Guidance to Companies on Referring to Registered Disinfectant (Enterovirus D68)

EPA has worked closely with Center for Disease Control (CDC) to develop the CDC recommendations for environmental infection control in healthcare settings against Enterovirus D68 (EV-D68). Based on these recommendations, EPA-registered disinfectants with label claims for hospital disinfection (or the equivalent microbial pathogen claims) and claims against non-enveloped viruses (e.g., norovirus, poliovirus, rhinovirus) are appropriate for use against Enterovirus D68. Such products should be used for the approved use site(s), in accordance with the manufacturer’s instructions for the specific disinfection label claim, and in a manner consistent with standard environmental infection control practices. Additional information on Enterovirus D68 is available in the CDC Health Advisory.

If a registrant has an EPA-registered product that meets the CDC guidance and was either 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, a registrant may identify such a product on company websites or through other non-label communications. To determine whether EPA has confirmed a product’s efficacy, please refer to the List of ATP-tested Hospital Sterilants, Disinfectants and Tuberculocides.

Non-label communications should indicate that:

1. the product meets the CDC criteria for a disinfectant product with label claims for a non-enveloped virus;
2. the product is intended for use on hard, non-porous surfaces; and
3. the product’s label use instructions for the non-enveloped virus or viruses should be followed.

Registrants interested in obtaining a product label claim against Enterovirus D68 may generate and submit efficacy data performed with Enterovirus D68 in accordance with the Agency efficacy guidelines.

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.