[co-author: Dorje Wu, 2025 Summer Associate]
Key Takeaways
- What Happened: EPA continues to assess significant penalties against manufacturers and distributors of antimicrobial products under the new administration.
- Who’s Impacted: Manufacturers, distributors, and importers of antimicrobial pesticides and devices.
- What Should Companies Do in Response: Ensure products making antimicrobial claims comply with FIFRA’s registration, labeling, reporting, and recordkeeping requirements. Violations may result in Stop Sale, Use, and Removal Orders (SSUROs), product seizures, and civil or criminal penalties.
The U.S. Environmental Protection Agency (EPA) continues to assess significant penalties against manufacturers and distributors of antimicrobial products under the new administration. Enforcement actions against alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) increased during the COVID-19 pandemic. While EPA continues to assess penalties related to alleged violations from that time, it is also bringing new actions related to more recent activity.
FIFRA Compliance
Antimicrobial pesticide products must comply with FIFRA requirements. Under FIFRA, bacteria, viruses, and other microorganisms in the air, water, or materials, or on objects or surfaces, are considered pests. Therefore, many antimicrobial products, including surface disinfectant wipes and sprays, and certain air filters and UV light systems, are subject to compliance obligations under FIFRA as pesticide products or devices.
Under FIFRA, companies must register pesticides with EPA. Pesticides include any substance intended to prevent, destroy, repel, or mitigate pests. As part of the registration process, antimicrobial pesticide producers must demonstrate that their products are effective for their claimed uses and do not create unreasonable risks to human health or the environment. Pesticide producers must also register their production facilities with the EPA (known as “establishments”).
In addition to chemical pesticides, FIFRA also regulates pesticide devices, which kill or suppress pests using physical means. Devices may include air or water filters, UV light systems, and others. Although companies do not need to register devices with EPA before distribution or sale, like pesticides, companies must produce them at EPA-registered establishments, and their labeling cannot contain false or misleading claims about the product or its uses.
FIFRA imposes additional compliance obligations on importers, who must submit a Notice of Arrival of Pesticides and Devices to EPA before shipments enter the U.S.
Significant antimicrobial pesticide penalties frequently result from the distribution or sale of unregistered antimicrobial pesticides. EPA may also assess major penalties in connection with false antimicrobial claims, incorrect product and usage information on product labeling, and failure to file notices with EPA. A FIFRA registration, labeling, or reporting violation may result in a civil penalty of up to $24,885. Because EPA may consider each occasion of distributing or selling unregistered or a misbranded pesticide and device as a separate violation subject to its own penalty assessment, total FIFRA penalty calculations can quickly reach six- or seven-figures in some cases.
Recent Trends
EPA ramped up FIFRA enforcement against false and misleading antimicrobial product claims at the beginning of the COVID-19 pandemic, and the Agency has continued to focus heavily on antimicrobial products over the last five years. In the first half of 2025 alone, EPA resolved at least 20 antimicrobial-related FIFRA allegations and appears on pace to exceed the number of similar settlements reached last year. While many of the violations alleged in these settlements date back to the 2020-2021 pandemic era, others reflect very recent activity.
In addition to the volume of enforcement actions, FIFRA civil penalty amounts also remain at historically high levels. For example, in May 2025, Costco Wholesale Corp. recently settled with EPA for $3,066,724 in connection with the alleged distribution of unregistered pesticides and misbranded pesticide devices. The Costco settlement ranks as one of the largest penalty settlements ever under FIFRA. Costco was alleged to have sold unregistered antimicrobial work gloves and misbranded air filters, failed to file Notices of Arrival for imported air filters, and continued to sell the air filters after EPA had issued a Stop Sale, Use, or Removal Order. In the same month, EPA also assessed a separate $1,145,795 penalty against the manufacturer of the filters, Winix America, Inc.
When calculating a penalty amount, EPA may consider the size of the business, the impact of the penalty on its ability to operate, the gravity of the violation, and the business’s efforts to address the alleged violations. For example, in a recent $300,000 penalty settlement with Olein Recovery Corp., EPA expressly considered the company’s good faith efforts to voluntarily recall non-compliant disinfectant spray products in determining an appropriate penalty size.
Manufacturers, Distributors, and Importers Should Ensure FIFRA Product Compliance
Many manufacturers, distributors, and importers of antimicrobial products may be unaware that their products are subject to FIFRA or the statute’s strict requirements. All companies that produce or distribute products with antimicrobial properties or claims should assess their product lines and marketing materials to ensure that they comply with FIFRA’s registration, labeling, reporting, and recordkeeping requirements.
Antimicrobial pesticide producers should be particularly aware of antimicrobial claims not made directly on the product label, as EPA may also assess penalties under FIFRA in connection with marketing claims on websites and in online advertisements that are false and misleading. Additionally, manufacturers should ensure that they register pesticide production facilities with EPA and that their distributors have accurate information on their product labels.
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