What regulatory duties apply to a pesticidal device in the United States?
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What regulatory duties apply to a pesticidal device in the United States?
40 C.F.R. § 152.500(b) states that a device is not required to be registered under FIFRA section 3 and that a device is subject to the requirements for labelling, establishment registration and reporting, books and records, inspection of establishments, violations, enforcement and penalties, import and export, child-resistant packaging, and the Agency’s authority under FIFRA section 25(c)(4).
The label is set by 40 C.F.R. part 156, establishment registration and the production reports by 40 C.F.R. part 167, and the records of devices produced, received and shipped by 40 C.F.R. § 169.2(b) to (d), each retained two years, with a current record of devices in stock under § 169.2(e). The other requirements rest on FIFRA sections 9, 12 to 14, 17, 25(c)(3) and 25(c)(4), as 40 C.F.R. § 152.500(b) states. The company classifies the NanoFlashing™ Air Filter as a device under Section 2(h) of FIFRA, 7 U.S.C. § 136(h), and 40 C.F.R. § 152.500(a), and it accepts that each of the requirements 40 C.F.R. § 152.500(b) lists for a device applies to the article. No agency has approved, registered or cleared the NanoFlashing™ Air Filter. The company classifies the article itself.
Source: Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.; 40 C.F.R. §§ 152.500, 156.10, 167.20, 167.85 and 169.2, as published on eCFR.
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Sources
- Statement of Classification for the NanoFlashing™ Air Filter, sections 3.7 and 4.1, issued by NF Technical Products Inc.
- 40 C.F.R. §§ 152.500, 156.10, 167.20, 167.85 and 169.2, as published on eCFR