Study: Nano-specific laws needed

The report, released here last week by the Woodrow Wilson International Center for Scholars, acknowledged that little is known about the possible detrimental effects of nanotechnology. Author J. Clarence Davies, former assistant administrator of the Environmental Protection Agency, stressed that a new regulatory regime is needed before nanodevices can be released into the environment.

"We know enough to recognize that there needs to be some type of governmental oversight to ensure that public health and safety are not adversely affected," the report states.

Existing U.S. laws like the Toxic Substances Control Act do not provide a basis for addressing new environmental concerns raised by nanotechnology, the study found. A law that specifically addressing those issues "would require manufacturers to submit a sustainability plan which would show that the product will not present an unacceptable risk," it states.

The report, issued by the Wilson Center's Project on Emerging Nanotechnologies, also called for more resources — including research, tax breaks, acquisition programs and regulatory incentives — to manage potential adverse effects.

The study warns that without nano-specific laws, the government would struggle to apply existing regulations that weren't designed for the new technology. The result could be a public backlash, loss of markets and potential financial liabilities, the report says.

The global nanotechnology industry is expected to reach $1 trillion by 2015, according to the National Science Foundation, with the United States investing about $3 billion annually in R&D.

"It is the right time to come up with the right regulatory framework for nanotechnology — a framework that encourages initiative and innovation, while also protecting the public and the environment," said Davies.

The EPA last October approved the manufacture of a new type of carbon nanotube under the "low-release and exposure exemption" of toxic-substances law. This was the first time the agency had approved a new chemical identified as "nano."

While some regulations may work for nanotechnology — for example, the Food and Drug Administration has the authority to review and regulate nanotechnology applications in the areas of drugs and biomedical devices — Davies warned that "most of the existing applicable programs are seriously flawed, lack resources and require new thinking and funding."

Tweak what we have
But a few industry players dispute the need for new laws. Matthew Nordan, vice president of research for Lux Research Inc. (New York), said a better route might be to tweak existing regulations as well as behaviors and practices at existing agencies. "We have the right tools in the kit but probably need to apply those tools differently," he said.

Materials behave differently at the nanoscale, and that is cause for concern about existing regulations tailored toward larger particles, said Nordan. Their application probably needs to be modified and better-coordinated among agencies, he said.

Alan Gotcher, president and chief executive of Altair Nanotechnologies Inc. (Reno, Nev.), criticized the report for treating all nanomaterials as if they were the same. "There are some nanomaterials that we should assume to have a high risk, and we need more data to characterize the risk better," he said.

Gotcher agreed that today's laws are a good starting point given the limited amount of information available on nanotechnology's environmental effects. "There is a wide range of materials, and we shouldn't characterize them as all the same," he said. "They have different properties, and we would expect them to have different risk profiles. We need to look at it more like that."