Environmental Update

EPA Issues First, Limited Exemption for Long-Lasting Surface Disinfectant Effective Against the Novel Coronavirus

August 26, 2020

On Monday, August 24, the U.S. Environmental Protection Agency (EPA or the Agency) approved a Section 18 emergency exemption under the federal pesticide law, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), for a long-lasting surface disinfectant effective against SARS-CoV-2, the novel coronavirus that causes COVID-19. EPA defines “long-lasting” or “residual” efficacy in antimicrobial products as continuously effective against bacteria or viruses “over the course of hours to months.” This is the Agency’s first approval of antiviral long-lasting efficacy claims, and the approval applies to Allied BioScience’s SurfaceWise2 product. SurfaceWise2 is meant to be applied to surface coatings and has been reviewed by EPA for claims that it inactivates viruses (including coronaviruses such as SARS-CoV-2) and bacteria within two hours of contact and for up to seven days thereafter. EPA has made clear that the product is not a replacement for regular cleaning and disinfection with other products the agency has approved in its List N for use against the novel coronavirus.

The Section 18 emergency approval itself is limited: It allows only the Texas Department of Agriculture to approve use of SurfaceWise2 in the state by American Airlines in certain airport facilities and aircraft and also by two Total Orthopedics Sports & Spine Clinics affiliated with Texas Methodist Health Group. The emergency exemption is effective for one year. EPA indicated that it will be accepting other FIFRA Section 18 emergency exemption applications for the same or similar long-lasting efficacy products, although such applications may only be made by state or federal agencies.

Currently, there are no other publicly available long-lasting efficacy products registered with EPA for antiviral efficacy. EPA indicated in its Monday announcement that it anticipates publishing in coming weeks testing guidelines and other guidance for companies and individuals interested in pursuing full FIFRA registration of antiviral long-lasting efficacy products beyond the limited emergency exemption pathway. If registered for effectiveness against viruses similar to the novel coronavirus or SARS-CoV-2 itself, the long-lasting efficacy product would likely be added to EPA’s List N and would be available for use by the general public on surfaces for the contact time and residual efficacy period approved on the product labeling. EPA watchers are also looking intently for whether the Agency will approve any products for use to combat the novel coronavirus in airborne virus particles, the primary mode of communication. As of yet, the Agency has not approved such products.

EPA’s announcement of this emergency exemption approval coincides with an upcoming webinar on Thursday, August 27, titled “COVID-19 Long Lasting Disinfectants” to be presented by EPA research scientists from the agency’s Center for Environmental Solutions and Emergency Response. Our expectation is that the federal regulatory landscape for surface disinfectants will continue to evolve in the coming month as EPA continues to adapt the historically slow-moving FIFRA regime in an ongoing response to the COVID-19 pandemic.

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