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In earlier columns I focused on the regulation of nanotechnology by the Environmental Protection Agency (EPA) under the Toxic Substances Control Act (TSCA). The Agency, perhaps emboldened by calls for TSCA reform and introduction of the Safe Chemicals Act, has taken a more aggressive enforcement stance and recently announced its intention expand this role under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The statute regulates pesticides and antimicrobials but federal officials have been largely silent on the impact of nanotechnology under the statute. Recent proclamations by EPA officials indicate that change is in the wind once again.
May 23rd, 2010
The Steady Drum Beat of Nanotechnology Regulation
EPA to Propose Regulatory Policy Based on New FIFRA "Interpretation"
A meeting of the FIFRA Scientific Advisory Panel last fall was one of the few times the Office of Pesticide Programs (OPP) publicly addressed nanotechnology and that was only in response to a citizen petition. In a presentation by OPP's Senior Policy Advisor, William Jordan, at the Pesticide Program Dialogue Committee meeting in April, acknowledged that at least one unnamed product on the market contained nanosilver but it was approved without the knowledge that it contained a nanomaterial. The product had been registered as a material preservative like many other registered silver products.
Jordan also conceded that there are probably other registered pesticides that contain nanoscale materials and indicated that OPP will attempt to identify these products and take appropriate regulatory action. There are several pending nanopesticides applications containing nanosilver and at least one product is pending which contains halloysite, a naturally occurring aluminosilicate nanotube.
OPP expects to issue a Federal Register Notice in June 2010 announcing a new "interpretation" of FIFRA in addition to proposing a new policy. The new interpretation is expected to provide several nano-specific approaches to the regulatory enforcement of FIFRA including: a requirement to report the presence of a nanoscale material in a pesticide product; all actives and inert ingredients will be considered "new" if it is a nanoscale material; and application of the policy for any new products or any previously-registered products. The last change could have a significant impact on products containing nanoscale silver because it will apply even though silver is already a registered pesticide.
Initial Emphasis on Nanoscale Silver
Nanoscale silver provides an excellent example of the challenges facing the EPA in establishing regulatory policy for the products of nanotechnology. Silver has been used medicinally for millennia and is registered as a pesticide yet the agency has spent more time on this one substance than any other nanomaterial despite a rather vocal response from the public touting its beneficial properties rather than its hazards.
The original petition by the International Center for Technology Assessment and 13 other organizations requested action by the EPA on an estimated 600 unregistered nanosilver products marketed in the U.S. The petition called on the EPA to regulate nanosilver as a pesticide citing the toxicity of silver and the prospect that nanosilver may be even more toxic to humans and the environment than bulk silver.
The Agency formed a FIFRA Scientific Advisory Panel to address questions on the evaluation of hazards and exposures from nanosilver and other nanoscale metal pesticide products and the Office of Research and Development is developing a Draft Case Study on Nanosilver which is expected to be released in June 2010. EPA's response to the citizen petition is expected to be released around the same time, according to Jordan. It will be interesting to see how the Agency deals with the hundreds of responses to the petition submitted to the public docket by individuals claiming a long history of colloidal silver as a medicine.
Enforcement Action Continuing
The EPA may not have all of the information it needs to determine if nanosilver is safe but it continues to take enforcement action on companies making unproven antimicrobial claims. Over $500,000 in fines have been levied against four companies using nanoscale silver in their products that made, but failed to prove, antimicrobial product claims. Under FIFRA, products that claim to kill or repel bacteria or germs are considered pesticides and must be registered with the EPA prior to distribution or sale.
"EPA will take decisive action against companies making unverified public health claims," said Jared Blumenfeld, Regional Administrator of EPA's Pacific Southwest region. "Unless these products are registered with EPA, consumers have little or no information about whether their claims are accurate."
VF Outdoor, Inc., a California-based company marketing the North Face label, will pay $207,500 for allegedly making unsubstantiated health claims including "antimicrobial protection" and inhibiting the growth of "disease-causing bacteria" for more than 60 shoe products. Similar claims led to a fine of $220,000 for another California company, Califone International, Inc. which marketed headphones claiming "to prevent the spread of bacteria, mold and mildew for student protection."
Component Hardware Group of Lakewood, New Jersey and John S. Dull Associates were fined nearly $100,000 for marketing sanitizers, disinfectants and other products to hospitals including faucets, spigots, handles, light switch and socket covers, door push and pull plates, and food service hardware. The companies claimed the products would control the growth of bacteria and contain antimicrobial technology that controls growth of E. coli, salmonella, staph and pseudomonas on treated surfaces. While the North Face, Califone, and Saniguard products all incorporated EPA-registered silver-based antimicrobial compounds to protect them against deterioration, they were never tested or registered to protect consumers against bacteria, fungus, mold, and/or mildew.
"We're seeing more and more consumer products making a wide variety of antimicrobial claims," said Katherine Taylor, associate director of the Communities and Ecosystems Division in EPA's Pacific Southwest region. "Whether they involve shoes, headphones, or household fixtures, EPA takes these unsubstantiated public health claims very seriously."
EPA Needs Better Engagement with Stakeholders
While followers of the debate over nanomaterials as ‘new' or ‘existing' substances under TSCA will note that the Agency has had public meetings and presentations by officials for years, OPP has struggled to establish a path forward in evaluating pesticides made at the nanoscale or pesticides containing nanomaterials in formulations. The recent public presentations represent a big step forward in an increasingly active regulatory climate regarding nanotechnology and nano-enhanced products.
With plans to re-interpret FIFRA and enforcement activity on nanomaterials increasing, it's time for the EPA to engage in a broader stakeholder dialogue on nanotechnology and pesticides. Public discussions on nanomaterial safety have been going on for years which have led to a better understanding of nanotechnology applications and potential hazards. Nanoscale silver isn't the only nanomaterial that can be used in pesticides and there needs to be better engagement with producers and users of a wider range of nanomaterials. The public meetings on nanosilver are a good start but the stakeholder universe extends beyond that realm and broader public engagement deserves more than an agenda item for a Pesticide Program Dialogue Committee meeting. The anticipated Federal Register notice proposing a new regulatory policy will provide a platform for serious stakeholder dialogue which can only enhance the growth and development of safe pesticides incorporating nanotechnology for years to come.