Guidance: Pesticides; Proposed Method for Antimicrobial Product Efficacy Claims against Planktonic Legionella Pneumophila in Cooling Tower Water

Pesticides; Draft Guidance and Proposed Method for Antimicrobial Product Efficacy Claims Against Planktonic Legionella Pneumophila in Cooling Tower Water; Notice of Availability and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

Dates

Comments must be received on or before December 1, 2023.

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.