December 9, 2008
We are closely tracking regulatory and legislative activity relating to the regulation of nanotechnology, which is an emerging technology that involves an increasing number of products and businesses. In light of recent activity by Congress, the Environmental Protection Agency (EPA), and the Food and Drug Administration, we expect that a new federal nanotechnology regulatory environment will begin to develop in 2009. We will provide updates on information and legal issues that might prove useful to nanotechnology stakeholders as regulation and law develops in this area.
This update focuses on the Environmental Protection Agency’s November 19, 2008 announcement that it will accept public comments until January 20, 2009 on a petition requesting the regulation of nanosilver products as pesticides. The EPA’s response to this petition could set the tone for broader nanotechnology regulation; therefore, this comment period is an auspicious opportunity for nanotechnology-related industries to participate in the formative stages of this technology’s regulatory development.
EPA’s Potential Regulation of Nanosilver Products as Pesticides
On May 1, a coalition of consumer groups led by the International Center for Technology Assessment (ICTA) filed a Petition for Rulemaking to the United States Environmental Protection Agency. The Petition asks for the review and regulation of 260 self-identified nanosilver consumer products under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq. The 100-page Petition, which includes an appendix listing the companies that sell nanosilver products, contends that “scientific studies have demonstrated the potential of nanomaterials to present serious toxicity risks for human health and ecosystems.”
With regard to nanosilver in particular, the Petition asserts that it has “quickly become the most commonly used nanomaterial in consumer products” and that “while the risks of nanosilver to the environment and human health are not well understood, existing studies have indicated cause for concern, such as harmful impacts on fish and aquatic ecosystems, potential interference with beneficial bacteria in our bodies and the environment, and the potential development of more virulent harmful bacteria.”
The Petition asks EPA to (1) classify nanosilver as a pesticide under FIFRA, (2) require manufacturers to register nanosilver according to FIFRA pesticide regulations, (3) analyze potential health and environmental risks of nanosilver, (4) prohibit the sale of nanosilver as an unregistered pesticide product, (5) apply pesticide regulations to any registered nanosilver products, and (6) undertake any reviews necessary to ensure proper regulation of nanosilver as a pesticide.
In response, EPA announced on November 19 that it is seeking public comments on the petition for 60 days—until January 20, 2009. 73 Fed. Reg. 69,644 (November 20, 2008). EPA’s notice states that “scientists have identified that nanoscale materials can have fundamentally different properties from the non-nanoscale or bulk forms of the same compounds, and that these unique properties may pose new environmental and human health risks.” EPA determined that the ICTA Petition “raises serious issues that potentially affect private and public sector stakeholders” and will review any comments received “before deciding how best to respond to the petition.”
There is reason to believe that this Petition could lead to future federal efforts to control nanosilver products, and there are several possible actions EPA could take through formal rulemaking or enforcement actions that would affect companies manufacturing or using nanosilver. In fact, EPA has already enforced nanosilver as a pesticide under FIFRA this year. On February 27, EPA settled with a company that allegedly violated FIFRA by marketing computer keyboards and mice coated with nanosilver as having antibacterial qualities without registering them as “pesticides.”
As we are at the beginning of nanotech regulatory activity, EPA’s response to this Petition could set the tone for a future nanotechnology regulatory framework. And nanotechnology, what some term a “general purpose technology” much like the Internet, will significantly impact a wide range of industry sectors and products. Although many applications of nanotechnology are not yet commercially available, over 800 manufacturer-identified nanotech products are already in the marketplace today, with an addition of about one new nanoproduct hitting the market every working day. It is estimated that by 2012 nanoproducts will account for 15 percent of total global manufacturing. This comment period therefore presents an opportunity for industries that may be significantly impacted by this emerging technology to address the shape of nanotechnology regulation at its inception.
Comments must be received by EPA on or before January 20, 2009, and they should be directed to docket ID EPA-HQ-OPP-2008-0650. Comments may be submitted online at http://www.regulations.gov, or by mail to the Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, D.C. 20460.
Gibson, Dunn & Crutcher lawyers are available to assist in addressing any questions you may have about these developments.
To learn more about the firm’s Environment & Natural Resources Practice, please contact the Gibson Dunn attorney with whom you work, or Jeffrey D. Dintzer (213-229-7860, [email protected]) in Los Angeles, or Peter E. Seley (202-887-3689, [email protected]) in Washington, D.C.
© 2008 Gibson, Dunn & Crutcher LLP
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