Federal agencies have been turning their backs on regulating nanotechnology, according to a report issued in May by the Wilson Center, largely because they are not convinced it warrants anything beyond the regulations already in place for standard-scale chemicals. But this might be a dangerous assumption, writes J. Clarence Davies, a senior fellow at Resources for the Future, a nonpartisan research center, in "EPA and Nanotechnology: Oversight for the 21st Century." According to Davies, "The relationship between science and regulation is complex" and filled with uncertainties. The best course is therefore "striking a balance between the harm that could be done by proceeding with an innovation and the harm that could be done by not proceeding."
Nanosilver is something of a jurisdictional oddity. Initially the EPA decided that a nanosilver-releasing Samsung washing machine was a device, like a flyswatter, and not a pesticide. But after public pressure from several interest groups, including NRDC, the agency reversed itself. It placed nanosilver -- an antimicrobial agent -- under the authority of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) rather than the Toxic Substance Control Act (TSCA), under which most other chemicals are regulated. FIFRA requires manufacturers to submit toxicity data before a product can be approved for sale and gives EPA broad authority to prohibit or limit the sale of pesticides.
"There is something surreal about asking whether washing machines or food-storage containers are pesticides," notes Davies in his report, "and it is a type of problem not envisioned by the drafters of the FIFRA statute." His reading of the act is that what matters in classifying an ingredient as a pesticide is not so much what the manufacturer says it does as what the ingredient has been put there to do. "It's less a matter of claim than intent," he says. "And in my opinion, it's pretty easy to show that the silver isn't doing anything in the products we're talking about other than acting as a pesticide."
After EPA's initial FIFRA decision, however, the agency decided to regulate only specific nanosilver products -- those that make explicit claims of antibacterial action. The result has been that several manufacturers have changed their claims from "kills germs" to less obvious formulations, such as "specially patented" or "stays fresh longer."
In early 2006, for instance, The Sharper Image was saying that its FresherLonger food-storage containers were "infused with naturally antibacterial silver nanoparticles." The company's Web site at the time featured photographs of strawberries and grapes stored for eight days in FresherLonger, compared with fruit stored for the same period in a conventional container. The conventionally stored fruit had grown "furry," the company wrote, and the FresherLonger fruit looked almost as good as new. The difference? "The silver nanoparticle miracle," according to Web site archives from April 2006. "In tests comparing FresherLonger to conventional containers, the 24-hour growth of bacteria inside FresherLonger containers was reduced by over 98 percent because of the silver nanoparticles!"
Berries stayed fresh, according to the 2006 Web site, because "patent-pending antimicrobial silver nanoparticles infused into the containers reduce growth of mold and fungus. . . . Silver in microscopic particle form is a safe, medically proven antibacterial agent. That is why silver nanoparticles are infused into the polypropylene containers of the FresherLonger system."
By May 2007, the text and the fruit photos were gone from the Web site, replaced with a bland description of the product as a "specially treated" polypropylene container that "helps to retard spoilage." Nothing nano is even mentioned. All that is specified is a "patent pending" airtight seal, and the fact that the containers are durable, dishwasher safe, and translucent, so you can see what's stored inside.
The Sharper Image also makes slippers with nanosilver, but while they were once called "Contour-Foam Silver Slippers" -- a name that had a kind of Wizard of Oz ring to it -- today the slippers are described simply as "Contour-Foam." The company's Web site in April 2006 said they were made with "viscoelastic foam insoles infused with microscopic particles of silver that is naturally antibacterial and reduces growth of odor-causing bacteria." The Web site today makes no mention of silver, nor of bacteria fighting.
A company spokesman declined to comment when asked to explain The Sharper Image's marketing decisions. But Patrick Lin, director of the Nanoethics Group, in San Luis Obispo, California, offers one possible explanation: Manufacturers are trying to have their cake and eat it too. "The manufacturers say that nanosilver is the key ingredient to kill bacteria in your laundry," he wrote in an e-mail follow-up to a telephone interview, "but in the same breath, they say (at least implicitly) that nanosilver won't have any significant impact after [it is] released into the water system. Well, which is it -- is nanosilver an effective killer or not?"
The new science of nanotechnology is poised precariously between two vistas. In one direction, scientific researchers and industry scramble to capitalize on the technique's alluring potential; in the other, regulatory agencies and environmental groups debate ways of keeping risks to a minimum. Complicating the tasks in both directions, the exploitation and the regulation, is something that can be thought of as Nano's Paradox: The qualities that make nanoparticles a potential threat to health and the environment are the very same qualities that offer a wonderful opportunity to improve that same health and environment.
Despite the uncertainty, even nanotechnology's critics stop short of calling for a moratorium. "Testing can be done on individual nano materials and products," Davies writes in "EPA and Nanotechnology," "and judgments on limiting production or marketing should be based on the results of these tests."
But just because testing can be done does not mean it will be done. Nor does it mean that scientists are even sure exactly how toxicology testing for nanoparticles should proceed. And the political process of imposing new regulations grinds slowly -- much more slowly than the field of nanotechnology is growing. This is why Maynard, for one, urges that we think in terms of "oversight" rather than regulation. "If you're looking at developing best practices for handling nanomaterials," he says, "you can be far faster than you can with new legislation leading to regulation. So there are ways of dealing with challenges in the near future that don't necessarily mean resorting to regulation."
When Maynard refers to oversight, he means whatever works to monitor and manage the impact of nanotechnology. Government regulation is just one tool for this kind of management; others, he says, include stewardship programs developed by industry, voluntary programs pushed by government, and guidance on safe practices in manufacture and disposal.
To Davies, who was one of the original architects of the EPA back in 1970, nanotechnology offers a chance to rethink the government's creaky regulatory apparatus altogether. He urges an overhaul of the EPA; a joint government-industry research institute on nanotoxicology; an interagency regulatory coordinating group, coupled with oversight committees in the House and Senate, focused on nanotechnology; and an annual appropriation of $50 million specifically for EPA research into the potential risk of nanomaterials to individual health and the environment ($38 million is currently spent on this by the federal government as a whole). Agency officials did not respond to repeated requests for comment on Davies's proposals.
"From a scientific perspective the field is incredibly exciting," says Sass of NRDC. "From a regulatory perspective, I sympathize -- it's a quagmire. But the real problem is from the economic perspective. Nanotechnologies are already out there in the marketplace, and we can't keep putting this stuff in products until we know more."