The U.S. Environmental Protection Agency (EPA) took additional actions to assure that safe and effective disinfectant products are available to the American public to help combat the spread of COVID-19. In response to reports of shortages of active ingredients used in the surface disinfectants that are effective against SARS-CoV-2, the virus that causes COVID-19, EPA is temporarily allowing registrants to notify EPA of certain formulation and manufacturing facility changes and immediately release the product for sale without waiting for EPA approval.
“There is no higher priority for the Trump Administration than protecting the health and safety of Americans,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Alexandra Dapolito Dunn. “EPA recognizes the important role the agency plays in protecting public health and the environment and ensuring that Americans continue to have access to effective and approved disinfectants that can help combat the spread of COVID-19. The flexibilities that we are providing in this temporary policy change will help ensure Americans have access to the products they need to protect their families during this public health emergency.”
This action builds on EPA’s temporary amendment to Pesticide Registration (PR) Notice 98-10 announced on March 31, 2020. Among other changes, this week’s temporary amendment to PR Notice 98-10 streamlines the process for adding additional registered sources of active ingredients to a formulation and setting up an approved pesticide manufacturing establishment. This enhanced flexibility allows List N: Disinfectants for Use Against SARS-CoV-2 (List N) with registered sources of active ingredients to be manufactured in those establishments without prior EPA approval. This will increase supply chain flexibility, ensuring that products effective against the novel coronavirus are more quickly available to the American public—and in greater volumes—all the while maintaining quality and safety of the product.
The changes allowed through notification by this action will not result in any substantive changes to the final pesticide formulations already approved by EPA. The products’ effectiveness will not be affected and the products’ current precautionary labeling will remain protective. Therefore, this action will not cause any unreasonable adverse effects to human health and the environment.
The temporary amendment includes the procedure for submission of notifications for registrants and can be found on the EPA website.
EPA will assess the need for this temporary amendment on a regular basis and will make updates if modifications are necessary. Once EPA determines the policy change is no longer needed, the agency will post a termination of this temporary amendment at least seven days prior at: www.epa.gov/pesticides.
Additionally, last week, EPA added new products to List N, bringing the total to 370. The new additions can be viewed by sorting List N by the “Date Added” column.
EPA also added nine additional chemicals to its list of commodity inert ingredients. This action is intended to help address supply chain issues for EPA-registered disinfectants and other pesticides by allowing manufacturers of already-registered EPA products to the change the source of supplier of the listed inert ingredients.
