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EPA Requests Comments on Rulemaking Petition Seeking Greater FIFRA Regulation of Nano-Silver

Beveridge & Diamond, P.C. - Client Alert, December 3, 2008

The Environmental Protection Agency (“EPA”) recently published a Federal Register notice (73 Fed. Reg. 69,644 (Nov. 19, 2008)) making available for comment a petition by several non-governmental organizations requesting that EPA take significant actions to regulate nanoscale silver products (“nano-silver”) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA,” 7 U.S.C. §§ 136 to 136y).  EPA’s case-by-case framework for pesticide regulation under FIFRA already applies to pesticidal uses of nano-silver, but the Federal Register notice provides an important opportunity for a high-level discussion about the future regulation of nanotechnology-enabled pesticides, including nano-silver.  The notice may also foreshadow increased EPA enforcement against some nano-silver applications. 

FIFRA Background

Some nanotechnology enterprises may be unaware that their products may be subject to FIFRA requirements.  Under FIFRA, no one may distribute or use a pesticide or an article containing a pesticide, including an antimicrobial pesticide, unless it is registered by EPA, or unless it is exempted by the regulations.  A substance or article is deemed a “pesticide” based on the intended purpose, whether expressly claimed or merely implied.  In order to register a pesticide or a new use of a registered pesticide, EPA must find on a case-by-case basis that using the pesticide according to the restrictions and specifications imposed by EPA “will not generally cause unreasonable adverse effects” on the environment or human health.  EPA also has extensive authority to regulate pesticide research and to require generation of data.  Silver is a registered antimicrobial pesticide under FIFRA, approved (most recently in the 1993 re-registration eligibility decision) for water purification uses in drinking water systems and swimming pools—with no mention of particle size. 

Nanotechnology and Nano-Silver Background 

Nanotechnology raises new issues under this FIFRA regime.  Nanotechnology is generally defined as the manipulation of matter at approximately the 1-100 nanometer (billionth of a meter) scale to create particles and materials that exhibit new and useful properties due to, among other attributes, their tiny scale and large relative surface area to volume ratio.  Nano-silver is one of the most common embodiments of nanotechnology, and has been used as an antimicrobial agent in water purifiers, food storage containers, curling irons, clothing, toys, electronics, and various other consumer products.  As a result of its growing market, nano-silver has recently been the focus of extensive analysis and important regulatory actions.  In particular, in September 2007, EPA determined that a silver-ion-generating washing machine would be regulated as a pesticide, though it maintained (contrary to many press accounts) that this action did not constitute a regulation of nano-silver.  EPA Region 9 also settled a landmark FIFRA enforcement action in February, 2008 against a company it said was selling unregistered pesticides in its nano-silver coated computer keyboards and mouses; the company paid a fine of more than $200,000. 

The Nano-Silver Rulemaking Petition

The petition on which EPA is seeking comment, filed on May 1, 2008 by the International Center for Technology Assessment (“ICTA”) and allied groups, argues that a number of consumer products do not meet FIFRA requirements and that EPA should therefore take action using a variety of regulatory tools.  The petition asks the EPA to initiate a formal rulemaking proceeding to:

  • Classify nano-silver as a new pesticide and require the registration of nano-silver products.
  • Clarify the definition of “pesticidal intent.”
  • Analyze the potential human health and environmental risks of nano-silver under FIFRA and other statutes (including the Food Quality Protection Act, Endangered Species Act, and National Environmental Policy Act.

Take regulatory actions against more than two hundred nano-silver products purportedly illegally sold without FIFRA approval.  (The list of products in an appendix to the petition appears to include some which are not pesticides, would be exempted under FIFRA, or are not sold in the United States.) 

  • Fully apply all FIFRA labeling, post-registration, and other requirements to any nano-silver pesticides that receive EPA approval.
  • Take other FIFRA actions for oversight of nano-silver, including undertaking a classification review and a special review, requiring data submission, amending regulations, regulating nano-silver devices, and setting a pesticide tolerance.

Most of these requested actions do not require a rulemaking by EPA.  For example, EPA analyzes and classifies pesticides on a case-by-case basis whether they are nanoscale or not and also already defines “pesticidal intent” broadly to include implied intent.  Nevertheless, the petition demonstrates that clearer notice and guidance from EPA would be helpful, especially in light of the regulatory actions involving silver ion washing machines and nano-silver electronics described above. 

Products containing nano-silver used as an antimicrobial raise issues about the “treated article” exemption, 40 C.F.R. § 152.25(a).  The petition takes the position that the products fail to meet EPA requirements for that exemption, and that they are therefore themselves pesticides in need of registration.

Implications

Following the comment period, EPA will “decide how best to respond to the petition.”  Recent agency actions suggest the range of options potentially available to EPA.  For instance, EPA could potentially follow the example of its recent Federal Register notice under the Toxic Substances Control Act (“TSCA”) regarding carbon nanotube (“CNT”) products (73 Fed. Reg. 64,946 (Oct. 31, 2008)).  In that instance, EPA gave notice that it believed a number of CNT products in commerce were not meeting TSCA premanufacture notice requirements; offered guidance on the TSCA Inventory status of CNTs; and announced that it would consider substantial enforcement efforts against noncompliant companies after several months.  EPA could pursue a similar approach with nano-silver.  Companies that are listed in the appendix of the petition should review their FIFRA compliance and consider submitting comments.  EPA could also potentially follow the example of the Food and Drug Administration (“FDA”), which responded to the concerns of an earlier rulemaking petition by ICTA and others regarding nanoscale materials in FDA-regulated products such as sunscreens with a task force report and subsequent public hearings regarding implementation of the report’s science and policy recommendations.

In any case, EPA’s request for comments on the ICTA rulemaking petition provides an important opportunity to address at a high level many scientific and policy issues regarding nanotechnology regulation under FIFRA.  Because EPA’s decision could have significant regulatory implications beyond nano-silver, companies that intend to commercialize other nanotechnology-enabled pesticides may want to submit comments as well, to address some of the broader issues that the petition raises and to help shape EPA policy. 

Comments must be received to Docket ID EPA-HQ-OPP-2008-0650 by January 20, 2009. 

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For more information about the request for comments, FIFRA compliance, or other aspects of nanotechnology regulation, please contact Mark Duvall at (202) 789-6090 (mduvall@bdlaw.com) or Phil Moffat at (202) 789-6027 (pmoffat@bdlaw.com). This alert was prepared with the assistance of Alexandra Wyatt.

Key documents are available below.