EPA Triggers Emerging Viral Pathogens Policy in Response to Hantavirus

The agency offers critical guidance for product eligibility and evaluating hantavirus efficacy claims for antimicrobial pesticide registrants, manufacturers, and brand owners

On May 18, in response to an emerging hantavirus threat, the U.S. Environmental Protection Agency issued an official notification adding hantavirus to its page on "Emerging Viral Pathogen Guidance and Status for Antimicrobial Pesticides." EPA and the Centers for Disease Control and Prevention have identified hantavirus as an emerging threat to public health, and EPA has triggered use of its Emerging Viral Pathogen (EVP) policy accordingly. The EVP activation for hantavirus is set to remain in effect through May 2028.

Hantavirus causes two rare but serious diseases: hantavirus pulmonary syndrome (HPS) and hemorrhagic fever with renal syndrome (HFRS), both caused by infection from certain hantaviruses, including the Andes Virus. Transmission in the U.S. is primarily associated with exposure to infected rodent droppings, urine, or saliva, making environmental surface disinfection an important tool for outbreak control.

Eligibility and evaluating claims under the EVP policy

There are currently 35 EPA-registered products with existing approved claims for hantavirus. Beyond those, the EVP policy extends the ability to make hantavirus efficacy claims to a broader set of registrants. Under the EVP policy, EPA-registered disinfectant products do not need an approved hantavirus claim on their existing product registration in order to communicate expected efficacy against the virus.

Products that have already received approval for similar or harder-to-kill viruses may also make hantavirus claims through off-label channels — including technical literature distributed to healthcare facilities, consumer information services, social media, and company websites — provided those claims conform to the terms of registration set out in the 2016 EPA Emerging Viral Pathogens Guidance for Antimicrobial Pesticides.

Under the EVP guidance, hantavirus is classified as a Tier 1: Enveloped Virus — the easiest category of virus to inactivate. EPA-registered products with existing claims against Tier 1 or harder-to-kill virus categories can be evaluated for potential hantavirus eligibility. Qualifying products are listed on EPA's List Q: Disinfectants for Emerging Viral Pathogens (EVPs).

What product registrants can do

Registrants, manufacturers, and brand owners whose products may be eligible under the EVP policy can evaluate whether their existing virus approvals meet the criteria outlined in the guidance. Companies whose products qualify may submit a non-PRIA fast-track amendment to EPA and begin making limited off-label hantavirus efficacy claims through approved channels.

All claims must conform to the terms of registration set out in the 2016 EPA Emerging Viral Pathogens Guidance for Antimicrobial Pesticides and must not appear on the marketed product label itself. Given the scope of the public health response, it is important for registrants to assess their eligibility and understand what claim language is permitted before communicating efficacy against hantavirus.