EPA Provides New Guidance for Pesticide Devices Making Coronavirus Claims

The compliance advisory highlights a key difference under federal pesticide law between “pesticides” (which kill pests using substances such as chemicals) and “devices” (which kill pests using an “instrument or contrivance” such as a mechanical device or UV light). Namely pesticides are subject to premarket review and registration by EPA, while pesticide devices are not. Nonetheless, both pesticides and devices must be manufactured in EPA-registered establishments (regardless of whether they are manufactured domestically or imported), and the pesticidal claims made with respect to both pesticides and devices must be supported by efficacy data.

The compliance advisory states that manufacturers of pesticide devices (e.g., UV light units and ozone generators) may be able to make coronavirus efficacy claims if the device has been tested against the coronavirus itself or on harder-to-kill viruses. EPA has not previously issued guidance on the issue of efficacy testing for devices; it had been thought that pesticide devices may make claims related to the coronavirus only if the devices had been tested on the coronavirus itself. Efficacy testing on the coronavirus, however, remains difficult given that SARS-CoV-2 is still not widely available in commercial laboratories. Thus, manufacturers, importers, and retailers should be cautious with any pesticidal device making claims to kill the coronavirus.

EPA does not provide a list of “harder-to-kill” viruses in this compliance advisory. However, the coronavirus is categorized by the U.S. Centers for Disease Control (CDC) as an “enveloped virus.” Per the Spaulding Classification model, used by the CDC and referenced in EPA’s 2016 Emerging Viral Pathogen Guidance for Antimicrobial Pesticides, viruses that are categorized as “small, non-enveloped” or “large, non-enveloped” may be considered harder to kill than enveloped viruses like the coronavirus.

While pesticide devices, unlike pesticide products, are not required to undergo EPA premarket review and approval, device manufacturers are still prohibited from making any “false or misleading” claims in labeling or marketing materials. All testing done by a device manufacturer on coronavirus or on harder-to-kill viruses must be sufficient to support the efficacy or safety claims being made on device labeling or marketing (and be maintained in a data file for inspection as needed).

The advisory also reiterates EPA’s current policies regarding surface disinfecting pesticides that make coronavirus claims. Pesticides, unlike pesticide devices, require manufacturers to submit efficacy and testing data as well as proposed product labeling to EPA for review and approval before the product can be sold. Since January, EPA has been allowing pesticide product manufacturers to make limited, off-label claims of efficacy related to the coronavirus consistent with EPA’s 2016 Emerging Viral Pathogen Guidance, referenced above. EPA has also been maintaining a living list (called List N) of pesticide products authorized to make such claims about the coronavirus. Pesticide devices are not included on List N because EPA does not review or approve devices or their efficacy claims or label language.

The compliance advisory also reiterates EPA’s commitment to bringing enforcement actions against pesticides and device manufacturers, importers, and retailers for making false and/or misleading claims related to the coronavirus, stating, “EPA is working with e-commerce platforms to remove/prohibit these fraudulent and/or otherwise inefficacious products from the marketplace [and] EPA is also coordinating with the U.S. Department of Justice and other federal partners to bring the full force of the law against those selling or otherwise distributing violative products.” See our prior coverage of EPA’s enforcement response here.