Tiny Molecules, Big Uncertainties

Warning: You might never look at your sunscreen the same way again. Earlier this spring, Friends of the Earth and the International Center for Technology Assessment teamed together to file legal petitions requiring the Food and Drug Administration to regulate nanotechnology in cosmetics. As policy wonks and environmentalists droned on about how antiquated our laws and environmental regulations are, zillions of consumers were left scratching their heads: “There’s nanotechnology in our cosmetics?”

The legal filings exemplify how effectively and quietly nanoparticles have inserted themselves into our lives. While we weren’t looking, sub-microscopic machines went from the stuff of science fiction to more than 200 products that you can buy today from the likes of Levi Strauss to L.L. Bean. These new products have been either enhanced or made possible by tiny particles less than a hundredth of a millimeter, so small that they can only be seen with the most powerful microscopes in the world. On the nanoscale (ten or fewer atoms), familiar materials turn strange—for instance, gold liquifies and opaque substances become transparent. They also react differently on a chemical and catalytic level than their macro counterparts.

“The growth in nanotechnology and the products that contain them has been astonishing,” says Tracy D. Hester, an attorney who heads the Houston environ-mental law group in the firm of Bracewell & Giuliani, a national law firm. He said the Friends of the Earth petitions could be the beginning of the first litigation over how nanomaterials should be regulated.

From Dockers Go Khakis to Daewoo vacuum cleaners, from sunscreen to golf clubs, nanotechnology is beginning to pervade our lives. Once the province of worried academics and starry-eyed inventors, the tiny molecules have hit the bright lights, appearing daily in your supermarket and mail order catalogs.

Indeed, it’s now possible to be in contact with this technology from the moment you arise in the morning and use your Wilkinson Sword razor to the moment your head hits the Sharper Image Contour-Foam neck-support pillow. From machine memory to environmental remediation, the chemicals are transforming old favorites and making the previously unthinkable a household necessity.

At the same time, many observers are concerned both at how little is known about the risks of these particles and how inadequate and inappropriate are many of the current laws dealing with issues ranging from human and animal health to disposal of nano-wastes. At least half a dozen agencies, including the EPA, the FDA, and the National Institute of Occupational Safety and Health, can or should play a role in overseeing the creation, use, and disposal of nanochemicals, but so far, it’s unclear what oversight the agencies might adopt.

Inadequate regulation is part of why so many consumers don’t even realize they are using nanotechnology: There is no requirement in the United States to label products that use nanoparticles. (To see which nano-products you might be using, click on the Nanotechnology Consumer Products Inventory at http://www.nanotechproject.org. The results will surprise you.)

Even researchers working on the cutting-edge of the field admit that it’s hard to know which products contain nanotechnology. “I couldn’t even say for sure which sunscreens use nano,” says Kristen Kulinowski, director for external affairs at Rice University’s Center for Biology and Environmental Nanotechnology and the director of the International Conference on Nanotechnology. “I can guess, by looking at the ingredients and at whether it is all white and goopy or mostly clear.” (You might want to steer clear of clear.)

Like any frontier, the field of nanotechnology is a place where the law is often inadequate to deal with day-to-day problems. “Unless it’s pharmacological or a radionucleotide, there are very few specific regulations that apply,” says Patricia McClellan-Green, assistant professor of environmental and molecular toxicology at North Carolina State University. She agrees that nanotechnology has been largely unregulated or underregulated. Sometimes it’s clear that nanotechnology has been used, but some chemicals have a currently regulated “macro” or traditional formulation and a new nanoformulation. The law treats the two chemicals as the same.

“So far, nanotechnology is regulated mostly under the Toxic Substances Control Act, but those laws don’t distinguish between nanotechnology and other chemicals,” says Kulinowski. “That means that, say, titanium dioxide [a chemical commonly used in sunscreens] might be covered under the Act, but a nano-formulation of titanium dioxide could conceivably have very different toxicological properties. That’s usually the very reason we’re interested in nanotechnology. “If it weren’t different in some way, we probably wouldn’t be interested in the nano form.”

She hastens to add that the general view of nano titanium dioxide is that it’s safe. But with some chemicals, the nano-formulation is so different that it should be regulated as if it’s a different chemical, and current laws don’t allow for two radically different formulations—with extremely different risks—of the same chemical.

For example, work done by Eva Oberdorster, formerly of Southern Methodist University, showed that water fleas were killed by synthetic carbon nanoparticles called “buckyballs,” and a species of fish suffered brain damage after exposure to them.

Follow-up research seems to indicate that simply formulating the outer structure of the particle a little differently can cause such drastic effects, says Kulinowski. Experts say the study underscores the need for more research and information-sharing about these technologies.

Such knowledge is hard to come by. Many firms jealously guard the specifics of their nanotechnology fabrications, so as not to clue in competitors about important differences in technique. “In particular, sometimes it’s difficult to get information about the coatings and the structure, which can be extremely limited,” says McClellan-Green.

Perhaps the scariest thing about nanotechnology is how little is known about the possible effects on wildlife and people. “We’re just starting to understand the most basic things about the risks,” says McLellan-Green, whose work includes studying the marine effects of nanoparticles. “For example, we’re just getting information on how the particles move in the environment, and how they’re taken up in different forms of life.” Until we understand the risks, she says, “We should exercise caution in how we treat these chemicals.”

“In nanotech, the first major environmental legal issue will be when a nanoparticle is truly new and should be regulated differently [from its non-nano counterpart] under the Toxic Substance Control Act. Current law is not clear at all in this area,” says Hester. “While the Toxic Substances Control Act provides a general framework, given the high stakes EPA has already proposed a voluntary pilot program to register and test certain nanomaterials. EPA also plans to provide additional guidance soon on when a chemical is considered ‘new’ under the Act.”

But don’t hold your breath; most observers don’t expect definitive action any time soon. “Some firms have taken voluntary action by setting guidelines on research,” says Douglas Kysar, a professor of law at Cornell and a member scholar of the Center for Progressive Reform. “But there are billions of dollars being spent on nanotechnology research, and 99 percent of it is dedicated to things other than risk assessment and mitigation.”

“There’s probably not going to be nano-specific regulation anytime in the near future, unless there is a consumer product scare,” says Kulinowski.

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