These documents provide general guidance to registrants and address public concerns on a process that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens. The guidance outlines a voluntary, two stage process involving product label amendments and modified terms of registration and applies only to emerging viruses. Actions described by this guidance may be taken for eligible products only after the Centers for Disease Control and Prevention has identified the emerging pathogen and recommended environmental surface disinfection to help control its spread.
After reading the guidance document linked below, registrants and applicants interested in making product claims against emerging viral pathogens should submit a label amendment request with the following items:
- A cover letter that includes:
- a request to make emerging viral pathogen claims;
- a description of how the product meets the eligibility criteria for use against one or more categories of viral pathogens;
- the identification of all viruses from the product label that support the emerging viral pathogen claims;
- a request to add the Terms of Registration outlined in Attachment I of the guidance document below to the product registration.
- A revised master label with a separate section for emerging viral pathogen claims that includes the generic claim statements identified in Attachment I of the guidance document below.