Following up on their 2008 Petition to EPA, a group of environmental and food safety citizens groups has filed suit in federal court to compel the US Environmental Protection Agency (EPA) to regulate consumer products that contain nano-scale silver particles. Nano-scale materials are generally engineered at the sub-molecular level to enable certain properties which are enhanced by the small size of the molecular configurations (often as minute as 1–100 nanometers in length).
Makers of consumer products that incorporate silver often claim that the silver in their products has antimicrobial properties that can eliminate or limit germs. EPA has the authority to regulate such products under the federal pesticide law (FIFRA). For decades, EPA has registered silver-containing pesticide products. The explosion of consumer demand for products claiming to fight germs, however, has created a robust market for products that incorporate antimicrobials (including silver and copper-based active ingredients) and are sold with claims suggesting the product is safer to use due to its “germ-fighting” properties.
EPA’s authority to regulate “treated articles” that are formulated using antimicrobial substances is well established. Eight years ago, nevertheless, EPA provided a painful reminder of its ability to reach silver-containing consumer products marketed with antibacterial claims, when it took action in response to the introduction of a popular washing machine that incorporated silver and touted its antimicrobial properties. Since then, EPA has repeatedly asserted through a series of enforcement actions that the Agency may restrict consumer products incorporating silver, including nano-scale silver, unless they are distributed in a manner that complies with FIFRA.
In 2008, EPA issued a Federal Register notice seeking public comment on the Center for Food Safety’s Petition (here and here) and has issued numerous other notices related to silver-based ingredients that may be incorporated into consumer products; each time reasserting its jurisdiction over nano-silvers. In 2009, EPA convened a scientific advisory panel meeting to review and advise EPA on the latest science concerning nano-scale silver (and other nano-scale metals). Following the meeting, the Agency issued a proposed “policy statement” pursuant to which EPA would presume that a nano-scale form of a previously-registered active or inert ingredient in any pesticide or antimicrobial product is a “new” ingredient if the existing registration for the same active ingredient did not specify use of a nano-scale molecule. This would trigger a requirement to register the new ingredient and provide certain health and environmental safety data to EPA. Notwithstanding the Agency’s activities with respect to nano-scale silver, a 2012 report by EPA’s Office of Inspector General found flaws in EPA’s regulatory regime for oversight of nano-scale materials more generally. No doubt, this encouraged the recently-filed lawsuit.
The Plaintiffs in the current case are trying to persuade a federal judge that EPA has failed to provide a timely response to the 2008 Petition and order EPA to respond to the 2008 Petition, to compel an EPA rulemaking, and to award attorneys’ fees and other expenses.
Pending the outcome of the litigation, 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.
For a more detailed discussion of this issue, click here.