Update to SRC’s 2022 blog: EPA Triggers Emerging Viral Pathogens Policy for Monkeypox Virus
In response to the recent outbreak of over 20,000 Mpox cases in the Democratic Republic of Congo (DRC) and spread of the disease to the Republic of Congo (ROC) and Central African Republic (CAR), EPA has reset the activation date for the Emerging Viral Pathogens Policy (EVP) for Monkeypox virus to August 2024. This new activation date will allow registrants to continue to make off-label claims against Monkeypox virus through August 2026.
What is the Monkeypox virus?
The Monkeypox virus (MPXV) falls under the same genus as many other “pox” viruses including smallpox, cowpox, and vaccinia virus (which is used in the smallpox vaccine). It is an enveloped, double stranded DNA virus, thus it is likely susceptible to EPA registered disinfectants which aligns with the CDC recommendation for environmental cleaning. Infection with MPXV causes Mpox, a rare disease that is typically self-limiting with symptoms including aches, fever, and pox blisters that can last 2-4 weeks. The fatality rate is generally 1-3%, with some strains being as high as 10%. Most primary cases of Mpox are caused by zoonotic transmission, meaning the infection is spread from an infected animal to a human, generally via bites or scratches. Once infected, humans are able to spread the disease to others via respiratory droplets or contact with pox fluids directly or via surfaces.
The Pathway to Make Off-Label Claims Against MPXV.
in 2022 EPA originally engaged the Emerging Viral Pathogens Policy for off-label claims against MPXV. This policy allows registrants to make off-label claims against MPXV, if they have an approved EPA stamped label with an EVP claim for enveloped viruses.
Below is an example of a compliant off-label statement following the EVP policy for a sample EPA registered “XYZ Disinfectant” with preapproved EVP claims for Rotavirus:
Testing
To make on-label claims against MPXV, efficacy testing must be completed on the virus and submitted to EPA for review and approval. SRC has partner labs that offer efficacy testing for claims against MPXV. Please contact your SRC Consultant to assist you in achieving on-label claims against the virus.
List Q of Disinfectants for Emerging Viral Pathogens (EVPs), including Mpox
In addition to renewing its EVP Policy, EPA is directing consumers to its list of Disinfectants for Emerging Viral Pathogens (EVPs): List Q, where they can find all products with approved EVP claims. Consumers can visit List Q and search for products approved for use on Tier 1 (enveloped) viruses to find disinfectants that have demonstrated efficacy against viruses that are more difficult to inactivate than Mpox.
If a qualified product is not already included on List Q or if errors are found, registrants may provide their product name and EPA Registration Number to disinfectantlist@epa.gov.
Contact SRC for additional information on obtaining an Emerging Viral Pathogen claim for your disinfectant so you are ready for these new pathogens as they appear in the US.
Sam Kappel
Consulting Specialist II
Posted on 05/23/22
Updated on 09/12/2024