Too Small To Grasp

The risky business of nanotechnology is growing faster than government can keep up.

What do scratch-resistant paints, clothes that never stain and longer-lasting tennis balls have in common with sun-blocking lotions, car bumpers and stadium JumboTrons? They are but a handful of products-among hundreds on the market-that claim to benefit from the unique properties of matter controlled at the nanoscale. That is as small as one-billionth of a meter, or one-100,000th the width of a human hair. About 60 percent of those products are made in the United States, where the government is under increasing pressure to regulate their manufacture and sale and to fund more research on the risks of exposure to them.

Nanotechnology is a convergence of emerging capabilities from the physical, chemical and biological sciences that offers opportunities to exploit the chemical properties of single atoms and molecules. It is the reengineering of familiar substances to create materials with novel properties and functions. It is as revolutionary a way of making things as the assembly line was at the turn of the 20th century. "It's really a broad, enabling technology that's going to affect a lot of different industries," says analyst Michael Holman of Lux Research Inc., a New York consulting firm that specializes in nanotechnology commercialization.

It's also a double-edged sword. "The whole reason we're in it and people are excited about it is that we can create novel properties never seen before. That's going to make some people exceedingly rich and we're going to have some incredible benefits for society," says David Rejeski, director of the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars in Washington. "But it's planned disruption. It's not a technology you want to be smug about."

What may have been the world's first health-related recall of a nano-engineered product happened in Germany in March. An aerosol bathroom cleaner called Magic Nano was pulled from store shelves after 97 users suffered respiratory distress. Six were hospitalized for treatment of fluid on the lungs.

The German Federal Institute for Risk Assessment said it couldn't determine whether nanoparticles in the very fine spray or chemicals in the cleaner caused the illnesses because it couldn't get a complete list of ingredients from product distributors. In an April 12 statement, institute President Andreas Hensel said the incident "demonstrated that the introduction of new technologies in consumer products must be coupled with an assessment of the possible risks arising from their use," and held the science community responsible for spelling out the dangers to consumers in the future.

"Clearly, there is reason for concern," says Holman, who was authoring a new study on the environmental, health and safety (EHS) implications of nanotechnology in May. "Almost everyone in industry we talk to is very much aware of EHS concerns and very much doing everything they can to address them. But because it is a new technology, there isn't always as much information as you would like." Holman and Rejeski are on the same side in the nanotechnology debate, which ignited after the European recall. "Something is going right-products are being commercialized-but clearly, things can go wrong if we fail to provide the adequate oversight," Rejeski said in testimony before the Senate Commerce, Science and Transportation Committee on May 4. Shockingly little is known about the possible health and environmental implications of nanotechnology, and the federal government is only beginning to develop regulatory approaches to deal with the science and its applications.

Nanotechnology has its naysayers. Among the most notable is Great Britain's Prince Charles. But windows that clean themselves, roof shingles that soak up affordable solar energy and medical devices that cruise the bloodstream to keep us healthy from the inside are ideas the majority of the public generally finds appealing. Still, more than half of Americans do not know that nanotechnology promises to enable futuristic cures and conveniences like these nor do they even know what nanotechnology is, according to a 2004 study funded by the National Science Foundation and conducted by the Wilson Center Project on Emerging Nanotechnologies. "Most people were stunned by the fact that government is spending billions of dollars a year on this technology and they've never heard about it," says Rejeski. For a second study in 2005, also funded by NSF, the project fed facts about nanotechnology to focus groups. Ninety-five percent of the participants doubted that government and industry can manage any risks effectively, but 76 percent were against banning new products until the risks are studied further.

A Matter of Control

• The world's smallest car. It's slightly wider than a strand of DNA. Built by scientists at Rice University in Houston, it has an organic chemical chassis with pivoting suspension, freely rotating axles and four wheels of pure carbon.
• A battery that recharges an electric vehicle in the time it takes to fill a gas tank. Developed by Altair Nano-technologies Inc. of Reno, Nev., the battery has a range of 200 miles.
• Cultured diamonds. Apollo Diamond Inc. of Boston claims its stones are larger and purer than the finest taken from the earth-good not only as gems, but also offering promise as a cost-effective semiconductor.
• The highest density electronically addressable computer memory reported to date. The demonstration circuit developed by HP Labs in Palo Alto is a 64-bit memory using molecules as switches. More than a thousand of them could fit on the end of a single strand of hair.
• Combat uniforms that sense danger. The Army-funded Institute for Soldier Nanotechnologies at Massachusetts Institute of Technology is developing an explosives-sniffing, laser-detecting fabric weave.
• Tumor terminators. Back in Houston, Nanospectra Biosciences Inc. anticipates human trials this year of a medical device that can be injected into the bloodstream to seek out and destroy tumors. It's not a drug; it's a nanoshell-a teeny-tiny glass bead covered with gold. Shine a laser on a bunch of these beads from the outside and they heat up, melting the deadly mass inside.

