EPA Updates Emerging Viral Pathogen Guidance

The EPA recently released updated draft guidance detailing the proposed process for obtaining temporary virucidal claims during human or animal virus outbreaks.  The two-stage label amendment process utilizes a hierarchy of viral resistance to disinfectants and includes guidelines to help expedite off-label claims for registered products.  In summary, the agency proposes the following:

  • The product must be registered as a broad spectrum or hospital-use disinfectant.
  • The product label must have at least two small non-enveloped virus claims to warrant a temporary claim of effectiveness against emerging small non-enveloped viruses (e.g. poliovirus, canine parvovirus or feline calicivirus). 
  • The product label must have at least one small non-enveloped virus claim to warrant a temporary claim of effectiveness against emerging large non-enveloped viruses (e.g. adenovirus or bovine rotavirus). 
  • The product label must have at least one large or one small non-enveloped virus claim to warrant a temporary claim of effectiveness against an emerging enveloped virus (e.g. influenza, measles or herpes viruses).

The EPA is accepting comments until May 6th.  Disinfectant registrants are encouraged to contact the lab with questions related to the updated guidance or viral testing in general.