UVC Light Devices and US Laws & Regulations:
Tool Klean Products are produced (w/foreign parts) in an EPA establishment in Florida, are certified FCC, and comply with strict US regulations regarding UVC light devices.
- UV Light products are considered Pesticide devices and fall under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for federal regulation of pesticide distribution, sale, and use. All pesticide devices are subject to EPA regulations and It is illegal to sell, import or manufacture non-EPA regulated devices in the US.
- EPA, also, regulates the importation of pesticide devices into the United States to ensure that only compliant products enter into the U.S. marketplace. UVC light devices cannot be imported in the US unless the factory is EPA registered with an EPA Establishment Number.
- Recognizing a legal Device by Reading the Label
A pesticide device that is EPA regulated will include an EPA Establishment Number on the label.
- EPA defines UVC light devices: Ultraviolet Light Units that kill, inactivate or suppress growth of fungi, bacteria or viruses.
- Water treatment units
- Bactericidal lamps
- Individual Water Purification Devices
UVC light devices emit frequency energy by radiation and are regulated by the FCC.
Products that, by design, contain circuitry that operates in the radio frequency spectrum need to demonstrate compliance using the applicable FCC equipment authorization procedure (i.e., Supplier's Declaration of Conformity (SDoC) or Certification) as specified in the FCC rules depending on the type of device . UVC light devices are considered RF device and must be approved using the appropriate equipment authorization procedure before it can be marketed, imported, or used in the United States. It is illegal to import, produce, sell, or use an UVC light device unless it has been tested and certified FCC and a Supplier’s Declaration of Conformity has been issued.
Most radiation-emitting products are not considered to be medical devices. However, if a UVC product makes any medical claim, it is considered a medical device and subject to the provisions of the FD&C Act for medical devices in addition to the provisions for radiation emitting products. These products must be registered with FDA.