What intended uses and claims would change the regulatory position described for this product?
Last reviewed: .
What intended uses and claims would change the regulatory position described for this product?
The position turns on two things: what the article is intended to do, and what performs that purpose.
A device is defined at 40 C.F.R. § 152.500(a) as “any instrument or contrivance (other than a firearm) intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than a bacterium, virus, or other microorganism on or in living man or living animals) but not including equipment used for the application of pesticides (such as tamper-resistant bait boxes for rodenticides) when sold separately therefrom.” EPA states the test for a device in its own words: “A device must work solely by physical means (such as electricity, light or mechanics).” That sentence is EPA's published interpretation in a compliance advisory, not the text of the statute. A claim that the article acts on a pest by some means other than physical means, a use on or in living man or living animals, or selling or packaging the article with a pesticide, would each take it outside that description. A claim to diagnose, treat, cure or prevent disease is a different law again, and the company's label states that the filter is not a medical device and is not intended to diagnose, treat, cure or prevent disease. For the NanoFlashing™ Air Filter, the Statement of Classification states at 3.3: “The filter is not intended for use on or in living man or living animals.” At 3.4 it states: “The filter is not equipment for applying a separately supplied pesticide. It is not sold or packaged with any pesticide.” The Terms of Use state: “As of the Effective Date, the Water, Textiles, Food packaging, and Medical devices chapters describe Research Applications. They do not describe finished products currently available from C-POLAR for those uses.” 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.
Source: 40 C.F.R. § 152.500, as published on eCFR; EPA Compliance Advisory 305F20004, EPA Regulations About UV Lights that Claim to Kill or Be Effective Against Viruses and Bacteria (October 2020), at 1; NanoFlashing™ Air Filter label, About This Product; Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.3, 3.4 and 3.6, issued by NF Technical Products Inc.; C-POLAR — Terms of Use, section 4, https://cpolar.tech/terms/.
Reviewed on .
Sources
- 40 C.F.R. § 152.500
- EPA Compliance Advisory 305F20004 (October 2020), at 1
- NanoFlashing™ Air Filter label, About This Product
- Statement of Classification for the NanoFlashing™ Air Filter, sections 2.1, 3.3, 3.4 and 3.6, issued by NF Technical Products Inc.
- C-POLAR — Terms of Use