Stricter Nanotechnology Laws Are Urged
Wednesday, January 11, 2006
An independent report being released this morning concludes that current U.S. laws and regulations cannot adequately protect the public against the risks of nanotechnology -- the rapidly growing science of making invisibly small particles and molecular devices.
Unless existing laws are modified or a new one is crafted, the report warns, the immense promise of the field -- predicted to be a trillion-dollar industry by 2015 -- may be short-circuited by either a disaster or an economically damaging crisis of public confidence.
"There is a chance to still do this right and learn from previous mistakes," said study author J. Clarence Davies, an environmental policy analyst who played major roles in the Johnson, Nixon and first Bush administrations and is now with Resources for the Future, a nonpartisan think tank on environmental and energy issues.
"We know from what happened with agricultural biotechnology and nuclear power that if you don't have public support, or at least public tolerance, a field's potential is not going to be realized. For nanotechnology, I don't think existing systems or laws can serve this purpose," said Davies, who researched and wrote the report for the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, a research and policy arm of the Smithsonian Institution.
Several government officials and industry representatives disputed the findings yesterday. Among them was E. Clayton Teague, director of the National Nanotechnology Coordinating Office, which oversees the federal government's approximately $1 billion annual investment in nanotechnology.
"We still have so much to learn," he said. "You get one paper that says it's extremely toxic and harmful, and another that says it's not only not toxic but it's beneficial. All the agencies we talk with . . . have generally said to us that with the information that's currently available, their regulatory authorities should be adequate."
Nanotechnology involves manipulating atoms to make things that are smaller than one one-thousandth the diameter of a human hair. At that size, even conventional materials exhibit unconventional physical and chemical properties, making them valuable for a wide variety of products. Already, nanomaterials are being used in computers, cosmetics, stain-resistant fabrics, sports equipment, paints and medical diagnostic tests. Scientists also hope to use nanomaterials to help clean up polluted sites.
But nanoparticles' peculiar characteristics are potentially hazardous. Animal studies have shown that at least some can cause deadly airway blockages or can migrate from nasal passages into the brain and other organs, where they may cause metabolic problems. Other studies suggest they can trigger environmental damage that would be difficult to reverse once the minuscule particles disperse into soil and water.
The report outlines the range of laws and regulations in place to protect people and the environment from such risks, and finds each one wanting when it comes to nanotechnology.
The Toxic Substances Control Act (TSCA), for example, requires manufacturers to tell the Environmental Protection Agency about new chemicals they want to market and gives the agency the authority to restrict those that pose undue risks.
But under TSCA's "low volume" clause, chemicals made in quantities of 11 tons or less are largely exempt. That may be reasonable for conventional chemicals, the report states. But given the extreme chemical reactivity of nanomaterials -- the very trait that makes them so special -- the mere fact that relatively small quantities are being made is hardly an assurance of safety, it concludes.
Moreover, because most nanomaterials are ordinary chemicals that differ only in their particle size, makers have been avoiding TSCA restrictions by classifying their products as conventional chemicals, even though their tiny size is precisely what makes them different. The EPA, which favors a "voluntary" regulatory regimen for nanotechnology, has not yet decided how to deal with that loophole.
Other laws are weak because they do not require safety studies before products are marketed, Davies said. The Federal Hazardous Substances Act and the provisions of the Food, Drug and Cosmetic Act that deal with cosmetics -- many of which are made with nano-ingredients -- allow the government to respond only after it is clear that people are being harmed.
Moreover, the report notes, the agencies in charge of implementing the nation's protective laws are understaffed. The Occupational Safety and Health Administration has 25 percent fewer employees than it did in 1980, even though it must oversee more workplaces than ever -- including nanotech factories with their uncertain risks -- Davies said. The Consumer Product Safety Commission, which administers the Hazardous Substances Act, today employs 446 people, less than half the number there in 1980.
The Food and Drug Administration yesterday reiterated that existing regulations are "probably adequate for most nanotechnology products."
"We are continuing to learn about the important scientific developments in this area and will evaluate and learn about the benefits this new technology will yield," the agency said in a statement.
David Rejeski, who leads the Woodrow Wilson Center's nanoscience program, warned that nanoscale materials are increasingly being enhanced with biologically active coatings that will only increase their health and environmental risks. He said it would help if companies were required to tell regulators more about what they are up to.
"The behaviors of these substances are going to get very complicated," Rejeski said. "But there hasn't been a big discussion yet. We're data-starved."