In Agency First, EPA Allows Limited Use of Antiviral Disinfectant with Long-Lasting Efficacy Claims
What Happened: EPA issued a FIFRA Section 18 emergency exemption to the state of Texas to allow certain limited uses of a surface coating with long-lasting disinfectant properties.
Who’s Impacted: Only two companies may use the new antiviral disinfectant under the current exemption, but EPA’s recognition of long-lasting antiviral claims in this context opens the door for others in the industry seeking similar approvals.
What Should They Consider Doing in Response: Manufacturers of surface disinfectants and antiviral coatings should evaluate their products for potential long-lasting effects and may seek registration of qualifying products as EPA makes new guidance available.
On August 24, 2020, the U.S. Environmental Protection Agency (EPA) issued an emergency exemption to permit the limited use of a new product that appears to kill viruses like the SARS-CoV-2 virus on surfaces for up to seven days. While EPA has approved almost 500 surface disinfectants for use against SARS-CoV-2—which are listed on the Agency’s List N: Disinfectants for Use Against SARS-CoV-2— EPA has not approved any of these products to claim continuous protection against new viral particles that may come into contact with a treated surface over the course of hours, weeks, or months after the disinfectant has been applied.
Accordingly, this new emergency exemption represents the first time that EPA has approved the use of any antiviral product with long-lasting effect. The product, Allied BioScience’s “SurfaceWise 2,” contains the active ingredient 1-octadecanaminium,N,N-dimethyl-N[3-(trihydroxysilyl)propyl],chloride and is intended for use after a List N disinfectant has already been applied. Under the exemption, the state of Texas is authorized to allow certain uses of SurfaceWise2 by American Airlines and Total Orthopedics Sports & Spine; the product is not yet available to the public, and application under the exemption is only allowed by trained and authorized users. When announcing the exemption, however, EPA also noted that it will soon release guidance to help disinfectant manufacturers pursue Agency approval of other antiviral surface coatings for the public.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) generally prohibits the distribution or sale of any pesticide that is not registered with EPA, including many products that make or imply antiviral claims. Surface disinfectants, wipes, and other products that are intended for use to kill, reduce, or mitigate coronavirus on objects, surfaces, or in the air or water will generally be regulated under FIFRA and require registration as pesticide products. EPA requires approval in advance of any sale or distribution of these products. EPA must also approve all labeling claims and regulates pesticide production, packaging, import, and advertising.
However, section 18 of FIFRA authorizes EPA to temporarily exempt state and federal agencies from certain provisions of FIFRA and allow the unregistered use of a pesticide when needed to address emergency conditions. Under such an exemption, EPA can authorize the limited use of a pesticide in a defined geographic area and for a finite period of time. Section 18 emergency exemptions are most frequently employed to address invasive pest outbreaks in agricultural settings, although EPA also has authority to grant “public health” exemptions in order to control a pest that will cause a significant risk to human health when certain regulatory criteria are met.
First-Ever EPA Recognition of Long-Lasting Antiviral Disinfectant
Historically, EPA-registered products that claim any continuous or long-lasting effectiveness have been limited only to those that control odor-causing bacteria on hard, non-porous surfaces. Although there are currently no EPA-registered products that claim long-lasting disinfection against viruses and other public health microorganisms, EPA announced last month that it was conducting research to help inform decisions on the use of longer-lasting disinfection products, including information on the frequency of use to maintain disinfection capabilities over time.
According to EPA, SurfaceWise2 is a surface coating that appears to inactivate viruses and bacteria within two hours of application and to continue to work against these microbes for up to seven days. EPA’s approval of the exemption allows the Texas Department of Agriculture (TDA) to permit use of SurfaceWise2 only at American Airlines airport facilities and planes at specific locations and two Total Orthopedics Sports & Spine Clinics under certain conditions, and TDA is responsible for ensuring that all of EPA’s requirements are met. This emergency exemption will be effective for one year, though EPA may alter the terms of the product’s emergency uses if it receives additional data.
In its announcement, EPA emphasized that it has not registered SurfaceWise2 under FIFRA, and thus the product is not yet available to the public or to any parties other than those specifically named in the emergency exemption. However, EPA also noted that it anticipates soon posting information for other disinfectant manufacturers who may be interested in pursuing full FIFRA registrations for their own long-lasting antiviral surface coatings.