December 8, 2021

Volume XI, Number 342

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December 07, 2021

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December 06, 2021

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EPA Indefinitely Extends COVID-19 Emerging Viral Pathogen Guidance

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. 

© 2021 Beveridge & Diamond PC National Law Review, Volume XI, Number 327
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About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Kathryn E. Szmuszkovicz Litigation Attorney Beveridge & Diamond Washington, DC
Managing Principal

Kathryn E. Szmuszkovicz litigates and provides strategic regulatory counsel.

Kathy litigates on behalf of individual companies, groups of companies and trade associations in federal and state courts across the country. She also provides alternative dispute resolution (ADR), compliance, strategic planning, and commercial services focused on the regulatory aspects of her clients’ businesses. Kathy’s practice focuses on clients who manufacture, sell, and use products regulated by EPA, USDA, FDA, DOI, DOC, and analogous state agencies under the environmental, health, and safety laws...

202-789-6037
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036
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