July 14, 2020

Volume X, Number 196

July 14, 2020

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July 13, 2020

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EPA Announces the Issuance of an Advisory on Disinfectants Making False and Misleading Claims against COVID-19

On June 1, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.

EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices.  EPA says it is actively reviewing these claims and is working to identify others.  EPA states that it intends to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2.  EPA has made available a webpage where tips can be reported.

The advisory reiterates EPA’s message that disinfectant products that claim to kill viruses must be registered with EPA before they can be sold and that pesticide products cannot legally make claims that they kill a particular pathogen, such as SARS-CoV-2, unless EPA has authorized the claim during the registration process.

In the advisory, EPA emphasizes that it will not register a product claiming to be effective against SARS-CoV-2 until it has determined that the product will not pose an unreasonable risk and will be effective when used according to the label directions.  EPA notes that it maintains List N, which is a list of disinfectants that meet EPA’s criteria for use against the virus that causes COVID-19.  While surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, EPA expects them to kill the virus because they demonstrate efficacy against a harder-to-kill virus or another human coronavirus similar to the one causing COVID-19.

The advisory also discusses devices that claim to kill SARS-CoV-2.  It states that a pesticidal device is an instrument or other machine that is used to destroy, repel, trap, or mitigate any pests, including viruses (i.e., ozone generators, UV lights).  EPA notes that unlike registered pesticide products, the safety and efficacy of pesticidal devices are not routinely reviewed by EPA.  EPA states that it therefore cannot confirm whether, or under what circumstances, such products might be effective against SARS-CoV-2.  The advisory states that consumers should be aware that pesticidal devices making such claims have not been reviewed and accepted by EPA.  It further states that while pesticidal device labels must have an EPA establishment number (which identifies where a product was produced), they will not have an EPA registration number because pesticidal devices are not subject to the same registration requirements as pesticides.

According to the advisory, pesticidal devices are subject to certain regulatory requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), one of which is a prohibition of false or misleading labeling claims.  The advisory specifically states:

Making 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. In addition, because EPA does not review these data as part of a registration review process, these claims are not supported by any government review.

Because EPA does not review or register pesticide devices, these products are not included on List N.

It is important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 154

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About this Author

Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
Partner

Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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Healther Collins, Regulatory Consultant, Bergeson and Campbell, health and safety compliance
Regulatory Consultant

Heather F. Collins, M.S., Regulatory Consultant with Bergeson & Campbell, P.C. has nearly two decades of experience developing, implementing, and managing environmental, health, and safety (EH&S) compliance for global chemical and chemical product companies.  Her prodigious skills in developing biocide and pesticide registration and compliance strategies, safety data sheet authoring, and dangerous goods management, coupled with her keen awareness of the financial and temporal pressures of the marketplace make her an excellent resource for clients seeking a competitive edge in their compliance management.  Ms. Collins holds a Masters in Science degree in Environmental Science and Management and a Bachelor of Science in Biology and Biochemistry from Duquesne University.

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Barbara Christianson, Bergeson & Campbell, P.C., Paralegal
Paralegal

Barbara Christianson has worked at Bergeson & Campbell, P.C. (B&C®) for over a decade, honing her experience in the industries that Bergeson & Campbell serves. As a paralegal, Ms. Christianson supports Bergeson & Campbell's professional staff with a broad range of detail-oriented, oftentimes deadline-driven activities.

Ms. Christianson plays a key role in coordinating and providing detailed quality control review of documents and submissions and has significant experience using industry-specific software programs. She...

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