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EPA Authorizes Anti-Coronavirus Claims for Pre-Designated Disinfectant Products

As part of the federal government’s response to the global spread of novel coronavirus (COVID-19), the U.S. Environmental Protection Agency (“EPA”) is activating a limited procedure that allows eligible disinfectant product manufacturers to publicly communicate certain efficacy claims against COVID-19.  In its January 29, 2020 announcement, EPA confirmed that registrants with a pre-qualified “emerging viral pathogen designation” can now include a statement indicating efficacy “against viruses similar to COVID-19” and authorize use against the virus.  The 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.

On March 5, 2020, EPA released a list of registered disinfectant products currently approved for use against the COVD-19 virus under this guidance.

A.  Background

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. 

However, when emerging viral pathogens like COVID-19 arise, few if any EPA-registered disinfectants usually specify use against them, and it can be very difficult for manufacturers to test and assess product efficacy in a timely manner in order to add these viruses to existing product registrations.  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.

B.  Emerging Viral Pathogen Designation

Accordingly, in August 2016, EPA developed a voluntary process for registrants of certain hospital, healthcare, or broad-spectrum disinfectant products to begin seeking advance authorization that would allow a registrant—in the event of a future human or animal disease outbreak caused by an emerging virus—to communicate that its product may be used against the emerging virus.  For registered disinfectants meeting EPA’s criteria, the Agency created an opportunity at any time prior to an outbreak for manufacturers to obtain emerging viral pathogen designation. 

Under this process, an eligible product registrant can submit a request to EPA for expedited 90-day (or “fast-track”) review under FIFRA sec. 3(c)(3)(B)(ii), or as a label amendment request under PRIA-4 (associated with a four-month review period).  Under either scenario, the request must explain why the product meets EPA’s criteria for use against a particular viral pathogen group (i.e., enveloped viral pathogens; large, non-enveloped viral pathogens; or small, non-enveloped viral pathogens).  Once approved by EPA, the designated statement is added to the product’s master label as a “non-label claim” and permitted only when EPA’s emerging viral pathogen conditions are met.

C.  Product Claims Against COVID-19

Following EPA’s recent announcement, a pre-qualified registrant may now use the emerging viral pathogen statement in off-label communications to inform the public of its product’s efficacy against COVID-19.  Note that EPA’s approval in individual cases may include additional terms and conditions further restricting how the designated statement may be communicated.

Importantly, EPA’s action applies only to registered disinfectants that have been pre-qualified under the 2016 process, and manufacturers and other stakeholders should expect EPA to closely monitor the use of COVID-19 claims in connection with all pesticide products.  This includes unregistered pesticide products distributed under FIFRA’s “minimum risk” exemption, which prohibits any claims to control microorganisms that pose a threat to human health.  If a purported minimum risk pesticide is labeled or marketed as effective against any such pathogen, it must be registered with EPA.

Similarly, EPA does not typically review efficacy data for pesticidal devices prior to their distribution or sale.  Nevertheless, a device may be “misbranded”—and thus unlawful to be marketed—if its labeling or other marketing materials include general or specific efficacy claims that are “false or misleading in any particular.”  Some devices, such as air purifiers, have been marketed as effective against coronavirus particles, and the producers or sellers of any such devices are responsible for ensuring that their products perform as claimed.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 67

TRENDING LEGAL ANALYSIS


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 that these agencies implement.

In particular, Kathy works with clients in the agricultural sector (including pesticides and seeds businesses), and food, chemicals, and consumer products industries. This includes traditional products and products produced through biotechnology or nanotechnology. Examples of her work include:

  • Bringing or defending litigation where necessary to protect clients’ products, projects, or practices.
  • Advising clients on strategies for obtaining federal approvals for new products or substances, defending products once they are on the market, and phasing out products for regulatory or commercial reasons.
  • Advising clients who manufacture, sell, license, or use these regulated products on government requirements and commercial transactions.
  • Defending companies against enforcement actions.
  • Proposing and commenting on regulatory and legislative initiatives.
  • Supporting acquisition or sale of particular products or businesses.
  • Advising on stewardship and sustainability practices.

Kathy has litigated in federal courts across the country, including the United States Supreme Court, and has represented clients in every EPA region and many states. She has advocated for clients in ADR proceedings, including ADR mandated by statute, mini-trials and other ADR designed by parties to resolve disputes privately without court intervention, and mediation.

Kathy is Beveridge & Diamond’s firmwide Managing Principal. Before assuming this role, she served for many years on B&D's Management Committee and as the chair or co-chair of the firm’s pesticides and biotechnology practices. Kathy served for six years on the Board of Directors of a privately held company that discovers, manufactures, and sells proprietary chemicals. Before her legal career, Kathy served in federal and Michigan state government.

202-789-6037