EPA Approves Eligible Disinfectants For Anti-Monkeypox LabelsMay 26, 2022
What Happened: EPA activated its Emerging Viral Pathogens guidance to permit limited claims that certain registered pesticides are effective against the monkeypox virus.
Who’s Impacted: Manufacturers and distributors of disinfectant products that are pre-qualified to make Emerging Viral Pathogens claims or that are potentially effective against the monkeypox virus.
What Should They Consider Doing in Response: Consider adding anti-monkeypox efficacy claims to permitted product labeling for eligible products.
In response to the recent identification of multiple clusters of monkeypox in North America and Europe and a confirmed case of that disease in Massachusetts, the U.S. Environmental Protection Agency (“EPA”) is activating a limited procedure that allows eligible disinfectant product manufacturers to publicly communicate certain efficacy claims against the monkeypox virus.
Like the SARS-CoV-2 virus that emerged in late 2019, the monkeypox virus belongs to a group of “enveloped” viruses that are more susceptible to disinfectants than other types of viruses. With its May 23, 2022 announcement, EPA indicated that registrants with a pre-qualified “emerging viral pathogen designation” can now include a statement indicating efficacy “against viruses similar to monkeypox virus” in certain product labeling and authorize use against that virus.
The approved statement may be made in product technical literature distributed to health care facilities, physicians, nurses, and public health officials; non-label-related websites; consumer information services; and social media sites. The policy does not permit registrants to add the efficacy statement to product labels themselves.
EPA has also published a new List Q of all registered disinfectant products currently approved for use against emerging viral pathogens (“EVP”). All products with EVP claims have been tested against viruses that are more difficult to kill than monkeypox and may now include anti-monkeypox statements in product literature consistent with EPA policy. Such claims will be permitted through May 2023.
Disinfectants, sanitizers, and other substances intended for use on objects and surfaces against microorganisms are considered antimicrobial pesticides and cannot be sold or distributed unless they are first registered by EPA under the Federal Fungicide, Insecticide, and Rodenticide Act (“FIFRA”). EPA considers antimicrobial pesticides intended to control microorganisms that pose a threat to human health to be “public health” products, and any claims for use against a specific public health pathogen must be supported by efficacy data reviewed by EPA.
However, when emerging viral pathogens like the monkeypox virus arise, few if any EPA-registered disinfectants usually specify use against them, and it can be very difficult for manufacturers to test and assess product efficacy promptly to add these viruses to existing product…