EPA Update: Interim Guidance to Expand Viral Claims to Additional Antimicrobial Products
On October 10, 2024, the US Environmental Protection Agency (EPA) released interim guidance for adding viral claims to food and non-food contact surface sanitizer antimicrobial products which have met the bacterial efficacy requirements for a sanitizer as outlined in EPA’s Product Performance Guidelines, OCSPP 810.2300. This interim guidance follows the EPA’s draft guidance posted by the EPA on July 17, 2023.
Historically, viral claims were only allowed by the EPA on sterilant and disinfectant products as the EPA felt that viral claims were primarily a concern in hospital and healthcare settings. The COVID-19 pandemic changed this thinking. Expanding the policy to include viral claims on sanitizers for use in non-healthcare settings increases the number of products available to the general public while assuring that these products meet rigorous virucidal efficacy performance requirements. Products with sanitization-only claims may be used in non-healthcare use sites in residential, commercial, and institutional settings such as cafeterias and waiting rooms but cannot be registered for use in patient care areas. The interim guidance is for hard, non-porous surface use and currently does not allow for virucidal residual or soft-surface sanitization claims
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 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 at the nominal concentration. The virucidal performance criteria for sanitization efficacy is the same as disinfection (≥99.9% or ≥3-log reduction) however, the maximum contact time allowed is consistent with the maximum contact time for the bacterial sanitizer claim; ≤30 seconds for food contact sanitization (label claim of 1 minute) and ≤5 minutes for non-food contact sanitization.
The expansion for adding viral sanitizer claims is currently for a maximum time-limited period of ten years with the time period starting from the date the draft guidance was finalized regardless of when the submission was made. This time limit allows the agency to determine if revisions to the policy are needed or if the policy can be made permanent. A public comment period for the interim guidance is currently open and is set to expire along with the sanitizer viral claim time-limited period on October 10, 2034.
To learn more about this new interim virucidal guidance or to inquire about testing the efficacy of your products, please contact Karen Ramm, Director of Client Relations at [email protected].
