On Wednesday, October 15, the U.S. Environmental Protection Agency (EPA or the Agency)
announced that it will now expedite review of certain long-lasting efficacy claims for products intended for use on hard surfaces against SARS-CoV-2, the novel coronavirus that causes COVID-19. As part of this announcement, the Agency also issued interim guidance on study design elements and testing protocols that interested registrants should use to support the long-lasting efficacy claims for these products. The interim protocols apply to both already registered products that will need to be amended as well as previously unregistered products. Currently, there are no publicly available EPA-registered products approved for long-lasting efficacy on viruses.
Long-lasting efficacy, sometimes called “residual efficacy,” is a claim that the product provides ongoing or continuous antimicrobial effects beyond the initial application, ranging from several hours to several months; this is in contrast to traditional antimicrobial disinfectant products, which claim only to kill viruses and bacteria on the surface at the time the product is used. Two months ago, EPA
issued for the first time a limited, “emergency” exemption for a specific long-lasting efficacy product that could be used only in the state of Texas in two specific commercial spaces and is effective for only one year. The long-lasting efficacy interim testing guidelines EPA issued on Wednesday are broadly applicable.
Typical EPA review times for these types of registration amendments or new product approvals can range anywhere from four months to two years, depending on product specifics and proposed uses. Under EPA’s expedited review timeframe for products claiming efficacy against SARS-CoV-2, the Agency anticipates being able to shave one to two months from the typical review timeline, provided registrants follow EPA’s interim testing protocol guidance.
Under the new interim guidance, EPA is differentiating between two categories of long-lasting efficacy products: supplemental residual antimicrobial products and residual disinfectants. Both can be approved for efficacy against viruses, including SARS-CoV-2.
Supplemental residual products — such as antimicrobial surface coatings and films and other products applied to fixed or solid surfaces (such as copper and other metals) or paints — are effective within two hours of contact and can remain effective for weeks to years, depending on the product. However, these products are not required to meet disinfection efficacy standards, and EPA will approve them for use only as a supplement to standard disinfection. When approved by EPA for efficacy against SARS-CoV-2, these products will be added to a
special List N appendix. Registrants can demonstrate efficacy against SARS-CoV-2 with direct testing on the SARS-CoV-2 virus itself or on other non-enveloped viruses or another human coronavirus.
By contrast,
residual disinfectants are effective within 10 minutes of coming in contact with bacteria or viruses and can remain effective for up to 24 hours. EPA states that hard surfaces treated with any approved residual disinfectant do not require additional cleaning or disinfection within the residual efficacy window. And because these products must satisfy all standard disinfection claim criteria, they can be added to
EPA’s List N (with the formulation type listed as “residual”) if the registrant demonstrates efficacy by testing directly on the SARS-CoV-2 virus or on other non-enveloped viruses or another human coronavirus.
EPA’s expedited review of these two long-lasting efficacy categories will begin immediately, although the Agency stated that it may revise testing protocol and efficacy standard guidance after the conclusion of a 60-day public comment period on the interim guidance. We understand that EPA’s Office of Pesticide Programs — the division within the Agency tasked with coordinating review and approval of pesticide product registrations — has recently hired a large number of new technical staff that we expect will be deployed to handle this, and other, SARS-CoV-2-related expedited antimicrobial product review and approval.
