Document ID: EPA-HQ-OPP-2023-0430-0001
Agency: epa
Document Type: Notice
Title: Guidance: Pesticides; Proposed Method for Antimicrobial Product Efficacy Claims against Planktonic Legionella Pneumophila in Cooling Tower Water
Posted Date: 2023-10-02T04:00Z

[Federal Register Volume 88, Number 189 (Monday, October 2, 2023)]
[Notices]
[Pages 67749-67750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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Pesticides; Draft Guidance and Proposed Method for Antimicrobial 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availability of and soliciting public comment on a draft guidance 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 The draft guidance document 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The draft guidance does not address adherent or sessile bacteria that 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 https://www.regulations.gov. 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 https://www.epa.gov/dockets.

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: 
[email protected].
    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: [email protected].

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 https://www.regulations.gov or email. If you wish to include CBI in your 
comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules 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 https://www.epa.gov/dockets/commenting-epa-dockets.

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]
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