Notice2023-18549
Pesticides; Antimicrobial Product Efficacy Claims on Soft Surface Textiles in Non-Residential Settings; Guidance, Methods, and Response to Comments; Notice of Availability
Primary source
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Published
August 29, 2023
Effective
August 29, 2023
Issuing agencies
Environmental Protection Agency
Abstract
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 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).
Full Text
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<title>Federal Register, Volume 88 Issue 166 (Tuesday, August 29, 2023)</title>
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[Federal Register Volume 88, Number 166 (Tuesday, August 29, 2023)]
[Notices]
[Pages 59522-59523]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<a href="/cdn-cgi/l/email-protection#4526243735202b3120376b28243726052035246b222a33"><span class="__cf_email__" data-cfemail="2d4e4c5f5d484359485f03404c5f4e6d485d4c034a425b">[email protected]</span></a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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]
BILLING CODE 6560-50-P
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