Yesterday, EPA announced that it has issued the first ever emergency use exemption for a “long-lasting” anti-viral coating. The exemption was granted upon request by the state of Texas to permit use of the coating at American Airlines airport facilities and at two orthopedic clinics in the state.
In granting the exemption, EPA determined that the coating (SurfaceWise2, manufactured by Allied BioScience):
Inactivates viruses and bacteria within two hours of application and continues to work for up to seven days.
Consistent with the agency’s Emerging Pathogens Policy, Allied BioScience supported the claims with data demonstrating the coating’s efficacy against a human coronavirus similar to SARS-CoV-2, as well as bacteria. EPA expects products that are effective against other human coronaviruses will also be effective against SARS-CoV-2.
Traditional disinfectants typically work within 10 minutes of application but do not provide residual effectiveness against contamination when touched after cleaning. EPA emphasized that the product is intended to fight viruses that land on a surface between regular cleanings, and that the product is not intended to be a replacement for routine cleaning and disinfection practices. This caveat is akin to similar language provided in EPA registrations granted to antimicrobially active surface materials over the past decade, such as copper alloys surface materials, which are intended to reduce microbial loads between regular cleanings of the surface.
EPA has embarked on a multi-faceted initiative to study the potential for a variety of disinfectant products to provide “long-lasting residual efficacy” and to speed approval of such products.
Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to allow for unregistered uses of pesticides to address emergency conditions. Under such an exemption, EPA allows limited use of the pesticide in defined geographic areas for a finite period of time — up to one year for public health emergencies — to address “urgent, non-routine” situations. Emergency exemptions may be requested by State or Federal agencies when an emergency condition jeopardizes public health, the environment, or production of agricultural goods, and inadequate tools exist to address the situation. To grant the exemption, EPA evaluates the safety, durability, and efficacy of the product to ensure it remains effective under the proposed conditions of use, even after repeated contact and treatment with cleaning and disinfection products.
In obtaining the exemption, Allied Bioscience also agreed to pursue a traditional registration (under FIFRA Section 3) by submitting additional data to the agency over coming months. If the full registration process is completed, the product would become available for purchase by members of the public.
EPA also announced that it plans to issue soon information to assist companies interested in obtaining a registration for anti-viral surface coatings.
More information on the Section 18 emergency exemption granted to Texas is available here.
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