Notice2022-27693
Pesticides; Evaluating the Efficacy of Antimicrobial Test Substances on Porous Surfaces in Non-Residential Settings; Interim Guidance and Methods; Notice of Availability and Request for Comments
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Published
December 21, 2022
Issuing agencies
Environmental Protection Agency
Abstract
The Environmental Protection Agency (EPA) is announcing the availability of and soliciting comment on interim guidance and methods for adding efficacy claims to antimicrobial products for use on porous materials, including fabrics, textiles, and upholstered items in non- residential settings. Specifically, EPA is seeking public comment on an interim guidance document that describes efficacy testing for antimicrobial products to support claims for use on surfaces of certain porous materials in clinical and institutional (non-residential) settings and how to prepare an application for registration, an interim quantitative method for evaluating the efficacy of antimicrobial products on porous surfaces against viruses, and an interim quantitative method for evaluating the efficacy of antimicrobial products on porous surfaces against bacteria. The interim guidance does not address residential use sites with surfaces such as upholstered furniture (including backing material/stuffing under the porous surface), carpets, rugs, draperies, etc. In addition to the feedback requested above, EPA is also seeking public comment on proposed carrier materials to represent the surfaces commonly found in residential settings.
Full Text
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<title>Federal Register, Volume 87 Issue 244 (Wednesday, December 21, 2022)</title>
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[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78105-78106]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-27693]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2022-0337; FRL-10497-01-OCSPP]
Pesticides; Evaluating the Efficacy of Antimicrobial Test
Substances on Porous Surfaces in Non-Residential Settings; Interim
Guidance and Methods; Notice of Availability and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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[[Page 78106]]
SUMMARY: The Environmental Protection Agency (EPA) is announcing the
availability of and soliciting comment on interim guidance and methods
for adding efficacy claims to antimicrobial products for use on porous
materials, including fabrics, textiles, and upholstered items in non-
residential settings. Specifically, EPA is seeking public comment on an
interim guidance document that describes efficacy testing for
antimicrobial products to support claims for use on surfaces of certain
porous materials in clinical and institutional (non-residential)
settings and how to prepare an application for registration, an interim
quantitative method for evaluating the efficacy of antimicrobial
products on porous surfaces against viruses, and an interim
quantitative method for evaluating the efficacy of antimicrobial
products on porous surfaces against bacteria. The interim guidance does
not address residential use sites with surfaces such as upholstered
furniture (including backing material/stuffing under the porous
surface), carpets, rugs, draperies, etc. In addition to the feedback
requested above, EPA is also seeking public comment on proposed carrier
materials to represent the surfaces commonly found in residential
settings.
DATES: Comments must be received on or before January 20, 2023.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2022-0337, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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#395a584b495c574d5c4b1754584b5a795c4958175e564f"><span class="__cf_email__" data-cfemail="e88b899a988d869c8d9ac685899a8ba88d9889c68f879e">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
This document 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 should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit CBI information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. In addition to one complete
version of the comment that includes information claimed as CBI, a copy
of the comment that does not contain the information claimed as CBI
must be submitted for inclusion in the public docket. Information so
marked will not be disclosed except in accordance with procedures set
forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
EPA received requests to develop interim test methods and an
associated registration process for antimicrobial products intended to
treat bacterial and viral public health pathogens on the surface of
porous materials. 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. Currently, most EPA-registered liquid-based
antimicrobial products are intended to treat hard, non-porous surfaces.
EPA is making available for comment interim quantitative efficacy
test methods for both bacteria and viruses on porous surfaces, in
addition to interim guidance for companies wishing to add specific
claims to antimicrobial products for efficacy against public health
pathogens when used on porous materials in clinical and institutional
(non-residential) settings. These materials include non-clothing
fabrics, textiles, and/or upholstery that may be laundered on an
infrequent (non-routine) basis where surface wiping and spot treatment
is the primary means of cleaning and or disinfection. Examples of non-
residential sites include waiting rooms and offices in clinical
settings, hospitals and long-term care facilities, schools, hotels,
movie theaters, office buildings, and retail establishments, with a
focus on high traffic areas and frequently used surfaces. The guidance
does not address claims for porous materials such as clothing,
untreated wood, concrete and other hard porous materials, carpet or
rugs, and the backing material/stuffing under the porous surface (e.g.,
beyond what can be visibly observed). The guidance does not address
claims for residual antimicrobial product efficacy when used on porous
materials.
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: December 15, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2022-27693 Filed 12-20-22; 8:45 am]
BILLING CODE 6560-50-P
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