There do seem to be risks. Scientists are learning that some things designed with nanotechnology to have unique functions also may have unique health effects. A few early experiments in the field have produced some curious, if not unpleasant, surprises. In November, the House Science Committee heard testimony about rats that developed unusual cell masses and tissue scarring after their lungs were exposed to a type of carbon nanoparticle; about 20 different nano-materials that damaged the liver, spleen, kidney and other organs in tests of their ability to target and kill tumor cells; and how it appears that inhaled nanomaterials can migrate from the lungs into the bloodstream and find their way to our brains. These are short-term effects on lab animals. Whether humans would suffer the same effects isn't clear. And to date, there have been no investigations of long-term effects such as cancer and birth defects. The situation begs a question: What might happen when discarded products incorporating nanotechnology start decomposing in landfills?

Until recently the domain of just a few physicists and chemists, nanotechnology suddenly is a worldwide scientific and industrial enterprise. The Project on Emerging Nanotechnologies issued the first public, online inventory of "nano" consumer products in March. At least 230 items in 15 countries are on the list, which the Wilson Center says is far from comprehensive. In 2004, according to Lux Research, $13 billion worth of products incorporating nanotechnology were available for purchase. By 2014, the supply will total $2.6 trillion. It will account for one-sixth of global manufacturing output and involve 10 million jobs, or 11 percent of the workforce. Public and private sector investments in nanotechnology amount to about $9 billion a year. About a third of that is invested in the United States, and a third of U.S. investment is by the government. Federal agencies spent more than $4 billion on nano R&D between 2001 and 2005. They will spend $1.1 billion this year and plan to spend $1.3 billion in 2007.

With the market poised to explode, E. Clayton Teague, director of the National Nanotechnology Coordination Office, is getting an earful. From the public: "It runs the gamut," he says, "from the real, genuine concerns about safety for the environment and public health [to] the long-ranging ones of superhumans and little machines taking over the world. We engage at all levels." From public outreach managers in two technical endeavors-nuclear power and bioengineered food-that are beleaguered by negative public opinion: "They've warned us that there's a lot of ways that things can go wrong, so we are looking at this very carefully to make sure we do it appropriately." He's also hearing from industrialists, environmentalists, investors, insurers, scientists, politicians and experts such as Holman and Rejeski. Most agree: Commercialization of the technology is outpacing the development of sound policies to assess and guard against adverse consequences. "We've managed this as though it was a large science project for years now, and the dynamics are changing," says Rejeski. "People radically underestimate the speed at which innovation is taking place. It's not a science project any more. It is a much bigger governance project."

Federal research and development agencies have been collaborating on nano-technology since at least 1997, three years before the Clinton administration kicked off the National Nanotechnology Initiative. The 21st Century Nanotechnology Research and Development Act, signed by President Bush in December 2003, culminated a ground-up effort by the Defense Department, the National Institutes of Health and other agencies. The act identified nanotechnology as one of the administration's top research and development priorities, authorizing funding for four years through 2009 and putting into law the programs and activities supported by the initiative.

As of May, 25 agencies had joined the initiative. Thirteen have research and development budgets dedicated to the use of nanotechnology. The other 12 participate because nanotechnology is important to their missions or their regulatory responsibilities. The two newest participants are the Labor and Education departments. They joined earlier this year to help ensure that the nation's workforce is prepared to deal with nanotechnology.

