Document ID: EPA-HQ-OPP-2022-0337-0001
Agency: epa
Document Type: Notice
Title: Pesticides: Evaluating the Efficacy of Antimicrobial Test Substances on Porous Surfaces in Non-Residential Settings; Interim Guidance and Methods
Posted Date: 2022-12-21T05:00Z

[Federal Register Volume 87, Number 244 (Wednesday, December 21, 2022)]
[Notices]
[Pages 78105-78106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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: 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 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 
regulations.gov 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 https://www.epa.gov/dockets/commenting-epa-dockets.

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]
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