EPA v. BUREAU OF CUSTOMS AND BORDER PROTECTION PORT OF PEMBINA

Case summary

These claims demonstrate a pesticidal intent pursuant to the definitions above. The LeveLuk K8 Kangen Water Filter is thus a pesticide device and subject to FIFRA regulation. The LeveLuk K8 Kangen Water Filter is a device under FIFRA section 2(h), 7 U.S.C. ? 136(h), and 40 C.F.R ? 152.500(a) because it falls within the definition of ?any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest, [which includes virus, bacteria, or other micro-organism,] or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals); but not including equipment used for the application of pesticides when sold separately therefrom.? The LeveLuk K8 Kangen Water Filter is misbranded pursuant to FIFRA section 2(q)(1), 7 U.S.C. ? 136(q)(1) because there is no EPA Establishment Number, no directions for use, and no caution or warning statements on their labels. The LeveLuk K8 Kangen Water Filter is also misbranded because the labeling contains false or misleading statements including, ?to sterilize vegetables? as defined by 7 U.S.C. ? 136(q)(1) and 40 C.F.R. ? 156.10(a)(5). Therefore, this product is misbranded pursuant to 7 U.S.C. ? 136(q)(1). Importing the product in the shipment referenced above is a violation of FIFRA section 12(a)(1)(F), 7 U.S.C. ? 136j(a)(1)(F), as a distribution or sale of a misbranded device. The shipment that arrived at the border for import is also in violation of FIFRA section 12(a)(2)(N), 7 U.S.C. ? 136j(a)(2)(N), because a registrant, wholesaler, dealer, retailer, or other distributor failed to correctly file reports required by the Act. As required by 19 C.F.R. ? 12.114, a Notice of Arrival of Pesticides and Devices (NOA), EPA form 3540-1, and a copy of one product label must be submitted.

Defendants (1)

• BUREAU OF CUSTOMS AND BORDER PROTECTION PORT OF PENamed in complaintNamed in settlement

Facilities (1)

• BUREAU OF CUSTOMS AND BORDER PROTECTION PORT OF PEMBINA

  10980 I-29, PEMBINA, ND, 58271

  Registry ID: 110070864754

Statutes cited

• FIFRA 12A2N — Failure to File Reports
• FIFRA 12A1F — Device Misbranded

Enforcement conclusions (1)

• BUREAU OF CUSTOMS AND BORDER PROTECTION PORT OF PEMBINAentered 2023-06-15

  Primary law: FIFRA

Timeline (3 milestones)

• 2023-06-15Final Order Issued
• 2023-07-03Enforcement Action Closed
• 2023-07-03Enforcement Action Data Entered