EPA uses nanotech regulation ploy to target colloidal silver while ignoring all other nanotech particles
Monday, December 04, 2006 by: Ben Kage
Nanomaterials -- products and materials changed or created at the atomic and molecular level -- are quickly gaining popularity for their multitude of uses, and while the Environmental Protection Agency is preparing to regulate popular nanosilver antibacterial products, ostensibly to protect consumers, critics say the move is a thinly veiled attempt to solely regulate nanosilver as a health supplement.
Nanosilver is used to kill harmful bacteria in food storage containers, shoe liners, washing machines and even bandages. Particles of nanosilver and other nanomaterials can be as small as one-millionth the size of a pinhead. However, the EPA, citing pressure from silver industry workers and environmental groups such as Natural Resources Defense Council, is investigating whether silver ions could pose an environmental threat by killing beneficial bacteria in the environment, or even harming humans. The agency also received a letter from Chuck Weir, chairman of a California wastewater treatment plant advisory group known as Tri-TAC, which claimed "silver is highly toxic to aquatic life at low concentrations and also bioaccumulates in some aquatic organisms, such as clams."
Silver was brought under close EPA scrutiny when washing machine manufacturers began making models that were lined with silver ions or sprayed them onto the clothes as an antibacterial agent. Last year, the EPA decided that the machines should not be regulated under the Federal Insecticide, Fungicide and Rodenticide Act, since they were considered devices rather than pesticides. Recently, however, the agency re-examined its decision and reversed it.
"We took a second look at the release of silver ions, and it was very clear that this is a pesticide and not a device," Jim Jones, director of the EPA's Office of Pesticide Programs, told the Washington Post. "Our original determination proved not to be a correct one."
Under the regulations, any silver product that claims it has antibacterial properties must prove the product is safe to be released into the environment. Mike Adams, a consumer health advocate and proponent of colloidal silver, suggested the regulations might work better were they aimed at antibiotics and pharmaceuticals.
"Isn't it interesting that the EPA chooses to completely ignore the environmental safety of all the millions of tons of pharmaceuticals flushed down toilets every year while selectively targeting silver products?" he said. "Why isn't the EPA concerned about the environmental toxicity of pharmaceuticals?"
A major point of contention for silver proponents is the fact that only products making antibacterial claims are subject to regulation. Jones' commented that, "Unless you're making a claim to kill a pest, you're not a pesticide." This decision has caused a severe backlash since it was announced Nov. 22, but not from washing machine manufacturers. Advocates of the use of silver in health have expressed outrage that the EPA has become involved and made this a safety issue, as their decision directly affects sellers whose silver products claim any antibacterial benefits.
"People have used silver flatware, and in the past silver coins, for thousands of years, releasing silver into the environment with no question of harm," said New Jersey lawyer Ralph Fucetola, who runs the Committee for the Responsible Use of Silver in Health (CRUSH) and the www.SilverFacts.com website. "The EPA will require proof of the safety of silver in the environment only if the companies make germ-killing claims," said Fucetola. "They are only concerned about safety if the public is being given information about benefits."
Fucetola, who is known as the Vitamin Lawyer for his work in the realm of dietary supplements, said CRUSH was developed to prevent irresponsible use of silver in health -- with special focus on ingested silver -- from both sides of the equation; both entities that would off-handedly disparage silver's benefits and those who would exaggerate them for profit.
"This is not a regulation designed to protect the environment from nanotechnology, it's a stealth ploy that selectively attempts to remove colloidal silver from the marketplace," Adams said. "Silver was gaining momentum in the marketplace as a safe, effective and natural antibacterial element. It cannot be patented and directly competes with antibiotics, antibacterial cleaners and other products from powerful corporations. That's why Big Business had to knock colloidal silver off track and regulate it out of the marketplace."
Fucetola noted there is a conflict between the EPA's decision and its own safety data on silver.
"EPA public records show that for ingested silver there is a safe level of use, known as the Reference Dose (RfD), determined by science as the safe daily amount for consumers," he said. "The guidelines make it clear that the only concern for the RfD is for the potential for the skin discoloration known as argyria. You would have to consume so much silver that it would discolor your skin before there would be any safety concerns."
Agyria, the most common health concern associated with silver, is a permanent yet medically benign conditioned marked by discoloration of the skin, usually brought on prolonged exposure to large amounts of the substance.
The EPA considers silver a water contaminant, but its Office of Drinking Water decided in the early 1990s that the effects of silver exposure in drinking water were cosmetic, and therefore downgraded the substance from a primary contaminant level to a secondary contaminant level. Additionally, the U.S. Centers for Disease control reports that spills of silver less than 1,000 pounds are not required to be reported to the EPA.
"If the EPA were to take the position that all nanosilver products had to qualify as 'safe and effective,' it would be acting contrary to its own long history of determining scientifically valid RfDs," Fucetola said. "Silver is spread throughout the environment already. Taking silver from the environment, using it and having some of it return to the environment is no different than the use of any other metal from the environment, whether iron, copper, or whatever."
Another factor that is drawing anger from silver proponents is the seeming focus of regulations on nanosilver to the exclusion of other nanomaterials. Indeed, the majority of nanomaterials will not be subject to EPA scrutiny, as they do not make any antibacterial claims.
"Consider this," said Adams. "Out of all the countless nanotechnology particles used in sun lotion, clothing and cookware, the EPA has decided to regulate only one -- colloidal silver, which is a naturally-occurring mineral. In doing so, the EPA ignores all the synthetic nanoparticles introduced into the environment through consumer products made by Big Business."
"'Nanosilver’ is the sexy new term for ionic silver," said Jay Newman, CRUSH member and president of supplement maker Invision International, in a press release. "Yet the imperative for an efficient delivery mechanism for human use is still the bottom line."
Newman said in a NewsTarget interview that free silver ions are needed to have an antimicrobial effect, but the ions will automatically bond with chlorine if they find their way into common drinking water, thereby rendering the ions inert.
"Our patented Silver100 is a perfect case in point, where it took many years of development and achieved patent protection because it has a specific molecular structure to control the release of silver ions in microbial forms," he said. "Once that occurs, the silver ions do not hang around. That's just the way the chemistry works.
"All appearances are that the EPA has been succumbing to corporate pressure of vested interests that do not want to see the word get out that silver has these benefits," Newman said. "I remain optimistic that the EPA will have the ethics and responsibility to let science prevail and that this will go away as quickly as it emerged."