Pesticide Registration: Clarification for Ion Generating Equipment
September 21, 2007-- EPA issued a Federal Register Notice that clarifies the Agency's position on the distinction between devices and pesticides with regard to ion-generating equipment and explains why such equipment will now be regulated as a pesticide. The Agency has now determined that these machines will be regulated as pesticides if the machines contain silver or other substances, and if they generate ions of those substances for express pesticidal purposes. This notice alerts manufacturers of the Agency's determination. The Agency will work to identify the information needed to apply to register the machine as a pesticide, and give those products currently out of compliance time to obtain registration.
Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a product that uses only physical or mechanical means to trap, destroy, repel, or mitigate a pest (including microbial pests) is a device and is not required to be registered (though its production and labeling are regulated). However, if the product incorporates a substance or mixture of substances intended to prevent, destroy, repel, or mitigate pests, then it is considered to be a pesticide and is required to be registered. Determinations as to whether a product is a device or pesticide are made on a case-by-case basis. The silver ion generating washing machine is marketed with claims that it will kill bacteria on clothing. Silver is already regulated as a pesticide active ingredient in other registered products.
While recent press articles have referred to the silver ion generating washing machine as a product of nanotechnology, EPA has not yet received any information that suggests that this product uses nanotechnology. EPA will evaluate any applications to register this type of equipment according to the same regulatory standards as any other pesticide. The notice does not represent an action to regulate nanotechnology.
Implementation/Timelines for Manufacturers
EPA will work with producers of ion generators to identify what data and other information are required to support an application for registration and to obtain registrations to bring such equipment into compliance for equipment being distributed or sold in the United States on the date of publication of this notice.Following is a summary of the implementation schedule as published in the Federal Register Notice.
Any person distributing or selling such equipment on or before the date of publication of this notice may continue the distribution or sale of such equipment for 6 months from the date of publication of the notice (March 21, 2008).
Any producer or importer of such equipment distributing or selling the equipment on or before the date of publication of this notice who wishes to continue that distribution or sale after 6 months from the date of publication of this notice may do so only if a prospective registrant has commenced the registration process for the equipment by submitting, at a minimum, an Application for Pesticide Registration Form (EPA Form No. 8570-1) for the equipment to EPA by March 21, 2008.
Persons distributing or selling such equipment on or before the date of publication of this notice other than the producer or importer may continue to distribute or sell such equipment until their inventories are exhausted.
Any producer or importer of such equipment distributing or selling the equipment on or prior to the date of publication of this notice who wishes to continue that distribution or sale after 18 months from the date of publication of this notice may do so only if a prospective registrant has submitted to EPA a completed registration package for the equipment by March 23, 2009 and may continue to distribute or sell such equipment only until such time as EPA acts upon the application or the application is withdrawn.
For further information contact Melba S. Morrow (email@example.com), 703-308-2716.