Getting It Right

This year, initiative agencies will spend less than $40 million on projects whose primary purpose is to understand and address the environmental, health and safety implications of nanotechnology. The funding is concentrated within the National Science Foundation, the National Institute for Occupational Safety and Health in the Centers for Disease Control and Prevention, and in the National Institutes of Health. The Environmental Protection Agency is a minor player. The funding represents less than 4 percent of the agencies' combined annual budgets for nano R&D-an amount Rep. Bart Gordon, D-Tenn., the ranking member of the House Science Committee, decries as "anemic." Industrialists and environmentalists together are recommending a budget two to four times larger than that for toxicology studies and other scientific analyses of possible risks. They say the only way for commercialization to proceed rapidly while ensuring that the necessary studies have been performed is for the government to fund them.

Teague says the $40 million figure is deceiving because it only covers research on risks as strictly defined by the Office of Management and Budget. The development of tools that are needed to measure and characterize nanomaterials in toxicity and exposure studies is funded elsewhere as is work on basic interactions between nanoscale materials and biological systems, which is performed in cancer research. "If you take some of the parts [that] are highly relevant to understanding the implications, the number would probably be far in excess of $100 million," he says. While acknowledging that many questions remain unanswered and more research is needed, Teague insists that the administration's 2007 budget request is adequate.

He backs up his argument with the initiative's first report card from the President's Council of Advisors on Science and Technology. The initiative got marks for advancing basic knowledge, promoting nanotechnology transfer and taking steps to address societal concerns. The council's May 2005 report, "The National Nanotechnology Initiative at Five Years: Assessment and Recommendations of the National Nano-technology Advisory Panel," also concluded that U.S. funding in the field is money well spent. But is it money well managed?

Rejeski has a plaque that reads, "U.S. Department of Unintended Consequences: We fail so you don't have to." He had it made up as a joke, but when he shows it off at speaking engagements, it gets his message across: "It doesn't matter whether a hurricane hits New Orleans or there's a terrorist attack. You want a bunch of people who have thought through what could go wrong, and played that over again and again, and failed, and figured out what to do to reduce the potential for failure." He feels the same way about nanotechnology, but says he sees no evidence that the government is anti-cipating and rehearsing misuse or accident scenarios. He believes that traditional stovepiping and inadequate resources are keeping the government from understanding and managing nanotechnology's big unknowns as efficiently or effectively as it could.

Many industries have sturdy risk-analysis frameworks, built on decades of lessons learned in coping with new materials. But Holman says they need two things from government before they can begin applying those frameworks to nano-technology: a solid toxicological database and clear and unambiguous statements from agencies such as EPA and the Consumer Product Safety Commission about how they plan to approach regulation. Holman points to EPA as a telling case because it is relying on a working group to suggest voluntary guidelines and the group has been slow to reach decisions.

As if to jump-start the process, on May 16, the Washington-based International Center for Technology Assessment and a coalition of consumer, health and environmental groups formally petitioned the Food and Drug Administration to address risks associated with untested and un-labeled nanomaterials in consumer products. The first-of-its-kind legal action was coordinated with the release of Washington-based Friends of the Earth's exposé detailing the unregulated use of nanomaterials in 116 sunscreens, cosmetics and personal care products. The filing targets sunscreens but demands that FDA clarify its stance on all products within its purview that are made with nanotechnology.

"I think everybody agrees that the regulatory framework is going to have to evolve in some way," says Holman. The Wilson Center project is backing the idea of starting over with a clean slate. Its January report, "Managing the Effects of Nanotechnology," outlines three major weaknesses in the federal regulatory structure: gaps in statutory authority, inadequate resources, and a poor fit between some of the regulatory programs and the characteristics of the science. The statutory gaps are obvious when it comes to cosmetics and consumer products, two of the most common uses of nanomaterials. In both cases, the report says, there is a large potential for human exposure but no authority to require health and safety protections. In addition to the statutory gaps, the report details major resource problems that could hinder government action. It makes an example of CPSC, whose staff of just over 400 is half what it was in 1980.

The report was prepared by J. Clarence Davies, one of the nation's foremost authorities on environmental research and policy. Davies co-authored the plan that created EPA in 1970 and served an assistant administrator at the agency during the first Bush administration. He wrote the original version of the Toxic Substances Control Act. In February testimony to the Senate Commerce, Science and Transportation Committee, Davies suggested that lawmakers start thinking about a new law because the existing framework cannot protect the public or offer a predictable marketplace. "No amount of coordination or patching will fix this problem," he said.