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December 07, 2021
Emerging viral pathogens guidance extended

On November 19, 2021, the EPA announced it is “indefinitely extending COVID-19 activation of the emerging viral pathogens (EVP) guidance for antimicrobial pesticides. EPA’s EVP guidance for antimicrobial pesticides is a part of the federal government’s pandemic preparedness, allowing manufacturers to provide the Agency with data, even in advance of an outbreak, demonstrating that their products are effective against hard-to-kill viruses.”

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EVP guidance allows “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,” according to a November 23, 2021, Beveridge & Diamond P.C. article in Lexology.

Substances claiming to kill microorganisms are known as antimicrobial pesticides, which must first be registered with the 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,” adds the Beveridge & Diamond article. “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.”

When new viral pathogens emerge, “antimicrobial product manufacturers must both test their products’ efficacy against the emerging pathogen and navigate the lengthy EPA review process,” states a bulletin published by Taft Law. “This process poses significant hurdles to ensuring the public’s timely access to EPA-approved products that can be used to combat the rapid spread of emerging viruses like SARS-CoV-2.”

With these hurdles in mind, the EPA first extended its EVP guidance to SARS-CoV-2 at the onset of the COVID-19 pandemic in January 2020.

“Under this guidance, antimicrobial pesticide manufacturers can support COVID-19 claims by providing EPA with data that shows that their products are effective against harder-to-kill viruses,” the Taft Law article continues. “Upon EPA approval, these manufacturers could make claims for their products’ use and efficacy against the novel coronavirus for up to 24 months after the viral outbreak began.”

Normally, regulations require manufacturers with registered products to remove EVP claims within 24 months of the original outbreak notification.

“With EPA’s latest announcement, registrants may continue to include SARS-CoV-2 EVP claims in their consumer messaging,” Beveridge & Diamond notes. “EPA will provide six months’ notice to registrants before inactivating the EVP guidance for SARS-CoV-2.”

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