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Washington Lawyer

Nanotechnology: Small Science, Huge Hurdles

From Washington Lawyer, March 2011

By Sarah Kellogg


Before nanotechnology even existed, there were vast libraries of science fiction books that envisioned
a future of miniaturized devices, bionic body parts, and nanobots that could travel through space and
kill with precision. Since that fanciful beginning, nanotechnology has moved beyond the hypothet-
ical to realistic applications, positing a future that is at once more wondrous and mundane than was imagined.

Nanotech research has yielded more effective pesticides, increasingly smaller electronics, more proficient pharmaceuticals, stronger tennis racquets, and antibacterial tube socks. Scientists see an even bolder future for nanotechnology. Engineers are working today on blockbuster applications such as sophisticated nanofilters that easily desalinate and purify water, nanomaterials that eat pollution for lunch, and disease-fighting nanomolecules that search, find, and destroy cancer cells.

“Nanotechnology is quite simply a game-changer,” says John C. Monica Jr., a partner at Porter Wright Morris & Arthur LLP and a recognized expert who works with established and startup nanotech companies. “It is one of the foremost innovations of the 21st century, and we are already seeing its value in hundreds of consumer products and its even larger promise in the biomedical industry where it could truly revolutionize medicine.”

Big Promise, Lingering Doubts
Still, nanotech’s maturation has not been without some controversy. The wide-eyed promise has been overshadowed in recent years by continuing questions about the threat nanomaterials may pose to human health and the environment. Advocacy groups say that nanotechnology is at best reasonably benign and at worst a threat on the scale of asbestos or DDT. While most researchers and industry leaders believe nanotechnology falls in the former category, there is continuing uncertainty on the environmental, health, and safety (EHS) effects of this small science, a doubt that hasn’t diminished despite more than 15 years of research.

That uncertainty extends to how government agencies will regulate the creation, production, and distribution of nanomaterials. Nanotech’s novelty and size have made designing governance mechanisms particularly difficult, as has the problematic politics of chemicals regulation in the United States and the European Union (EU). Add in the reluctance of the nanotech industry to fully embrace regulation for fear it will squash the sector’s economics, and that explains why a whole generation of nanotech products has entered the marketplace with little or no government oversight.

Industry officials say that, of course, they want to avert chemical catastrophes and that they favor some limited government intervention. Regulations would go a long way toward easing concerns of consumers and investors, conveying the imprimatur of legitimacy on nanotechnology, and warning off nanotort chasers. A widely accepted regulatory framework would ensure uniformity as well. With states, multiple federal agencies, and international tribunals adopting their own unique rules and guidelines, companies will be hard-pressed to maneuver the patchwork of nanotech regulations to get a product to market. The end result, they argue, is the danger of delaying for years, if not decades, solutions to society’s most intractable problems.

“We’re not adrift in a sea of nanomaterials. These materials are the result of years and years of thoughtful product stewardship and risk avoidance,” says Lynn Bergeson, a founding member of Bergeson & Campbell, P.C., which specializes in chemicals regulation, and a leading legal expert on nanotechnology. “Do we need to know more as a society? Of course, but that is underway.”

But designing a governance process that fits nanotech is no easy matter. There is no standard definition for nanotechnology or a vetted nomenclature to categorize its many elements and processes. Furthermore, there are no readily available tools to test nanomaterials to determine if they could result in adverse health effects or damage the environment. In many respects, the nanotechnology sector is flying blind, a situation that has left its critics wondering what it will take to regulate technology that is already in people’s medicine cabinets (sunscreen and cosmetics) and workplaces (nanocomposites of all kinds).

“There’s a lot of promise with nanotechnology, but I don’t see why the promise has to be compromised by having some basic protections in place and, at the very least, having government in a position to study these things and moving incrementally toward applying appropriate controls,” says Richard Denison, a senior scientist with the Environmental Defense Fund (EDF) whose work focuses on industrial chemicals and nanomaterials. “I don’t see regulation as being at odds with development. It just seems like the industry stance has become one of viewing any regulatory requirement, even to report materials being developed, as somehow compromising its competitiveness.”

More than 20 years into the nano era, government regulators and industry leaders are still struggling with how best to regulate the technology—calculating the right balance between the needs of the public and the needs of the industry. Yet despite the slow walk to a regulatory framework, government rules and guidelines may be the best avenue for the industry to secure its future.

