EPA Issues New Interim Guidance on Expedited Review for Certain Long-Lasting Disinfectants

Morgan Lewis

Morgan LewisThe Environmental Protection Agency will expedite review of certain types of applications for new and amended registrations of pesticide products intended for use against the coronavirus (COVID-19).

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), all pesticide products (including antimicrobials) must be registered with the Environmental Protection Agency (EPA) prior to sale, distribution, or use. EPA maintains a list of pesticide products that are expected to kill SARS-CoV-2, the virus that causes COVID-19, called List N. EPA recently released new interim guidance under which it will expedite review of certain types of applications for new and amended registrations of pesticide products intended for use against SARS-CoV-2.

Under the new guidance, EPA will expedite its review of the addition of residual efficacy claims for current or new registrations on List N, products that would qualify for List N, or products that can be used as a residual supplement for disinfecting products already on List N. Residual efficacy claims are, in essence, claims that a product has antimicrobial effects for extended or long-lasting periods of time—often days, weeks, or even months.

Under the regular review process, decisions on these registrations would often take 4–24 months, depending on the type of submission. EPA has indicated that it is expediting the decisionmaking process under the guidance for the aforementioned categories of products by decreasing the decisionmaking time frame for eligible products by one to two months.

There are two major categories of antimicrobial products making residual effects claims that will qualify for expedited review under the interim guidance: (1) products that have residual efficacy, and (2) supplemental residual antimicrobial products. Supplemental residual antimicrobial products are those that do not meet FIFRA’s pesticide standards themselves, but that are intended to supplement products that are already on List N.

EPA also notes in the interim guidance that some antimicrobial products may be subject to both EPA and Food and Drug Administration (FDA) jurisdiction, potentially requiring FDA review. The interim guidance does not, however, apply to products that are subject to FDA’s exclusive jurisdiction (such as liquid disinfectants for use on humans, e.g., hand sanitizers).

Companies should ensure that they are compliant with all FIFRA regulations, particularly those related to List N and products that claim to kill SARS-CoV-2. EPA continues to pursue companies that are selling unregistered or otherwise illegal pesticide products, and Region 2 recently issued 29 advisory letters and 8 notices of warning against companies that marketed products with unsubstantiated claims of efficacy against SARS-CoV-2 and other pathogens.

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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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