December 29, 2014

New Lawsuit Seeks EPA Regulation of Products Containing Nano-silver

Arnold & Porter Advisory

In mid-December, a group of plaintiffs filed suit in federal district court seeking to compel the U.S. Environmental Protection Agency (EPA) to take certain steps to regulate consumer products that contain nano-scale silver particles.  The actions follows up on a 2008 petition filed with EPA by the same group of non-governmental organizations (NGOs) to which the groups assert EPA has failed to respond.1 The group of plaintiffs include Beyond Pesticides and the Center for Food Safety (Center for Food Safety et al v Gina McCarthy; Case No. 14-cv-2131). 

For a number of years, makers of consumer products have included silver in certain forms and marketed the products bearing claims that the silver has antimicrobial properties (e.g. "this product kills germs").  EPA regulates pesticides, which includes antimicrobial products, under the federal pesticide law (FIFRA).  Products that bear antimicrobial claims may be marketed lawfully if they conform with EPA regulations, which require, among other things, that the active ingredient in the product and the claims made for the product are in conformance with a registration issued by EPA.  EPA first registered silver as an active ingredient for use in pesticides and antimicrobials decades ago.2 Silver has been incorporated into countless consumer-use products including articles as large as household appliances to as small as fabrics used in socks.  Other products include those that also can be subject to the jurisdiction of the Food and Drug Administration (FDA), such as food contact articles, cosmetics and even toothbrushes.

It has been eight years since EPA asserted its ability to regulate silver-containing products when they are marketed with antimicrobial claims by taking action in response to claims that a washing machine that incorporated silver had antimicrobial properties.  Since then, EPA has repeatedly asserted that it has and will continue to regulate products using silver, including nano-silver, for such purposes unless they are distributed in a manner that complies with a registration or an exemption from FIFRA.  For example, in September 2007, EPA issued a Federal Register notice to clarify its position that silver ion generating equipment will be treated as a pesticide.3  In the years that have followed, EPA has issued subsequent Federal Register notices asserting its jurisdiction over nano-silver, seeking public comment on the 2008 petition filed by plaintiffs in the current litigation,4 issuing registrations for certain silver-based active ingredients that may be incorporated into consumer products, and requesting data from registrants of silver products.5 There has been no shortage of enforcement actions taken by EPA against makers and distributors of certain consumer products (including computer keyboards) marketed with explicit and implicit pesticide claims implying  the products killed harmful germs.6   In 2009, EPA even convened  a scientific advisory panel meeting to review and advise EPA on the latest science concerning nano-scale silver (and other nano-scale metals) having uses in pesticides.7  EPA later issued a proposed "policy statement" pursuant to which EPA would presume that a nano-scale form of a previously-registered active or inert ingredient is a "new" ingredient if the existing registration for the same active ingredient did not specify use of a nano-scale molecule.8  This would trigger a requirement to register the new ingredient and provide certain health and environmental safety data to EPA.9  More recently, a 2012 report by the EPA's Office of Inspector General found flaws in EPA's regulatory regime for oversight of nano-scale materials more generally.10  No doubt, this encouraged the recently-filed law suit.

Notwithstanding the litany of actions taken by EPA concerning nano-silver in pesticides during the 6 years following receipt of the Plaintiffs' 2008 Petition, the Plaintiffs assert EPA has thus far "failed to address the risks of pesticide nano-materials such as nano-silver-containing products," further asserting that, "questions persist as to the potential risks associated with nano-silver and other nano-materials" and, echoing themes suggested by IG's report that "studies indicate that nano-technology-based products may be harmful to beneficial bacteria, fish, and aquatic ecosystems."  Consequently, the Plaintiffs filed suit under the Administrative Procedure Act (APA) seeking declaratory and injunctive relief compelling EPA pursuant to Section 706 of the APA to take action in response to the 2008 Petition.  Plaintiffs also allege EPA has violated FIFRA, the Food Quality Protections Act, the Endangered Species Act, and the National Environmental Policy Act. Citing among the many reasons that EPA should be compelled by the Court to take action, plaintiffs claim that "[s]ome researchers suggest that nano-silver could damage bacterial cells by destroying the enzymes that transport the cell nutrient and weakening the cell membrane or cell wall.  Other researchers believe nano-silver destroys the ability of the bacteria's DNA to replicate."  Moreover, "[o]nce released, there is no way to recall nano-particles…[which] will likely threaten the beneficial bacteria that underpin ecosystem functions."  Frustrated that EPA has not acted through a rulemaking, Plaintiffs assert that "EPA's proposed guidance and singular enforcement actions are utterly inadequate to fulfill the agency's statutory duties with regard to protecting health and the environment from the impacts of nano-pesticides."  Thus, Plaintiff are hoping to persuade a federal judge to declare that EPA has violated the APA by failing to provide a timely response to the 2008 Petition and order EPA to respond to the 2008 Petition and "award Plaintiffs attorneys' fees and all other reasonable expenses incurred in pursuit of this action."

It is not entirely clear at this juncture what the Plaintiffs really hope to achieve, especially given the long list of actions to which EPA will likely refer to make a case that it has responded to the 2008 Petition (although at this writing, EPA has not yet filed its Answer in response to the Complaint).  It may be that the Plaintiffs hope to reach a settlement with EPA in which the Agency commits to take a regulatory action (perhaps issuing a final version of its proposed policy statement) by a certain date.  Such a settlement might be intended to provide a "friendly" outcome for EPA by providing leverage to the Agency and help it avoid having to seek Office of Management and Budget approval for any final EPA action taken in response to the Petition and the lawsuit. 

Makers of consumer use products that contain silver, whether or not such products are marketed with explicit antimicrobial claims, are encouraged to monitor EPA actions, and Arnold & Porter's website, for further updates.

  1. For a 2009 Arnold & Porter advisory discussing this petition, please click here.

  2. U.S. Envtl. Prot. Agency, Registration Eligibility Document, Silver 19 (1992), available here.

  3. Pesticide Registration; Clarification for Ion-Generating Equipment; Notice, 72 Fed. Reg. 54039, Sept. 21, 2007.

  4. Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Notice of Availability, 73 Fed. Reg. 69644, Nov. 19, 2008; Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides; Extension of Comment Period, 74 Fed. Reg. 2072, Jan. 14, 2009.

  5. Available here.

  6. For example, see U.S. Envtl. Prot. Agency, U.S. EPA Settles with Calif. Shoe Insert Companies (Aug. 12, 2014), available here.

  7. Available here.

  8. 76 Fed. Reg. 35383 (June 17, 2011).

  9. Pesticides; Policies Concerning Products Containing Nanoscale Materials; Opportunity for Public Comment, 76 Fed. Reg. 35,383 (June 17, 2011).  The proposed statement noted the policy to be non-binding, permitting EPA to waive the presumption on a case-by-case basis. Id. at 35,393.

  10. Available here.

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