EPA Releases Interim Guidance to Expand Availability of Virus Claims to Additional Antimicrobial Products
Released on October 10, 2024
Today, the U.S. Environmental Protection Agency (EPA) released interim guidance describing how registrants of antimicrobial products may add label claims that sanitizing products (e.g., household antimicrobial wipes and sprays) are effective against viruses. If laboratory data indicate that a product registered only with sanitizing claims meets EPA's criteria for efficacy against viruses, the product can include claims against viruses on its label. New virucidal claims for sanitizers rely on the same performance and testing standards currently used to assess products efficacy against disinfectants with virus claims. The guidance is expected to expand the availability of antimicrobial products that are effective against viruses such as SARS-CoV-2, which provides more products for reducing the spread of illnesses, including products that generally use lower amounts of active ingredients.
Under federal law, all antimicrobial products that claim to kill pathogens like viruses and bacteria on surfaces must be registered with EPA before they can be sold or distributed in the United States. EPA primarily classifies antimicrobial products as sanitizers, disinfectants, and/or sterilants based on the product performance, test methods used to demonstrate efficacy, and microorganisms tested. Many products are registered with EPA as both sanitizers and disinfectants because they have undergone testing to support both claims.
Products registered with only sanitizing claims may contain lower amounts of active ingredients and may have shorter contact times (the time the product must be in contact with the surface in order to be effective) compared to products registered as disinfectants. Sanitizers are commonly registered for use on surfaces in homes, schools, and retail establishments. Sanitizers can be registered for food-contact use and can be used in food service and food processing facilities on surfaces such as dishes and utensils. Historically, EPA guidance has addressed the addition of claims against bacteria—but not against viruses—to products registered only with sanitizing claims.
Products registered as disinfectants must demonstrate a higher level of efficacy against bacteria than products registered only as sanitizers. Disinfectants may contain higher concentrations of active ingredients and may have longer contact times. Many disinfectants are intended for use in clinical settings (like hospitals, healthcare clinics, and dental offices) where there is an elevated risk that disease could be spread through surfaces. As described in the interim guidance, sanitizers with claims against viruses are not intended to be used in healthcare settings, due to the higher level of efficacy against bacteria that is needed in hospital patient care areas.
EPA will pilot this guidance for up to 10 years to assess implementation and the outcome of this guidance.
The interim guidance will be available for public comment in docket EPA-HQ-OPP-2023-0288 at www.regulations.gov, which will open on October 10, 2024. To read the guidance now, please visit EPA's website.