(Beyond Pesticides, September 26, 2007) In a Federal Register Notice issued on September 21, 2007, the U.S. EPA clarified the distinction between devices and pesticides by stating that ion-generating equipment will now be regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as a pesticide, if the equipment uses electrodes to emit ions (of silver or other substances) for pesticidal purposes. The notice outlines the timeline and process for manufacturers, sellers and other affected parties to come into compliance with the clarified requirements of FIFRA.
In 2005, the EPA was made aware of equipment incorporating substances, such as silver and copper that, through the use of electrodes, release the ions of the substances for the purpose of preventing, destroying, repelling, or mitigating a pest (e.g., bacteria or algae). Since such devices incorporate substances that accomplish a pesticidal function, the agency has determined that they are to be considered a pesticide for the purposes of FIFRA and must therefore be registered prior to sale or distribution as outlined in the federal notice issued.
Section 2(h) of FIFRA defines a device as “any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling or mitigating any pest.” Section 2 (u) defines a pesticide as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” In a federal notice issued in 1976 (41 FR 51065), the agency first provided a distinction between devices and pesticides to be the means by which they achieve their pesticidal purpose. According to the agency’s statutory interpretation, the key distinction between pesticides and devices is whether the pesticidal activity of the article is due to physical or mechanical actions or due to a substance or mixture of substances. As such, any equipment that generates ions of substances for the killing of bacteria, etc. is to be considered a pesticide.
Potentially affected equipment include, but are not limited to, washing machines that contain electrodes that emit silver, copper or zinc ions and swimming pools that use ion generators to kill algae as an adjunct to chlorination. The silver ion generating washing machine is currently marketed with claims that it will kill bacteria on clothing. The agency is currently requesting information on any other type of equipment that generates ions for pesticidal purposes. However, determinations as to whether a product is a device or pesticide are to be made on a case-by-case basis.
For further information contact: Melba S. Morrow, Antimicrobials,
Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 308-2716; fax number: (703) 308-8481; e-mail address: [email protected].
Source: Federal Register: September 21, 2007 (Volume 72, Number 183)