[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68897-68898]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19306]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2023-0430; FRL-11382-02-OCSPP]


Pesticides; Final Guidance and Test Method for Antimicrobial 
Product Efficacy Claims Against Planktonic Legionella Pneumophila in 
Cooling Tower Water; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of the final guidance and test method for 
adding efficacy claims to antimicrobial products for use in cooling 
tower water to reduce the level of planktonic Legionella pneumophila 
(L. pneumophila). The method and guidance describe quantitative 
efficacy testing of 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 
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: The guidance is effective on August 28, 2024.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2023-0430, is available online at 
https://www.regulations.gov. Additional information about dockets 
generally, along with instructions for visiting the docket in-person, 
is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: 
    About the method: Lisa S. Smith, Microbiology Laboratory Branch 
(7503M), Biological and Economic Analysis Division, Office of Pesticide

[[Page 68898]]

Programs, Environmental Protection Agency, Environmental Science 
Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number: 
(410) 305-2637; email address: [email protected].
    About the guidance: 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. Executive Summary

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 appropriate person listed under FOR 
FURTHER INFORMATION CONTACT.

B. What is the Agency's authority for taking this action?

    EPA is issuing this guidance and test method document pursuant to 
its authority under the Federal Insecticide, Fungicide and Rodenticide 
Act (FIFRA), 7 U.S.C. 136 et seq.

C. What action is the Agency taking?

    EPA is announcing the availability of the final guidance and test 
method for adding efficacy claims to antimicrobial products for use in 
cooling tower water to reduce the level of planktonic Legionella 
pneumophila (L. pneumophila). The final method and guidance documents 
describe quantitative efficacy testing for antimicrobial products to 
support planktonic L. pneumophila reduction claims in cooling tower 
systems' water and how to prepare an application for registration. The 
guidance and method do not address any use sites outside of water in 
cooling tower systems or efficacy against L. pneumophila bacteria that 
can be found inside cells of other organisms (e.g., protozoa), attached 
to a surface or associated with biofilms.

D. Does this guidance document impose 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.

II. Background

    EPA developed the guidance and test method in response to requests 
from stakeholders that asked EPA to develop a test method, guidance, 
and an associated registration process to support adding claims to 
antimicrobial products intended to control planktonic L. pneumophila in 
cooling tower water. Stakeholders and the public have significant 
interest in the availability of antimicrobial products with these 
claims, particularly industrial, institutional and health care settings 
where large cooling tower systems are often used.
    In October 2023, EPA announced the availability and sought public 
comments on the draft guidance and test method (88 FR 67749, October 2, 
2023 (FRL-11382-01-OCSPP)). The Agency received 41 comments regarding 
clarifications and revisions to the draft guidance and test method. 
After considering the public comments, EPA is releasing the final 
guidance and test method documents, as well as a response to comments 
document.
    Authority: 7 U.S.C. 136 et seq.

    Dated: August 22, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-19306 Filed 8-27-24; 8:45 am]
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