EPA Releases Unprecedented Recommendation to Use Unregistered Substances as Disinfectants Against Coronavirus
New cleaning and disinfecting guidance released by the U.S. Environmental Protection Agency (EPA) on April 29, 2020 includes an unprecedented recommendation to the American public to use unregistered commodity substances for disinfection when EPA-approved products are not available. Issued by EPA together with the Centers for Disease Control and Prevention (CDC), the new guidance characterizes such products “as effective in reducing the risk of exposure to COVID-19” as those registered disinfectants approved for use against coronavirus on EPA’s List N. As examples of what EPA terms “alternative disinfectants,” the guidance suggests use of one-third cup bleach added to one gallon of water, as well as “70 percent alcohol solutions”. Notwithstanding this guidance, producers and distributors of all cleaning products should continue to carefully evaluate the regulatory status of their products under federal and state law, while closely watching for additional updates and clarifications from EPA during this very dynamic period.
Many surface, air, and water disinfectants (including sprays, wipes, and liquids intended for use against viruses, bacteria, and other microbial pests) are regulated as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which prohibits their distribution or sale unless registered by EPA. When determining a product’s intended use under FIFRA, EPA considers the distributor’s express and implied claims, along with significant commercially valuable uses of the product and the distributor’s actual or constructive knowledge that the product will be used (or is intended to be used) for a pesticidal purpose. EPA’s regulations expressly provide that deodorizers, bleaches, and cleaning agents must be registered as pesticides if a pesticidal claim is made on their labeling or in connection with their sale or distribution. As a matter of longstanding policy, EPA has distinguished between non-pesticidal cleaning products that are intended only to clean away or remove inanimate material (even if they may have incidental pest mitigation effects), and antimicrobial pesticides that trigger FIFRA’s registration requirements because they make or imply claims to clean away, wash away, or remove any pest.
Distributing and Selling Cleaning Products After EPA’s New Guidance
Several EPA statements contained in the new guidance appear to be in tension with FIFRA’s regulatory framework, including the traditional distinctions between cleaners, sanitizers and disinfectants. Such statements include EPA’s recommendations to use soap and water to “remove germs” and “decrease how much of the virus is on surface and objects,” as well as its recognition that unregistered “alternative disinfectants” may be used to “kill germs on surfaces” and help reduce risk of exposure to COVID-19. Although FIFRA does not specifically prohibit use of unregistered pesticides, it strictly regulates their distribution and sale. In addition, EPA’s COVID-19 public statements have emphasized the importance of using only registered disinfectants on EPA’s List N, which it has explained meet the Agency’s criteria for use against the virus that causes COVID-19.
Significantly, EPA’s new guidance does not authorize the distribution or sale of unregistered products, which remain a high enforcement priority for EPA during the COVID-19 pandemic. Instead, EPA’s guidance is directed at facility operators, businesses, families, and other users of disinfectant products. It does not address commodity chemical producers at all. Accordingly, EPA offers no specific enforcement relief for producers and distributors of commodity substances who may have reason to know that customers intend to use their unregistered products as “alternative disinfectants” for virus removal consistent with the new guidance. Under these circumstances, manufacturers, retailers, and others who distribute or sell cleaning products should continue to carefully evaluate their associated claims and intended uses under FIFRA, and pay close attention to future EPA updates and clarifications regarding this serious public health topic.
Visit Beveridge & Diamond’s COVID-19 EH&S Resource Center for more information on navigating the global pandemic. Beveridge & Diamond’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 represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides practice helps 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.