EPA Takes Aim at Anitmicrobial Products Under FIFRA

In this article, we note a couple of recent EPA enforcement actions against manufacturers allegedly making unsubstantiated antimicrobial claims for their products – much like occurred in the IOGEAR computer keyboard/mice episode in 2008.  Although these products do not purport to use nanoscale materials, the alleged claims for these products are similar to those made by manufacturers for certain nano-based antimicrobial products. Thus, our readers may be interested in EPA’s actions.

The EPA issued a press release today stating that the parent company of North Face camping and outdoor gear faces up to $1,000,000 in fines for allegedly making unsubstantiated health-related claims for almost 70 of its shoe products using Agion silver ion technology. The EPA press release states:

“At issue were more than 70 styles of footwear that incorporated an AgION silver treated footbed. The company sold the products making unsubstantiated claims that the footwear would prevent disease-causing bacteria. Specifically, The North Face made the following public health claims about the footwear on-line and on product packaging:  • ‘AgION antimicrobial silver agent inhibits the growth of disease-causing bacteria’ • ‘Prevents bacterial and fungal growth’ • Continuous release of antimicrobial agents”

The fines are being sought by EPA under the Federal Insecticide Fungicide and Rodenticide Act which prohibits unsubstantiated public health claims regarding unregistered products.

From Agion’s website: “Agion technology 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. We offer a variety of silver-based technologies to suit various manufacturing and product requirements.” 

In another press release, EPA publicized a complaint it filed “against Peoria, Ariz.-based Granite Marketing, Inc. for the alleged sale and distribution of an unregistered pesticide in violation of the Federal Insecticide, Fungicide and Rodenticide Act. The EPA is seeking up to $5,200 in civil penalties from Granite Marketing, Inc., located at 8190 W. Deer Valley Road, for offering for sale the unregistered antimicrobial pesticide known as Titania Antibacterial System.”


 

Environmental Pollution from Nanosilver Socks?

A recent study by two Arizona State University researchers found that socks made of fabric incorporating nanoscale silver may potentially release that silver into wash-water.

T. Benn, et al., "Nanoparticle Silver Release into Water from Commercially Available Sock Fabrics," Environmental Science & Technology, Vol. 42, at 4133-4139 (2008).

Why put silver in your socks?  Because it is a well-known antimicrobial agent and microbes cause sock odor.  Kill the microbes, and your feet smell fresh.  At least that's the marketing angle. 

 

Several environmental NGOs, however, are concerned with whether silver might be released from the socks, enter the wash-water and waste-water streams, and keep on killing microbes. While you may not want microbes in your socks, they are a vital part of the ecosystem. The authors theorize that "[t]he ubiquitous use of commercial products containing n-Ag could potentially compromise the health of many ecosystems." (This is yet another twist to the Samsung Silver Care washing machine controversy a couple of years ago).

As for the socks themselves, the researchers selected pairs from Sharper Image, Fox River, Arctic Shield, Zeusah, and AgActive "based on the manufacturers' claims that the socks contained nanoparticles of silver. " We checked the advertising for ourselves, and only Arctic Shield and AgActive London actually make nanosilver claims, while Fox River and Zeusah make general silver and/or silver ion claims. As for the Sharper Image socks, the company is in the final stages of bankruptcy and is closing its stores. Its new owner may or may not continue direct sales through its catalog and the internet. No work on whether they will continue to sell socks at all.

Perhaps the most interesting thing about the advertising was efficacy claims:

"Your feet feel and smell fresher for longer."
"Stay fresh no matter how long you wear them."
"You can wear our socks for days on end and they won't smell."
"Just by wearing [our] socks we guarantee no more foot odor."
Testimonial: "I bought some of [your] socks for my nephew when he came to stay with me for the holiday. His feet always smelled but with the new socks, the smell is all gone. I am very happy."
Testimonial: "I wore them three days and there was no smell at all."
Regarding the test itself, the socks were first analyzed for their nanosilver content. Three of the six socks contained silver particles in the 100-500 nm range; only one contained silver particles in the traditional nanoscale range (under 100 nm). The socks were then washed three times in ultra-pure distilled laboratory water for 24 hour or 1 hour periods using an orbital shaker/agitator. No soaps or detergents were used. The researchers analyzed the resulting wash-water.

To cut a long story short, the researchers found that "at least some of the n-Ag is released into the wash-water as nanoparticles; not just as dissolved ionic silver."

As for total silver release, three of the six socks were found to have leached silver into the wash-water. (Sharper Image, Fox River, AgActive London). During the three 24 hour tests, the AgActive socks released a total of 19 of their 20 micrograms of silver, the Fox River socks released 165 of their 31,241 micrograms of silver, and the Sharper Image socks released 1578 of their 1845 micrograms of silver. In the three, one hour tests, the Sharper Image socks released 1020 micrograms of silver, and the Fox River socks released 390 micrograms of silver.

Interestingly, socks washed in plain old tap water did not release near as much silver as those washed in the ultra-pure, distilled, laboratory water.