This Ozone Generator Atlas 30 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 Ozone Generator Atlas 30 is 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 its label.
Importing this 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, EPA form 3540-1, and a copy of one product label must be submitted.