Overview
For additional guidance, please refer to Steptoe's COVID-19 Resource Center.
On April 14, the US Environmental Protection Agency (EPA) announced additional measures to ensure a steady supply of safe and effective disinfectant products for use against the novel coronavirus, SARS-CoV-2. A second temporary amendment to Pesticide Registration (PR) Notice 98-10 has now been issued to streamline the "process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment." Registrants may now temporarily "notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval."
This action is the latest in a series of measures the agency has taken to promptly respond to industry concerns that the usual EPA approval process was creating bottlenecks to expanding disinfectant supply. EPA's responses generally have provided temporary flexibility for registrants to make certain changes in their supply chains without having to wait for EPA approval. It is important to note that these temporary measures will continue to ensure effectiveness of registered antimicrobial products.
The agency maintains and regularly updates its List N: Disinfectants for use against SARS-CoV-2, which now contains over 360 products registered with EPA that meet emerging viral pathogen claims or have demonstrated efficacy against previous strains of coronavirus (i.e., SARS, MERS) and was recently expanded to include other known products that meet EPA criteria for efficacy. EPA announced the first temporary amendment to PRN 98-10 on March 31 to allow use of any "similar source" of eight specific active ingredients "without having to first apply for and receive EPA approval of an amendment to their pesticide registration identifying the new source of ingredient."
The April 14 amendment to PRN 98-10 supersedes the previous one from March 2020 and is time-limited. EPA will post an online notification at least seven days prior to termination of the temporary amendment and any permanent modifications to PRN 98-10 will only be made following a public comment period.
Steptoe's chemicals team continually focuses on antimicrobial registration and regulatory issues and is available to assist registrants in working through the issues associated with expanding production.