Companies making false or misleading claims regarding a disinfectant’s effectiveness in killing SARS-CoV-2 (the coronavirus that causes COVID-19) will face enforcement according to the Environmental Protection Agency's (EPA) new May 2020 compliance advisory. Scrutiny of antimicrobial/disinfectant claims by EPA has never been higher, and both civil and criminal penalties for non-compliance can be severe.
In response to the COVID-19 pandemic and a surge in marketing of products claiming to be effective in treating SARS-CoV-2/COVID-19, EPA’s new compliance advisory reiterates that all disinfectant products claiming to kill viruses on surfaces must first be registered with EPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and comply with FIFRA’s labeling and marketing requirements.
EPA extensively regulates the sale and distribution of pesticide products in the United States under FIFRA, including pesticide products imported into or exported from the United States. For instance, pesticide products, which include disinfectants, cannot lawfully make claims that they kill a particular pathogen unless EPA has accepted those claims during the registration process. Because of the sudden emergence of SARS-CoV-2, EPA’s normal registration process would pose significant hurdles to ensuring that the public has access to EPA-approved disinfectants that can be used against SARS-CoV-2/COVID-19. To remedy that situation, EPA has created a list of disinfectants (referred to as “List N”) that meet EPA’s criteria for use against the novel coronavirus based on that disinfectant’s demonstrated efficacy against other viruses that are harder to kill than SARS-CoV-2. There are currently 427 products on EPA’s List N. Read more about List N and EPA’s associated guidance in prior Taft posts available here and here.
EPA’s advisory also highlights that pesticide “devices”, defined as an instrument or machine that is used to destroy, repel, trap, or mitigate any pests, are not subject to the same registration requirements as “pesticides.” Examples of pesticide “devices” include ozone generators or UV lights that are claim to destroy SARS-CoV-2. While pesticide devices are not subject to the same registration requirements, they remain subject to other FIFRA provisions, including the requirement that they must be produced at registered establishments and cannot make false or misleading claims in labeling or marketing materials (including websites). Because EPA does not routinely review efficacy data for pesticide devices and does not “register” them, those products are not included on EPA’s List N. As such, companies selling or distributing pesticide “devices” that claim to be effective against SARS-CoV-2/COVID-19 are at a high risk of enforcement by EPA.
EPA and the Department of Justice are actively searching for non-compliant products, including scouring consumer and other websites selling products claiming to be effective against SARS-CoV-2/COVID-19, and soliciting (and receiving) tips from members of the public. Coupled with a drastic increase in companies rushing into the antimicrobial/disinfectant space (many times without assessing FIFRA compliance), this will undoubtedly lead to a significant increase in civil and criminal enforcement of FIFRA violations for months, and possibly years, to come.
Taft has some of the most experienced FIFRA attorneys in the Midwest, having dealt with FIFRA compliance, registration, enforcement defense and other pesticide issues on a daily basis for years. Taft advises major agricultural and anti-microbial pesticide registrants regarding FIFRA compliance and has defended and negotiated dozens of FIFRA civil and criminal enforcement matters. For more information, please contact a member of Taft’s Environmental practice.
Please visit our COVID-19 Toolkit for all of Taft’s updates on the coronavirus.