EPA regulates nano product, not nano industry


Legal experts say decision more about EPA policy revamp than nanotechnology

By Richard Acello

The headline in the Washington Post read: “EPA to Regulate Form of Nanotechnology.” But the Environmental Protection Agency’s action may have more to do with whether a washing machine can be considered a pesticide.

On Nov. 21, the EPA said it had determined that the Samsung silver ion generating washing machine, which releases nano silver ions into wash water, is subject to registration requirements under the Federal Insecticide, Fungicide and Rodentcide Act, or FIFRA.

This was a reversal of an earlier determination that said that the Samsung washer was a device, rather than a pesticide, and therefore not subject to regulation. Under the registration requirement, manufacturers must provide evidence that the use of nanosilver won’t cause harm to public health.

The agency now says that if a product “incorporates a substance intended to prevent, destroy or mitigate pests,” it is considered a pesticide and is required to be registered.

However, the EPA also said it had not come to any conclusions about whether a washing machine that releases silver ions or any other product is using “nanomaterials.” Nano silver is used as a germicide in food-storage containers, air fresheners, and shoe liners, among other products.

Samsung’s washing machine that uses silver ions to clean clothes must be registered with EPA because it acts like a pesticide, the agency said. Image courtesy of Samsung
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“I think this is about the delineation between a device - a washing machine - and a pesticide, or a washing machine that disperses an anti-microbial into the wash and into the waste treatment system, and not necessarily nano silver,” said Sean Murdock, executive director of the NanoBusiness Alliance. “The washing machine application is very different than the use in food containers or wound care, which is regulated by Food and Drug Administration. As such, I suspect the new ruling will primarily affect dispersive uses of nano silver, which are not nearly as common.”

Dick Stoll, a lawyer at Foley & Lardner in Washington who specializes in EPA issues, said the next day press coverage was “pretty misleading.”

“They made it sound as if some earthshaking event has occurred and it hasn’t,” Stoll said.

Stoll says the agency has already been involved in regulation of nanotechnology under the Clean Air Act, and FIFRA. The larger issue, which has already been joined in salvos between industry and environmental groups, is whether EPA should move to consider any nanotechnology product a “new substance” under the Toxic Substances Control Act (TSCA or “Tosca”).

“If EPA said yes to that, it would be a very big deal,” Stoll said.

The effect of a move to regulate nanotech products under TSCA could result in a delay of months or years, Stoll says, in bringing a product to market.

Lynn Bergeson, an attorney with Bergeson & Campbell in Washington, and chair of the American Bar Association’s Section of Environment, Energy and Resources, said the washing machine decision is “far more about EPA revisiting its device policy than being driven by a determination to regulate things made at the nanoscale level.”

The EPA recently formed a nanotechnology task force working within its Office of Pesticide Programs, and Bergeson said the agency “has been clear that it’s at the very early stages of review.”

Bergeson says the agency has more authority to regulate under FIFRA than under TSCA. “EPA has enormous authority under pesticides versus TCSA,” she explained. “Under TSCA, once a substance is on the approved inventory list, any use is legitimate, but FIFRA is use-specific. The EPA always has the authority to assess the risk of pesticides, regardless of the use.”

Environmentalists seized on the EPA’s washing machine decision to urge the agency to regulate a wider group of products containing nano silver.

In a Nov. 22 letter to the director of the EPA’s Office of Pesticide Programs, environmental action organization Natural Resources Defense Council (NRDC) said “....there are currently more than 40 consumer products in the marketplace that contain nano silver, some of which either expressly make pesticidal claims or imply pesticidal effectiveness and none of which are currently registered with EPA.” The NRDC says the agency is “obligated to examine these products and require registration for any product that uses nano silver as a biocide.”

The NRDC said Sharper Image has removed statements of pesticidal claims from its products treated with nano silver, including slippers, socks and food containers, an action that “denies the public’s right to know the active ingredient of these products.”