2024-19306. Pesticides; Final Guidance and Test Method for Antimicrobial Product Efficacy Claims Against Planktonic Legionella Pneumophila in Cooling Tower Water; Notice of Availability

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Environmental Protection Agency

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

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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 ( print page 68898) Programs, Environmental Protection Agency, Environmental Science Center, 701 Mapes Road, Ft. Meade, MD 20755-5350; telephone number: [phone]; email address: [e-mail].

About the guidance: César 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: [phone]; email address: [e-mail].

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.