EPA Releases Draft Guidance to Expand Availability of Virus Claims to Additional Antimicrobial Products
Released on July 17, 2023
Today, EPA released for public comment draft guidance proposing how registrants of antimicrobial products with sanitizing claims could add claims that these products are effective against viruses. The guidance, once finalized, would expand the universe and availability of antimicrobial products that are effective against viruses such as SARS-CoV-2.
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. Certain types of sanitizers (i.e., food-contact sanitizers) 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.
Based on the proposed guidance, if laboratory data indicate that a product registered only with sanitizing claims meets EPA's criteria for efficacy against viruses, the product could include claims against viruses on its label. New virucidal claims for sanitizers would rely on the same performance and testing standards currently used to assess products efficacy against viruses, such as disinfectants.
Products registered as disinfectants must demonstrate a higher level of efficacy against bacteria than products registered only as a sanitizer. 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 draft 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 proposes to pilot this draft guidance over seven years to allow enough time to assess the outcome. Based on the outcomes that EPA observes during that time, the Agency will determine whether the guidance should be modified, terminated, or made permanent at the end of this period.
The draft guidance is available for public comment in docket EPA-HQ-OPP-2023-0288 at www.regulations.gov for 60 days.