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June 1, 2022

EPA Activates Emergency Viral Pathogen Guidance for Monkeypox Virus

Heather F. Collins, M.S.

The U.S. Environmental Protection Agency (EPA) announced on May 26, 2022, that on Monday, May 23, 2022, it has activated its Emerging Viral Pathogen (EVP) Guidance for Antimicrobial Pesticides (Guidance) in response to monkeypox, which had been considered to be a rare disease caused by infection with the monkeypox virus. According to the U.S. Centers for Disease Control and Prevention (CDC), monkeypox was first discovered in 1958 when two outbreaks of a pox-like disease occurred in colonies of monkeys kept for research, hence the name “monkeypox.” The first human case of monkeypox was recorded in 1970 in the Democratic Republic of Congo during a period of intensified effort to eliminate smallpox. CDC states that its scientists are tracking multiple cases of monkeypox that have been reported in several countries that do not normally report monkeypox, including the United States.

EPA developed its Guidance in 2016 to address emerging pathogens. Under this Guidance, EPA provides pesticide registrants with a voluntary “two-stage process to enable use of certain EPA-registered disinfectant products against emerging viral pathogens not identified on the product label.” These pathogens may not be identified on a label because the occurrence of EVPs is less common and predictable than that of established pathogens and because the pathogens are often unavailable commercially and standard methods for laboratory testing may not exist. EPA’s intent is for the Guidance to “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against EVPs associated with certain human or animal disease outbreaks. Registrants with a pre-qualified EVP designation can include an efficacy statement in technical literature distributed to health care facilities, physicians, nurses, public health officials, non-label-related websites, consumer information services, and social media sites. Additional information on the EVP Guidance is available here and here.

The monkeypox virus belongs to the Orthopoxvirus genus in the family Poxviridae and is an enveloped virus, meaning it is one of the easiest to kill with the appropriate disinfectant product. EPA recently developed the new List Q: Disinfectants for Emerging Viral Pathogens (EVPs). Monkeypox virus is a Tier I (enveloped virus); thus, when disinfectants damage their lipid envelope, the virus is no longer infectious. EPA’s List Q currently has 422 disinfectant products for use on Tier 1 viruses.

The EVP Policy for the monkeypox virus expires in May 2023.

Information on the monkeypox virus is available on CDC’s website.