The U.S. Environmental Protection Agency (EPA) continues to expand the number of surface disinfectants approved for use against coronavirus, announcing the addition of 70 new products to the agency’s “List N: Disinfectants for Use Against SARS-CoV-2.” This brings the total number of products on the list to over 350. A copy of the current list is available here.
Keep in mind that List N only includes surface disinfectant products, such as sprays and aerosols. Many other effective disinfection products, including hand sanitizers and body wipes, are regulated by the U.S. Food and Drug Administration (FDA) and do not appear on EPA’s list. These FDA-regulated products typically will not include EPA registration information on the product label, as discussed in my post from last week: Coronavirus: Does My Disinfectant Work Against the COVID-19 Pathogen?.
EPA is moving rapidly to expand the number of disinfectant products allowed to make claims of effectiveness against coronavirus under the agency’s “emerging pathogens” policy (for more information on the policy, see my prior blog post). While the policy sets a 90-day period for EPA to review requests to add claims against “emerging pathogens” like coronavirus, the agency said yesterday that it has been able, in many cases, to grant approvals within 14 days. The policy, and such expedited review, is premised on the products already having data showing anti-viral efficacy on file with EPA.
In addition, EPA is now allowing companies to source certain “commodity inert ingredients” from different suppliers without first obtaining agency approval. These inactive ingredients, such as sodium chloride and glucose, can readily be obtained from a large number of suppliers without meaningful difference in composition. Typically, companies may only use ingredients from the specific sources identified in the product registration application. Given potential shortages in the supply chain, this added flexibility will help minimize potential disruptions in the production of disinfection products, as well as ease the registration requirements for new products.
Please see the Kelley Drye COVID-19-Response Resource Center website for daily and up-to-date information about the potential legal and business implications of the evolving pandemic: https://www.kelleydrye.com/Our-Practices/Hot-Topics/COVID-19-Response-Resource-Center.