and improving human health, safety, and the environment;
• enabling accurate and efficient risk assessments, risk management, and cost-benefit trade-offs;
• creating a predictable, stable, and efficient regulatory environment that fosters investment in nanotechnology-related innovation;
• ensuring public confidence in the safety of nanotechnology research, engineering, manufacturing, and use;
• preventing the negative consequences of a problem in one application area of nanotechnology from harming the use of nanotechnology in other applications due to public fears, political interventions, or an overly broad regulatory response; and
• ensuring that society can enjoy the widespread economic and societal benefits that nanotechnology may offer.

Policy issues associated with EHS impacts of nanotechnology include the magnitude, timing, foci, and management of the federal investment in EHS research; the adequacy of the current regulatory structures to protect public health and the environment; and cooperation with other nations engaged in nanotechnology R&D to ensure all are doing so in a responsible manner.

Nanomanufacturing

Securing the potential economic and societal benefits of nanotechnology requires the ability to translate knowledge of nanoscience into market-ready nanotechnology products. Nanomanufacturing is the bridge connecting nanoscience and nanotechnology products. Although some nanotechnology products have already entered the market, these materials and devices have tended to require only incremental changes in manufacturing processes. Generally, they are produced in a laboratory environment in limited quantities with a high degree of labor intensity, high variability, and high costs. To make their way into safe, reliable, effective, and affordable commercial-scale production in a factory environment may require the development of new and unique technologies, tools, instruments, measurement science, and standards for nanomanufacturing.

Several federal agencies support nanomanufacturing R&D focusing on the development of scalable, reliable, cost-effective manufacturing of nanoscale materials, structures, devices, and systems. In its FY2014 budget supplement, the NNI reported nanomanufacturing R&D funding of eight agencies totaling $93.9 million in FY2013, and proposed funding of $100.3 million for FY2014. In its FY2015 budget supplement, the NNI changed its data collection and reporting taxonomy, eliminating the Nanomanufacturing program component area (PCA).⁴⁶47 Under the new PCA taxonomy, nanomanufacturing R&D funding is included in the Nanotechnology Signature Initiatives⁴⁷48 PCA under the subcategory "Sustainable Nanomanufacturing: Creating the Industries of the Futures" and may also be included as part of the figures reported for other PCAs, the Foundational Research PCA and Nanotechnology-Enabled Applications, Devices, and Systems PCA in particular. Since the other PCAs are not further parsed, it is not possible to identify total funding for nanomanufacturing R&D. The President's FY2016 budget proposes $42.6 million for the Sustainable Nanomanufacturing initiative in FY2016, with NSF ($26.4 million, 62% of total proposed funding), NIST ($6.8 million, 16%), and DOE ($3.0 million, 7%) accounting for the largest amount of funds.

In addition, some agencies seek to advance nanomanufacturing through non-R&D activities. For example, the National Institute for Occupational Safety and Health is seeking to stave off potential nanomanufacturing EHS problems by developing and disseminating case studies that demonstrate the utility of applying "Prevention through Design" principles to nanomanufacturing.

Public Attitudes and Understanding

What the American people know about nanotechnology and their attitudes toward it may affect the environment for research and development (especially support for public R&D funding), regulation, market acceptance of products incorporating nanotechnology, and, perhaps, the ability of nanotechnology to weather a negative event such as an industrial accident.

In 2009, the Woodrow Wilson International Center for Scholars Project on Emerging Nanotechnologies (PEN) reported results of a nationwide poll of adults that found 68% had heard little (31%) or nothing at all (37%) about nanotechnology, while only 31% said that they had heard a lot (9%) or some (22%).⁴⁸49 In a 2007 poll, more than half of those surveyed felt they could not assess the relative value of nanotechnology's risks and benefits. Among those most likely to believe that the benefits outweigh the risks were those earning more than $75,000 per year, men, people who had previously heard "some" or "a lot" about nanotechnology, and those between the ages of 35 and 64. Conversely, those most likely to believe that the risks of nanotechnology outweigh the benefits included people earning $30,000 or less; those with a high school diploma or less; women; racial and ethnic minorities; and those between the ages of 18 and 34 or over age 65.⁴⁹

50 The 2007 PEN survey found a strong positive correlation between nanotechnology familiarity/awareness and perceptions that benefits will outweigh risks. However, the survey data also indicate that communicating with the public about nanotechnology in the absence of clear, definitive answers to EHS questions could create a higher level of uncertainty, discomfort, and opposition.

Congress expressed its belief in the importance of public engagement in the 21^st Century Nanotechnology Research and Development Act of 2003 (15 U.S.C. §§7501-7502.). The act calls for public input and outreach to be integrated into the NNI's efforts. The NNI has sought to foster public understanding through a variety of mechanisms, including written products, speaking engagements, a web-based information portal (nano.gov), informal education, and efforts to establish dialogues with stakeholders and the general public. The NSET subcommittee has also established a Nanotechnology Public Engagement and Communications working group to develop approaches by which the NNI can communicate more effectively with the public.

Concluding Observations

The federal government has made sustained investments in nanotechnology under the NNI since FY2001. While numerous nanotechnology applications have been incorporated in commercial products, they have generally offered incremental improvements in product performance. Proponents assert that nanotechnology has the potential to bring revolutionary products to market, reshaping existing industries and creating new ones. These products may bring significant economic and social benefits to the United States and to the world; however, substantial research, development, and innovation-related hurdles remain before these benefits might be realized.

Congress may play an active role in addressing some or all of these hurdles. The issues Congress may opt to consider include: budget authorization levels for the covered agencies; R&D funding levels, priorities, and balance across the program component areas; administration and management of the NNI; translation of research results and early-stage technology into commercially viable applications; environmental, health, and safety issues; ethical, legal, and societal implications; education and training for the nanotechnology workforce; metrology, standards, and nomenclature; public understanding; and international dimensions.

Appendix. Department/Agency Members of the NSET Subcommittee

As of April 2014, the NSET subcommittee included the following member departments and agencies:

Consumer Product Safety Commission^†*

Department of Agriculture

Agricultural Research Service†

Forest Service†

National Institute of Food and Agriculture†

Department of Commerce

Bureau of Industry and Security

Economic Development Administration

National Institute of Standards and Technology†

U.S. Patent and Trademark Office

Department of Defense^†

Department of Education

Department of Energy^†

Department of Health and Human Services

Agency for Toxic Substances and Disease Registry

Food and Drug Administration†

National Institute for Occupational Safety and Health†

National Institutes of Health†

Department of Homeland Security^†

Department of the Interior

Department of Justice

Department of Labor

Department of State

Department of Transportation^†

Department of Treasury

Environmental Protection Agency^†

Intelligence Community

National Aeronautics and Space Administration^†

National Science Foundation^†

Nuclear Regulatory Commission*

U.S. International Trade Commission*

† Indicates a federal department, independent agency, or commission with a budget dedicated to nanotechnology research and development.

* Indicates an independent commission that is represented on NSET but is non-voting.

Footnotes