January 25, 2022

Volume XII, Number 25

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January 24, 2022

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EPA Announces One of Its Largest-Ever FIFRA Civil Settlements

Key Takeaways:

  • What Happened: EPA settled with Electrolux for nearly $7 million in connection with the import of household appliances with antimicrobial-treated air filters that were not registered under the federal pesticides law.

  • Who’s Impacted: Manufacturers, distributors, and importers of products that incorporate antimicrobial substances or make antimicrobial claims.

  • What Should Companies Do in Response: Evaluate the regulatory status of any products that make antimicrobial claims to ensure compliance with federal registration, production, and recordkeeping requirements. Violations of these requirements may result in stop sale orders, product seizures, or civil penalties.

  • By When: As soon as possible.

The U.S. Environmental Protection Agency (EPA) last month announced one of the largest civil penalties ever issued under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). In its October 6, 2020 Consent Agreement and Final Order (CAFO) with Electrolux Home Products, Inc. (Electrolux), EPA settled hundreds of alleged FIFRA violations in connection with Electrolux’s import and distribution of approximately 420,000 dehumidifiers and air conditioners that each contained a filter manufactured with nanosilver. With a $6,991,400 penalty, EPA’s action is consistent with the Agency’s continued enforcement focus on imported pesticides and also appears to reflect a trend toward significantly higher FIFRA civil penalty assessments in recent years.

Unless otherwise exempted under FIFRA, any pesticide product imported into the United States for distribution or sale first must be registered with EPA. In addition, imported pesticides must comply with specific production, labeling, and notification requirements under FIFRA. A “pesticide” is defined to mean “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest,” and a “pesticide product” refers to the pesticide in the particular form (including composition, packaging, and labeling) in which the pesticide is distributed or sold. Under FIFRA, pests include microorganisms found on surfaces or in the air or water.

Significantly, the Electrolux products characterized by EPA as pesticides in this matter were not chemical products themselves. Instead, they were all household dehumidifiers and air conditioners, each of which contained a filter manufactured with nanosilver, which is an antimicrobial substance. As described in EPA’s CAFO, the products were marketed with claims such as “cleans air by removing harmful bacteria” and “reduces bacteria . . . for a healthier, more comfortable environment.” According to EPA, these appliances were intended to provide an antimicrobial benefit to users and, in light of the incorporated nanosilver, therefore required registration under FIFRA prior to their sale or distribution.

EPA’s penalty calculation was informed by its FIFRA Enforcement Response Policy, which includes detailed guidance for computing FIFRA penalties based on case-specific factors. In its CAFO, EPA specifically notes that the $6,991,400 penalty reflected a 20 percent “good faith” reduction of the gravity-based penalty amount, in acknowledgment of Electrolux’s efforts to bring the products into compliance with FIFRA after EPA’s discovery of the alleged violations. These efforts included an EPA-authorized “rework plan” that allowed Electrolux to consolidate its products at specified locations and, under the supervision of an independent monitor, systematically replace the products’ nanosilver filters with filters that do not contain any pesticidal substances, and remove any pesticidal claims on the labeling and in associated marketing materials.

Manufacturers, Distributors, and Importers Should Assess FIFRA Product Compliance

In light of this latest enforcement action, importers, manufacturers, and distributors of products that incorporate antimicrobial substances or make antimicrobial claims should closely evaluate their status under FIFRA and confirm full compliance with EPA’s requirements.

Determining FIFRA regulatory status requires careful assessment of each product’s composition and claims, which should be frequently revisited as product design and marketing strategies change over time. Some product manufacturers and suppliers may not be aware that they are subject to FIFRA in the first place. While certain products containing antimicrobial substances may be eligible for exemption under FIFRA as “treated articles,” those that do not meet all of EPA’s applicable criteria remain at enforcement risk. In addition, products that do not contain any antimicrobial substances at all may still be subject to regulation under FIFRA as “pesticidal devices” if they are intended to operate against pests by physical or mechanical means.

© 2022 Beveridge & Diamond PC National Law Review, Volume X, Number 307
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About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Daniel B. Schulson Environmental & Administrative Attorney Beveridge & Diamond Washington, DC
Principal

Daniel Schulson applies the insight and experience he gained from working in the Office of General Counsel at the U.S. Environmental Protection Agency to clients’ challenges on a broad array of issues.

He assists clients with many aspects of environmental and administrative law, including compliance counseling, permitting, due diligence, audits, commenting on agency rulemakings, administrative enforcement defense, and litigation.

Examples of Dan’s experience include:

  • Providing counsel to the U.S. government-appointed Independent...
202-789-6007
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036
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