EPA Establishes New Expedited Approval Pathways for Long-Lasting Residual Antimicrobial Products

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As part of the agency’s ongoing response to the coronavirus pandemic, EPA has issued new interim guidance outlining the path for expedited approval of products that demonstrate the ability to provide durable residual antimicrobial activity of hard surfaces.  Specifically, the guidance establishes registration criteria for two new categories of antimicrobial products:  (1) “residual disinfectants” (including liquid spray and other surface treatments), and (2) “supplemental residual antimicrobial products” (including paints, coatings and solid surface materials).  EPA is seeking to review and approve registrations for these products at least 1-2 months quicker than the usual agency review time.

Historically, traditional disinfectant or sanitizer products that receive EPA registration under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) provide a relatively quick kill of the vast majority of bacteria, viruses or other microbes on the surface at the time of application, but are subject to immediate recontamination as soon as they are touched.  In recent years, a number of products have emerged with the ability to provide more durable antimicrobial activity that lasts beyond the immediate application to the surface.  The demand for such long-lasting disinfectants and sanitizers has spiked in recent months in light of the pandemic.

EPA’s new policy responds to this increased demand and is the first-ever guidance that specifically outlines the data requirements for approval of such “residual” antimicrobials.  For the new category of “residual disinfectants,” products must kill 99.9% of bacteria or 99.999% of viruses within 10 minutes of application and continue providing such efficacy for at least 24 hours.

In contrast, “supplemental residual antimicrobial products” do not meet the quick kill time standard for a “disinfectant” but provide at least a 99.9% microbial reduction within 2 hours, and continue to be effective over weeks, months or years.  EPA considers these products to be “supplemental” in that they provide beneficial microbial reductions on the treated surface during the time between routine cleaning and disinfection practices.  Products receiving this type of registration must bear the following qualifying language:

Although this product DOES NOT meet EPA’s standards for disinfectants, EPA has determined that, when used with an EPA-registered disinfectant, this product can provide some additional protection against [microorganism(s)] for up to X days. This product DOES NOT achieve the same level of efficacy as an EPA-registered disinfectant; it is only intended to provide supplemental protection between routine applications of EPA-registered disinfectants.”

In addition, companies that register these “supplemental” products must prepare and implement a written stewardship plan that addresses their “proper sale … distribution, and responsible use.”   EPA notes that “[u]nlike the conventional antimicrobial products, these products represent unique challenges that require timely feedback to ensure proper use and compatibility in combination with current infection control practices.”  The plan must include the the following elements:

  • Advertising and promotional materials that clearly and consistently include a disclaimer that the product does not meet EPA’s standards for disinfectants and is intended to supplement the use of EPA-registered disinfectants.
  • Outreach to the infection control community;
  • Customer feedback consisting of product issues/concerns, adverse events, compliance challenges/observations, and contraindications/adverse events gathered through quarterly registrant-initiated surveys, customer complaints, and suggestion boards; and
  • Development of a stewardship website.

EPA currently maintains a list of disinfectants that meet EPA’s criteria for efficacy against the SARS-CoV-2 virus (“List N“).  While approved “supplemental residual antimicrobial products” are not eligible for List N, they will be added to a separate appendix.

In conjunction with the new guidance, EPA also released draft residual efficacy testing protocols, an updated draft testing protocol for evaluating the ability of copper surfaces to kill bacteria, and a draft efficacy protocol for antimicrobial surface coatings.

The new guidance is effective now but subject to amendment after a 60-day comment period, which runs through December 11th.  A copy of the guidance is available here.

[View source.]

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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