Size Matters

When is a washing machine not a washing machine? When it’s a pesticide. Last month, the Environmental Protection Agency (EPA) took the unusual step of ruling that Samsung’s high-tech SilverCare line, which the company says kills germs by flushing 100 quadrillion nanoparticles of silver into each wash load, should be treated - and regulated - just like any other germicidal product.

The decision caused a stir in green circles: It’s the closest any government agency has come to regulating nanotechnology, the science of building structures on scales 1/80,000th the width of a human hair. But officials quickly moved to dampen the excitement, saying they would only monitor products that claim to kill germs; all other nano-products - even those using exactly the same technology as Samsung’s machines - would continue to go unregulated.

The move perpetuates the agency’s long-standing laissez-faire approach to nanotechnology: From a regulatory standpoint, officials argue, size simply doesn’t matter. Why treat nanoparticles of silver and carbon any differently than one would treat silver cutlery or carbon pencil leads?

Unfortunately, the value of nanotechnology lies in the fact that on a nano-scale, substances behave very differently. That can be enormously useful - carbon nanotubes are stronger than steel, and conduct electricity better than copper - but are also highly dangerous. Some nanocarbons cause fatal lung diseases in lab rats; nanosilver, the most common particle in commercial use, is toxic to aquatic life and numerous ecologically important microorganisms.

That might not matter if nanotechnology were still the stuff of bad sci-fi; but the science of small things has moved off the drawing board and into the marketplace. Nanotechnology is already on American shelves, in everything from condoms and cosmetics to beer bottles and baby toys. The global market already tops $50 billion, and is expected to reach $1 trillion by 2015.

So far, the scant efforts to regulate the industry have been driven by nanotech companies themselves, who are well aware of the potential risks and hope to head off a damaging backlash. Unsurprisingly, that’s led to business-friendly policies, with companies dictating the terms of voluntary risk reduction deals and even convincing lawmakers to consider shielding them from future lawsuits and cleanup costs.

Nanotechnology is a promising technology, with potential uses in everything from treating HIV to preventing pollution; greens shouldn’t align themselves with the grey goo brigade who believe it should be banned altogether. But we do need to understand the risks as we move forward - and that means proper regulation. It’s time the EPA stopped ducking the issue and did its job.

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When is a product of nanotechnology not a product of nanotechnology? When it merely electrolyzes a block of silver to form silver ions. While I agree that care should be taken when introducing metals such as silver into the environment, I am disappointed to see that this blog entry continues to perpetuate the misperception that there's anything "nano" about this device. Despite the highly equivocal and contradictory language employed by Samsung (nano-silver, silver nanoparticles, silver ions, Ag+), it is extremely unlikely that this device is releasing anything other than silver ions (Ag+) into the wash water. Silver ions are not nanoparticles, therefore this device is not a product of nanotechnology. So keep the discussion going about the merits of releasing silver into the environment, but lose the nano frame, please.

This article is almost totally misinformation and indicates the author did not actually read the Federal Register Notice, has no clue about the definition of nanotechnology, or has put a lot of spin on the truth for his own self interest. First, the Federal Register notice of 17 September clearly identifies the active substance used by the Samsung device as “silver ions” and the word “nano” does not appear at all in the notice. Silver ions do not represent nanotechnology. They are not particles but hydrated soluble ions; a technology that has been in use over 100 years as an antimicrobial. Second, the author states that other devices using the same technology will go unregulated. How can a clear statement by the EPA that ion generators using a “substance (e.g. silver or copper) in the form of an electrode…………must be registered prior to sale or distribution” be misinterpreted by 180 degrees?

ASTM published E2456 in November 2006 providing consensus definitions for nanotechnology terms. Nanoparticles are accepted to mean a particle with lengths in two or three dimensions greater than a nanometer but less that 100 nanometers. A silver ion is round with a diameter of 0.23 nm. Maybe if you could get 40 of these to stick together you could have a nanoparticle – but being negatively charged they repel one another and will not combine to form a larger structure.

