Due to the outbreak of the novel coronavirus, SARS-CoV-2, the cause of COVID-19, EPA is expediting the review of submissions from companies requesting to add Emerging Viral Pathogens claims to the labels of their already-registered surface disinfectants.
Information for Registrants
At this time, only claims that do not require review of new efficacy data are being expedited. These claims can be submitted as non-PRIA fast-track amendments. In addition, registrants should not include other label changes typically covered under amendments and notifications as part of the submission to add Emerging Viral Pathogen claims.s.
To ensure the efficient processing of your submissions, please include the following in a cover letter to EPA:
- a subject line that clearly indicates "Emerging Viral Pathogen Claim for SARS-CoV-2";
- 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 consistent with the guidance;
- the identification of the virus(es) from the product label that you are using to support the emerging viral pathogen claims and the study ID number (MRID) that supports the claim;
- Note: We recommend using the minimum number of supporting viruses needed for the emerging pathogen claim in order to expedite EPA's review
- an up-to-date matrix (Form 8570-35); and
- a request to add the Terms of Registration outlined in Attachment I of the Emerging Viral Pathogens Guidance.
Registrants should also submit 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 Emerging Viral Pathogens guidance document.
Submit your application via the CDX portal. Once you submit or if you have already submitted your application, please email disinfectantslist**At_Symbol_Here**epa.gov with your CDX tracking number (CDX_2020_XXXXXXX) so that your submission can be expedited.
If approved, your product will be added to List N: Disinfectants for Use Against SARS-CoV-2, during the next update to the list.
This information is also available at Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants.
