By Rebecca A. Davis, Brent I. Clark, Patrick D. Joyce, Ilana R. Morady, and Kay R. Bonza
Seyfarth Synopsis: As an early and aggressive response to potential threats related to the novel coronavirus disease, now identified as COVID-19, the United States Environmental Protection Agency (EPA) activated its Emerging Viral Pathogen Guidance for Antimicrobial Pesticides (Guidance).
The Guidance, first developed in 2016, provides a process to enable the use of certain EPA-registered disinfectant products against emerging pathogens, such as SARS-CoV-2, the pathogen which causes the disease known as COVID-19, that are not otherwise identified on the product label. If a registrant already holds a “pre-qualified emerging viral pathogen designation,” then respecting COVID-19, it can provide an efficacy statement on the efficacy of a product to disinfect SARS-CoV-2 (that is, protect against COVID-19) in technical literature issued to health care facilities and medical providers, and in publicly available resources such as non-label-related websites, consumer information services, and social media sites.
The efficacy criteria is based on the ease with which the type of virus is inactivated by the disinfectant. Specific to SARS-CoV-2, the disinfectant must be EPA-approved as a hospital/healthcare or broad spectrum disinfectant; the disinfectant must already be approved by EPA for one small or one large non-enveloped virus (viruses that are generally more difficult to kill or inactivate); and the EPA-approved label must contain emerging pathogen “terms of registration” language describing the emerging pathogen claims the manufacturer can make. SARS-CoV-2 is an enveloped virus, meaning it has a membrane wrapped around it, which makes it easier to kill with the appropriate disinfectant product than small or large non-enveloped viruses.
Registrants that don’t meet the criteria set forth in the Guidance, but who make claims related to inactivation of SARS-CoV-2 may face enforcement actions and stiff penalties for distributing mislabeled pesticides.
For more information on this or any related topic please contact the authors, your Seyfarth attorney, or any member of the Seyfarth Labor & Employment Group, OSHA Compliance, Enforcement & Litigation Team, or the Environmental Compliance, Enforcement & Permitting Team.