MoxSync

The war on germs is being fought on many fronts these days.

Hand-washing with antibacterial soap, using tissues laced with germ-fighting agents, scrubbing down poultry, and keeping the E. coli menace at bay by cooking hamburger to a crisp are only the first lines of defense in many homes against the health havoc that modern germs can cause.

That's why the Microban Products Co., which has been selling its antimicrobial agent for more than a decade to makers of hospital and other institutional equipment, figured its product would help inhibit germs on items such as toys, toothbrushes and kitchen cutting boards.

Microban Plastic Additive "B," as it's called, is a pesticide whose active ingredient is triclosan. The product was registered with the Environmental Protection Agency in 1983 and was later approved for use on various items such as shower curtains, pillows and handrailings in hospitals. The chemical works by forming a surface protection that resists the growth of microorganisms such as bacteria and mildew.

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Encouraged by recent research that showed many Americans will go out of their way to buy products that have antibacterial ingredients, Microban thought it was well positioned to sell its pesticidal pellets to companies that incorporate them into the plastics of their own products. It started showing up in items such as Johnson & Johnson's Reach toothbrushes and some Hasbro Inc. Playskool toys.

But Microban ran into trouble -- big trouble -- when its corporate customers started claiming or implying that their products contained antibacterial agents that could inhibit germs and disease-causing bacteria such as E. coli, salmonella, staph and strep.

The EPA, which registers and regulates pesticides under the Federal Insecticide, Fungicide and Rodenticide Act, considered these public health claims outside the scope of the approvals originally granted to the pesticide makers. EPA said the approvals given to Microban allow it to be used as a pesticide that protects the treated product from rot and deterioration. But it cannot be claimed that Microban goes after infectious germs, the way a disinfectant does.

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"Their current view is all these {pesticide} registrations were to keep the products from rotting," said Glenn Cueman, president and chief executive of Microban. "Our several hundred products have never had anything to do with rotting. Hospital handrails have nothing to do with rotting. It's to minimize staph and E. coli on the surface of the product."

Cueman points out the inconsistency in EPA's recent pronouncements. He said the EPA in 1987 approved five claims for Microban, including that it provides a hygienic surface and inhibits the growth of bacteria -- claims that Microban's customers then adopted.

But as items with antibacterials started flying off the shelves in stores, the EPA worried that consumers would think they were protected from infectious microorganisms and didn't have to clean household items. EPA insisted that every manufacturer using a substance such as Microban get each individual product approved for any health claims it was making, and not depend on the broader registration given to the pesticide manufacturer.

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"Nobody has sent us data on these products. We'd love to have it. We don't know if it works or not. If it doesn't work, then the consumer may be short-changed from a public health point of view," said an EPA official, who asked not to be named. "The implication is, if you buy the product, you are somehow safer."

In the last year, the EPA has fined the Minnesota Mining and Manufacturing Co. (3M) for making claims about sponges that kill germs. Two other household goods companies were fined and another seven displaying kitchen cutting boards at a trade show got "stop sale, use or removal orders" from the EPA on the spot.

One of the companies fined was Lifetime Hoan Corp. EPA said it was making unregistered claims with labels that said such things as, "Microban antibacterial protection built-in to inhibit the growth of bacteria on the product."

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"Cutting boards are identified {by the EPA} as an article that can be treated {with Microban}. We included a disclaimer that told people to clean this product as usual," said David Sarvadi, an attorney with Keller & Heckman, who represents Lifetime. "It's baffled us why EPA got so testy about these claims."

Sarvadi said Lifetime was careful to tailor its labels to fall under an EPA "treated article exemption" that allows products not to have to go through registration.

Hasbro, which used Microban in nine of its toys, also was fined and spent more than $1 million to adjust its advertising. The agency said the toys acted as pesticides because of claims such as "unique germ fighting technology inhibits the growth of germs on toys."

All of this has enraged Microban, which has hired lawyers to fight the EPA and try to get congressional attention. Besides disagreeing with the actions taken against customers, Microban has had some germ warfare of its own with the EPA.

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Last December, the agency hit Microban for claims it made in internal public relations documents prepared for Hasbro that said Microban was effective in "virtually eliminating" the growth of household germs such as E. coli, salmonella, staph and strep.

Gerald Yamada, an attorney representing Microban, said the EPA has overstepped its authority and is changing its pesticide policy without any notice to regulated companies.

Meanwhile, the EPA soon will publish "guidance" for companies, instructing them to say on their labels that antibacterial properties "do not protect users or others against bacteria, viruses, germs or other disease organisms."

Companies that have had run-ins with the agency said they want quick regulatory action rather than more enforcement cases.

Microban's Cueman thinks a system of "supplemental" registration for these products might work. "All we ask is that the system go in right now," he said. "But don't take products off the market that consumers want and pose no threat at all."

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