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, 78105-78106 [2022-27693]
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Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices
SACC website. You may also subscribe
to the following listserv for alerts
regarding this and other SACC-related
activities: https://
public.govdelivery.com/accounts/
USAEPAOPPT/subscriber/new?topic_
id=USAEPAOPPT_101.
III. Virtual Public Meeting of the SACC
A. What is the purpose of this public
meeting?
The focus of the 4-day virtual public
meeting is the SACC peer review of the
following two draft documents:
• Draft Proposed Principles of
Cumulative Risk Assessment Under the
Toxic Substances Control Act; and
• Draft Proposed Approach for
Cumulative Risk Assessment of HighPriority Phthalates and a Manufacturer
Requested Phthalate Under the Toxic
Substance Control Act.
EPA will be soliciting comments from
the SACC on issues related to chemical
grouping for purposes of Cumulative
Risk Assessment (CRA), health
outcomes related to phthalate
syndrome, and possible approaches to
developing the cumulative hazard and
exposure assessment for High-Priority
phthalates and a ManufacturerRequested phthalate. In addition, EPA
intends to publish a separate document
in the Federal Register to announce the
availability of and solicit public
comment on the two draft documents, at
which time EPA will provide
instructions for submitting comments
and registering to provide oral
comments at the meeting. EPA also
intends to provide a meeting agenda for
each day of the meeting, and, as needed,
may provide updated times for each day
in the meeting agenda that will be
posted in docket and on the SACC
website.
lotter on DSK11XQN23PROD with NOTICES1
B. Why did EPA develop these
documents?
Between 2020 and 2022 EPA
published final scoping documents for
twenty High-Priority and three
Manufacturer-Requested chemical
substances for risk evaluation under
TSCA. During the scoping process, EPA
received comments from stakeholders
urging the Agency to consider
evaluating several chemical substances
undergoing risk evaluation for
cumulative risk to human health. TSCA
does not explicitly require EPA to
conduct cumulative risk assessments
(CRAs). However, TSCA does require
EPA to consider the reasonably
available information and to use the best
available science and to make decisions
based on the weight of scientific
evidence [15 U.S.C. 2625(h), (i), (k)].
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19:56 Dec 20, 2022
Jkt 259001
EPA recognizes that for some chemical
substances, the best available science
may indicate that the development of a
CRA is appropriate to ensure that any
risks to human health and the
environment are adequately
characterized.
1. Proposed principles of CRAs under
TSCA. EPA’s document entitled ‘‘Draft
Proposed Principles of Cumulative Risk
Assessment Under the Toxic Substances
Control Act’’ will describe the
fundamental principles of CRA of
chemical substances and how they may
be applied within the regulatory
requirements of TSCA to ensure TSCA
risk evaluations are based on the best
available science and are protective of
human health. This draft document is
not intended to be a framework nor a
guidance document on conducting
CRAs of chemical substances under
TSCA, and it will not address
cumulative impacts.
2. Proposed approach for a CRA of
phthalates under TSCA. Recognizing
that human exposure to phthalates is
widespread and that multiple phthalates
can disrupt development of the male
reproductive system in laboratory
animals at potentially human relevant
doses, EPA asked the National Research
Council (NRC) of the National
Academies of Science to review the
health effects of phthalates and
determine whether a cumulative risk
assessment of phthalates should be
conducted, and if so, what approaches
could be used for the assessment. In
2008, NRC published their findings to
EPA in a final report entitled
‘‘Phthalates and Cumulative Risk
Assessment: The Task Ahead’’ (https://
cfpub.epa.gov/si/si_public_record_
report.cfm?Lab=NCEA&
dirEntryId=202508). In that report, the
NRC recommended that a cumulative
risk assessment should be conducted for
phthalates. EPA’s document entitled
‘‘Draft Proposed Approach for
Cumulative Risk Assessment of HighPriority Phthalates and a Manufacturer
Requested Phthalate Under the Toxic
Substance Control Act’’ will describe
EPA’s proposed approach for evaluating
a subset of High-Priority and
Manufacturer-Requested phthalates for
cumulative risk to human health under
TSCA based on the principles of CRA
described in EPA’s draft principles
document referenced previously. EPA’s
draft proposed approach will follow
many of the recommendations made by
the NRC in 2008. This draft document
is not a CRA, and no risk estimates are
presented. Instead, this draft document
will outline several options EPA is
considering for conducting a phthalate
CRA under TSCA.
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78105
C. How can I access the documents
submitted for review to the SACC?
EPA is planning to release the two
draft documents mentioned above and
all background documents, related
supporting materials, and draft charge
questions provided to the SACC by late
February 2023. At that time, EPA will
publish a separate document in the
Federal Register to announce the
availability of and solicit public
comment on the two draft documents
and provide instructions for submitting
comments and registering to provide
oral comments. These materials will
also be available in the docket through
https://www.regulations.gov (docket ID
number EPA–HQ–OPPT–2022–0918)
and the SACC website. In addition, as
additional background materials become
available and are provided to the SACC,
EPA will include those additional
background documents (e.g., SACC
members and consultants participating
in this meeting and the meeting agenda)
in the docket and on the SACC website.
D. How can I participate in the virtual
public meeting?
The public virtual meeting will be
held via a webcast platform such as
‘‘Zoom.gov’’ and audio teleconference.
You must register online to receive the
webcast meeting link and audio
teleconference information. Please
follow the registration instructions that
will be announced on the SACC website
in February. You may subscribe to the
following listserv for alerts regarding
this and other SACC-related activities:
https://public.govdelivery.com/
accounts/USAEPAOPPT/subscriber/
new?topic_id=USAEPAOPPT_101.
Authority: 15 U.S.C. 2625(o); 5 U.S.C.
appendix 2 et. seq.
Dated: December 16, 2022.
Michal Freedhoff,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2022–27707 Filed 12–20–22; 8:45 am]
BILLING CODE 6560–50–P
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
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
E:\FR\FM\21DEN1.SGM
21DEN1
78106
Federal Register / Vol. 87, No. 244 / Wednesday, December 21, 2022 / Notices
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:
carpenter.marc@epa.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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
VerDate Sep<11>2014
19:56 Dec 20, 2022
Jkt 259001
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 (nonroutine) basis where surface wiping and
spot treatment is the primary means of
cleaning and or disinfection. Examples
of non-residential sites include waiting
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
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
ENVIRONMENTAL PROTECTION
AGENCY
[FRL–10506–01–OW]
Notice of Public Meeting of the
Environmental Financial Advisory
Board (EFAB) With Webcast
Environmental Protection
Agency (EPA).
ACTION: Notice of public EFAB meeting.
AGENCY:
The Environmental Protection
Agency (EPA) announces a public
meeting with a webcast of the
Environmental Financial Advisory
Board (EFAB). The meeting will be
shared in real-time via webcast and
public comments may be provided in
writing in advance or virtually via
webcast. Please see SUPPLEMENTARY
INFORMATION for further details. The
purpose of the meeting will be for the
EFAB to provide updates on the
SUMMARY:
E:\FR\FM\21DEN1.SGM
21DEN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
[[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]
BILLING CODE 6560-50-P
