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GOVERNMENT & POLICY

NANOTECHNOLOGY INVESTMENT U.S. focuses on COMMERCIALIZATION and strengthening environmental, health, and safety research BRITT E. ERICKSON, C&EN WASHINGTON

THE U.S. REMAINS the world’s leader in

turing by 100% over the next five years. In 2011, government funding for nanomanufacturing is proposed to make up only 5.8% of the total NNI budget. Along with nanomanufacturing comes responsible product development and understanding the risks of a product. The report recommends a more rationalized approach to identifying the risks of nanotechnology and developing a cross-agency strategic research plan to fill EHS knowledge gaps. “It is important not only to continue increasing the federal investment in environmental, health, and safety research but to do so in a coordinated way so the most important questions are answered first,” said Ed Penhoet, cochair of PCAST’s NNI Working Group and director of Alta Partners, a venture capital firm. “That approach will ensure safety, bolster public confidence, and provide a clear path to market for new companies and their products.”

Over the past decade, NNI has pronanotechnology, but that position is bevided about $12 billion for nanotech R&D, ing threatened by China, South Korea, and which has had a “catalytic and substantial the European Union, according to a report impact” on U.S. nanotechnology growth, released last month by the President’s the PCAST report concludes. However, Council of Advisors on Science & Technolthe report recommends that NNI increase ogy (PCAST). its investment, particularly in the area of The report, which was prepared for the nanomanufacturing, to ensure that the U.S. White House and Congress, recommends keeps its leadership position. The U.S. has several changes to the government’s interlagged behind Asia and the EU in terms of agency program that coordinates federally government funding for nanotech R&D funded nanotechnology R&D, the National since 2006, according to data from Lux Nanotechnology Initiative (NNI). The Research, a research and advisory firm speANOTHER KEY recommendation in the changes aim to ensure that the U.S. concializing in emerging technologies. report is for Congress and the Obama tinues to dominate the field over the next “Our early investments in nanotechnolAdministration to take steps to provide decade. ogy have brought us to the point where the permanent resident status for foreign inTop recommendations of the report science is being translated into important dividuals who hold an advanced degree in include increasing investments in nanonew products in health, electronics, energy, science and engineering from an accreditmanufacturing and product ed institution and are employed commercialization so that novel within the U.S. in that discipline. FUNDING PORTFOLIO nanotech products enter the The report points to the lack of Federal nanotech support falls into eight research categories marketplace, increasing the a skilled American workforce number of workers with exin nanotechnology, adding that Instrument research, metrology & standards pertise in nanofabrication, and one-third of foreign individuals 4% Education & societal dimensions Nanomanufacturing 2% strengthening commitments trained in the U.S. return to live 6% to environmental, health, and in their native countries. Fundamental Environment, safety (EHS) research. Some of the PCAST recomphenomena health & safety The priorities outlined in mendations were also brought & processes 7% 28% the PCAST report are the same up by members of the NanoMajor research facilities & areas that many different stakeBusiness Alliance, an industry instrument acquisition holders—including the governtrade association dedicated to 12% Nanoscale devices ment itself—are already actively commercializing nanotechnol& systems Nanomaterials 23% 19% discussing. They are the focus ogy, during a congressional of legislation working its way briefing on March 16. The group Proposed 2011 federal funding = $1.8 billion through Congress, and they are was in town for its 9th Annual NOTE: May not sum to 100% because of rounding. of great concern to the nanotech Washington, D.C., Roundtable SOURCE: National Science & Technology Council industry, which held a two-day Event, which included visits gathering in Washington, D.C., with key senators to discuss last month to meet with congressmen and defense, and other fields,” Maxine L. Savitz, nanotechnology legislation. federal regulators. Also in March, NNI cochair of PCAST’s NNI Working Group The nanotech industry, along with wrapped up a series of workshops to adand vice president of the National Academy many other stakeholders, is particularly dress gaps in EHS research. of Engineering, noted in a statement. “Gointerested in seeing Congress pass the NNI NNI was created in 2001, with eight paring forward we need to place even more Amendments Act of 2009. The bill shifts ticipating agencies and an annual budget of emphasis on the commercialization of the priorities away from basic research toward $464 million. Today, 25 agencies participate technology—through, for example, strategic activities that encourage commercializain the initiative. Of those agencies, 14 confunding of nanomanufacturing,” she says. tion of nanotech products and lead to ecotribute to its funding, which for fiscal 2011 The report recommends that NNI nomic benefits. It also requires all federal is proposed to total $1.8 billion. increase its investment in nanomanufacagencies that participate in NNI to develop WWW.CEN-ONLINE.ORG

