/>iOn November 20, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its draft guidance for public comment to support registration and evaluation of efficacy claims for pre-saturated antimicrobial towelettes on hard non-porous surfaces such as stainless steel, metal, glass, hard plastic, or sealed wood, commonly seen in the market as “disinfecting wipes,” using a recently approved standard test method. The draft guidance is available at EPA-HQ-OPP-2024-0414-0004. Comments are due on or before January 21, 2025.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), antimicrobial pesticides that claim to kill harmful microbes must be registered with EPA before they can be sold or distributed in the United States. As part of its pesticide product registration review process, EPA must receive and review appropriate efficacy data to support these claims. EPA’s new draft guidance addresses efficacy testing for pre-saturated antimicrobial towelettes intended to be used as disinfectants on hard, non-porous surfaces against bacteria. Note, this method is only intended to support registration for disinfection claims against bacteria. For all other disinfectant claims (e.g., those against viruses, C. difficile, C. auris), the draft guidance indicates that registrants should continue to follow existing efficacy guidance and test methods.
According to EPA, the existing test methods used to evaluate the efficacy of disinfecting wipes were originally designed to test liquid formulations and had to be modified to accommodate wipes. The standard test method, ASTM E3363, published by ASTM International in September 2023, provides a specific and consistent way to evaluate the efficacy of antimicrobial towelettes (i.e., disinfecting wipes). EPA’s draft guidance document identifies this ASTM standard test method as the recommended test method for evaluating the efficacy of antimicrobial wipes with disinfectant claims against bacteria, given it is both effective and widely accepted by registrants. The draft guidance also provides regulatory guidance for pesticidal claims for disinfecting wipes. Until this guidance is finalized, EPA states that registrants should continue to reference OCSPP 810.2200 to support product registration.
Disinfecting wipes are to be tested with the formulation as offered for sale, using the complete product packaged in the same packaging intended to be marketed. Because disinfecting wipes are a unique combination of antimicrobial chemical and towelette substrate pre-packaged as a unit in fixed proportions for application, the complete product must be tested according to the directions for use to ensure efficacy as a disinfecting wipe.
EPA notes that this guidance is not intended to address dry-to-wet towelettes (e.g., spraying a disinfectant on a dry cloth), and/or other deviations from pre-saturated towelettes. Those product types will be handled on a case-by-case basis. This guidance is also not intended for use sites such as drinking glasses, dishes, utensils, cutting boards, or soft and porous surfaces. According to EPA, formulations beyond pre-saturated disinfecting wipes may fall outside of the scope of this test guidance, so registrants are encouraged to consult with EPA prior to conducting efficacy testing.
