The United States Environmental Protection Agency (“EPA”) is increasing its scrutiny of sanitizers, disinfectants and other products that claim to kill viruses, bacteria, and other microbial organisms. Under the Federal Insecticide, Fungicide and Rodenticide Act (“FIFRA”), EPA has authority to regulate “pesticides” and “pesticide devices.” The definition of “pesticides” under FIFRA includes sanitizers, disinfectants and many cleaners and disinfectants that are intended to be applied to surfaces for cleaning. EPA is taking enforcement action against companies importing, producing and selling products associated with antimicrobial claims if they have failed to register under FIFRA and/or have made unsubstantiated claims about a product’s effectiveness against SARS-CoV-2, the virus that causes COVID-19 disease, including requesting such products be removed from third-party marketing platforms (e.g., Facebook and eBay).
FIFRA requires that any person or company manufacturing, selling, distributing and importing “pesticides” (including disinfectants, sanitizers and other antimicrobial substances or devices) within the United States register the product with the EPA. EPA grants a registration and/or license that permits the distribution, sale and importation of pesticides only after EPA has concluded that there is reasonable certainty of no harm to people or the environment from the product. If the product makes any claims on its labels or other marketing materials regarding the effectiveness of the product against, viruses, bacteria and other microbial organisms, then the seller or distributer of the product also must obtain approval from EPA prior to making such claims.
EPA has announced that it is concerned with pesticide products manufactured in, sold in, or imported into, the United States that claim to kill SARS-CoV-2. When EPA identifies a product that is not compliant with the requirements of FIFRA, EPA can issue a “Stop Sale, Use or Removal Order” if it finds that such an order is necessary to prevent an “imminent hazard.” FIFRA provides EPA with the discretion to impose civil and criminal penalties for violations.
EPA also is expediting its review of products seeking to make claims that they are effective against SARS-CoV-2. EPA’s Emerging Viral Pathogens Guidance for Antimicrobial Pesticides allows sanitizers, disinfectants and cleaning products to be approved for claims regarding their effectiveness against SARS-CoV-2 if the claims are made off-label (e.g., in technical reports, websites, consumer information services and on social media sites) rather than on the label of the product. EPA also has created a list of products that have complied with the FIFRA registration requirements for use against COVID-19.
EPA has taken enforcement action against companies that manufacture and sell products intended or claimed to combat the spread of COVID-19 if the products or companies do not comply with FIFRA.
The heightened demand for disinfectants during the COVID-19 crisis may drive more frequent and aggressive actions to control or exclude from the United States unregistered products or products with unverified antimicrobial claims.
 7 U.S.C. §§135 et seq.
 EPA regulates sanitizers, antiseptic washes and antibacterial soaps that should not be applied to human skin while the Food and Drug Administration (“FDA”) regulates sanitizers, antiseptic washes and antibacterial soaps that should be applied to human skin. See EPA, Why aren’t hand sanitizers listed on List N?, https://www.epa.gov/coronavirus/why-arent-hand-sanitizers-listed-list-n
 “Misbranded” as defined by 7 U.S.C. § 136, subd. (q), meaning the product's labeling lacks required elements such as warnings, directions for use, an ingredient statement, or includes false or misleading claims, etc.
 An “imminent hazard” is a substantial likelihood of serious harm during the duration of a cancellation proceeding.
 EPA, Emerging Viral Pathogen Claims for SARS-CoV-2: Submission Information for Registrants, https://www.epa.gov/pesticide-registration/emerging-viral-pathogen-claims-sars-cov-2-submission-information-registrants (last visited on May 6, 2020).
 EPA, List N: Disinfectants for Use Against SARS-CoV-2, https://www.epa.gov/pesticide-registration/list-n-disinfectants-use-against-sars-cov-2 (last visited on May 6, 2020).
 EPA, U.S. EPA Acts to Protect the Public from Unregistered “Virus Shut Out” Product Imported into Honolulu and Guam, Mar. 25, 2020, https://www.epa.gov/newsreleases/us-epa-acts-protect-public-unregistered-virus-shut-out-product-imported-honolulu-and.
 U.S. Department of Justice, Georgia Resident Arrested for Selling Illegal Products Claiming to Protect Against Viruses, Apr. 9. 2020, https://www.justice.gov/opa/pr/georgia-resident-arrested-selling-illegal-products-claiming-protect-against-viruses.
 EPA, U.S. EPA calls on eight technology companies to address fraudulent COVID-19 disinfectants, Apr. 23, 2020, https://www.epa.gov/newsreleases/us-epa-calls-eight-technology-companies-address-fraudulent-covid-19-disinfectants.
 EPA, Amazon Services LLC FIFRA Settlement, https://www.epa.gov/enforcement/amazon-services-llc-fifra-settlement (last visited on May 6, 2020).
 EPA, EPA Issues Order to Seal Shield, LLC in Orlando, Florida to Stop Selling Unregistered Pesticides and a Misbranded Pesticide Device, Apr. 24, 2020, https://www.epa.gov/newsreleases/epa-issues-order-seal-shield-llc-orlando-florida-stop-selling-unregistered-pesticides.