posted 03-05-2008 11:05 PM            

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March 6, 2008
Small Business
New Device for Germophobes Runs Into Old Law
By BARNABY J. FEDER

With so many people worried about getting sick — whether from the common cold and flu or exotic new strains of antibiotic-resistant bacteria — Paul and Jeffrey Metzger had every reason to hope that the germ-fighting key fob they invented would be a runaway hit.

Their device, known as the Handler, began selling last year online and in stores like Duane Reade pharmacies for about $11. It features a pop-out hook so germophobes can avoid touching A.T.M. keypads, door handles and other public surfaces where undesirable microbes may lurk. As added protection, the Handler’s rubber and plastic surfaces are impregnated with tiny particles of silver to kill germs that land on the device itself.

But those little silver particles have run Maker Enterprises, the Metzger brothers’ partnership in Los Angeles, into a big regulatory thicket. The Metzgers belatedly realized that the Environmental Protection Agency might decide that a 1947-era law that regulates pesticides would apply to antimicrobial products like theirs.

The agency ruled last fall that the law covered Samsung’s Silvercare washing machine. Samsung was told it would have to register the machine as a pesticide, a potentially costly and time-consuming process, because the company claims the silver ions generated by the washer kill bacteria in the laundry.

The Metzgers halted production of their key fob while they sought legal guidance on how to avoid a similar fate.

Their quandary highlights a challenge facing the growing number of entrepreneurs who have ventured into nanotechnology, a field that gets its name from its reliance on materials so small their dimensions are measured in nanometers, or billionths of a meter.

Nanoscale materials are best known at the moment for uses like adding exceptional stain resistance to textiles, making sunscreens transparent and improving battery life. The Handler is just one of scores of products marketing the antimicrobial potency of minute quantities of silver.

The E.P.A. has so far rejected calls from environmental groups to automatically classify nanoscale forms of known materials as new chemicals under the broad toxic chemical control regulations. Nor does the agency consider size when determining what needs to be registered under its pesticide regulations. Business groups generally support such restraint but the effort to squeeze nanomaterials into existing regulations has left many companies worried about how to market their products without running afoul of the regulators.

The Metzgers ended up hiring Lawrence Culleen, one of the most experienced and expensive specialists in E.P.A. regulation in Washington, but have nonetheless had trouble determining how far they can go with their health claims.

“Everything is still on hold,” Paul Metzger said last week. Meanwhile, the Chinese factory that makes their devices is pressuring the brothers to restart production, he said. And once the green light is given, it will be two more months before the Handler is once again widely available.

The law at issue — the Federal Insecticide, Fungicide and Rodenticide Act, better known as Fifra — was conceived in 1947 to protect humans from agri-chemicals sprayed by the millions of gallons to kill weeds, plant viruses and bugs. In the case of the Handler, the question is how the law applies to barely measurable amounts of silver — in particles thousands of times thinner than a human hair — that are intended to be strictly confined instead of spread into the environment.

“They don’t really know how they want to register these particles,” said Tracy Heinzman, a lawyer in Washington who deals frequently with the E.P.A. “There’s no clear path forward.”

More broadly, the limbo into which the Handler has tumbled shows how the limited resources of agencies like the E.P.A. can combine with creaky regulations to act as a brake on innovation. “The marketplace is always ahead of the E.P.A.,” Ms. Heinzman said.

Indeed, the tension has created a business opportunity for Agion, a supplier of ionized silver, an antimicrobial form of silver that has been registered under Fifra. Businesses willing to pay premium prices to use Agion silver can also get advice from the company on how to advertise antimicrobial abilities without making explicit health claims that may violate the law. Agion, which is based in Wakefield, Mass., says it has spent over a million dollars registering various applications of its product with the E.P.A.

“We’ve developed expertise in this,” said Ginger Merritt, Agion’s vice president for sales and marketing.

Some nanotechnology skeptics say that slowing commercialization is exactly what the E.P.A. ought to be doing. The silver particles provide a good example of why, in their view.

Silver’s sterilizing powers were first noticed by the ancient Egyptians, but no one can be certain that long experience with the metal is a complete guide to its hazards in its newly engineered forms. Nanoscale particles — those in the Handler average 20 nanometers in diameter — are often unusually potent. They may also have other unexpected properties that will become apparent only if many people or other living things are exposed to significant quantities over long periods of time.

One of the biggest concerns with such particles is that they may easily penetrate the brain and other organs that larger particles cannot reach.

Moreover, some critics worry that the technology may contribute to the evolution of microbes resistant to silver poisoning. And some health experts say that constantly reducing exposure to troublesome microbes may eventually weaken the human immune system.

Environmental groups point out that pesticide regulators may simply ignore an antimicrobial product, no matter how potent, if its manufacturer and distributors avoid making health claims. As the E.P.A. interprets the regulation, a product is not “designed” to be a health-protecting antimicrobial — and thus subject to registration requirements — if it is not advertised as such.

Several other companies that have been using silver nanoparticles in ways similar to Maker Enterprises reacted to the Samsung decision by simply dropping any antibacterial claims.

Recently, for example, Domtar, a paper company based in Montreal, halted test marketing of a paper it advertised as laced with antimicrobial nanosilver particles, a product other paper makers had successfully sold to health-conscious Europeans.

E.P.A. officials deny that a review of antimicrobial claims for such products would be so burdensome and said that they have tried to develop a cooperative way of working with companies.

Samsung, for instance, was allowed to keep selling its washing machine while it develops its pesticide registration data. The agency has an ombudsman to help small businesses, said William Jordan, senior policy adviser for the Office of Pesticide Programs.

Mr. Jordan declined to discuss the Handler case but said that several companies were talking informally with the agency about registration, and how far they could go without it. “We try to use common sense in dealing with smaller companies,” he said.

The agency said its handling of earlier antimicrobial products, especially the synthetic disinfectant triclosan, provided a model for nanosilver. Companies that had rushed to market with products as diverse as toys and toothbrushes impregnated with triclosan — also known as Microban — ended up paying fines and changing their labels. Mr. Jordan said that many triclosan products have since been registered under the pesticide law, some with reviews as short as 60 days.

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