EPA Releases Draft Guidance to Support Registration of Pre-saturated Disinfecting Wipes
Released on November 20, 2024
Today, the U.S. Environmental Protection Agency (EPA) released for public comment draft guidance to support registration and evaluation of efficacy claims for pre-saturated antimicrobial towelettes on hard non-porous surfaces such as stainless steel,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. 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 — published by ASTM International in September 2023 — provides a specific and consistent way to evaluate efficacy of antimicrobial towelettes (i.e., disinfecting wipes). The draft guidance document identifies this standard test method, ASTM E3363, as the agency’s recommended test method for evaluating the efficacy of antimicrobial wipes with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 The draft guidance also provides registration guidance for pesticidal claims for disinfecting wipes. Until this guidance is finalized, registrants should continue to reference OCSPP 810.2200 to support product registration.
Under federal law, antimicrobial pesticides that claim to kill harmful microbes must be registered with EPA before they can be sold or distributed in the United States. The agency must receive and review appropriate efficacy data to support these claims. EPA is responsible for regulating disinfectants and other antimicrobial pesticides used in healthcare and other settings pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The new guidance being released addresses efficacy testing for pre-saturated antimicrobial towelettes intended to be used as disinfectants on hard, non-porous surfaces against bacteria.
Disinfecting wipes are to be tested with the formulation offered for sale, using the product packaged in the same packaging intended to be marketed. Disinfecting wipes are a unique combination of antimicrobial chemical and towelette substrate pre-packaged as a unit in fixed proportions for application. Therefore, the complete product, as packaged in the manner to be offered for sale, must be tested according to the directions for use to ensure efficacy as a disinfecting wipe.
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. Formulations beyond pre-saturated disinfecting wipes may fall outside of the scope of this test guidance. In these cases, registrants are encouraged to consult with the agency prior to conducting efficacy testing.
The draft guidance is available for public comment in docket EPA-HQ-OPP-2024-0414 at www.regulations.gov for 60 days.