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###### Environmental Protection Agency

          - [Docket Id: EPA-HQ-OPP-2022-0337; FRL-10497-03-OCSPP]

# AGENCY:

Environmental Protection Agency (EPA).

# ACTION:

Notice.

# SUMMARY:

                        The Environmental Protection Agency (EPA) is announcing the availability of revised guidance and methods for adding efficacy claims to antimicrobial products for use on soft surface textiles in non-residential settings. Revisions to the guidance document and associated methods were made based on the Agency's consideration of public comments                               ( print page 59523)                            received. Specifically, EPA is announcing the availability of a guidance document that describes efficacy testing for antimicrobial products to support claims for use on soft surface textiles in clinical and institutional (non-residential) settings and how to prepare an application for registration, a quantitative method for evaluating the efficacy of antimicrobial products on soft surface textiles against viruses, and a quantitative method for evaluating the efficacy of antimicrobial products on soft surface textiles against bacteria. The guidance does not address residential use sites, clothing, frequently laundered items, untreated wood, concrete and other hard porous materials, carpet or rugs, or the backing material/stuffing under the soft surface textile (                        *e.g.,*                         beyond what can be visibly observed).                    

# DATES:

This guidance is effective on August 29, 2023.

# FOR FURTHER INFORMATION CONTACT:

                        Marc Carpenter, 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) 305-2927; email address:                         *carpenter.marc@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 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. How can I get copies of this document and other related information?

                    A copy of the documents are available in the docket under docket identification (ID) number EPA-HQ-OPP-2022-0337 at                     *https://www.regulations.gov.*

## II. Background

EPA received requests to develop test methods, guidance, and an associated registration process for antimicrobial products intended to treat bacterial and viral public health pathogens for use on soft surface textiles in non-residential settings. There is significant interest from stakeholders and the public in the availability of antimicrobial products with these public health claims, particularly in institutional, clinical, and health-care settings.

EPA announced the availability and sought public comments on an interim guidance document and test methods (87 FR 78105, December 21, 2022 (FRL-10497-01-OCSPP)). EPA received approximately 160 public comments, including comments regarding claim nomenclature, clarifications to the methods and revisions to the guidance. After considering the public comments, EPA is releasing revised test methods and guidance document, as well as a response to comments document.

                    The final guidance document and test methods describe efficacy testing for antimicrobial products to support claims for use on soft surface textiles in clinical and institutional (non-residential) settings and how to prepare an application for registration, a quantitative method for evaluating the efficacy of antimicrobial products on soft surface textiles against viruses, and a quantitative method for evaluating the efficacy of antimicrobial products on soft surface textiles against bacteria. This guidance does not address residential use sites, clothing, frequently laundered items, untreated wood, concrete and other hard porous materials, carpet or rugs, or the backing material/stuffing under the soft surface textile (                    *e.g.,*                     beyond what can be visibly observed).                

## 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 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: August 23, 2023.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.

[FR Doc. 2023-18549 Filed 8-28-23; 8:45 am]

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