EPA to Sunset Temporary Disinfectant Supply Chain FlexibilitiesSeptember 17, 2021
ISSA members, particularly U.S. formulators and manufacturers of disinfectants, should be aware that the U.S. Environmental Protection Agency (EPA) recently announced that the agency will sunset temporary disinfectant supply chain flexibilities.
In 2020, EPA introduced regulatory flexibilities to ensure that critical antimicrobial products remained available as the United States responded to the COVID-19 public health emergency. According to the EPA, “As supply chains have stabilized and disinfectant products expected to kill SARS-CoV-2 (the virus that causes COVID-19) have become consistently available to consumers, the agency has determined that this flexibility is no longer needed.”
Accordingly, the EPA will terminate the Temporary Amendment to Pesticide Registration (PR) Notice 98-10, effective September 15, 2022. Acknowledging that registrants have made changes in their supply chains and may require time to adjust their contractual commitments, the EPA is providing 12 months’ notice before the termination takes effect. Registrants must ensure that by September 15, 2022, their product is produced using a source of active ingredient identified in the product’s approved confidential statement of formula or otherwise complies with the requirements of PR Notice 98-10.
To read the memorandum addressing this termination, see the EPA’s PR Notice 98-10 webpage.
- On March 30, 2020, the EPA issued a Temporary Amendment to PR Notice 98-10. This time-limited modification allowed registrants of products on the EPA’s List N: Disinfectants for Coronavirus (COVID-19) to switch suppliers of certain active ingredients by notification without waiting for EPA approval.
- On April 14, 2020, the EPA issued a revised Temporary Amendment to PR Notice 98-10 in response to additional reports of supply chain disruptions by pesticide registrants who manufacture disinfectants for use against SARS-CoV-2. Several of the provisions also applied to pesticide products that serve as the source of active ingredients in List N disinfectants.
- On May 11, 2020, the EPA issued another revised Temporary Amendment in response to reports of shortages of sanitizers used in the production and manufacture of foods like grains, cereal, flour, and industrial baked goods. This time-limited modification extended the flexibility detailed in the April amendment to food-contact surface sanitizer products containing the active ingredient isopropyl alcohol.