Overview
For additional guidance, please refer to Steptoe's COVID-19 Resource Center.
On March 31, the Environmental Protection Agency (EPA) announced additional aggressive measures to ensure that the nation continues to have disinfectant products available that are efficacious against the novel coronavirus, SARS-CoV-2. The latest policy is intended to ensure that manufacturers of disinfectant products on EPA’s list of products effective against emerging viral pathogens (List N) will be allowed to "obtain certain active ingredients from any source of suppliers without checking with the agency first." In additon, EPA has provided supplier flexibility for "certain inert ingredients" to facilitate uninterrupted production of these important antimicrobial products. Eligible active ingredients are citric acid (PC Code 021801), ethanol (PC Code 001501), glycolic acid (PC Code 000101), hydrochloric acid (PC Code 045901), hypochlorous acid (PC Code 129054), hydrogen peroxide (PC Code 000595), L-lactic acid (PC Code 128929), and sodium hypochlorite (PC Code 014703). Eligible inert ingredients are included on EPA’s recently released list of Commodity Inert Ingredients for which registrants can now procure these specific inert ingredients from "various commercial sources without having to provide EPA the supplier name and address."
This EPA announcement is another rapid response to requests for action from registrants and trade associations in light of concerns of potential supply chain shortages. Prior to this, EPA issued a policy effective January 29, 2020, that allows claims against emerging viral pathogens provided that acceptable efficacy data was submitted. Both the American Chemistry Council (Novel COVID-19-Fighting Products) and EPA (List N: Disinfectants for Use Against SARS-CoV-2) maintain disinfectant product lists, which are continually updated and now contain over 350 products that meet EPA's efficacy criteria for claims against the new viral threat. To allow the rapid processing of new disinfectant products with emerging viral pathogen claims, the EPA then took the additional step on March 30, 2020, to issue a temporary amendment to Pesticide Registration Notice 98-10 that allows EPA-registered surface disinfectant products that do not require review of new efficacy data to be expedited as non-PRIA "fast track" amendments. Decisions on these amendments are expected to be made rapidly and incorporated into List N as quickly as possible. It is important to note that inclusion on List N does not authorize a registrant to state that products are effective against SARS-CoV-2. That can only be done if the product is tested on this virus strain. We understand some testing labs believe they will have access to the virus in the near future and can begin testing.
The recent actions by EPA provide registrants with important flexibility in sourcing materials for formulation of disinfectants efficacious against SARS-CoV-2. Steptoe is working with companies seeking to have products included on EPA List N and with companies proposing other solutions to ensure an adequate disinfectant supply.
