Friday, July 6, 2012

How Environmentalists Are Destroying the Market for Antimicrobial Silver


For the past 12 years the American public has been clamoring for more consumer products that utilize antimicrobial silver in order to help reduce levels of infectious microorganisms and prevent infections and disease. 

But the Environmental Protection Agency (EPA) has thrown roadblock after roadblock into the paths of companies willing to meet the growing public demand for products that utilize antimicrobial silver, even to the point of stringently enforcing their strange categorization of antimicrobial silver as a “pesticide,” and imposing mounds of new regulations (which we’ll look at in this article) making it more difficult for companies to bring such products to market.

Worse yet, whenever a company agrees to jump through the EPA’s regulatory hoops in order to manufacture a product containing antimicrobial silver, litigious environmental groups emerge out of the woodwork to file lawsuits against the EPA in order to prevent the agency from allowing the product to be manufactured and sold to the American public.

Here’s why the future of consumer products containing antimicrobial silver is now so bleak, in spite of massive public demand for such products…

Hi, Steve Barwick here, for www.TheSilverEdge.com...

A little more than a decade ago consumers were thrilled to find that common household products such as computer keyboards, kitchen cutting boards, plastic food containers or even bathroom towels could be infused with antimicrobial silver in order to help reduce the spread of pathogens and prevent infections and disease.

I was among the first to report on the emergence of such products back in 2000, in my article, Big Business Moves Into Silver-Based Antimicrobial Products In a BIG Way, which has since been read by millions of people worldwide.

However, about six years after businesses began producing consumer products containing antimicrobial silver, radical environmental groups sued the EPA, demanding they more broadly enforce their classification of antimicrobial silver as a "pesticide" under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

These environmentalist groups -- some of which have apparently been taking millions of dollars in “contributions” from charitable foundations set up by Big Pharma -- asserted without any real-life evidence whatsoever that silver could leach from such products and potentially harm little critters in the environment.

“Killing the Planet”

They sensationalistically claimed in press release after press release, and in articles planted on dozens of environmentalist news websites, that the use of silver in consumer products was an “environmental catastrophe waiting to happen” and would end up “killing the planet.”  

They further asserted that the EPA would be to blame for the impending doomsday crisis if it didn’t act quickly to ban the use of antimicrobial silver in consumer products. And using these overblown theatric and sensationalistic tabloid-style claims, they rallied their legions of unwitting environmentalist members against the use of antimicrobial silver.

The EPA, in turn, claimed it was being “forced by public opinion” to more stringently regulate consumer products containing antimicrobial silver, even to the point of categorizing products like silver-infused computer keyboards, plastic food containers or kitchen cutting boards as “pesticides.” 

Because of this, fewer and fewer such silver-based products have been brought to market because the newly imposed regulatory burdens have become so egregious and costly, companies are discovering it’s simply not worth the time, money or the effort to invest in them, in spite of the growing public demand. 

Huge Fines

Indeed, as I’ve pointed out in previous articles, the EPA is now fining companies hundreds of thousands of dollars simply for failing to register their products as “pesticides” if they contain antimicrobial silver and advertise its benefits. 

Only recently, the EPA fined a company called IOGEAR a whopping $208,000.00 for selling a silver-impregnated computer mouse and failing to properly register it as a “pesticide” with the agency.

Then the EPA fined a company called Kinetic Solutions, Inc., $82,400 for selling an unregistered air purifier which contained a pre-filter incorporating nanosilver into its makeup. 

The EPA also fined Samsung Corp. $205,000 for selling a computer keyboard infused with silver nanoparticles. 

What’s more, according to news reports, when faced with up to $1 million in fines from the EPA, a retail company called The North Face was forced to stop making claims that its nanosilver footwear products protect against germs.

And finally, the EPA leveled a whopping $206,000 fine against the famous computer peripherals company, Logitech, Inc., for incorporating nanosilver into its computer keyboards without registering it with the EPA as a “pesticide” product! 

Do you understand now why all of those wonderful consumer products infused with antimicrobial silver are slowly disappearing from the marketplace? 

Regulatory Nightmare…

Last year, the EPA mandated which types of studies and tests would have to be conducted by companies wanting to manufacture products containing antimicrobial silver. 

