What is an emerging viral pathogen claim?
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. SARS-CoV-2, the coronavirus that causes COVID-19, is a pathogenic virus.
Because the occurrence of emerging viral pathogens 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 harder-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 such as SARS-CoV-2 (COVID-19). 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.
EPA’s emerging viral pathogen guidance was triggered for SARS-CoV-2 on Jan. 29, 2020. This type of human coronavirus is an enveloped virus, meaning it is one of the easiest types of viruses to kill. Products with human coronavirus claims but not the emerging viral pathogen claim cannot make the same marketing claims in these materials listed above.
- What is the process for EPA approval of disinfectant products related to COVID-19?
- Are there any changes to the registration of disinfectants due to COVID-19?
- Do I need to register disinfectant products with EPA in order to import them?
- Does EPA regulate companies that require cleaning services claiming to disinfect for SARS-CoV-2 (COVID-19)?
- Will EPA take enforcement action against companies making false claims that their disinfectants work against SARS-CoV-2 (COVID-19)?
- Why aren’t hand sanitizers listed on List N?
- What’s the difference between products that disinfect, sanitize, and clean surfaces?