EPA v. Clean Membranes Inc. (0031)

Case summary

The Ultrafiltration Membrane Modules NEOPHIL UF120-S2F are misbranded pursuant to FIFRA section 2(q)(1), 7 U.S.C. ? 136(q)(1) because there is no EPA Establishment Number, there are no directions for use, and no caution or warning statements on their label. Therefore, these products are misbranded pursuant to 7 U.S.C. ? 136(q)(1). Importing these products 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. section 12.114, a Notice of Arrival of Pesticides and Devices, EPA form 3540-1, and a copy of one product label must be submitted.

Defendants (1)

• Clean Membranes Inc.Named in complaintNamed in settlement

Facilities (1)

• CLEAN MEMBRANES INC.

  400 W CUMMINGS PARK, WOBURN, MA, 01801

  Registry ID: 110071293296

Statutes cited

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

Enforcement conclusions (1)

• Clean Membranes Inc. (0031)entered 2022-06-23

  Primary law: FIFRA

Timeline (3 milestones)

• 2022-06-23Final Order Issued
• 2022-06-30Enforcement Action Closed
• 2022-07-08Enforcement Action Data Entered