EHS efforts caught in the crosstalk

11/01/2006

Government, researchers and industry disagree over best approaches to environment, health and safety oversight

By Andreas von Bubnoff

With three reports, one Congressional hearing, and the FDA holding a major public meeting on regulating nanotech products, this fall saw a lot of discussion about the safety of nanotechnology. As more nanotech products are entering the market, pressure on governmental agencies to study and regulate their safety is growing rapidly.

And the nanotech products keep coming. The Project on Emerging Nanotechnologies at the Wilson Center updated its inventory of nanotech products in October. It has tracked more than 320 consumer products whose manufacturers claim to be using some form of nanotechnology, said project director David Rejeski. He said a new Japanese directory contains more than 200 nanotech products, 87 of which are cosmetics. Cosmetics are the largest group in both inventories.

“This is a global phenomenon,” Rejeski said. He and others argue that not enough is being done to deal with health and safety concerns, while some in industry and government maintain current efforts are sufficient.

At a September 21 Congressional hearing, the House Science Committee criticized federal agencies for being late to deliver a report on priorities for governmental nanotech safety research. The report was prepared by a working group of the agencies that are part of the National Nanotechnology Initiative, or NNI, the U.S. government program that coordinates nanotech research and development. It was expected to be completed in the spring, but was delivered just in time for the hearing.

Not only was the report late, complained committee members, but it did not contain the expected research priorities. “It doesn’t fully set priorities, never mind assign them,” said Rep. Sherwood Boehlert (R-N.Y.), who chairs the committee. “What essentially we have is a basic inventory.” Rep. Bart Gordon (D-Tenn.) said he was “very disappointed,” and, addressing the report’s authors, called it a “very juvenile piece of work, given the time that you have had to work on this.”

“All of us have other jobs,” said Norris Alderson, associate commissioner for science at the FDA and chair of the interagency working group that prepared the report.

Boehlert also said that governmental safety research is under-funded. The government’s own numbers indicate that it spent almost $40 million between October 2005 and September 2006 on nanotech safety related research. But Andrew Maynard, chief science advisor for the Wilson Center’s Project on Emerging Nanotechnologies, said his analysis found the government spent only about $11 million in 2005. At the hearing, Maynard called for at least $100 million over the next two years for “targeted risk research.”

More safety research was also one of the recommendations of the National Research Council’s triennial assessment of the NNI. The Congressionally mandated report, released on September 25, calls the results of safety studies “inconclusive,” and states that there are too few studies that address the effects of nanomaterials in vitro and in vivo.

But the lack of safety studies is not the only problem. Another challenge is to regulate the safety of nanotech products. The FDA, in charge of the safety of many of the products that use nanotechnology, may lack the tools and the resources to regulate them, according to a report released by the Wilson Center in October. “The key conclusion is that the FDA is not fully prepared to handle what’s coming,” said Michael Taylor, the report’s author, himself a former FDA official and now a professor at the University of Maryland School of Medicine.

For example, he said, the FDA doesn’t have access to company safety data for products such as cosmetics before they enter the market. For now, the agency should at least request voluntary submission of safety data, the report recommends, but ultimately it suggests Congress should give the FDA the legal authority to request the data under certain circumstances.

But while legal tools are important, the FDA is in a budget crisis that is the larger threat to adequate oversight, Taylor said. “You can have all the legal tools in the world,” he said. “Without the resources to apply those tools, the tools don’t mean a great deal.” The FDA’s 2006 budget would have to be 49 percent higher just to do what it was doing in 1996 and to continue the new activities mandated for it since then, Taylor’s report states.

The report appeared just five days before a public meeting the FDA organized on nanotech safety on October 10. At that meeting, Taylor and Rejeski joined more than two dozen experts and stakeholders who spoke before the FDA’s Nanotechnology Task Force to give advice as to whether and how the agency should regulate nanotechnology.

Overall, that advice was mixed. Some speakers, such as representatives of environmental groups, called for safety testing and mandatory labeling of nanotech products, especially ones with little current FDA oversight, such as cosmetics. But others, such as John Bailey, executive vice president of science of the Cosmetic, Toiletry, and Fragrance Association, an industry group, said current regulations are sufficient.

Experts also disagreed as to how to define a nanoparticle or nanotechnology or even if there should be a definition in the first place. Some questioned the NNI’s current definition that the size of a nanoparticle is roughly between 1 and 100 nanometers.

“Is 101 nanometers no longer toxic?” asked Martin Philbert of the University of Michigan School of Public Health. “As far as the FDA is concerned, there is no such thing as nanotechnology,” he added. “We need to get away from labeling things and get down to the business of risk analysis.”

And toxicological assessments need to look at more than just size, other experts told the FDA’s Task Force. For example, certain nanoparticles become more toxic as they become smaller, but only if they are positively charged, not if they are negatively charged, said Stacey Harper, a toxicologist at Oregon State University.

The mixed nature of the advice will likely make it a challenge for the Task Force to come up with their recommendations to the FDA’s Acting Commissioner, slated for nine months after the public meeting.

Whatever the case, all the talk and meetings about nanotech safety are useless without the money to do the risk research, said Günter Oberdörster, an inhalation toxicologist who studies the health effects of nanoparticles at the University of Rochester Medical Center in Rochester, N.Y.

“The problem is, there are a lot of meetings, often sponsored by governmental agencies, and talk that we need to do the appropriate risk assessment,” Oberdörster said. But he maintains that additional funding would be required to perform the studies that are needed.