Solar Leaves Mimic Nature
As nanotechnology provides insights into nature’s processes, it also helps researchers find new approaches to old problems. Instead of employing ungainly silicon-based solar panels on rooftops and in backyards, engineers are creating photovoltaic “leaves” that mimic nature’s own.

These leaves are pliable and less expensive than today’s traditional solar cells, and they can be made using any of a number of photovoltaic materials. Researchers at the North Carolina State University are using water-based gels infused with light-sensitive molecules and electrodes coated with carbon nanotubes.

And one Brooklyn, New York, company has created Solar Ivy using stainless steel mesh to install fist-sized solar leaves on buildings or walls. The leaves mimic conventional ivy, making the solar cells a reliable alternative for almost any structure. Much like a windmill, Solar Ivy also can convert movement into energy, and leaves can be colored to match their new homes (red for red bricks) or to mimic the green of real ivy.

Power of the Unseen
When noted author and scientist Richard Feynman proposed the direct manipulation of individual atoms in a 1959 talk, a computer was the size of a living room and the term “nanotechnology” would not be coined for another 15 years. Yet Feynman’s vision of an atom-powered world offered enormous opportunities for science and greater society.

“When we get to the very, very small world—say circuits of seven atoms—we have a lot of new things that would happen that represent completely new opportunities for design,” Feynman said in his speech titled “There’s Plenty of Room at the Bottom.” “Atoms on a small scale behave like nothing on a large scale, for they satisfy the laws of quantum mechanics. So, as we go down and fiddle around with the atoms down there, we are working with different laws, and we can expect to do different things.”

Fifty years later, much of Feynman’s vision has been realized. Materials at the atomic level do behave differently, and the field of nanotechnology continues to excel at divining those differences and translating them into products used in daily life. Nanomaterials ensure refrigerators are cleaner (antibacterial coatings), revolutionize telecommunications (smartphones and i-anything from Apple), allow amateur duffers to hit for distance (lightweight golf clubs with bigger sweet spots), and even provide fountain-of-youth cosmetics (anti-aging creams).

“In some sense, nanomaterials have always been out there,” says J. Steven Rutt, a partner at Foley & Lardner LLP and head of its nanotechnology industry team. “Companies have used carbon black in tires for a long time. The reason why you can carry a smartphone in your pants pocket is because of nanotechnology. We’ve been making things smaller and smaller for years. There’s just been much more of a focus in the last decade on the new developments like quantum dots and nanowires.”

Sizing Nano Up
But what is nanotechnology? When discussing the subject, it’s easy to slip into a fog of dimensional confusion. The most basic element of nanomaterials is the nanometer (nm), which is one billionth of a meter. Researchers describe the relative size of the nanometer this way: A human hair is about 100,000 nm in diameter; spores of pollen are 10,000 nm; red blood cells are 3,000 nm; viruses are 100 nm; and a molecule is 1 nm. At that size, proportions are difficult to grasp. Perhaps Harvard University’s George Whitesides, a respected expert in nanotechnology and its potential uses, has come up with the most useful illustration of nanotech’s scale: Alaska’s Denali (also known as Mt. McKinley, with a respectable elevation of 5,934 meters) is to a common ant as a baby’s finger is to a nanometer.

Nanotechnology is an interdisciplinary field, crossing everything from chemistry and biology to materials and metal sciences. The intersection of nanotechnology and these various sectors is resulting in new, unanticipated applications. When particles fall below 50 nm in size, the laws of physics give way to quantum effects, triggering optical, electrical, and magnetic behaviors that are not found in similar materials at a standard scale.

In addition, nanoparticles are more mobile than their conventional-sized cousins, so they’re able to cross the blood-brain barrier, a characteristic that raises the red flag for health advocates. Nanomaterials also have a larger surface area relative to their size than conventional-sized forms, which makes them more reactive and affects their strength and flexibility.

