EPA is announcing the expedited review of certain applications for registration and amended registration for products intended for use against the SARS-CoV-2, the novel human coronavirus that causes COVID-19. Pursuant to Title VII of the CARES Act passed on March 27, 2020, EPA is providing notice of its intention to expedite reviews for addition of residual (i.e., extended or long-lasting) efficacy claims for currently registered or new product registrations that are on EPA’s Disinfectant List N, that would qualify for List N, or products that can be used as a residual supplement to disinfectants on List N.
Under the Pesticide Registration Improvement Act (PRIA), typical decision review timeframes for these types of registration actions range from four months for amendments and new registrations for products similar to existing products, to 24 months for new active ingredient submissions (AD PRIA Action Code Tables). For antimicrobial products that may be of use against SARS-CoV-2, EPA is currently making every effort to expedite the review and make regulatory decisions for the submissions discussed in this document by at least one to two months faster than the normal PRIA timeframe, depending on the submission, provided the procedures described in this interim guidance are followed. This is consistent with EPA’s previous guidance for expedited review. As EPA gains more experience with expedited procedures, we may revise the expected completion timeframes for these actions.