2024-27058. Pesticides; Draft Guidance; Evaluating the Efficacy of Pre-Saturated/Impregnated Antimicrobial Towelettes for Disinfection Claims; Notice of Availability and Request for Comment

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Environmental Protection Agency

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

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

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The Environmental Protection Agency (EPA or Agency) is announcing the availability of and soliciting comment on its draft guidance for adding disinfectant efficacy claims against bacteria to antimicrobial towelettes for use on hard non-porous surfaces.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: [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 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 ( print 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.