One of nanotech’s most formidable early inventions is the carbon nanotube. Discovered in 1991, carbon nanotubes are sheets of graphite rolled up into seamless, porous tubes that have remarkable strength and conductive properties depending on a particle’s structure. Carbon nanotubes’ applications are varied, including energy storage and conversion, probes, and high-strength composites for everything from automobile bumpers to tennis racquets. A carbon cousin of the nanotube is the buckminsterfullerene or buckyball, named for American architect R. Buckminster Fuller. The round buckyball is an attractive component because it can withstand intense collisions and is twice as hard as diamonds.

While much of nanotech’s promise remains in the lab, many products have managed to make it to the marketplace in the last decade. The only publicly available register of nanomaterials in distribution in the United States is published by the Project on Emerging Nanotechnologies (PEN), an initiative of the Washington, D.C.-based Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. The registry lists more than 1,000 manufacturer-identified nanotech products, including antibacterial coatings, cosmetics, sunscreens, and clothing.

Next Generation of Weapons
The future of war may be an insect—a robotic one. In Frank Herbert’s sci-fi thriller Dune, flying darts assassinated enemies with lethal speed and accuracy. Today, researchers are using nanotechnology to construct similar weapons.

The so-called Bionic Hornet is the size of a wasp and will be able to chase, photograph, and kill terrorists with little or no collateral damage. Viewed as the next generation of flying weapons, the Bionic Hornet would carry out the work of the much larger drone aircraft, which the United States has used in Afghanistan and Iraq for similar missions.

When Israel first publicly acknowledged its Bionic Hornet research in 2006, Shimon Peres, Israel’s then deputy prime minister, said nanotechnology allowed scientists to “find creative solutions to problems the army has been unable to address.”

Playing Catch-Up With Nanotech
There is a long list of reasons why government officials in the United States and abroad have been slow to establish nanotechnology governance frameworks. Some of those reasons are political, others are due to the complexity of the technology, and still others due to the level of uncertainty that characterizes nanotechnology.

U.S. and international laws and regulatory tools have been designed to function on the basis of scientific certainty. With nanotechnology, regulators must act without definitive proof of nanotech’s safety—or of whether it’s a new chemical or a slightly reconfigured version of a known material. With the pace of invention and discoveries, there has been little time to eliminate that ambiguity.

“The speed with which we go from innovative laboratory to market has been so reduced in the last 15 years that we don’t have time to get certainty about the technology and about the right regulation for that technology,” says David Azoulay, managing attorney at the Geneva office of the Center for International Environmental Law, an advocacy and legal group that works on global legal issues.

Periodic announcements about the toxicity of certain nanomaterials have given direction and energy to critics who believe nanotechnology needs to be governed by a stern and watchful hand. (Research by the National Institute for Occupational Safety and Health, an agency under the Centers for Disease Control and Prevention, show that carbon nanotubes share some similar properties with asbestos fibers.) Already, emerging evidence is bearing out advocacy group concerns about the toxicity of manufactured nanoparticles—zinc, zinc oxide, silver, and titanium dioxide—that are in widespread commercial use in sunscreens and antibacterial products.

“Do we know enough about toxicity mechanisms to know whether something is dangerous or not today?” asks Azoulay. “The industry may feel something is not dangerous, but they cannot know for certain at this stage. Knowing that research is currently ongoing, and that there are efforts to expand the knowledge base for these materials, is not very reassuring for products that are on the market because there are so many unknowns and because the question of risks is far from being settled.”

The United States has a long history of watching new technologies—whether it’s the Internet or genetically modified organisms—speed out of the laboratory or off the assembly line before the government grasps their implications. Experts believe the same is true of today’s emerging technologies such as nanotech, synthetic biology, and geoenergineering, which are accelerating from lab to market much faster than earlier generations. Meanwhile, lumbering government institutions are falling even farther behind in developing mechanisms and regimes to govern these new technologies.

Challenges of Regulation
Many regulatory hurdles come from the complexity of the science and the federal regulatory landscape. For example, the U.S. Environmental Protection Agency (EPA) regulates nanotechnology through the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). While carbon nanotube applications are governed by the TSCA, antimicrobial products containing nanosilver would be regulated under FIFRA. The same complexity can be found at the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA).

