EPA recently released a compliance advisory addressing pesticidal products that make claims to mitigate the novel coronavirus. While the advisory largely reiterates past guidance relating to pesticides, EPA has increased its emphasis on pesticidal devices, such as UV lights and ozone generators, which are subject to their own distinct set of regulations.
Most notably, EPA has emphasized that device marketers must have adequate data to support any claims they make to kill or mitigate the coronavirus. EPA advises that “[m]aking false or misleading labeling claims about the safety or efficacy of a pesticidal device may result in penalties under FIFRA. Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses.” (emphasis in original). The guidance also reminds manufacturers that devices must be produced in an EPA-registered establishment. Other requirements not mentioned in EPA’s guidance, such as the need to maintain proper records and comply with requirements to import devices, also apply to pesticidal devices.
EPA has in the past brought significant enforcement actions against device manufacturers. For example, in 2013, EPA obtained a $2.68 million penalty relating to the production and sale of pesticidal devices.
The ongoing pandemic raises the question whether EPA should consider developing additional guidance to device manufacturers—potentially in the form of “safe harbor” guidance—describing efficacy data that the agency would regard as presumptively sufficient. Notably, the recent EPA Science Advisory Board draft report on COVID-19 issues observed that “[t]here are ample studies showing that UV, ozone, and heat (steam) are effective for virus inactivation at well described doses (e.g., temperatures). . . . the SAB recommends that the EPA include this issue in a guidance document.” The report also observed that UV disinfection within HVAC systems could be a potential method of mitigating coronavirus transmission indoors.
Another possibility would be for EPA to create a voluntary program that would allow device manufacturers to submit efficacy data to EPA, in exchange for being pre-approved to make anti-coronavirus claims. One potential model would be EPA’s “Safer Choice” program, which is a voluntary initiative that allows pesticide registrants to submit safety and efficacy data for EPA to review, with qualifying products allowed to use the “Safer Choice” label.
Safe-harbor guidance or the creation of a voluntary program would arguably be consistent with Executive Order 13924, released last month, which directs agencies to “accelerate procedures” for regulated parties to obtain “pre-enforcement rulings” “with respect to whether proposed conduct in response to the COVID-19 outbreak … is consistent with statutes and regulations administered by the agency.” Such guidance or program might allow for EPA to provide greater certainty to consumers and device manufacturers, while remaining within the scope of EPA’s authority to regulate pesticidal devices, which is more limited than its authority to regulate pesticides. See 41 Fed. Reg. 51,065 (Nov. 19, 1976) (noting differences between device and pesticide regulatory authority).
At the same time, such guidance could raise concerns. For example, if EPA were to effectively treat any such guidance as binding on device manufacturers, that could potentially run afoul of Executive Order 13892 (as well as the Administrative Procedure Act), which generally prohibits guidance documents from imposing “new standards of conduct” on regulated parties. Unduly prescriptive or narrow standards could also discourage innovation in the pesticidal device industry.
To date, EPA has not yet made clear whether it will provide additional guidance relating to pesticidal devices and COVID-19, and if so, what the nature and scope of such guidance might be. Interested parties should keep a close eye on further developments in this area.