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The United States Environmental Protection Agency (EPA) has granted its first approval for a pesticide based on a nanoscale material. The product, Swiss-made antimicrobial nanosilver used in fabrics, was given a four-year conditional registration.
The EPA announced Thursday that it is moving forward with a four-year "conditional registration" for HeiQ Materials' AGS-20 product, which is essentially a composite of nanosilver and nanoscale silica. According to HeiQ's application—first filed in 2008—AGS-20 will be incorporated into textiles.
Nanosilver is being used more and more in workout clothing, touted as a way to fight that gym-rat smell.
The agency proposed the conditional registration—which comes with a laundry list of required tests—in August 2010, and opened a public comment period. Then there was radio silence, except for an EPA announcement last summer that it planned to seek more information from manufacturers using nanomaterials, potentially including nano-enabled products that got the green light before the agency sharpened its focus on ultra-tiny substances.
Nano-watchers have been waiting eagerly for the agency's decision, wondering whether the move would signal a larger shift in how nanomaterials, including silver, are monitored and regulated.
Nanotechnology leverages the often-unique properties of super-small particles to create products with amazing qualities. These materials can make better batteries or lighter and stronger bike frames, as well as new medical instruments and medicines that can save lives. They're increasingly common in consumer products, from "mineral-based" sunscreens to stain-repellent pants to boat paints that resist algae growth.
Nanomaterials are believed to hold great promise for a wide variety of applications. But shrinking these substances can change their properties, and scientists are struggling to figure out whether that shift can make them dangerous in the process, and how and why it happens.
HeiQ CEO Carlo Centonze said in a statement that the company is "pleased that that EPA has recognized the potential benefits provided by HeiQ AGS-20." He said the EPA's approval came "in part because it could lead to less silver released in the environment while providing longer protection against the growth of odor- and stain-causing bacteria."
Lynn Bergeson, a lawyer at the Washington firm Bergeson & Campbell who works with nanotechnology companies on navigating the regulatory process, said she was "thrilled" by the EPA's move, but wasn't sure it portends additional action by the agency.
"It really is very difficult to speculate as to whether this means anything other than the decision was made early on to approve this and the agency has carefully considered the comments and is sticking by its decision," said Bergeson, who doesn't represent HeiQ.
The EPA considers nanosilver, and its larger-sized counterpart, a pesticide, and evaluates it under the Federal Insecticide, Fungicide and Rodenticide Act, or FIFRA. According to that law, pesticides must be registered before going on the market.
EPA officials weren't available for comment Thursday, aside from a brief press release announcing the move. (Click here to read the rules it proposed in 2010; it's unclear whether there have been significant changes.)
Nanosilver has drawn a lot of attention from scientists and regulators. It's widely used as an antimicrobial, in toothbrushes and other products as well as sweat socks. Studies have shown nanosilver turns up in sewage sludge—and also sloughing off of larger silver objects, raising questions about how much silver has been all around us, and whether these new products might have an additional impact.
Environmental groups and other advocates have warned that nanosilver could be a problem for the environment, by building up in water, soil and marine life or by disrupting the natural bacteria that are all around us. Others have questioned whether the widening use of nanosilver might create problems with resistance, either in people or in bacteria.
The silver industry maintains that the metal, which has been used for centuries to fight germs, is safe in any size.
In his statement, Centonze said HeiQ will comply with all the EPA's requirements: "It is our constant effort to produce and communicate scientific findings to EPA and other regulators in their efforts to adapt risk assessment to new policies and environmental findings."
Jaydee Hanson, policy director at the International Center for Technology Assessment, said he was disappointed that the EPA decided to move ahead with HeiQ's application before completing work on broader guidelines for nanoscale pesticides. The ICTA, in concert with other advocacy groups, has petitioned both the FDA and EPA to start regulating products that contain nanomaterials.
The company should get credit for going through the registration process, he said, noting that other manufacturers seem to be cloaking their nanopesticide ingredients in order to avoid EPA scrutiny.
But the agency should have waited, Hanson said, at least until it gets the results of the toxicology tests required under the conditional registration.
"It's a little bit like, ‘OK, let your horses out, and maybe we can recall them afterwards,'‘' Hanson said.
"There are serious potential environmental problems, if we get every fabric out there impregnated with nanosilver," he said, adding that he expects to see more companies apply to register nanosilver pesticides in the wake of the EPA's decision.
HeiQ's application, and the EPA proposal for the conditional registration, drew a variety of comments from industry, environmental and consumer advocates and the public (click here to see all of the background information). Many were negative, and it's unclear how—or if—they affected the EPA's decision.
"I think it's going to be when we see their new regulations before we know whether they really paid attention to the comments or not," Hanson said.
Bergeson said she also anticipates more applications for nanopesticides. The conditional nature of the registration is not ideal for a commercial product, since there's the potential that after the four-year trial period, the EPA could pull it from the market. But it's better than the stop sign companies have been getting, she said.
The wait for this decision "was a signal to pesticide registrants that the agency had now to find its sea legs" on nano-enabled products, she said. "Now, with the issuance of the final registration, I think you can expect EPA to be more confident and for pesticide registrants to be more hopeful."
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