Guidance to Companies on Referring to Registered Disinfectant Products that Meet the CDC Criteria for Use Against the Ebola Virus
EPA has worked closely with Center for Disease Control (CDC) to develop the CDC Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus (pdf). Although few EPA-registered products have specific label claims against the Ebola virus, enveloped viruses such as Ebola are susceptible to a broad range of hospital disinfectants used to disinfect hard, non-porous surfaces. In contrast, non-enveloped viruses are more resistant to disinfectants.
As a precaution, the selection of a disinfectant product with a higher potency than what is normally required for an enveloped virus is being recommended by the CDC at this time. EPA-registered hospital disinfectants with label claims for hospital disinfection (or the equivalent microbial pathogen claims) and claims against non-enveloped viruses (e.g., norovirus, rotavirus, adenovirus, poliovirus) are broadly antiviral and capable of inactivating both enveloped and non-enveloped viruses and are used to disinfect environmental surfaces in rooms of patients with infectious diseases.
Additional information is available in the CDC guidance documents:
- Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus (pdf)
- Interim Guidance for the U.S. Residence Decontamination for Ebola Virus Disease (Ebola) and Removal of Contaminated Waste
If a registrant has an EPA-registered product(s) that meets the criteria stated in the CDC guidance and the product was registered during or after 2010, or EPA has tested the product’s efficacy under the Antimicrobial Testing Program, or the Agency has “confirmed” the product’s efficacy, the registrant may identify such product(s) on company websites or through other non-label communications. To determine whether EPA has confirmed a product’s efficacy refer to List of ATP-tested Hospital Sterilants, Disinfectants and Tuberculocides.
Non-label communications should indicate that:
- the product meets the CDC criteria for disinfectant products with label claims for a non-enveloped virus;
- the product is intended for use on hard, non-porous surfaces; and
- the product’s label use instructions for the non-enveloped virus or viruses should be followed.
At this time, the Agency is not allowing label claims related to antimicrobial product efficacy specifically against the Ebola virus since a scientifically available testing procedure with a surrogate has not been developed.
For registration-related questions contact the Antimicrobials Division Ombudsman at [email protected].
For this pathogen, the guidance on this page supersedes the April 3, 2008 “Implementation of the Emerging Pathogens and Disinfection Hierarchy for Antimicrobial Products."