July 2023

On July 17, 2023, the US Environmental Protection Agency (EPA) released draft guidance to expand the availability of virus claims to additional antimicrobial products, specifically food and non-food contact sanitizers, which have met the bacterial efficacy requirements for a sanitizer as outlined in EPA’s Product Performance Guidelines OCSPP 810.2300.

The draft guidance is posted on an EPA docket for a 60-day comment period with comments due by September 15, 2023.

Historically, viral claims were only allowed by the EPA on sterilants and disinfectants but not on sanitizers. Expanding the policy to include viral claims on sanitizers increases the number of products available to the general public while assuring that these products meet rigorous virucidal efficacy performance requirements. These sanitizer-claims-only products may be used in non-healthcare use sites in residential, commercial, and in institutional settings such as cafeterias and waiting rooms but cannot be registered for use in patient care areas.

Per the draft guidance, efficacy testing for a food contact or non-food contact viral sanitizer claim is performed following the same method currently used for testing the efficacy of hard surface disinfectants, ASTM E1053: Standard Practice to Assess Virucidal Activity of Chemicals Intended for Disinfection of Inanimate, Nonporous Environmental Surfaces. Consistent with EPA’s Product Performance Guidelines OCSPP 810.2200 for testing disinfectants against viruses, testing of two individual batches of product is required with the active ingredient level at the lower certified limit (LCL) for the hardest to kill virus on the product label. All additional viruses on the product label may be tested with the product active ingredient at or below the nominal concentration. The virucidal performance criterion for sanitization efficacy is the same as disinfection (≥99.9% reduction) however, the maximum contact time allowed is consistent with the maximum contact time for the bacterial sanitizer claim.

The proposed expansion for adding viral claims to sanitizer only products will have a seven-year time limit claim period starting from the date the draft guidance is finalized regardless of when the submission was made. This time limit allows the EPA as well as registrants, industry, and users to submit comments to the agency to determine if revisions to the policy are needed or if the policy can be made permanent.

To learn more about this new draft virucide guidance or to inquire about testing the efficacy of your products, please contact Karen Ramm, Director of Client Relations at [email protected].