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24
Sep

Antimicrobial Claims Prompt Lawsuit by EPA under Pesticide Law

(Beyond Pesticides, September 24, 2009) The U.S. Environmental Protection Agency (EPA) has just announced that it filed suit against San Leandro based VF Corporation for the sale and distribution of unregistered pesticides through its retail company, The North Face. An AgION silver treated footbed, which the company claims has antimicrobial properties, is featured in over 70 styles of shoes by the company. These claims, according to the EPA, are in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The company could face up to $1 million in fines.

While these products do not purport to usie nano-sized silver materials, the claims that are made for these products are suspiciously similar to those made by manufacturers for other nano-based antimicrobial products. These claims include: inhibiting the growth of disease-causing bacteria; preventing bacterial and fungal growth; and the continuous release of antimicrobial agents.

Because of the lack of regulation, nanotechnology products are not always easy to recognize in the marketplace, and even the best lists do not include everything. Consumer products that include nano-based technologies, however continue to grow.

EPA has taken a few regulatory actions against other manufacturers whose products made similar claims as this case, including action against the manufacturer of a washing machine generating silver nanoparticles. In early 2008, the EPA imposed a landmark fine of over $200,000 on a California company selling computer keyboards and other parts coated with nanosilver without being registered.

In 2004, EPA prevailed in a case against the manufacturers of microban (triclosan) for making health-related claims that are not supported by its EPA pesticide registration. The company had claimed that its microban-treated plastic protected people, particularly children, from the transmission of bacterial disease. In that case, EPA iissued a fine, citing the language of FIFRA §12(a)(1)(B), which states, that each sale or distribution is a violation. The former EPA enforcement attorney in the case, James Handley, wrote in a piece in Pesticides and You, “The company’s liability was hardly in doubt: we even obtained copies of the registration documents that appeared to have been altered to omit crucial restrictive language; apparently these alterations were made in order to market microban’s alleged health benefits to companies such as those that make children’s toys.” (See “Reflections by Former EPA Enforcement Attorney James Handley on Triclosan and the EPA Review,” vol.24, no. 4, p11.)

Under FIFRA, silver nanoparticles meet the definition of a pesticide; that is, as a substance that is intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms. As such, silver nanoparticles, with their antimicrobial activity, should and must be regulated by EPA as a pesticide. However, despite over 200 products being sold on the consumer marketplace, EPA has done little to regulate or evaluate the potential health and environmental impacts these particles may cause.

According to AgION, the “cornerstone” of their technology is silver, which operates at the surface of a product through the controlled release of silver ions which attack microbes and inhibit their growth in three different ways. Under FIFRA, this meets the definition of a pesticide, and as such, it should and must be regulated by the EPA as a pesticide.

While AgION asserts that its silver is proven to be “safe” with “no toxic affects” on people, plants or animals, silver is known to be toxic to aquatic ecosystems. It is particularly harmful to aquatic organisms and microorganisms, such as fish and amphibians.

EPA, however, does not mention any plans to register this product as a pesticide “until it has been tested to show that it will not pose an unreasonable risk when used according to the directions.”

Recent scientific studies have shown that nano-silver is even more toxic and can cause damage in new ways. A 2008 study showed that washing nano-silver socks released substantial amounts of the nano-silver into the laundry discharge water, which will ultimately reach natural waterways and potentially poison fish and other aquatic organisms. Another 2008 study found that releases of nano-silver destroy benign bacteria used in wastewater treatment.

The human health impacts of nano-silver are still largely unknown, but some studies and cases indicate that the nanomaterial has the potential to increase antibiotic resistance and potentially cause kidney and other internal problems.

After being contacted by EPA, The North Face stopped making claims that its footwear protects against germs, removed all claims from their website, and revised the packaging on their products. Whether the actual product materials have changed remains to be seen.

For more information on antimicrobials, including the use of silver nanoparticles, please see Beyond Pesticide’s Antibacterial page.

Source: EPA Press Release

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