The diversity within nanotechnology presents barriers to regulation as well. Take labeling, the bête noire of the industry. When should a product be labeled as containing nanotechnology? The answer seems obvious if the base materials are nanoparticles, but what happens if the base elements were created using nanotechnology? Not so obvious now since there isn’t really any nanotechnology in the product. And which company along the product chain is responsible for the labeling? For example, some pesticides have components that have come through several manufacturers before they land in a consumer product. Where does the responsibility fall to label—on the original producer or the downstream manufacturer?

Some also believe that what is needed is a hierarchy of risks to set priorities for testing and monitoring. If some nanotubes have the qualities of asbestos, then the government should prioritize its efforts there first and then move to other nanomaterials as needed.

“The issue of whether you’ve got certain kinds of nanomaterials bound up in various products and components is different than using applications where there is the possibility of direct human exposure and putting it into the blood stream,” says Leslie Carothers, president of the Environmental Law Institute (ELI), an independent education and research center based in Washington, D.C.

Finally, concerns about the economic impact of regulation cannot be dismissed as industry-whining. New technologies are the engine that drives the economy, and overly aggressive regulations could detour the emerging field.

“Regulation definitely has an effect on startups as far as trying to generate interest and generate money to finance their research and development,” says Donald Featherstone, a director at Sterne, Kessler, Goldstein & Fox who specializes in emerging technology patents. “To the extent that a whole layer of regulation is placed on top of them so they can’t do their research, then they won’t be able to get traction as a company.”

Monitoring Diabetes Through Color
Nanotechnology is advancing the production of new devices to assist diabetics in precisely monitoring their glucose levels, without all the painful and messy poking. Since monitoring plays an important role in controlling blood sugar levels, researchers have been looking for a way to simplify the process.

Scientists in Canada have developed special disposable contact lenses that change color as a diabetic’s blood sugar levels fluctuate. Reacting with glucose in tears, the lenses change tint in response to spikes and drops in blood sugar.

Meanwhile, research teams in the United States are developing several types of nano “tattoos” to gauge blood sugar levels. Each process would embed temporary nano ink into the skin, and the material would fluoresce based on glucose levels. Still in the early stages of development, these tattoo systems would require an external device to appraise and interpret the fluorescence.

States Take Action
Without public confidence in nanotechnology and the laws regulating its use, even applications that are socially useful will be viewed as suspect. While some in corporate America eschew government regulation, most nanotech insiders believe an effective regulatory framework is the road to public confidence and to the marketplace.

“My mantra has been with all constituencies that . . . we need to ensure that the governance structures are there to address any potential risk and to provide the comfort that these technologies do have value and their value exceeds the potential risk,” says Bergeson.

In a rather confused way, government officials have constructed some governance mechanisms for nanotechnology in the last decade. Since 2005, the EPA alone has received and reviewed more than 100 new chemical notices for nanoscale materials, including carbon nanotubes, to control and limit exposures to those chemicals. But early efforts have resulted in a piecemeal approach, say interest groups, and the science of nanotechnology is only now yielding effective tools to measure its impact on humans and the environment.

The quickest route to constructive oversight may be through voluntary regulations, some say. A report released in November 2010 by the PEN encourages voluntary initiatives as a beginning strategy. “Issues like nanotechnology require more creative and innovative solutions than did many of the problems we have had to deal with in the past,” said Dr. Daniel Fiorino, author of the report and director of the Center for Environmental Policy at American University, on the release of the report. “Voluntary initiatives, partnerships, and collaboration may be used as part of a larger strategy. They may complement, help prepare the ground for, and in some cases be used independently of a more traditional regulatory approach.”

The report, “Voluntary Initiatives, Regulation, and Nanotechnology Oversight: Charting a Path,” cites as example the voluntary initiative launched in 2007 by the EDF and DuPont. The Nano Risk Framework is an all-inclusive and flexible system to address the potential risks of nanoscale materials. It creates a process for the conscientious development of nanoscale materials and a tool to share key information with stakeholders.

“Investors in these companies want their companies to be EHS compliant and have viewed voluntary compliance as part of that,” says Foley & Lardner’s Rutt. “Any well-run company has EHS as part of its business plan and its due diligence, and it’s aware of the risks of EHS issues. It understands that government regulations are part of the business process, and [it knows] regulation instills consumers with the confidence to use nanomaterials.”