Here’s just a partial list of these studies and tests a company must perform, including a staggering array of toxicity tests such as fish toxicity, bird toxicity, algal toxicity, human toxicity, inhalation toxicity, dermal toxicity, repeated dose toxicity, environmental toxicity, genetic toxicity as well as “environmental fate” toxicity tests and a host of other tests:

Tier 1 Data Requirements Product Chemistry

830.1550

Product Identity and Composition. Topology of the nanocomposite needs to be fully described. Information on the binding and distribution of nanosilver in the matrix (uniform or heterogeneous).

830.1750

Certified Limits. Data are needed on the upper and lower limits for the nanosilver present.

830.1800

Enforcement Method. Analytical method needs to include high resolution images of the active.

830.6313
 
Stability to Normal and Elevated Temperatures, Metals, and Metal Ions. Methods also need to include test of stability to sunlight, detergents, and salinity.

830.6317

Storage Stability. Storage Stability studies were submitted using accelerated method. EPA requires one-year study at ambient temperature.

830.6320

Corrosion Characteristics. See Storage Stability above.

830.7050

UV-Visible Light Adsorption. UV/visible spectrum of nano-material. This study is a reliable identification method for nanoproducts and one that the SAP recommended.

830.7520

Particle Size, Fiber Length, and Diameter (size) Distribution. Data required to characterize adequately the size distribution of the nanoproduct composite and the nanosilver particles in the composite.

830.7840

Water Solubility: Column Elution Method; Shake Flask Method is needed at pH 5, 7, and 9.

NoGuideline

Surface Area Determination. Data required to characterize adequately the size distribution of the nanoproduct composite and the nanosilver particles in the composite.

Environmental Fate

No Guideline

Dissolution Kinetics Study. This is a fundamental study on the persistence of the nanoparticle in the environment and the extent of silver ion or nanoparticle release. This test will dictate the test substance to be used for the Tier 2 other studies.

Environmental Effects

850.1010

Acute Toxicity Freshwater Invertebrates

850.1075

Freshwater Fish Toxicity

850.2100

Avian Oral Toxicity

850.5400

Algal Toxicity, Tier 2 The proposed use of the conditionally registered nanosilver product could lead to surface water contamination that could impact fish, invertebrates, avian, and algal communities. The above studies will address concerns regarding the potential risks of the nanosilver compound and will provide toxicity endpoints applicable to ecological risk assessment.

Human Exposure

875.1200
875.1400

Applicator, Indoor Exposure. These studies provide information useful for evaluating the form, route, and level of exposure experienced by workers who handle the nanosilver compound in the process of treating textiles. The exposure data are used in conjunction with the toxicology endpoints to assess the risk to applicators.

No Guideline

Textile Leaching Study. A leaching study is needed to determine what, if any, materials are released from the nanosilver treated textiles under conditions of use. This study should be done in the manner of Geranio et al. [no reference given] with the addition of electron microscopy to characterize the particulate.

Toxicology

870.3465

90-Day Inhalation Toxicity (Rat). This is a conditional required study triggered by the potential for inhalation exposure to the nanosilver based upon its formulation as a powder and is use in textiles.

870.3200

21-Day Dermal Toxicity (Rat). This is a conditional required study triggered by the potential for dermal exposure to the nanosilver based upon its formulation as a powder and its use in textiles. Consumer dermal exposures could occur while wearing treated clothing.

870.3650

Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test. This is a conditional required study triggered by the potential for incidental oral exposure to the nanosilver based upon its use in textiles.

870.5100
870.5300
870.5375
870.5385
870.5395

Genetic Toxicity Tests. Genetic toxicity tests are used to screen chemicals for mutagenic or carcinogenic potential. The data from these tests will be used to determine if the nanosilver product is a potential mutagen or carcinogen.

Tier 2 Requirements

Tier 2 data are required if the nanoparticles are released during the Tier1 stability, dissolution, or leaching studies. Tier 2 data requirements are the same as above for all disciplines except for the environmental fate studies listed below. The testing for Tier 2 should be carried out with the material(s) that are released from the nanosilver composite.

Environmental Fate

850.1730
 
Fish Bioaccumulation Factor. Bioconcentration studies will assess the potential that the test substance will accumulate in fish and therefore its potential to impact the food chain.

835.1230

Adsorption/Desorption (Batch Equilibrium). EPA is requesting adsorption/desorption equilibrium studies to be conducted with the nanosilver. This information will be used to assess the sorption of a test material on soil/sediment and to estimate exposure.

