The new coronavirus SARS-CoV-2 continues to wreak havoc across the globe. According to the Johns Hopkins Virus Tracker as of this writing on April 1, 2020, there have been over 911,000 cases and over 45,000 deaths worldwide. Rapid spread across the U.S. continues, with more than 203,000 cases and 4,400 deaths reported. New York has by far the greatest concentration of cases and deaths, accounting for approximately fifty percent of each.
In response to supply chain problems being encountered by disinfectant registrants, the U. S. Environmental Protection Agency (EPA) has now simplified procedures for substituting ingredients in disinfectants. Registrants are already permitted to switch sources of registered active ingredients by a process known as Notification. Such actions are governed by Pesticide Registration Notice 98-10: Notifications, Non-Notifications and Minor Formulation Amendments. Normally a registrant of antimicrobial products must wait sixty days after filing a Notification before distributing an EPA-registered product subject to it, unless EPA approves the Notification sooner. Even before the pandemic, EPA was overburdened and often was not responding to Notifications for many months.
On March 30, 2020, EPA issued Temporary Amendment to Pesticide Registration Notice 98-10. The Amendment makes two changes to the Notification process. For a select group of active ingredients that EPA considers to be commodity chemicals, registrants may now utilize non-registered sources. Previously a change to an unregistered source required a formal amendment. In addition, registrants now may distribute product subject to the notification immediately upon filing it with EPA.
The ingredients subject to this new process are: Ethanol; Hypochloric acid; Sodium hypochlorite; Hydrogen peroxide; Hypochlorous acid; Citric acid; L-lactic acid and Glycolic acid.
The substituted ingredient must the specific version of the chemical as identified by EPA by Chemical Abstract Service (CAS) number and must meet the original certified limits specified on the product’s Confidential Statement of Formula (CSF). Registrants using non-registered sources may continue to do so as long as the Temporary Amendment is in force, which at this point is undetermined. If the registrant desires to utilize an unregistered source beyond the duration of the Temporary Amendment, a formal amendment to the CSF is required.
EPA continues to update list of registered disinfectants available for use on hard surfaces for the control of the novel coronavirus SARS-CoV-2, which causes COVID-19. See EPA List of Disinfectants for Control of SARS-CoV-2. EPA also continues to expedite reviews of amendments seeking to add claims for control of SARS-CoV-2, but only for products that already have approved claims for other emerging pathogens. See Guidance on Outbreak of Novel Coronavirus SARS-CoV-2. Registrants who wish to add claims for emerging pathogens for the first time must go through the standard amendment process.