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Tiny Particles Pose Major Obstacles
by Randy Barrett
Nanomaterials are being incorporated into commercial products, but the federal government has no idea whether any of the tiny substances are harmful to human health or the environment.
A nanometer is one billionth of a meter, or a substance about 60,000 times smaller than the width of a human hair. With 1,200 new companies developing nano products based on such materials created at the atomic or nuclear levels, federal agencies lack the research data necessary to decide which may need regulating in the first place.
"We don't have the information to make that basic decision," conceded Norris Alderson, director of a federal interagency working group on nanotechnology and environmental health, which convened about 18 months ago.
Gauging The Risks And Benefits
It is still early in the process, said Alderson, who predicted that it could be three to five years or more before the basic science is available. In fact, the government is still trying to figure how to approach the problem. "We're now working on preparing a document that defines from a federal regulatory perspective what is the basic information we don't have," he said.
The situation does not inspire confidence among environmental and health advocates. The Environmental Defense Fund (EDF) feels that the government needs to spend at least $100 million per year on nano research and testing. The National Nanotechnology Coordinating Office (NNCO) now spends about $39 million annually on toxicity and environmental effects research out of its $1 billion budget.
"The risks at issue here are not only those related to health and the environment but also risks to the very success of this promising set of technologies," EDF said in a recent white paper. "If the public is not convinced that nanotechnology and nanomaterials are being developed in a way that identifies and minimizes the risks to human health and the environment, we can be virtually assured of a backlash."
According to a recent study from the Wilson Center for International Scholars, there is strong public support for the potential benefits of nanotechnology, but also a distrust of both the federal government and industry to adequately regulate the materials.
Meanwhile, companies already are using nanomaterials in cosmetics, sunscreen and stain-resistant fabrics, among other areas, including industrial uses. Carbon nano tubes, fullerines and quantum dots are close to market.
"They're putting it in commerce," said David Rejeski, director of the Wilson center. "If the agencies are thinking this is all in the lab, they're wrong."
The interagency working group is well aware of the situation. The goal is to get the primary regulatory agencies -- the Centers for Disease Control and Prevention (CDC), Consumer Product Safety Commission, Environmental Protection Agency, Food and Drug Administration (FDA), and Transportation Department -- to work closely on nanomaterials from the beginning.
"We have most of the relevant research and regulatory agencies [in the working group]," said Clayton Teague, director of the NNCO. "It is very effective."
Under The Federal Microscope
Critics hope he is right because early research on nano exposure to humans is troubling.
According to a study by Gunter Oberdorster, a leading researcher at the University of Rochester in New York, inhaled, nano-sized particles can accumulate in nasal cavities, lungs and brains of rats. There is speculation that the buildup could lead to inflammation, brain damage or disorders of the central nervous system.
"I'm not advocating that we stop using nanotechnology, but I do believe we should continue to look for adverse health effects," Oberdorster said in a statement. Last year, he received a $5.5 million grant from the Defense Department to run a five-year study and develop a model to predict nano-particle toxicity.
The research record is not empty when it comes to the toxicity of ultra-fine particulates, many of which are nano-sized. Most of the work done so far is on combustion particles and their effects on human health.
"There have been ultra-fine particles for years and years," said Mark Hoover, a senior research scientist at the National Institute for Occupation Safety and Health (NIOSH), a division of the CDC. "Now we're dealing with a matter of scale. The use of nanomaterials is ballooning."
NIOSH is one of the primary research agencies responsible for determining if certain nanomaterials are dangerous. It funds university and private laboratory research, and gathers and publishes the data on its Web site. From there, regulatory agencies track the information and decide whether to look closer at a particular material.
The focus on nano toxicology at NIOSH has been increasing over the last two years, Hoover said. In the absence of real federal regulation, he credited industry with being careful so far by limiting employee exposure to the novel compounds. Hoover thinks industry has every reason to be worried about nano safety because it could lose millions of dollars in potential marketability. "If they screw it up, they will really hurt themselves," he said.
Another federal agency leading the research foray is the National Institute of Environmental Health Sciences (NIEHS), a division of the National Institutes of Health. Its findings get cataloged in the National Toxicology Program database, also housed at NIH.
Finding The Right Focus
Industry also is trying to get involved in the data sharing. Last month, the International Council on Nanotechnology at Rice University unveiled a database to help speed the transfer of particulate research among the chemistry, environmental and biomedical fields.
"An informed decision about how to ensure the safety of nanomaterials requires a comprehensive review of where we are and where we've been with prior research," Jack Solomon, chairman of the Chemical Industry Vision 20/20 Technology Partnership, said in a statement.
But researchers and regulators alike are confounded by a simple problem: which nanomaterials to watch. "What will be the commercially viable products?" NIEHS staff scientist Nigel Walker wondered. "They may not be what we think they are."
When it comes to medicines, the research situation is somewhat clearer for the FDA, said Alderson, who is also associate commissioner for science. Because the body breaks drug compounds into nano-sized particles automatically, it already is organized to study their toxicity.
"We don't see a big issue with these products," Alderson said. But nano-based medical devices are another matter entirely. "These we haven't dealt with before."
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