No Guideline

MITI Glucose. The purpose of the study is to assess the impact of nanosilver or its constituents on microbial activity in waste water treatment.

Are you boggled by the regulatory morass companies have to navigate in order to bring a product to market containing antimicrobial silver? 

You can bet the companies that would like to meet the consumer demand for such products are boggled, also -- so much so, in fact, that the numbers of new consumer products being produced with antimicrobial silver have now literally slowed to a trickle in the United States.  And the same thing is happening in other countries, as well.

The HeiQ Story:
A Cautionary Tale

Here’s an eye-opening example of the kind of nonsense companies have to go through in order to market a consumer product containing antimicrobial silver in the United States. 

You’ll be stunned to see that while such companies have to risk millions of dollars in the process, they have no guarantees their product will ever be allowed on the market even if they agree to comply with every regulatory hurdle.

Several years back, a Swiss company named HeiQ petitioned the EPA to allow them to market consumer products containing antimicrobial silver in the U.S. These products apparently included textiles such as sheets, blankets, towels, napkins, sportswear, sleepwear, undergarments, socks and hosiery.

After several year’s worth of negotiation, the EPA finally issued HeiQ a conditional permit to sell their products.  But it was strictly limited to four years.  In return, HeiQ had to agree to perform the required studies during the four year conditional period, and report the results to the EPA as each study was completed. 

The EPA apparently felt this would give them invaluable information on the environmental impact of consumer products containing antimicrobial silver.  And HeiQ felt this would allow them to demonstrate conclusively -- under real-world conditions -- that consumer products containing antimicrobial silver are no threat to the environment.

Of course, such testing is extremely expensive, in some cases costing hundreds of thousands or even millions of dollars to complete. And it all has to be done to strict EPA specifications and standards, or the tests results are simply rejected out-of-hand. 

As you can imagine, not many companies have the financial wherewithal to complete such an astonishing battery of tests on their products.  But HeiQ agreed, even though they knew that at the end of the four year conditional period, they could end up losing all of the money they’d invested on testing, plus potentially millions of dollars more in product development, manufacturing and marketing costs.

They apparently felt the risk would be worth it, if they could demonstrate conclusively, once and for all time, that consumer products imbued with nanosilver were environmentally safe.

Triggering the Ire of Environmental Groups

But when the EPA finally issued HeiQ a conditional permit to manufacture products infused with antimicrobial silver, it triggered the ire of anti-silver environmentalists groups who saw the EPA’s permit approval as a betrayal of their efforts to ban the sale of consumer products containing antimicrobial silver. 

That’s right.  It didn’t matter to the radical, anti-silver environmentalists that HeiQ was willing to complete all of those toxicology tests and demonstrate there would be no appreciable harm to the environment from their consumer products containing antimicrobial silver. 

And it didn’t matter that HeiQ had agreed to conduct and complete the testing at its own expense during the four years of its conditional permit. 

Nope.  The environmental groups simply acted in typical, sensationalistic knee-jerk fashion and sued the EPA for granting HeiQ the permit claiming essentially that the EPA had acted in reckless disregard for public safety in granting the permit!

Indeed, on January 26, 2012, the Natural Resources Defense Council (NRDC) filed suit against the Environmental Protection Agency (EPA) over the HeiQ permit. 

The NRDC is known as one of the country’s largest environmental lobbying and litigating groups – which means if they can’t force their agenda on you politically, they’ll happily sue the daylights out of you, instead.   

According to news reports, this radical anti-silver group insists that HeiQ should have to conduct all of the required studies and tests without ever manufacturing a single product containing antimicrobial silver. This of course, is a physical impossibility. You can’t test the potential environmental impact of a product that doesn’t exist

Even the EPA, not always known for being reasonable, had ruled that the marketing and sales of the HeiQ consumer products containing antimicrobial silver would pose “no unreasonable adverse health or environmental effects” in such a short time. 

And this is true, of course, particularly considering the fact that antimicrobial silver has already been used commercially for over 120 years and to date has never caused a single serious environmental concern.

But the enviro-litigators in the Natural Resources Defense Council saw it otherwise.  They claim the EPA must consider the HeiQ products to be dangerous “pesticides” right from the get-go, without any evidence, and disallow their sales. 

