EPA v. Biosure North America LLC
Unilateral Administrative Order Without Adjudication
Case summary
NOTICE OF RECOMMENDATION TO REFUSE ADMISSION: 12/16/2024 Consignee: Biosure North America LLC Entry Number: SCS-75039788 Product(s): Biosure Water Disinfection System By this memorandum, the U.S. Environmental Protection Agency is notifying the U.S. Customs and Border Protection (CBP) that it is the opinion of the EPA that one or more of the pesticidal products in the shipment SCS-75039788 described below, is in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, or the Act), as amended, 7 U.S.C. ? 136o(c), and should be refused entry into the United States pursuant to the authority of Section 17(c) of FIFRA as more fully detailed below. The following information pertains to this shipment: Entry Number: SCS-75039788 Product Name(s): Biosure Water Disinfection System Shipper/Manufacturer: Yantai United Ozonetec Corporation Consignee: Biosure North America LLC Date of Importation: November 19, 2024 Port of Entry: Port of Louisville, Kentucky (4196) It appears that the product is not in compliance with the Act and is subject to refusal of entry into the United States due to the following violation(s): FIFRA ? 12(a)(1)(F): To sell or distribute a pesticide device that is misbranded. Specifically, the device is not labeled in accordance with FIFRA ? 2(q)(1) in that it contains false and misleading claims as to the efficacy of the product. Pursuant to the foregoing, and in accordance with Section 17(c) of FIFRA, the EPA is notifying CBP of these violations so that it may either refuse delivery of the abovementioned product(s) to the consignee, or if the shipment has been released to the consignee under bond, require redelivery of the shipment under the terms of the bond. Please provide the EPA with a copy of the export waybill or other documentation demonstrating that exportation or destruction of the product(s) has occurred within 90 days after notice of the refusal of delivery or within 90 days after redelivery, as applicable.
Defendants (1)
- Biosure North America LLCNamed in settlement
Facilities (1)
BIOSURE NORTH AMERICA LLC
30621 SWEETRIDGE CIRCLE, BOERNE, TX, 78015
Registry ID: 110071883489
Statutes cited
- FIFRA 12A1F — Device Misbranded
Enforcement conclusions (1)
Biosure North America LLCentered 2024-12-16
Primary law: FIFRA
Timeline (3 milestones)
- 2024-12-16Enforcement Action Closed
- 2024-12-16Final Order Issued
- 2024-12-17Enforcement Action Data Entered
Case metadata
- EPA activity ID
- 3604201448
- Case number
- 04-2025-3109
- Lead agency
- EPA
- EPA region
- 04
- Voluntary self-disclosure
- No
- Primary statute
- Device Misbranded
Sourced verbatim from EPA ECHO Enforcement Case Report for case 04-2025-3109 . Bulk data: ICIS-FEC download summary.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.