[Federal Register Volume 88, Number 166 (Tuesday, August 29, 2023)]
[Notices]
[Pages 59522-59523]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-18549]


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ENVIRONMENTAL PROTECTION AGENCY

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


Pesticides; Antimicrobial Product Efficacy Claims on Soft Surface 
Textiles in Non-Residential Settings; Guidance, Methods, and Response 
to Comments; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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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

[[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: 
[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 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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