Notice2024-19306
Pesticides; Final Guidance and Test Method for Antimicrobial Product Efficacy Claims Against Planktonic Legionella Pneumophila in Cooling Tower Water; Notice of Availability
Primary source
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Published
August 28, 2024
Effective
August 28, 2024
Issuing agencies
Environmental Protection Agency
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 167 (Wednesday, August 28, 2024)</title>
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[Federal Register Volume 89, Number 167 (Wednesday, August 28, 2024)]
[Notices]
[Pages 68897-68898]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. Additional information about dockets
generally, along with instructions for visiting the docket in-person,
is available at <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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: <a href="/cdn-cgi/l/email-protection#790a14100d115715100a180a391c0918571e160f"><span class="__cf_email__" data-cfemail="d8abb5b1acb0f6b4b1abb9ab98bda8b9f6bfb7ae">[email protected]</span></a>.
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: <a href="/cdn-cgi/l/email-protection#80e3eff2e4e5f2efaee3e5f3e1f2c0e5f0e1aee7eff6"><span class="__cf_email__" data-cfemail="187b776a7c7d6a77367b7d6b796a587d6879367f776e">[email protected]</span></a>.
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]
BILLING CODE 6560-50-P
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