On October 10, the importer Fastee Trading Co., attempted to import a shipment of Pondo Water Pond Filter Pump and Ultraviolet Light devices into the United States. The broker provided the Pondo Water Pond Filter Pump user manual, photos of the device packaging, a website where this device is sold and a test report for the efficacy of the Ultraviolet Light, which is a component of the filter pumps.
The germicidal claim is overly broad, and the sterilization claim is misleading since it is not supported by efficacy data, therefore the device described above is misbranded as that term is defined in Section 2(q)(1)(A) of FIFRA, 7 U.S.C. Section 136(q)(1)(A). Additionally, the product box does not bear an EPA establishment number. Therefore, the devices described above are also misbranded as that term is defined in Section 2(q)(1)(D) of FIFRA, 7 U.S.C. Section 136(q)(1)(D). Finally, the Notice of Arrival of Pesticides and Devices was not filed on EPA Form 3540-1 in accordance with 19 C.F.R. Section 12.112. Failure to file a report required by the Act is a violation of FIFRA Section 12(a)(2)(N), 7 U.S.C. Section 136(j)(a)(2)(N). For these reasons these devices cannot be allowed entry into the United States and should be denied pursuant to Section 17(c) of FIFRA 7 U.S.C. Section 136o(c).