Barely out of the lab three years ago, nanotechnology–a method used to manipulate materials at the level of individual atoms and molecules–has advanced to the point where there are more than 450 nano-enabled products in today's commercial market and more than 600 nanotechnology-related raw materials available to manufacturers.

“Given the large investments in nanotech research, development and commercialization, many more are sure to follow,” says David Rejeski, director of the Emerging Nanotechnologies Project at the Woodrow Wilson International Center for Scholars, a nonpartisan think tank established by Congress in 1968.

Indeed, the Center estimates that 15 percent of all goods manufactured globally by 2014 will involve nanotechnology. Those numbers, however, are making some people nervous.

“The difficulty is that these products open a wide array of questions concerning the risk to workers, consumers and the environment,” Rejeski says.

Things are moving so quickly that the EPA has been scrambling to catch up with a regulatory agenda. Meanwhile, some environmental and consumer groups have been calling for a complete moratorium on nanotech products until more is known about their impact.

Needless to say, businesses oppose a moratorium, though they understand the need for regulation. Their hope was that the EPA would offer some clues as to what that regulatory regime will look like in its white paper on nanotechnology released in April.

“A lot of businesses were wondering whether and how the EPA is likely to regulate and what to do in the interim about exposure to liability in the production and dissemination of the products,” Rejeski says.

But they were sorely disappointed.

Slow Changes

Nanotechnology is the science of controlling matter by manipulating individual atoms or molecules. It enables manufacturers to change the physical characteristics of a substance. By way of example, opaque substances such as copper become transparent when manipulated at the molecular level; stable materials such as aluminum can become combustible; and solid gold can turn into a liquid at room temperature.

Companies have used nanotechnology to improve everything from sunscreens and cosmetics to tennis rackets and metal-cutting tools.

The problem, though, is that nobody is quite sure what the environmental effects are of this manipulation. A 2006 study raised eyebrows when it demonstrated that exposure to man-made nano-particles was harmful to fish. In addition, some are worried about the potential risk workers face if they inhale nano-sized particles.

“The great unknowns of new products and society's experience with them are why nanotechnology is under a microscope so early in its evolution,” says Michael Pontrelli, a partner at Foley & Lardner.

Because of this concern, the National Science and Technology Council of the Executive Office of the President published a strategic plan in December 2004 that advocated the responsible development of nanotechnology. The EPA Science Council followed by creating a cross-agency group to address the issue, which it did by producing the white paper.

Unfortunately for business, the paper focuses on the scientific research the EPA needs in order to regulate nanotechnology without providing any guidance on the agency's regulatory direction.

“If you're looking for real information on what the EPA is going to do, there's no point reading the paper,” says Scott Walsh, project manager of corporate partnerships at Environmental Defense, a non-profit organization that partners with business, government and individuals in pursuit of solutions to environmental problems. “At most, it makes a vague allusion to the fact that the EPA will be moving very slowly in the direction of modifying existing legislation, rather than in the direction of new laws.”

Dearth of Oversight

Most experts believe the EPA will resort to the Toxic Substances Control Act (TSCA) to regulate nano-materials. But it's questionable whether the EPA can adapt the law to the unique properties and effects of nano-materials.

“Current laws and regulations are set up to deal with chemicals that come in the form of traditional molecules and not with nano-scale substances,” says Christine Peterson, president of the Foresight Nanotech Institute, a California-based think tank.

In any event, the debate over whether new laws are required does little to resolve the regulatory uncertainties pervading the industry today.

“The accelerating pace of nano-discoveries and new products means that time is running short for the establishment of an oversight system,” writes Clarence Davies, senior adviser to the Woodrow Wilson Center's Project for Emerging Technologies, in the May study EPA and Nanotechnology: Oversight for the 21st Century.

Davies' primary recommendation is that the EPA equip TSCA to deal with nano-substances by changing its regulations and convene “a dialogue of stakeholders to formulate the outlines of a next-generation oversight system” appropriate for 21st century technologies.

“With new nanoproducts being commercialized each week,” Davies adds, “we need a system now for considering whether the products pose a risk.”

Still, it's unlikely that the EPA will depart from its slow approach. “In light of the white paper, no broad regulatory initiative for nanotechnology appears likely in the foreseeable future,” Pontrelli says.

The only solution, then, may lie in self-policing. Fortunately, important initiatives are in the works. “Industry is stepping up to the plate,” Pontrelli says.

Self Determination

At the forefront of the self-policing initiative is a partnership between DuPont and Environmental Defense. In 2005 the two agreed to collaborate on a framework for the responsible development, production, use and disposal of nano-scale substances.

“The intent of the framework was to define a systematic and disciplined process that companies could use to identify, manage and reduce the potential risks of nano-scale materials,” Walsh says.

DuPont and Environmental Defense released a draft of a “Nano Risk Framework” in February. The framework consists of six steps for nanotech developers to use as a research advances and new information about substances becomes available. At press time, DuPont and Environmental Defense were planning to launch the final version of the framework at the end of June.

As Rejeski sees it, however, self-policing is not the final solution.

“It's an important development because the government doesn't have enough information to regulate effectively,” he says. “But the EPA is still going to have to figure out how to get up the learning curve very quickly.”