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May 25, 2023

EPA Region 9 Settles with Watts Regulator Company on Violations of Product Safety Law

Lisa R. Burchi Heather F. Collins, M.S.

On May 23, 2023, U.S. Environmental Protection Agency (EPA) Region 9 announced a settlement with Watts Regulator Company for alleged violations under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) related to the sale or distribution of misbranded water filtration devices and importation of pesticides into the United States. Watts, which is headquartered in Massachusetts, imported devices through a port of entry within EPA Region 9.

The specific alleged violations relate to sales and distribution of various water filtration products that EPA concluded are misbranded devices. EPA’s misbranding violations included false and misleading claims on the labeling that the water filtration products reduce water impurities; reduce parasitic cysts; kill microorganisms such as bacteria, viruses, and mold; and sterilize. EPA states that “The sale of misbranded products that claim to sterilize or kill microorganisms is both unlawful and a clear risk to human health.”

EPA asserts that Watts also failed to display EPA establishment numbers clearly and prominently on its labels and did not file all necessary importation requirements. Under FIFRA, EPA establishment numbers must appear on the labels of pesticide devices, and the importer of such devices must submit a Notice of Arrival of Pesticides and Devices form before the arrival of the shipment in the United States.

Watts has agreed to pay a civil penalty of $60,558 under the settlement to resolve these violations.

Commentary

Under FIFRA and its implementing regulations, devices are exempt from pesticide registration requirements but are subject to certain other FIFRA requirements. EPA published in February 2023 a compliance advisory for devices. EPA states that the purpose of the advisory is to provide critical information to the regulated community about producing, distributing, or selling pesticide devices.

This case serves as another reminder to producers, importers, suppliers, and distributors to review their devices and the FIFRA requirements for devices that are found at 40 C.F.R. Section 152.500 and related guidance. EPA enforcement for issues related to pesticide devices has been robust, and failure to identify a product as a device and to comply with all requirements related to devices (e.g., establishment, recordkeeping, imports, exports, child-resistant packaging, labeling, false or misleading claims) may result in a range of EPA actions, including delaying import of the device; a Stop Sale, Use, or Removal Order (SSURO); device seizure; and/or civil and/or criminal penalties.