Key Takeaways:

• What Happened: EPA has indefinitely extended its activation of the emerging viral pathogens guidance for antimicrobial pesticides, permitting registrants with a pre-qualified “emerging viral pathogen designation” to continue to include a statement indicating efficacy “against viruses similar to SARS-CoV-2.”

• Who’s Impacted: Manufacturers, distributors, and importers of FIFRA-regulated antimicrobial pesticides, including surface disinfectants.

• What Should Companies Do in Response: Evaluate product eligibility under EPA’s EVP guidance for use of pre-approved emerging viral pathogen efficacy statements.

As the COVID-19 pandemic continues, EPA has indefinitely extended its activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides, which it first initiated in January 2020.  Under the EVP guidance, EPA permitted registrants with a pre-qualified “emerging viral pathogen designation” to include a statement indicating efficacy “against viruses similar to SARS-CoV-2” and authorize use against the novel coronavirus.  With this announcement, registrants may continue to make such statements in their consumer messaging until EPA says otherwise.

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.  Under the Pesticide Registration Improvement Extension Act of 2018 (“PRIA-4”), EPA’s review of a request to add a new use to an existing registered antimicrobial pesticide can take a year or more.

However, when emerging viral pathogens like SARS-CoV-2 arise, few if any EPA-registered disinfectants usually specify use against them, and it can be difficult for manufacturers to test and assess product efficacy in a timely manner in order to add these viruses to existing product registrations.  When EPA activates its EVP guidance for a specific pathogen, an 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. 

Typically, registrants must remove EVP claims from consumer messaging no later than 24 months after the original notification of the outbreak.  With EPA’s latest announcement, registrants may continue to include SARS-CoV-2 EVP claims in their consumer messaging.  EPA will provide six months’ notice to registrants before inactivating the EVP guidance for SARS-CoV-2.