And now years of litigation must go by before HeiQ will ever know whether or not it can finally begin to manufacture and sell its products here in the U.S., and conduct the necessary regulatory testing.

Regulatory Hell

After seeing this, how many other companies do you think will attempt to meet the growing consumer demand for products containing antimicrobial silver?  The likelihood is:  None.   

Why:  Regulatory hell.  After all, the risks are just too great.  Companies like this have to spend millions of dollars on product development and manufacturing.  Then they have to spend hundreds of thousands or even millions more to meet the costs of the regulatory requirements. 

And after all of that, there’s no way for them to know whether or not, at the whim of some lawsuit-happy environmental group or some faceless environmental bureaucrat, they’ll lose every penny of their investment and never be able to recoup their substantial costs.

The risk-costs of doing business under such an egregiously contentious anti-business environment are just too high, and the environmentalists know it.

They don’t really want to know whether or not antimicrobial silver will harm the environment.  They simply want to make sure it is so financially risky to bring consumer products that utilize antimicrobial silver to market that no company will even attempt it.

And that, my friends, is exactly how the environmentalists have destroyed the market for antimicrobial silver, and deprived consumers of its powerful, infection-fighting protection.

The Plain Truth, Left Untold…

Of course, what the environmentalists always fail to mention when they sensationalistically claim that antimicrobial silver is “threat to the environment” is that silver came from the environment in the first place

And more importantly, they fail to mention that the world is already awash in natural trace silver without any harm whatsoever to the environment or to the ecology. 

In fact, the oceans alone contain millions of tons of natural trace silver, and have for millions of years.  Yet they’re teaming with life from the smallest microbe to the biggest whale. 

What’s more, the lakes and streams of the world contain tons of natural trace silver, yet they too are teaming with life.  Indeed, the very ground you walk on contains tons of natural trace silver, yet it is abundantly rich in microbial life as well as numerous other forms of life. 

You see, in nature, silver tends to bond rapidly with other natural substances, such as biological silica, salts, sulfur and other common minerals that in turn neutralize its powerful antimicrobial qualities. 

So the entire idea that adding a little bit of nanosilver to a computer keyboard or kitchen cutting board or plastic food container to keep germs from growing on it will "harm the environment" is ludicrous at face value. 

But the truth be damned, because once the environmentalists get their hands around a thing, they simply won't let go of it.   

While They’re Still Legal…

In this age of strange diseases, widespread infections and antibiotic-resistant super-pathogens, I hope you’ll consider the many dramatic and potentially life-saving benefits of making your own high-quality colloidal silver with a new Micro-Particle Colloidal Silver Generator.

By putting the means of colloidal silver production into your own hands, you guarantee yourself access to this remarkable natural infection-fighting agent for life – no matter what the environmentalists do.  But you must act quickly and decisively while these little machines are still legal to sell. 

After all, it won’t be long before the environmentalists turn their sites on them, too.  Learn more about the powerful antimicrobial qualities of colloidal silver by clicking the link. 

Yours for the safe, sane and responsible use of colloidal silver,


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Important Note and Disclaimer:  The contents of this Ezine have not been evaluated by the Food and Drug Administration.  Information conveyed herein is from sources deemed to be accurate and reliable, but no guarantee can be made in regards to the accuracy and reliability thereof.  The author, Steve Barwick, is a natural health journalist with over 30 years of experience writing professionally about natural health topics.  He is not a doctor.  Therefore, nothing stated in this Ezine should be construed as prescriptive in nature, nor is any part of this Ezine meant to be considered a substitute for professional medical advice.  Nothing reported herein is intended to diagnose, treat, cure or prevent any disease.  The author is simply reporting in journalistic fashion what he has learned during the past 17 years of journalistic research into colloidal silver and its usage.  Therefore, the information and data presented should be considered for informational purposes only, and approached with caution.  Readers should verify for themselves, and to their own satisfaction, from other knowledgeable sources such as their doctor, the accuracy and reliability of all reports, ideas, conclusions, comments and opinions stated herein.  All important health care decisions should be made under the guidance and direction of a legitimate, knowledgeable and experienced health care professional.  Readers are solely responsible for their choices.  The author and publisher disclaim responsibility or liability for any loss or hardship that may be incurred as a result of the use or application of any information included in this Ezine.

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