[Federal Register Volume 72, Number 183 (Friday, September 21, 2007)]
[Notices]
[Pages 54039-54041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-18591]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0949; FRL-8149-4]


Pesticide Registration; Clarification for Ion-Generating 
Equipment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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

[[Page 54040]]

Division (7510P), 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].

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 (703) 305-5805.
    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.

[[Page 54041]]

    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.
[FR Doc. E7-18591 Filed 9-20-07; 8:45 am]
BILLING CODE 6560-50-S