But many states are not convinced, especially after watching an unenthusiastic Bush administration postpone mandatory compliance in favor of voluntary efforts. In response, states adopted their own rules to evaluate risk and regulate the handling and use of nanotechnology. A number of states—California, Massachusetts, Pennsylvania, South Carolina, and Washington state—have taken steps to identify nanoparticles as emerging chemicals or contaminants of concern, and are gathering vital information about nanomaterials and requiring product registries.

Not surprisingly, the state of California is out front. Both its Office of Environmental Health Hazard Assessment and its Department of Toxic Substances Control (DTSC) are developing nano-specific regulations. In 2009 it conducted a data call-in for carbon nanotubes to collect information from manufacturers; it is planning additional data call-ins on metal oxides and other nanoscale materials. In addition, California’s Draft Regulation for Safer Consumer Products specifically identifies nanomaterials and establishes nano-related definitions.

“All these efforts, state and local, are driven by the feeling that the EPA wasn’t doing enough, fast enough,” says Monica, the nanotech expert at Porter Wright. “Really, the opposite is true now. With the change in administrations, there’s been a renewed emphasis at the EPA on issuing regulations. The perceived lack of aggressive effort created these state and local initiatives that are unfortunate in my view. We’re going to end up with 20 or 30 different state approaches to nanotechnology, and companies cannot operate that way.”

While the industry favors a national approach, the EPA recognizes the usefulness of some state action. “National standards are better to make industry compliance simpler and more straightforward, but there is value in states identifying issues, gathering information, and developing other rules which can support development of national standards,” according to a written statement from the EPA. “Under the pesticide law, states may regulate pesticides more stringently than EPA provided that they do not impose any requirements for labeling or packaging in addition to or different from those required by the agency. EPA is actively collaborating with California in sharing information about nanomaterials in pesticides.”

Closer Federal Scrutiny
Under President Obama, the EPA has jumpstarted its efforts. In the last year, the agency used TSCA to develop a reporting rule to gather information on nanoscale materials in the marketplace and a testing rule to require testing of certain nanoscale materials already in commerce. It also developed a Significant New Use Rule to require reporting of new nanoscale materials based on chemicals already on the TSCA Inventory. These are in various stages of the rulemaking process, but they represent the agency’s more vigorous approach to nanotech.

Additionally, the EPA’s Office of Pesticide Programs (OPP) has identified several registered pesticides that contain nanomaterials, and is considering how it can identify other currently registered pesticides the EPA might have approved without knowing of the presence of nanoscale materials. The OPP also is drafting data call-ins for information about existing products known to contain nanoscale materials. In 2010 the OPP issued a draft decision on the registration of nanosilver as an antimicrobial and preservative additive used to treat fibers, plastics, polymers, and ceramics.

The industry is chafing at these new EPA regulations, although there is a general recognition that the EPA would likely have to act at some point. Bergeson calls some government proposals “well-intentioned but misguided” when they seek to equate nanomaterials with chemical contaminants or suggest nanotechnology always leads to adverse health effects. She says the industry will fight those efforts.

While the FDA has been slower to jump into the nanotech regulatory stew, mostly because it regulates products and not processes or base chemicals, it has taken steps to conduct research into nanoscale materials and seek information about their use in products. Most recently, in September 2010, the FDA held workshop on nanotechnology and medical devices.

The agency is also working with its counterparts in other countries through the International Cooperation on Cosmetic Regulation (ICCR) on a number of initiatives, including the Joint Ad Hoc Working Group on Nanotechnology’s July 2010 report on determining whether materials used in cosmetics should be considered nanomaterials and how best to monitor them.

In late October, the USDA’s National Organic Standards Board (NOSB) unanimously recommended that the USDA National Organic Program (NOP) prohibit the inclusion of engineered nanomaterials in certified organic products. The NOSB also approved a definition of engineered materials as substances “deliberately designed, engineered and produced by human activity to be in the nanoscale range,” approximately 1–300 nm, with very specific properties or compositions (e.g., shape, surface properties, or chemistry).

If the nanotech sector is feeling beleaguered, its consolation is its early successes. In 2007 the EPA declared nanotech forms of existing chemicals as existing rather than new chemicals, ensuring the materials would not fall under the TSCA and would not have to be reviewed by the EPA before entering the market. Another victory was the EPA’s agreement with industry officials to adopt a voluntary reporting mechanism for nanomaterials, which had only lackluster compliance and the records were sealed due to company claims of confidentiality.

