Which exact product, intended purpose and claim set support the company's reliance on the device definition in FIFRA section 2(h)?
Last reviewed: .
Which exact product, intended purpose and claim set support the company's reliance on the device definition in FIFRA section 2(h)?
The product is the NanoFlashing™ Air Filter, a panel air filter for forced-air heating, ventilation and air-conditioning systems.
It is a dry, solid, finished article. The company classifies the NanoFlashing™ Air Filter as a device under section 2(h) of the Federal Insecticide, Fungicide, and Rodenticide Act and the definition at 40 C.F.R. § 152.500(a). Under 40 C.F.R. § 152.500(b), a device is not required to be registered under FIFRA section 3, and the requirements listed there apply instead. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. The intended purpose is stated in the company's Statement of Classification: the filter is intended to destroy the viruses, bacteria and fungal spores it captures, on direct contact with the positive electric charge, by physical means, and only while the organism is captured by the positive electric charge. NanoFlashing™ is a permanent positive polarity engineered into filter media itself. It is a physical property of the filter. A charge is a physical property. It is not a substance or a mixture of substances. The filter therefore incorporates no substance or mixture of substances to perform its intended pesticidal purpose. The filter is not equipment for applying a separately supplied pesticide, and it is not sold or packaged with any pesticide. This classification is stated for that article. It is not stated for any other construction, any other size or any other product.
Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 2.1, 2.6, 3.4, 3.6, 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. § 152.500, as published on eCFR.
Reviewed on .
Sources
- Statement of Classification for the NanoFlashing™ Air Filter, sections 1.2, 2.1, 2.6, 3.4, 3.6, 3.7, 4.1
- 40 C.F.R. § 152.500