EPA’s Draft Residual Efficacy Protocols for “Long-Lasting” Efficacy for Antiviral Products
On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. EPA’s guidance specifies scientific testing requirements for two different types of products: (1) disinfectants that also provide residual efficacy, and (2) supplemental residual antimicrobial products (e.g., coatings, paints, solid surfaces) that do not meet EPA’s standards for disinfectants but are intended to be used as a supplement to standard List N disinfectants.
In addition to releasing the draft residual efficacy protocols, EPA has also released an updated draft testing protocol for evaluating a copper surface’s ability to kill bacteria and a draft protocol for evaluating the efficacy of antimicrobial surface coatings. These laboratory testing methods act as a foundation for EPA’s interim guidance to registrants regarding residual effectiveness.
While EPA does not have an approved standard method to support virus claims for these types of products, EPA states that the following information is intended to provide interim guidance on the study design elements necessary to support these types of claims. EPA states that it may consider other methods or studies to support residual efficacy claims, provided they are scientifically sound. Applicants are highly encouraged to consult with EPA prior to submitting. Of significant interest, EPA states that products may make both types of residual claims provided that they are supported by the appropriate data.
Due to lab capacity concerns, EPA plans to consider non-GLP (Good Laboratory Practice) data to support residual claims, provided that the study submission accurately represents how the study differs from the GLP standards in the 40 C.F.R. Section 160.12 statement of non-compliance. Additional details provided in the EPA guidance on how to qualify products for residual disinfectants or supplemental residual antimicrobial products are briefly outlined below.