Chemical industry officials also successfully delayed consideration of a TSCA reform proposal in Congress in 2010. It would have likely included provisions to regulate nanotechnology. With the new Republican-controlled U.S. House of Representatives, it is unlikely there will be any movement on TSCA or nanotechnology regulations in the next two years.

Yet nobody is interested in delaying the inevitable, especially if there are substantial consequences to a delay, such as those that befell genetically modified (GM) food in the 1990s. There again a promising new technology, with the potential to revolutionize food production, hit a wall of public skepticism when it looked like the GM industry failed to openly discuss GM safety concerns. Many argue that the GM movement has yet to recover from that near-fatal misstep.

Cloaking Invisibility
When Harry Potter donned his invisibility cloak to sneak out of Hogwarts, the mere idea of invisibility seemed like what it was—a magical fantasy. But even invisibility cloaks may be possible with nanotechnology.

Researchers are assembling tiny arrays of metamaterials that deflect and bend light, ultimately making a molecule-sized object invisible. This process, known as transformation optics, is possible because these new materials capture rays of visible light and reroute them around the object. The success of this process has been limited to a fraction of the visible light spectrum.

While invisibility is a nice side benefit, transformation optics research is focused on the more “ordinary” discoveries, including developing microscopes powerful enough to see things as small as DNA, more proficient solar collectors, and computers that use light instead of electronic signals to process information.

A Global View
Despite its diminutive scale, nanotechnology is having a global impact. Government officials and public health and environmental advocates have collaborated across national borders to seek an international agreement that would provide some consistency in defining and regulating nanotechnology. When the marketplace is the world, no single nation’s laws or standards will be comprehensive enough to address a technology of this reach, especially when there are such diverse national thresholds for proliferating new technologies.

International organizations such as the Organisation for Economic Co-operation and Development and the International Organization for Standardization are leading efforts to develop strict governance mechanisms that would ensure the safety of nanomaterials. Under consideration are a series of rules to establish a legal definition of nanomaterials, require mandatory reporting of nanoparticles when they are in a product or used to manufacture a product, and enforce compulsory registration and traceability of nanomaterials. Most importantly, advocates are looking for a mandate to require manufacturers to provide scientific evidence that nanomaterials are not hazardous through an open testing process.

If there’s a new energy behind regulation in the EU, it may be because the pace of product releases is quickening there. In October, the European Consumer Voice in Standardisation and the European Consumers’ Organisation released their 2010 inventory of consumer products in the EU containing nanomaterials. The 2010 inventory listed 475 products containing nanomaterials, a tripling of the 151 products on the list in 2009.

The European Commission (EC) floated a definition for nanomaterials in late October, and then asked industry stakeholders to comment on it. Once the EC writes its final definition, it will be used to guide EU policy and legislative processes. In its definition, the EC recognized both size and surface area, adopting the traditional dimensional floor of 1 nm and ceiling of 100 nm.

The EU and the United States are not the only international powers taking action on nanotechnology. A report released in 2009 by the School of Public Policy and Administration at Carleton University in Canada showed how five top jurisdictions— Australia, Canada, EU, the United Kingdom, and the United States—are addressing nanotechnology-based products in the marketplace. The report found that the entities were moving more swiftly to regulate nanotech, following parallel paths and adhering to comparable guiding principles in establishing policy and regulations.

But U.S. observers urge caution in looking for a coordinated international solution. “We cannot reinvent the wheel all over the world on things like testing and defining what nanotechnology is,” says Mark Greenwood, a partner at Ropes & Gray where he focuses on emerging chemicals and technologies. Greenwood, however, believes that an international definition would be helpful. “The one thing you do have to be careful about is expecting international processes to be efficient. They’re not. They’re slow- moving. It’s hard enough to do within a country and even harder internationally.”

‘Smart Underwear’
The most refreshing aspect of nanotechnology is how it can turn the ordinary into the extraordinary. Take the latest in intelligent underwear. Engineers at the University of California, San Diego have created chemical-sensing underwear that could be invaluable in monitoring patients at home or soldiers on the battlefield.

