New laws needed for nanotech safety?

WASHINGTON--The risks posed by nanomaterials remain largely unknown, but now is the time for the U.S. government to begin drafting regulations addressing the tiny particles, a former Environmental Protection Agency official said.

Source: (click for PDF), J. Clarence Davies, who served as an EPA assistant administrator in President George H.W. Bush's administration, suggested that new laws tailored to such products are the surest way to protect health and environmental safety, boost consumer confidence and allow the young industry to flourish.

Insufficient government oversight could hinder consumer confidence and lead to a "public rejection of the technology," Davies said at a press conference here on Wednesday.

Davies' report, called "Managing the Effects of Nanotechnology," was produced by Project on Emerging Nanotechnologies, for which he is now a senior adviser. The nanotech project runs under the auspices of the Woodrow Wilson International Center for Scholars, a nonpartisan research group established by Congress as part of the Smithsonian Institution.

Nanotechnology involves work with chemicals at an unimaginably small scale, yielding substances that measure between one and 100 nanometers. (For comparison's sake, a human hair measures about 100,000 nanometers in width.)

Scientists in recent years have been exploring ways to use the technology to concoct fumeless paint, detect cancer and even cure smelly feet, among other things. The National Science Foundation estimates that by 2015, the global marketplace for items that use the technology will reach $1 trillion and the industry will employ 2 million workers.
But as progress zooms ahead, a number of industry groups and the U.S. government have acknowledged that not enough is known about the potential health risks carried by the tiny particles.

Existing laws are inadequate to address such risks because they make "a lot of assumptions that don't apply to nanotechnology," Davies said. One example, he said, lies in the Toxic Substances Control Act, passed by Congress in 1976 with the intention of preventing the marketing of potentially harmful new chemicals without proper oversight. Because that law bases some of its requirements on the chemicals' weight and volume, he said, it becomes impractical where minute nanomaterials are concerned.

In the short run, it may be possible to adapt laws such as the Toxic Substances Control Act, the Occupational Safety and Health Act, and the Food, Drug, and Cosmetic Act--all of which regulate potentially risky materials--to nanotechnology. But "patching up the existing framework is going to be a much more difficult job than starting over again," Davies said.

Extent of risk
No research has been able to conclude that, without a doubt, nanomaterials cause health risks. Some researchers, after experimenting on mice, have speculated that build-up of nanoparticles in the human body through inhalation or other exposure could lead to health problems. Many researchers believe the greatest risk is for people who will work with nanomaterials, rather than the general public who use the products.

Businesses are wary that unfounded fears could lead U.S. politicians and regulators to embrace the so-called "precautionary principle," or the idea that new technologies should be banned or regulated unless they can be proven safe.

The U.S. Chamber of Commerce has said (click for PDF) that production of nanoparticles is limited and that existing laws are sufficient to protect the public.

But Davies suggests in his report a broad framework for a law governing nanotechnology products. First, the government agency in charge, likely the EPA, would need to establish strict testing and reporting requirements, preferably aligned with international standards. All nanomaterial makers would have to submit a "sustainability plan" detailing any risks with their products and what makes those risks "acceptable." Finally, the government agency would review that plan and rule on whether the product in question could go to market.

David Rejeski, director of the Project on Emerging Nanotechnologies, was quick to note that the document "is not an advocacy piece for new legislation." He did add, though, that in the coming decades, "the idea of a new law is not a radical proposition."

Congress has already begun exploring the issue of nanotechnology safety. In November, the U.S. House of Representatives Science Committee convened an exploratory hearing at which Committee Chairman Sherwood Boehlert, a New York Republican, said further research on the topic should be an immediate priority. The Environmental Protection Agency, for its part, has not yet had a chance to review the report, Susan Hazen, the acting assistant administrator for the agency's Office of Prevention, Pesticides and Toxic Substances, said in a statement sent to CNET News.com.

Hazen said the EPA is "moving expeditiously, but cautiously, on this emerging issue." She added that existing laws provide the agency with "a strong framework for ensuring that industrial nanoscale materials are safely manufactured and used." The agency is working with a wide range of interested parties to ensure that the technology is developed in a responsible way and that it produces benefits, she said.

The National Nanotechnology Coordination Office, which oversees the work of about a dozen federal agencies on the topic, said it, too, was unconvinced of the need for new regulations, adding that "not enough is known to make wise and informed decisions about regulatory needs at this time."