EPA Provides Flexibility to Manufacturers of Isopropyl Alcohol-Based Disinfectants and Sanitizers
Manufacturers of certain disinfectants and food-contact surface sanitizers containing isopropyl alcohol (IPA) will now be able to use unregistered sources of that active ingredient and may change such sources by notification alone, thanks to the most recent temporary amendment to pesticide registration procedures by the U.S. Environmental Protection Agency (EPA). EPA’s May 15, 2020 action is the latest in a series of efforts taken over the last several months to help manufacturers quickly source and obtain the ingredients necessary to produce products approved by the Agency on its List N of disinfectants effective against the novel coronavirus, SARS-CoV-2.
In support of this latest change, EPA cited challenges among participants in the food manufacture and preparation industries in acquiring sanitizer products used in production facilities processing low-moisture products such as grains, cereal, flour, and industrial baked goods. This action represents EPA’s first expansion of its temporary amendment to products beyond List N disinfectants. The Agency intends for these latest changes to increase the availability of products for use against the novel coronavirus.
An active ingredient is a chemical in a pesticide product that acts to prevent, destroy, repel, or mitigate a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer. Consistent with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Pesticide Registration Notice 98-10, EPA permits pesticide manufacturers to change the source of an active ingredient to an alternate, registered source by notification if the new source is chemically “similar” to its current source (i.e., it has the same CAS number and purity), but generally requires that manufacturers apply for and obtain EPA approval before changing to a non-similar registered source or an unregistered source of any active ingredient.
2. Temporary Procedures Applicable to IPA-based Disinfectants and Sanitizers
On April 14, EPA published a list of “widely available” and “easily-manufactured commodity” active ingredients that manufacturers of listed anti-coronavirus disinfectants may temporarily source from similar, unregistered sources by notification alone, and without first obtaining Agency approval.
With its latest amendment to PR Notice 98-10, which determines registrants’ requirements for amending their product registrations, EPA adds IPA to that list of “commodity” active ingredients. EPA will also permit List N disinfectant manufacturers to source IPA from dissimilar sources (e.g., those of different purity from their registered source), so long as the nominal concentration of the active ingredient in the product remains the same and the only adjusted inert ingredient is water.
Visit Beveridge & Diamond’s COVID-19 EH&S Resource Center for more information on navigating the global pandemic. B&D’s Pesticides practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices. We help clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives. If you have any questions, please contact the authors.