Notice2023-21643
Pesticides; Draft Guidance and Proposed Method for Antimicrobial Product Efficacy Claims Against Planktonic Legionella Pneumophila in Cooling Tower Water; Notice of Availability and Request for Comments
Primary source
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Published
October 2, 2023
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting public comment on a draft guidance document and proposed method for adding efficacy claims to antimicrobial products for use in cooling tower water to reduce the level of planktonic Legionella pneumophila. The draft guidance document describes efficacy testing for antimicrobial products to support claims for the reduction of planktonic L. pneumophila in water within cooling tower systems and how to prepare an application for registration. The proposed method is for evaluating the efficacy of antimicrobial products in water of cooling towers against planktonic L. pneumophila. The draft guidance does not address adherent or sessile bacteria that attach to a surface (e.g., biofilm) of the cooling tower system or any other microorganism other than L. pneumophila which may be found in the water of cooling tower systems.
Full Text
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<title>Federal Register, Volume 88 Issue 189 (Monday, October 2, 2023)</title>
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[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67749-67750]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21643]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2023-0430; FRL-11382-01-OCSPP]
Pesticides; Draft Guidance and Proposed Method for Antimicrobial
Product Efficacy Claims Against Planktonic Legionella Pneumophila in
Cooling Tower Water; Notice of Availability and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting public comment on a draft guidance
document and proposed method for adding efficacy claims to
antimicrobial products for use in cooling tower water to reduce the
level of planktonic Legionella pneumophila. The draft guidance document
describes efficacy testing for antimicrobial products to support claims
for the reduction of planktonic L. pneumophila in water within cooling
tower systems and how to prepare an application for registration. The
proposed method is for evaluating the efficacy of antimicrobial
products in water of cooling towers against planktonic L. pneumophila.
The draft guidance does not address adherent or sessile bacteria that
attach to a surface (e.g., biofilm) of the cooling tower system or any
other microorganism other than L. pneumophila which may be found in the
water of cooling tower systems.
DATES: Comments must be received on or before December 1, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2023-0430, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
FOR FURTHER INFORMATION CONTACT:
For information on the proposed method contact: Lisa S. Smith,
Microbiology Laboratory Branch (7503M), Biological and Economic
Analysis Division, Office of Pesticide Programs, Environmental
Protection Agency, Environmental Science Center, 701 Mapes Road Ft.
Meade, MD 20755-
[[Page 67750]]
5350; telephone number: (410) 305-2637; email address:
<a href="/cdn-cgi/l/email-protection#02716f6b766a2c6e6b716371426772632c656d74"><span class="__cf_email__" data-cfemail="6a1907031e02440603190b192a0f1a0b440d051c">[email protected]</span></a>.
For information on the draft guidance contact: C[eacute]sar E.
Cordero, Efficacy Branch (7510M), Antimicrobials Division, Office of
Pesticide Programs, Environmental Protection Agency, William Jefferson
Clinton East Building, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number: (202) 564-3716; email address: <a href="/cdn-cgi/l/email-protection#c0a3afb2a4a5b2afeea3a5b3a1b280a5b0a1eea7afb6"><span class="__cf_email__" data-cfemail="e5868a978180978acb8680968497a5809584cb828a93">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This action is directed to the public in general; although this
action may be of particular interest to those persons who are or may be
required to conduct efficacy testing of chemical substances under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult the person listed under FOR FURTHER
INFORMATION CONTACT.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not CBI to EPA through <a href="https://www.regulations.gov">https://www.regulations.gov</a> or email. If you wish to include CBI in your
comment, please follow the applicable instructions at <a href="https://www.epa.gov/dockets/commenting-epa-dockets#rules">https://www.epa.gov/dockets/commenting-epa-dockets#rules</a> and clearly mark the
part or all of the information that you claim to be CBI. In addition to
one complete version of the comment that includes information claimed
as CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
Legionella pneumophila is a bacterium that is often identified as
the causative agent of Legionnaires' Disease, which is a disease
acquired by inhaling water droplets contaminated with Legionella
bacteria. Legionellae are found naturally in freshwater environments
but can become a health concern when they grow and spread in human-made
building water systems like cooling towers. Cooling towers are a
potential breeding ground for L. pneumophila and subsequent
aerosolization of L. pneumophila can occur if cooling towers are not
properly disinfected and maintained. Following a Legionnaires' disease
outbreak in New York City in 2015, New York State began requiring
cooling towers to be registered with the state and monitored and
treated for L. pneumophila. However, EPA currently does not have
guidance providing a framework for those seeking to register
antimicrobial products with public health claims to reduce Legionella
in cooling tower water. EPA received requests to develop a test method
and guidance for registration of antimicrobial products intended to
reduce L. pneumophila in water used in cooling tower systems. There is
significant interest from stakeholders and the public in the
availability of antimicrobial products with these claims.
III. Guidance Documents Do Not Contain Binding Requirements
As guidance, these documents are not binding on the Agency or any
outside parties, and the Agency may depart from these documents where
circumstances warrant and without prior notice. While EPA has made
every effort to ensure the accuracy of the discussion in the guidance,
the obligations of EPA and the regulated community are determined by
statutes, regulations, or other legally binding documents. In the event
of a conflict between the discussion in the guidance documents and any
statute, regulation, or other legally binding document, the guidance
documents will not be controlling.
Authority: 7 U.S.C. 136 et seq.
Dated: September 26, 2023.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2023-21643 Filed 9-29-23; 8:45 am]
BILLING CODE 6560-50-P
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