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NATIONAL NANOTECHNOLOGY INITIATIVE

Federal funding is up within departments dealing with consumer products, foods, occupational safety, and energy $ MILLIONS

2009a

2010b

2011c

Department of Energy National Science Foundation National Institutes of Health Department of Defense National Institute of Standards & Technology Environmental Protection Agency National Institute for Occupational Safety & Health

$332.6 408.6 342.8 459.0 93.4 11.6 6.7

$372.9 417.7 360.6 436.4 114.4 17.7 9.5

$423.9 401.3 382.4 348.5 108.0 20.0 16.5

13.7 6.5 15.3 9.1 0.2 0.9 1.2

13.7 7.3 15.8 11.7 0.2 3.2 0.0

15.8 15.0 14.3 11.7 2.2 2.0 0.0

$1,701.6

$1,781.1

$1,761.6

National Aeronautics & Space Administration Food & Drug Administration Department of Agriculture Department of Homeland Security Consumer Product Safety Commission Department of Transportation Department of Justice TOTAL

CHANGE 2010–11

13.7% -3.9 6.0 -20.1 -5.6 13.0 73.7 15.3 105.5 -9.5 0.0 1,000.0 -37.5 0.0 -1.1%

a Actual. b Estimate. c Proposed. SOURCE: National Science & Tecnology Council

a plan for EHS research. The bill passed the House of Representatives in February 2009, but it has yet to move in the Senate. To help build momentum for the bill in the Senate, representatives from several companies spoke at the March 16 briefing, hosted by Sen. Ronald L. Wyden (D-Ore.) and the Congressional Nanotechnology Caucus. The representatives provided members of Congress and staffers with information about nanotech products under development and how nanotechnology helps create jobs. They also took the opportunity to let Congress know what keeps them up at night. High on the nanotech industry’s list of concerns are the lack of Americans with training in nanotechnology, the lack of H-1B visas that allow foreigners to work in the U.S., and the lack of access to capital in the $5 million to $100 million range. Such capital is needed for nanotech R&D and product development, but has dried up because of uncertainty about the risks of nanotechnology. Several industry representatives at the briefing emphasized the need for training people at the technician level in nanomanufacturing. There are plenty of people with Ph.D.s that have expertise in nanotechnology, but they don’t run the machines, said James M. Hussey, chief executive officer of NanoInk, an Illinois-based company that specializes in nanotechnology manufacturing and applications for the life sciences and semiconductor industries. What’s really needed, he added, are lower level tech-

nicians who know how to use the necessary nanomanufacturing equipment. Because of the lack of U.S. workers with nanomanufacturing expertise, and the difficulty in obtaining H-1B visas for foreign workers with such expertise, NanoInk had to open a small lab in Cambridge, England, to get the skilled workforce it needs, Hussey stressed. WHILE IN WASHINGTON, members of the

NanoBusiness Alliance also met with federal regulators to stimulate dialogue and find out the latest on regulatory actions regarding nanotechnology. At that meeting, industry representatives expressed frustration with the current regulatory system because various offices within a single agency regulate nanotechnology differently and one office doesn’t seem to know what another is doing. For example, the Environmental Protection Agency regulates nanotechnology by two different laws—the Federal Fungicide, Insecticide & Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA)—which are managed under two different offices. So when an antimicrobial claim is made on a nanotech product, such as those containing nanosilver, the product is regulated under FIFRA and handled by EPA’s pesticides office. But for other nanoscale materials, such as carbon nanotubes and graphene, regulation is handled by EPA’s toxics office under TSCA. A similar situation exists at the Food & WWW.CEN-ONLINE.ORG

