28 July 2020

EPA Approves First Surface Disinfectants for On-Label Efficacy Claims Against the Novel Coronavirus

Updated July 31, 2020

As of July 31, the U.S. Environmental Protection Agency (EPA or the Agency) has approved 15 surface disinfectant products to make on-label claims of efficacy directly against the SARS-CoV-2 virus, the novel coronavirus that causes COVID-19. This marks the first time since the novel coronavirus pandemic began that EPA has reviewed and approved testing data on the SARS-CoV-2 virus itself. The registrants of these products, which include dilutable, ready-to-use, and wipe formulation types, can now update the product labeling registered with EPA to include directions for use and claims directly against SARS-CoV-2. The registrants will also be permitted to market and advertise their efficacy against the SARS-CoV-2 virus, consistent with all applicable EPA regulations. EPA has indicated that it is planning to review and approve on a rolling basis additional products for on-label claims against the SARS-CoV-2 virus. It has been processing these on an expedited basis since May.

EPA has regulatory authority to review, register, and approve claims made by antimicrobial surface disinfectants under the Federal Insecticide, Fungicide, and Rodenticide Act, the federal pesticide law. During the COVID-19 pandemic, the Agency has been allowing registrants of antimicrobial disinfectants to make limited, off-label claims of efficacy against SARS-CoV-2 if the product has demonstrated efficacy against other human coronaviruses or other viruses harder to kill than SARS-CoV-2. EPA has been approving these off-label claims pursuant to its 2016 Emerging Viral Pathogen guidance and collecting the list of “emerging viral pathogen”-approved products on its List N, which currently contains 468 products.1 The approved off-label claims can be made only on company websites or social media pages, on 1-800 telephone information services, and in technical literature distributed to medical professionals and hospitals. Product registrants are allowed to keep the off-label “emerging viral pathogen” claims in the approved marketing media for up to two years after the onset of the public health emergency unless EPA provides guidance extending that timeline due to continuing public health effects of the virus.

1 EPA now indicates in List N whether a product has been approved to make on-label claims directly against the SARS-CoV-2 virus. To see whether a product is approved directly against SARS-CoV-2, search for the List N column titled “[t]o kill SARS-CoV-2 (COVID-19), follow disinfection directions for the following pathogen(s)” and filter by “SARS-CoV-2.”