The HEPA Filters are devices 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 HEPA Filters are 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.
Therefore, these products are misbranded pursuant to 7 U.S.C. ? 136(q)(1). Importing the 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.