E7-18591. Pesticide Registration; Clarification for Ion-Generating Equipment

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

With this notice, the Agency clarifies its position on the distinction between devices and pesticides with regard to ion-generating equipment and explains why such equipment is regulated as a pesticide. The notice also invites all interested parties to collaborate with the Agency in identifying data and other information that would be needed to support registration of these products. Through this notice, the Agency is establishing a process and a timeline for any parties affected by this notice to come into compliance with the clarified requirements of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

FOR FURTHER INFORMATION CONTACT:

Melba S. Morrow, Antimicrobials Division (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: [phone]; fax number: [phone]; e-mail address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be affected by this action if you sell or distribute ion-generating equipment that uses electrodes to emit chemical substances for pesticidal purposes. Potentially affected equipment include but are not limited to, washing machines containing electrodes that emit silver, copper, or zinc ions and ion generators used in swimming pools to kill algae and as an adjunct to the chlorination process.

This listing is not exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of technology not listed in this notice could also be affected. The Agency requests information on any other type of equipment that generates ions from electrodes for pesticidal purposes that could be covered under this notice.

B. How Can I Get Copies of this Document and Other Related Information?

1. Docket. EPA has established a docket for this action under docket identification (ID) number EPA-HQ-OPP-2007-0949. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is [phone].

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www./​epa.gov/​fedrgstr.

II. Background

A. What Action is the Agency Taking?

In a Federal Register notice published on November 19, 1976 (41 FR 51065), EPA consolidated and clarified the requirements applicable to pest control devices and device producers. In that notice, the Agency listed the types of products that would be affected by the notice and further provided a distinction between devices and pesticides. The notice clearly stated that if an article uses physical or mechanical means to trap, destroy, repel, or mitigate any pest, it is considered to be a device. In contrast, if the article incorporates a substance or mixture of substances to prevent, destroy, repel, or mitigate any pest, it is considered to be a pesticide.

In September 2005, Agency staff advised a manufacturer that washing machines utilizing silver electrodes to produce silver ions for the pesticidal purpose of killing germs are considered devices rather than pesticides, and do not require registration. However, the Agency has since determined that under the statutory interpretation set out in the 1976 policy statement, such ion-generating equipment would require registration as a pesticide under FIFRA. This notice provides additional clarification of the Agency’s longstanding position, and gives the regulated community time to come into compliance with the requirements of FIFRA.

B. What is the Agency’s Authority for Taking this Action?

Under FIFRA, it is unlawful to sell or distribute any “pesticide” unless it is registered by EPA pursuant to FIFRA section 3. EPA has authority to register pesticides under FIFRA section 3, and therefore to interpret the terms “pesticide” and “device” for purposes of determining what is and what is not subject to the registration requirements of FIFRA.

C. EPA’s Interpretations of “Pesticide” and “Device” Under FIFRA

In the 1976 Federal Register notice that consolidated and clarified requirements for pest control devices and device producers, EPA stated its interpretation of the statutory terms “pesticide” and “device” for the purpose of distinguishing between items that were subject to the registration requirements of FIFRA (i.e., pesticides) and those that were not (i.e., devices).

Section 2(h) of FIFRA defines “device” as “any instrument or contrivance (other than a firearm) which is intended for trapping, destroying, repelling or mitigating any pest.” Section 2(u) of FIFRA defines “pesticide” as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest.” In the 1976 Federal Register notice, EPA stated its statutory interpretation that the primary distinction between pesticides and devices was the means by which they achieved their pesticidal purpose. “If an article uses physical or mechanical means to trap, destroy, repeal [sic], or mitigate any [pest], it is considered to be a device. If the article incorporates a substance or mixture of substances intended to prevent, destroy, repeal [sic], or mitigate any pest, it is considered to be a pesticide.” (41 FR 51065).

Therefore, 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. Some of the types of products that were specifically identified as devices in the notice included, but were not limited to, ultra violet light systems, ozone generators, water and air filters (except those containing substances or mixtures of substances), and ultrasonic devices making claims to inactivate, entrap, or suppress the growth of fungi, bacteria, or viruses in various sites. At the time of the 1976 Federal Register notice, EPA was not aware of equipment such as the ion generating washing machine that was presented to EPA in 2005. In addition to the washing machine, EPA is also aware of other ion-generating equipment that is subject to this clarification.

The articles covered by this notice are ion generators that incorporate a substance (e.g., silver or copper) in the form of an electrode, and pass a current through the electrode to release ions of that substance for the purpose of preventing, destroying, repelling, or mitigating a pest (e.g., bacteria or algae). Because these items incorporate a substance or substances that accomplish their pesticidal function, such items are considered pesticides for purposes of FIFRA, and must be registered prior to sale or distribution.

D. Implementation

EPA is aware that there may be some confusion in the regulated community regarding EPA’s interpretation of the distinction between pesticides and devices. 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. Any person distributing or selling such equipment on or prior to 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 this notice, March 21, 2008.

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 6 months from the date of publication of this notice, March 21, 2008, 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. This form should be submitted to EPA on or before March 21, 2008. On the form, only the following information must be provided: Section I, Item 4: Company and Product Name; Section I, Item 5: Name and Address of Applicant; Section II, check “other” and place in explanation “Ion Generator FR Notice;” and all of Section IV. Persons distributing or selling such equipment on or prior to 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. An electronic version of this form is available at http://www.epa.gov/​opprd001/​forms.

Further, any producer or importer of such equipment who is 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, March 23, 2009, may do so only if a prospective registrant has submitted to EPA a completed registration package for the equipment on or before March 23, 2009. Producers or importers of such equipment may continue to distribute or sell such equipment pursuant to this paragraph only until such time as EPA acts upon the application or the application is withdrawn. Again, persons distributing or selling such equipment on or prior to 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.

The completed one page application, EPA Form No. 8570-1, may be submitted to EPA by mail or by courier:

1. Mail (U.S. Postal Service):

Document Processing Desk (AD ION)

Office of Pesticide Programs (7504P)

Environmental Protection Agency

1200 Pennsylvania Ave., NW.

Washington, DC 20460-0001.

2. Courier:

Document Processing Desk (AD ION)

Office of Pesticide Programs (7504P)

Environmental Protection Agency

Room S-4900, One Potomac Yard

2777 S. Crystal Dr.

Arlington, VA 22202-4501.

List of Subjects

• Environmental protection
• Copper ions
• Ion-generating equipment
• Pesticide devices
• Pesticides and pests
• Silver ions
• Zinc ions

Dated: September 13, 2007.

Anne E. Lindsay,

Acting Director, Office of Pesticide Programs.