Emerging Viral Pathogen Guidance and Status for Antimicrobial Pesticides
- Overview
- Active cases triggering the emerging viral pathogens policy
- Information for registrants
- Additional resources
Overview
The National Institute of Allergy and Infectious Diseases defines “emerging infectious diseases/pathogens” as those “that have newly appeared in a population or have existed but are rapidly increasing in incidence or geographic range.”
Many of the emerging pathogens of greatest concern are pathogenic viruses. How long these viruses last on surfaces can play a role in the disease transmission.
Because the occurrence of emerging viral pathogens (EVPs) is less common and less predictable than established pathogens, few if any EPA-registered disinfectant product labels specify use against this category of infectious agents. Therefore, in 2016, EPA provided a voluntary, two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.
A company can apply for an emerging viral pathogen claim, even before an outbreak occurs, based on previous EPA-approved claims for specific hard-to-kill viruses.
EPA reviews the supporting information and determines if the claim is acceptable. Once approved, a company can make certain off-label claims as specified in that guidance in the event of an outbreak. For instance, the preapproved company can include certain statements about expected efficacy on:
- technical literature distributed to health care facilities, physicians, nurses, and public health officials;
- non-label-related websites;
- consumer information services; and
- social media sites.
Active Cases Triggering the Emerging Viral Pathogens Policy
The Emerging Viral Pathogens guidance is currently active for the following pathogens:
| Pathogen | Description | Activated | Expires | More Information |
|---|---|---|---|---|
| Marburg Virus | Marburg virus disease is a rare disease that is caused by an infection from the Marburg virus. Learn more about Marburg virus. | October 2024 | October 2026 | List Q: Disinfectants for Emerging Viral Pathogens (EVPs) |
| Mpox virus | Mpox (formerly monkeypox) is a rare disease that is caused by infection with mpox virus. Learn more about mpox in the United States. | August 2024 | August 2026 | List Q: Disinfectants for Emerging Viral Pathogens (EVPs) |
| Rabbit Hemorrhagic Disease Virus (RHDV2) | RHDV2 is a highly contagious fatal disease in rabbits. It does not impact human health. | July 2020 | EPA has extended its EVP policy for RHDV2 indefinitely and will provide at least 6 months notice before terminating activation. |
List O: Disinfectants for Use Against Rabbit Hemorrhagic Disease Virus (RHDV2) |
| SARS‑CoV‑2 and variants | SARS‑CoV‑2 is the virus that causes COVID‑19. | January 2020 | EPA has extended its EVP policy for SARS‑CoV‑2 indefinitely and will provide at least 6 months notice before terminating activation. | List N: Disinfectants for Coronavirus (COVID-19) |
Information for Registrants
The following 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 off label 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 non-PRIA fast-track amendment.
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”;
- 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;
- 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.
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. Submit your application via the CDX portal.