The waistband of this special underwear has chemical-sensing electrodes that are printed on the cotton and provide a clean, simple approach to monitoring human sweat secretions. Even after repeated stretching and folding, the underwear and its sensors survive the workout—a must for a war zone. The U.S. military is intrigued enough by the science to fund some of the research.

Once a biosensor detects a problem, it could direct the release of predetermined drugs to relieve pain or treat an injury, all of which would be carefully calibrated to fit the person wearing the underwear. Of course, no word on whether researchers have found a way to keep the underwear perpetually clean.

How Much of a Nanotech Future?
While industrial revolutions often take time—information technology took some 50 years to mature from vacuum tube computers to the Web—nanotechnology is moving at a much faster clip. Since it crosses many sectors, it has the advantage of an army of scientists advancing the research both individually and in a coordinated fashion. It is a formula that nearly guarantees frequent breakthroughs and jolting technological jumps.

Government is trying to keep pace. The National Nanotechnology Initiative (NNI), launched during the Clinton administration to push nanotech development and policy, is made up of 25 participating federal agencies and has invested $12 billion in nanotech research and development over the last decade. It will be spending another $1.8 billion in fiscal year 2011, if approved. Meanwhile, hundreds of millions of dollars more are spent annually through the EPA, FDA, USDA, and a host of other agencies and departments to research, monitor, and regulate nanotechnology. Almost everyone agrees that the EHS research has been miniscule compared to research dollars earmarked for commercialization purposes.

“No doubt, the industry is moving forward. The federal government has a huge investment in trying to accelerate this technology because it has so many positive applications,” says Carothers of ELI. “The criticism for years has been that the portion of resources devoted to figuring out the risk of this material has been a very small part of the scientific enterprise. People have been trying to change that, and I think we’ve reached that point where it’s happening.”

The NanoBusiness Alliance, an industry trade association dedicated to commercializing nanotechnology, has lobbied Congress to approve the NNI Amendments Act of 2009, which would require NNI’s federal agency partners to develop plans for EHS research while refocusing on commercializing nanotech to boost the still sputtering economy.

Despite these efforts, Lux Research, a research and advisory firm specializing in emerging technologies, says the United States’ domination of funding and patents is slowly falling behind in its ability to commercialize technologies for economic advantage. Today, Germany, Japan, and South Korea are poised to transition nanotech from the lab to the marketplace more quickly than the United States.

Looming in the distance is also the threat of so-called nanotorts. While no lawsuit has been filed at this point, it’s not for a lack of effort. Attorneys in the field are ambitiously discussing the opportunities, with conferences, white papers, and blawgs dedicated to the subject. With so much uncertainty surrounding products that have already entered the marketplace, it makes litigation sense to keep tabs on potential health and environmental threats.

The lawsuits will come, but success in court may be elusive, some say. “The ability of somebody to actually win a lawsuit based on harm from nanomaterial is going to be difficult,” says EDF’s Denison. “The burden of proof is going to be very high, and having the tools to assess any adverse health effects is going to be even harder.”

Looking ahead, the success of U.S. nanotech may ultimately be dependent on the industry’s ability to efficiently collaborate with government regulators.

“The one thing that’s a great mystery if you’re sitting in the government is what’s coming down the pike,” says Ropes & Gray’s Greenwood, who worked at the EPA for more than 16 years. “If you hear the scientists tell you nanotechnology is going to overtake all parts of industry in the next five to 10 years, it sounds pretty big. The question is, what’s really going to happen and where do we focus next? Only once you know where to focus can you start looking at testing and risk. Only then will you be able to answer what’s dangerous and what’s good enough, what pushes us forward and what takes us back.”

Feynman’s 1959 lecture cleverly divined a nano future and may offer some clues into regulating the small science. “The principles of physics, as far as I can see, do not speak against the possibility of maneuvering things atom by atom,” he said. “It is not an attempt to violate any laws; it is something, in principle, that can be done; but in practice, it has not been done because we are too big.”

Going forward, the challenge then for government at all levels, no matter the technological complexity or speed of change, will be to guide the biggest of institutions in service to and in oversight of the smallest particles known to science.

Sarah Kellogg is a freelance writer in Washington, D.C. She wrote last about the U.S. Supreme Court’s Citizens United decision in the October issue of Washington Lawyer.