Pesticides; Draft Guidance and Proposed Method for Antimicrobial Product Efficacy Claims Against Planktonic Legionella Pneumophila in Cooling Tower Water; Notice of Availability and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, 67749-67750 [2023-21643]

Download as PDF Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices approximately 9:30 a.m. to 5:00 p.m. and on Thursday, November 16, 2023, from approximately 9:00 a.m. to 3:00 p.m. Requests to participate in the meeting must be received on or before November 8, 2023. To request accommodation of a disability, please contact the technical person listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. ADDRESSES: The meeting will be held at the U.S. Environmental Protection Agency Ruckelshaus Conference Center in the East West William Jefferson Clinton Building at 1201 Constitution Avenue NW, Washington, DC 20004. Please visit https://www.epa.gov/ pesticide-advisory-committees-andregulatory-partners/pesticide-programdialogue-committee-ppdc to find a link to register for the meeting. FOR FURTHER INFORMATION CONTACT: Jeffrey Chang, telephone number: (202) 566–2213, email address: chang.jeffrey@ epa.gov. SUPPLEMENTARY INFORMATION: I. General Information lotter on DSK11XQN23PROD with NOTICES1 A. Does this action apply to me? You may be potentially affected by this action if you work in in agricultural settings or if you are concerned about implementation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136 et seq.); the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 301 et seq.); the Pesticide Registration Improvement Act (PRIA) (which amends FIFRA section 33); and the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq.). Potentially affected entities may include but are not limited to: Agricultural workers and farmers; pesticide industry and trade associations; environmental, consumer, and farm worker groups; pesticide users and growers; animal rights groups; pest consultants; state, local, and tribal governments; academia; public health organizations; and the public. If you have questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How can I get copies of this document and other related information? The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2023–0467, is available online at https://www.regulations.gov. The docket will also be available inperson at the Office of Pesticide Programs Regulatory Public Docket VerDate Sep<11>2014 18:41 Sep 29, 2023 Jkt 262001 67749 (OPP Docket) in the EPA/DC, West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744. For further information on EPA/DC services, docket contact information and the current status of the EPA/DC and Reading Room, please visit https:// www.epa.gov/dockets. ENVIRONMENTAL PROTECTION AGENCY II. Background SUMMARY: The PPDC is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92–463. EPA established the PPDC in September 1995 to provide policy advice, information and recommendations to the EPA Administrator through the Director of the Office of Pesticide Programs, Office of Chemical Safety and Pollution Prevention. The PPDC provides a public forum to discuss a wide variety of pesticide regulatory developments and reform initiatives, evolving public policy and program implementation issues associated with evaluating and risks from the use of pesticides. III. How can I request to participate in this meeting? Please visit https://www.epa.gov/ pesticide-advisory-committees-andregulatory-partners/pesticide-programdialogue-committee-ppdc to find a link to register to attend the meeting in person. Requests to make brief oral comments to the PPDC during the meeting should be submitted to the individual listed under FOR FURTHER INFORMATION CONTACT on or before noon on the date set in the DATES section. Authority: 5 U.S.C. Appendix 2 et seq. and 7 U.S.C. 136 et seq. Dated: September 26, 2023. Edward Messina, Director, Office of Pesticide Programs. [FR Doc. 2023–21647 Filed 9–29–23; 8:45 am] BILLING CODE 6560–50–P PO 00000 Frm 00023 Fmt 4703 Sfmt 4703 [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 Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: 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– E:\FR\FM\02OCN1.SGM 02OCN1 67750 Federal Register / Vol. 88, No. 189 / Monday, October 2, 2023 / Notices 5350; telephone number: (410) 305– 2637; email address: smith.lisas@ epa.gov. For information on the draft guidance contact: Ce´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: cordero.cesar@epa.gov. 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-epadockets#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. lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 18:41 Sep 29, 2023 Jkt 262001 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] BILLING CODE 6560–50–P EQUAL EMPLOYMENT OPPORTUNITY COMMISSION [Agency Docket No: EEOC–2023–0005] RIN: 3046–ZA02 Proposed Enforcement Guidance on Harassment in the Workplace Equal Employment Opportunity Commission. AGENCY: PO 00000 Frm 00024 Fmt 4703 Sfmt 4703 Notice of availability and request for comment. ACTION: The Equal Employment Opportunity Commission (‘‘EEOC’’) is announcing that its proposed ‘‘Enforcement Guidance on Harassment in the Workplace’’ is available for public comment. DATES: Comments must be received on or before November 1, 2023. Please see the sections below entitled ADDRESSES and SUPPLEMENTARY INFORMATION for additional information on submitting comments. SUMMARY: You may submit comments, identified by docket number EEOC– 2023–0005 or Regulatory Information Number (RIN) 3046–ZA02, by any of the following methods—please use only one method: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. • Fax: 202–663–4114. Only comments of six or fewer pages will be accepted via FAX transmittal, in order to assure access to the equipment. Receipt of FAX transmittals will not be acknowledged, except that the sender may request confirmation of receipt by calling the Executive Secretariat staff at 202–921–2815 (voice), 1–800–669–6820 (TTY), or 1–844–234–5122 (ASL video phone). • Mail: Raymond Windmiller, Executive Officer, Executive Secretariat, U.S. Equal Employment Opportunity Commission, 131 M Street NE, Washington, DC 20507. • Hand Delivery/Courier: Raymond Windmiller, Executive Officer, Executive Secretariat, U.S. Equal Employment Opportunity Commission, 131 M Street NE, Washington, DC 20507. Instructions: The Commission invites comments from all interested parties. All comment submissions must include the agency name and docket number (EEOC–2023–0005) or RIN (3046–ZA02) for this guidance. Comments need be submitted in only one of the abovelisted formats. All comments received will be posted without change to https://www.regulations.gov, including any personal information you provide. However, the EEOC reserves the right to refrain from posting libelous or otherwise inappropriate comments, including those that contain obscene, indecent, or profane language; that contain threats or defamatory statements; that contain hate speech directed at race, color, sex, national origin, age, religion, disability, or genetic information; or that promote or endorse services or products. ADDRESSES: E:\FR\FM\02OCN1.SGM 02OCN1

Agencies

[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.

-----------------------------------------------------------------------

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]
BILLING CODE 6560-50-P


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