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Drug Administration, where regulation of nanoscale materials is handled by a variety of offices. For instance, depending on a product’s intended use, it may fall to the agency’s food, cosmetic, or drug center for evaluation. Industry wants the agencies to come up with a more streamlined approach to regulating nanotechnology because it is difficult to navigate the current system. Some company representatives questioned how regulators will handle multifunctional products, such as those that use nanotechnology for imaging as well as therapeutics. Such products are coming “fast and furious,” one participant noted. A clear and robust regulatory process is also important, according to industry representatives, to reduce the uncertainty around their products. The concern is that the longer it takes for regulatory agencies to harmonize their processes, the more the industry will move offshore because investors are willing to fund development of products with such high uncertainty. Frustrations about regulation aside, industry representatives agreed that it is in their best interests to proactively address the risks of nanotechnology. Assessing the risks of nanotechnology is difficult, however, because in most cases toxicity data on nanomaterials are insufficient. Although government investment in EHS research has grown from $35 million in 2005 to a proposed $117 million in 2011, several knowledge gaps still remain. And, although there are calls like the one in the PCAST report for more investment in this area, funding for EHS research still only makes up a small percentage (6.6% in 2011) of the total NNI budget. To help identify those knowledge gaps and prioritize nanotech EHS research needs, NNI convened a series of four workshops over the past year. The first workshop focused on exposure assessment, the second on environmental impacts, and the third on human health effects. The second and third workshops also examined the need for new instrumentation, metrology, and analytical methods. The final workshop, held at the end of March, focused on risk management methods and the ethical, social, and legal implications of nanotechnology. NNI plans to use the information gathered during the workshops as it develops a new strategic plan for EHS research. Its current strategy, released in February 2008, was heavily criticized by stakeholders, including industry trade groups, nano-

material manufacturers, and environmental organizations. In late 2008, the National Research Council released a report that blasted NNI’s EHS research strategy, saying it lacks a clear vision, specific goals, and an evaluation of the current state of the science. The report recommended that NNI hold a series of meetings to gather broader stakeholder input about EHS data gaps, and that is just what NNI did. NNI is now trying to make sense of all the information it gleaned from the four EHS workshops. Some of the biggest challenges pointed out by participants include the lack of characterization of nanomaterials used in toxicology studies and the need for better models to predict the toxicity of nanomaterials. There was also a lot of talk about designing nanomaterials to be less toxic, but, as some participants noted, that is not always possible. For example, nanoscale titanium dioxide, an ingredient found in many sunscreens, generates reactive oxygen species. “You can’t design away that property,” Gregory V. Lowry, professor of civil and environmental engineering at Carnegie Mellon University, stressed at the March workshop. In such cases, he said, one should eliminate the potential for exposure by coating nanoparticles with aluminum oxide or using protective equipment during manufacturing. Kristen Kulinowski, director of the International Council on Nanotechnology (ICON) at Rice University, pointed out that in the scientific literature hazard data far outstrip exposure data for nanomaterials. As a result, she said, there has been an imbalance in the discussion, with few people asking, can we be exposed?

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WORKER SAFETY is another issue that Kulinowski is concerned

about. She noted that there is limited work in the literature on nanomaterial toxicity that is relevant to occupational settings. As a result, ICON has teamed up with several other organizations to launch the GoodNanoGuide (goodnanoguide.org), an online interactive forum for exchanging ideas on best practices for handling nanomaterials in the workplace, including university laboratories. Many other participants at the March workshop agreed that more needs to be done to train chemists and engineers in toxicology so they better understand the EHS risks of the materials they are working with. But incorporating such a change into a chemistry department’s curriculum would have to involve accreditation bodies, such as the American Chemical Society. And those conversations have yet to begin. In the meantime, NNI appears to have gotten the message that its 2008 EHS strategic plan is inadequate. Efforts are under way to revise that plan, and for the first time, the ethical, legal, and social implications of nanotechnology are being considered. NNI is also planning to rewrite its strategic plan for the entire program, not just EHS research, according to Sally S. Tinkle, who cochairs the National Science & Technology Council’s Nanoscale Science, Engineering & Technology Subcommittee. That subcommittee is responsible for coordinating the development of NNI’s strategic plan and mechanisms for interagency communication and coordination on nanotech R&D. At the March workshop, Tinkle emphasized that NNI will integrate EHS studies into all of its research. “EHS considerations have to be a part of all of our work in nanotechnology,” echoed Jeff Morris, national program director for nanotechnology in EPA’s Office of Research & Development. The ultimate success will come “when EHS research is no longer considered a separate area, but rather an integral part of all we do as we advance nanotechnology,” he said. ■

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