Can the company obtain clarification of an ambiguous agency response without treating silence as agreement?

Can the company obtain clarification of an ambiguous agency response without treating silence as agreement?

The company’s classification does not rest on any agency response, and it publishes and claims none.

No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself. 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. The company publishes no agency decision about the article and claims none. Where the company cites an agency document, it cites it for what it is. A compliance advisory is EPA's published guidance to producers generally, and it names no company and no product. The text of a regulation is the text of a regulation. Neither is a decision about this article. EPA describes a voluntary route for a producer to ask whether a product is a device or a pesticide, in Chapter 13 of its Pesticide Registration Manual. Asking is not a decision, and an answer to a question is not an approval.

Source: EPA, Pesticide Registration Manual, Chapter 13, Devices, read on 19 September 2026; 40 C.F.R. § 152.500, as published on eCFR; Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1.

Reviewed on 21 September 2026.