Taking EPA to task for not already regulating nanoparticles displays a lack of understanding about the regulatory system and process. Under FIFRA, EPA cannot regulate a nanotechnology product unless a manufacturer presents it to them for registration or a nanotechnology product is found in use as a pesticide – even then EPA would only be able to stop it’s sale and not regulate uses until it was presented for registration. There are greater possibilities to regulate nanomaterials under the Toxic Substance Control Act (TSCA), where EPA could chose to regulate a nanomaterials made of a substance already on the TSCA inventory by declaring the application as a significant new use of an existing material, or more likely manufactures will present nanomaterials to the EPA for review as a new chemical. EPA is to be commended for allocating resources to study nanotechnology and its health and environmental implications and joining in the ongoing debate about the safety of specific nanomaterials. The EPA realizes that nanotechnology is going to be with us for the long term and that they need to develop a coherent policy for regulation across all offices. We should all commend the Agency for not stifling this technology but watchfully let it develop as many opportunities for pollution prevention and remediation will be presented by the emerging technology.

Hi there - and thanks for taking the time to comment. You’ve both certainly got plenty of chops in this area - Kristen runs ICON, Rice University’s project aimed at bringing together academic, industry and regulatory nanotech stakeholders; Elmer is a consultant who helped with EPA negotiations on the Samsung project - so thanks for sharing your views.

You both make the valid point that it’s debatable whether the technology used by the Samsung devices actually qualifies as nanotechnology, since the particles of ionized silver the machines produce fall below the lower size limits for nanoscale particles. I tend to see this as hair-splitting (or 1/80,000th-of-a-hair splitting, if you will); despite the ASTM standards, nanoscale definitions aren’t universally agreed upon, and even if they were the logic of the EPA decision would appear to apply to nanoscale products as well as to products that emit “sub-nano” particles.

Regardless, though, the EPA’s ruling - which took pains to avoid regulating the Samsung devices qua nanotechnology - remains the closest any government agency has come to regulating nanotechnology, and has rightfully stirred up fresh debate about the government’s role in monitoring this important and growing sector. My view, at least, is that nanotechnology is an exciting and important new technology that will be with us for a long time to come; as such, it merits coherent and serious study by the EPA and other government agencies. As a regulatory philosophy, “size doesn’t matter” simply isn’t good enough.

From a scientific perspective, I respectfully disagree that a lower limit on size is not an important feature of the definition of nano. Without such a limit, all garden-variety chemistry becomes nanotechnology. That steals much of the novelty from nano which should derive from effects distinct from individual molecules or ions (as in the washing machine) and distinct from objects that behave like macroscopic materials. While I know plenty of chemists who might like to reframe their chemical research as nanotech, if only to access the generous funding streams available in the US for nano research, there is still a difference.

From a regulatory perspective, I completely agree that whether or not the device is nanotech is irrelevant. What matters is the impact of the product on the environment. I also agree that EPA should carefully consider whether a nanoparticle should be treated as having a unique molecular identity, which is relevant under TSCA. Those definitions seem very rigidly based on what the material is rather than what it does. That's why and how nano might slip through the cracks (I can pun, too!)

As for this being the closest thing to regulation, EPA has already made regulatory decisions about nanomaterials under TSCA when it passed 15 nanoscale materials through its review process for not being different from materials already on the inventory or found to be benign. I guess you could count that as regulation in that they applied a statute and made a regulatory decision.

But let's not forget the Berkeley notification statute which, if I'm not mistaken, was the nation's first nano-specific regulation.

Reducing EPA’s July 2007 guidance piece to “size dosen’t matter” is akin to arguing that nanotechnology products are completely exempt from chemical regulation and MSDS requirements because they meet the definition of “Article”. (An "article" means a manufactured item: (1) which is formed to a specific shape or design during manufacture (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and (3) which does not release, or otherwise result in exposure to, a hazardous chemical under normal conditions of use. Any product which meets the definition of an "article," would be exempt from the requirements of the Standard. 29CFR1910.1200).

Clearly size does matter to EPA. Simply look at all the EPA work on the differential hazards of various sized particulates in air and you can feel confident EPA has a grasp on the influence of size. In the wonderful world of new chemicals; however, EPA’s hands are tied by the Toxic Substance Control Act which treats all size particles of a substance as equal. If EPA would brand carbon nanotubes as dangerous, it would drag carbon fibers right along. I won’t go on for now but another philosophical point might be useful for context as you are a “Brit”.

Our ancestors came to America to escape “regulation” and we call it the Land of the Free for that reason. We allow ourselves to be regulated for the common good but not without a struggle and a cup of tax-free tea. There is less responsibility on government to assure our safety than in Europe but more responsibility on industry to release safe products and this is enforced to a large part by legal remedies through active litigation. Ben, as we grew up with different philosophies, it is inevitable that our views will be different. I may argue with you but I will defend your right to have your own opinion (free of regulation; sorry, but couldn’t resist).

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