The U.S. Environmental Protection Agency (EPA) has published a draft guidance document addressing the registration and efficacy testing of pre-saturated antimicrobial towelettes, commonly known as disinfecting wipes. Released on November 20, 2024, the document introduces a newly standardised testing protocol, ASTM E3363, tailored for evaluating disinfecting claims on hard, non-porous surfaces such as glass, stainless steel, and hard plastics.
Purpose and Significance
This initiative aligns with EPA’s regulatory responsibilities under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), ensuring the effectiveness of disinfectant products before they are marketed in the U.S.. Historically, efficacy assessments for wipes were adaptations of liquid formulation methods. The ASTM E3363 method, approved in September 2023, standardises this process to better accommodate the unique properties of antimicrobial towelettes.
Key Testing Framework
The draft specifies:
- Testing Requirements: Evaluations must use the complete, packaged product as sold, ensuring consistency in antimicrobial efficacy.
- Testing Method: ASTM E3363 combines chemical inactivation with mechanical removal of microbes, targeting claims against bacteria such as Staphylococcus aureus and Salmonella enterica. Products must demonstrate a minimum 4.5 log reduction in viable bacteria to qualify.
- Exclusions: Products deviating from pre-saturated formats, such as dry-to-wet wipes, require case-by-case evaluations.
Impact on Manufacturers
The guidance does not impose new regulatory requirements but provides a streamlined approach for compliance, potentially reducing the burden on registrants. Stakeholders have 60 days to comment on the draft via the docket EPA-HQ-OPP-2024-0414 at Regulations.gov, with submissions closing on January 21, 2025.
This document reflects EPA’s commitment to upholding public health standards while facilitating innovation in antimicrobial product development. Finalisation of this guidance will mark a significant milestone in the regulatory landscape for disinfecting wipes.
