Biomedicine

Can EPA Regulate Nano?

Monitoring complex new nanotech materials may be too much for the agency to handle.

While much nanotech is still in its early stages and far from marketable, experts now estimate that nano-engineered materials have found their way into as many as 700* products. That growing presence is lending an urgency to learning what environmental and health effects these novel materials may have – and to regulate them accordingly.

In fact, the fate of a host of industries, spanning every sector of the economy, may depend on whether or not regulators get it right. But as things stand now, according to many industry-watchers, the necessary resources to oversee this burgeoning new field just aren’t there.

In early December, the U.S. Environmental Protection Agency released a draft white paper on nanotechnology that identifies gaps in scientists’ understanding of the environmental and health effects of nanotechnology. According to Andrew Maynard, a senior science advisor at the nonpartisan Woodrow Wilson Institute in Washington, DC, it provides what may be the most comprehensive collection yet of researchers’ concerns, balanced with an analysis of the numerous ways nanotechnology could help the environment and human health.

Yet the sheer breadth of these concerns suggests that regulating nanotech may be a task far beyond the capacity of a single government program, says Maynard. The EPA hasn’t settled on how it will regulate nano-engineered materials, but the substances will probably come under the purview of environmental laws already on the books and draw on the agency’s existing funding – which many critics say is far from adequate.

The EPA program will likely take primarily responsibility for regulating nanotechnology, since the Office of Pollution Prevention and Toxics lacks the funding and personnel for the field offices necessary to monitor manufacturing, says Mark Greenwood, a former senior EPA toxicology official, now a partner in a Washington, DC, law firm specializing in environmental law.

If the EPA is not up to the challenge, it could mean that some nano-enabled products that turn out to be unsafe make it into the marketplace. The fear among the proponents of nanotech’s benefits is that health problems linked to just one such product may lead to a consumer backlash against all nanotechnology. And that could lead to the loss of not only billions of dollars in profits and wasted R&D, but also a loss of nanotech-based products that could have health and environmental benefits, such as ones for reducing the side effects from cancer treatment or quickly cleaning up toxic waste sites.

To be sure, nanotechnology poses a regulatory challenge. Many nanoparticles are made of the same basic chemicals as current products that have already been regulated. But their new physical structures – which make them so appealing for new applications – also give them highly different properties.

Pure carbon, for example, is used as graphite in pencil lead; and, arranged differently, it becomes a diamond. In the world of nananotechnology carbon is transformed into soccer-ball-shaped fullerenes, and their close relatives, nanotubes. The latter have properties that make them appealing for applications as diverse as high-performance computing, photovoltaics, and drug delivery. However, these properties and dimensions may also make them dangerous, if they get into air or water.

If all fullerenes were the same, it would be a relatively straightforward task to learn how they affect humans and the environment, researchers say. But they aren’t. Different manufacturing methods can produce widely varying products with, for example, different amounts of impurities. Further, researchers continue to alter the surfaces of these particles to create new properties.

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*This figure is cited in an Environmental Law Institute publication, “Securing the Promise of Nanotechnology: Is U.S. Environmental Law Up to the Job?”  Estimates of the number of products varies. A representative from the National Nanotechnology Initiative has cited EmTech Research (a subsidiary of Small Times) data showing there are approximately 80 consumer products containing nano-engineered materials and more than 600 raw materials, intermediate materials (such as coatings), electronics components and sensors, drug delivery technologies, research tools, process tools, and software tools.

The differences among varieties of fullerenes, for instance, may be the reason behind some recent, seemingly contradictory research results, says Richard Denison, a senior scientist at Environmental Defense (formerly the Environmental Defense Fund) in Washington, DC. Some research shows that fullerenes are powerful anti-oxidants, possibly useful for improving the health of cells by neutralizing free radicals. In contrast, other research seems to show that they’re powerful oxidants, capable of working their way into the brain and damage cell membranes.

If regulations were to be based only on the research indicating potentially dangerous properties, consumers might never see the health benefits of some fullerenes. Alternatively, if the wrong type of fullerene were used as an anti-oxidant, it could also do damage.

Here’s where the policy issue arises: If the effort at regulation is underfunded, it may not ferret out these distinctions, Maynard and others say. On the other hand, if the field of nanotechnology is over-regulated, it could stifle innovation and prevent new products from coming to market. Yet of course there needs to be an adequate level of research and regulation, to prevent the destruction of ecosystems and also head off a possible consumer backlash that would stifle progress. “We can’t afford to get it wrong,” says Maynard. “If something does go wrong, not only will this put human health and the environment at risk, it will put businesses at risk.”

Former EPAer Greenwood says the Office of Pollution Prevention and Toxics, which is charged with administering the Toxic Substances Control Act, is likely to be regulating nanotechnology. This program, which reviews new chemicals and enforces quality controls on existing chemicals, is “woefully underfunded,” says Greenwood, especially over the last several years. “I don’t think that the current program is capable of dealing with the complexity, the variety, and the data needs of nanotechnology, unless they get a big infusion of resources,” he says.

Denison concurs. Environmental Defense has suggested that 10 percent of the budget for the National Nanotechnology Initiative, which involves* about one billion dollars in federal money spent by a range of agencies, be earmarked for studying the environmental, social, and health implications of new nanomaterials. Other groups have suggested that even more be spent. Currently, no more than four percent of the money goes for such research.

In addition to greater funding, Denison says, some group would need to coordinate the efforts of multiple agencies more than is the case now. The size of the problem may require international cooperation, he claims: “The magnitude of the research that really needs to be done is probably beyond what any single country could do.”

As regulations are imposed, it will likely affect small nanotechnology startups. Materials testing could be too time consuming and expensive. Since some regulation is inevitable and necessary, though, such innovative startups may need to develop partnerships with other, larger companies to meet regulatory requirements.

Another possibility is a government- or an industry-sponsored fund to help such companies jump through the regulatory hoops necessary before their products can start making a profit.

“There’s a window of opportunity here for maintaining the ability of this technology to deliver the benefits it promises and for building public trust,” Denison says. But he warns that the task will be difficult. “I think we’ve got a really fine balancing act.”

*The story originally indicated that the NNI allocates the money. The money is technically allocated by Congress.

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