Examples of antimicrobial pesticidal devices include UV devices, steam cleaners, ozone generators, and air filters.
While pre-market approval or registration of such devices is not required, the EPA may conduct a review during compliance monitoring and product distribution.
The advisory highlights pesticidal device requirements such as production in an EPA-registered establishment that reports production annually, maintaining facility records, and ensuring that labels and advertisements do not contain false or misleading claims. Devices must adhere to statutory and regulatory requirements, and non-compliance may constitute unlawful action.
The advisory follows an increase in the number of devices being distributed or sold in the US and substantial non-compliance with FIFRA in the device and pesticide marketplace. Examples of non-compliance include unregistered pesticides posing as pesticidal devices, pesticidal devices bearing false and misleading statements, and pesticidal devices being sold and distributed that were not produced in an EPA-registered establishment.
Microchem would also like to remind companies making or selling pesticidal devices that certain states, roughly 20 percent of them, require registration of pesticidal devices prior to legal sale. For additional registration details, we are glad to point companies in the direction of reliable antimicrobial regulatory consultants.
Along with releasing the guidance, the EPA updated its webpage on pesticidal devices with additional information. While this guidance does not change current requirements for manufacturers, it is a helpful resource.
Manufacturers should conduct testing to ensure product performance claims are in compliance with EPA requirements and are not false or misleading. Please contact our lab for more information on pesticidal devices at [email protected].