December 2, 2021

EPA Extends COVID-19 Activation of Emerging Viral Pathogens Guidance

In recognition of the continued impact of COVID-19 on public health, EPA has indefinitely extended the COVID-19 activation of its emerging viral pathogens (EVP) guidance for antimicrobial pesticides, according to a Nov. 19 press release. EPA’s EVP guidance for antimicrobial pesticides is a part of the U.S. government’s pandemic preparedness that allows manufacturers to provide EPA with data to demonstrate products’ effectiveness against specific hard-to-kill viruses and enable their use against EVPs, even before the beginning of an outbreak. This has permitted accelerated review and approval of surface disinfectant products for use against SARS-CoV-2, the virus that causes COVID-19.

Due to the less common and predictable occurrence of EVPs as opposed to established pathogens, few EPA-registered disinfectant products were approved and labeled for use against EVPs before the emergence of SARS-CoV-2. In 2016, EPA provided guidance outlining a voluntary two-step process that could enable some EPA-registered disinfectant products to be used against EVPs not identified on their product labels. In this process, manufacturers apply for an EVP claim based on previous EPA-approved claims of their products’ effectiveness against certain viruses that have been classified by CDC as highly resistant to disinfectants. If EPA approves a claim, the manufacturer will be allowed to make off-label statements—such as in technical literature, on websites, in consumer information services, and on social media—to inform the public that their product may be used against a specific EVP not listed in its label, albeit only in the event of an outbreak.

EPA’s EVP guidance for microbial pesticides was activated for the first time in January 2020. By late November 2021, EPA had added about 400 products with EVP claims to List N, the agency’s register of disinfectants approved for use against SARS-CoV-2, through this expedited review process. Originally, manufacturers were required to remove EVP claims from off-label messaging within 24 months after the beginning of an outbreak. However, under the indefinite extension of the EVP guidance for SARS-CoV-2, EPA will now notify manufacturers at least six months before inactivating the guidance in order to allow registrants time to adjust off-label materials.

For more information about EPA’s EVP guidance for antimicrobial pesticides, including the claim submissions process, visit the agency’s website.