On September 6, 2023, EPA held a webinar relating to pesticidal devices, focused on air cleaning devices.  The webinar highlighted EPA’s expectations for data that manufacturers must have on file to substantiate efficacy claims for these devices.  This provides important additional guidance to manufacturers regarding the types of testing EPA expects to be conducted.

 Specifically, EPA indicated the following:

  • Testing should demonstrate at least a 3-log (99.9%) reduction over a control experiment (i.e., one not involving the pesticide device);
  • Testing should be conducted on the specific organism for which claims will be made;
  • Testing should be conducted in as large of a chamber as possible to render the testing more similar to real-world conditions;
  • At least three tests should be conducted to ensure that results are repeatable;
  • Guidelines for testing traditional, EPA-registered pesticide products should be followed and used as a reference point, though they are not binding.

In addition, EPA indicated that pesticide device manufacturers should consider the following questions when evaluating efficacy data and whether it substantiates the relevant claims:

  • Were the tests conducted by an independent laboratory?
  • Were there replicate tests conducted?  Were the results reproducible?
  • How were the tests conducted?  On what microorganism?  What size test chamber?
  • How is efficacy calculated?  Was it based on a time-match comparison to a control experiment?
  • Can the text conditions be reasonably compared to real-world settings?
  • How might differences in lab vs. installed settings impact real-world technology performance?

While this guidance is informal and non-binding, and EPA has yet to provide detailed written guidance on appropriate efficacy testing and associated permissible claims for devices, manufacturers should carefully consider their testing data before making claims for pesticidal devices.  In doing so, manufacturers should make sure to employ appropriate technical and legal expertise to minimize the risk of an EPA or other enforcement action.

Tags: chemical, EPA, Pesticidal devices, pesticide
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Photo of Thomas Brugato Thomas Brugato

Thomas Brugato is of counsel in the firm’s Washington, DC office. His practice focuses on environmental matters, as well as civil and administrative litigation. He has experience advising clients on a wide variety of environmental issues, including under the Clean Air Act, Clean…

Thomas Brugato is of counsel in the firm’s Washington, DC office. His practice focuses on environmental matters, as well as civil and administrative litigation. He has experience advising clients on a wide variety of environmental issues, including under the Clean Air Act, Clean Water Act, RCRA, CERCLA, EPCRA, TSCA, FIFRA, the Endangered Species Act, the Occupational Safety and Health Act, and EPA’s Renewable Fuel Standard program.

Thomas has extensive experience in representing companies on FIFRA matters relating to a wide range of products—such as antimicrobials, devices, treated articles, and traditional pesticides—including in EPA enforcement actions. He also has particular expertise in advising companies on a wide range of Administrative Procedure Act (APA) issues, including in litigation involving agencies in federal court. Finally, Thomas has significant experience advising clients on Indian law related issues, particularly relating to the Indian Gaming Regulatory Act and tribal sovereign immunity.

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