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[Federal Register Volume 89, Number 224 (Wednesday, November 20, 2024)]
[Notices]
[Pages 91741-91742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-27058]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2024-0414; FRL-12308-01-OCSPP]

Pesticides; Draft Guidance; Evaluating the Efficacy of Pre-
Saturated/Impregnated Antimicrobial Towelettes for Disinfection Claims; 
Notice of Availability and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing the availability of and soliciting comment on its draft 
guidance for adding disinfectant efficacy claims against bacteria to 
antimicrobial towelettes for use on hard non-porous surfaces. 
Specifically, the guidance document describes a pathway for efficacy 
testing using a new standardized method designed specifically for 
antimicrobial towelettes, how to prepare an application for 
registration, and regulatory guidance for pesticidal claims for those 
products.

DATES: Comments must be received on or before January 21, 2025.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2024-0414, 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: Ryan Karcher, 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 20755-5350; telephone 
number: (410) 305-2860; 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 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 is the Agency's authority for taking this action?

    This guidance is issued under the Federal Insecticide, Fungicide, 
and Rodenticide Act, 7 U.S.C. 136 et seq.

C. What action is the Agency taking?

    EPA is announcing the availability of and soliciting comment on a 
draft guidance document that describes a pathway for efficacy testing 
using a new standardized method designed specifically for antimicrobial 
towelettes, how to prepare an application for registration, and 
regulatory guidance for pesticidal claims for those products. 
Specifically, the guidance describes the use of a standard test method, 
ASTM E3363, for adding for adding efficacy claims to pre-saturated 
antimicrobial towelettes for use on hard, non-porous surfaces against 
bacteria.

D. What are the incremental economic impacts of this action?

    This action has no substantive economic impacts because the draft 
guidance will not affect the regulatory status of any registration or 
application for registration of any pesticide product. Applicants are 
already required to conduct testing, and the adoption of this new 
testing method does not alter those requirements. The agency believes, 
however, that the draft guidance has the potential to reduce the 
regulatory burden by providing a more streamlined process for 
antimicrobial products intended to treat bacterial public health 
pathogens with pre-saturated/impregnated towelettes on hard, non-porous 
surfaces.

E. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI.
    Do not submit CBI to EPA through email or https://www.regulations.gov. 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 information that you 
claim to be CBI. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR parts 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

    Towelettes are a unique combination of antimicrobial chemical and 
towelette substrate pre-packaged as a unit in fixed proportions for 
application. Previous test methods used to evaluate the efficacy of 
antimicrobial towelettes were originally designed to test liquid 
formulations and had to be modified to accommodate towelettes. EPA 
received requests from registrants and stakeholders to implement use of 
the recently standardized efficacy method for assessing antimicrobial 
towelettes identified as ASTM E3363. Test method ASTM E3363 provides a 
specific and consistent means to assess the efficacy of towelettes 
through the combination of chemical inactivation of the test microbe 
and mechanical removal of inoculum from a surface.
    EPA received requests from registrants and stakeholders to 
implement use of the recently standardized efficacy method for 
assessing antimicrobial towelettes (ASTM E3363). EPA worked closely 
with stakeholders during the development of this test method. There is 
significant interest from stakeholders and the public in the 
availability of antimicrobial towelettes with these public health 
claims, particularly in institutional, clinical, and health-care 
settings.

III. Do guidance documents contain binding requirements?

    As guidance, these documents are not binding on the Agency or any 
outside parties, and the Agency may depart from it where circumstances 
warrant and without prior notice. While EPA has made every effort to 
ensure the

[[Page 91742]]

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: November 14, 2024.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2024-27058 Filed 11-19-24; 8:45 am]
BILLING CODE 6560-50-P
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