EPA: Long-Lasting Anti-Viral Disinfectant Approval Pathway Announced - The National Law Review

Monday, October 19, 2020

Key Takeaways:

• What Happened: EPA announced a new and expedited review process for surface disinfectant products with residual anti-viral efficacy claims of up to 24 hours, as well as a new category of “supplemental” residual antimicrobial products such as hard-surface coatings, paints, and impregnated solid materials with efficacy claims of weeks or years. Although these supplemental residual products do not independently meet EPA’s standards for disinfectants, they can be used together with EPA-registered disinfectants to provide additional, ongoing antimicrobial protection.

• Who’s Impacted: Manufacturers and distributors of disinfectant and supplemental antimicrobial products that are potentially effective against the novel coronavirus for an extended time following application.

• What Should They Consider Doing in Response: Evaluate product eligibility under EPA’s announced procedures for expedited data review, and consider whether to submit comments on EPA’s interim guidance to the Agency.

For the first time, manufacturers of antimicrobial pesticides can seek U.S. Environmental Protection Agency (EPA) approval of “long-lasting” or residual claims for antimicrobial surface disinfectants, surface coatings, and impregnated solid materials that may be effective against the novel coronavirus, SARS-CoV-2, and other viruses. EPA’s new interim guidance, published on October 14, 2020, represents EPA’s first-ever recognition of residual anti-viral claims for any antimicrobial products under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).

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 FIFRA. EPA considers antimicrobial pesticides intended to control viruses and other 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. If a particular pesticide is already registered and its producer would like to add antimicrobial claims to its label, the producer must submit a registration amendment application and, as for an initial registration application, support those new claims with efficacy data.

To date, EPA has approved over 500 disinfectant products for distribution and use against the novel coronavirus, which are listed on EPA’s List N. Until now, however, EPA only approved disinfectants with claims for activity upon contact with a surface, and did not recognize claims for any extended or long-lasting efficacy against viruses or other public health microorganisms. In August 2020, EPA approved the first-ever use of a surface disinfectant with residual antiviral efficacy of up to seven days under a FIFRA emergency exemption; however, this unregistered product is only available for use by specific parties and at specific locations in Texas. Under EPA’s new guidance, the Agency will now consider approving similar claims for registered products that will be available for use by the general public.

Long-Lasting Efficacy Claims

In its new guidance, EPA announced expedited decision timelines for three new categories of products with residual efficacy claims:

• disinfectants on (or eligible for) List N, with residual efficacy for up to 24 hours;

• supplemental residual antimicrobial coatings and films, with residual efficacy measured in weeks; and

• supplemental residual antimicrobial fixed or solid surfaces, with residual efficacy measured in years.

Supplemental residual antimicrobial products could include EPA-registered surface coatings, or solid EPA-registered materials that incorporate antimicrobial agents. Under EPA’s guidance, use sites for these supplemental products must be limited to hard, non-porous surfaces, although EPA will also consider proposed uses in or on textiles and other material types upon consultation with EPA on a case-by-case basis prior to submission of an application.

These supplemental residual products do not meet EPA’s criteria for disinfectants and are only intended to provide supplemental protection between routine applications of EPA-registered disinfectants. EPA will require that all approved supplemental residual antimicrobial products be labeled to this effect, and provides appropriate qualifying label text in the interim guidance. Once approved, supplemental residual antimicrobial products will be listed on a separate appendix to List N.

Product Stewardship Requirements

According to EPA, supplemental residual antimicrobial products present unique challenges to ensuring their proper use and compatibility in combination with traditional disinfection practices. For this reason, EPA intends to require as a term of registration that all registrants of such products prepare and implement a written stewardship plan to support their responsible use. These plans must include marketing materials that clearly and consistently provide the required disclaimer language, community outreach, customer feedback, and development of a product stewardship website. EPA may deny or cancel the registration of a supplemental residual antimicrobial product if the registrant’s submitted stewardship plan is insufficient or not adequately or timely implemented.

Public Comment

Though expedited review of the products described above is available immediately, EPA is also accepting public comment on its interim guidance for sixty days, ending Friday, December 11, 2020.

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EPA: Long-Lasting Anti-Viral Disinfectant Approval Pathway Announced - The National Law Review
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